SAJBL Vol 11, No 1 (2018)

ISSN 1999-7639

THE SOUTH AFRICAN JOURNAL OF

BIOETHICS & LAW JULY 2018 Vol. 11 No. 1

SAJBL is published by the Health and Medical Publishing Group.

THE SOUTH AFRICAN JOURNAL OF

BIOETHICS & LAW JULY 2018 Vol. 11 No. 1

CONTENTS

3

EDITORIAL The Life Esidimeni tragedy Arbitration award: A step in the direction of justice A Dhai

CORRESPONDENCE 4 Euthanasia and our worldview

J V Larsen

ARTICLES 5 Life Esidimeni deaths: Can the former MEC for health and

public health officials escape liability for the deaths of

the mental-health patients on the basis of obedience to

‘superior orders’ or because the officials under them were negligent?

D J McQuoid-Mason 8 Healthcare in crisis: A shameful disrespect of our Constitution

A Dhai, S Mahomed 11

Employer-generated complaints to the statutory registration authority: The regulatory framework for the supervision of employed health professionals in the South African public sector D T Hagemeister

15 Legal implications of data sharing in biobanking research

in low-income settings: The Nigerian experience

S O Akintola 20 What the contract does not say… A current analysis of

what’s missing in clinical trial agreements

G Agar, L J Burgess 24

Gender-affirming care in the context of medical ethics – gatekeeping v. informed consent A Tomson

29 Human guinea pigs? The ethics of undergraduate and

postgraduate student involvement in medical training

in South Africa

M de Roubaix 35

The need to develop objective criteria for suitability as a surrogate mother: Reflections on Ex Parte KAF D W Thaldar

38

Should the state fund assisted reproductive technologies for HIV-discordant couples in South Africa who want to have children?

A W Moodley

EDITOR Ames Dhai. Wits CO-EDITOR David McQuoid-Mason. UKZN EDITORIAL BOARD David J McQuoid-Mason. UKZN Freddy Mnyongani. UNISA Liz Gwyther. UCT Leslie London. UCT Peter Cleaton-Jones. Wits J P van Niekerk. HMPG Joseph Mfutso-Bengo. University of Malawi Godfrey B Tangwa. University of Yaounde Alexander Morgan Capron.

University of S California Daniel Wikler. Harvard TH Chan School HMPG CEO AND PUBLISHER Hannah Kikaya Email:hannahk@hmpg.co.za EXECUTIVE EDITOR Bridget Farham MANAGING EDITORS Claudia Naidu Naadia van der Bergh TECHNICAL EDITOR Kirsten Morreira PRODUCTION AND ADMINISTRATION MANAGER Emma Jane Couzens SENIOR DESIGNER Clinton Griffin CUSTOMER SERVICE AND ONLINE SUPPORT Gertrude Fani FINANCE AND ADMINISTRATION Tshepiso Mokoena HMPG BOARD OF DIRECTORS Prof. M Lukhele (Chair) Dr M R Abbas Mrs H Kikaya Dr M Mbokota Dr G Wolvaardt ISSN 1999-7639

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Can the consent provisions in the Choice on Termination of Pregnancy Act, which do not require children to be assisted by a parent or guardian, be used for live births by caesarian section in emergency situations?

D J McQuoid-Mason

REVIEW 46 Is there room for religious ethics in South African abortion law?

F Jogee FORUM 52 Witnessing injustice: What is the student’s role in

advocating for patients?

N Ramagaga 56

CPD

The SAJBL is published by the Health and Medical Publishing Group (Pty) Ltd, Co. registration 2004/0220 32/07, a subsidiary of SAMA. Suite 11, Lonsdale Building, Gardener Way, Pinelands, 7405 All letters and articles for publication must be submitted online at www.sajbl.org.za Tel. 021 532 1281/Email: publishing@hmpg.co.za

EDITORIAL

This open-access article is distributed under Creative Commons licence CC-BY-NC 4.0.

The Life Esidimeni tragedy Arbitration award: A step in the direction of justice Past issues of the South African Journal of Bioethics and Law have discussed the ethical violations and human rights abuses that were committed during the Life Esidimeni tragedy. This editorial describes some aspects of the subsequent Arbitration award.

A total of 144 mental healthcare patients died after their moves from the Life Esidimeni facilities, which began in October 2015.

An additional 1 418 were exposed to trauma and morbidity, but fortunately survived. Of these, the whereabouts of 44 patients remain unknown. The arbitration proceedings started on 9 October 2017, and lasted 4 months. The sittings were over 45 days, and 60 witnesses, of whom 12 were senior state officials, took the stand and gave evidence under oath. The Arbitration was established as a result of a recommendation by the health ombud, in his report that investigated the circumstances leading to the death of these patients. The core dispute to be resolved by the Arbitrator, Justice Dikgang Moseneke, was the nature and extent of equitable redress due to patients and their families. The arbitration process was also intended to achieve closure for the families.

Justice Moseneke aptly summarises the situation in the introduction to his report,[1] in which he states: ‘ This is a harrowing account of the death, torture and disappearance of utterly vulnerable mental healthcare users in the care of an admittedly delinquent provincial government. It is also a story of the searing and public anguish of the families of the affected mental healthcare users, and of the collective shock and pain of the many other caring people in our land and elsewhere in the world.’

The Arbitration found that there was an arrogant and forceful disregard for the regulatory regime that was set up in 1994 by the state for the care of mental healthcare patients, and that is aligned with international human rights and mental healthcare norms and standards. Accordingly, there were severe breaches of Constitutional obligations, resulting in justifiable Constitutional damages claims.

Both the former member of the executive council (MEC) of the Gauteng Department of Health and its head of department failed to explain the true reason why the contract with Life Esidimeni had been terminated, and diverted responsibility and accountability to a ‘decision of the collective’. Justice Moseneke places the reason for the death and torture that ensued as their irrational and unconstitutional decision to terminate the contract, but highlights the fact that the actual reason for this act of commission is still unknown, and hence true closure is still denied to families and the country.

The state argued that an amount of ZAR200 000 would be adequate recompense for the families of the deceased and for patients who had survived the tragedy. This would cover funeral expenses

and common-law general damages arising from pain, suffering and emotional shock. It resisted compensation for Constitutional damages. The Arbitrator found that this would not be equitable redress, and made a binding reward, with costs, of ZAR1 200 000 for most of the claimants. This was to be paid by the government in a lump sum by not later than 19 June 2018. Also awarded were the services of qualified mental healthcare practitioners to assess the counselling and support needs of the families and surviving patients, to be provided within a month of the date of publication of the award (19 March 2018). The required counselling and support services were to be provided immediately or within 30 days of the assessment.

The government was also directed to construct, at its exclusive expense and within a year of the publication of the award, a monument at an appropriate and prominent location to commemorate the suffering and loss caused by the tragedy, and also to serve as a reminder of the human dignity and vulnerability of mental healthcare patients. The health ombud and claimants were to be provided with the recovery plan for systemic change and improvement in the provision and delivery of mental healthcare by the Gauteng Department of Health. The government was to report to the health ombud and to the claimants within 6 months, and thereafter on a 6-monthly basis until the conclusion of the recovery plan. The government was also directed to promptly report or cause to be reported the conduct of the relevant healthcare practitioners to the Health Professions Council of South Africa and the South African Nursing Council, as appropriate. The government was to give notice to the health ombud and the claimants or their representatives of the steps it had taken, within 30 days of initiating these steps.

When drawing up the award, the Arbitrator was quite scathing about the conduct of senior officials in the Gauteng Department of Health. Their shameless abuse of the human rights of mental healthcare patients is unconscionable. The award is a step in the direction of justice for the victims of the tragedy and their families.

However, it remains to be seen how far the government will go with regard to delivery of the award.

Ames Dhai Editor ames.dhai@wits.ac.za 1. Moseneke J. The Life Esidimeni Arbitration Report. http://www.saflii.org/images/ LifeEsidimeniArbitrationAward.pdf (accessed 11 June 2018).

S Afr J Bioethics Law 2018;11(1):3. DOI:10.7196/SAJBL.2018.v11i1.650

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CORRESPONDENCE

This open-access article is distributed under Creative Commons licence CC-BY-NC 4.0.

Euthanasia and our worldview To the Editor: As a generation, we are ill-equipped to deal wisely with ethical issues such as euthanasia. Our culture has chosen a humanism that makes ‘man the measure of all things’ as our philosophy. We have held to that even though the philosophy has not been able to create a basis of meaning and values since René Descartes’ famous quote, ‘I think, therefore I am,’ in the 16th century. We know that the project has foundered for this reason in the pessimism of postmodernism, with its many contradictions.

Francis Schaeffer[1] points out that Jean-Paul Sartre (1905 - 1980) summed up the problem with his concept that a finite point is absurd if it has no infinite reference point. With respect to ethics and morals, Schaeffer states that ‘if there is no absolute moral standard, then one cannot say in a final sense that anything is right or wrong. By absolute we mean that which always applies, that which provides a final or ultimate standard. There must be an absolute if there are to be morals, and there must be an absolute if there are to be real values. If there is no absolute beyond man’s ideas, then there is no final appeal to judge between individuals and groups whose moral judgments conflict. We are merely left with conflicting opinions … we need absolutes if our existence is to have meaning.’

We have arrived at an ethical absurdity. We live in the torrent of a deteriorating culture, and we have no rock to cling to. And so we keep developing further ethical absurdities. For example, we say a fetus has no rights, and can be aborted for trivial reasons (in some jurisdictions up to term), yet we award huge compensation to mothers whose babies are born with cerebral damage because of perceived poor care of the fetus.

With no clear ethical absolutes, we struggle for wisdom in deciding whether to abandon ethical standards that have served our civilisation well down the centuries, and we turn to science for clarity and authority. But if we do not acknowledge that integrity in scientific endeavour also requires ethical absolutes, we have an unreliable authority. Without ethical absolutes, especially in the social sciences, a huge amount of work is produced with results carefully slanted toward proving an opinion already held by the researcher, usually one which is currently politically correct. A similar lack of wisdom can be detected in the laws we enact.

Part of the humanist ideal is the concept that we humans are no more than highly evolved mammals. When we make that judgment, we largely deny our humanness. The concept of the sanctity of human life is thrown out, together with the concept that we are made in the image of God. An important consequence is that we make much of physical wellbeing, but are generally soft on the psychological consequences of our decisions, and do not consider spiritual consequences at all. Our decisions are largely pragmatic, with little recognition of long-term realities.

In the West, our generation’s discussion around euthanasia is a good example of all this. We find ourselves trapped in discussions about the legal concepts of autonomous individuality and dignity, which we think can make ethically acceptable the killing of selected individuals.

But in our reductionist thinking, we deny a major aspect of our builtin humanness, the reverence for the life of another. Thus we suppress the essential importance of the high levels of post-traumatic stress disorder which expresses the guilt and grief experienced by family members and healthcare providers involved in active euthanasia and assisted suicide. We pretend that there are no spiritual aspects of dying which are cardinally important in managing that process. We deny the humanness of longing for eternal life, and the relevance of that in our decision-making.

We pay little attention to the slippery slope experienced by European nations, which have progressed from making euthanasia available only to those few suffering from terminal illnesses with uncontrollable distress, to making it available for the suicidally depressed and those simply weary of life. We do that rather than helping them to find meaning and direction. We even offer euthanasia to children. We are not alarmed that we are in danger of substituting euthanasia for caring.

We shrug our shoulders when medical aids offer incentives for going the assisted suicide route rather than the route of terminal care, to protect their bottom line.

We are not appalled by this utilitarian thinking, which makes it acceptable to offer euthanasia to people with illnesses such as motor neuron disease, so that we can reap their organs for reimplantation. We think that might make them feel useful.

It is salutary to consider that Nazi Germany began with the euthanasia of children with major congenital abnormalities, progressed to the mentally retarded and then the disabled before it got to genocide of the politically undesirable. But we are blind to the possibility that the political development of modern nations can easily go that way too.

We are losing our humanness – our reverence for the persons of others, especially the vulnerable. It really is essential that our nation does not join this process, but fiercely guards the sanctity of life and continues to oppose every attempt to add euthanasia to our practice of medicine.

J V Larsen Retired Obstetrician/Gynaecologist 1. Schaeffer F. How Should We Then Live? Old Tappan, New Jersey: Fleming H Revell Co. 1976:145.

S Afr J Bioethics Law 2018;11(1):4. DOI:10.7196/SAJBL.2018.v11i1.637

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ARTICLE

This open-access article is distributed under Creative Commons licence CC-BY-NC 4.0.

Life Esidimeni deaths: Can the former MEC for health and public health officials escape liability for the deaths of the mental-health patients on the basis of obedience to ‘superior orders’ or because the officials under them were negligent?

D J McQuoid-Mason, BCom, LLB, LLM, PhD Centre for Socio-Legal Studies, Howard College School of Law, University of KwaZulu-Natal, Durban, South Africa Corresponding author: D J McQuoid-Mason (mcquoidm@ukzn.ac.za)

Arising out of the reported evidence in the Life Esidimeni Arbitration hearings into the deaths of mental-health patients, the question arises as to whether the former member of the executive committee (MEC) for health, the mental health director, the head of the department of health and the project manager can use the defence of ‘superior orders’ to escape criminal or civil liability. Can the former MEC for health escape liability, by blaming the mental health director, the head of the department of health and the project manager for the deaths, as she did in her evidence? It is suggested that based on the reported evidence, neither the former MEC for health nor the mental health director, the head of the department of health nor the project manager can escape liability for negligently causing the deaths of the patients. They could all be prosecuted for culpable homicide, and in some instances – depending on the results of the arbitration hearings – be held liable to compensate surviving mentally ill patients for physical or psychological harm, and the families of deceased patients for psychological harm.

S Afr J Bioethics Law 2018;11(1):5-7. DOI:10.7196/SAJBL.2018.v11i1.640

During the Arbitration hearings on the Life Esidimeni tragedy, it emerged that the then-member of the executive committee (MEC) for health ordered the removal of 1 700 long-term mental health patients from state-funded care at the private Life Esidimeni facilities to 122 community non-governmental organisations (NGOs), and to some less expensive state hospitals in 2016. During the process, mentally ill patients were transported from private psychiatric facilities ‘like cattle on the back of open bakkies, to ill-equipped and unlicensed NGOs, where unqualified staff had no idea how to care for them’.[1] It was reported that by the end of January 2018, 143 patients had died,[1] and the number may have increased since then. It was stated that the former MEC for health and other public health officials had ignored ‘protests, pleas, warning after warning, and even court action by activists’.[1] The former MEC, in her evidence, said: ‘I cannot carry personal blame because I wasn’t working for myself. I was an elected official’.[1] In this capacity she was ‘busy with political work’, and only doing ‘MEC work in between’ when the news about the deaths became public.[1] She maintained that it was the fault of the mental health director, the head of department and the project manager – not her. She further claimed, correctly so, that the Public Finance Management Act No. 1 of 1999[2] and the Public Service Act No. 103 of 1994[3] precluded MECs from becoming involved in the day-to-day management of the department of health.[1] However, according to witnesses, she appeared to have done precisely what the Acts prohibited her from doing. For instance, witnesses stated that the former MEC was ‘fixated on cancelling the Life Esidimeni contract’.

The mental health director and head of the department both stated that ‘she would not take advice from anyone and … ruled by fear’.[1] For instance, the head of the department said that ‘he was too scared to stand up to her’. The mental health director stated that she was merely following the orders issued by the former MEC and the head of the department.[1] The former MEC herself had also claimed that she had been forced to end the contract because of pressure by the Auditor General. She said that the contract ‘had not been subject to tender and budget constraints’. However, the MEC for finance said during the Arbitration hearings that there was no evidence to support this.[4] MECs for health are political appointees who should not interfere with the day-to-day running of provincial departments of health.[2] Heads of departments of health are the line functionaries responsible for the day-to-day running.[2] The criminal and civil liability of MECs for health and public health officials for their intentional or negligent wrongful conduct leading to the deaths of patients has been dealt with elsewhere.[5,6] If they act with ‘eventual intention’, whereby they subjectively foresaw that their act or omission could kill someone if they did not take corrective action, they may be guilty of murder.[7] If they negligently fail to take reasonable steps to prevent the deaths, they may be guilty of culpable homicide.[6] In either instance, apart from any criminal sanctions – depending on the results of the Arbitration hearings – they could all be liable to compensate surviving mentally ill patients for physical and psychological harm, or the families of deceased patients for psychological harm.[5]

July 2018, Vol. 11, No. 1 SAJBL

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ARTICLE In light of the above, the question arises as to whether, if they were sued civilly or prosecuted criminally, the former MEC for health, the mental health director, the head of the department of health and the project manager could use the defence of ‘superior orders’ to escape liability, and whether the former MEC for health could escape liability by blaming the mental health director, the head of the department of health and the project manager for the deaths.

When can subordinates escape criminal and civil liability for harming patients by raising the defence of obedience to ‘superior orders’?

The law regarding ‘superior orders’ has only been used in criminal cases, but similar principles will apply to civil actions for delict.[8] A person may raise the defence of ‘superior orders’ provided that: (i) the order is given by a person who has lawful authority over the subordinate; (ii) there was a duty on the subordinate to obey the order; and (iii) the subordinate must have done no more harm than was necessary to carry out the order.[9] Determining whether or not the order was lawful is the most difficult part of the defence, because – even if the other elements are satisfied – subordinates do not have an absolute duty of obedience ‘where the order is grossly illegal’.[10] As a general rule, a person may not raise the defence of ‘superior orders’ if the person knew that the order was unlawful, or the order was ‘manifestly unlawful’, in which case the court may infer that the person raising it ‘ought to have realised the manifest illegality of the order’.[7] However, if subordinates can show that the superior had threatened them with harm, ‘possibly bodily harm or death’, if they did not carry out the orders, the subordinates may raise the defence of ‘compulsion’ or ‘necessity’, which would negate their fault.[7]

Can the former MEC for health, the mental health director, the head of the department of health and the project manager escape liability for the deaths by raising ‘superior orders’ as a defence?

The former MEC for health claimed that she had been pressurised by the Auditor General to cancel the contract with Life Esidimeni – but there was no evidence to support this. Even if she had been pressurised by the Auditor General, she would have to establish the three criteria listed above to mount an adequate defence of ‘superior orders’. She is likely to fail on all three: the Auditor General does not have the lawful authority to tell her to transfer patients to save costs incurred from using private facilities if it would put patients at risk.

There was no duty on her to obey such an order if it would lead to patients being transferred to unlicensed facilities with untrained staff that might result in their deaths. Finally, even if she did have a duty to obey, she would be at a loss to show that by transferring patients to such unlicensed facilities with untrained staff she had done no more harm than was necessary to carry out the order. On the contrary, she should have made sure that the patients were transferred to NGOs that were licensed, with qualified staff. In short, she would not be able to show that as a result of having to obey ‘superior orders’, she was not at fault and had acted lawfully.

The same principles would apply to the mental health director, the head of department and the project manager. Despite the former MEC claiming that legislation prohibited her from dealing with the

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day-to-day administration of the Life Esidimeni project, the evidence was that she had interfered and assumed authority over it. She herself admitted in her evidence that in terms of the Public Finance Management Act and Public Service Act, she had no legal authority to do so.[1] Therefore, the public health officials could not claim that she had lawful authority over them. However, if she did have such authority, for the same reasons as those that apply to the former MEC, they also could not claim that there was a duty on them to obey her ‘manifestly unlawful’ orders, or that they had not caused more harm than was necessary, by allowing the mentally ill patients to be transferred to unlicensed facilities with untrained staff, which led to their deaths.

Can the former MEC for health escape liability by blaming the mental health director, the head of the department of health and the project manager for the deaths?

It is trite to say that the former MEC, at the time, could have been sued vicariously in her representative capacity for the harmful negligent conduct of public health officials in the department of health. However, when it comes to personal liability, as previously mentioned, the former MEC for health maintained that the Public Finance Management Act and the Public Service Act precluded her, as an MEC, from becoming involved in the day-to-day management of the department of health.[1] This being so, the interferences by her were illegal, and maybe she could be prosecuted in terms of both Acts. The question remains, however, as to whether under the common law she can escape liability by blaming the mental health director, the head of the department of health and the project manager for the deaths.

As a general rule, under the common law, a person who is in a position to control another person’s unlawful conduct, and who ought to have foreseen that a failure to prevent such conduct from occurring will harm another, must take reasonable steps to prevent such harmful occurrence from happening. If he or she fails to take such preventive steps, the person in control may be held personally liable, together with the person engaging in such harmful conduct, for any harm suffered by others.[8] An example is the case of independent contractors, where the person employing the independent contractor can tell the contractor what to do, but not how to do it. In such circumstances, the employer is not liable for the negligence of the independent contractor (e.g. a surgeon and an anaesthetist in the operating theatre),[8] unless the employer takes control and orders the contractor to engage in unlawful conduct.[9] Where there is a danger to another, the courts will apply the ordinary principles of negligence, and consider whether the harm was reasonably foreseeable and preventable by the employer.[8] Here, direct liability rather than vicarious liability is imposed on the person in control. It makes no difference whether the person who assumed control was acting legally or illegally. Therefore, in the Esidimeni case, the former MEC cannot escape liability on the basis that the wrongful acts and omissions were the fault of her subordinates – not her – because she was busy campaigning for her political party and was only doing ‘MEC work in between’.[1] Once she directly interfered in the administration of the project, by ordering the transfers of mentally ill patients to unlicensed and unqualified NGOs and some

ARTICLE state hospitals to take place, she should have closely monitored the situation – especially after protests, pleas, warnings and the results of court action were reported to her and the other public health officials by activists.[1] Her failure to do so because of her duties as a politician was gross negligence on her part.

Furthermore, as indicated above, the subordinates who obeyed the unlawful orders issued by the former MEC to engage in wrongful conduct cannot themselves escape liability on the basis of obedience to ‘superior orders’ – except in very limited circumstances, if they had feared for their lives or were threatened with serious bodily injury.[7]

Conclusion There was no evidence to support the claim by the former MEC for health that she had to cut costs in the department of health. Even if there was such evidence, she cannot escape liability for the deaths of the mentally injured patients who were transferred by raising the defence of ‘superior orders’. Such a defence would only apply if she feared death or serious bodily injury had she failed to comply – which is most unlikely. Likewise, the mental health director, the head of the department of health and the project manager cannot escape liability for their negligent conduct in causing the deaths of the patients, unless they too can show that they obeyed the orders of the former MEC because they feared death or serious bodily injury had they failed to comply – also extremely unlikely.

The former MEC also cannot escape liability for the deaths by blaming the mental health director, the head of the department of health and the project manager for the deaths, because once she assumed control by directly ordering the transfers of the patients to take place, she should have closely monitored the situation, and not focused on campaigning for her political party. Such conduct amounts to gross negligence on her part – particularly as warnings and complaints had been communicated to her and the other public health officials.

In the result, the former MEC for health, the mental health director, the head of department and the project manager were all guilty of negligence and could be charged criminally with culpable homicide.[4] They could also be sued civilly by the surviving mentally ill patients for physical and psychological harm, and by the families of the deceased patients for psychological harm.[12] Acknowledgements. None.

Author contributions. Sole author.

Funding. National Research Foundation.

Conflicts of interest. None.

1. Kotze A, Lopez Gonzalez L, Malan M. Life, death and political gain. Johannesburg: Mail & Guardian 2018, January 26 - February 1:15.

2. South Africa. Public Finance Management Act No. 1 of 1999.

3. South Africa. Public Service Act No. 103 of 1994.

4. Van Dyk J. Life Esidimeni: Officials could face culpable homicide charges.

Johannesburg: Mail & Guardian 2018, February 16 - 22:22-23.

5. McQuoid-Mason DJ. Public health officials and MECs for health should be held criminally liable for causing the death of cancer patients through their intentional or negligent conduct that results in oncology equipment not working in hospitals. S Afr J Bioethics Law 2017:10(2):83-85. https://10.7196/SAJBL.2017. v10i2.00611 6. McQuoid-Mason DJ. Public health officials and MECs should be held liable for harm caused to patients through incompetence, indifference, maladministration or negligence regarding the availability of hospital equipment. S Afr Med J 2016;106(7): 681-683. http://dx.doi.org/10.7196/samj.2016. v106i7.10722. https://10.7196/SAMJ.2016.v106i7.10722.

7. Burchell J. Principles of Criminal Law. 3rd ed. Cape Town: Juta and Co. Ltd, 2006.

8. Loubser M, Midgley, Mukheiber A, Niesing, Perumal D. The Law of Delict in South Africa. Cape Town: Oxford University Press Southern Africa, 2010.

9. S v Banda 1990 (3) SA 466 (B).

10. R v Smith (1900) 17 SC 561.

11. S v Kramer 1987 (1) SA 877 (W).

12. Cf. Barnard v Santam Bpk 1999 (1) SA 202 (SCA).

Accepted 22 May 2018.

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ARTICLE

This open-access article is distributed under Creative Commons licence CC-BY-NC 4.0.

Healthcare in crisis: A shameful disrespect of our Constitution A Dhai,1 PhD, MB ChB, FCOG, LLM, PGDip Int Res Ethics; S Mahomed,2 BCom, LLB, LLM, PhD 1 2

Steve Biko Centre for Bioethics, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa School of Law, College of Law, University of South Africa, Pretoria, South Africa

Corresponding author: A Dhai (ames.dhai@wits.ac.za)

Healthcare in South Africa (SA) is in crisis. Of the complaints received by the health ombud, 40% are from Gauteng Province. Despite the dire shortage of human resources, the Gauteng Department of Health has decided not to fill vacated posts. As a result, the training of registrars and medical students suffers. Legal constraints have also created an impasse between tiers of government, allowing for near self-governance with impunity at the provincial offices. The public sector provides healthcare access to 84% of patients in SA, and this group is being denied access to healthcare in the country. The fundamental right to healthcare is affirmed in the Constitution; however, its implementation is riddled with impediments. Urgent intervention is necessary to address the crisis.

S Afr J Bioethics Law 2018;11(1):8-10. DOI:10.7196/SAJBL.2018.v11i1.649

In the wake of the Life Esidimeni tragedy Arbitration, Prof. Malegapuru Makgoba, the South African (SA) health ombud, on 4 June 2018, expressed his concerns on ‘The Modise Network’ that SA’s public healthcare system was on the verge of collapse. Since his appointment in 2016, he had received over 2 000 complaints, of which 40% were from Gauteng Province.[1] The Minister of Health, Dr Aaron Motsoaledi, subsequently acknowledged that the healthcare system was ‘very distressed’. While attributing this ‘distress’ to the exponential growth of the burden of disease, he also acknowledged that management skills in most of the hospitals were poor, and stated that at that time, 200 officials had been sent from the department’s head office to assist with management issues. He confirmed that there also were many other problems, including overcrowding, long waiting lists for treatment, irregular buying of goods, poor financial management and a chronic shortage of human resources.[2] Despite the dire human resources situation, the Gauteng Department of Health has decided not to fill posts once they have been vacated. The SA Committee of Medical Deans has expressed concerns that posts have been frozen by the department because it is cash-strapped. This means that fewer specialists-in-training (registrars) will be employed after they qualify. A further concern is that specialists are not replaced in vacant posts created by resignations or retirements.

Thus too few teachers are left to train registrars and medical students.

Dr Motsoaledi has expressed his anxiety about the three training centres in Gauteng losing training capacity, which is particularly concerning because Gauteng trains the largest number of doctors in Africa. He stated that he would impress on the province the need to fill its posts, but unfortunately, he has no power over provinces because of legal constraints.[3] This is because legislation has created an impasse between tiers of government, allowing for near self-governance with impunity at the level of provincial offices.

Because of salary disputes, non-payment of bonuses and lack of salary increases, the National Education, Health and Allied Workers’

Union (NEHAWU) embarked on strike action in the healthcare sectors in the North West and Gauteng provinces, despite this not being compliant with the Labour Relations Act No. 66 of 1995. They stopped providing services, prevented patients from entering hospitals, closed medicine depots, trashed hospital corridors, erected burning barriers outside hospitals, stoned vehicles including ambulances and threatened or otherwise prevented healthcare professionals from treating patients. Security personnel and even the police were reluctant to intervene.[4,5] Of all patients in SA, 84% access healthcare in the public sector,[6] which this group is being denied. In the main, they are SA’s most vulnerable poor. They are the victims of failing leadership, incompetent management, poor governance, legislative constraints and strikes amongst workers in essential services. They are forced to bear the associated burdens of morbidity and mortality. Poor people are more vulnerable than others to a range of illnesses, and may also experience poor healthcare because of a lack of access.[7] This vulnerability is further heightened by institutional and functional failures that further impede access.

SA’s healthcare is clearly in intensive care, and urgently needs rigorous resuscitation. We review the right to healthcare in the context of international and regional human rights instruments, and discuss relevant laws and the SA Constitution. Specific reference is made to the Gauteng Department of Health, because most of the complaints received by the health ombud come from this province, and it trains the largest number of doctors in Africa.

The right to health – international instruments The right to health is enshrined in the Universal Declaration of Human Rights, several international treatises and the Constitution of the World Health Organization (WHO). This right was first articulated in 1946, in the WHO’s Constitution, the preamble of which states that

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ARTICLE ‘the enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being, without distinction of race, religion, political belief, economic or social condition.’[8] Health was included as an aspect of the right to an adequate standard of living in the 1948 Universal Declaration of Human Rights.[9] The International Covenant on Economic, Social and Cultural Rights of 1966 is widely considered as the cornerstone of international human rights law, in terms of the protection of the right to health.

It affirms the ‘right of everyone to the enjoyment of the highest attainable standard of physical and mental health’.[10] This is similar to the statement in the WHO Constitution. The right to health is also established regionally in the African Charter on Human and People’s Rights (the Banjul Charter).[11] Freedoms and entitlements are embedded in the right to health. Freedoms include informed choice. The provision of equal opportunities for everyone to enjoy the highest attainable level of health is a constitutionally safeguarded entitlement. The right to health refers to the ‘right to the enjoyment of a variety of goods, facilities, services and conditions necessary for its realisation.’[12] Despite the notion of ‘highest attainable standard’ being decreed by international human rights law, it lacks direction on its meaning and attainment. This deficiency in specificity and enforcement are major gaps in achieving health rights on the ground. Within their available resources, member states are free to make determinations on its progressive realisation. Without any tangible obligation, a default position of not realising the right to health because of resource constraints could ensue. This is the situation that has arisen at the level of the provincial offices in SA.

The SA Constitutional right to healthcare Section 27 of the Bill of Rights of the Constitution of the Republic of SA[13] affirms everyone’s right to access to healthcare services, including reproductive healthcare. Within its available resources, the state has an obligation to take reasonable legislative and other measures to achieve the progressive realisation of this right. The Bill of Rights also establishes that no one may be refused emergency medical treatment. Legislative and policy measures towards SA’s Constitutional mandate on the progressive realisation of health include the National Health Act No. 61 of 2003 (NHA)[14] and the Patients’ Rights Charter.[15] The NHA serves to provide a uniform framework for a structured health system in the country. It recognises the socioeconomic injustices, imbalances and inequities of the past, and the need to improve the quality of life of all citizens and free the potential of each person in the country.

Regarding children, section 28 of the Constitution affirms every child’s right to healthcare services, but unlike section 27, contains no qualification based on available resources for its progressive realisation. It defines a child as a person under the age of eighteen, and states that in every matter concerning the child, his or her best interests are of paramount importance. The Children’s Act No. 38 of 2005[16] enacts certain rights of children, as stipulated in the Constitution. Similarly to the NHA, it promises to improve quality of life and free each person’s potential. However, it also underscores the need to extend particular care to children, as decreed in several international human rights instruments, including the Geneva Declaration of the Rights of the Child, the United Nations Declaration on the Rights of the Child, the Convention on the Rights of the Child,

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the Universal Declaration of Human Rights and the African Charter on the Rights and Welfare of the Child.

The right to healthcare is closely linked to the Constitutional rights to life (section 11) and dignity (section 10), because not obtaining necessary treatment could result in grave morbidity impacting dignity, or in death. Lack of access to healthcare has resulted in the death of 144 patients, as evidenced in the Life Esidimeni tragedy Arbitration.[17] Justice Dikgang Moseneke stated during the hearings that the right to human dignity is ‘critical to a meaningful departure from the oppression of the apartheid era. Colonialism and apartheid were the antithesis of human dignity. The recognition of the self-worth of each individual, regardless of their circumstances, is a prerequisite to the achievement of our constitutional values, and therefore our democratic project.’[17] Several non-derogable rights, including the extents to which these are protected, are listed in the Constitution. The rights to life and dignity are entirely non-derogable. With access to healthcare being denied to many of our country’s patients, the impact of violating health access on two fundamental non-derogable rights creates a grave situation.

The duties imposed by the Constitution As stated in the Life Esidimeni Arbitration Report,[17] the Constitution is binding on all organs of state and every state official entrusted with public power. Section 8 (1) states that ‘the Bill of Rights applies to all law, and binds the legislature, the executive, the judiciary and all organs of state.’ The Constitution imposes overarching duties on those delegated to exercise public power. Essential to this is the need to be faithful to the law. Public officials must act within the constraints of the law, and avoid unlawful conduct. The founding values of openness, responsiveness and accountability in the exercise of public power that affects all people in the country are embedded in the Constitution’s democratic practices.[17] The Constitution sets high values and principles for officials in the public service and public administration must respect these, including holding to ‘a high standard of professional ethics, using public resources in an efficient, economic and effective manner, providing services impartially, fairly, equitably, and without bias, and being responsive to people’s needs’.[17] Schedule 2, section 5 of the Constitution[13] requires the provincial premiers and members of the executive councils to swear an oath or take a solemn affirmation to be faithful to the country and uphold the Constitution and all other laws, and to undertake to hold one’s office with honour and dignity, and to perform the functions of one’s office conscientiously and to the best of one’s ability.

The legal bottleneck According to section 104 of the Constitution, provincial authority includes the power to legislate with regard to any Schedule 4 matter, including health services, as a concurrent competency. However, where there is a conflict between national legislation and a provision of a provincial constitution with regard to a Schedule 4 matter, then national legislation applies, subject to specific conditions (section 147(1)(c) read with section 146 of the Constitution). National legislation that applies uniformly to the whole country will prevail over provincial legislature where the national legislation is necessary to promote equal access to government services (section 146 (2 )(c)).

National legislation will also prevail over provincial legislation where

ARTICLE the national legislation is aimed at preventing unreasonable action by a province that is prejudicial to the health interests of the country as a whole (section 146(3)(a) Constitution). The NHA provides specific roles and functions for national (section 3) and provincial (section 25) government. Provincial governments are empowered to develop and implement policy, removing the need for centrality of power.

Conclusion Freezing posts to address the poor financial management that has resulted in healthcare being in distress is not being responsive to the needs of patients; it further intensifies their suffering. It also demonstrates the inability of hospital management to respond to patients’ needs fairly and effectively. Clinics and surgical slates being cancelled, longer waiting times, increasing morbidity and mortality and increasing adverse events, resulting in a worsening of the country’s medicolegal storm, illustrate complications arising from such a decision. Furthermore, the horrific impact on the training of practitioners and specialists will be overwhelming. Such an action is an irrational abuse of public power, and unlawful conduct in conflict with the Constitutional duties imposed on those delegated to exercise such power.

When a province fails to fulfil an executive obligation in terms of the Constitution or legislation, appropriate steps may be taken by the national executive to ensure its fulfillment. This could be achieved by issuing a directive to the provincial executive describing the extent of its failure to fulfil its obligations, and stating the steps necessary to address these, as set out in section 100(1)(a). Section 100(1)(b) allows for the national executive to assume responsibility for the relevant obligations to the extent necessary to maintain essential national standards or meet established minimum standards for the rendering of a service. It can be argued that it is time for the national executive to exercise section 100(1)(b), and take over the responsibility of healthcare delivery in provinces such as Gauteng, as it has done in North West.[18] The healthcare crisis gripping the country, and some provinces in particular, is evidence again that while SA has one of the most laudable Constitutions globally, its implementation is riddled with impediments. This is further compounded by the impasse created by the legal constraints between national and provincial governments.

Decision-makers impinge adversely on the rights of 84% of our country’s patients, and shamefully disrespect our Constitution.

Impeding access to healthcare impacts human dignity and disregards the self-worth of each individual. For healthcare to be nursed out of intensive care, urgent interventions, including exercising section 100(1)(b), are necessary. Medium- and long-term interventions must include addressing legal obstacles and leadership failures, and improving management skills. Furthermore, strikes and protests in the healthcare context must be dealt with appropriately, through relevant legal channels and via law enforcement.

Acknowledgements. None.

Author contributions. Equal contributions.

Funding. None.

Conflicts of interest. None.

1. ENCA. SA healthcare system on verge of collapse: Health Ombudsman. ENCA, 4 June 2018. http://www.enca.com/south-africa/watch-sa-healthcare-system-onverge-of-collapse-health-ombudsman (accessed 6June 2018).

2. Mkize V. Health minister outlines plan of action. News24, 10 June 2018. https:// www.news24.com/SouthAfrica/News/health-minister-outlines-plan-ofaction-20180609? (accessed11 June 2018) 3. Child C. Medical specialists crisis: ‘If you don’t fill these posts, the whole health structure will collapse’. TimesLive, 6 June 2018. https://www.timeslive.co.za/ news/south-africa/2018-06-06-medical-specialists-crisis-If-you-don’t-fill-theseposts-the-whole-health-structure-will-collapse/ (accessed11 June 2018).

4. Masweneng K. ‘Patient dies during strike in Klerksdorp hospital’ Sunday Times, 25 April 2018. https://www.timeslive.co.za/news/south-africa/2018-04-25-patientdies-during-strike-in-klerksdorp-hospital/ (accessed 4 June 2018).

5. Medical Brief. ‘Mahikeng doctor defies strike violence to deliver babies’ Medical Brief, 2 May 2018. https://www.medicalbrief.co.za/archives/mahikeng-doctordefies-strike-violence-deliver-babies/ (accessed 6 June 2018).

6. South Africa. Department of Health White Paper: National Health Insurance Policy: Towards Universal Health Coverage, 2017. http://www.health.gov.za/ index.php/component/phocadownload/category/383 (accessed 10 June 2018) 7. Vergunst R, Swart L, Mji G, Kritzinger J, Braathen SH. Beyond the checklist: Understanding rural health vulnerability in a South African context. Glob Health Action 2016;9(1):33272. http://doi.org/10.3402/gha.v9.33272 8. World Health Organization. Constitution of the World Health Organisation.

Geneva: WHO, 1946. http://apps.who.int/gb/bd/PDF/bd47/EN/constitution-en. pdf?ua=1 (accessed 1 October 2017).

9. United Nations. The Universal Declaration of Human Rights. Geneva: UN, 1948. http:// www.un.org/en/universal-declaration-human-rights/ (accessed 1 October 2017).

10. United Nations. International Covenant on Economic, Social and Cultural Rights.

Geneva: UN, 1976. http://www.pwescr.org/PWESCR_Handbook_on_ESCR.pdf (accessed 1 October 2017).

11. Organisation of African Unity. African Charter on Human and People’s Rights.

Banjul: OAU, 1986. https://hrnjuganda.org/wp-content/uploads/African-Charteron-Human-and-Peoples-Rights.pdf (accessed 1 October 2017).

12. United Nations, World Health Organization. The Right to Health. UN Fact Sheet No. 31. Geneva: UN, WHO, 2008. http://www.ohchr.org/Documents/Publications/ Factsheet31.pdf (accessed 1 October 2017).

13. Constitution of the Republic of South Africa, 1996. Chapter 2: Bill of Rights. https://www.gov.za/documents/constitution/chapter-2-bill-rights (accessed 1 October 2017).

14. South Africa. The National Health Act No 61 of 2003. https://www.gov.za/sites/ www.gov.za/files/a61-03.pdf (accessed 1 October 2017).

15. South Africa. The Patients’ Rights Charter. Pretoria: HPCSA, 1999. http://www. hpcsa.co.za/downloads/conduct_ethics/rules/generic_ethical_rules/booklet_3_ patients_rights_charter.pdf (accessed 1 October 2017).

16. South Africa. Children’s Act No. 38 of 2005. http://www.hpcsa.co.za/Uploads/ editor/UserFiles/downloads/legislations/acts/childrens_act_38_2005.pdf (accessed 10 June 2018).

17. Moseneke J. The Life Esidimeni Arbitration Report. http://www.saflii.org/images/ LifeEsidimeniArbitrationAward.pdf (accessed 11 June 2018).

18. Gerber J. Cabinet places North West Health Department under Administration.

News24, 26 April 2018. https://www.news24.com/SouthAfrica/News/cabinetplaces-north-west-health-dept-under-administration-20180426 (accessed 10 June 2018).

Accepted 18 June 2018.

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ARTICLE

This open-access article is distributed under Creative Commons licence CC-BY-NC 4.0.

Employer-generated complaints to the statutory registration authority: The regulatory framework for the supervision of employed health professionals in the South African public sector D T Hagemeister, BA, MPH, EMMB, FAfAllgMed, DA, Dip HIV Man, DIRE Department of Family Medicine, Faculty of Health Sciences, University of the Free State, Bloemfontein, South Africa Corresponding author: D T Hagemeister (hagemeisterdt@ufs.ac.za)

Work as an employed health professional comes with a great number of challenges. Health professionals are often oblivious to the legal and regulatory framework that governs their employment situation. At least three legal frameworks are of relevance in each employer-employee relationship in the South African public healthcare sector, namely the Labour Relations Act, the Public Service Act and the profession-specific Acts such as the Health Professions Act, the Nursing Act or the Pharmacy Act, respectively. Starting with two cases where the professionspecific Act has been used by the employer against the employed health professional, rather than the legislation regulating the employeremployee relationship, it will be illustrated how the three Acts and their regulatory environment are structured. Based on this illustration, the impact that the creation of employer-generated complaints has on the employer-employee relationship, and on the system at large, will be discussed.

S Afr J Bioethics Law 2018;11(1):11-14. DOI:10.7196/SAJBL.2018.v11i1.628

As health professionals in South Africa (SA), we are facing huge challenges: the deteriorating situation in the public health service, the questionable sustainability of the private health sector, massive disease burdens and the social determinants of (ill) health. This is compounded by ever-increasing medicolegal litigation, and the suboptimal functioning of statutory professional bodies.

Recently, a sinister development has emerged, which will be referred to as ‘employer-generated complaints’. These occur when the line managers of health professionals submit (or instruct others to submit) complaints to the statutory registration authority (e.g. the Health Professions Council of SA (HPCSA)) about healthcare professionals whom they supervise as line managers.

In the following, I will present two cases from the Free State Province public health sector. A review of the legal and regulatory framework for the supervision of clinical personnel in the public sector and for the labour relations of employed healthcare professionals will follow. Taking into account the regulatory framework, the matter of ‘employer-generated complaints’ will be discussed.

Case 1: Allegation of violation of privacy as possible retaliation for a whistleblower report The Free State Department of Health has been subject to harsh criticism from civil society groups, such as the Treatment Action Campaign[1] and Section27.[2] In February 2015, an online article very critical of the circumstances in the province’s health facilities was published, illustrated with photographs.[3] Subsequently, this clinician was subjected to questionable acts by line managers. This

included a visit by a provincial manager, who introduced himself as investigating officer in a case of ‘alleged misconduct’. The meeting had been arranged by the targeted clinician’s direct line manager.

Despite producing a letter appointing him as investigating officer, signed by a higher-level manager, this ‘investigating officer’ was unable or unwilling to specify the alleged misconduct. No other communication, such as for example an ‘audi’-letter (see below), was ever received regarding this ‘misconduct’.

Three months later, communication from the HPCSA, the medical practitioners’ statutory professional body, indicated that a complaint about the clinician had been received. A copy of the complaint was attached, which had been submitted by the direct line manager, who in very vague wording implied that his supervisee might have violated a patient’s right to privacy. The HPCSA found that no evidence of unprofessional conduct could be established.

Case 2: ‘Collective’ reporting of alleged unprofessional behaviour In this case, the ‘target’ of the HPCSA complaint had been ‘transferred’ to another health facility without consultation or consent (a process later labelled ‘unfair demotion’ by the commissioner in arbitration, and subsequently reversed). The role of the targeted clinician in the new facility had not been clarified after 5 months. A grievance had recently been submitted, which eventually led to the mentioned arbitration. A younger colleague, recently qualified as a specialist, acted as head of the clinical section where the targeted clinician was performing teaching ward rounds.

During one of these ward rounds the targeted clinician, a seasoned specialist, was correcting common errors in the management of

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ARTICLE patients, a situation the addressed medical officer responded to by first disappearing from the ward round, and then by an outburst of insults against the consultant after the ward round. Without obtaining any details about the actual incident from the more senior consultant, this incident was reported to the HPCSA by the junior consultant the day after the incident took place, in poor English and effectively implicating both clinicians involved. In subsequent discussions between this consultant and the principal consultant, the former apologised for this, quoting both ‘instructions from line managers’ and a ‘need to report any incident to the HPCSA’ (sic). Like in many a process submitted to the HPCSA, the HPCSA has yet to finalise this ‘case’, more than 12 months after the submission of statements.

Legal and regulatory framework

The HPCSA and its duty ‘to guide the professions and to protect the public’[4] The HPCSA is a statutory body created under the Health Professions Act No. 56 of 1974 (HPA),[4] as amended (section 2), with the SA Nursing Council (SANC) and the SA Pharmacy Council (SAPC) created under the respective Acts for these other professions.[5,6] It is the statutory registration authority for a wide range of health professions, including medical and dental practitioners, medical scientists, physiotherapists, occupational therapists and speech therapists, radiographers and paramedics. The Minister of Health, on the recommendation of the HPCSA, establishes professional boards for one or more profession(s) falling under the Act (section 15). For medical and dental practitioners, this is the ‘Medical and Dental Board’. According to the HPA, the composition and functions of these professional boards are governed by regulations issued by the Minister of Health.[7] The professional boards have, inter alia, the power to register or deregister health professionals, to regulate education and training in the profession(s) and to establish committees as necessary.

Chapter IV of the HPA deals with the ‘Disciplinary Powers of Professional Boards’. On its website, the Medical and Dental Board of the HPCSA lists four ‘Medical Committee(s) of Preliminary Inquiry’ and a ‘Dental Committee of Preliminary Inquiry’ among its 19 committees.[8] Process and responsibilities for inquiries into unprofessional conduct have been regulated by the Minister of Health,[9] and there is the position of an ombudsman ‘to mediate in the case of minor transgressions’ (regulation 3).

As to the expected standards of ethical behaviour and professional performance, the Committee for Human Rights, Ethics and Professional Practice of the HPCSA has compiled booklets on expected standards of ethical behaviour and professional performance on a number of topics, which have been promulgated in the Government Gazette and can be found on the council’s website.[10] Similarly, SANC has published a ‘Code of Ethics for Nursing Practitioners in SA’.[11] The HPCSA’s website also gives guidance on how to launch a complaint against a health professional, and it lists, inter alia, ‘Improper conduct’ and ‘Disclosure of information […] without permission’ as possible cases of unprofessional conduct.[12]

The Public Service Act, Public Service Regulations and the Public Service Commission SA’s 1996 Constitution[13] makes provisions for the Public Administration and the Public Service within the Public Administration (sections 195 to 197). The Public Service Act Proclamation No. 103[14] was passed by Parliament in 1994. Revised

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Public Service Regulations came into effect on 1 August 2016, and contain a comprehensive ‘Code of Conduct’ (chapter 2).[15] This Code of Conduct stipulates that an employee (of the public sector) shall be familiar and compliant with relevant legislation (section 11(d)), shall not abuse the position to favour a political party or other interest group (12(f )), shall show respect for rights and dignity of every person (12(g)), shall not unfairly discriminate against anybody (13(j)) and shall ‘be committed to the optimal development, motivation and utilisation of employees reporting to him or her and the promotion of sound labour and interpersonal relations’ (14(h)).

Under section 196 of the SA Constitution, the Public Service Commission was established. The powers and functions of this commission include, as per section 196 4(f )II, ‘to investigate grievances of employees in the public service concerning official acts or omissions, and recommend appropriate remedies’.[13]

Section 23(1) of the SA Constitution and the Labour Relations Act SA’s 1996 constitution introduced and guarantees, among many other achievements, the right of everybody to fair labour practices.

Concurrently, the Labour Relations Act No. 66 of 1995 (LRA)[16] was passed to realise these rights. The LRA establishes bargaining councils for the public sector. Bargaining councils bring together representatives of the employees (e.g. trade unions) and of the employer, with the purpose of concluding collective agreements that regulate the relationship between the two sides. For the public sector, i.e. for the situation where the employer is the (SA) state and the employees are public servants, the LRA (section 35) establishes a ‘Public Sector Co-ordinating Bargaining Council’[17] for the general public service as well as sectoral bargaining councils.

For the health services, a sectoral bargaining council, the ‘Public Health and Social Development Sectoral Bargaining Council’,[18] was established in terms of section 37 of the LRA. The co-ordinating bargaining council has concluded resolution 2 of 1999 to adopt the ‘Disciplinary Code and Procedures for the Public Service’,[19] and amended it with resolution 1 of 2003.[20] These resolutions establish clear processes for the handling of disciplinary enquiries in the public service, including sanctions and the suspension of public employees for disciplinary reasons, and even prescribe a ‘spirit’ for the disciplinary process, in that ‘discipline is a corrective measure and not a punitive one’.[20] The Disciplinary Code also determines the process and time limits for the appeal process against disciplinary sanctions. Through these resolutions, the co-ordinating bargaining council provides guidance on disciplinary matters for the entire public sector.

In contrast to the general applicability of the co-ordinating bargaining council’s resolutions, the sectoral bargaining council concerns itself with matters that are specific to the health (and social development) service delivery field, such as the ‘Occupation Specific Dispensation for Medical and Dental Professionals’.[21,22] Currently, there are no sector-specific disciplinary codes (or codes of conduct) for the SA public health sector.

In summary, the three bodies of legislation relevant for health professionals in the public sector are those laws regulating the health professions themselves (the HPA, Nursing Act, Pharmacy Act), those regulating the public service and administration and those regulating labour relations, each with their respective regulations, which are

ARTICLE issued by three different ministers: the Ministers of Health, Public Service and Administration and Labour, respectively.

Discussion Using the above legal frameworks, ‘employer-generated complaints’ will be discussed from three different perspectives: the situation of the targeted employee, the role of the reporting supervisor and the impact on the general (healthcare) system.

Situation of the implicated employee Employed health professionals, like all employees, have a constitutional right to fair labour practices. The Disciplinary Code mandates that the employee needs to be both informed and heard about the alleged misconduct (section 5). Typically, this happens through an ‘audi’ (et alteram partem – Latin for ‘also hear the other party’) letter. An employee would expect open engagement from his or her line manager in the case of an alleged misconduct, including the right to appeal against a sanction. ‘Employer-generated complaints’ omit this step, in favour of submitting allegations without investigation to the statutory registration authority. The employee’s basic right to be heard is denied.

But could the inquiry by the statutory registration authority not replace the disciplinary process by the employer, especially if there are allegations of serious misconduct or breach of professional rules? Any healthcare professional who has experienced an inquiry by a body such as the HPCSA will agree that the very fact of a registration authority inquiry results in an existential fear about his or her own professional future. As the clinician is well advised to seek legal advice, the inquiries are often slow and cumbersome in their proceedings, in stark contrast to the spirit of the Disciplinary Code, in which ‘discipline must be applied in a prompt, fair, consistent and progressive manner’ (section 2.2). The impact of such inquiries on the clinician’s mental health[23] and on doctor-patient relationships[24] has been described in the literature.

In summary, ‘employer-generated complaints’ cause significant emotional damage. Anger and frustration experienced by clinicians exposed to such processes negatively affects both their ability to deliver quality care, and their general quality of life. Instead of the corrective effect intended in the Disciplinary Code, this results in cynicism or ‘mental/inner resignation’ by the employee, and often in a breakdown of communication with line managers.

Role of the supervisor/line manager The Code of Conduct for the Public Sector, as seen above, makes clear statements regarding supervisors’ responsibilities towards their supervisees, including ‘sound labour and interpersonal relations’.

How do the Public Service Regulations relate to the constitutional right to fair labour practice, and to the supervisor’s choice to pursue an investigation under the health professions legislation rather than the LRA? Assuming good faith on the side of the supervisor, one would argue that possibly the transgression might be of such seriousness that it would put patients (or at least the public employer’s reputation) at risk. In that case, more than ever, the Disciplinary Code should be applied, and the employee would need to be suspended. Proceedings at the HPCSA often drag out over years, and are certainly anything but a ‘quick fix’ to an urgent situation, especially compared with the tools provided by the labour relations processes. It is critical that

the supervisor investigates the alleged transgressions in a timely manner, and acts on the findings, which could include reporting to the professional body at a later stage. Omitting to establish the facts of the case and to act decisively might aggravate the potential risk.

In the assumption of good faith, this would suggest inappropriate labour relations skills, resulting in an ‘accidental’ use of inappropriate approaches. Poor or absent advice to the manager from institutional labour relations personnel might contribute to this. Even a line manager acting in good faith might thus be guilty of a dereliction of duty by not following appropriate processes to investigate a supervisee’s alleged misconduct. The supervisor does not only fail to comply with the principles of the Code of Conduct, but might put patients and the employer at risk. If the supervisor is a registered healthcare professional, such transgression might even constitute unprofessional and unethical conduct, which in return might require an investigation into such conduct by the statutory registration authority.

But what if other unfair actions have occurred from the line manager’s side against the employee? For example, if one were to assume that the line manager might not have acted in good faith, but rather out of morally deficient motives, such as to intimidate the employee, or to protect the interests of a specific political party or interest group?

In such case, obviously, most of the considerations mentioned above regarding the supervisor’s potential transgressions would still apply, such as the dereliction of duty to follow proper labour relations processes, or the unprofessional and unethical behaviour of a health professional. However, in the case of such bad faith, the supervisor would also violate the Code of Conduct’s abovementioned principles: 12 (f), to ‘not abuse his or her position … to promote or prejudice the interest of any political party or interest group’; 12 (g), to ‘respect and protect the dignity of every person and his or her rights as contained in the Constitution’; and 13 (j); to ‘deal fairly, professionally and equitably with all other employees or members of the public, irrespective of race, gender, ethnic or social origin, colour, sexual orientation, age, disability, religion, political persuasion, conscience, belief, culture or language’. In the absence of lawful reason and with malicious intent, such an action might even qualify as a criminal offence under the Intimidation Act No. 72 of 1982.[25]

Impact on the system at large There are numerous negative consequences of ‘employer-generated complaints’ on the system at large. Firstly, a breakdown of trust between the clinician(s) and management occurs. In an underresourced system where too few clinicians are battling daily to prevent disasters, an experience in which line managers report supervisees to the registration authority without investigating the circumstances will (further) demotivate the workforce. Clinicians may fear that they would be ‘sold out’ in the case of fatal health outcomes, if accused of negligence even without any omission. They would fear being trapped between the allegations of patients or family members on one side, and an unsupportive employer on the other. As a soughtafter resource, clinicians are likely to vote with their feet and leave such an offensive public system.

Secondly, ‘employer-generated complaints’ undermine the functioning of the systems regulating conduct of employed clinicians, the labour relations system and the statutory registration authority’s complaints system. The essential consensus on the disciplinary system between the employees (and their unions) and the employer is destroyed. In many cases, the disciplinary system has been abused as an oppressive rather

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ARTICLE than a corrective tool, denying the employee’s right to fair labour practice, as realised in the right to correct procedures and the right to appeal a decision. The utter bypassing of the disciplinary system devaluates its role further.

Complaints systems at statutory bodies are generally seen as a redress for patients or their family members in cases where they feel harmed by clinicians, not as a heavy-handed management tool for line managers. Further caseload to systems that struggle to achieve decent turnaround times worsens the trauma experienced by the clinicians under investigation.[23] Being seen as a tool for intimidation by the employer rather than an independent body overseeing the profession might reduce the statutory body’s credibility.

Thirdly, matters that should have been investigated and resolved in the workplace are instead ‘inflated’ to medicolegal cases. The financial burden shifts from the labour relations environment, where the financial risk lies with the labour representation/trade union, to the malpractice environment. A lawyer’s involvement to protect the interests of the clinician adds further to the upwardly spiralling fees for malpractice cover from the Medical Protection Society and others.

Summary and conclusion As discussed above, ‘employer-generated complaints’ typically occur when a line manager, based on vague suspicions and hearsay, reports a healthcare professional to the statutory registration authority without having properly investigated the facts of the alleged transgression. In this way, the prescribed processes, as delineated in the Disciplinary Code, are ignored. Often, such action from the line manager’s side lacks the ‘corrective spirit’ demanded in the Disciplinary Code, and instead seems to display an intention to intimidate.

This constitutes a dereliction of duty by the respective line managers, as the action not only infringes on the employee’s constitutional right to fair labour practice, but may even put patients and the employer’s reputation at risk. This weakens the public service and undermines the integrity of the labour relations framework and the credibility of the statutory authorities.

Recommendations To prevent abuse of the complaint system for intimidation of employees, complaints processes should include a mandatory declaration from the complainants, declaring their role as supervisor and possible reasons for not having investigated the allegation.

Line managers and labour relations officers should be adequately trained regarding the regulatory framework provided by the Public Service Act and the LRA, as well as the reporting and protection mechanisms of the professional bodies. These matters should be included in the performance assessment of such officials. If we want to sustain the public service, compliance with ethical and legal principles is more important than obedience to misguided principals. A health-sector-specific code of conduct might assist this process.

Acknowledgements. The author thanks Ms T Mulder, medical editor, School of Medicine, University of the Free State, for technical and editorial preparation of the manuscript.

Author contributions. Sole author.

Funding. None.

Conflicts of interest. None.

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1. Treatment Action Campaign. Stop the Free State Health Crisis. Cape Town: TAC, May 2018. https://tac.org.za/news/free-state-state-of-health/ (accessed 2 July 2018).

2. Section27. Spotlight. AIDS Durban 2000 - 2016. Johannesburg: TAC and Section27, July 2016. http://section27.org.za/wp-content/uploads/2017/02/000-spotlight15-web.pdf (accessed 8 April 2017).

3. Daily Maverick. GroundUp: How the Free State health system is being destroyed – whistleblowers’ account. 27 February 2015. https://www.dailymaverick.co.za/ article/2015-02-27-groundup-how-the-free-state-health-system-is-beingdestroyed-whistleblowers-account/# (accessed 21 August 2017).

4. South Africa. Health Professions Act No. 56 of 1974 (as amended by Health Professions Amendment Act No. 29 of 2007) 5. South Africa. Nursing Act No. 23 of 2005.

6. South Africa. Pharmacy Act No. 53 of 1974 (as amended by the Veterinary and Para-Veterinary Professions Amendment Act, No. 10 of 2002).

7. Health Professions Council of South Africa. Legislation. General Rules & Regulations. http://www.hpcsa.co.za/Legislation/Rules (accessed 20 March 2017).

8. Health Professions Council of South Africa. Professional Boards. Medical and Dental (and Medical Science) Committees. http://www.hpcsa.co.za/PBMedicalDental/ Committees (accessed 20 March 2017).

9. South Africa. Health Professions Act No. 56 of 1974. Regulations relating to the Conduct of Inquiries into alleged unprofessional Conduct under the Health Professions Act. Government Gazette No. 31859, 2009 (Published under Government Notice R102).

10. Health Professions Council of South Africa. Professional Conduct & Ethics.

Conduct and Ethics. http://www.hpcsa.co.za/Conduct/Ethics (accessed 20 March 2017).

11. South African Nursing Council. Code of Ethics for Nursing Practitioners in South Africa. http://www.sanc.co.za/pdf/Learner docs/SANC Code of Ethics for Nursing in South Africa.pdf (accessed 24 March 2018).

12. Health Professions Council of South Africa. Complaints. Lodge Complaint. http:// www.hpcsa.co.za/Complaints/LodgeComplaint (accessed 21 August 2017).

13. South Africa. Constitution of the Republic of South Africa, Act No. 108 of 1996 (as amended by the Constitution of South Africa Second Amendment Act No. 3 of 2003).

14. South Africa. Public Service Act. Proclamation No. 103 of 1994.

15. South Africa. Public Service Act 103 of 1994. Public Service Regulations.

Government Gazette No 40167, 2016 (published under Government Notice R877).

16. South Africa. Labour Relations Act No. 66 of 1995 (as amended by Legal Aid South Africa Act, No. 39 of 2014).

17. Public Service Co-ordinating Bargaining Council. https://www.pscbc.org.za (accessed 8 April 2017).

18. Public Health and Social Development Sectoral Bargaining Council. http://www. phsdsbc.org.za (accessed 11 June 2017).

19. Public Service Co-ordinating Bargaining Council. Resolution 2 of 1999.

Disciplinary Code and Procedures for the Public Service. Pretoria: PSCBC, 1999. https://www.pscbc.org.za/index.php/collective-bargaining/psbc-resolutionsdocman/1999/38-resolution-2-of-1999-adoption-of-disciplinary-code-andprocedures-for-ps/file (accessed 8 April 2017).

20. Public Service Co-ordinating Bargaining Council. Resolution 1 of 2003.

Amendment to Resolution 2 of 1999. Disciplinary Code and Procedures for the Public Service. Pretoria: PSCBC, 2003. https://www.pscbc.org.za/index.php/ collective-bargaining/psbc-resolutions-docman/2003/96-resolution-1-of-2003/ file (accessed 8 April 2017).

21. Public Health and Social Development Sectoral Bargaining Council. Resolution 03 of 2009. Occupational Specific Dispensation (OSD) for Medical Officers, Medical Specialists, Dentists, Dental Specialists, Pharmacologists, Pharmacists and Emergency Care Practitioners. Pretoria: PHSDSBC, 2009. http://www.phsdsbc. org.za/agree/Resolution%203%20of%202009.pdf (accessed 11 June 2017).

22. Public Health and Social Development Sectoral Bargaining Council. Resolution 01 of 2010. Agreement on the Addendum to PHSDSBC Resolution 3 of 2009: Occupational Specific Dispensation (OSD) for Medical Officers, Medical Specialists, Dentists, Dental Specialists, Pharmacologists, Pharmacists and Emergency Care Practitioners. Pretoria: PHSDSBC, 2010. http://www.phsdsbc. org.za/agreements/PHSDSBC%20Resolution%2001%20of%202010.pdf (accessed 11 June 2017).

23. Horsfall S. Doctors who commit suicide while under GMC fitness to practice investigation. Internal review. London: General Medical Council, December 2014. http://www.gmc-uk.org/Internal_review_into_suicide_in_FTP_processes. pdf_59088696.pdf (accessed 31 May 2017).

24. Cunningham W. The immediate and long-term impact on New Zealand doctors who receive patient complaints. N Z Med J 2004;117(1198):U972.

25. South Africa. Intimidation Act No. 72 of 1982 (as amended by Internal Security and Intimidation Amendment Act No. 138 of 1991 and Criminal Law Second Amendment Act No. 126 of 1992).

Accepted 27 March 2018.

ARTICLE

This open-access article is distributed under Creative Commons licence CC-BY-NC 4.0.

Legal implications of data sharing in biobanking research in low-income settings: The Nigerian experience S O Akintola, LLB, BL, LLM, PhD Department of Private and Property Law, Faculty of Law, University of Ibadan, Nigeria Corresponding author: S O Akintola (simiakintola@yahoo.com)

It is increasingly recognised that effective and appropriate data sharing in biobanking research requires the development of models of good data-sharing policy capable of ensuring that the rights and privacy interests of participants are protected. However, the effectiveness and efficacy of biobank research depend on data and samples. In the same vein, making such data available to the research community generates tension between two important goals: advancing scientific goals, and protecting the individual privacy interests of the tissue source. More critically, data sharing requires the development of models that promote an environment in which privacy rights and interests of participants are protected throughout the lifecycle of biobank initiatives. Many ethical issues are raised when genomics research is conducted on populations characterised by lower average income and literacy levels, such as populations included in lower-middle income countries (LMICs). These issues are further exacerbated in Nigeria by cultural and religious inflections. In this paper, to analyse the implications of data sharing within the legal framework of an LMIC, an analysis of existing laws in Nigeria was conducted. It was discovered that there were no provisions relating directly to data sharing, and its governance framework could only be gleaned from the patchwork of laws on privacy and confidentiality in Nigeria. There is a need for ethical guidelines in Nigeria to be adapted to the changing landscape of science, which increasingly involves storage and secondary use of samples and data. Current laws are inadequate for the challenges presented by biobanking.

S Afr J Bioethics Law 2018;11(1):15-19. DOI:10.7196/SAJBL.2018.v11i1.601

There are ethically sound reasons for research to be conducted on diseases affecting populations with lower average income and literacy levels. Despite evident global inequalities existing in health measures such as mortality, quality of life and disease incidence,[1] only a small proportion of medical research focuses on the problems primarily affecting the world’s poorest people.[2] It has been argued that applying the methods of genomics/biobanking research to these diseases is one way to address this imbalance.[3] Increasingly, biobanks have become a strategic tool in the field of biotechnology and genomics. In fact, the current century has been referred to by Francis Collinsas the ‘genome era,’ both in science and in medicine.[4] Authorities in many European countries, including the UK biobank[5] and the German National Ethics Council[6] have noted the potential of biobanks for the identification of causes and the treatment of diseases. Although the definition of ‘biobank’ is not settled, and is multifaceted, it usually refers to a large collection of human biological tissue specimens and related data.[7] Biobanks have, over the years, become an important means of gaining further understanding of the multifactorial nature of diseases.[8] Biobanks, as large collections of both tissue samples and data, serve as a platform for enabling the sharing of samples and data for research, which will ultimately lead to improved health outcomes and personalised medicine.[9] Underpinning the significance of data sharing in biobank research is a growing call for its recognition as a priority for the success of research,[10] particularly in the context of biobanking research where tissue samples in the form of DNA, cell lines, tissue, plasma, medical information and blood samples have become essential tools for research and analysis, to seek and identify

biomarkers and drug targets for diseases. However, sharing data and samples in genomic research via biobank platforms raises a number of legal and ethical challenges, regardless of where it is carried out.[11] Some of these issues include consent,[12] privacy[13] and the collection, storage and release of genomic data.[14] Despite the existence of a substantial and developing literature on the ethical and legal issues arising from sharing data in biobank research, this literature has as yet not adequately addressed the specific legal challenges presented by genomics research to the legal systems of lower-middle income countries (LMICs) such as Nigeria. De Vries et al.[15] conclude that there is a need for guidelines in African countries to be adapted to the changing landscape.

The shift to genomic research and data sharing has been facilitated by funding from sponsors such as the USA, through the National Institutes of Health, and the UK Wellcome Trust, which has encouraged collaboration in this regard.[16] However, there has not been as much development in the legal frameworks and administration of justice in the field of genomic research. In discussing the development of a governance framework, at a global level that guarantees equity and fairness in biobank collaboration, Chen et al.[17] explain that LMICs struggle with data sharing in genomic research for many reasons, including culture, religious beliefs and inadequate ethical and legal frameworks. In Nigeria, the focus of this paper, the legal framework on research is largely developmental, consisting of a patchwork of various legislation, which also does not augur well for consistency and precision in terms of determining the pervading jurisprudence for this area.

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ARTICLE The aim of this paper is to analyse and explore data sharing in biobank research in Nigeria as a low-income setting, focusing on the regulatory instruments that apply directly or tangentially to data sharing and biobank research. In analysing this, the article examines the legal implications of data sharing for research participants in lowincome settings such as Nigeria. It describes how data sharing tests current principles, and discusses ways of resolving these challenges.

It should be noted, however, that this discussion is not exhaustive, as the legal and cultural implications of data sharing in biobanking research are broad.

Biobanking research in Nigeria Nigeria has recently demonstrated its commitment to, and support for genomic research. It is one of only six countries (with Canada, China, Japan, the UK and the USA) involved in the International HapMap Project. Genomic research continues in Nigeria, and the Nigerian government, institutions and scientists are committed to genome science and research. Through the intervention of the national government, the Nigerian Biotechnology Development Agency (NABDA)[18] was established in Abuja, promoting biotechnology across disciplines in health and agriculture. Universities and research institutes also receive foreign grants to fund training and research on genomic technology and biobanking research, as in the case of the Institute of Medical Research and Training (IMRAT) in the Department of Virology, University of Ibadan, Nigeria.[19] However, despite Nigeria being a pioneering member of the international consortium of genomics, the development of a legal regulatory framework in the country has been slow,[20] in the sense that local capacity is struggling to keep pace with the regulatory and ethical challenges associated with genomic and biobank research.

For instance, although some of the nation’s tertiary hospitals have tissue collections, the size and specific concentration of each repository are unknown. There is a biobank in the country, affiliated with the Institute of Human Virology in Nigeria (IHVN), known as the H3Africa (Human Heredity and Health in Africa) biobank. The H3Africa consortium is an international collaboration of scientists engaged in developing genomic research capacity in Africa. The biobank currently has 45 358 samples in storage. IHVN also operates two repositories in Jos, a capital city in the Middle Belt of Nigeria, and Zaria, a major city in Kaduna state in Northern Nigeria. With respect to data sharing, informed consent and protection of health information, inter alia, the H3Africa biobank in Nigeria does not have an independent internal policy guideline, and therefore has to rely on those issued by appropriate authorities such as the National Health Research Ethics Committee (NHREC) in Nigeria, and in some cases the H3Africa consortium. Nonetheless, remarkable progress has been recorded in terms of the operation of the biobank.[20] At present, the three biorepositories can support long- or short-term storage of samples that require –20 or –80oC storage, and the biorepository at the National Tuberculosis and Leprosy Training Centre, Kaduna, supports the storage of TB isolates and other Mycobacteria.[20] The following paragraphs examine the Nigerian legal framework on privacy, data, data sharing and human rights, to evaluate the relationship between data sharing and the laws in Nigeria. The Nigerian legal framework on privacy and data sharing includes statutes, case law, policies and guidelines.

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Privacy and the Nigerian Constitution Generally, data sharing is the practice of making data used for scholarly research available to other investigators. In genomic research, data sharing is a significant characteristic that allows secondary use of data in future, unspecified research. In this regard, data sharing poses several problems with respect to trust, privacy and uncontrolled secondary use of data, among other issues.[21] Protection of individual privacy interests is governed by legal instruments in most democracies of the world. Although privacy is not an absolute right, derogating or interfering with this right must be justified by law as being in the public interest. In Nigeria, the 1999 Constitution of the Federal Republic of Nigeria[22] provides for a fundamental human right to privacy in the following terms: ‘The privacy of citizens, their homes, correspondence, telephone conversations and telegraphic communications is hereby guaranteed and protected.’

From the above, although there is no express mention of genomic or biobanking research, it is evident that Nigeria recognises and protects the right of all its citizens to privacy. It is arguable that sharing personal data as correspondence, electronically or via telecommunication, without the consent of the individual, can infringe an individual’s right to privacy.

National Information Technology Data Agency Guidelines Section 2 of the National Information Technology Data Agency (NITDA) guidelines requires that a data controller shall protect the privacy of natural persons with respect to the collection and processing of personal data, in accordance with their prescription.

It also requires that data processing shall not take place without the consent of the data subject, who in this case is a Nigerian citizen. The NITDA is the national authority responsible for planning, developing and promoting the use of information technology in Nigeria. It is the body saddled with the responsibility of issuing guidelines that prescribe the minimum data-protection requirements for the collection, storage, processing, management, operation and technical controls of information. The guidelines regulate all organisations or persons that control, collect, store and process personal data of Nigerian residents within and outside Nigeria, for the protection of a specific category of data commonly known as personal data, or object-identifiable information.[23]

The Freedom of Information Act, 2011[24] The Freedom of Information Act, 2011 is: ‘an Act to make public records and information freely available, provide for public access to public records and information, protect public records and information to the extent consistent with the public interest and the protection of personal privacy, protect serving public officers from adverse consequences for disclosing certain official information and establish procedures for the achievement of those purposes and related purposes thereof.’[25] The Act deals with information in the custody of public institutions, which may include personal and genetic data such as that contained in national biobanks. It would appear that the objective of the Act is

ARTICLE to provide access to public information that the Official Secrets Act, 1962[26] hitherto withheld from Nigerians. Again, providing access or sharing data creates an inherent conflict between the right to privacy on the one hand, and the right to know on the other. The reason for this potential conflict is evident: laws of data protection and privacy are primarily concerned with the restriction of disclosure of information, while freedom of information laws, by design, are meant to facilitate general access to information.[27] Even though the Nigerian Freedom of Information Act[28] does not specifically cover genetic information, it can be safely deduced that genetic information in national biobanks may be within the purview of the Official Secrets Act.[29] Other than these deductions, there is no judicial interpretation on record of this in relation to genetic information.

Other attempts at legislation There have been several attempts at legislating data protection in the recent past by the Nigerian legislature. Apart from the Nigerian Cyber Crime Act, 2015, several Bills have been drafted that address areas relating to data sharing in Nigeria; however, to date, most have not yet been passed into law. Some of these are: the Computer Security and Critical Information Infrastructure Protection Bill, 2005;[30] the Cyber Security and Data Protection Agency Bill, 2008;[31] the Nigeria Computer Security and Protection Agency Bill, 2009;[32] and the Computer Misuse Bill (Amendment) Bill 2010.[33]

Implications of data sharing While biobanking research presents both legal and ethical challenges regardless of where it is conducted, prospective participants in LMICs are more likely to be affected by them, given the inadequate legal framework surrounding data sharing.[34,35] Coupled with this is the fact that a greater number of the population are poor and have limited access to healthcare, education and other resources. This means that the carrying out of research in these settings invariably presents challenges of a different order than those in higher-income countries. In the following section, the paper explores some of the challenges presented by genomic research for law relating to privacy and obtaining valid consent, both generally and in LMICs.

Informed consent When individuals provide information about themselves for medical treatment, or even medical research, the parameters of informed consent are relatively clear, in the sense that there is a presumption that such consent was obtained from a competent research subject or patient who was given adequate disclosure of information at the point of recruitment.[36] In other words, individuals must be told what uses their information and samples will be put to, and standard notices of privacy practices inform patients that their information may be used in lieu of treatment payment, or healthcare operations.

In biobank research, however, it is usually not as clear-cut. The possibility of future use in research is a characteristic of biobank/ genomic research, posing the question of the permissibility of later research use. In addition to this, designing consent processes for biobanking/genomic research in low-income settings presents peculiar challenges, such as language and cultural inflexions.[37] For instance, there are difficulties in providing information in a comprehensible manner to participants in genomics research, or

finding synonyms in local dialects to convey information necessary to give consent.[38] In genomics, these challenges are presented by the need to explain concepts such as ‘genetics’, ‘genomics’ and ‘data release’, and the reasons underlying the need to collect large quantities of samples and data from healthy populations for controls.[39] Aside from this, one of the peculiarities of genomic research is that the data produced have the potential to affect others, in the sense that such data can be informative about people other than the research participant. Even where personal identifiers are removed from genetic datasets, there may arguably be limited risk of participant identification. Yet even where this is the case, there remains a possibility that unwanted information about populations, communities or families can still be revealed. This raises questions of privacy protection not only for the research participant, but also for communities and population groups. For instance, a genomewide association study (GWAS) can reveal that a stigmatising condition is more likely to occur in one community than another.

In that sense, it is possible to generate research results that could stigmatise communities, and thus have adverse effects on them socially. It is therefore important to consider this when generating informed-consent documents or processes for communities such as this.

Community engagement through a community advisory board (CAB), as envisaged by the Nigerian National Code of Health Research Ethics (NCHRE),[40] is intended to be a way to accommodate and respect the rights of members of a community engaged in research.

Under the code, the NHREC is saddled with the responsibility of ensuring that communities engaged in research are protected from exploitation. The precise definition of exploitation is a subject of debate, and the code does not define what it means by exploitation.

Nonetheless, from its tone and the provisions, it seems to refer to exploitation in the sense of taking unfair advantage of community members.[41] Therefore, collaborative involvement of a CAB, to provide a forum for members of the community to share their views on ethical issues that the proposed research raises, is considered a way to reduce the potential for exploitation. In relation to data sharing, it would be difficult, if not impossible, for members of the community on the CAB to effectively share views on data that are yet to be collected, analysed and shared. It is doubtful whether these members are sufficiently knowledgeable to engage in discussion on implications of global data sharing in light of technological advancements in the field of genomics and data analysis. Laudable as this provision on CABs is, the CAB model has been criticised for being prone to limitations such as a lack of power and technical knowledge, and for failing to adequately protect the privacy interests of tissue sources in population studies, and subsequent data sharing.[42,43]

Privacy and confidentiality within the context of African communitarian values Privacy protects individuals from unwarranted access to the person; confidentiality protects information about the person from unwanted use or disclosure. Both have been thought to raise special issues regarding genomic information. Privacy in the fabric of the African ethos and culture raises questions that are different from those in Western thought. In African communities, there is a strong awareness

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ARTICLE of one’s existence and relationship with others in the community, a strong sense of ‘social self’. The support of others is seen as more important than one’s capacities to achieve one’s own existential ends, hence the value placed on corporate existence. According to Menkiti,[44] a crucial distinction therefore exists between the African view of man and the view in Western thought: in the African view, it is the community that defines the person as a person, not necessarily an isolated static quality of rationality, will, or memory.

This African social ethic is expressed in many maxims, proverbs, extended family relationships and communal living, which all emphasise the importance of the values of mutual helpfulness, collective responsibility, co-operation, interdependence and reciprocal obligations. The extended family setting, for instance, reflects an ethic of mutual help, survival and care for each other.[8] The social, communal or relational character of the African prescribes a social ethic rather than one of individualism.[45] Individualistic ethics that focus on the welfare and interests of the individual are seldom regarded in African moral thought. In African cultures, such as in Nigeria, the boundaries of personal privacy are narrower. Extended family and communal living tends to blur demarcations of personal and spatial privacy within the family setting. The extended family setting is essentially a communal one in which everyone looks out for the other, including in matters relating to health and welfare.[46] Research reveals that when conducting genetic screening in Africa, issues of confidentiality are not limited solely to the individual participant, but extend to family members who are still living, and also, critically, the interests of departed souls and those yet unborn.[47] In an African community, the interests of the community or extended family may be more important than the interests of the individual. This is because communities may bear risks that are not simply aggregates of the risks to individuals, and, in an African culture, community participation is a fundamental aspect of individual decisions.[48] Thus the decision to participate in future unspecified research where data associated with the community may be shared may be that of the community as a whole, in conjunction with the tissue source.

Despite the fact that the margin of privacy is narrower in African communities, however, the concept of privacy within communities is not discounted. Privacy, as the concept of being left alone to make choices best suited to the individual, remains the norm in these communities. The application of privacy to the individual, as opposed to a corporate norm, is the point of digression from Western thought in African communities.[38] According to de Vries et al.,[39] data sharing and research in communities with a communal ethos present important ethical challenges that have been shown to differ from those with an individualistic Western ethos in significant ways.

Conclusion and recommendations There is a need for more research on the legal and ethical implications of data sharing for Nigerians and other citizens of LMICs. Data on African communities and localities where re-identification is possible should be secured. Genomic data need to be secured with up-todate security software back-up, and this should be made a legal requirement. Currently, most laws relating to data sharing in Nigeria fail to adequately describe biobanking research or genomics.

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The perspectives of Nigerians and other citizens of LMICs on data sharing policies as they exist are sparsely represented in the literature, and therefore more social science research should examine this aspect.

Community involvement should be as important as individual consent in these settings, yet it should not override or substitute for an individual’s choice as to whether or not to participate in future, unspecified research.[49] Identifying and recognising the ethical challenges that arise in diverse, though interconnected, ways in different research settings is a step in the right direction. However, this requires more legal and social science-based research, to establish a proper understanding of the legal jurisprudence and perspectives of relevant low-income settings regarding what constitutes legally acceptable and ethical data sharing.

Acknowledgements. None.

Author contributions. Sole author.

Funding. None.

Conflicts of interest. None.

1. Berlinguer G. Bioethics, health, and inequality. Lancet 2004;364 (9439):1086-1091. https://doi.org/10.1016/s0140-6736(04)17066-9 2. World Health Organization. Global Forum for Health Research: The 10/90 report on Health Research 2001 - 2002. Geneva: WHO, 2002. http://announcementsfiles. cohred.org/gfhr_pub/assoc/s14792e/s14792e.pdf (accessed 7 September 2017).

3. McGuire AL, Beskow LM. Informed consent in genomics and genetic research. Ann Rev Genomics Hum Genet 2010;11(1):361-381. https://doi.org/10.1146/annurevgenom-082509-141711 4. Chalmers D. Genetic research and biobanks. In: Dillner J, ed. Methods in Biobanking.

New York: Springer International, 2011:1-37. https://doi.org/10.1007/978-1-59745423-0 5. Sudlow C, Gallacher J, Allen N, et al. UK Biobank: An open access resource for identifying the causes of a wide range of complex diseases of middle and old age.

PlOs Med 2015;12(3):e1001779. https://doi.org/10.1371/journal.pmed.1001779 6. German National Ethics Council (ed.) Biobanks for research: Opinion. Berlin: German National Ethics Council, 2004. http://www.ethikrat.org/files/der_opinion_ human-biobanks.pdf (accessed 6 July 2017).

7. Hewitt R, Watson P. Defining biobank. Biopreservation Biobanking 2013;11(5):309315. https://doi.org/10.1089/bio.2013.0042 8. Kigongo JK. The relevance of African ethics to contemporary African society.

In: Dalfovo AT, ed. Ethics and Human Rights Development in Africa: Ugandan Philosophical Studies III, Africa; Cultural Heritage and Change Series II. Africa.

Washington DC: 2002,8:51-66.

9. Swede H, Stone CL, Norwood AR. National population-based biobanks for genetic research. Genetics Med 2007;9(3):141-149. https://doi.org/10.1097/ gim.0b013e3180330039 10. Parker M, Bull S. Sharing public health research data: Towards the development of ethical data-sharing practice in low and middle income settings. J Empir Res Hum Res Ethics 2015;10(3):17-24. https://doi.org/110.1177/1556264615593494 11. Kaye J, Boddington P, De Vries J, Hawkins N, Melham K. Ethical implications of the use of whole genome methods in medical research. Eur J Hum Genet 2009;18(4):398-403. https://doi.org/10.1038/ejhg.2009.191 12. McGuire AL, Caulfield T, Cho MK. Research ethics and the challenge of whole genome sequencing. Nat Rev Genet 2008;9(2):152-156. https://doi.org/10.1038/ nrg2302 13. Lunshof JE, Chadwick R, Vorhaus DB, Church GM. From genetic privacy to open consent. Nat Rev Genet 2008;9(5):406-411. https://doi.org/10.1038/nrg2360 14. Chokshi DA, Parker M, Kwiatkowski DP. Data sharing and intellectual property in a genomic epidemiology network: Policies for large-scale research collaboration. Bull World Health Organ 2006;84(5):382-387. https://doi.org/10.2471/blt.06.029843 15. De Vries J, Munung SN, Matimba A, et al. Regulation of genomic and biobanking research in Africa: A content analysis of ethics guidelines, policies and procedures from 22 African countries. BMC Med Ethics 2017;18(1):1-9. https://doi.org/10.1186/ s12910-016-0165-6 16. Kaye J. The tension between data sharing and the protection of privacy in genomics research. Annu Rev Genomics Hum Genet 2012;13(1):415-431. https:// doi.org/10.1146/annurev-genom-082410-101454

ARTICLE 17. Chen H, Pang T. A call for global governance of biobanks. Bull World Health Organ 2015;93(2):113-117. https://doi.org/10.2471/blt.14.138420 18. Nigerian Biotechnology Development Agency. http://www.nabda.gov.ng/ (accessed 11 September 2017).

19. Akintola S, L Callier S, O Ogundiran T. Personalizing medicine in Nigeria by tailoring the research process: Points to consider for genomic research. Curr Pharmocogenomics Personalized Med 2013;11(4):267-273. https://doi.org/10.2 174/18756921113119990010 20. Nnamuchi O. Biobank/genomic research in Nigeria: Examining relevant privacy and confidentiality frameworks. J Med Ethics 2015;43:776-904. https://doi. org/10.1111/jlme.12319 21. Egea M, Matteucci I, Mori P, Petrocchi M. Definition of data sharing agreements.

In: Felici M, Fernandez-Gago C (eds.) Accountability and Security in the Cloud.

Basel: Springer International Publishing, 2015:248-272.

22. Constitution of the Federal Republic of Nigeria, 1999. Section 37, Cap. C23 LFN. 23. Belo-Osagie, Udoma U. Data Privacy Protection in Nigeria. Elexica, Simmons & Simmons, 2015. http://www.uubo.org/downloads/SIMM0715001-Data_Privacy_ Protection_in_Nigeria.pdf (accessed 6 July 2017).

24. Federal Republic of Nigeria. Freedom of Information Act, 2011. Cap F36, LFN, 2004.

25. Preamble of the Freedom of Information Act, 2011. https://www.cbn.gov.ng/ FOI/Freedom%20Of%20Information%20Act.pdf (accessed 11 September 2017).

26. Federal Republic of Nigeria. Official Secrets Act, 1962. Cap. O3, LFN, 2004 27. Federal Republic of Nigeria. Freedom of Information Act, 2011. Section 14(1)(a) and 15(4).

28. Federal Republic of Nigeria. Freedom of Information Act, 2011. Cap F36, LFN, 2004.

29. Jemilohun BO, Akomolede TI. Regulations or legislation for data protection in Nigeria? A call for a clear legislative framework. Glob J Pol Law Res 2015;3(4):1-16.

30. Federal Republic of Nigeria. Computer Security and Critical Information Infrastructure Protection Bill, 2005.

31. House of Representatives, Federal Republic of Nigeria. Order Paper. Cyber Security and Data Protection Agency (Establishment etc.) Bill, 2008. http://www.nass.gov. ng/document/download/2419 (accessed 6 July 2017).

32. A Bill for an Act to Establish a Legal and Institutional Framework for Securing Computers and Networks and Proetcting Critical Information Infrastructure in Nigeria. http://www.nass.gov.ng/document/download/1230 (accessed 6 July 2017).

33. Federal Republic of Nigeria. A Bill for an Act to Make Provision for the Safety and Security of Electronic Transactions and Information Systems. http://nass.gov.ng/ document/download/1168 (accessed 6 July 2017).

34. De Vries J, Pepper M. Genomic sovereignty and the African promise: mining the genome for the benefit of Africa. J Med Ethics 2012;38(8):474-478. https://doi. org/10.1136/medethics-2011-100448 35. Parker M, Bull SJ, de Vries J, Agbenyega T, Doumbo OK, Kwiatkowski DP. Ethical data release in genome-wide association studies in developing countries. PLOS Med 2009;6(11):1000143. https://doi.org/10.1371/journal.pmed.1000143

36. Gikonyo C, Bejon P, Marsh V, Molyneux S. Taking social relationships seriously: Lessons learned from the informed consent practices of a vaccine trial on the Kenyan Coast. Soc Sci Med 2008;67(5):708-720. https://doi.org/10.1016/j. socscimed.2008.02.003 37. Tindana PO, Kass N, Akweongo P. The informed consent process in a rural African setting: A case study of the Kassena-Nankana District of Northern Ghana. IRB: Ethics Hum Res 2006;28(3):1-6.

38. Molyneux CS, Peshu N, Marsh K. Understanding of informed consent in a low-income setting: Three case studies from the Kenyan Coast. Soc Sci Med 2004;59(12):2547-2559. https://doi.org/10.1016/j.socscimed.2004.03.037 39. De Vries JBS, Doumbo O, Ibrahim M, Mercereau-Puijalon O, Kwiatkowski D, Parker M. Ethical issues in human genomics research in developing countries. BMC Med Ethics 2011;12(5):1-10. https://doi.org/10.1186/1472-6939-12-5 40. National Health Research Ethics Committee, Nigeria. Nigerian National Code of Health Research Ethics, 2007. Section E (r) (3) (d) http://www.nhrec.net/nhrec/ NCHRE_Aug%2007.pdf (accessed 7 September, 2017).

41. Pratt B, Lwin KM, Zion D, Nosten F, Loff B, Cheah PY. Exploitation and community engagement: Can Community Advisory Boards successfully assume a role minimizing exploitation in international research? Dev World Bioethics 2015;15(1):18-26. https://doi.org/10.1111/dewb.12031 42. Strauss RP, Sengupta S, Quinn SC, et al. The role of community advisory boards: Involving communities in the informed consent process. Am J Pub Health 2001;91(12):1938-1943. https://doi.org/10.2105/ajph.91.12.1938 43. Slevin KW, Ukpong M, Heise L. Community Engagement in HIV Prevention Trials: Evolution of the Field and Opportunities for Growth. Seattle: Path Publications, 2008.

44. Menkiti IA. Person and community in African traditional thought. In: Wright RA, ed. African Philosophy: An Introduction. 3rd ed. New York: University Press of America, 1984;171-181.

45. Ekpe CP. Social welfare and family support: The Nigerian experience. J Sociol Soc Welfare 1983;10(3):484-496.

46. Teffo LJ. Both/ubuntu as a way forward for contemporary South Africa. Word Action 1998;38(365):3-5.

47. Jegede AS. Culture and genetic screening in Africa. Develop World Bioethics 2009;9(3):128-137. https://doi.org/10.1111/j.1471-8847.2009.00259.x 48. Diallo DA, Doumbo OK, Plowe CV, Wellems TE, Emanuel EJ, Hurst SA. Community permission for medical research in developing countries. Clin Infect Dis 2005;41(2):255-295. https://doi.org/10.1086/430707 49. Hall AJ. Public health trials in West Africa: Logistics and ethics. IRB: Ethics Hum Res 1989;11(5):8-10. https://doi.org/10.2307/3564470

Accepted 6 March 2018.

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This open-access article is distributed under Creative Commons licence CC-BY-NC 4.0.

What the contract does not say… A current analysis of what’s missing in clinical trial agreements G Agar, BA (Hons) Psychol, BA (Hons) Brand Leadership, BSc Human Physiol, Genetics Psychol; L J Burgess, PhD Chem Pathol, MSc Clin Res, MB ChB, MMed, Postgrad Dip Internat Res Ethics TREAD Research CC, Cardiology Unit, Department of Internal Medicine, Tygerberg Hospital and Stellenbosch University Corresponding author: L J Burgess (lesley@treadresearch.com)

Introduction. Increasing numbers of litigation cases in clinical research highlight the need for definitive and transparent clinical trial agreements (CTAs). The requirements set by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) are an attempt to minimise miscommunication between sponsor and site, and promote human research protection. These requirements include: (i) the obligation of the sponsor and/or its representative to communicate study results; (ii) the obligation of the sponsor and/or its representative to promptly report any findings that could affect the participants’ safety and/or influence study conduct; and (iii) the sponsor’s liability for the cost of medical care in the event of a research-related injury.

Objective. To analyse 40 CTAs as to which of the AAHRPP requirements they met.

Methodology. Forty consecutive CTAs signed by our institution, with 15 different research sponsors, were analysed and tracked as to which AAHRPP criteria they met.

Results. No CTAs complied with all the AAHRPP requirements. Notably, 17.5% stipulated that the sponsor would communicate study results, but none stipulated that it would directly inform the site of these results; 35% stated that the sponsor would be responsible for reporting any findings/additional information that might affect participants’ safety and/or influence the conduct of the study; and 40% explicitly stipulated that the sponsor was obliged to pay for the cost of patients’ medical care in the event of a research-related injury.

Conclusions. The AAHRPP requirements are an attempt to minimise miscommunication between sponsor and site, yet most CTAs fail to stipulate what should be fundamental requirements of every contract.

S Afr J Bioethics Law 2018;11(1):20-23. DOI:10.7196/SAJBL.2018.v11i1.603

There has been an increase in clinical trial litigation in the last few years both in South Africa (SA) and abroad, with plaintiffs suing various role players – including research sponsors, institutions and investigators.[1-4] This has highlighted the need for a legally effective clinical trial agreement (CTA) to be concluded between the various parties prior to the commencement of a clinical trial.

The CTA should describe and acknowledge responsibilities, terms of collaboration, requirements for payment and reimbursement, publication and intellectual property terms, indemnification and/or insurance, subject injury coverage, guidelines for dispute resolution, grounds for termination of contract and the possibility of amending contract terms in the future.[1] In addition, the CTA should protect the participant, sponsor and investigator.

In recent years, global human research protection programmes (HRPPs) have put steps in place to minimise contract ambiguity and cause for litigation. One such example is the Association for the Accreditation of Human Research Protection Programs (AAHRPP), which promotes high-quality, ethically sound research through an accreditation process that helps organisations worldwide strengthen their HRPPs.[5] An independent, non-profit accrediting body, AAHRPP uses a voluntary, peer-driven, educational model to ensure that HRPPs meet rigorous standards for quality and protection. To earn accreditation, organisations must provide tangible evidence – through policies,

procedures, and practices – of their commitment to scientifically and ethically sound research, and to continuous improvement.[6] As the ‘gold seal’, AAHRPP accreditation offers assurances – to research participants, researchers, sponsors, government regulators and the public – that an HRPP is focused first and foremost on excellence.[6] In accordance with AAHRPP, the following statements need to be included in the CTA: ‘(i) The sponsor and/or its representative will be responsible for costs of medical care [if] a participant suffers a research-related injury. (ii) The sponsor and/or its representative is/are obligated to promptly report to the Organisation any findings that could:

a. affect the safety of participants

b. influence the conduct of the study. (iii) The sponsor and/or its representative is/are obligated to promptly send the organisation all data and safety monitoring plans and reports. (iv) The sponsor and/or its representative is/are obligated to promptly communicate findings from any research study, even after its closure, when those findings could directly affect the safety of participants.’[5] In this study, we aimed to analyse whether CTAs from various sponsors met these minimum requirements.

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All 40 trials had been approved by the SA Medicines Control Council (MCC) and the Stellenbosch Health Research Ethics Committee (HREC). It should be noted that as per AAHRPP regulations, containing any of the above requirements in the informed consent forms does not absolve the clinical trial agreement from also needing to include them (apart from the statement that ABPI guidelines would be followed). Also, stating that the trial will be carried out as per good clinical practice guidelines does not secondarily fulfil any of the above criteria.

This study did not involve research participants, as it is an analysis of our own records, which are kept confidential. Therefore, ethics approval was not necessary.

Results None of the CTAs demonstrated compliance with all the AAHRPP requirements. CTAs are becoming longer and more complex, yet the onus remains on the clinical trial sites to comply with them[7] – more obligations are being assigned to sites, while sponsor obligations are overlooked, as demonstrated below. This is especially prevalent in the reporting of safety issues and the communication of study results, as seen in Fig. 1.

Only 17.5% of contracts analysed in this study stipulated that the sponsor would communicate study results, and of these, none stipulated that it would directly inform the site of these results. They merely stated that the results would be released publically, meaning that the busy site would have to follow up themselves. Sponsors seem overly concerned with sites first obtaining permission to publish study results, and most fail to mention their own obligation to share study results.

Only 35% of contracts stated that the sponsor would be responsible for reporting any findings/additional information that may affect participant safety or influence the conduct of the study. And only 15% of contracts acknowledged the sponsor’s responsibility to share data

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40

40

39

35 30 25 20 6

15 10 5

7

16

14

ins Prov i ce uran de r ti fic ce ate

0

Co m stu mu dy nic res ate ult s saf Sen ety d d mo ata nit and o rep ring or ts Re p inf ort s orm afe ati ty on Sta me te dic lia al bili ca t y re co co for mp sts en St sat ate ion th wi a ll b guid t AB e f eli PI oll ne ow s ed I res nde ea mn rch ify sit e

Forty consecutive CTAs that were signed by our institution, with 15 different SA-based research sponsors, were analysed as to which AAHRPP criteria they met. All studies analysed were cardiovascular research studies. These 40 CTAs were signed between May 2013 and February 2016. The analysis took place during March - May 2016.

The CTAs were listed in a table format, and individually tracked by a single rater as to which of the following criteria they met, by including: • a statement discussing the obligation of the sponsor to communicate study results • a statement discussing the obligation of the sponsor to report findings that may affect participant safety/influence study conduct • a statement discussing the obligation of the sponsor to send data and safety-monitoring reports • a statement that the sponsor and/or its representative will be responsible for costs of medical care if a participant were to suffer a research-related injury • an insurance certificate • indemnification of the research site • a statement in the informed consent form that the Association of the British Pharmaceutical Industry (ABPI) compensation guidelines will be followed.

CTAs meeting AAHRPP criteria, n

Methodology

AAHRPP criteria to be met

Fig. 1. Prevalence of each AAHRPP criterion in CTAs (N=40).

(AAHRPP = Association for the Accreditation of Human Research Protection Programs; ABPI = Association of the British Pharmaceutical Industry; CTA = clinical trial agreement.) and safety monitoring reports with the site. Only 40% of clinical trial agreements explicitly stipulated that the sponsor was obliged to pay for the cost of the patients’ medical care. An encouraging finding from the study is that 100% of contracts contained insurance certificates, and 97.5% contained statements covering indemnification of the research site. Additionally, every contract’s corresponding informed consent form (ICF) contained a statement that ABPI compensation guidelines would be followed. Overall, out of the 280 criteria analysed (7 × 40 CTAs), 162 were met, giving a general completion rate of 58.86%.

Discussion

Sponsors’ obligation to communicate study results with the study site Of the 40 CTAs reviewed, only 7 (17.5%) of the contracts stated that the sponsor was obligated to communicate the study results.

Furthermore, this was invariably an obligation to the sites and not to the actual trial participants themselves.[8] These results are made more pertinent by the recent European Union (EU) regulations, which dictate that a lay language summary of study results must be made available to study participants, irrespective of the study outcome.[8] The EU states that this summary must include: • clinical trial identification • name and contact details of the sponsor • main objectives • population of subjects (including eligibility criteria) • investigational medicinal products used • description of adverse events and frequency • overall results of the clinical trial • comments on the outcome of the clinical trial • information as to whether follow-up clinical trials are foreseen • information on where additional information can be found.[9] Given that these EU regulations were implemented in 2016, it is concerning that such a low number of contracts made mention of this obligation. It is important to communicate study results to participants. For many, the stigma of clinical trial participants being

ARTICLE seen as ‘human guinea pigs’ remains; therefore it is vital for the industry to be as transparent and trustworthy as possible, to move towards shifting public perception away from such myths.[10] The 2015 Center for Information & Study on Clinical Research Participation (CISCRP) Report on Participation Experiences[11] conducted a study in which approximately 12 000 participants of clinical trials worldwide completed surveys pertaining to their experiences. Of these, 90% of participants want to know the results of their clinical trial, 91% had never heard back from the study staff or sponsor, and 68% would not participate in future trials if left uninformed.[11] These results portray the considerable number of patients who are never informed about the results of their trial, and highlight the importance of keeping participants informed, as it is often mistakenly taken for granted that they ‘are not interested.’

There is also the ethical obligation to communicate study results to participants, as it is fundamentally the ‘right thing to do’ and helps build patients’ trust and satisfaction with their clinical trials.[8] Many participants finish their trials and remain unaware of the study results indefinitely, as they are simply not communicated to them.

Sponsors’ obligation to share current study safety data with the research site Only 15% of CTAs stated that the sponsor was obligated to send data and safety monitoring reports to the site. Furthermore, only 35% of these CTAs stated that the sponsor was obligated to report findings that may affect participants’ safety and/or influence study conduct.

This may have a negative effect on sites’ ability to communicate results to participants and, more importantly, their ability to protect the participant legally, ethically, and physically.

While it is true that sponsors, in the research site’s own experience, do usually communicate this information through safety letters, weekly reports, etc., the lack of a legal obligation to do so can lead to intentionally hidden or misrepresented data being communicated.

Sponsors may choose to do this in order to deceive investigators into carrying on with the study, and also to make the results ‘look better’ in order to have their product approved and bring it to shelves. While extremely unethical, these sorts of practices have occurred in the past, such as with the Vioxx fiasco.[12] Vioxx (rofecoxib) was introduced in 1999 by Merck as an effective, safer alternative to non-steroidal anti-inflammatory drugs for treating osteoarthritis pain.[12] The drug was found to raise the risk of developing cardiovascular disease, and eventually withdrawn from market. However, there is evidence that early suspicion of cardiovascular risk existed as well as deliberate obscuring of data in order to downplay these risks and promote the efficacy of the drug, in order to bring it to market. Since early development, some scientists at Merck were concerned that the drug may affect the cardiovascular system by altering the ratio of prostacyclin to thromboxane, which act in opposition, balancing blood flow and clotting.[12] From internal emails there is evidence that Merck sought to soften academic authors’ interpretation that the drug might lead to increased thrombus formation. Yet despite this knowledge, none of the early intervention studies were designed to evaluate the drug’s cardiovascular risk. Instead, data were pooled and results circulated to promote the drug’s safety to doctors through Merck’s ‘cardiovascular card,’ a non-FDA (Food and Drug Administration)approved marketing tool.[12]

There is evidence of deliberate obscuring of data to downplay the cardiovascular risks. An interim analysis of the drug’s VIGOR study changed the termination dates for cardiovascular event reporting in order to exclude three events of myocardial infarction. The termination date for gastrointestinal events remained the same, with results favouring the drug’s effect on gastrointestinal events while understating the risk of cardiovascular events.[12] The data were further concealed by Merck using naproxen (the comparator drug) as the intervention group for presenting the hazard of myocardial infarction, even though all other results were properly presented with rofecoxib as the comparator. By presenting the information in this manner, Merck argued that naproxen increased cardiovascular protection (despite no evidence of this), rather than Vioxx increasing cardiovascular risk.[12] Merck has since voluntarily withdrawn Vioxx, but has upwards of 30 000 legal claims from people who suffered cardiovascular events while taking the drug, which Merck denies liability for.[12] The withholding of (or tampering with) safety data can have resonating repercussions for the participant, sponsor and, by extension, the site. It highlights the importance of transparency when conducting clinical research, and the need to communicate the safety data.

Obligation to cover the costs of medical care Only 40% of the CTAs explicitly stated that the sponsor and/or its representative would be responsible for the cost of medical care if a participant were to suffer a research-related injury. The importance of this is highlighted by the fact that clinical trial sites have been exploited by patients and sponsors alike, owing to contracts not being explicit enough. A recent case that drew attention in the SA clinical trial industry was Venter v Roche Products (Pty) Limited and Others. In this case the Western Cape High Court had to adjudge whether the plaintiff, Mr Venter, was due additional compensation for non-medical costs such as pain and suffering, loss of income and general damages, even though Mr Venter had signed an ICF which expressly excluded such claims.[3] This ICF stated that the sponsor would pay only for the cost of any trial-related medical treatment the participant may have undergone, and that any further claims for compensation would be determined using the ABPI compensation guidelines. Mr Venter suffered a research-related injury and hospitalisation, and it was as a result of this incident that the plaintiff claimed to have suffered damages.[3] Upon review of the aforementioned ICF and the ABPI guidelines, it was determined that there was no legal obligation for compensation to be paid beyond the medical costs incurred. It must also be noted that the court took into consideration the fact that such studies and their corresponding documents undergo expert legal and ethical review by the MCC and research ethics committees before being approved. The court accepted that limiting compensation in this way was reasonable, as these regulatory committees had the legal authority to approve or not approve such research.[3] Therefore, in light of the arguments above, the court dismissed the case.[3] Many of the clinical trials in SA form part of multinational trials that take place at numerous sites across the world. The parent company sponsor for these trials is rarely South African, and as such, the original CTAs are drafted in countries with different health practices and laws to SA’s. Contracts are amended to suit the trial country; however,

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ARTICLE sometimes the differences are not fully realised and implemented, and ambiguity and exclusion of necessary information can occur.

An example of this would be difference between SA and the USA with regard to remunerating health research participants. US contracts typically state that were a patient to suffer a research-related injury, they would pay above what healthcare covers, whereas in SA participant remuneration is determined using the aforementioned ABPI compensation guidelines. It is promising that 100% of the reviewed ICFs contained statements that ABPI guidelines would be followed.

Specific compensation guidelines are vital for cases such as the 2010 India incident. Of the 25 people who suffered trial-related deaths in India in 2010, only 5 of the families had been compensated an amount of INR1.5 - 3 lakh (approximately ZAR30 000 - 60 000 at the time).[13] The Drug Controller General of India summoned the nine pharmaceutical companies responsible to question them on the compensatory amount (determined by the companies’ internal ethics committees), and ordered them to pay all compensation or risk any future trials being disallowed. As a direct reaction to this incident, in 2011, the Indian Council of Medical Research drafted official compensation guidelines for participants suffering research-related injuries in India.[13]

Conclusion With the increasing number of litigation cases in clinical research, both locally and abroad, there is a growing need for definitive and transparent clinical trial agreements.[3,4] Clearly defined roles for both sponsor and site would help to reduce ambiguity and confusion between the two. The AAHRPP requirements are an attempt to minimise miscommunication between sponsor and site, yet as this study shows, a worrying number of CTAs fail to stipulate what should be fundamental requirements of every contract.

Of the 40 CTAs reviewed, only 7 (17.5%) of the contracts stated that the sponsor was obligated to communicate the study results.

Furthermore, this was invariably an obligation to the sites, and not to the actual trial participants themselves. These results are made more pertinent by the EU regulations dictating that a lay language summary of study results must be published to study participants, irrespective of the study outcome.[9] And as shown through the CISCRP study, patients do want to be informed about the results of their trials.[11] Only 15% of CTAs stated that the sponsor was obligated to send data and safety-monitoring reports to the site. Furthermore, only 35% of these CTAs stated that the sponsor was obligated to report findings that may affect participant safety and/or influence study conduct. This may have a negative effect on sites’ ability to communicate results to participants and, more importantly, their ability to protect the participant legally, ethically and physically.

Only 40% of the CTAs explicitly stated that the sponsor and/or its representative would be responsible for the cost of medical care were a participant to suffer a research-related injury. The importance of this is highlighted by the fact that clinical trial sites have previously been

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exploited by patients and sponsors alike, as a result of insufficiently explicit contracts.[3] Further research of this nature could be useful in addressing this study’s limitations. For example, more clinical research sites could conduct similar studies, and multiple raters could be used to improve reliability.

Acknowledgements. None.

Author contributions. Equal contributions.

Funding. None.

Conflicts of interest. None.

1. The Ohio State University Center for Clinical & Translational Science. Clinical Trial Agreement. Columbus: The Ohio State University, 2012. https://ccts.osu.edu/ education-and-training-programs/research-education-and-training-programs/ clinical-research-coordinator-resources/clinical-trial-agreement (accessed 25 March 2017).

2. Wilson R. The death of Jess Gelsinger: New evidence of the influence of money and prestige in human research. Am J Law Med 2010;36(2-3):295-325. https://doi. org/10.1177/009885881003600202 3. Strode A, Singh P. Compensation for research-related harm: The implications of Venter v Roche Products (Pty) Limited and Others for research ethics committees.

S Afr Med J 2014;104(11):759-761. https://doi.org/10.7196/SAMJ.8596 4. Wadlund J. Heading off a clinical trial liability lawsuit. Appl Clin Trials 2003;12:50-53.

5. Association for the Accreditation of Human Research Protection Programs.

Domain I: Organization. Washington, DC: AAHRPP, 2012. http://aahrpp.org/ apply/web-document-library/domain-i-organization (accessed 8 February 2017).

6. Association for the Accreditation of Human Research Protection Programs. Our Mission, Vision, and Values. Washington, DC: AAHRPP, 2017. http://www.aahrpp. org/learn/about-aahrpp/our-mission (accessed 14 November 2017).

7. Burgess LJ, Sulzer NU. The growing disparity between clinical trial complexity and investigator compensation. Cardiovasc J Afr 2010;21(5):249-250. https:// www.ncbi.nlm.nih.gov/pmc/articles/PMC3721298/ (accessed 15 Nov 2017).

8. Bierer BE, Li R, Myers L, Collyar D. Practical implementation of return of results to patients. Cambridge, MA: Multi-Regional Clinical Trials Center, Harvard University, 19 February 2017.

9. European Parliament, Council of the European Union. EUR-Lex. http://eur-lex. europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2014.158.01.0001.01.ENG (accessed 2 June 2017).

10. Memorial Sloan Kettering Cancer Center. Despite Pressing Need, Survey Finds Most Americans Unlikely to Enroll in Clinical Trials. New York: Memorial Sloan Kettering Cancer Center, 2016. https://www.mskcc.org/press-releases/despite-pressing-needsurvey-finds-most-americans-unlikely-enroll-clinical-trials (accessed 15 Nov 2017).

11. Center for Information & Study on Clinical Research Participation.

Report on Participation Experiences. Boston: CISCRP, 2015. https://www. ciscrp.org/download/2015-perceptions-insights-study-par ticipantexperiences/?wpdmdl=5742 (accessed 2 June 2017).

12. Krumholz HM, Ross JS, Presler AH, Egilman DS. What have we learnt from Vioxx?

BMJ 2007;334(7585):120-123. https://doi.org/10.1136%2Fbmj.39024.487720.68 13. Sinhal K. Clinical trials claimed 25 lives in 2010, only 5 paid compensation. Mumbai: The Times of India, 2011. http://timesofindia.indiatimes.com/india/Clinical-trialsclaimed-25-lives-in-2010-only-5-paid-compensation/articleshow/8740602.cms (accessed 2 June 2017).

14. Prescriptions Medicines Code of Practise Authority. Introduction. London: PMCPA, 2016 http://www.pmcpa.org.uk/thecode/InteractiveCode2016/Pages/ Introduction.aspx# (accessed 19 March 2017).

15. Anderlik M, Elster N. Currents in contemporary ethics. J Law Med Ethics 2001;20(1):220-228. https://doi.org/10.1111%2Fj.1748-720x.2001.tb00710.x 16. Steinbrook R. Protecting research subjects – the crisis at John Hopkins.

New Engl J Med 2002;346(9):716-720. https://doi.org/10.1056%2Fne jm200202283460924 Accepted 5 March 2018.

This open-access article is distributed under Creative Commons licence CC-BY-NC 4.0.

ARTICLE

Gender-affirming care in the context of medical ethics – gatekeeping v. informed consent A Tomson, MB ChB Task Applied Science, Bellville, Cape Town, South Africa Corresponding author: A Tomson (anastacia@doctomson.co.za)

Introduction. For many transgender patients, access to healthcare – and specifically gender-affirming care (such as hormone replacement therapy) – is limited by a variety of different barriers. Despite evidence showing that access to medical transition is not only safe, but also improves suicide risk in transgender patients, these services are often subject to excessive gatekeeping by medical professionals and healthcare workers.

Objectives. To evaluate the ethical merits of the two most prominent models of providing gender-affirming care to patients who identify as transgender.

Methods. The author compares the gatekeeping model and the informed consent model of providing gender-affirming care, in terms of the well-recognised four fundamental ‘pillars’ of medical ethics, namely respect for autonomy, non-maleficence, beneficence and distributive justice.

Results. The gatekeeping model is found to be in violation of all four principles, while an informed consent model of care respects these ethical pillars.

Discussion. A variety of ethical factors are at play in the provision of gender-affirming care to transgender patients, and these need to be considered carefully in formulating approaches or models. There are many other factors that can present a barrier to gender-affirming care in a South African context, but an examination of the ethical considerations can be of immediate benefit to an already marginalised population.

Conclusion. Clinicians should be aware of the ethical factors in withholding gender-affirming care from transgender patients, and the potential consequences thereof. An approach based on a model of informed consent, which respects a patient’s agency over their own body, is both clinically safe and ethically sound.

S Afr J Bioethics Law 2018;11(1):24-28. DOI:10.7196/SAJBL.2018.v11i1.616

It is a well-established fact that transgender people often face difficulty in accessing healthcare[1] – both gender-affirming as well as general healthcare. As a marginalised group, transgender people are already at a higher risk of suicide than the general population, in addition to being more likely to be unemployed or have a low income, and more likely to suffer sexual or physical assault.[1] A 2015 Canadian study suggested that among intervenable factors that can reduce suicide risk among transgender populations, access to medical transition (i.e. gender-affirming care) was a significant roleplayer.[2,3 ] Furthermore, multiple studies exist to suggest that gender-affirming hormonal intervention in transgender people can be considered as generally safe, and is associated with minimal side-effects, morbidity or increases in mortality.[4,5] Despite these data that point towards access to gender-affirming care not only being safe, but also playing a significant role in reducing suicide risk in transgender people, there are still difficulties in accessing this care.

A small study of 101 assigned-male-at-birth (AMAB) transgender people in New York City enumerated some of the most prominent barriers to accessing care as a lack of knowledge among service providers, a paucity of transgender-friendly providers and cost.[6] Focus groups in Boston comprising both adults and youth – and both AMAB and assignedfemale-at-birth (AFAB) patients – yielded similar results.[7]

The fundamentals of medical ethics Beauchamp and Childress,[8] in Principles of Medical Ethics, first published in 1979, posited four basic ethical principles applicable to medical practice; although the specifics of actually applying these principles need to be considered on an individual case-by-case basis, and the framework itself is not flawless,[9] these principles are widely accepted and taught in medical schools across the globe as a framework for decision-making.

The four ‘pillars’ of medical ethics are as follows:[8,9] (i) Respect for autonomy: this principle provides the basis for ‘informed consent’, recognising the patient as an independent agent with the capacity and right to make their own decisions with respect to their healthcare and bodies. (ii) Non-maleficence: this principle imposes a requirement on the healthcare provider not to intentionally cause injury or harm to the patient, be it through commission or omission of an act. (iii) Beneficence: the principle of beneficence establishes a responsibility on the provider to act in ways that are of benefit to the patient. (iv) Justice: this is a complex and sometimes difficult-to-navigate principle that requires providers to distribute resources in ways that are fair and equitable, particularly in situations where resources are limited.

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ARTICLE History of gatekeeping access to genderaffirming care For many years, the Harry Benjamin International Gender Dysphoria Association has provided guidelines, standards and recommendations on the requirements for initiating gender-affirming care in transgender patients. The organisation, named after endocrinologist Harry Benjamin, one of the first physicians who worked with transgender patients, has subsequently been renamed as the World Professional Association for Transgender Health (WPATH), and continues to publish guidelines as the Standards of Care for the Health of Transsexual, Transgender, and Gender Nonconforming People (SOC).

The most recent iteration of the SOC is Version 7, released in 2011.

The document was first published in 1979; prior to the release of the 7th edition, the most recent update to the SOC was published in 2001.[10] According to the 2001 version of the SOC, in order to be eligible for gender-affirming hormonal interventions, adult patients needed to fulfil the following requirements (a separate set of requirements is suggested for younger patients, though this is beyond the scope of this article): ‘1. be of at least 18 years of age.

2. possess demonstrable knowledge of the medical effects and limitations of hormones, as well as the social benefits and risks thereof.

3. have had either: a) a documented real-life experience (RLE) of at least 3 months; or b) a period of psychotherapy of a duration specified by the mental health practitioner (usually a minimum of 3 months).’

In addition to these eligibility criteria, a further set of ‘readiness criteria’ are imposed: ‘1. The patient has had further consolidation of the patient’s gender identity during RLE or psychotherapy 2. The patient has made some progress in mastering other identified problems, leading to improving or continuing stable mental health (this implies satisfactory control of problems such as sociopathy, substance abuse, psychosis or suicidality).

3. The patient is likely to take hormones in a responsible manner.’

A concession is made for patients who do not fulfil readiness criterion 3, in instances where the patient is likely to use black-market hormone therapy, as a means of harm reduction.

Although the document itself introduces these standards of care as ‘flexible directions’, they came to be widely known and adopted by healthcare providers – specifically, the requirements of psychotherapy and RLE. Consequently, these requirements have been the subject of criticism by activists and mental healthcare practitioners alike.[11,12] The document goes on to refer to the RLE as the ‘ultimate diagnosis’ of transgender identity, and suggests that based on the RLE, patients might decide that transition is ‘not in their best interest’. In fact, detransition and rates of ‘transition regret’ are known to be very low, even after surgery – depending on the study cited, this rate varies from as little as 0% to a maximum of 4%, significantly lower than regret rates in cisgender patients following elective plastic surgery procedures.[13-15] Also worth noting is that the document positions the clinician as the ultimate assessor of whether the RLE is ‘successful’. As part of this assessment, the patient must prove sufficiently able:

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‘1. to maintain full or part-time employment 2. to function as a student 3. to function in community-based volunteer activity 4. to undertake some combination of items 1 - 3 5. to acquire a (legal) gender-identity-appropriate first name 6. to provide documentation that persons other than the therapist

know that the patient functions in the desired gender role.’

Although these requirements are problematic for many different reasons, three stand out to this author as especially significant: (i) the subjectivity of assessing whether or not the patient is able ‘to function’ (ii) the imposition of cis-normative standards in determining whether a first name is ‘gender-identity-appropriate’ (iii) the requirement of a patient to ‘out’ themselves to others as a requirement for intervention.

There are many other difficulties that can be raised with RLE, in terms of intersectional feminism and queer theory; those arguments, however, are beyond the scope of this paper.

Informed consent as the basis for genderaffirming care As already discussed, WPATH’s SOC is currently in its 7th iteration.

Published in 2011, the SOC Version 7 introduces significant changes to the guidelines. According to WPATH, the document has been created on the basis of the best available science and expert professional consensus, and Version 7 represents a ‘significant departure from previous versions … based upon significant cultural shifts, advances in clinical knowledge and appreciation of the many healthcare issues that can arise for transsexual, transgender, and gender nonconforming people beyond hormone therapy and surgery’.[16] The current edition of the SOC requires that healthcare providers educate their patients or clients not just on the diversity of gender identities and expressions, but also on the various options available for managing gender dysphoria. It is the responsibility of the provider to prepare the patient to make a fully informed decision regarding treatment options.

Furthermore, the document goes on to state that ‘decisions about hormones are first and foremost the client’s decisions – as are all decisions regarding healthcare,’ a significant change in position from previous versions of these guidelines, and an important assertion that prioritises the patient’s agency and autonomy.

Psychotherapy, although recommended, is explicitly stated not to be an absolute requirement for hormone therapy. The document also asserts that its suggestions are in line with the informed-consent models of treatment employed at such renowned centres for transgender healthcare as Callen-Lorde and Fenway Health.

According to WPATH, the current criteria for eligibility for hormone therapy in transgender individuals are as follows: 1. persistent, well-documented gender dysphoria 2. the capacity to make a fully informed decision and to consent for treatment 3. having reached the age of majority in a given country 4. reasonably well-controlled medical or mental health concerns, if present and significant.

ARTICLE It is particularly important to note that RLE is no longer listed in these criteria, although many service providers still assume that it is, and insist on it as a requirement.

Furthermore, the purpose of the document as a flexible guideline is reinforced, and acknowledgment granted to the notion that in certain cases, one or more of these criteria may be waived, again citing harm reduction (such as preventing the use of black-market hormones) as an example of when this might be done.

It should also be noted that, as outlined in criterion 4 above, the presence of comorbid mental health conditions should be managed appropriately. Such conditions, however, should not preclude access to gender-affirming care, unless they interfere with an individual’s capacity to make an informed decision.

Comparison of gatekeeping and informed consent within the framework of medical ethics Despite the support of WPATH, the Callen-Lorde Community Health Center and Fenway Community Health for an informed consent model of treatment,[16-18] gatekeeping remains a pervasive barrier to accessing care for transgender people.[19-22] In light of this, the author believes that it might be of benefit to compare these two models of gender-affirming care, namely gatekeeping and informed consent, within the already-introduced framework of medical ethics.

Respect for autonomy The argument in terms of this principle is straightforward and virtually self-explanatory. If access to care is gatekept by service providers – that is to say, if the healthcare provider makes the assessment of whether or not a patient should be allowed access to gender-affirming care – this is a blatant violation of the principle of respect for autonomy.

In contrast, an informed consent model preserves the integrity of this ethical principle by empowering a patient to make their own decision with regard to their healthcare.

Non-maleficence A gatekeeping approach to gender-affirming care is founded on the idea that hormonal therapy may be harmful to patients – either directly, through the biological and chemical consequences of such treatment, or because of the ‘social risks’, or the fear that patients will regret their decision to pursue medical transition.

Although gender-affirming hormonal intervention is not without side-effects, these side-effects are well established, and are outlined comprehensively in the SOC. Furthermore, many of these sideeffects (for example, the cessation of menses in AFAB patients) might be regarded as beneficial rather than detrimental in the case of transgender individuals.

As already established, hormonal therapy in transgender patients has been demonstrated scientifically to be safe.[4,5] Furthermore, it is known that many of the irreversible effects of hormone therapy take significant periods of time to develop – notably: breast growth (onset 3 - 6 months; maximal effect 2 - 3 years) in AMAB patients, and scalp hair loss (onset <12 months; maximal effect variable), clitoral enlargement (onset 3 - 6 months; maximal effect 1 - 2 years),

deepened voice (onset 3 - 12 months; maximal effect 1 - 2 years) and facial hair growth (onset 3 - 6 months; maximal effect 3 - 5 years) in AFAB patients.[16,23-25] Therefore, it is established that these consequences – which are often not viewed by patients as deleterious – take time to develop; they are not instantaneous. Furthermore, there are interventions available should these effects later be viewed by the patient as undesirable – for example, surgical removal of breast tissue, or laser hair removal for unwanted facial hair.

Given the length of time needed for these changes to develop to any noteworthy extent, and acknowledging that although cessation of hormone therapy alone will not reverse these changes, there are other means by which they may be reversed, it seems fair to argue that non-maleficence is not a valid justification to gatekeep access to gender-affirming care.

As clinicians, we strive to act with our patients’ best interests at heart, and that can lead to a tendency to try to ‘protect patients from themselves’, which, in this instance, may be motivated by fear of the effects or consequences of gender-affirming care. Two points are important to note here. Firstly, although there are side-effects associated with gender-affirming care, we should not neglect the fact that exposure to endogenous hormones for transgender persons is also not without deleterious (and often irreversible) effects; these should not be neglected when considering what is in a patient’s best interests. Secondly, bearing in mind the principle of respect for autonomy already discussed, it should be reiterated that the practitioner’s responsibility is to inform the patient of potential risks or side-effects, and to assess the patient’s capacity to make an informed decision,[26] without letting personal preconceptions or misgivings influence this process.

Furthermore, it can be argued that since access to medical transition improves outcomes (particularly suicide risk) for transgender patients,[2,3] limiting access to these interventions can be seen as harmful in and of itself, and as such, is a violation of the principle of non-maleficence.

Conversely, an informed consent model of treatment that educates patients as to the risks of hormone therapy, as well as the benefits, and allows them to make a decision on their own can hardly be viewed as harmful, given that we have already established the safety of hormonal interventions.

Beneficence The discussion around beneficence is closely related to the points already outlined in discussing non-maleficence, and so the discourse that follows will be brief. Recognising that gatekeeping is cited as a barrier to accessing care, and that the inability to access care is in fact deleterious to transgender patients, it becomes difficult to reconcile such a practice with the principle of beneficence.

In contrast, by respecting, validating and affirming a patient’s identity, and their right to make their own decisions regarding their healthcare and treatment, we are directly improving outcomes for patients – there are numerous studies that show improved quality of life and outcomes in transgender patients following interventions such as hormone therapy and surgery.[2,27,28] As such, the informed consent approach to treatment is respectful of the ethical principle of beneficence.

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ARTICLE Justice Within the gatekeeping model of access to care, it is the healthcare provider or clinician who ultimately assesses whether or not a patient will gain access to healthcare. These assessments might be made on several different grounds, but in accordance with the guidelines posited by editions of SOC[10] earlier than version 7, they are usually contingent on either (i) the ‘success’ of the RLE, and/or (ii) a period of psychotherapy.

‘Success’ in terms of RLE is defined as the ability of the patient to ‘prosper in the preferred gender’, in terms of the patient’s resolve, and their capacity to function in that gender, as well as the adequacy of social, economic and psychological supports.

It is not difficult to understand that this is a flawed metric, for a number of reasons. Much of the ‘assessment’ is contingent not on the patient’s actual experience, but rather on how the patient is seen by outside observers – specifically the clinician or provider, but also the rest of society.

Firstly, for patients who identify outside of the gender-binary, how is ‘success’ defined? There is no established objective metric for ‘capacity to function’ in a gender; by definition, it is subjective, and patients with a non-binary identity are, from the outset, prejudiced in this assessment, as their experiences lie outside of cultural and societal norms.

Secondly, the guidelines themselves suggest that this assessment is contingent on the ‘adequacy of social, economic and psychological supports’; therefore, a patient who is financially secure, for example, fulfils this criterion, whereas one who is economically disadvantaged might not.

To illustrate: consider two hypothetical transgender patients. The first patient, Sue, is AMAB, with a female gender identity, white, college-educated and gainfully employed. Sue is 5’7” tall and has a slight frame. She does not have thick facial or body hair, but anyway can afford laser hair removal, regular waxing, skin treatments, a wardrobe of flattering clothes and expensive makeup.

The second patient, Jo, is AMAB, with a female gender identity, is a person of colour, has a disadvantaged background, lives in a rural area and works a minimum-wage job. She is 6’3” tall, has broad shoulders and heavy bone structure, and dense facial and body hair.

She cannot afford cosmetic treatments or products, and has only her old masculine clothes in her wardrobe.

Of these two patients, who is likely to be more ‘successful’ in the RLE? Almost certainly, Sue will have an easier time – she is likely to face less discrimination and prejudice, and has better access to resources, including psychotherapy. This is especially significant in the absence of hormonal intervention – which promotes the development of physical features that are concordant with an individual’s gender identity.

In the example scenario, the patient who has better resources, and a more ‘fortunate’ genetic profile, is more likely to gain access to gender-affirming care.

Certainly, this is a blatant violation of the ethical principle of distributive justice.

(It should be noted that there is potential to discuss the implications and ramifications of what constitutes ‘successful’ RLE in terms of gender theory, with particular attention given to the concept of ‘passing’, and the distinction between gender identity and expression, but again that is beyond the scope of this article – for the purposes

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of this discussion, it is assumed that these assessments are made according to binary and cis-normative standards, which themselves are flawed.)

An informed consent approach, conversely, promotes equity and fairness by allowing patients to decide on their own healthcare, without subjecting them to restrictions based on factors that are beyond their control. By refusing to prejudice a patient’s right to access care based on such factors as race, social class, finances or genetics, we respect and maintain the integrity of the principle of justice.

Conclusion In conclusion, there are several points that should be taken into account when evaluating approaches to initiating gender-affirming care in transgender patients.

It is important to recognise that there is a growing body of evidence to suggest that hormonal therapy in transgender patients is safe, and is not associated with increases in morbidity or mortality. Furthermore, there is also evidence suggesting that access to gender-affirming care is an important intervenable factor that can significantly reduce suicide risk in what is known to be a vulnerable population.

In addition, many renowned clinics and expert groups have led by example in distancing themselves from such practices as gatekeeping, opting rather to treat patients in accordance with an informed consent model of treatment. It is not without relevance to acknowledge that WPATH, at the time known as the Harry Benjamin Gender Dysphoria Association, was once the most significant proponent of a gatekeeping model of gender-affirming care, and has recognised the problems inherent in such a model. In response to this recognition, WPATH now advocates for an informed consent approach that is consistent with the model employed by leading gender clinics.

Being cognisant of these developments, and examining the two differing approaches to gender-affirming care within a framework of medical ethics, based upon Beauchamp and Childress’[8] wellrecognised four pillars of medical ethics, it can be demonstrated that a gatekeeping model of care is found to be in violation of all four principles: autonomy, non-maleficence, beneficence and justice.

In stark contrast, an approach based on the principles of informed consent preserves the integrity of these pillars of medical ethics.

It should, of course, be noted that there remain additional obstacles to accessing gender affirming care – such as costs of treatment, competence of providers, and social circumstances, among others – but overcoming these barriers involves a separate, and far lengthier, discussion. Moving towards an informed consent model of care is not a silver bullet that solves all problems when considering genderaffirming care, but it is nonetheless a significant step, and one that is ethically sound.

The author therefore concludes that any approach to genderaffirming care that utilises gatekeeping, particularly in the form of enforced RLE or psychotherapy, should be regarded as unethical, and that clinicians should be aware of this when managing or interacting with transgender patients.

Acknowledgments. None.

Author contributions. Sole author.

Funding. None.

Conflicts of interest. None.

ARTICLE 1. Grant JM, Mottet LA, Tanis J, Herman JL, Harrison J, Keisling M. National Transgender Discrimination Survey Report on Health and Health Care.

Washington, DC: National Center for Transgender Equality and the National Gay and Lesbian Task Force, 2010.

2. Bauer GR, Scheim AI, Pyne J, Travers R, Hammond R. Intervenable factors associated with suicide risk in transgender persons: A respondent driven sampling study in Ontario, Canada. BMC Pub Health 2015;15(1):525. https://doi. org/10.1186/s12889-015-1867-2 3. Clements-Nolle K, Marx R, Katz M. Attempted suicide among transgender persons: The influence of gender-based discrimination and victimization. J Homosex 2006;51(3):53-69. https://doi.org/10.1300/j082v51n03_04 4. Asscheman H, Giltay EJ, Megens JA, van Trotsenburg MA, Gooren LJ. A long-term follow-up study of mortality in transsexuals receiving treatment with cross-sex hormones. Eur J Endocrinol 2011;164(4):635-642. https://doi.org/10.1530/eje10-1038 5. Asscheman H, T’Sjoen GG, Gooren LJ. Morbidity in a multisite retrospective study of cross-sex hormone-treated transgender persons. In: Disorders of Sex Development and Transgender Medicine. Endocrine Society’s 96th Annual Meeting and Expo, June 21 - 24, 2014 (abstract). Chicago: Endocrine Society, 2014. http://doi.org/10.1210/endo-meetings.2014.re.2 6. Sanchez NF, Sanchez JP, Danoff A. Health care utilization, barriers to care, and hormone usage among male-to-female transgender persons in New York City. Am J Pub Health 2009;99(4):713-719. https://doi.org/10.2105/ ajph.2007.132035 7. Sperber J, Landers S, Lawrence S. Access to health care for transgendered persons: Results of a needs assessment in Boston. Int J Transgenderism 2005;8(2-3):75-91. https://doi.org/10.1300/j485v08n02_08 8. Beauchamp TL, Childress JF. Principles of Biomedical Ethics. New York: Oxford University Press USA, 2001.

9. McCormick, Thomas R. Principles of Bioethics. Seattle: Department of Bioethics and Humanities, School of Medicine, University of Washington, 2013. https:// depts.washington.edu/bioethx/tools/princpl.html (accessed 1 September 2017).

10. Benjamin H. Standards of care for gender identity disorders. International Gender Dysphoria Association, 2001. http://www.cpath.ca/wp-content/ uploads/2009/12/WPATHsocv6.pdf (accessed 22 June 2018).

11. Serano J. Whipping Girl: A Transsexual Woman on Sexism and the Scapegoating of Femininity. New York: Seal Press, 2009.

12. Karasic D, Drescher J. Sexual and Gender Diagnoses of the Diagnostic and Statistical Manual (DSM): A Reevaluation. New York: Haworth Press, 2005.

13. Dhejne C, Öberg K, Arver S, Landén M. An analysis of all applications for sex reassignment surgery in Sweden, 1960 - 2010: Prevalence, incidence, and regrets.

Arch Sexual Behav 2014;43(8):1535-1545. https://doi.org/10.1007/s10508-0140300-8 14. Krege S, Bex A, Lümmen G, Rübben H. Male-to-female transsexualism: A technique, results and long-term follow-up in 66 patients. BJU International 2001 Sep;88(4):396-402. https://doi.org/10.1046/j.1464-410x.2001.02323.x 15. De Cuypere G, Elaut E, Heylens G, et al. Long-term follow-up: Psychosocial outcome of Belgian transsexuals after sex reassignment surgery. Sexologies 2006;15(2):126-133. https://doi.org/10.1016/j.sexol.2006.04.002

16. Coleman E, Bockting W, Botzer M, et al. Standards of care for the health of transsexual, transgender, and gender-nonconforming people, Version 7. Int J Transgender 2012;13(4):165-232. https://doi.org/10.1080/15532739.2011.700873 17. Callen-Lorde Community Health Center . Protocols for the Provision of Hormone Therapy. New York: Callen-Lorde Community Health Center, 2018. http://callenlorde.org/graphics/2018/04/Callen-Lorde-TGNC-Hormone-Therapy-Protocols. pdf (accessed 22 June 2018).

18. Fenway Community Health Transgender Health Program. Protocol for Hormone Therapy. Boston: Fenway Community Health Transgender Health Program, 2007. http://fenwayhealth.org/documents/medical/transgender-resources/Fenway_ Protocols.pdf (accessed 31 October 2016).

19. Gridley SJ, Crouch JM, Evans Y, et al. Youth and caregiver perspectives on barriers to gender-affirming health care for transgender youth.

J Adolesc Health 2016;59(3):254-2561. https://doi.org/10.1016/j. jadohealth.2016.03.017 20. Stocking CA. Transgender Patients’ Experiences of Discrimination at Mental Health Clinics. Portland: MSc thesis, Portland State University. Paper 2993, 2016. https://doi.org/10.15760/etd.2994 21. Safer JD, Coleman E, Feldman J, et al. Barriers to healthcare for transgender individuals. Curr Opin Endocrinol Diabetes Obes 2016;23(2):168-171. https://doi. org/10.1097/med.0000000000000227 22. Thompson HM, Karnik NS, Garofalo R. Centering transgender voices in research as a fundamental strategy toward expansion of access to care and social support. J Adolesc Health 2016;59(3):241-242. https://doi.org/10.1016/j. jadohealth.2016.06.019 23. Meriggiola MC, Jannini EA, Lenzi A, Maggi M, Manieri C. Endocrine treatment of transsexual persons: An Endocrine Society Clinical Practice Guideline: Commentary from a European perspective. Eur J Endocrinol Bioscientifica 2010;162(5):831-833. https://doi.org/10.1530/eje-09-1091 24. Transgender Health Information Program. Masculinizing Hormones. British Columbia: Provincial Health Services Authority, 2018. http://transhealth.phsa.ca/ medical-options/hormones/masculinizing-hormones (accessed 22 June 2018).

25. Transgender Health Information Program. Feminizing Hormones. British Columbia: Provincial Health Services Authority, 2018. http://transhealth.phsa.ca/ medical-options/hormones/feminizing-hormones (accessed 22 June 2018).

26. Health Professions Council of South Africa. HPCSA Guidelines for Good Practice in the Health Care Professions: Seeking Patients’ Informed Consent: The Ethical Considerations. Booklet 9. Pretoria: HPCSA, 2016.

27. Johansson A, Sundbom E, Höjerback T, Bodlund O. A five-year follow-up study of Swedish adults with gender identity disorder. Arch Sexual Behav 2009;39(6):14291437. https://doi.org/10.1007/s10508-009-9551-1 28. Murad MH, Elamin MB, Garcia MZ, et al. Hormonal therapy and sex reassignment: A systematic review and meta-analysis of quality of life and psychosocial outcomes. Clin Endocrinol 2010;72(2):214-231. https://doi.org/10.1111/j.13652265.2009.03625.x

Accepted 6 February 2018.

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REVIEW

This open-access article is distributed under Creative Commons licence CC-BY-NC 4.0.

Human guinea pigs? The ethics of undergraduate and postgraduate student involvement in medical training in South Africa M de Roubaix, MB ChB, MMed, MD, DPhil Centre for Applied Ethics, Department of Philosophy, Stellenbosch University, South Africa Corresponding author: M de Roubaix (malcolmderoubaix@gmail.com)

Irrespective of theoretical and skills laboratories training, clinical competencies need to be honed through real patient contacts. South African (SA) medical training takes place mainly in tertiary hospitals. Most patients come from disadvantaged backgrounds, are scientifically naïve, have difficulty communicating with medical staff and may be intimidated by their surroundings. These patients may be particularly vulnerable and resigned to insidious paternalism. The question is whether authentic informed consent is actually provided by these patients for their involvement in medical training. Implied consent for this purpose is invalid. I justify the demand for explicit consent on the grounds of ethical and regulative frameworks. The human rights of patients and the dictums of the SA National Health Act and the Health Professions Council of SA should actively be promoted and upheld. I conclude with practical suggestions intended to stimulate debate and action at institutional and clinical departmental levels.

S Afr J Bioethics Law 2018;11(1):29-34. DOI:10.7196/SAJBL.2018.v11i1.617

Contrary to what the title might imply, I refer not to research subjects, but to guinea pigs of another ilk. Indeed, South Africa (SA) has a well-institutionalised and developed ethics review system. Clinical researchers should be trained in and comply with SA good clinical practice[1] and international ethical research guidelines and standards.

SA research ethics committees and institutional review boards are rigorous in their demands for authentic informed consent (IC) for research subjects. Regrettably, however, there are no comparable structured courses and requirements for ethics at the clinical patientprofessional interface, and perhaps there should be, although all medical students undergo an approved ethics training programme.

What concerns me and inspired this article is the question as to what extent patients in training hospitals in SA are used as ‘training material’ for medical students and registrars without being fully informed and providing explicit IC. Before responding to this question I shall argue that the metaphorical elephant in the room is a fundamental asymmetry in the doctor-patient relation.[2] Furthermore, the social and economic circumstances of many patients attending SA training hospitals exacerbate this asymmetry, contributing to the disempowerment of patients, increased vulnerability and resignation to the inevitable – to being used as ‘training material’ even if without explicit prior IC. First then, let us examine the asymmetrical professional-patient power relation.

Asymmetry in the doctor-patient power relation The power asymmetry between doctor and patient, favouring the doctor, has influenced the nature of the professional-patient relation and the development of bioethics. This disparity has several roots, including:

•• Knowledge asymmetry: medical students and registrars (synonyms: clinical assistants, trainees, residents) spend the formative years of their careers acquiring knowledge, clinical acumen and practical experience that define them as professionals. They are expected to remain students for the duration of their professional lives through continued professional development (CPD). In the eyes of society, they are figures of authority, and patients consult with practitioners because they are regarded as knowledgeable. However, the knowledge differential, given the nature of the knowledge in question, creates a power differential. The knowledge of diseases, their natural courses, possible treatments and prognoses translates into power over those conditions and over the patient. The antidote to inherent paternalism is to level the knowledge playing fields and promote the ability of patients to make decisions regarding their treatment, i.e. to promote patient autonomy. Yet providing sufficient contextual information leading to authentic IC for all examinations, diagnostic and therapeutic procedures and treatments may be problematic and insufficient.[2] Clinicians are aware that informing patients explicitly and comprehensively is impossible, hence the argument that we should ‘rethink’ the principles and practice of IC.[2] The knowledge/power asymmetry may lead to therapeutic misconception.[3] Patients who are simultaneously clinical research subjects may misconceive the nature of research-associated treatments and misunderstand the nature of clinical research. It is not uncommon for them to believe that such treatments will always benefit them and are tailored to their needs. Clinical research usually has totally different ends depending on the aims of research and the underlying research protocols, with fixed treatment regimens and often placebo arms, or tests one drug against another.

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REVIEW •• Control of discourse: Foucault[4] described how the creation and control of discourse may be applied to create power relations and lead to eventual control. Many patients, arguably not those attending SA training hospitals, are well informed and have other means of obtaining information. Nevertheless, contextual medical discourse remains controlled by the medical profession, aided by the doctor’s allusion to ‘higher authority’. The extent of this phenomenon depends on the practitioner’s elected language, communication skills and general behaviour and demeanour, and the socioeconomic status of the patient.

•• Vulnerability: all patients are vulnerable because of the psychosocial implications of disease. Vulnerability may increase in direct relation to the seriousness of the disease and treatment, and inversely to socioeconomic standing, education levels and insight. Patients may have no option but to place their trust in those who provide care, and may be totally reliant on such care, for example, in intensive care settings. Vulnerability further distorts the patientdoctor power relation.

aspiration to high ethical standards. Clinical skills laboratories (CSLs) and models are in wide use in all undergraduate and many postgraduate medical training, and even some CPD programmes.

CSLs assist in preparatory instruction and may limit student-patient interaction, but in the end, what is learned theoretically and in CSLs has to be applied to and practised and perfected in human subjects.

It would be impossible to train medical students without using human subjects. The ready availability of human ‘training material’ for hands-on training contributes to the quality of medical training in SA. Each patient is unique, and each student-patient interaction presents unique opportunities and challenges. The end result is obviously beneficial to society as a whole, and consequently society is greatly indebted to these unknown and unsung heroes. One may argue that the quid pro quo is excellent care and additional personal attention.

However, in a study in which patients were not explicitly made aware of their role in training and generally agreed that they would have consented had they been asked, they maintained that their consent should have been obtained.[12]

Power relations in the public health setting

Patients as guinea pigs?

Some or all of the factors described above operate when patients are admitted to SA state hospitals. Vulnerability is exacerbated through poverty, language and communication difficulties, diseases such as AIDS and tuberculosis, the awe inspired by the white coat, logistics related to transport and the local availability of facilities, and unfamiliarity with procedures, medicoscientific discourse and the nature of treatments. To top this, patients may not fully appreciate their rights as enshrined in the SA Bill of Rights,[5] the SA National Health Act No. 61 of 2003[6] (NHA) and Patients’ Rights Charter,[7] and are likely to be unfamiliar with the ethics guidelines of the Health Professions Council of SA (HPCSA). The latter are described in 16 booklets under the general title Ethical Guidelines for Good Practice in the Health Care Professions.[8] Nevertheless, an increasing number of state patients may decide to sue when harm befalls them or their children.[9] Vulnerable patients may become intimidated, marginalised and resigned to their fate, raising few questions regarding their rights and treatment. They may not want to jeopardise their treatment by being ‘difficult’, and rely on the beneficence, integrity and good intentions of their medical carers; ergo, the nascence of a new paternalism. Student training takes place in various settings, from primary-care clinics and private consulting rooms through to tertiary hospitals. The quality of professional care may not be consistent at all levels, yet the general standard of care in the SA training environment is high. However, it is equally important that patient treatment should be ethically sound and in accordance with the HPCSA guidelines. It is a fundamental responsibility of every member of the healthcare team to recognise, respect and, where possible, further patients’ human rights, irrespective of whether patients are aware of these guidelines and rights or not.[10] Unfortunately there is no evidence that IC principles are adequately applied at the SA student-patient interface. This is regrettable, given the fact that without studentpatient interaction student training is impossible.

Real-life training of medical students The training of medical students is based on an apprenticeship model,[11] albeit that unusual demands have to be met, e.g. the

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Relying on available international literature, in the absence of SA data, patients are not necessarily explicitly informed that they are to participate in student/registrar training, and do not always provide explicit and comprehensive IC.[13-15] Patients are not always informed that the person examining or treating them is a student, not a doctor.

Some students may even introduce themselves as ‘doctor’.[16] The question is, should patients be so informed, and if so, why and how? Explicit consent would not be required if, as has been fallaciously argued, we could be sure that all patients admitted to training hospitals appreciate their secondary role as ‘training material’ and implicitly agree to this by being admitted to what they should know is a training institute.[17] However, we should not presume that patients appreciate that they are entering a training institution, comprehend the nature of medical training and accept and implicitly consent to becoming participants in such training.

Firstly, there is little evidence to support this assumption.[18] Secondly, patients are entitled to know the identity of those providing treatment. Without being specifically informed, they are unlikely to appreciate the complex hierarchy of their care team, from junior students through to professors or department heads.[19] Thirdly, vulnerable patients may be unaware of their rights as human beings and patients, including the right to refuse and the requirement of explicit consent. The factors that promote vulnerability intensify the asymmetrical power relation, and diminish the patient’s ability and enthusiasm to question, but rather encourage them to succumb to unintended paternalism. Implied consent is problematic and should never be presumed, particularly not blanket consent for a variety of, at that point, unknowns. HPCSA Booklet 4[19] expressly warns about the legitimacy of implied consent (clause 14): ‘Consent must at all times be expressed and not implied.’ It is inappropriate to assume that patients admitted to training institutes are sufficiently informed to justify their implied consent for participation as human subjects purely for training purposes.

Apart from this, SA guidelines are quite clear in requiring specific IC for all examinations and procedures. To start with, the SA Bill of Rights (clause 10) refers to each person’s ‘inherent dignity and the right to have their dignity respected and protected’.[5] The SA

REVIEW Patients’ Rights Charter (HPCSA Booklet 3, clause 2.2)[7] reiterates that ‘everyone has the right to participate in decision-making on matters affecting one’s own health’, and in 2.6, the right to ‘know the person that is providing healthcare’ and to ‘be attended to by only clearly identified healthcare providers.’ Chapter 2 of the NHA deals with informed consent, and in 6.1 and 7.1 reiterate the requirement for informed consent. HPCSA Booklet 4 deals more comprehensively with the subject, and among others, states the following requirements in terms of information that should be supplied to the patient: ‘3.1.3.8. The name of the doctor who will have overall responsibility for the treatment and, where appropriate, names of the senior members of his or her team; 3.1.3.9. Whether students will be involved, and the extent to which students may be involved in an investigation or treatment.’

Not complying with the HPCSA ethical rules and ignoring the SA Bill of Rights may in itself have serious consequences. Furthermore, the autonomy argument and the right to bodily integrity and privacy trump any argument that might be presented to oppose specific IC. Examples of such arguments are: •• obtaining IC in these situations is impracticable •• patients may refuse •• it places an additional unnecessary burden on both patient and an already taxed healthcare team •• for the sake of distributive justice, allocating a little less time to each patient is better than giving some none •• the societal value of proper training outweighs any individual autonomy concerns •• patients will not be harmed, and may be advantaged •• patients implicitly consent and this is sufficient.

Booklet 4 (at 18.2) legitimises the sharing of a patient’s health-related information ‘to the extent that it is necessary to enhance the quality of care to be provided to that patient and the patient has given consent to treatment and disclosure of such information to another healthcare practitioner’. Medical students are legitimate members of the healthcare team, as are paramedical staff, nurses and therapists, and information may be shared with them. The same exacting standards of maintaining patient confidentiality apply to all.

The conclusion is that patients should be explicitly and fully informed about the extent of the involvement of students. What is less obvious is whether the requirement of informing ipso facto extends to obtaining consent; in the prior clause (3.1.3.8, cited above), this clearly does not, and the reasonable deduction is that patients need only be informed and not asked to consent to the participation of students. This is contrary to most international norms and practices[20] and my own inclination, but excludes specific student-patient interactions, e.g. taking history, physical examination and procedures such as phlebotomy. For non-invasive contact, a simple introduction and explanation, including an explanation of why the examination will aid the student in his/her training (e.g. ‘you have a heart murmur’), plus explicit uncoerced but verbal consent by the patient, should suffice.[20] For phlebotomy, an explanation of the intended tests and verbal consent would serve. Formal written consent should be obtained for intimate examinations.[21,22,12] The student should make an appropriate note of all consent conversations in the patient’s folder or notes, and should be aware of what information has already been shared and discussed with the patient. Students should not be the harbingers of bad, or in fact any, tidings. This is an ideal opportunity for training of a different kind – for students to hone their communication skills and practise the art of obtaining IC. Since student contact with patients can occur at various levels, it may be advisable that a relatively senior team member at admission explain why and how students will be involved and that students may act as valued care team members, e.g. performing phlebotomy.

The role of students who attend and assist at operations should also be explained. Consent should be obtained if preoperative intimate examinations for training purposes are envisaged, and students should reobtain consent. The consent requirement helps to keep track of the number of students who examine a specific patient, to prevent overtaxing any individual.

Supplying information about student participation in outpatient settings, and obtaining consent, may be more problematic.

Nevertheless, expediency is not an excuse, and concise verbal consent will suffice. This, too, is an art that has to be learnt and developed.

Intimate examinations of patients under general anaesthesia A particular conundrum that has attracted a lot of media attention is medical students performing intimate pelvic examinations. This can take place in outpatient and ward settings, and is integral to proper student training. When done in wards without supervision, written IC is advisable, as is the presence of a chaperone (nurse). In outpatient settings, supervision is likely, and verbal consent should be sufficient, since a witness is present. However, a controversy has developed around medical students doing these examinations on anaesthetised patients prior to surgery without specific consent. The utilitarian justification for these examinations is that women are not harmed because they are unaware, that these are ideal conditions to learn how to perform pelvic examinations and that society at large ultimately benefits. It is fallacious to argue that persons can only be harmed if they are aware of the harm; millions of South Africans were harmed because their human rights were denied under apartheid, even if they were unaware that such rights existed. Several groups of students, including Israeli[23] and American[24] students, have objected to being expected to examine patients under these circumstances.

A multicentre study in Wales, England and Australia confirmed both this expectation and students’ discomfort.[25] Specific guidelines exist in various jurisdictions, but there is consensus that these clinically unnecessary examinations violate patients’ rights to privacy and bodily integrity, and may constitute assault unless fully informed prior consent is obtained.[17]

Student procedures and risk With respect to actual procedures performed by students as part of the healthcare team, including suturing wounds, phlebotomy, deliveries and lumbar punctures, special care has to be taken to minimise risk and harm through adequate pre-training, assessment and supervision. Where appropriate, patients should be informed of these measures. It is likely that risks may nevertheless be increased in inexperienced hands, although few empirical data exist to quantify

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REVIEW these risks.[16] There is, however, some anecdotal SA evidence that medical students may be required to perform procedures for which they do not feel adequately prepared, without specific IC.[26] It might be counterproductive to overplay risks, yet they should not be underplayed and be presented as a matter of fact. The possibility of patient refusal to be examined/treated by a student is no excuse to deny patients the information they require to make decisions.

Registrars, midwives and therapists in training A special case has to be made for house officers, registrars (particularly in the surgical and gynaecological disciplines, and in anaesthesiology), midwives and therapists who are in training.

I focus on surgical and anaesthesiology registrars, since the argument is more pertinent. These healthcare providers are both students and qualified doctors. Moreover, they are at various levels of training, knowledge, expertise, experience and clinical acumen.

However, they are, as yet, not qualified specialists. They work under different levels of supervision, or no direct supervision, depending on the type of procedure performed, attendant risks, their own experience and expertise and the availability of senior personnel to act as supervisors. Even if not in close attendance in the operating suite, consultants should always be available to consult or assist.

Personnel who supervise junior staff may be held accountable for mistakes and preventable complications. Senior registrars are usually skilled at their art. Training is customarily well structured and monitored, and no one should be put in a position where (s)he is required to perform beyond his/her experience or expertise. That being said, each operation is unique, and adds to the experience of the operator. It is precisely to cater for the unexpected and unusual that experience is required.

The decision as to what surgical procedures a registrar should be allowed to perform has both objective and subjective aspects and implications. Objectively, supervisors (consultants) should assess the registrar’s eligibility to perform more advanced procedures.

Subjectively, each registrar is expected to comply with the guidelines in HPCSA Booklet 2, clause 21: ‘A practitioner shall perform, except in an emergency, only a professional act (a) for which he or she is adequately educated, trained and sufficiently experienced,’[27] so a registrar may be held personally accountable if (s)he performs surgery beyond this pale and complications ensue. The word ‘certified’ is omitted from this clause. The onus is on the doctor to decide what is within his/her grasp, and to justify decisions if required.

It therefore seems reasonable to deduce that there is no requirement to supply additional information to the patient, and a registrar may perform surgery judged within his/her capabilities provided: •• authentic IC is obtained and the provisions of the NHA and HPCSA guidelines on IC are met •• patients are informed about the identities of all members of the healthcare team, and specifically about who will finally take responsibility •• a proper and effective supervision system is in place to evaluate and review the registrar’s competence •• the registrar complies with Clause 21(a) above.

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Strict adherence to such protocols could ultimately be to the patient’s benefit.

However, this set of circumstances and requirements applies only to clinically indicated diagnostic and therapeutic interventions. A different scenario exists when examinations and interventions are performed which have no diagnostic or therapeutic value, i.e. for instructional reasons only. To start with, there is a grey area where instruction and therapy coexist. Take as an example, firstly, pelvic examination of a patient under general anaesthesia preceding a decision to perform either a vaginal or abdominal hysterectomy (or just preceding surgery). A registrar who will assist at the operation co-examines the patient, and the consultant who will make the final decision and perform the surgery first elicits the registrar’s opinion before making his/her own known. The registrar has a dual role: that of professional assistant, for which no specific additional consent is required, and also that of trainee, for which consent should possibly be obtained. A second example to which I have been exposed has to do with training anaesthesiology registrars to use aids to endotracheal intubation. These are helpful to intubate difficult airways when visualisation of the vocal cords is impossible during direct laryngoscopy, or when the patient’s head should not be moved, e.g. with unstable cervical spine fractures. Examples of these aids are fibre-optic intubating scopes and a type of airway which is placed in the pharynx to cover the larynx, and through which an endotracheal tube can be passed blindly. Training on normal healthy subjects undergoing routine surgery is required to ensure smooth and less stressful utilisation in emergencies, when these aids can save lives. There may also be clinical indications for the use of these aids.

The murkiness of these scenarios is that it is up to the professionals involved to determine which role predominates or should apply, particularly if adjudging the encounter to be predominantly educational requires extra effort, forethought and time to obtain prior consent. It is unlikely that there will ever be any repercussions if the policy in a particular unit maintains that the educational aspects of encounters such as these be habitually underplayed, on the face of it rendering additional consent unnecessary. However, professionals have an additional responsibility to protect and advance the rights of their wards when the latter are incapacitated (e.g. anaesthetised) and cannot fend for themselves. Ethics is, after all, an aspirational endeavour, whereas rules invariably set a minimum standard.

Consideration should also be given to the message that our actions and practices may send out to junior staff, nurses and students, which could either further or negate the importance of ethically sound practice. The importance of role models in practical ethics education should not be overlooked.

In the cases quoted above, no real harm was done. In other instances, the potential for increased harm or risk may exist. A good example is anaesthesiology registrars learning to perform spinal and epidural blocks. The dura should not be punctured when doing epidurals, but it is well documented that the risks of dural puncture, among other procedures, are inversely proportional to the experience of the operator.[28] Dural puncture with a large-bore epidural needle may cause severe headaches owing to leakage of cerebrospinal fluid, requiring follow-up invasive treatment. Unless otherwise informed, when IC is obtained it is implied and the patient accepts that the caregiver is appropriately competent. On top of this,

REVIEW HPCSA Booklet 2, clause 21, clearly requires that practitioners, except in emergencies, only perform professional acts ‘for which he or she is adequately educated, trained and sufficiently experienced’.[26]

Quo vadis?

In this section I outline some general principles and thoughts without being over-prescriptive. It is left to institutes where training is provided, hospital authorities and departments and clinical specialties, guided by clinical ethics committees and e.g. the Council for Health Service Accreditation of Southern Africa (COHSASA) IC and ethics standards[29] to consider how these principles should be applied. Institutes should monitor and regularly audit the authenticity of IC for patient participation in medical training. My reflection will cover, firstly, attitudes towards patients, and secondly, institutional and departmental policies, practices and procedures, and is intended to promote dialogue and appropriate action within institutions and departments. Note that I have focused on undergraduate and postgraduate medical students, but my comments are applicable to all registered healthcare students who interact with patients.

To begin with, following clause 9 of the SA Bill of Rights[5] and Clause 5.6 of HPCSA Booklet 1,[10] it should be our firm conviction that any form of discrimination has no place in authentically ethical medical practice. Just because patients attend state hospitals, and may not be educated or be illiterate and medically/scientifically naive, may not know their rights and may trust those who care for them, is no licence to discriminate. Ethically speaking, the ideal is that all patients be treated equally, because human rights are universal.

Procedures need to be in place and appropriate steps taken to ensure that their rights are upheld and promoted.[10] Secondly, each institute should develop a set of ethical principles (a credo or mission statement if you like) that should govern the treatment of patients. Necessary principles should be developed by clinical ethics committees, and should include: •• a reference to distributive justice and non-discrimination •• the assurance that no examinations or procedures will take place without expressed IC •• confirmation that medical and ethical principles and guidelines governing medical practice and ancillary services will be upheld •• a statement that the interests of patients will always predominate.

This poster-sized notice or a separate dedicated notice should declare that the institute trains medical personnel, and provide details of student and registrar training as it might affect patients. It should confirm that appropriate supervision of training always applies and measures are in place to minimise risk and prevent harm, and that the patient’s prior consent will always be sought. Complaints procedures should be outlined. This should be written in understandable lay terms and language, translated into all languages locally used, and clearly displayed at all public hospital entrances and throughout the institute. The Patient’s Rights Charter should be displayed in the same way. Each patient should be given copies of these documents to read in his or her own time. A ward sister or other appropriately trained staff member, or the student to whom the patient will be allocated, should explain these documents and co-sign with the patient, confirming comprehension. Regular audits of this process should be performed to ensure compliance.

The ethos of the institute should reflect its mission statement. Each institution should reflect on and develop principles and guidelines

on student interaction with patients, particularly regarding IC for all patient interactions. The Consensus Statement[20] developed by the healthcare faculties of the universities of Auckland and Otago is an excellent departure point. Note that the act of providing IC is voluntary. This implies that patients have the right to refuse participation in student training, and may not be coerced. Most patients are likely to consent, but may not be penalised or abandoned if they do not.[16] Where the meeting of service delivery and training may cause inherent tensions, particularly where procedures are performed purely for training purposes, departments should be sensitive to the requirements for specific IC and develop appropriate policies to guide the management of IC. Guiding principles are that training should always be appropriately supervised and consented to, and that patients should not be exposed to additional harm or risk. Risks cannot invariably be prevented (such as in the epidural headache example described above), but can be curtailed. Departmental policies and procedures should ensure that they are, and patients be informed accordingly.

Acknowledgements. None.

Author contributions. Sole author.

Funding. None.

Conflicts of interest. None.

1. National Department of Health, South Africa. Guidelines for Good Practice in the Conduct of Clinical Trials with Human Participants in South Africa. Pretoria: NDoH, 2006. http://www.kznhealth.gov.za/research/guideline2.pdf (accessed 7 August 2017).

2. De Roubaix M. Dare we rethink informed consent? S Afr J Bioethics Law 2017;10(1):25-28. https://doi.org/10.7196/sajbl.507 3. Henderson GE, Churchill LR, Davis AM, et al. Clinical trials and medical care: Defining the therapeutic misconception. PLoS Med 2007;4(11):e324. https://doi. org/10.1371/journal.pmed.0040324 4. Nola R. Knowledge, discourse, power and genealogy in Foucault. Crit Rev Int Soc Pol Phil 1998;1(2):109-154. https://doi.org/10.1080/13698239808403240 5. Constitution of the Republic of South Africa, 1996: Chapter 2: Bill of Rights. http:// www.gov.za/documents/constitution/chapter-2-bill-rights (accessed 7 August 2017).

6. South Africa. National Health Act No. 61 of 2003. https://www.acts.co.za/ national_health/index.html (accessed 9 August 2017).

7. Health Professions Council of South Africa. Booklet 3: Guidelines for Good Practice in the Health Care Professions. National Patients’ Rights Charter. http:// www.hpcsa.co.za/Conduct/Ethics (accessed 31 July 2017).

8. Health Professions Council of South Africa. Ethical Guidelines for Good Practice in the Health Care Professions. http://www.hpcsa.co.za/Conduct/Ethics (accessed 30 July 2017).

9. Malherbe J. Counting the cost: The consequences of increased medical malpractice litigation in South Africa. S Afr Med J 2013;103(2):83-84. https://doi. org/10.7196/samj.6457 10. Health Professions Council of South Africa. Booklet 1: General ethical guidelines for the healthcare professions. Clause 5.2.5. http://www.hpcsa.co.za/Conduct/ Ethics (accessed 30 July 2017) 11. Dornan T. Osler, Flexner, apprenticeship and ‘the new medical education.’ J Royal Soc Med 2005;98(3):91-95. https://doi.org/10.1258/jrsm.98.3.91 12. Wainberg S, Wrigley H, Fair J, Ross S. Teaching pelvic examinations under anaesthesia: What do women think? J Obstetrics Gynaecol Canada 2010;32(1):4953. https://doi.org/10.1016/s1701-2163(16)34404-8 13. Kalantri SP. Ethics in medical education. Indian J Anaesth 2003;47(6):435-436. http://medind.nic.in/iad/t03/i6/iadt03i6p435.pdf 14. Graber MA, Pierre J, Charlton M. Patient Opinions and Attitudes toward Medical Student Procedures in the Emergency Department. Acad Emerg Med 2003;10(12):1329–33. https://doi.org/10.1111/j.1553-2712.2003. tb00006.x 15. Barnett AT, Cawich SO, Crandon IW, et al. Informed consent from patients participating in medical education: A survey from a university hospital in Jamaica. BMC Res Notes 2009;2(1):252. https://doi.org/10.1186/1756-0500-2252

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REVIEW 16. Marracino RK, Orr RD. Entitling the student doctor. J Gen Internal Med 1998;13(4):266-270. https://doi.org/10.1046/j.1525-1497.1998.00078.x 17. Gibson E, Downie J. Consent requirements for pelvic examinations performed for training purposes. Can Med Ass J 2012;184(10):1159-1161. https://doi. org/10.1503/cmaj.110725 18. Picard A. Time to end pelvic exams done without consent. Toronto: Globe and Mail, 28 January 2010. www.theglobeandmail.com/life/health/time-to-endpelvic-exams-done-without-consent/article1447337 (accessed 10 August 2017).

19. Health Professions Council of South Africa Booklet 4: Seeking patients’ informed consent: Ethical considerations. http://www.hpcsa.co.za/Conduct/Ethics (accessed 30 July 2017).

20. Bagg W, Adams J, Anderson L, et al. Medical students and informed consent: A consensus statement prepared by the Faculty of Medical and Health Sciences of the University of Auckland and the University of Otago Medical School, Chief Medical Officers of District Health Boards, New Zealand Medical Students’ Association and the Medical Council of New Zealand. NZMJ 2015;128(1414):27-35. http:// www.nzmsj.com/uploads/3/1/8/4/31845897/informed_consent_nzmj_2015.pdf (accessed day month year).

21. Magrane D, Gannon J, Miller C. Student doctors and women in labor: Attitudes and expectations. Obstetr Gynecol 1996;88(2):298-302. https://doi. org/10.1016/0029-7844(96)00191-3 22. Navomita R. A study on pelvic examination under anaesthesia. In J Med Health Res 2017;3(1):76-79. www.medicalsciencejournal.com/download/422/3-5-25-652. pdf (accessed 8 August 2017).

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23. Mankuta D, Shehadeh S, Kaitz M. Failure to obtain informed consent for intimate examinations by medical students. Open Access J Gynecol 2006;1(1):000102 http://medwinpublishers.com/OAJG/OAJG-16-000102.pdf (accessed 8 August 2017).

24. Rees CE, Monrouxe LV. Medical students learning intimate examinations without valid consent: A multicentre study. Med Edu 2011;45(3):261-272. https://doi. org/10.1111/j.1365-2923.2010.03911.x 25. York-Best CM, Ecker JL. Pelvic examinations under anesthesia. Obstetrics Gynaecol 2012;120(4):741-742. https://doi.org/10.1097/aog.0b013e31826ce689 26. Kirkman MA. Medical electives in South Africa. S Afr Med J 2012;99(11):789-790.

September 12, 2017, from http://www.scielo.org.za/scielo.php?script=sci_ arttext&pid=S0256-95742009001100013&lng=en&tlng=en (accessed 12 September 2017).

27. Health Professions Council of South Africa. Booklet 2: Guidelines for Good Clinical Practice in the Healthcare Professions. Ethical and Professional rules of the HPCSA. http://www.hpcsa.co.za/Conduct/Ethics (accessed 30 July 2017).

28. Waise S, Gannon D. Reducing the incidence of post-dural puncture headache. Clin Med 2013;13(1):32-34. https://doi.org/10.7861/clinmedicine.13-1-32 29. Council for Healthcare Service Accreditation of South Africa. Hospital accreditation standards. Version 6.7. Cape Town: COHSASA, 2015. http://www.cohsasa.co.za/ sites/cohsasa.co.za/files/cohsasa_accreditation_standards_for_website_-_ hospital_standards_6.7_-_oct2015.pdf (accessed 25 August 2017).

Accepted 15 November 2017.

This open-access article is distributed under Creative Commons licence CC-BY-NC 4.0.

ARTICLE

The need to develop objective criteria for suitability as a surrogate mother: Reflections on Ex Parte KAF D W Thaldar, BLC, LLB, MPPS, PGDip (Strategy & Innovation), PhD School of Law, Howard College, University of KwaZulu-Natal, Durban, South Africa, and associate member, KwaZulu-Natal Bar, South Africa Corresponding author: D W Thaldar (ThaldarD@ukzn.ac.za)

This article points out a problematic lacuna in our law on surrogate motherhood, namely the lack of objective criteria for evaluating the suitability of a surrogate mother. The recent case of Ex Parte KAF – a case in which a surrogate motherhood agreement confirmation application was dismissed by the Johannesburg High Court – demonstrated how this lacuna can cause conceptual disjunction between the court and the clinical psychologist who evaluates the candidate surrogate mother. The solution suggested in this article is that clinical psychologists who evaluate candidate surrogate mothers should give urgent and careful thought to identifying such objective criteria, and start explicitly articulating these criteria in the reports that they file in surrogate motherhood agreement confirmation applications. This practice will give the court the opportunity to engage with such criteria and to develop precedents in this regard.

S Afr J Bioethics Law 2018;11(1):35-37. DOI:10.7196/SAJBL.2018.v11i1.618

The basic legal framework for surrogate motherhood is established in Chapter 19 of the Children’s Act No. 38 of 2005.[1] In Ex Parte WH,[2] the Pretoria High Court placed some essential flesh on the bones of the Children’s Act. Subsequently, some other cases have also contributed to the law on surrogate motherhood.[3,4] The most recent addition is Ex Parte KAF,[5] which was decided on 10 August 2017 by the Johannesburg High Court. The purpose of this article is to analyse the contribution made by Ex Parte KAF to the development of our law on surrogate motherhood.

The growing body of case law on surrogate motherhood might cause one to ask whether it is fair to require commissioning parents and the surrogate mother to jump through so many legal hoops – especially considering there are no similar legal requirements for procreating through sexual intercourse. The case law on surrogate motherhood is, in theory at least, merely clarification and elaboration of the law within the framework created by statute. It is the Children’s Act in section 295 that inter alia requires: the commissioning parent(s) to be unable to give birth to a child and that the condition must be permanent and irreversible; the commissioning parent(s) to be suitable persons to accept parenthood of the child; and the surrogate mother to be a suitable person in all respects to act as a surrogate mother.[1] The court gradually, on a case-by-case basis as required by the facts of a particular matter, applies the general principles of our law to the requirements stipulated by the Act. Metaphorically, the Act created the legal hoops, and the court determines how one is to jump through them – or, in the case of Ex Parte KAF, how not to jump through them.

I first discuss the facts and decision in Ex Parte KAF, and then analyse the potential impact of the judgment on the way in which clinical psychologists should prepare their reports on the suitability of the surrogate mother.

Ex Parte KAF At face value, Ex Parte KAF is a typical surrogacy confirmation application: the applicants were the commissioning mother and

father (a married couple) and the surrogate mother and her life partner. The commissioning couple had been married since 2006, but were not able to have a child. The reason for this inability, according to the reproductive medicine specialist who provided an opinion in support of the surrogacy confirmation application, was that the commissioning mother had a uterine septum which had been removed twice – but each time it grew back. The commissioning mother underwent five IVF cycles without success.

Subsequent to these failures, the reproductive medicine specialist advised the commissioning couple that surrogacy was the only option if they wanted a genetically related child. Through the surrogacy programme operated by the reproductive medicine specialist’s clinic, the commissioning couple were introduced to the surrogate mother, a 20-year-old, stay-at-home mother of two young children. The surrogate mother’s life partner is in full-time employment. All the applicants were interviewed by a clinical psychologist, who provided positive reports on the suitability of both the commissioning couple and the surrogate mother. At least superficially, the application appeared to be problem-free and set for success in court.

Despite the apparently standard nature of the surrogacy application, it was dismissed for three reasons, each being sufficient: (i) concern about surrogacy as a means of income; (ii) concern about the intended surrogate mother’s psychological wellbeing; and (iii) concern about the impartiality of healthcare professionals.

The first reason was that the intended surrogate mother was likely to use surrogacy as a means of income. According to the proposed surrogate motherhood agreement, the commissioning parents would reimburse the intended surrogate mother for pregnancy-related expenses up to ZAR4 000 per month – increasing to up to ZAR6 000 per month after she falls pregnant. Although the proposed surrogate motherhood agreement provided examples of pregnancy-related expenses, these examples were not exhaustive and there was no budgetary limit on any specific item. (Ex Parte WH at paragraph 29 had

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ARTICLE already laid down the requirement that ‘a detailed list of surrogacy expenses with sufficient specificity should be provided’).[2] Furthermore, the court expressed concern about the surrogate mother’s financial position: the intended surrogate mother lived with her life partner and his extended family on a smallholding; no facts were placed before the court regarding any of these people’s income. However, the municipal account for the smallholding, which was attached to serve as proof of the surrogate mother’s residence, revealed that about ZAR15 000 was outstanding. Based on these facts, the court decided that there was a risk that the intended surrogate mother was using surrogacy as a means of income.

The court’s second reason for dismissing the application was concern about the intended surrogate mother’s psychological wellbeing – in spite of the psychological report that declared the intended surrogate mother suitable to become a surrogate mother.

The court highlighted the following facts from the commissioning mother’s founding affidavit: the intended surrogate mother, ND, fell pregnant with her first child at the age of 16, and subsequently dropped out of school. There were no facts before the court that ND has since made any attempt to finish school or to gain any type of vocational training. Given these facts, the court rejected the psychologist’s conclusion that ND is suitable to be a surrogate mother, as being unsupported by the facts. Does ND have the maturity to appreciate that she will have to hand over the child to the commissioning parents after birth? The court was not convinced of this, and held that it was not satisfied that ND has the maturity to appreciate the implications of her life decisions.

The third reason for dismissing the application is especially relevant to healthcare professionals involved in surrogacy. In this case, the reproductive medicine specialist who provided the court with his opinion on the commissioning mother’s infertility, and the psychologist who provided opinions on the applicants, both seem to be associated with the same fertility clinic. This fertility clinic would also have been contracted to provide in vitro fertilisation (IVF) treatment for the surrogate mother, had the application been successful. Given these facts, the court expressed two related concerns: firstly, about the objectivity of the relevant healthcare professionals, and secondly about the possible commercialisation of surrogacy. The court held that it had insufficient information about the exact financial arrangements between the relevant healthcare professionals and the clinic to make final findings on these concerns.

Analysis The court in Ex Parte KAF held that, on the facts before it, it was unpersuaded about the suitability of the surrogate mother.

However, the court did not elaborate on what information or kinds of information would have persuaded it otherwise. In other words, even if a clinical psychologist explores every aspect of a candidate surrogate mother’s life in detail, and metaphorically looks under every stone, how does the psychologist decide whether a candidate is a suitable surrogate mother? Accordingly, the underlying problem in our law that was exposed in Ex Parte KAF is the lack of objective criteria for evaluating the suitability of a surrogate mother. I suggest that clinical psychologists who evaluate candidate surrogate mothers should give urgent and careful thought to identifying such objective criteria, and start explicitly articulating such criteria in the reports

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that they file in surrogate motherhood agreement confirmation applications. In fact, experts in general have a duty to furnish the court with the criteria that they used to reach their conclusions, so as to enable the court to form its own independent judgment by application of the criteria to the facts.[6] Moreover, this practice would give the court the opportunity to engage with such criteria and to develop precedents in this regard. Absent clear, objective criteria, different psychologists and different judges will all be working with their own tacit, subjective criteria. This is clearly not in the interests of justice.

The Ex Parte KAF judgment emphasised the general legal requirement that experts must be objective in fact and in perception.

But what exactly is meant by objectivity in our law? Can objectivity be reconciled with personal interests? The reality is that no expert – or even a judge – is ever completely free from personal interests. As the Constitutional Court held in paragraph 14 of its judgment in South African Commercial Catering and Allied Workers Union v Irvin & Johnson (footnotes omitted):[7] ‘“Absolute neutrality” is something of a chimera in the judicial context. This is because judges are human. They are unavoidably the product of their own life experiences, and the perspective thus derived inevitably and distinctively informs each judge’s performance of his or her judicial duties.’

The same is true of experts. The key to objectivity is not to have no personal interests – which is impossible – but rather to deliberately act free of such interests. The Missouri Court of Appeals succinctly articulated this principle, as it relates to expert opinions, as follows:[8] ‘“Objectivity” is the quality of being free from the influence of personal considerations in the exercise of professional skills and professional judgment.’

In the context of psychological reports on the suitability of surrogate mothers, the key to acting in an independent, objective way – and being perceived to act as such – is to implement the objective-criteria approach that I suggested above: a clinical psychologist should explicitly state the criteria used for evaluating the suitability of a surrogate mother, and should explain how these criteria are applied to the facts. In this way, a clinical psychologist will demonstrate that he or she does not merely provide a subjective opinion on suitability, but deliberately acts objectively.

Conclusion Our legal system is dynamic and continuously developing – especially through case law. Ex Parte KAF applied some of the general principles of our law of evidence to surrogacy confirmation applications. The result is that a problematic lacuna in our law regarding surrogate motherhood has surfaced. To a large extent, applicants in surrogate motherhood agreement confirmation applications have been trying to jump through the suitable-surrogate-mother legal hoop’ n the dark.

The way to illuminate this legal hoop is through the development of objective criteria.

Acknowledgements. None.

Author contributions. Sole author.

Funding. None.

Conflicts of interest. None.

ARTICLE 1. South Africa. Childrenâ&#x20AC;&#x2122;s Act No. 38 of 2005. http://www.justice.gov.za/ legislation/acts/2005-038%20childrensact.pdf (accessed 15 November 2017).

2. Ex Parte WH (2011) ZAGPPHC 185; 2011 (6) SA 514 (GNP). http://www.saflii.org/ za/cases/ZAGPPHC/2011/185.html (accessed 15 November 2017).

3. Ex Parte MS 2014 ZAGPPHC 457. http://www.saflii.org/za/cases/ZAGPPHC/2014/457. html (accessed 15 November 2017).

4. Ex Parte HPP; Ex Parte DME 2017 ZAGPPHC 70; 2017 (4) SA 528 (GP). http://www. saflii.org/za/cases/ZAGPPHC/2017/70.html (accessed 15 November 2017).

5. Ex Parte KAF 2017 ZAGPJHC 227. http://www.saflii.org/za/cases/ZAGPJHC/2017/227. html (accessed 15 November 2017).

6. Twine v Naidoo 2017 ZAGPJHC 288. http://www1.saflii.org/za/cases/ ZAGPJHC/2017/288.html (accessed 15 November 2017).

7. South African Commercial Catering and Allied Workers Union v Irvin & Johnson Limited Seafoods Division Fish Processing 2000 ZACC 10; 2000 (3) SA 705. http://www.saflii.org/za/cases/ZACC/2000/10.html (accessed 15 November 2017).

8. State Ex Rel. Lichtor v Clark, 845 S.W.2d 55 (Mo. Ct. App. 1992). https://www. courtlistener.com/opinion/2429713/state-ex-rel-lichtor-v-clark/ (accessed 15 November 2017).

Accepted 29 January 2018.

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This open-access article is distributed under Creative Commons licence CC-BY-NC 4.0.

ARTICLE

Should the state fund assisted reproductive technologies for HIV-discordant couples in South Africa who want to have children?

A W Moodley, MB ChB, DA, FCA Department of Anaesthesia, Charlotte Maxeke Johannesburg Academic Hospital, Johannesburg, South Africa; School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa Corresponding author: A W Moodley (alastairwm@gmail.com)

Assisted reproductive techniques (ARTs) can provide a way for HIV-serodiscordant couples to safely fall pregnant. However, their high cost raises concerns about distributive justice, especially now as we are laying the foundation for a national health insurance. Considering that the right to access reproductive healthcare services is specifically mentioned in the South African Constitution, a discussion surrounding ARTs and their funding is warranted. This article argues that the state does not have a moral duty to provide ARTs for serodiscordant couples in the current socioeconomic environment that SA finds itself.

S Afr J Bioethics Law 2018;11(1):38-42. DOI:10.7196/SAJBL.2018.v11i1.622

HIV-positive patients on antiretroviral (ARV) therapy have managed to reclaim much of their lives from the grip of the disease. However, HIV is largely a sexually transmitted infection, and interventions such as condom usage, which protect the uninfected from the infection, also preclude procreation via conventional means. Assisted reproduction techniques (ARTs) that were pioneered to assist couples with fertility issues now find another valuable use in serodiscordant couples (in which one partner is HIV-positive and the other HIVnegative) who desire to have children. In the situation where the male partner is HIV-positive, techniques such as sperm washing and intrauterine insemination may be used to protect the female partner from HIV infection. In the situation where the female partner is HIVpositive, the concern of vertical transmission to the infant needs to be considered. Some authorities suggest that the female partner needs to be virally suppressed for 6 months prior to conception to keep the risks of vertical transmission low.[1] In this case, in vitro fertilisation and intracytoplasmic sperm injection may be used to protect the uninfected male partner. Despite being revolutionary, and offering the possibility of what was once considered impossible, the cost of ARTs runs into tens of thousands of rands per cycle, meaning that for the majority of people it remains out of reach.[2] In considering the use of ARTs in people affected by HIV, several ethical concerns have been raised. Some have questioned the risk of HIV transmission to the infant, and suggest that subjecting a child to that risk may be considered unethical.[3] Others have raised the issue of the potentially harmful side-effects that ARV therapy may have on the unborn child.

Further to these concerns, some have raised the issue of the expected lifespan of people infected with HIV, suggesting that a parent’s potentially limited life expectancy could affect child rearing.[3] This article, however, will not address these concerns, but solely examine the question of ART funding.

The health of a nation: Why South Africans are dying South Africa (SA) has the world’s largest population affected by HIV/ AIDS.[4] Hundreds of thousands of people continue to die each year from a lack of access to ARVs, which can change an HIV/AIDS diagnosis from a fatal condition to a manageable disease. Less than half of those who are infected are on ARV therapy. According to the World Health Organization (WHO), HIV/AIDS is the leading cause of death in SA.[5] However, since HIV is treatable, the real leading cause of death of South Africans is a lack of treatment (which not only depends on ARVs, but also on doctors, nurses, pharmacists, clinics and hospitals). Poverty, then, is truly the leading cause of death in this country.

In the late 1990s, medical science made a leap forward in the treatment of HIV. An ARV combination was formulated that produced dramatic results in those dying of AIDS. These ARVs were heralded as ‘life-saving’. However, their cost was far beyond the reach of most patients in Africa, a continent that shouldered the overwhelming burden of the disease. And despite the victory by campaigners in eventually obtaining generic ARVs at a reduced cost (it now costs USD125 per patient per year), the sheer number of patients affected in SA still multiplies that cost into billions of rands each year.[6] One of the particularly tragic effects of HIV infection is the fact that it affects the young, previously healthy and vital members of the population. Untreated, it leaves large segments of the working population incapacitated – striking a country where it should be strongest, hitting hard at the most productive group of its population, leaving in its wake innumerable orphans, a crippled workforce and a skyrocketing fiscal deficit.

Over 20% of children under 5 years old are stunted by malnutrition, and up to a third of SA children have not received basic vaccinations.[5] More than two-thirds of children from impoverished households live below the ‘dollar a day’ mark, indicating extreme poverty.

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ARTICLE Maternal mortality in SA is still much higher than the targets set by the Millennium Development Goals.[7] SA’s maternal mortality rates are still more than twice that of Brazil, a country with a similar economic profile.[8] It is against this background that pertinent questions around resource allocation beg to be asked – the rands and sense of ARTs in SA. ARTs range from intrauterine insemination (IUI), which is the most basic technique, to in vitro fertilisation (IVF), intracytoplasmic sperm injections (ICSI) and semen decontamination in male patients who are HIV-positive. Huyser et al.[2] estimated that for a single treatment involving IUI, which is the least expensive of the treatments mentioned, the cost would amount to more than ZAR9 000. This treatment has a success rate of only 15% per month. Patients often require 2 - 3 cycles, translating to ZAR27 000 in the best-case scenario, to result in a single pregnancy. This amount is enough to provide ARVs to 16 patients for an entire year (based on a rate of USD1:ZAR 13.3). In vitro fertilisation has a higher success rate, but comes at a higher cost. A single cycle costs more than ZAR50 000.

Countries in the developed world provide no cover or only partial coverage of treatment by the state. In the USA, which has the world’s largest economy, the state does not pay for ARTs.[9] Australia provides only a partial subsidy to its citizens for ARTs.[10] If these first-world countries cannot afford to pay for these therapies, how is it possible to expect SA to do so?

ARTs for couples who are HIV-negative If ARTs can be used to help subfertile couples just as they can help HIV-serodiscordant couples, why then should HIV-negative couples be excluded from the consideration for state funding? This only adds to the unfeasibility of state funding of ARTs, since in order to be ethically correct, the state would have to consider funding the treatment of the entire collective of people who could potentially benefit from ARTs, and at these numbers it makes it even more of an economic impossibility.

An argument from justice The state functions within economic constraints and struggles with resource limitations. If it were to fund expensive ARTs for a large section of the population, it would mean that a significant chunk of resources would have to be sacrificed from other healthcare initiatives. SA’s healthcare system is struggling to keep up with rising healthcare costs. It is fair to say then that funding ARTs means diverting resources from somewhere else – be it childhood immunisation, ARVs or safe obstetric care. This bears examining from the perspective of the notion of distributive justice, which is defined as ‘fair, equitable and appropriate distribution determined by justified norms that structure the terms of social co-operation’.[11] The fundamental idea behind utilitarianism is the promotion of utility (good) for the greatest number of people. In providing a means for a serodiscordant couple to have a child, it can be argued that the good or happiness brought about is limited to the couple. Providing ARVs, on the other hand, saves the life of someone. It allows them to be productive members of society. It enables them to work and earn a living, raise a family, pay taxes and contribute to society. Recall that strikingly, the cost of the cheapest form of ART could treat 16 HIV-positive people for a year. It becomes clear that no utilitarian

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argument could favour state-funded ARTs on the balance of the number of people whose lives would be saved by funding ARVs instead. The amount of utility produced by ARV therapy far outweighs the utility brought about by a single pregnancy with ARTs. Egalitarianism suggests that resources be equally distributed to all people. SA’s limited budget suggests that if healthcare rands were distributed equally among all citizens, it would be a very thin spread indeed. The state would have to now fund the more than 8 million people who do not utilise public healthcare, in addition to the 42 million who do.[12] This would set the threshold for each person at a substantially low level. No-one would be able to afford ARTs, and certainly those with HIV would not be able to afford both ARVs as well as ARTs. An egalitarian approach therefore means that state-funded ARTs are impossible in our country.

Communitarianism suggests that communities decide how resources would be distributed. A key feature of communitarianism is the idea that the welfare of the community is prioritised over the welfare of the individual. This theory of distributive justice bears a striking resemblance to the African notion of ubuntu (the SA concept of ubuntu is shared with many other sub-Saharan cultures, although referred to by other names, e. g. umundu in Kenya and vumuntu in Mozambique,) which recognises that we do not exist in isolation and that by ensuring the welfare of the collective, we ensure our own welfare as well.[13] How would state-funded ARTs fare when viewed through the framework of communitarianism and ubuntu? At first glance it may appear that, if limited resources can be used to bring safe drinking water, sanitation and basic essential drugs to community, the utilisation of a large portion of that resource for a single couple would not be in the best interests of the community and would not be sanctioned by ubuntu. However, it must be appreciated that procreation and child-bearing are highly valued in African culture.[14] The inability to bear children may have significant negative psychological and social effects on African women. These may include loss of social status, social isolation and marital instability.[14] Women bear a disproportionate procreative responsibility in African society, and are often held solely responsible if a marriage does not produce children.[15] As such, the concept of fertility in African culture (particularly from the point of view of women) is highly complex. While ubuntu as a cultural entity may be understood in its wider context, there is still much work that needs to be done before it can be accepted as a fully fledged moral theory.

Taking this into consideration, it may be difficult to determine how ubuntu might prioritise ARTs, particularly in the situation where a choice exists between life-saving ARVs for many and ARTs for the few.

This particular constellation of factors (the complexity of fertility from an African cultural viewpoint, the incompleteness of ubuntu as an accepted moral theory and the economic realities of healthcare funding and prioritisation) is sufficiently complicated that a separate detailed philosophical examination of them is warranted.

Virtue ethics suggests that justice is a virtue that society should possess. However, the application of virtue ethics to individual situations often does not provide us with an answer as to what to do. This is not surprising, since the focus of virtue ethics is on who to be rather than on what to do. In choosing between ARVs or ARTs, a virtue ethics argument may be used on both sides to justify either choice.

ARTICLE Priority-setting and a Rawlsian approach Countries across the globe, whether developing or industrialised, all face the problem of funding healthcare within a limited budget. All countries have to grapple with the problem of determining which healthcare services the state can afford to fund, i.e. which they have to set as priorities.[16] Some countries, such as Norway, have set out to formulate a set of principles to guide the setting of priorities – e.g., does the treatment prevent catastrophic consequences? Other places, such as New Zealand, and Oregon in the USA, list specific services in order of importance. Despite the differences in the way in which countries prioritise services, one thing seems to be almost universally accepted: preventative care (which includes basic immunisations and screening for diseases) and primary healthcare (e.g. diarrhoeal diseases in children, and family planning) should always form the core of a decent minimum level of care.

Rawls described a hypothetical situation where decision-makers stand at what he called the original position behind the veil of ignorance, i.e. having no knowledge of the place that they would eventually take up in society, only knowing that they have the capacity to determine beforehand the distribution of society’s goods and services. What this amounts to is a situation where decisionmakers ensure that the least well off in society have at least their basic needs taken care of, since any one of those decision-makers could end up taking the position of the least well off.

Taking Rawls’ theory of justice into consideration, the suggestion can be made that the fairest way to distribute services would be to decide on a minimum level of state-funded healthcare that would be available to all. Would we then be comfortable to play the lottery of life and be born into a society that funds ARTs, but not maternal care or lifesaving ARVs? Or would one roll the dice more easily knowing that basic healthcare, preventative medicines and lifesaving drugs are provided by the state even if sophisticated medical services are not?

SA has not even secured the position of having met its decent minimum healthcare requirements for all its citizens; therefore, a Rawlsian approach would not favour state-funded ARTs, since the funds allocated to ARTs may be used more effectively to provide basic care for a greater number of patients.

‘Ought implies can’ – the Kantian perspective on state duty Kant considered the idea that what we ‘ought’ to do (in order to be morally and ethically right) should fall within the reach of our capabilities – i.e. ‘ought implies can.’

Current conditions in SA limit the degree to which the state can fund healthcare. Basic healthcare needs are not being universally met owing to, among other things, economic limitations. It would be unwise to take resources aimed at addressing this problem and redirect them to sophisticated ARTs that do not address the needs of the majority, are not life-saving and are prohibitively expensive.

Therefore funding of ARTs by the state falls outside of its current capabilities, and from a Kantian perspective there is no moral duty on the part of the state to fund them.

Wants v. needs Wiggins[17] suggests three conditions for considering something a ‘need’. Firstly, not having the item of need would harm one’s

functioning as a human being; secondly, there are no available alternatives; and finally, the item of need is integral to the person’s life having at least minimal value.[17] Safe drinking water, food and ARV drugs can clearly be considered ‘needs’. For those with HIV, a lack of ARVs may very well be equated to a lack of food or water. Ultimately, without ARVs, these patients will die.

In examining the desire to have one’s own biologically related child, we see that it falls short of Wiggins’ criteria for deeming it a ‘need’. People can live and be productive members of society without having children; indeed, many do so intentionally. But it is Wiggins’ second criterion, that of there being no alternative, that is particularly relevant to SA. There are more than three-and-a-half million orphans in SA.[18] More than half of this number have been orphaned as a result of losing their parents to AIDS. With this number of children desperately in need of a home, some difficult questions need to be asked in regard to adoption being an alternative to ARTs. Would the state be acting responsibly and ethically in funding ARTs for HIV serodiscordant couples when there are so many children already in need of a home?

Loewy, in an online comment quoted on http://bioethicsdiscussion. blogspot.com, makes a convincing argument in terms of distinguishing exactly what our ‘wants’ and ‘needs’ actually are. He suggests that ‘having your own child may be a want, but it surely is not a need.’[19] He makes the case that medical care (first-tiered, essential services) is not a want but a need, and a decent society should provide that.

Loewy admonishes that: ‘Being unable to have my own child is no more a “need” than is my having perfect pitch is. It seems perverse to me that a society and world which already have more than it can take care of … goes out and with great effort and the use of many resources tries to make more of what we already have but neglect severely. [sic]’[19] In Maslow’s hierarchy of needs, the need for family and friends (or love and belonging) occupies the third level of needs. What this suggests is that the need to have a child (or what essentially amounts to the desire to have a child) cannot be viewed as having equal importance to satisfying our physiological needs (which are addressed by basic medical care).

The inability to have children may affect people’s lives in deep and significant ways. Their unfulfilled desire to have children may lead them to feel that their lives are incomplete and of a lower quality than they would experience if they were to have children. But does having a child necessarily improve the quality of life of infertile couples or couples who may need ARTs for medical reasons (such as HIV)? A few studies provide some surprising answers. In a study undertaken in the USA, Abbey et al.[20] found that infertile women who later became parents experienced greater global wellbeing, but decreased marital wellbeing. Infertile men experienced fewer of the positive improvements than their wives after having a child, and still experienced diminished marital wellbeing. Another study using data from Germany[21] found that after 2 years of having had a child, a previously childless couple’s level of happiness reverted back to their pre-childbirth levels, suggesting that having a child may not be an enduring solution to the dissatisfaction felt from being childless. Studies investigating the effects of adoption on marriage have produced conflicting results; however, in her review

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ARTICLE of the topic from a Canadian point of view, Ward[22] suggests that biological parenthood and parenthood via adoption share many similar challenges and effects on the marriage.

Is it then appropriate for those couples affected by HIV (but benefitting from ARVs) to now ask the state to fund even more interventions that are not life-saving, at the expense of ARVs that could save others? It is unreasonable to expect the state to meet all our needs and desires.

A response to the rights-based argument for government funding The Bill of Rights[23] guarantees all citizens certain rights and freedoms, including the right to have access to ‘healthcare services including reproductive healthcare’.

Some would argue that these are sufficient grounds to expect the state to fund ARTs. However, this is only a prima facie obligation.

The International Covenant on Economic, Social and Cultural Rights (ICESCR) has taken cognisance of the fact that not all socioeconomic rights can be realised immediately.[24] It echoes the understanding of ‘progressive realisation’ of rights that is found in the SA Bill of Rights.

The Bill of Rights makes clear which rights are non-derogable.

These include the rights to life, dignity, equality, freedom and security, freedom from slavery and rights pertaining to the protection of children. All of these rights are negative rights, i.e. they do not place the burden on the state for the provision of something; rather, they require that something not be done. Access to healthcare services, however, requires the provision of something material or of some service. It is therefore a positive right. Additionally, it is derogable, implying that there may be circumstances under which that right may be limited. Indeed, section 36 deals entirely with the limitations of rights.

One can appreciate that not all rights exist on the same level. Some rights are clearly more fundamental, more basic and less negotiable than others.

According to Vasak,[25] the right to healthcare is a second-generation human right, while the right to life is a first-generation right. From this viewpoint, second-generation rights (largely social and economic rights) may be limited by the availability of resources.

The ruling of the Constitutional Court in the 1997 case of Subramoney v Minister of Health[26] made clear that it is the duty of the state to ‘take reasonable legislative and other measures, within its available resources, to achieve the progressive realisation of each of these rights’.

Therefore it is clear that healthcare (including reproductive healthcare and advanced reproductive techniques), and the degree to which it can be provided by the state, is limited by the economic realities of our time. As such, a rights-based argument for state funding of expensive ARTs would fail to be convincing.

Conclusion The landscape of SA today is one of a healthcare system in crisis, while its population is dealing with the world’s largest share of HIV infection. While there is no denying the negative effects of childlessness on certain couples, those effects can hardly be compared with the life-threatening effects of HIV without ARVs, or with suffering through childhood malnutrition, or any of the other

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severe diseases that can be treated by basic medical care but still require funding. Providing ARTs at the expense of the state cannot be a part of the national strategy to improve the health of our nation.

None of the many theories of distributive justice could realistically envision this as a viable solution in our country, when even wealthy nations cannot justify the expense of ARTs from government funds.

Even a rights-based argument could not demand that the state fund ARTs, since the Constitution acknowledges the limitations of our resources. SA currently has several pressing health concerns and priorities, and all the information at hand suggests that ARTs are not one of them.

Acknowledgments. None Author contributions. Sole author.

Funding. None.

Conflicts of interest. None.

1. Bujan L, Pasquier C. People living with HIV and procreation: 30 years of progress from prohibition to freedom? Hum Reprod 2016;31(5):918-925. https://doi. org/10.1093/humrep/dew036 2. Huyser C, Boyd L. Assisted reproduction technology procedures in South Africa: The price to pay. Suid-Afrikaanse Tydskrif vir Natuurwetenskap en Tegnologie 2014;33(1). https://doi.org/10.4102/satnt.v33i1.1258 3. Dhai A, Noble R. Ethical issues in HIV. Best Pract Res Clin Obstet Gynaecol 2005;19(2):255-267. https://doi.org/10.1016/j.bpobgyn.2004.10.001 4. HIV and AIDS in South Africa. AVERT, 2017. http://www.avert.org/professionals/ hiv-around-world/sub-saharan-africa/south-africa (accessed 16 October 2017).

5. The World Health Organization. Geneva: WHO, 2017. http://www.who.int/gho/ countries/zaf.pdf?ua=1 (accessed 16 October 2017).

6. Weak rand means South Africa pays more for ARVs in latest tender. Spotlight, 2017. http://www.spotlightnsp.co.za/2015/06/10/weak-rand-means-south-africa-paysmore-for-arvs-in-latest-tender (accessed 16 October 2017).

7. Statistics South Africa. Johannesburg: StatsSA, 2017. http://www.statssa.gov.za/ wp-content/uploads/2013/10/MDG_October-2013.pdf (accessed 16 October 2017).

8. Szwarcwald C, Escalante J, Rabello Neto D, Souza Junior P, Victora C. Estimação da razão de mortalidade materna no Brasil, 2008 - 2011. Cad Saúde Pública 2014;30( Suppl 1): S71-S83. https://doi.org/10.1590/0102-311x00125313 9. Falloon K, Rosoff PM. Who pays? Mandated insurance coverage for assisted reproductive technology. Virtual Mentor 2014;16(1):63-69.

10. Ivf.com.au. IVF and Medicare | IVF Fees | IVF Australia.Ivf.com.au, 2017. http:// www.ivf.com.au/ivf-fees/ivf-and-medicare (accessed 16 October 2017).

11. Beauchamp T, Childress J. Principles of Biomedical Ethics, 5th ed. New York: Oxford University Press, 2001.

12. Edmeston M, Francis K. Beyond Band-Aids: Reflections on public and private health care in South Africa. Focus 67. Johannesburg: The Helen Suzman Foundation, 2012. http://hsf.org.za/resource-centre/focus/focus-67/MEdmeston_KFrancis. pdf (accessed 16 October 2017).

13. Gade C. What is Ubuntu? Different interpretations among South Africans of African descent. S Afr J Philos 2012;31(3):484-503. https://doi.org/10.1080/0258 0136.2012.10751789 14. Ombelet W, Cooke I, Dyer S, Serour G, Devroey P. Infertility and the provision of infertility medical services in developing countries. Hum Reprod Update 2008;14(6):605-621. https://doi.org/10.1093/humupd/dmn042 15. Dyer S, Abrahams N, Mokoena N, Lombard C, van der Spuy Z. Psychological distress among women suffering from couple infertility in South Africa: A quantitative assessment. Hum Reprod 2005;20(7):1938-1943. https://doi. org/10.1093/humrep/deh845 16. Sabik L, Lie R. Priority setting in health care: Lessons from the experiences of eight countries. Int J Equity Health 2008;7(1-13). https://doi.org/10.1186/14759276-7-4 17. Garrett J. Needs, Wants, Interests, Motives. People.wku.edu, 2017. http://people. wku.edu/jan.garrett/ethics/needs.htm (accessed 16 October 2017).

18. United Nations Children’s Fund South Africa. Child protection – orphans and vulnerable children. Geneva: UNICEF, 2017. http://www.unicef.org/southafrica/ protection_6631.html (accessed 16 October 2017).

19. Bernstein M. A Child by IVF vs Adoption: Ethical Defining of ‘Want’ vs ‘Need’.

Bioethicsdiscussion.blogspot.co.za, 2017. http://bioethicsdiscussion.blogspot. co.za/2009/09/child-by-ivf-vs-adoption-ethical.html (accessed 16 October 2017).

ARTICLE 20. Abbey A, Andrews F, Halman L. Infertility and parenthood: Does becoming a parent increase well-being? J Consulting Clin Psychol 1994;62(2):398-403. https://doi.org/10.1037//0022-006x.62.2.398 21. Clark A, Diener E, Georgellis Y, Lucas R. Lags and leads in life satisfaction: A test of the baseline hypothesis. Economic J 2008;118(529):F222-F243. https://doi. org/10.1111/j.1468-0297.2008.02150.x 22. Ward M. The impact of adoption on the new parentsâ&#x20AC;&#x2122; marriage. Adopt Q 1998;2(2):57-78. https://doi.org/10.1300/j145v02n02_04 23. South Africa. The Constitution of the Republic of South Africa, 1996. http://www. justice.gov.za/legislation/constitution/SAConstitution-web-eng.pdf (accessed 16 October 2017).

24. United Nations Office of the High Commissioner. International Covenant on Economic, Social and Cultural Rights. Geneva: UNOHC, 1976. https://www.ohchr. org/EN/ProfessionalInterest/Pages/CESCR.aspx (accessed 16 October 2017).

25. Weston, B. Human rights. Hum Rights Q 1984;6(3):257-283. https://doi. org/10.2307/762002 26. Soobramoney v Minister of Health (KZN) (CCT32/97) ZACC 17; 1998 (1) SA 765 (CC); 1997 (12) BCLR 1696 (27 November 1997).

Accepted 5 March 2018.

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ARTICLE

This open-access article is distributed under Creative Commons licence CC-BY-NC 4.0.

Can the consent provisions in the Choice on Termination of Pregnancy Act, which do not require children to be assisted by a parent or guardian, be used for live births by caesarian section in emergency situations?

D J McQuoid-Mason, BCom, LLB, LLM, PhD Centre for Socio-Legal Studies, Howard College School of Law, University of KwaZulu-Natal, Durban, South Africa Corresponding author: D J McQuoid-Mason (mcquoidm@ukzn.ac.za)

The answer to the question as to whether in emergency situations, when there is no time for the procedures in the Children’s Act No. 38 of 2005 to be followed, doctors may use the consent provisions in the Choice on Termination of Pregnancy Act No. 92 of 1996 (CTOP), which do not require children to be assisted by a parent or guardian, for live births by caesarian section, will depend on how ‘termination of pregnancy’ is defined and interpreted in the CTOP. It is argued that, unless it is modified by Parliament or the courts, the definition in the Act is sufficiently wide to justify doctors using the provisions applicable to the third trimester to rely on the consent of the child alone, in situations where the caesarian section is performed to save the mother’s life or to prevent the fetus suffering the risk of injury. Whatever Parliament or the courts decide, doctors can always fall back on the ‘best interests of the child’ Constitutional principle, using the provisions in the CTOP and standards in the Children’s Act as guidelines for determining the pregnant child’s ‘best interests’ in emergency situations requiring a caesarian section, where there is no time to obtain the consent required by the Children’s Act. Such an approach is also consistent with the bioethical principles of patient autonomy, beneficence, non-maleficence and justice or fairness.

S Afr J Bioethics Law 2018;11(1):43-45. DOI:10.7196/SAJBL.2018.v11i1.644

Generally, in emergency situations, medical treatment and surgical operations may be undertaken without consent – provided they are not against the expressed wishes of the patient.[1] In the case of children facing medical emergencies, special procedures are provided for in the Children’s Act No. 38 of 2005.[1] The Act provides that the superintendent of a hospital, or the person in charge of the hospital in their absence, may consent to the medical treatment or surgical operation on a child if (i) the treatment or operation is necessary to preserve the life of the child or to save the child from serious lasting physical injury or disability, and (ii) the need for treatment or an operation is so urgent that it cannot be deferred for the purpose of obtaining the consent that would otherwise be required.Where an urgent caesarian section has to be performed on a pregnant child, and there is no time to comply with these provisions, some doctors have relied on the child’s consent alone by applying the third trimester provisions of the Choice on Termination of Pregnancy Act No. 92 of 1996 (CTOP)[3] (Dr Neil F Moran, personal communication).

In light of the above, the Head of Clinical Department: Obstetrics and Gynaecology, Department of Health, KwaZulu-Natal, has recently raised the question of whether the consent provisions in the CTOP may be used for live births by caesarian section on children in emergency situations (Dr Neil F Moran, personal communication). When interpreting a statute a judge will not simply rely on the grammatical meaning of the words in the text. The judge will consider them in the context of the Act, and try to interpret the Act in line with what they regard as the purpose of the legislation and in favour of the persons the Act seeks to protect, as demonstrated in the purpose of, or preamble to, a statute.[4]

To answer the question as to whether the consent provisions of the CTOP can also be used for live births, it is necessary to consider (i) the definition of ‘termination of pregnancy’ in the CTOP; (ii) the purpose of the CTOP; (iii) the definition of ‘abortion’ in the Abortion and Sterilization Act No. 2 of 1975 (Abortion Act),[5] which the CTOP repealed because it was too restrictive; and (iv) whether the consent provisions in the CTOP may be used for live births by caesarian section on children. If the CTOP is used, the consent provisions in the Children’s Act or any other law do not apply.[3]

Meaning of ‘termination of pregnancy’ in the CTOP The ordinary dictionary meaning of ‘termination’ is to ‘end’ something, although the dictionary states that the secondary meaning of ‘termination’ in the context of ‘termination of pregnancy’ is ‘an abortion’.[6] In order to determine the meaning intended by the CTOP, it is necessary to consider the definition provided in the Act. The Act defines ‘termination of pregnancy’ as ‘the separation and expulsion, by medical or surgical means, of the contents of the uterus of a pregnant woman’.[3] This is a much wider definition than that used, for instance, in Rhode Island in the USA, which makes it clear that it refers to abortion by stating that ‘termination of pregnancy … shall mean administering to a woman any medicine, drug, substance, or thing whatever, or the employment upon her of any instrument or other means whatever, with intent to procure or induce the miscarriage of such woman’.[7] Zambia has a Termination of Pregnancy Act that does not define ‘termination of pregnancy’, but instead refers directly

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ARTICLE to ‘abortion’ throughout the Act.[8] Zimbabwe also has a Termination of Pregnancy Act in which it is stated that the purpose is to ‘change the law relating to abortion by defining the circumstances in which a pregnancy may be terminated’.[9] The Act goes on to state that: ‘Any reference in this Act to the termination of a pregnancy shall be construed as meaning the termination of a pregnancy otherwise than with the intention of delivering a live child’.[9] In the South African CTOP, the term ‘contents of the uterus’ clearly refers to the fetus. However, the Act begs the question as to whether a caesarian section that involves the removal of a live fetus from the mother’s uterus, amounts to ‘the separation and expulsion, by … surgical means, of the contents of the uterus of a pregnant woman’.[3] The answer must be in the affirmative, because a caesarian section is a surgical procedure which separates and expels the fetus from its mother’s uterus. A caesarian section that separates a live fetus from its mother’s uterus satisfies the wide definition of ‘termination of pregnancy’ in the CTOP. As the CTOP allows terminations of pregnancy in the third trimester, where the fetus is viable, and the continued pregnancy will ‘endanger the woman’s life’ or would ‘pose a risk of injury to the fetus’,[3] it can be argued that such a caesarian section would be lawful if undertaken in terms of the Act. This is because if surgical terminations may be undertaken for abortions after the 20th week of gestation, there is no reason in principle why the provisions of the CTOP may not also be used for live births after the 20th week – in situations where the mother’s life is endangered or there is a risk of injury to the fetus.

Where they are applicable, the relevant parts of the Act could be interpreted to apply to both abortions and live births.

Purpose of the CTOP The argument that the CTOP may also apply to live births when the termination is undertaken in the third trimester is also strengthened by the stated purpose of the Act in the Preamble.[3] This is stated to be that Parliament recognises, inter alia, that ‘women have the right of access to appropriate healthcare services to ensure safe pregnancy and childbirth’.[3] This statement seems to indicate that the Act is not only aimed at terminating pregnancies in the context of abortions, but also at ensuring that women have access to proper health services so that they can have safe pregnancies and childbirth. On this interpretation, a caesarian section that needs to be undertaken in emergency situations, to save the life of the mother or a fetus in situations where the child mother wishes to have the baby, clearly falls into the category of ‘a safe pregnancy and childbirth’.

In addition, the Preamble states that the Act ‘repeals the restrictive and inaccessible provisions of the Abortion and Sterilization Act … and promotes reproductive rights and extends freedom of choice by affording every woman the right to choose whether to have an early, safe and legal termination according to her individual beliefs’.[3] Once again, where in an emergency situation a caesarian section has to be performed on a pregnant child mother, to save her life and comply with her wish to save her unborn child from injury, this can be construed as the mother exercising her ‘right to have an early, safe and legal termination’.

Definition of ‘abortion’ in the Abortion Act The Abortion Act defined an ‘abortion’ as ‘the abortion of a live fetus of a woman with intent to kill such fetus’.[7] The emphasis on the

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killing of a fetus is consistent with the definition of terminations of pregnancy in Rhode Island, where reference is made to procuring or inducing miscarriages in pregnant women;[7] in Zambia, where direct reference is made to abortions in their Termination of Pregnancy Act;[8] and in Zimbabwe, where terminations of pregnancy are those that are undertaken ‘otherwise than with the intention of delivering a live child’.[9] As previously mentioned, the CTOP is aimed at overcoming the ‘restrictive’ provisions of the Abortion Act – and it can be argued that the very narrow definition of abortion in the Abortion Act is one of the ‘restrictive’ provisions that the CTOP was designed to eliminate.

There is no mention of ‘procuring an abortion’,[8] or ‘to procure or induce a miscarriage’,[7] or undertaking a procedure ‘otherwise than with the intention of delivering a live child’[9] in the definition of ‘termination of pregnancy’ in the CTOP. The CTOP does not narrow the definition of termination of pregnancy, and in the context of the Act as a whole, there is no provision that indicates that the Act only applies to abortions. Some provisions may not be relevant to live births, such as those dealing with terminating pregnancies during the first and second trimesters when a fetus is not viable, but this does not mean that the provisions for the third trimester should only apply to abortions if they are broad enough to apply to live births.

Can the consent provisions in the CTOP be used for live births by caesarian section on children?

The CTOP states that a termination of pregnancy may only be undertaken with the consent of the pregnant person. In the case of children, they should be advised to consult with their parents, guardian, family members or friends before their pregnancy is terminated, but if they choose not to, the termination of pregnancy ‘shall not be denied’.[3] Furthermore, the consent provisions in the CTOP apply ‘notwithstanding any other law or the common law’,[3] which means that the provisions of the Children’s Act dealing with consent by children in the case of surgical procedures, where they require assistance from their parent or guardian, do not apply.

Although not yet decided by the courts, it is submitted that the wording in the CTOP can be interpreted to also apply to live births because (i) the definition of ‘termination of pregnancy’ in the Act is wide enough to apply to both abortions and live births in the third trimester, and (ii) the purpose of the Act is, inter alia, to ensure ‘safe pregnancy and childbirth’ and to allow women to choose to have ‘an early, safe and legal termination’.[3] A caesarian section is a surgical method of terminating a pregnancy as it expels and removes a fetus from its mother’s uterus, as provided for in the Act. It can be argued, therefore, that in the third trimester, when the fetus is viable, a pregnant child may alone consent to a termination of pregnancy by caesarian section to deliver a live baby, in order to save her own life or to prevent the fetus from suffering the risk of injury, as provided for in the Act. If this interpretation is correct, then it would apply whether or not the doctors involved were faced with an emergency situation, as they would not be bound by the provisions of the Children’s Act.[3] It is submitted that the ordinary meaning of the words ‘termination of pregnancy’ as defined in the CTOP are broad enough to encompass terminations through caesarian section in the third trimester for the reasons set out above. Should the legislators wish the CTOP to apply only to abortions in the third trimester, they should limit

ARTICLE the definition of terminations of pregnancy to those specifically undertaken to ‘procure an abortion’;[8] to ‘kill a fetus’;[5] to terminate a pregnancy ‘otherwise than with the intention of delivering a live child’;[10] or to ‘procure or induce a miscarriage’.[7] Until the courts or Parliament decide otherwise, it can be argued that doctors are fully justified in relying on the consent of the child alone in terms of the CTOP, when conducting caesarian sections for live births during the third trimester, where they are done to save the mother’s life or to prevent the fetus from suffering a risk of injury.

Whatever Parliament or the courts decide, doctors can always fall back on the ‘best interests of the child’ principle in the Constitution,[10] using the provisions in the CTOP and the standards mentioned in the Children’s Act as guidelines for determining the pregnant child’s ‘best interests’ in emergency situations where there is no time to obtain the consent required by the Children’s Act.[11] Such an approach is also consistent with bioethical principles of patient autonomy, beneficence, non-maleficence and justice or fairness.[12] Acknowledgements. Dr Neil F Moran, Head of Clinical Department: Obstetrics and Gynaecology, KwaZulu-Natal Department of Health.

Author contributions. Sole author.

Funding. National Research Foundation.

Conflicts of interest. None.

1. McQuoid-Mason DJ. Medical Professions and Practice. The Law of South Africa.

2nd ed. Durban: LexisNexis, 2008: Vol 17 part 2: para 43.

2. South Africa. Children’s Act No. 38 of 2005.

3. South Africa. Choice on Termination of Pregnancy Act No. 92 of 1996.

4. Du Plessis LM. Statute Law and Interpretation. The Law of South Africa. 2nd ed.

Durban: LexisNexis, 2011, Vol 24 part 1: paras 323 and 361.

5. South Africa. Abortion and Sterilization Act No.18 of 1976.

6. Hornby AS. Oxford Advanced Dictionary of Current English. 3rd ed. Oxford: Oxford University Press, 1986.

7. State of Rhode Island and Providence Plantations Department of Health. Section 1.5 of the Rules and Regulations for the Termination of Pregnancy. R23-1-TOP. 1973. https://sos.ri.gov/documents/archives/regulations/released/pdf/ DOH/ DOH_32.pdf (accessed 18 April 2018).

8. Zambia. Section 2 of the Termination of Pregnancy Act 76 of 1972. Chapter 304. https://www.Zambia.org/zm/legislation/consolidated_act/304 (accessed 18 April 2018).

9. Zimbabwe. Preamble to the Termination of Pregnancy Act No. 29 of 1977.

Chapter 15.10. www.parlzim.gov.zw/acts-list/termination-of-pregnancyact-15-10 (accessed 18 April 2018).

10. Constitution of the Republic of South Africa, 1996.

11. McQuoid-Mason D. Mandatory reporting of sexual abuse under the Sexual Offences Act and the ‘best interests of the child’. S Afr J Bioethics Law 2011;4(2): 74-78.

12. Beauchamp TL, Childress JF. Principles of Biomedical Ethics. 3rd ed. Oxford: Oxford University Press, 1989.

Accepted 12 June 2018.

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This open-access article is distributed under Creative Commons licence CC-BY-NC 4.0.

Is there room for religious ethics in South African abortion law?

F Jogee, LLB, LLM Centre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal, Durban, South Africa Corresponding author: F Jogee (faadielajogee@gmail.com)

In light of the prominence and influence of secular bioethics, one could argue that religious ethics concerning weighty medical ethical issues such as abortion are often overlooked. South Africa (SA) is one of just five African countries which have legalised abortion without undue restriction, notwithstanding its gestational restrictions, placing it among the countries with the most liberal abortion laws in Africa.[1] More than 94% of South Africans are religious, predominantly following Christianity, African Traditional Religion, Islam, Judaism and Hinduism.[2] This raises the question of whether contemporary abortion law is inclusive of the religious ethical values that dictate the lives of the great majority of citizens. This article will explore religious ethics and secular morality in SA, followed by a discussion of the legal status of the fetus and contemporary abortion legislation. Subsequently, this article will determine whether the law is inclusive of religious ethical views on abortion, and if so, how.

S Afr J Bioethics Law 2018;11(1):46-51. DOI:10.7196/SAJBL.2018.v11i1.624

Approximately 90% of African women live in countries with overly restrictive abortion laws.[1] While the vast majority of African countries strictly condemn abortion, proscription may be waived under certain conditions: to preserve life (out of necessity); for health preservation; if the pregnancy is a result of rape or incest; or if the fetus is impaired.[1] However, the aforementioned grounds for abortion are not available to all women. For instance, Nigeria, Uganda and Somalia condone abortion solely out of necessity.[1] Burundi and Cameroon extend the grounds to physical health, at the exclusion of mental health and fetal impairment, while Burkina Faso permits abortion on all three grounds, including cases of rape and incest.[1] Ghana, Algeria and Namibia also make provision for all of the aforementioned grounds.[1] Women are further required to seek parental or spousal consent to procure an abortion in Equatorial Guinea and Mauritius.[1] Abortion is strictly prohibited, without any legal exceptions, in 11 African countries, including Angola, Congo-Kinshasa in the Democratic Republic of Congo , Congo-Brazzaville in the Republic of Congo and Senegal.[1] Although these statistics are perturbing, as the majority of African women are being stripped of their human rights, they are to be expected, since Africa is the most religious continent in the world.[3] A recent world survey revealed that ‘more than 8 out of 10’ Africans identify as religious, actively participating in religious practices and traditions.[3] Approximately 95% of South Africans are religious.[2] Nevertheless, SA is one of only five African countries (along with Cape Verde, Mozambique, Tunisia and Zambia) that currently provide women with unrestrictive abortion services, within gestational limitations.[1] SA’s liberal abortion laws are to be expected since it is a secular state, established upon a Constitution[4] that ensures that women are guaranteed rights conducive to their reproductive health, which is echoed in the country’s laws governing abortion.[5] Although reportedly half of all African countries are considered secular,[6] most implement rigorous legal prohibitions on abortion that often coincide with religious ethical and moral views.

SA’s Choice on Termination of Pregnancy Act (CTOPA) No. 92 of 1996[7} is lauded as one of the most liberal abortion laws worldwide.[8] It encapsulates and endorses several constitutional rights that women were denied during Apartheid,[9] particularly the rights to reproductive health, bodily integrity, privacy and access to information. In light of the vast strides the CTOPA has contributed towards safeguarding and championing women’s constitutional, sexual and reproductive rights, one might also ask whether SA’s current abortion law is inclusive of religious ethics. This question entails an understanding of religious ethics, secular morality and SA abortion laws.

Religious ethics and secular morality in SA ‘Religious ethics’ refers to the moral principles that underpin religions and dictate the condemnation or condonance of believers’ actions.[10,11] Consequently, these provide a basis for moral deliberation on numerous issues, including abortion. Given SA’s cultural, ethnic and racial diversity, it comes as no surprise that it is a bastion for religious pluralism. More than 94% of South Africans are affiliates of a myriad of religious denominations, predominantly Christianity (86%), ATR (5.4%), Islam (1.9%), Hinduism (0.9%) and Judaism (0.2%).[2,11]

Judaism Human life is immensely venerated in Judaism; while the fetus is deemed a potential life, it enjoys certain rights that cannot be infringed except in overwhelming circumstances.[11-13] The Torah does not explicitly mention abortion; however, Jewish law expressly condemns it.[11] The condemnation is predicated on Genesis 9:6, which states that: ‘Whosoever sheddeth the blood of man in man, his blood shall be shed.’ The verse is believed to be inclusive of the unborn child; consequently, the act of feticide can be equated to murder.[11,13,14] Nevertheless, abortion is condoned if a continued pregnancy will jeopardise the woman’s life, as normative religious rules may be overturned in life-threatening circumstances.[11,16-18]

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REVIEW Christianity Catholicism states that life originates at conception; accordingly, abortion is almost entirely prohibited.[11,19,20] Moreover, orthodox Catholics believe that even under the rare circumstances when abortion may be permissible, the fetus must not suffer any direct harm; this belief is founded on the principle of double effect, whereby an action is acceptable on condition that it produces more positive than negative consequences.[11,21-23] Consequently, surgical abortion procedures that directly harm the fetus are strictly prohibited.[11] Protestant beliefs and views on abortion vary greatly. Conservative Protestants condemn abortion as it is believed that life engages at conception, while liberal Protestants believe that a woman’s right to self-determination should be weighed against the fetal right to life, and others believe that the decision lies with the woman and her physician within the first trimester.[11,24,25] Protestantism generally appears to underscore maternal interests, whereas Catholicism upholds fetal interests.[26,27,11]

Islam The preservation of Islam, life, knowledge, family and property are the principal objectives of Islamic law.[11,28] Islam permits Muslims to act outside of normative religious rules and regulations if any of the aforementioned objectives are threatened.[28,29] Therefore, if the life of a Muslim woman is jeopardised by her pregnancy, she is entitled to terminate it in order to prevent her death. The Prophet Muhammad stated that upon ensoulment, which occurs after 120 days of gestation, the fetus acquires personhood and the majority of the rights accompanying its new status.[11,30­,31] Consequently, abortion is condemned post-ensoulment except when it is used to preserve the life of the woman concerned, or in cases of fetal malformation.[11,32-34] Pre-ensoulment, abortion is only permissible in cases of rape or incest.[11,32-34]

Hinduism Hindu scripture strictly forbids the procurement of abortion, as it completely disregards the Hindu concept of nonviolence, and fails to acknowledge fetal life.[35] Abortion was so abhorred that ancient Vedic scripture enabled a man to divorce his wife if she procured an abortion; the punishment for procurement of abortion according to Dharma scriptures was the stripping of caste status, which could be particularly devastating for women occupying high positions in the caste system.[11,36,37] Since personhood is believed to begin at conception, abortion disrupts the process of karma and rebirth, core elements of Hinduism.[11,35,38,39] Abortion is therefore unacceptable except under life-threatening circumstances.[11,40,41]

African Traditional Religion Human life is held in the highest regard, as life and religion are not only interconnected; they are cornerstones of African Traditional Religion (ATR).[11,42] Procreation, child care and child protection are prominent features of ATR; children are of significant importance to the community regardless of the circumstances surrounding their conception.[11,43] Marriage provides a means for procreation[11,44] and culture dictates that African children belong the community at large.[11,45] African traditionalists hold the view that abortion is equivalent to murder, since personhood is originates at conception.[11,46-50] Accordingly, abortion is condemned by African

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traditionalists; however, ATR makes provision for abortion only in cases of rape and incest.[11,50]

Secular morality Secular morality reinforces the congruous coexistence of hetero­ geneous societies, regardless of religious differences.[11,51] Secular morality is predicated upon logic and evidence, as opposed to religious morals and values; it places emphasis on the best interests of humanity as a whole rather than a notion of the divine.[11,50-53] Thus secular morality is capable of substantiating women’s autonomous right to abortion on several grounds correlating with her human and constitutional rights, including socioeconomic standing and career advancement,[11,53] although this often goes against religious beliefs.[11,54] Secular morality dictates that legal personhood and its subsequent rights engage upon birth, and therefore abortion is not equivalent to murder, since a fetus is not a person.[11,55]

The legal status of the fetus In accordance with SA law, legal personhood, with all its accompanying rights, is assigned at birth.[11,56] Birth itself does not guarantee legal subjectivity, as the latter is reliant on two common-law requirements collectively known as the ‘born alive’ rule, which requires the child to be separated from and exist freely apart from its mother.[11,57-59] Legal subjectivity will be granted as long as the child fulfills the commonlaw requirements, even if it should pass away shortly after birth, as the duration of its life after birth does not negate legal subjectivity.[11,59] This view was reiterated in Christian Lawyers Association of SA and Others v Minister of Health and Others,[60] where the court held that the Constitution did not include any provisions granting fetal personhood.[11,60] If the drafters of the Constitution had any intention of recognising and safeguarding fetal interests, the drafters would have included a provision pertaining to the fetus under section 28, which deals specifically with children, defined as persons aged 18 years and younger.[11,60] However, since age commences at birth and a fetus is by definition unborn, Section 28 does not apply to the fetus.[11,60] Furthermore, if fetal interests were acknowledged under Section 28, those interests would apply throughout the Constitution, and consequently the term ‘everyone’ would be inclusive of the fetus, which would then acquire the same constitutional rights as the woman.[11,60] If both woman and fetus hold the right to life, abortion would be rendered unconstitutional. This argument is untenable, hence fetal personhood is not recognised in SA.[11,60] Although fetal personhood is unrecognised in SA law, both the common law and statutory law acknowledge fetal interests. For instance, not only does the common law take cognisance of fetal interests, it safeguards them by way of the nasciturus fiction.[9] The nasciturus fiction states that when a benefit accrues to an unborn child, the unborn child will be treated as if it is has been born alive, until its actual birth.[9,54] Subsequently, the child will be entitled to the benefit.[11,56] The nasciturus fiction is only permissible if the unborn child is the subject of the accrued benefit, or if the benefit is jointly accrued to the unborn child and a third party, provided the third party does not benefit to the exclusion of the unborn child.[11,56,59] Lastly, the unborn child has to be born alive in order to qualify for the accrued benefit.[11,56] In addition to the common law, the National Health Act proscribes experimentation in embryos that are older than 14 days, unless written

REVIEW permission has been obtained from the Minister of Health.[61] The Birth and Deaths Registration Act obliges physicians to register the death of stillborn children of gestational age 26 weeks and over;[62] thereafter, a burial order is authorised for the deceased.[11,63] The aforementioned gestational age corresponds with fetal viability, which occurs around 24 weeks.[11,64] Accordingly, fetal viability ultimately determines the requirements for the registration and burial of a stillborn child. Hence, recognition is given to the interests of the fetus.[11]

The Choice on Termination of Pregnancy Act[7] CTOPA ushered in a new era for women’s reproductive health rights.

The Act ensures a number of constitutional rights that were previously denied to women in pre-democratic SA.[9] CTOPA makes provision for safe and legal termination of pregnancy services to all women without an age limitation[65] or additional consent requirements; CTOPA explicitly states that in order to procure termination of pregnancy, only the informed consent of the woman concerned is compulsory.[11,66] Consequently, CTOPA encompasses the constitutional right to bodily integrity, which promotes women’s autonomous reproductive health decisions, and the constitutional right to reproductive healthcare.[67] According to CTOPA, a woman can procure an abortion under the following conditions: (i) Within the first 12 weeks of gestation, a woman may terminate her pregnancy on demand.[11,68] She does not have to fulfil any additional requirements to terminate her pregnancy, nor does she have to provide any reason as to why she wishes to terminate it. (ii) Between 13 and 20 weeks’ gestation, a woman may terminate her pregnancy if her medical practitioner, after having consulted with the patient, determines that her pregnancy will threaten her mental or physical health; the fetus may be subjected to acute physical or mental disability; pregnancy arose out of rape or incest; or her pregnancy will detrimentally affect her socioeconomic standing.[11,69-72] (iii) After 20 weeks’ gestation, a woman may only terminate her pregnancy if her medical practitioner, after consulting with another medical practitioner or registered midwife, determines that the patient’s life is in jeopardy; there is acute malformation of the fetus; or the fetus could be significantly injured during delivery. [11,73-76] Moreover, a woman seeking to procure an abortion is entitled to counselling from the state before and after the procedure, as long as she consents to these services.[11,77] If the woman concerned happens to be a minor, a healthcare professional is expected to encourage the patient to seek the counsel of those closest to her before she decides to go ahead with the procedure.[79] Regardless of whether or not she heeds the advice, abortion will always be available to the patient.[11,79] Additionally, women are entitled to be informed of their rights under the Act.[11,80] While CTOPA does not include a conscientious clause, medical practitioners may conscientiously object to performing an abortion via the constitutional right to freedom of conscience, religion belief, thought and opinion.[81,82] Medical practitioners may conscientiously object free of any unfair discrimination from colleagues or employers,[81,82] provided another medical practitioner is willing to perform the procedure and there is no constitutional and ethical obligation to provide medical assistance to the patient, such as in an emergency context.[83] The Health Professions Council of SA (HPCSA) reiterates the constitutional and ethical duty to provide emergency medical assistance to preserve

the health and/or life of a patient requiring an abortion.[11,84] According to the HPCSA, medical practitioners may conscientiously object to performing an abortion in non-emergency contexts, provided he or she refers to the patient to a colleague who is prepared to perform the procedure.[11,84] The HPCSA expressly condemns the practice of medical practitioners imposing subjective cultural and religious opinions regarding abortion onto patients; medical practitioners are obligated to objectively counsel patients seeking to procure an abortion.[11,84] Failure to perform an abortion in an emergency context will give rise to legal repercussions.[85] Should the right to conscientious objection be invoked, CTOPA requires the medical practitioner concerned to inform the patient of her rights under CTOPA, thereby ensuring that she is capable of procuring a safe and legal abortion elsewhere.[11,85] Should the medical practitioner refuse to inform the patient, he or she will be guilty of an offence and subject to either a fine or imprisonment up to 10 years.[86] Furthermore, the identity of women who have terminated their pregnancies cannot be made public unless the woman concerned sanctions disclosure,[11,87] which safeguards women’s constitutional rights to access to information and privacy.[88,89] Although it appears that CTOPA caters exclusively to maternal interests, the drafters of the legislation evidently made significant efforts to counterpoise fetal and maternal interests by introducing a gestational limitation framework into the law.[11] It is apparent that during the first trimester, the law has a vested interest in maternal interests, as abortion is available on demand to women until the conclusion of the first trimester.[67] However, as pregnancy progresses, the law gradually centres its attention on maintaining a balance between the interests of both parties. For the duration of the second trimester, the grounds for abortion are limited, albeit moderately, as the decision to terminate a pregnancy warrants the opinion of a medical practitioner in consultation with the patient concerned, and the latter can no longer procure the procedure on demand.[68-72] This limitation is predicated on the interests of the nascent fetus, and as it approaches viability, the grounds for abortion are progressively limited.[11] Once gestation approaches the third trimester, abortion is restricted to rare circumstances, in order to serve the interest of the viable fetus. The decision to terminate a pregnancy no longer lies with the patient; it is made by her medical practitioner, who is required to consult with another medical practitioner or registered midwife.[73-76] Nevertheless, the gestational limitations do not unduly limit women’s constitutional or statutory rights, as the principal objective of the law is to provide safe and legal abortions for women while upholding their constitutional rights to bodily integrity, including the right to make autonomous reproductive health decisions, and reproductive healthcare. Therefore, maternal interests take precedent over fetal interests. However, even though CTOPA ultimately serves women’s interests, it does take into account the interest of the fetus.

CTOPA and religious ethics We now know that CTOPA attempts to counterbalance maternal and fetal interests by upholding and championing women’s constitutional and reproductive rights, while progressively restricting the grounds for abortion as pregnancy progresses, particularly towards fetal viability. In doing so, CTOPA simultaneously integrates secular and religious ethics, thereby creating an equilibrium between secularism and religion in the context of abortion.

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REVIEW Section 2(a) of CTOPA makes provision for abortion on demand within the first 12 weeks of gestation.[6] Drawing on our discussion on Christian ethics, liberal Protestant groups believe that abortion is permissible at the discretion of the woman and her physician within the first trimester. Hence, not only does CTOPA uphold women’s right to autonomy regarding reproductive healthcare, it is also inclusive of liberal Protestant ethical views on abortion. This makes sense in a context where the majority of SA Christians are Protestant,[90] with a significant number belonging to liberal denominations, including the Lutheran, Methodist and Presbyterian Churches that are known to hold pro-choice views.[91] Additionally, there is evidence of Islamic jurisprudential precedent sanctioning abortion in times of adversity, exclusive of any grounds affecting the health of the woman, such as in cases of a minor falling pregnant, rape or incest, provided termination occurs pre-ensoulment.[92] Thus, should a Muslim minor fall pregnant and wish to terminate her pregnancy during her first trimester, she could do so within the confines of liberal Islamic ethics.

This is reassuring considering the growing number of Muslims in SA, coupled with the fact that it is the most prevalent religion practised in the country after Christianity and ATR.[2] In this sense, CTOPA is representative of Islamic and Protestant ethics, secular morality and the constitutional rights to bodily integrity and reproductive healthcare, by granting women the ability to terminate their pregnancies on demand within the first trimester.

Section 2(b) provides for abortion between 13 and 20 weeks of gestation in cases of rape, incest, and/or physical and mental health preservation, as determined by the medical practitioner upon consultation with the patient.[68-72] Collectively, all five aforementioned religions, except for liberal protestant denominations, generally prohibit abortion except on the specific grounds that happen to be listed in Section 2(b) of CTOPA. Specifically, Christian, Jewish and Hindu ethics dictate that abortion is permissible when the health of the woman is at stake, while ATR and Islamic ethics extend those grounds to cases of rape and incest. Accordingly Section 2(b) of CTOPA is inclusive of Christian, Jewish, Hindu, Islamic and ATR ethics. Section 2(b) furthermore makes provision for abortion on socioeconomic grounds, thus taking into account the socioeconomic standing of the woman and its effect on sexual and reproductive healthcare decisions. Additionally, liberal Islamic scholars state that abortion can be considered in times of socioeconomic hardship, albeit in rare instances.[93] Hence it may be permissible for Muslim women to terminate their pregnancies on socioeconomic grounds without breaching Islamic ethical views on abortion, in some instances. It is worth noting that in these instances it is likely that a Muslim woman will have to terminate her pregnancy within 17 weeks of gestation (119 days), as abortion post-fetal ensoulment is only permissible in cases of necessity or fetal malformation. Thus Section 2(b) balances religious ethics and secular morality by providing abortion on socioeconomic grounds.

Nevertheless, one could still argue that Section 2(b) does not fully comply with the health exception outlined by Christian, Jewish and Hindu religious ethics, since the general normative Christian, Jewish and Hindu prohibitions on abortion can only be overturned to prevent death. While Section 2(b) does not explicitly address abortion in lifethreatening circumstances, Section 2(c) unambiguously regulates abortion on the grounds of necessity, and so it is trite to state that this ground would also apply to Section 2(b)(i). According to Section

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2(c), after 20 weeks of gestation, abortion is only permissible on the grounds of necessity, severe fetal malformation, or fetal endangerment, as determined by the medical practitioner upon consultation with another medical practitioner or registered midwife.[74-77] It is clear that while Jewish, conservative Christian, Islamic, Hindu and ATR ethics generally proscribe abortion, the significant exception for four of the five is for life preservation, principally with respect to late termination of pregnancy (LTOP). As previously mentioned, Islam extends the grounds for LTOP to severe fetal malformation. Thus, the inclusion of Section 2(c) of CTOPA takes cognisance of religious ethics in the context of LTOP and upholds the right to bodily integrity and healthcare, while simultaneously protecting the interests of the fetus, as LTOP is restricted, except in rare circumstances, on the basis of fetal viability.

Conclusion The prominence and influence that secular bioethical principles and theories have had on medical ethical issues such as abortion could lead to the presumption that religious ethics hold no weight in medical ethics, healthcare and law. Although SA is considered a secular country, the majority of its population is religious, and its abortion legislation is among the most liberal the world over.

SA’s current abortion legislation attempts to create a balance between maternal and fetal interests. CTOPA promotes and upholds women’s legal and constitutional rights with respect to bodily integrity, autonomy and reproductive healthcare, while taking cognisance of the nascent fetus and its accompanying interests by limiting the grounds for abortion as pregnancy progresses. Similarly, CTOPA has attempted to counterbalance secular morality, which correlates with the legal and constitutional rights of women and their interests, with religious ethics, which largely advocates a pro-life stance on abortion. This attempt is evident in the provisions of CTOPA that address the circumstances under which abortion is permissible in SA. Section 2 of CTOPA encompasses conservative and liberal religious ethical grounds as well as secular grounds for abortion. The religions predominantly practised in the country collectively permit abortion for reasons relating to the preservation of life and health, severe fetal impairment, and cases of rape and incest. Some liberal denominations grant abortions to minors and on socioeconomic grounds, as well as permit abortion on demand during the first trimester. These views coincide with the secular ethical approach to abortion, which advocates maternal rights and interests over fetal interests.

Thus, CTOPA is unique in the sense that it belongs to one of only five African countries that provide abortion without restriction, notwithstanding its gestational limitation framework, yet encompasses the religious ethical views of every major religious group practising in the country; it balances religious and secular ethical views, while upholding and endorsing women’s constitutional rights as well as fetal interests.

Acknowledgements. None.

Author contributions. Sole author.

Funding. None.

Conflicts of interest. None.

1. Guttmacher Institute. Factsheet – Abortion in Africa. New York: Guttmacher Institute, 2017. https://www.guttmacher.org/fact-sheet/facts-abortion-africa (accessed 7 November 2017).

REVIEW 2. Statistics South Africa. Statistical Release P0318 – Household Survey 2015.

Pretoria: StatSA, 2016. http://www.statssa.gov.zapublicationsP0318P03182015.pdf (accessed 7 November 2017).

3. Worldwide Independent Network of Market Research – GALLUP International.

Losing Our Religion? Two thirds of people still claim to be religious. Sofia: GALLUP International, 2015. http://gallup-international.bg/en/Publications/2015/223Losing-Our-Religion-Two-Thirds-of-People-Still-Claim-to-Be-Religious (accessed 7 November 2017).

4. South Africa. The Constitution of the Republic of South Africa Act No. 108 of 1996.

5. Fourie P. The SA Constitution and religious freedom: Perverter or preserver of religion’s contribution to the public debate on morality? Scriptura 2003;82:94-107. https://doi.org/10.7833/82-0-901 6. Propel Steps. KNOW: List of Secular, Non Secular and Ambiguous Countries.

Mannargudi: Propel Steps, 2013. https://propelsteps.wordpress.com/2013/11/19/ know-list-of-secular-non-secular-and-ambiguous-countries/ (accessed 7 November 2017).

7. South Africa. The Choice on Termination of Pregnancy Act 92 of 1996.

8. Morna CL, Makaya-Magarangoma M. The impact of women’s political leadership on democracy and development in South Africa. In: Commonwealth Secretariat.

The Impact of Women’s Political Leadership on Democracy and Development Case Studies from the Commonwealth. London: Commonwealth Secretariat, 2013;7-38.

9. Guttmacher S, Kapadia F, Naude JTW, et al. Abortion reform in South Africa: A case study of the 1996 choice on termination of pregnancy act. Int Family Planning Persp 1998;24(4):191-194. https://doi.org/10.2307/2991980 10. Gellman R, Hartman T. Exploring Religious Ethic in Daily Life. http://www.dummies. com/religion/exploring-religious-ethics-in-daily-life/ (accessed 7 November 2017).

11. Jogee F. The Legal and Ethical Implications of Implementing Partial-Birth Abortion in South Africa. LLM thesis. Durban, University of KwaZulu-Natal, 2017.

12. Goldsand G, Rosenberg ZRD, Gordon M. Ethics for clinicians: 22. Jewish ethics. Can Med Ass J 2000;164(2):219-222.

13. Falk S, Judson D. The Jewish Pregnancy Book: A Resource for the Soul, Body, Mind during Pregnancy, Birth & the First Three Months. Woodstock: Jewish Lights, 2004.

14. Rosner F. Biomedical Ethics and Jewish Law. Hoboken: KTAV Publishing House, 2001.

15. Engelhardt HT. The euthyphro’s dilemma reconsidered: Variation on a theme from Brody on Halakhic method. In: Cherry MJ, Iltis AS, eds. Pluralistic Casuistry: Moral Arguments, Economic Realities, and Political Theory. Dordrecht: Springer, 2007:109-130.

16. Schiff D. Abortion in Judaism. Cambridge: Cambridge University Press, 2002.

17. Kohn D. Judaism. In: Sorajjakool S, Carr MF, Nam JJ, eds. World Religions for Health Professionals. New York: Routledge, 2010;113-129.

18. Chryssides GD. Abortion. In: Cohn-Sherbok D, Chryssides GD, El-Alami D. Love, Sex and Marriage: Insights from Judaism, Christianity and Islam. London: SCM Press, 2013:219-225.

19. Kohmescher MF. Catholicism Today: A Survey of Catholic Belief and Practice. 3rd ed.

New York: Paulist Press, 1999.

20. O’Brien GD. The Church and Abortion: A Catholic Dissent. Lanham: Rowman and Littlefield Publishers, 2010.

21. Gregory E. Religion and ethics. In: Kuhse H, Singer P, eds. A Companion to Ethics.

2nd ed. Oxford: Wiley-Blackwell, 2009;46-55.

22. Cassidy K. A convenient untruth: The pro-choice invention of an era of abortion freedom. In: Schmiesing K, ed. Catholicism and Historical Narrative: A Catholic Engagement with Historical Scholarship. Lanham: Rowman and Littlefield, 2014;72-103.

23. Kelly DF, Magill G, Have HT. Contemporary Catholic Health Care Ethics. 2nd ed.

Washington: Georgetown University Press, 2013.

24. Pauls M, Hutchinson RC. Protestant ethics. In: Singer PA, Viens AM, eds. The Cambridge Textbook of Ethics. Cambridge: Cambridge University Press, 2008;430435.

25. Brown SF. Protestantism. 3rd ed. New York: Chelsea House Publishers, 2009.

26. Davis DT. Contemporary Moral and Social Issues: An Introduction through Original Fiction, Discussion, and Readings. Chichester: Wiley-Blackwell, 2014.

27. Wilcox C. Evangelicals and abortion. In: Cromartie M, ed. A Public Faith: Evangelicals and Civic Engagement. Lanham: Rowman and Littlefield, 2003;101-116.

28. Olwan RM. Intellectual Property and Development: Theory and Practice. Berlin: Springer, 2013.

29. Keshavjee M. Islam, Sharia and Alternative Dispute Resolution: Mechanisms for Legal Redress in the Muslim Community. London: IB Tauris, 2013.

30. Khorfan R, Padela A. The bioethical concept of life for life in Judaism, Catholicism, and Islam: Abortion when the mother’s life is in danger. J Islamic Med Ass N Am 2010;42:99-105. https://doi.org/10.5915/42-3-5351 31. Ziebertz H, Reindl M. Religion and attitudes towards euthanasia and abortion. In: van der Ven JA, Ziebertz H, eds. Human Rights and the Impact of Religion. Boston: Brill, 2013;119-143.

32. Fischmann T. Distress and ethical dilemmas due to prenatal and genetic diagnostics. In: Fischmann T, Hildt E, eds. Ethical Dilemmas in Prenatal Diagnosis.

Dordrecht: Springer, 2011;51-64.

33. Alamri YA. Islam and Abortion. J Islamic Med Ass N Am 2011;43(1):39-40. https:// doi.org/10.5915/43-1-5755.

34. Daar AS, Al Khitamy AB. Ethics for clinicians: 21. Islamic Ethics. Can Med Ass J 2001;164(1):60-63.

35. Mayled J, Ahluwali L. Philosophy and ethics for OCR GCSE Religious Studies Cheltenham: Nelson Thornes Ltd, 2002.

36. Renard J. Responses to 101 Questions on Hinduism. New York: Paulist Press, 1999.

37. Lochtefeld JG. The Illustrated Encyclopedia of Hinduism Vol One: A-M. New York: The Rosen Publishing Group, Inc, 2002.

38. Coward H, Sidhu T. Ethics for Clinicians: 19. Hindu and Sikh ethics. Can Med Ass J 2000;169(3):1167-1168.

39. Maguire DC. Sacred Choices: The Right to Contraception and Abortion in Ten World Religions. Minneapolis: Fortress Press, 2001.

40. Faúndes A, Barzelatto JS. The Human Drama of Abortion: A Global Search for Consensus. Nashville: Van der Bilt University Press, 2006.

41. Bailey J. Abortion. New York: Rosen Publishing Group Inc, 2012.

42. Nwaigbo F. Faith in the one god in Christian and African traditional religions: A theological appraisal. Afr J Online 2010;7:56-68. http://dx.doi.org/10.4314/ og.v7i1.57922 43. Tanju F. Multicultural/Multiethnic Divide: Interrogation of politics, identity and culture towards transcending the multiculturalism conundrum. In: Tosam MJ, Takov P, eds. Philosophy in Culture: A Cross-Cultural Perspective. Bamenda: Langaa Research, Publishing Common Initiative, 2016.

44. Tangwa GB. Some African reflections on biomedical and environmental ethics. In: Wiredu K, ed. A Companion to African Philosophy. Oxford: Blackwell Publishing, 2004;387-395.

45. Lajul W. African Philosophy: Critical Dimension. Kampala: Fountain Publishers, 2013.

46. Lugira AM. African Traditional Religion. New York: Chelsea House Publishers, 2009.

47. Kalu H. Together as One: Interfaith Relationships between African Traditional Religion, Islam and Christianity in Nigeria. Bloomington: iUniverse Inc, 2011.

48. Onwubiko OA. African Thought, Religion and Culture: Christian Mission and Culture in Africa, Vol 1. Enugu: Snaap Press, 1991.

49. Gehman RJ. African Traditional Religion in Biblical Perspective. Nairobi: East African Educational Publishers Ltd, 2005.

50. Rakhudu MA, Mmelesi MM, Myburgh CPH, Poggenpoel M. Exploration of the views of traditional healers regarding the termination of pregnancy (TOP) law.

Curationis 2006;29(3):56-60. https://doi.org/10.4102/curationis.v29i3.1099.

51. MacKinnon B, Fiala A. Ethics: Theory and Contemporary Issues. 8th ed. Stamford, CT: Cengage Learning, 2015.

52. Kurtz P. Multi-secularism: A New Agenda. New Brunswick: Transaction Publishers, 2014.

53. Engelhardt HT. Abortion and the culture wars: Competing moral geographies and their implications for ethics. In: Caplan A, Engelhardt HT, Gomperts R, et al.

The Fulbright Brainstorms on Ethics – Ethics Frontiers and New Challenges. São João do Estoril: Principia, 2006;27-34.

54. Tomlinson T. Methods in Medical Ethics: Critical Perspectives. Oxford: Oxford University Press, 2012.

55. Engelhardt HT. The Foundations of Ethics. 2nd ed. New York: Oxford University Press, 1996.

56. Boezaart T. The Law of Persons. 5th ed. Cape Town: Juta, 2010.

57. Cronje DSP, Heaton J. The South African Law of Persons. 3rd ed. Durban: LexisNexis 2008.

58. Pillay R. The beginning of human personhood: Is South African law outdated?

Stellenbosch Law Rev 2010;21(2):230-238.

59. Davel CJ, Jordaan RA. The Law of Persons. 4th ed. Cape Town: Juta, 2005.

60. Christian Lawyers Association of SA and Others v Minister of Health and Others 1998 (4) SA 1113 (T).

61. South Africa. National Health Act No. 63 of 2003. Section 57.

62. South Africa. Birth and Deaths Registration Act No. 51 of 1992. Section 1.

63. South Africa. Birth and Deaths Registration Act No. 51 of 1992. Section 18.

64. Niekerk EC, Siebert I, Kruger TF. An evidence-based approach to recurrent pregnancy loss. S Afr J Obstetr Gynaecol 2013;19(3):61-65. https://doi. org/10.7196/SAJOG.670 65. South Africa. The Choice on Termination of Pregnancy Act No. 92 of 1996. Section 1(xi).

66. South Africa. The Choice on Termination of Pregnancy Act No. 92 of 1996. Section 5(1).

67. South Africa. The Constitution of the Republic of South Africa Act No. 108 of 1996.

Section 12(2)(a).

68. South Africa. The Choice on Termination of Pregnancy Act No. 92 of 1996. Section 2(1)(a).

69. South Africa. The Choice on Termination of Pregnancy Act No. 92 of 1996. Section 2(1)(b)(i).

70. South Africa. The Choice on Termination of Pregnancy Act No. 92 of 1996. Section 2(1)(b)(ii).

July 2018, Vol. 11, No. 1 SAJBL

50

REVIEW 71. South Africa. The Choice on Termination of Pregnancy Act No. 92 of 1996. Section 2(1)(b)(iii).

72. South Africa. The Choice on Termination of Pregnancy Act No. 92 of 1996. Section 2(1)(b)(iv).

73. South Africa. The Choice on Termination of Pregnancy Act No. 92 of 1996. Section 2(1)(c).

74. South Africa. The Choice on Termination of Pregnancy Act No. 92 of 1996. Section 2(1)(c)(i).

75. South Africa. The Choice on Termination of Pregnancy Act No. 92 of 1996. Section 2(1)(c)(ii).

76. South Africa. The Choice on Termination of Pregnancy Act No. 92 of 1996. Section 2(1)(c)(iii).

77. South Africa. The Choice on Termination of Pregnancy Act No. 92 of 1996. Section 4.

78. South Africa. The Choice on Termination of Pregnancy Act No. 92 of 1996. Section 5(2).

79. South Africa. The Choice on Termination of Pregnancy Act No. 92 of 1996. Section 5(3).

80. South Africa. The Choice on Termination of Pregnancy Act No. 92 of 1996. Section 6.

81. South Africa. The Constitution of the Republic of South Africa Act No. 108 of 1996.

Section 15(1).

82. South Africa. Constitution of the Republic of South Africa Act No. 108 of 1996.

Section 9(3).

83. South Africa. The Constitution of the Republic of South Africa Act No. 108 of 1996.

Section 27(3).

84. Health Professions Council of South Africa. Health Professions Council of South Africa Guidelines for Good Practice in Health Care Professions – General Ethical Guidelines for Reproductive Health Booklet 13, 2008. http://juta.co.za/academic/ support-material/resource/277 (accessed 7 November 2017).

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July 2018, Vol. 11, No. 1 SAJBL

85. McQuoid-Mason D. State doctors, freedom of conscience and termination of pregnancy revisited. S Afr J Bioethics Law 2010;3(2):75-78. https://doi.org/10.7196/ SAJBL.116.

86. South Africa. The Choice on Termination of Pregnancy Act No. 92 of 1996. Section 10(1)(c).

87. South Africa. The Choice on Termination of Pregnancy Act No. 92 of 1996. Section 7(5).

88. South Africa. The Constitution of the Republic of South Africa Act No. 108 of 1996.

Section 14.

89. South Africa. The Constitution of the Republic of South Africa Act No. 108 of 1996.

Section 32.

90. Statistics South Africa. Census 2001: Census Primary tables South Africa: Census ’96 and 2001 compared 2001. Pretoria: StatsSA, 2004. http://www.statssa.gov.za/ census01/html/RSAPrimary.pdf (accessed 7 November 2017).

91. Newport F. On Moral Issues, Not All Protestants Are Created Equal. September 8, 2017. Sofia: GALLUP International, 2017. http://news.gallup.com/poll/218204/ moral-issues-not-protestants-created-equal.aspx?version=print (accessed 7 November 2017).

92. Scholar of the House and the search of beauty. Fatwa on the permissibility of abortion, Searchforbeauty.org, 2015. https://www.searchforbeauty.org/2015/01/04/ fatwa-on-the-permissibility-of-abortion/ (accessed 7 November 2017).

93. Hashemi N. Islam, Secularism, and Liberal Democracy: Toward a Democratic Theory for Muslim Societies. Oxford: Oxford University Press, 2009.

Accepted 4 May 2018.

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This open-access article is distributed under Creative Commons licence CC-BY-NC 4.0.

Winning Student Essay Witnessing injustice: What is the student’s role in advocating for patients?

N Ramagaga, MB BCh Steve Biko Centre for Bioethics, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa Corresponding author: N Ramagaga (ramagaganeo@gmail.com)

By the time they graduate, South African (SA) health sciences students are armed with all the necessary tools required to diagnose and treat patients. However, patient care is comprised of more than simply identifying and treating a combination of symptoms. A patient’s state of health is determined by more than biological factors – the circumstances that they face outside the hospital setting directly affect their wellbeing as well. Identifying vulnerable patients and managing their health holistically should therefore be an integral part of health education. This will ensure a future in which SA healthcare professionals apply the biopsychosocial approach in patient care. The country’s healthcare system is currently riddled with structural and systemic barriers that exist because of its tumultuous history. These barriers are yet to be rectified to provide healthcare that is equitable and accessible to all South Africans. This article deals with the role that the health sciences students of today play in identifying the various ways in which the current SA health system benefits certain demographics, while leaving others marginalised and without access to appropriate healthcare. The role that students can play in advocating for the rights of the patient who is denied equitable healthcare, and the skills required to do so, are also explored.

S Afr J Bioethics Law 2018;11(1):52-55. DOI:10.7196/SAJBL.2018.v11i1.646

The state of the healthcare system of any country is, inextricably, an indicator of the overall performance of the country [1] – it is one of the most important parameters that shows the separation between the First World and the Third. Yet a country like South Africa (SA) is able to boast First-World status to a certain extent, while at the same time, more than half of its population lives in dire poverty.[2] This article focuses on how the unequal and unjust distribution of basic healthcare services to people of colour in apartheid SA laid the foundation for these disparities, and has allowed whiteness to remain the definitive currency in receiving the best healthcare possible in SA, 24 years into our democracy. It first defines healthcare disparities in the context of the SA population, understanding the role that the government should play in protecting vulnerable patients, and exploring the role that medical students can play in protecting patients from being subjected to injustice.

Under apartheid rule, the black African, coloured and Indian populations of SA were all harshly discriminated against because they did not qualify as white citizens.[3] The term ‘black’ in this paper is therefore used to encompass all these racial groups.

The purpose of this article is not to point out that apartheid rule was unjust – that is a blatant blemish in SA history. Instead, it serves to underscore the facts that there exists severe health inequity between the different racial groups in SA, and that there has been very little change effected since the abolishment of apartheid rule to redress and to standardise the level of healthcare received by all South Africans – and that this is unjust.

Injustice in the context of healthcare In exploring what justice means in the context of healthcare, author Norman Daniels[4] argues that critically answering three focal questions is a tool with which we can determine if health inequalities within a society are unjust: (i) What is the special moral importance of health? (ii) When are health inequalities unjust? (iii) How can we meet health needs fairly when we can’t meet them all?

In answering the above questions, Daniels puts forth a theory that states that firstly, health is of special moral importance because it affects the way in which people function and the opportunities that may become available to them because of their level of functioning.

Secondly, Daniels argues that health inequalities are unjust when access to healthcare is unfairly distributed. Lastly, fairness in healthcare is attained when a fair process delineates a course of action that is legitimate, and is defined by unbiased, ‘limit-setting’ decisions.[4] Thus injustice in the context of healthcare is defined as a state in which a patient is subjected to inadequate healthcare, either because the service is comparably inequitable, and/or because the lack of healthcare for said patient negatively affects their level of functioning, and therefore the opportunities that they are able to pursue.

History of healthcare in South Africa In the 1960s, the average lifespan was approximately 65 years for white men and 72 for white women, but only 51 for black men and 59 for black

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FORUM women.[5] This was a direct result of the SA apartheid government’s deregulation of public health, allowing the private health sector and those who had access to it – white South Africans – to flourish.[6] Under the Group Areas Act No. 41 of 1950,[7] black African people were forced to live in ‘Bantustans’ and were to essentially function independently of various governmental support structures.[8] Black people were severely marginalised, and were afforded little to no healthcare in these segregated areas. The few healthcare practitioners of colour available in the areas were heavily burdened with the immense patient load, and eventually, they could attend only to patients in dire need of medical attention.[9] This was not made any easier by the fact that the development of traditional SA medicine had suffered and dwindled under oppressive colonial pressures for many years before apartheid even began.[10] By the time of apartheid, traditional African medicine had become severely stigmatised, and the practice was then further marginalised by apartheid policy (the Witchcraft Suppression Act No. 3 of 1957[11] and the Witchcraft Suppression Amendment Act No. 3 of 1970[12] declared the practice of traditional African medicine unconstitutional, as it was believed that African healing had roots in dark magic/witchcraft).[10] Under these harrowing conditions, SA black people had neither Western nor traditional African medicine to turn to – increasing their burden of disease and resulting in their poor life expectancy statistics.

By 2009, 15 years into SA’s democracy, the average life expectancy for white South Africans was 71,[13] while the life expectancy for the average South African was only 54.68.[14] With white South Africans constituting only 8% of the total SA population,[15] it was clear that even after the abolishment of apartheid, white South Africans still enjoyed a higher standard of healthcare than black South Africans.

The evident disparity can be attributed to two very important factors, both heavily impacted by the socioeconomic realities of the country – the first being access to adequate healthcare, and the second being the differential burden of disease between black and white South Africans.

Inequities in healthcare access Access to adequate healthcare in post-apartheid SA has been affected by various intersecting factors, but some of the most remarkable effects on healthcare access are best exemplified by the drastic inequality between the public and private healthcare sectors. Private healthcare, as their sole healthcare service, is used by only 14% of South Africans, yet it accounts for approximately 60% of national healthcare expenditure.[16] The private sector, which developed enormously under the apartheid regime, is not primary-healthcare centred, unlike the public sector.[6] It has been criticised because patient care is often augmented to include unnecessary procedures, leading to inflated costs for patients, and further increasing the exclusivity of the service.[17] Even with 28% of South Africans making use of both private and public healthcare services,[18] the free services provided by the public sector remain the only accessible option for the masses of South Africans who cannot afford private healthcare – resulting in the overburdening of an already under-resourced public healthcare system.[19]

Differential burden of disease The World Health Organization (WHO) describes the relationship between health and socioeconomic factors as one of great

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interdependence.[20] The WHO details how factors such as one’s income and social status, physical environment and education level all impact and are impacted by one’s state of health,[20] thus perpetuating the cycle of poverty in the already poor, and helping to maintain the comforts of the privileged. Limited access to adequate healthcare since the end of apartheid rule has severely contributed to maintaining the burden of disease that was established due to the dire circumstances emanating from the time of the Group Areas Act.[7] This, coupled with the restrictions that were imposed upon black people in order to keep them economically and educationally disadvantaged, perpetuated the vicious and unjust cycle that is implicated in the differential burden of disease seen between white and black South Africans to this day.

It should be made clear, however, that the focus herein is on the inherent burden of disease of SA black peoples that are either a direct or indirect result of apartheid. This therefore excludes the disparities seen among racial groups that have a purely biological and/or genetic basis, e.g. oculocutaneous albinism type 2, which is fairly common among black Africans, but almost never affects whites,[21] or melanoma, which is prevalent among SA white women but almost never affects black African, coloured or Indian women.[22] There are several ways in which the SA healthcare system has been unjust, particularly to black citizens. Firstly, the inability to access healthcare affects the normal functioning of patients, and infringes on their ability to acquire new opportunities, which, according to Daniels, is not only unjust but also immoral.[4] The differential burden of disease as seen between the white and black populations of SA reflects the inequity of healthcare among the different racial groups, which is also considered unjust under Daniels’ theory.[4]

Post-apartheid strategies for reform Since the end of apartheid, several measures have been put in place by post-apartheid administrations to advance health equity, which is defined as ‘everyone having a fair opportunity to attain their full health potential without being disadvantaged from achieving this potential’.[23] With the appointment of Nelson Mandela as the president of the Republic in 1994, the new ruling party, the African National Congress (ANC), with technical support from the WHO and the United Nations Children’s Fund (UNICEF), devised a National Health Plan that would ensure that healthcare in the country would no longer revolve around ‘curative and private medicine’, but would instead have a focus on primary healthcare and would ‘change medical culture to provide the best care possible’.[24] Practically, this involved educating the public on issues of healthcare, as well as the building of many new clinics.[22,24] Addressing the social determinants of health also became a priority to the post-apartheid administration, as the relationship between socioeconomic factors and health was identified as a contributor to the burden of disease.[24] However, the development of the primary-healthcare-centred public sector could only go so far, considering the severe shortage of healthcare workers available within the public sector.[16] In 2010, the WHO estimated that only 30% of all SA physicians were working in the public sector,[19] despite the fact that the public sector provides healthcare to more than 80% of the SA population.[19] A recently published study in the South African Medical Journal cited reasons such as the inadequacy of the working conditions and workplace security as directly affecting doctors’ decisions to enter the private sector,

FORUM or to leave SA entirely.[25] Nevertheless, despite the shortcomings of some elements of the National Health Plan, one of the most effective of the efforts at recompense was the introduction of certain standard protocols that would work to regulate the provision of healthcare,[22] which satisfies one of the conditions necessary to ensure justice in healthcare, according to Daniels’ theory.[4] The implementation of the National Health Insurance (NHI) is the SA government’s latest large-scale method to advance health equity in the country. The government describes the NHI as ‘a financing system that will make sure that all the citizens of SA (and legal longterm residents) are provided with essential healthcare, regardless of their employment status and ability to make a direct monetary contribution to the NHI Fund’.[30] This is a significant measure of redress on the SA government’s part and, if successful, will definitely increase access to better healthcare for the multitudes, and will ultimately decrease the burden of disease in South Africans as a whole, but especially in black people, who have been more severely affected historically.

The role of students Current SA health sciences students have the potential to effect a great deal of change in the country’s healthcare system, if they are properly equipped with the necessary tools to do so during their schooling. A consequence of medical education, as seen all over the world, is the desensitisation to patients that many health sciences students seem to undergo due to the dominating biomedical model of healthcare, which ‘attributes a key role to biological determinants in disease aetiology’ and never goes further than viewing patients outside their physical symptoms.[26,28] This emotional detachment from patients may impinge on the necessary ability of students, and so future doctors, to identify vulnerable people – who are defined as individuals whose human rights are more likely to be infringed upon, as a result of specific systemic barriers.[27] The type of vulnerability can be defined using either one or a combination of the following: cognitive, juridic, deferential, social, infrastructural, medical, or allocational.[27] In the context of healthcare justice, students need to be equipped with a set of skills that will help them to identify vulnerable patients and treat them without further marginalising them. The course of treatment should take into account all of the intersecting factors that have led to the patient’s vulnerability and/or state of ill health, and should not aggravate that state, but seek to protect the patient as far as possible.

This level of patient interaction and care would be best facilitated if the biopsychosocial model of healthcare were well ingrained in students, as opposed to taking the purely biomedical approach that is predominantly used in current medical practice.[28] The biopsychosocial model of health is simply defined as one that ‘takes into account all relevant determinants of health and disease, and that supports the integration of biological, psychological and social factors in the assessment, prevention and treatment of diseases’.[28] Under this model of healthcare, students of the health sciences would have a wider scope to use to determine the aetiology of certain conditions and to understand why there exists a difference in the burden of disease among different SA racial groups. In understanding the nature of the condition, they would be better equipped to manage patients’ health with long-term

solutions, instead of merely alleviating the symptoms and not mitigating the actual problem.

Patient advocacy is also an important part of patient care that should be taught to SA medical students. Advocating for the rights of one’s patient can be a crucial part of affording the patient equitable healthcare, especially if (s)he is unable to advocate for him- or herself.[29] However, there exists a fine line that ought not to be crossed, as inappropriate advocacy for one’s patient could be perceived as paternalistic in nature, and could effectively strip the patient of their agency.[29] A key skill to be adopted by students would encompass both an understanding of when to appropriately advocate for one’s patient, and the ability to discern when not to overstep the boundaries.

Conclusion This article has explored the definition of healthcare injustice with the use of substantial examples within the context of SA healthcare. It has been shown that the disparities between the black and white populations of SA can essentially be reduced to two very important factors: unequal access to healthcare and the differential burden of disease – which are the results of the enduring effects of apartheid. It has also been noted that post-apartheid administrations have made some strides in an attempt to rectify what was thrown out of balance by apartheid policy and by colonial pressures even before that. The imminent implementation of the National Health Insurance is promising in that it will try to establish health equity in SA. The role that current health sciences students will one day have to play in protecting patients from being treated unjustly relies heavily upon the biopsychosocial model for the assessment, prevention and treatment of disease, as well as on patient advocacy.

Acknowledgements. Prof. Ames Dhai and Miss Lizeka Tandwa.

Author contributions. Sole author.

Funding. None.

Conflicts of interest. None.

1. Mokoena S. Health Status of Any Country Key Condition for its Economic Development – Cathy Dlamini. Pretoria: Parliament of the Republic of South Africa, June 2017. https://www.parliament.gov.za/news/health-status-anycountry-key-condition-its-economic-development-cathy-dlamini (accessed 27 February 2018).

2. Magombeyi MT, Odhiambo NM. Poverty dynamics in South Africa: trends, policies and challenges. Socioeconomica 2015;4(8):333-348. https://doi. org/10.12803/sjseco.48140 3. South Africa. Population Registration Act. No. 30 of 1950. http://www. s a h i s to r y. o rg. z a / s i te s / d e f a u l t / f i l e s / D C / l e g 1 9 5 0 0 8 0 7 . 0 2 8 . 0 2 0 . 0 3 0 / leg19500707.028.020.030.pdf (accessed 24 March 2018).

4. Daniels N. Just Health: Meeting Health Needs Fairly. Cambridge: Cambridge University Press, 2007.

5. Horwitz S. Health and Health Care under Apartheid. Johannesburg: Adler Museum of Medicine, University of the Witwatersrand, 2009.

6. Price M. Health care as an instrument of Apartheid policy in South Africa.

Health Pol Planning 1986;1(2):158-170 (abstract). https://doi.org/10.1093/ heapol/1.2.158 7. South Africa. Group Areas Act No. 41 of 1950. http://www.sahistory.org.za/ archive/group-areas-act%2C-act-no-41-of-1950 (accessed 29 June 2018).

8. Li V. South Africa’s return to primary care: The struggles and strides of the primary health care system. J Glob Health 2014;4(1):10-14. http://www. ghjournal.org/south-africas-return-to-primary-care-the-struggles-andstrides-of-the-primary-health-care-system/ (accessed 21 February 2018).

9. Kautzky K, Tollman SM. A perspective on primary health care in South Africa. S Afr Health Rev 2008;2008(1):17-30. hdl.handle.net/10520/EJC35514 (accessed 27 February 2018).

July 2018, Vol. 11, No. 1 SAJBL

54

FORUM 10. Berger J, Hassim A, Heywood M, eds. Health & Democracy: A Guide to Human Rights, Health Law and Policy in Post-apartheid in South Africa. Cape Town: Siber Ink, 2007.

11. South Africa. Witchcraft Suppression Act No. 3 of 1957. http://www.justice.gov. za/legislation/acts/1957-003.pdf (accessed 29 June 2018) 12. South Africa. Witchcraft Suppression Amendment Act No. 50 of 1970. https://www.greengazette.co.za/acts/witchcraft-suppression-amendmentact_1970-050 (accessed 29 June 2018).

13. Vavi Z. How can we build on the World Cup success and mobilise our society to build a more egalitarian nation? Proceedings of Civil Society Conference, Boksburg, 27 October 2010. http://www.cosatu.org.za/show.php?ID=4170 (accessed 27 February 2018).

14. World Bank Group. Life Expectancy at Birth, Total (years). Washington, DC: World Bank Group, 2018. https://data.worldbank.org/indicator/SP.DYN.LE00.IN?end=20 09&locations=ZA&start=200 (accessed 27 February 2018).

15. Statistics South Africa. Mid-year Population Estimates 2017. Pretoria: StatsSA, 2018. http://www.statssa.gov.za/publications/P0302/P03022017.pdf (accessed 27 February 2018).

16. Coovadia H, Jewkes R, Barron P, Sanders D, McIntyre D. The health and health system of South Africa: historical roots of current public health challenges.

Lancet 2009;374(9692):817-834. https://doi.org/10.1016/S0140-6736(09)60951X 17. Francis K. Private Health Care and the Right to Health. Focus 67 – State and Nation. Johhanesburg: Helen Suzman Foundation, 2013.

18. Pretorius L. Does SA’s private healthcare sector only serve 16% of the population?

Africa Check, 2017. https://africacheck.org/reports/does-sas-private-healthcaresector-only-provide-care-for-16-of-the-population/ (accessed 27 February 2018).

19. Keeton C. Bridging the gap in South Africa. Bull World Health Org 2010;88(11): 803-804.

20. World Health Organization. Health Impact Assessment (HIA) – the Determinants of Health. Geneva: WHO, 2010. http://www.who.int/hia/evidence/doh/en/ (accessed 28 February 2018).

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21. Manga P, Kerr R, Ramsay M, Kromberg J. Biology and genetics of oculocutaneous albinism and vitiligo – common pigmentation disorders in southern Africa. S Afr Med J 2013;103(12):984-988. https://doi.org/10.7196/SAMJ.7046 22. Ngassa Piotie P. Analysis: Is cancer a white people’s disease in South Africa?

Africa Check, 2017. https://africacheck.org/2017/12/05/analysis-cancer-whitepeoples-disease-south-africa-legend/ (accessed 28 February 2018).

23. World Health Organization. Health Equity. Geneva: WHO, 2018. http://www.who. int/topics/health_equity/en/ (accessed 27 February 2018).

24. African National Congress. A National Health Plan for South Africa. Pretoria: ANC, 1994. http://www.anc.org.za/content/national-health-plan-south-africa (accessed 27 February 2018).

25. Van der Spuy ZM, Zabow T, Good A. Money isn’t everything – CMSA doctor survey shows some noteworthy results. S Afr Med J 2017;107(1):550-551. https://doi. org/10.7196/SAMJ.2017.v107i7.12643 26. Cockerham WC. Medical Sociology. 14th ed. London: Routledge, 2017.

27. Kipnis K. Vulnerability in research subjects: A bioethical taxonomy (commissioned paper). Manoa: University of Hawaii, 2004.

28. Havelka M, Lucanin JD, Lucanin D. Biopsychosocial model – the integrated approach to health and disease. Collegium Antropolegicum 2009;33(2009); 303 -310. https:// www.ncbi.nlm.nih.gov/pubmed/19408642 (accessed 28 February 2018) 29. Schwartz L. Is there an advocate in the house? The role of healthcare professionals in patient advocacy. Abstract. J Med Ethics 2002;28(1):37-40. https://doi. org/10.1136/jme.28.1.37 30. South Africa. Department of Health Green Paper: National Health Insurance in South Africa. Pretoria: NDoH, 2011.

Accepted 25 May 2018.

CPD QUESTIONNAIRE

July 2018 True (A) or false (B): The Life Esidimeni tragedy Arbitration award: A step in the direction of justice 1. The Life Esidimeni tragedy claims included Constitutional damages.

2. The Arbitration award is not binding.

L ife Esidimeni deaths: Can the former MEC for health and public health officials escape liability for the deaths of the mental-health patients on the basis of obedience to superior orders’ or because the officials under them were negligent?

3. The law regarding ‘superior orders’ has only been used in criminal cases, and similar principles will not apply to civil actions for delict.

4. There is evidence to support the fact that the Auditor General pressurised the former MEC of health to terminate the contract with Life Esidimeni.

Healthcare in crisis: A shameful disrespect of our Constitution 5. 84% of patients in South Africa access healthcare in the public sector.

6. The International Covenant on Economic, Social and Cultural Rights (ICESCR) of 1966 is silent on healthcare.

Employer-generated complaints to the statutory registration authority: The regulatory framework for the supervision of employed health professionals in the South African public sector 7. Professional boards of the HPCSA do not have the power to register or de-register health professionals.

8. Section 196 of the Constitution of the Republic of South Africa establishes the Public Service Commission.

Legal implications of data sharing in biobanking research in lowincome settings: The Nigerian experience 9. Increasingly, biobanks have become a strategic tool in the field of biotechnology and genomics.

10. Sharing data and samples in genomics research raises a number of challenges including those associated with consent, privacy and the collection, storage and release of genomic data.

What the contract does not say… A current analysis of what’s missing in clinical trial agreements 11. Clinical trial litigation has not increased over the last few years.

12. There is evidence of data being obscured to downplay risks in some studies.

Human guinea pigs? The ethics of undergraduate and postgraduate student involvement in medical training in South Africa 13. There is no power asymmetry in the doctor-patient relationship.

14. Patients are vulnerable because of the psychosocial implications of disease.

The need to develop objective criteria for suitability as a surrogate mother: Reflections on Ex Parte KAF 15. There is a hiatus in South African law on surrogate motherhood.

16. Objectivity as an expert in court means being free from the influence of personal considerations in the exercise of professional skills and judgement.

Should the state fund assisted reproductive technologies for HIVdiscordant couples in South Africa who want to have children?

17. Maternal mortality in South Africa has stabilised and is lower than the targets set by the Millennium Development Goals.

18. Distributive justice is defined as fair, equitable and appropriate distribution determined by justified norms that structure the terms of social co-operation.

Is there room for religious ethics in South African abortion law?

19. Most countries in Africa have overly restrictive abortion laws.

20. In terms of South African law, legal personhood and all accompanying rights are assigned at conception.

A maximum of 6 CEUs will be awarded per correctly completed test.

The CPD programme for SAJBL is administered by Medical Practice Consulting.

CPD questionnaires must be completed online at www.mpconsulting.co.za After submission you can check the answers and print your certificate.

Questions may be answered up to 6 months after publication of each issue.

Accreditation number: MDB015/030/01/2018 (Ethics)

June 2017, Vol. 10, No. 1 SAJBL

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