SAJBL Vol 10, No 1 (2017)

ISSN 1999-7639

THE SOUTH AFRICAN JOURNAL OF

BIOETHICS & LAW JUNE 2017 Vol. 10 No. 1

SAJBL is published by the Health and Medical Publishing Group.

THE SOUTH AFRICAN JOURNAL OF

BIOETHICS & LAW June 2017 Vol. 10 No. 1

CONTENTS

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EDITORIAL After Life Esidimeni: True human rights protections or lip service to the Constitution?

A Dhai

CORRESPONDENCE 4 The Life Esidimeni disaster

C Grobler

ARTICLES 5 Liver transplantation for non-resectable colorectal liver metastases at a single centre in South Africa: A report of the ethics and regulatory approval process

H R Etheredge, J Botha, P Cleaton-Jones 8 The intellectual challenge of doing bioethics in South Africa

A Egan 11 Incentives for HIV testing at the workplace in the auto­motive industry in the Nelson Mandela Bay Municipality: Ethical considerations

M Weihs, A Meyer-Weitz, F Baasner-Weihs 15 Routine referrals: A possible solution for transplantation shortages

M Slabbert, B Venter 20 A global bioethical perspective on organ trafficking:

Discrimination, stigmatisation and the vulnerable

R Rheeder 25

Dare we rethink informed consent?

M de Roubaix

29 A constitutional critique on the regulations relating to

artificial fertilisation of persons

D W Jordaan 32 Strange (and incompatible) bedfellows: The relationship

between the National Health Act and the regulations

relating to artificial fertilisation of persons, and its impact on

individuals engaged in assisted reproduction

C van Niekerk 36

Retraction: Ethical issues in health promotion

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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

EDITOR Ames Dhai CO-EDITOR David McQuoid-Mason 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 DESIGN AND LAYOUT Clinton Griffin Travis Arendse CUSTOMER SERVICE AND ONLINE SUPPORT Gertrude Fani FINANCE AND ADMINISTRATION Tshepiso Mokoena HMPG BOARD OF DIRECTORS Prof. M Lukhele (Chair) Dr M R Abbas, Dr M J Grootboom Mrs H Kikaya Prof. E L Mazwai Dr M Mbokota Dr G Wolvaardt ISSN 1999-7639

EDITORIAL

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

After Life Esidimeni: True human rights protections or lip service to the Constitution?

A Dhai, PhD, MB ChB, FCOG, LLM, PGDip Steve Biko Centre for Bioethics, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

Ames Dhai Editor amaboo.dhai@wits.ac.za South Africa (SA)’s Constitution,[1] in its preamble, affirms that it was adopted to, inter alia, ‘lay the foundations for a democratic and open society in which government is based on the will of the people and every citizen is equally protected by law’, and ‘improve the quality of life of all citizens and free the potential of each person’. The latter principle is reiterated in the preamble of the National Health Act.[2] Other constitutional protections in the healthcare context include those of respecting the rights to equality (s (section) 9), human dignity (s 10), life (s 11), freedom and security of the person (s 12), privacy (s 14) and healthcare (s 27). In the Bill of Rights, the right to freedom and security of persons is established. This includes the right ‘not to be tortured in any way’ (s 12(d)) and the right ‘not to be treated or punished in a cruel, inhuman or degrading way’.

The Mental Health Care Act No. 17 of 2002,[3] in its preamble, gives realisation to the prohibition of unfair discrimination against those with mental and other disabilities, in line with section 9 of the Constitution.

It also gives recognition to the fact that people with mental disabilities may require protection, and to the need to promote mental healthcare services ‘in a manner which promotes the maximum wellbeing of users of mental healthcare services and communities in which they reside’.

Several sections of the Act emphasise the importance of respecting the rights of patients with mental disabilities. In particular, chapter 3 of the Act is specific as to the rights and duties owed to these patients, and the promotion at all times of their best interests is underscored.

Respect for the person, human dignity and privacy of these patients is stressed (s 8), and it is highlighted that the patients must be ‘provided with care, treatment and rehabilitation services that improve the mental capacity of the user to develop to full potential and to facilitate his or her integration into community life’. Protection against unfair discrimination is again brought up in the Act (s 10), and standards for provision of quality care are affirmed. Steps must be taken to

ensure that these patients are protected from exploitation, abuse and degrading treatment (s 11), and determinations concerning them must be based on factors specific to their mental health status rather than on socioeconomic or sociopolitical grounds (s 12). Furthermore, section 4 places the obligation for promoting the rights and interests of patients with mental disabilities squarely on the shoulders of those organs of the state responsible for health services.

Despite all the constitutional and statutory protections in place, and the several international protective instruments that the country has signed, the three highest-ranking officials at the Gauteng Department of Health rushed into executing the Gauteng Mental Health Marathon Project (GMMP) when a contract with Life Esidimeni was ‘precipitously’ terminated in 2016. The patients were hurriedly relocated, some from sick bays and others with comorbid medical conditions requiring highly specialised care, into NGOs that could not provide such services. These patients, even the frail, disabled and incapacitated, were ‘transported in inappropriate and inhumane modes of transport, some without wheelchairs, but tied with bedsheets to support them’. Some NGOs transported these patients in open bakkies, like cattle being herded to the slaughter[4] – and carnage ensued because as many as 100 unlawfully lost their lives due to this ruthless and cruel process.

Life Esidimeni (place of dignity), an established facility, delivered healthcare services to SA’s indigent, vulnerable and mentally ill patients for 5 decades under contract to national and provincial departments of health. Pleas from families, healthcare professional and civil society organisations fell on deaf ears. Qedani Dorothy Mahlangu (provincial minister of health, Gauteng), Tiego Ephraim Selebano (head of department) and Makgabo Manamela (director, mental health) ruthlessly hounded the patients, who were transferred to 27 newly contracted, illprepared, unlicensed NGOs strewn over different parts of Gauteng, with some in distant, faraway locations. To make matters worse, subsidies to these NGOs were not paid, or where paid, this was up to 3 months late, resulting in starvation for many patients. While the Gauteng department of health claimed that the transfers were effected to integrate these patients into the community, and that there were plans afoot to upscale community health services, the investigation by the health ombudsman commissioned by the national minister of health showed unequivocally that this was not the case. The motive behind this evil action was to cut costs and save money. Disgracefully, when the fiasco was exposed, ‘some relatives were unexpectedly offered food parcels’ by Manamela to ‘quieten them down’. Clearly, the hands of this terrible trio are drenched with the blood of the 100 killed in this way and of any more that may follow.[4] Moreover, Selabano and Manamela are medically qualified doctors who have publically declared in the oaths they have taken that their actions will always be for the benefit of patients, and that they will steer away from deleterious activities that could harm patients. Caring

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EDITORIAL and compassion are core values in the practice of healthcare. Did they forget this, or did they choose not to remember?

Negative attitudes towards people with mental disability, as a result of prejudice and misinformation, are major obstacles to providing care for them. At times, because of this stigma, health decisionmakers are reluctant to invest resources for mental healthcare, and this results in discriminatory practices.[5] Could the atrocities executed by the three be a result of their being ensnared in this stigma, or was it that they just did not care? Were the patients punished because of this stigma? Their acts of violence can be equated with torture, because they inflicted severe pain and great suffering on these patients, possibly as punishment for being mentally ill. Whatever their reasons, all three unashamedly disregarded international, constitutional and statutory protections,

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all of which had been enacted to protect the weak and vulnerable. It remains to be seen whether they will be appropriately punished, or whether they will be given a ‘backdoor’ handshake, in keeping with the track record of our country where lip service to human rights laws has become the norm by so many state actors, thereby making a mockery of the constitutional requirement that every citizen is to be equally protected by our laws.

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

2. South Africa. National Health Act No. 61 of 2003.

3. South Africa. Mental Health Care Act No. 17 of 2002.

4. The Life Esidimeni disaster: The Makgoba report. http://www.politicsweb.co.za/ documents/the-life-esidimeni-disaster-the-makgoba-report (accessed 4 April 2017).

5. Sartorius N. Stigma and mental health. Lancet 2007;370(9590):810-811. https:// doi.org/10.1016/s0140-6736(07)61245-8

EDITORIAL

The Life Esidimeni disaster To the Editor: About a year ago I went to London to support my brother, who had been diagnosed with colorectal cancer. His surgery was imminent, and I could hear that he was struggling emotionally.

Upon my arrival at the airport, as we sat down for a quick cup of coffee before heading home, he admitted to me that he was feeling significantly depressed and contemplating taking his own life.

For the next week I struggled to get him an appointment in the NHS’s mental healthcare services. After being sent from pillar to post, at one point even told to ‘go away, because neither you nor him are in the system’ by a secretary at the local psychiatric hospital, I eventually managed to get him a prescription for antidepressants from a general practitioner and a referral to a psychologist.

While in London, an artist friend of mine, Raymond Westraadt, sent me a photograph of a painting he was busy with and asked my opinion as to the symbolism I saw in the painting. Given my personal experience at the time, as well as the fact that I am a public service psychiatrist, I was immediately struck by how effectively he had captured the powerlessness, pain and challenges a mental healthcare user faces.

The dilapidated wheelchair symbolising helplessness and negligence. The steel structures protruding from a wall looking eerily like gallows and an invitation for suicide. The political poster with its empty promise of ‘working together we can do more’. Seeing the early stages of the painting and the emotions it evoked, I immediately agreed to buy the painting.

Shortly after Raymond learnt of the crisis in Gauteng regarding the death of 94 mental health care users, he posted the following on his Facebook wall: ‘Little did I know of the impending crisis that was looming when I painted this image. I am now nauseated and disturbed as I follow the unfolding tragedy of the 94 mentally ill patients who died at the hands of the Gauteng Department of Health. DISGUSTED!!’.

I know that all of us in the psychiatric fraternity in South Africa (SA) are appalled by what happened in Gauteng, and our thoughts are with the families of the deceased patients, as well as with our colleagues there who had to deal with the aftermath of this disaster.

The National Mental Health Policy Framework and Strategic Plan 2013 - 2020 contains a wonderful picture of what our mental health services could look like, and yet, in the province I work in, I am desperately worried that not only are we nowhere near implementing this plan, we are in fact regressing evermore into a state of defectiveness. I cannot help but think our local services are heading towards a similar disaster to the one in Gauteng.

We, as public service psychiatrists, can do so much more, but our hands are tied by cutbacks and bureaucracy and empty promises.

It would appear that, inasmuch as our mental healthcare users are facing challenges in South Africa, in my experience it is not much

better in the UK. Paying lip-service to what can be achieved together by politicians, regardless of their affiliation to a specific political party, seems to be the case elsewhere in the world as well, while those with mental illness continue to suffer.

I sincerely hope that the over 100 deaths will not be in vain, and that one day we will look back and say that that was the year that politicians in South Africa started taking the plight of the mentally ill seriously.

PS: The author obtained permission from both his brother as well as the artist prior to publication.

C Grobler Head, Clinical Unit, Elizabeth Donkin Hospital, Port Elizabeth, Eastern Cape, South Africa; Associate Professor, Walter Sisulu University, Mthatha, Eastern Cape, South Africa; and Research Associate, Nelson Mandela University, Port Elizabeth, Eastern Cape, South Africa. dr.stof@mweb.co.za

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ARTICLE

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

Liver transplantation for non-resectable colorectal liver metastases at a single centre in South Africa: A report of the ethics and regulatory approval process H R Etheredge,1 MSc Med, PhD; J Botha,2 MB BCh, FCS; P Cleaton-Jones,3 MB BCh, PhD, DSc, FCD Wits Donald Gordon Medical Centre, and Wits Human Research Ethics Committee (Medical), University of the Witwatersrand, Johannesburg, South Africa 2 Transplant Programme, Wits Donald Gordon Medical Centre, and Department of Surgery, University of the Witwatersrand, Johannesburg, South Africa 3 Steve Biko Centre for Bioethics, and Wits Human Research Ethics Committee (Medical), University of the Witwatersrand, Johannesburg, South Africa 1

Corresponding author: H Etheredge (harriet.etheredge@mediclinic.co.za)

Non-resectable colorectal liver metastases (CLMs) are generally considered an absolute contraindication for liver transplantation. However, a 2013 Norwegian study transplanted livers in 21 patients with CLMs and reported excellent outcomes. The current article reports on the deliberations of the Wits Human Research Ethics Committee (Medical), which resulted in approval of the first liver transplant for a patient with CLMs in South Africa (SA). Factors considered included the scarcity of donor organs in SA, weighing the best interests of different groups of patients and the requirement for extensive and careful information provision. Originally under the auspices of Section 37 of the World Medical Association Declaration of Helsinki (2013), the protocol has now been formalised as a research project.

S Afr J Bioethics Law 2017;10(1):5-7. DOI:10.7196/SAJBL.2017.v10i1.534

Non-resectable colorectal liver metastases (CLMs) are generally considered an absolute contraindication for liver transplantation, because of poor outcomes reported during the 1990s.[1] However, a 2013 Norwegian pilot study by Hagness et al.[1] transplanted livers in 21 patients with non-resectable CLMs, and reported excellent oncological outcome and a 60% 5-year survival. This result far exceeds that which is obtained with chemotherapy.[1] Although a promising development, consensus is that larger studies with longer follow-up times, in different cohorts, are needed to validate the results and to support CLMs as an indication for liver transplant, or not.[2] In South Africa (SA), an upper-middle income country (UMIC),[3] a relatively small number of organ transplants are performed annually. In recent years, teams of committed academic surgeons and physicians have developed, or adopted, new transplant techniques, in a bid to extend this treatment to a larger number of patients.

However, the supply of donor organs in SA falls far short of the demand for them. Wits Donald Gordon Medical Centre (WDGMC) is a tertiary academic hospital in Johannesburg, and is one of three hospitals in SA offering liver transplantation. As it falls within the University of the Witwatersrand (Wits) hospital complex, all research taking place at WDGMC requires approval from the Wits Human Research Ethics Committee (Medical) (HREC(M)).

This article reports on the deliberations of the Wits HREC(M) that eventually led to the approval of a research project to transplant, and prospectively follow-up, patients presenting with CLMs at WDGMC. To date, to the best of our knowledge, Columbia is the only other UMIC that has performed a transplant on a patient presenting with CLMs.[4] Both the Norwegian and Columbian articles recorded ethics committee approvals, but no details were mentioned.[1,4]

Given that a number of other UMICs, including Belarus, Brazil, China, Iran and Romania host liver transplant programmes, it is foreseeable that they may consider similar research. We hope that this article may be useful for HRECs at other SA transplant centres and in UMICs that are similar to SA, where transplant indications and outcomes may differ from those in high-income countries.

The case In early 2015, we were approached by Patient A, a well-informed medical doctor diagnosed with non-resectable CLMs. Patient A, who had searched the internet for information, requested consideration for liver transplantation, based on the outcome of Hagness et al.[1] and because he fitted the inclusion criteria. The WDGMC Clinical Research Office advised the transplant team, and forwarded an application to undertake the liver transplant as a case study to the HREC(M).

The request was urgent as Patient A required transplant work-up, so the matter was debated by the four co-chairs of the HREC(M), in collaboration with the WDGMC team. All decisions were subsequently ratified by the full HREC(M) (ref. nos. M150362 and M151037). The application was made under section 37 of the 2013 Declaration of Helsinki.[5] This has been the basis for a number of international studies proposing to use new or non-indicated modalities in patients who have exhausted conventional management options, and states: ‘In the treatment of an individual patient, where proven interventions do not exist or other known interventions have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorised representative, may use an unproven intervention if in the physician's judgement it offers hope of saving life, re-establishing health or alleviating

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ARTICLE suffering. This intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information must be recorded and, where appropriate, made publicly available.’[5] The HREC(M) felt that these terms were sufficient for approving the case, with the condition that the principal investigator report back and formalise the intervention as a research study, if applicable. In making this decision, several points of ethics were deliberated.

Scarcity of donor organs in SA Studies using scarce resources (such as donor livers) to treat a condition for which such management is not yet indicated pose unique ethical challenges. Hagness et al.[1] justified their study based on a surplus of donor livers in Norway. In SA, the ethical challenges are heightened, as the supply of donor organs falls short of the demand for them. Donor organs are usually allocated to listed individuals on the basis of need (‘sickest person first’ principles), and depending on the size of graft required and blood group compatibility.

Because the waiting list for liver transplants in SA is relatively short, the HREC(M) concluded that it would be ethically sound to allocate a marginal (expanded criteria) graft – which had been refused by all other centres countrywide – to Patient A. A marginal graft would not usually be suitable for implantation, owing to factors such as markedly elevated liver function tests, older age or HIV-positive status of the donor or excessive macrosteatosis on hepatic biopsy.

This decision may have been different if the liver waiting list was much longer, with other patients who could have benefitted from a marginal graft – as is often the case with patients who require kidney transplantation.

There was no comparable precedent from other UMICs for the decision to allow a marginal graft for Patient A at the time. In the more recent case of a liver transplant for CLMs in Columbia, it is unclear whether the graft was marginal (the publication states only that the graft was from a 22-year-old male in cold ischaemia for 7.5 hours). It is possible that the Columbian centre had a surplus of donor livers.[4] Until the procedure is validated by further research, it seems that offering patients with CLMs marginal grafts is the only ethical solution in the SA context of organ scarcity.

also a consideration for informed consent. Nonetheless, as per SA ethics guidelines,[6] HREC(M) stipulated that Patient A should be fully informed of the potential risks involved in receiving a marginal graft, and their consequences.

Questions of cost Identifying who will bear the financial costs of clinical research is essential for HRECs. SA ethics regulations stipulate that no research costs should be incurred by a participating institution.[6] Liver trans­ plantation is very expensive, and the HREC agreed that either Patient A’s medical scheme should fund the transplant on an ad hoc basis, or the patient would need to pay his own medical expenses. In the latter case, the HREC stipulated that Patient A must be notified of all potential costs, in order to make an informed decision. Ultimately, the research procedure was authorised by the medical scheme.

Brief concluding remarks and study progress Patient A received a transplant from a 75-year-old donor in August 2015. Based on encouraging short-term findings, a submission was made to the HREC(M) to formalise the protocol as a research study, and the request was approved. Recruitment for the study is ongoing, and the study process is illustrated in Fig. 1.

The mandates to further evidence-based medicine (EBM) on the one hand, and protect research participants on the other, can present HRECs with something of a catch 22 – exemplified by this case. EBM is constantly evolving, as studies identify superior treatment modalities; however, these studies may often seem precipitous at the outset, with too many risks to participants. Nonetheless, it is essential that they take place in order for EBM to evolve. This may require difficult decisions, which are not always widely acceptable. There are a

Referral to PI. PI will determine if you meet the criteria to be a part of the study

Standard of care management with chemo

Patients already listed for liver transplants A number of patients with recognised indications are waiting for liver transplants at any given time. Because liver transplantation is not accepted for CLMs, it was essential that these patients were not disadvantaged by the decision to perform the transplant on Patient A. Recognising the imperative to balance the best interests of listed patients with the best interests of Patient A, the HREC(M) stipulated that Patient A may receive a donor liver only if there was no other suitable recipient for the graft, countrywide. This decision effectively meant that irrespective of model for end-stage liver disease (MELD) score or urgency, Patient A would not be prioritised for transplant.

Eligible

Not eligible

Referred for standard transplant work-up

Not eligible for transplant

Application to medical aid for funding

Standard of care management with chemo Funding not approved

Standard of care management with chemo

Eligible for transplant

Funding approved Listed for transplant and enrolled onto study

Patient undertakes to pay for transplant and subsequent immunosuppression Funding secured

Transplanted

Listed for transplant and enrolled onto study

Risks and benefits to the patient Careful analysis concluded that for Patient A, the anticipated benefits of transplant (prolonged life, possibly by several years) categorically outweighed the concomitant risks (contracting HIV, life-long medication, rejection). The fact that Patient A was a medical doctor and perhaps better able to appreciate the extent of the risk was

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Not transplanted Standard of care management with chemo

Fig. 1. Study process.

Transplanted

Post-transplant care and research follow-up visits

ARTICLE number of examples of evolving EBM in liver transplant research. Studies of transplant patients with CLMs may follow the same pattern, and should be judiciously encouraged. Primary hepatocellular carcinoma is now considered an indication for liver transplant because of improved screening and the development of standardised criteria (Milan) that have facilitated better outcomes. The same goes for cholangiocarcinoma, with ~65% of patients recurrence-free after 5 years, having undergone improved neoadjuvant therapy followed by liver transplant.[2] For additional references, please contact the corresponding author.

1. Hagness M, Foss A, Line P-D, et al. Liver transplantation for nonresectable liver metastases from colorectal cancer. Ann Surg 2013;257(5):800-806. http://dx.doi. org/10.1097/SLA.0b013e3182823957

2. Martins PNA, Movahedi B, Bozorgzadeh A. Liver transplantation for unresectable colorectal cancer liver metastases: A paradigm change? Ann Surg 2015;62(1):e12. http://dx.doi.org/10.1097/SLA.0000000000000483 3. The World Bank. World Bank Country and Lending Groups. 2016. Washington DC: World Bank, 2017. https://datahelpdesk.worldbank.org/knowledgebase/ articles/906519-world-bank-country-and-lending-groups (accessed 3 March 2017).

4. Caicedo L, Buitrago D. Thomas L, et al. Liver transplantation for unresectable metastases from colon adenocarcinoma. Case Rep Gastroenterol 2017;10(3):808813. http://dx.doi.org/10.1159/000454984 5. World Medical Association. WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects 2013. Geneva: WMA, 2013. http:// www.wma.net/en/30publications/10policies/b3/ (accessed 3 March 2017).

6. National Department of Health, Republic of South Africa. Ethics in Health Research – Principles, Processes and Structures, 2nd ed. Pretoria: National Health Research Ethics Committee. http://www.nhrec.org.za/docs/Documents/ EthicsHealthResearchFinalAused.pdf (accessed 3 March 2017).

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ARTICLE

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

The intellectual challenge of doing bioethics in South Africa A Egan, BA Hons, MA, MDiv, STL, PhD Steve Biko Centre for Bioethics, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa Corresponding author: A Egan (anthegan2@gmail.com)

Contemporary bioethics is a complex and multidisciplinary combination of medicine, philosophy and law, made more difficult because few, if any, bioethicists are masters of all three disciplines. To further complicate matters, each discipline contains specialised subdisciplines and internal debates. Philosophy is used to illustrate this point. Given constraints of expertise on practising bioethicists in South Africa, a few modest proposals are suggested to make bioethics as a discipline more rigorous in its use of medicine, philosophy and law.

S Afr J Bioethics Law 2017;10(1):8-10. DOI:10.7196/SAJBL.2017.v10i1.535

How do we make medical moral judgments as practising bioethicists?

Do we simply follow the prescriptions of law and professional codes of practice; do we start with the best available medical knowledge and act accordingly; or do we ask in the light of law and science what is the right thing to do? Our starting point tells us a lot about who we are as bioethicists. It may also highlight the problems facing the teaching, learning and practice of the discipline today.

Although bioethics is now a compulsory component of South African (SA) medical education, having previously been something of a ‘Cinderella’ subject in most faculties in the past, it is by no means clear that students, professors and professionals in healthcare know what to make of it, or indeed how to do it. This is at least in part due to the nature of bioethics’ necessarily complex mixture of philosophy, law and medicine – each of them disciplines that require years of study for mastery, and each of which is subject to its own internal debate.

Most working bioethicists enter the field through one of these three disciplines. Although they acquire knowledge of the others, how they do bioethics will reflect their starting point. However, a philosopher will gain a working knowledge of medical law and the basics of medicine in order to be effective. Similarly, a lawyer will need to acquire broader skills in philosophy as well as jurisprudence and basic medicine. And a healthcare professional will need more legal knowledge than medical law, and to develop a solid grounding in philosophy. (Those who come from outside these fields – sociology, history or theology, for example – will have to do comprehensive study in all three to get on board.)

To further complicate things, within each core discipline there are many different approaches to the subject that sometimes compete and sometimes complement each other. Legal theory (jurisprudence) is often split between an approach that emphasises interpretation and application of laws, and a profound scepticism about the hidden or not-so-hidden interests and ideologies behind a given law. Health science education, too, has hidden curricula: claims of empirical, observable truth following a scientific experimental method combined with a realisation, at least since Thomas Kuhn,[1] that intuitions can result in paradigm shifts; and certain ideological worldviews about the nature of care (prevention or cure) and access

to it (public or private health). Philosophy is even more complex, and to illustrate my general point let me try, through a (necessarily) simplified history, to illustrate the point I am making in detail.

Philosophy is an intellectual family of subjects – epistemology, metaphysics, logic, politics, mind and ethics, to name a few – bound together by reason. Done properly, they interlink with each other: you cannot really reflect ethically unless you have a clear understanding of the nature of ethics (metaphysics) and how you know something is right (epistemology), based upon a coherent argument (logic). To further complicate matters, philosophising is often done – since the 19th century at least – within two broad traditions that have, until recently, barely spoken to each other: the analytic and continental schools.

This split between the traditions emerged out of a response to Kant’s theory of knowledge. Kant[2] (1724 - 1804) held that some things can be known by our experience of them (the phenomenal) while others cannot: they can be known only in themselves (the noumenal). Hegel (1770 - 1831)[3] denied the distinction, arguing that both subsisted within what he called the Ideal. While Hegelian thought in various forms dominated European philosophy (and often applied in theology) until the early 20th century, it was challenged from a variety of perspectives.

In Denmark, Kierkegaard[4] (1813 - 1855), a Lutheran theologian at odds with a Church he considered too conformist to his society, objected to Hegel’s claim that thought could be objective, insisting that truth was subjective – the truth of a fact (for example, a Christian doctrine) lies in one living it out, not simply in its logical coherence or reference to reality. Similarly, the German Nietzsche[5] (1844 - 1900) reacted against any Hegelian application of the Idea to religion (and against religion in general), and developed his own subjective theory of self-mastery (the Ubermensch). These ideologically divergent thinkers would form the basis for the 20th-century existentialism of thinkers as varied as Heidegger, Jaspers, Sartre and Camus.[6] Together with phenomenology, drawn as the word implies at least in part from Kant’s idea of the phenomena, it would be a major component of continental philosophy,[7] which would expand to include the postmodern thinking of philosophers such as Derrida and Foucault.

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ARTICLE Continental philosophy’s interests generally lay – lie – within the ‘big picture’: movements of history, the working of institutions, the nature of religion and belief, literature and ethics. Its breadth of scope often leads it into dialogue with other disciplines: history, sociology, theology, literature and art. Critics may well object that it is in fact these disciplines and not philosophy. (I remember a philosopher in London objecting bitterly to Kierkegaard being taught as a philosophy elective: ‘He’s a bloody theologian!’ he snorted.)

These critics usually come from the analytical philosophical tradition,[8] which emerged as another revolt against Hegel in the early 20th century, mainly at the universities of Cambridge and Vienna. Rejecting the possibility of Kant’s noumenal and Hegel’s synthesis, they insisted on an epistemology based on the truth of evidence. Central to this, and played out in various ways, was the emphasis on truth claims referring to what can be objectively discovered. Since what many analytical philosophers prized above all was evidence, there was a tendency to look into the finer details of things, drawing heavily on logic and philosophy of language to establish verifiable truths.

Quite quickly these philosophical traditions took on geographical associations: while continental thought dominated mainland Europe and Latin America, analytical philosophy had as its base Britain (and by extension universities in the British ‘Empire’) and North America.

This distinction is somewhat muddied by the existence of a more continental tradition in religiously founded universities, notably Catholic universities and seminaries, where, since the Middle Ages, philosophy has been integrated into the study of theology.

Within SA, faculties at historically English-speaking universities usually work within the analytical school, while Afrikaans universities more often lean towards the continental.[9] These differences, despite a current tendency to greater dialogue between them, and growing integration of philosophers in them working together in the same departments, affect how philosophers approach questions of bioethics.

This is within what we call the Western tradition that has dominated academia during the centuries of European-North American global power. Beyond this we see a range of Eastern philosophies that have persisted for centuries, and now vibrant traditions emerging from Africa. These too are gaining traction in SA. What does this mean for bioethics in SA today? Firstly, it is clear that bioethicists coming to the field primarily from philosophy are probably coming in with one or other of the dominant Western philosophical traditions. This all-too-brief account of them shows that differences in content and method exist, and have an effect on the conclusions bioethicists make. There is nothing wrong in that: divergent opinions are the lifeblood of academic discourse. Agreeing to disagree is a sign of maturity and a careful corrective to mental rigidity.

But, secondly, what is important is to note how this affects bio­ ethicists from other primary disciplines. Those whose fields emphasise objectivity, empirical data and ‘facts’ may be frustrated by such divergent opinions – particularly those emanating from people of the continental tradition. Similarly, those whose primary interest is to know what the law commands may question the point of such speculation – until of course there arises a need to change laws. At the very least, thirdly, we may find ourselves talking at cross-purposes.

There is an even deeper risk: superficiality. The great English

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philosopher of history, Collingwood,[10] (1889 - 1943), warned against what he called ‘scissors and paste’ history. By this he meant ‘excerpting and combining the testimonies of different authorities’, having already concluded what one wanted to know about a subject. The mere act of cobbling together bits of ‘evidence’ (I suppose in the age of computers we might more accurately call the process ‘cut and paste’), without asking the underlying question why?, often results in at best a narrative, at worst a half-baked bricolage of statements.

As a historian I agree with Collingwood that such a method is unsatisfactory; it is equally unhelpful in bioethics.

How many of us, I wonder, haven’t come across student essays or even academic papers that are little more than a string of quotes and a conclusion? One sees citations of laws (‘The National Health Act says … so …’), sweeping appeals to ethical theory (‘From the theory of deontology, it seems … so … ) or to principles (‘The principle of autonomy says … so … ) or claims based on medical evidence (‘From the medical fact that … so … ). My instinctive response to such statements is often, “So … what?” Without careful engagement with law – whether taking the cited law as a starting point and then either working through its possible application, if not also engaging in the background, intentions and ideological assumptions behind law that are central to critical legal theory – the conclusion is usually shallow. Without insight into the origins, internal controversies and critiques of a philosophical theory, its application is too easily facile (and certainly unsatisfactory to any professional philosopher). And without accepting that most medicine is based on best currently available evidence, often subject to ongoing and further experimental research, informed at times by paradigm shifts in thinking, one might come across as having a fixed understanding of science. A contemporary medical practitioner whose thought is rooted in Aristotelian biology would be laughed out of court by peers – and considered dangerous to patients.

At bottom, it is a question of academic rigour. The problem I have illustrated above reminds me of trying to hold water in leaky buckets.

One can of course arrange one bucket within another (and so on, theoretically ad infinitum) in a sequence such that water runs out more slowly. It is conceivable that one might even manage, through careful arrangement, to minimise leakage, but the leak will remain.

Does this mean that any ethical reflection – where law is subject to development or change, medical knowledge is constantly evolving and philosophy is almost by definition a constantly evolving set of arguments – is impossible?

I don’t think so. The classical-medieval philosophical and theological idea of probabilism offers us a way forward here.[11-13] Essentially a guide to making a moral judgment when conflicting strong arguments coexisted, probabilism describes a continuum of moral reasoning – from laxism at one extreme to tutiorism at the other. Laxism effectively suggests that one could act so long as one had a reason (however thin); tutiorism holds that one should always take the morally ‘safest’ side, usually identified with positions of the highest authorities (which in medieval terms meant popes and councils of the Catholic Church). Neither extreme position is intellectually satisfactory, but in-between the extremes there are positions that offered (and offer) a fruitful approach. Probabiliorism (from the Latin, ‘more likely’) argues that one should adopt a position that had a preponderance of evidence on its side. Equiprobabilism, occupying the centre of the continuum, argues that all things being

ARTICLE equal, one could take a less safe option if it was as good as, or very close to, the safe option. While some might see all this as medieval hair-splitting, what it offers makes sense to ethicists who admit that, in the light of limited knowledge of law, medicine and philosophy, the best we can do is to present provisional moral arguments as coherently as possible, while having the epistemological humility to recognise that we may not have solved a problem for all time: we’ve arranged our buckets together in such a way that we have minimised the leaks.

Such sophistication and epistemological humility is vital for the further growth of SA bioethics as both an academic discipline and as a practice in healthcare. But, as I have argued, the level of complexity of its components makes the goal difficult to attain, particularly when they are not the sole focus of its practitioners.

What, then, can be done?

Broader and deeper education for bioethicists is obviously needed. Specialised programmes of study (such as the University of the Witwatersrand MSc in Bioethics and Law, for example) are a good start, although even here there may need to be a more expanded curriculum. What may be needed is more jurisprudence, so that bioethicists understand the nature of law more fully, in addition to the specifics of medical law; some introduction to the different forms of philosophy, particularly differing epistemologies, in addition to ethics; and even perhaps some philosophy of science and the scientific method.

Given the limits – time, resources, costs, etc. – of any formal programme, and given that many practising bioethicists may not

even be able to engage in further specialised studies, the least we can perhaps hope for is ongoing personal study in the areas I have mentioned above. To make this easier, more systematic and less lonely, one possibility is setting up informal cross-disciplinary reading groups for bioethicists.

While this may seem a nuisance, I think it may be necessary.

Bioethics is more than intellectual speculation. At bottom, it’s often about people’s lives.

1. Kuhn T. The Structure of Scientific Revolutions. Chicago: University of Chicago Press, 1962.

2. Kant I. Critique of Pure Reason. Cambridge: Cambridge University Press, 1999.

3. Hegel GWF. Phenomenology of Spirit. Oxford: Oxford University Press, 1977.

4. Kierkegaard SA. Concluding Unscientific Postscript to Philosophical Fragments.

Princeton, NJ: Princeton University Press, 1992.

5. Nietzsche FW. Thus Spake Zarathustra [1883]. London: Penguin: 2003.

6. Crowell S. (ed.). The Cambridge Companion to Existentialism. Cambridge: Cambridge University Press, 2012.

7. Kearney R. Continental Philosophy in the 20th Century. London & New York: Routledge, 2012.

8. Schwartz SP. A Brief History of Analytic Philosophy: From Russell to Rawls.

Hoboken, NJ: Wiley-Blackwell, 2013.

9. Millar S, MacDonald I. The Role of Philosophy in South Africa. New York: Berghahn Books, 1989.

10. Collingwood RG. The Idea of History (revised edition). Oxford: Oxford University Press, 1994.

11. Franklin J. The Science of Conjecture: Evidence and Probability before Pascal.

Baltimore: Johns Hopkins University Press, 2001.

12. Maryks RA. Saint Cicero and the Jesuits: The Influence of the Liberal Arts on the Adoption of Moral Probabilism. London & New York: Routledge, 2008.

13. Schüssler R. On the anatomy of probabilism. In: Kraye J and Saarinen R, eds. Moral Philosophy on the Threshold of Modernity. Dordrecht: Springer, 2005:91-113.

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

ARTICLE

Incentives for HIV testing at the workplace in the auto­ motive industry in the Nelson Mandela Bay Municipality: Ethical considerations M Weihs,1 PhD; A Meyer-Weitz,2 PhD; F Baasner-Weihs,3 MPhil Social Aspects of HIV/AIDS Research Alliance (SAHARA) and HIV/AIDS, Sexually Transmitted Infections and TB (HAST), Human Sciences Research Council (HSRC), Port Elizabeth, South Africa 2 Discipline of Psychology, School of Applied Human Sciences, University of KwaZulu-Natal, Durban, South Africa 3 HIV and AIDS Research Unit, Department of Research and Engagement, Nelson Mandela Metropolitan University, Port Elizabeth, South Africa

1

Corresponding author: Martin Weihs (martin.weihs1@gmail.com)

Comprehensive HIV and AIDS workplace programmes made use of substantial lottery incentives in HIV counselling and testing drives to promote HIV testing at four companies in the automotive industry in the Nelson Mandela Bay Municipality. The main aim was to use lottery incentives to increase uptake for HIV testing. This would help to define company HIV prevalence and ensure timely support, care and treatment of employees. In total, 1 324 employees, making up about 90% of the total staff, were tested for HIV in the four companies during wellness testing days. In order to gain an understanding of employees’ experiences of the lotteries as part of the HIV counselling and testing drive, quantitative data were collected among a total of 414 employees, and 17 interviews were conducted in the four companies. In this article, we investigate the issue of whether the lotteries unduly influenced the employees’ participation in workplace HIV testing, and an approach to resolving an identified ethical dilemma is presented. The ethical question as to whether lottery incentives contribute to undue coercion was explored using both a utilitarian and a deontological approach. The analysis concluded that the use of lotteries to encourage HIV testing in the workplaces of the automotive industry in the Nelson Mandela Bay Municipality can be deemed morally acceptable.

S Afr J Bioethics Law 2017;10(1):11-14. DOI:10.7196/SAJBL.2017.v10i1.531

Globally, 90% of people living with HIV are in the most productive period of their lives, be they workers, managers or employers.[1,2] Health management of employees is therefore a common imperative for companies that do business in regions where HIV impacts employees and communities.[3] No accurate estimates exist about the extent of the current HIV prevalence within the South African (SA) workforce, but the Health and Sciences Research Council (HSRC) has estimated that 6.4 million people were living with HIV in 2012 in SA, and that only 44.8% were aware of their HIV status.[4] Therefore, it can be assumed that many of those currently infected are not yet seeking treatment. Private-sector HIV/AIDS workplace programmes (WPPs) in SA have evolved considerably,[5] and by encouraging HIV counselling and testing (HCT) in the workplace, companies can define their HIV prevalence rate more accurately. This is a prerequisite for efficient and effective HIV and AIDS management[6] aimed at helping to diminish morbidity and mortality.[7] Furthermore, this also allows for the support of the National Health Promotion Policy and Strategy of 2015 - 2019,[8] and the National Strategic Plan on HIV, STIs (sexually transmitted infections) and TB (tuberculosis) 2012 - 2016, that together aimed for 80% of adults in SA to know their HIV status by the year 2016.[9]

Lotteries to encourage HIV testing in the workplace as part of HIV/AIDS workplace programmes During a project run by the Deutsche Gesellschaft für Internationale Zusammenarbeit (GIZ) GmbH and the Automotive Industry Develop­

ment Centre Eastern Cape (AIDC EC) from 2008 to 2016, several suppliers of the automotive industry based in the Nelson Mandela Bay Municipality have benefitted from support with the implementation of comprehensive HIV and AIDS WPPs. One of the main AIDC EC-GIZ project key performance indicators of these HIV and AIDS WPPs was the workplace HCT uptake rate in the companies at the end of the 1-year WPP implementation process. Inspired by companies that seemed to have successfully made use of lottery incentives[10] in order to increase workplace HCT uptake, the project team looked at using lotteries to motivate employees to test for HIV in the workplace.

However, there was a lack of evidence on how these lotteries influenced employees’ decisions to test for HIV, and the suggestion of offering such incentives sparked off controversial discussions within the project team. Therefore, a study was conducted to accompany this project in order to obtain evidence on how lottery incentives influence employees’ HIV workplace testing behaviour.

In all four companies that participated in the study, comprehensive HIV/AIDS WPPs of the same standard had been implemented independently. Employees had participated in at least 5 months of workplace HIV/AIDS interventions that included, for example, the development of HIV/AIDS policies and activities in order to educate workers about HIV prevention, treatment and care. A post-test only quasi-experimental, explanatory, mixed-methods approach was adopted in which quantitative data for the experimental studies were first collected at the four companies, followed by qualitative studies conducted in the same companies in order to gain a deeper

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ARTICLE understanding of employees’ lottery experiences as part of the HCT drive. Quantitative data were collected among a total of 414 shopfloor workers in the four companies on the same day that the HCT drive dates and the lotteries’ incentives were announced to staff.

In-depth interviews were conducted about 2 weeks after the HCT drive events at the same companies. Seventeen shop-floor workers who had been exposed to the lottery incentives were interviewed, irrespective of whether they had sought HIV testing or not. Leaflets, posters and peer-education sessions were used to make all workers aware of the fact that HCT and three other health tests (body mass index, blood pressure and blood sugar level) would be offered at no cost during the HCT drives, during worktime. For more information about the methodology of the quantitative and qualitative studies, see the respective publications.[11-13] In total, 1 324 employees were tested for HIV in the four companies during the HCT drives, making up about 90% of the total staff. This can be seen as a higher-thanaverage HIV workplace testing rate.[1,3,15,16]

Ethical concerns around lotteries for HIV testing in the workplace Fulfilling the entry requirements for the lottery made employees eligible to win gift cards of considerable value (first prize R2 000, second prize R500, and 10 extra R100 prizes). In addition, they each received a t-shirt. The first prize amounted to nearly half a month’s normal wage for a participant (shop-floor workers in the four companies earned on average ~ZAR5 000 per month).

A first concern is that lottery incentives may undermine the moral values that form an important foundation of our open society, as discussed in an article by Cameron and Van der Merwe.[16] However, the results of our study showed that the announcement of lotteries made shop-floor workers develop a stronger intention to participate in workplace HIV testing, through anticipation of stronger social support and encouragement from partners, friends and colleagues.

Therefore, participation in HCT did not seem to hinge only on the likelihood of winning a prize.[13] A further concern was that offering lotteries with substantial prizes to encourage participation in workplace HIV testing raises the question of whether such incentives put undue pressure on employees to volunteer for testing. Lotteries have been found to improve participation in desirable, healthy behaviours, particularly among staff with lower levels of income:[18] it seems, therefore, that lottery approaches may be a particularly useful way to encourage higher rates of engagement in health- and wellness-focused behaviour among lower-income employees. However, employees’ freedom of choice can be curtailed or manipulated by lottery incentives, and participants can be coerced in this way to participate in HIV testing at the workplace. Lotteries have been described as ‘coercive’, as they can be seen as putting undue pressure on people to participate in HIV testing.[17] This may be especially so in the case of a person in desperate need of extra financial income.

Resolving the ethical dilemma around lotteries for HIV testing in the workplace The ethical dilemma stemming from the use of lottery incentives to encourage workplace HIV testing participation can be described from the perspectives of both the employers and their employees.

Organisations may see the lotteries as an effective means of persuading

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employees to participate in workplace HCT. Some studies and grey literature suggest that when lottery incentives were offered to employees, the workplace HIV-testing intention significantly improved,[11] or HIV-testing behaviour increased.[3,10] This suggests that some employees would probably not participate in workplace HCT if lottery incentives were not offered. Therefore, making use of lotteries allows the company to capture more reliable and muchneeded data about their company’s HIV prevalence rates, as more employees are ready to test. But from the employee point of view, some might test HIV-positive and have to bear major emotional distress, and possibly encounter stigma and discrimination.

Therefore, the lotteries might indirectly have pushed them into a situation for which they are not ready. Not making use of lotteries might protect these employees from this level of distress, but companies then might not be able to ensure that all employees know their status, nor would they be able to determine a reliable measure of their workforce’s HIV prevalence.

This problem shows the characteristics of an ethical dilemma,[19] as there are two similarly convincing obligations. Firstly, managers have an obligation to make sure that their company stays globally competitive, and this, therefore, requires the collection of adequate and reliable data for the reduction of the HIV and AIDS impact on employees and the company. Secondly, companies are obliged to offer necessary conditions for all their employees to be in a position to make autonomous decisions relating to HIV testing and test outcomes. In short, management has the moral duty to protect employees and the company from the impact of HIV and AIDS, but it is also morally obliged to respect employees’ autonomy in decisionmaking regarding HIV testing. The answer to whether or not to use lottery incentives for workplace HCT is therefore not at all clear cut.

There are numerous approaches to resolving apparent ethical dilemmas. We examine the options from two perspectives: firstly, the utilitarian approach, a form of consequentialism whereby the consequences of a behaviour are analysed in order to ascertain whether it can be judged as being wrong or right; and secondly, the deontological approach, which looks at the moral content of the behaviour itself rather than at its outcomes.

Results from the quantitative data suggest that the announcement of lotteries made shop-floor workers develop a stronger intention to participate in workplace HIV testing, through anticipation of stronger social support and encouragement from partners, friends, colleagues and the company, rather than by attracting them to HIV testing solely to win a prize.[13] Fig. 1 shows in a simplified way how the theory of planned behaviour (TPB) used in our study as a framework for predicting intended use of HCT in the workplace helped to highlight how far the lottery incentives influenced workers’ behaviour intention to participate in workplace HCT.[11] These findings are in line with several studies that have shown that the relationship between incentives and targeted behaviour can go beyond the limits of such incentives’ economic effects.[21-24] The qualitative data collected in the four companies revealed that the introduction of the lotteries renewed employees’ personal interest in HCT. The excitement created by the lottery incentives facilitated social interactions and seemed to mitigate the burden of HIV stigma, both in the workplace and at home. The following quotes show how the lottery incentives facilitated open communication about HCT in the workplace and at home:

ARTICLE

Value towards HCT behaviour Fear towards HCT behaviour Perceived affect towards HCT behaviour (attitude)

Incentives

Perceived subjective norm towards HCT behaviour*

HCT behaviour intention*

Perceived behavioural control towards HCT behaviour (self-efficacy)

*

Significant increase due to experimental intervention Significant predictor of behaviour intention Non-significant predictor of behaviour intention

Fig. 1. TPB for workplace HCT with incentives, experimental group, setting 1.[11,20] ‘ Because as I said, most, most of us, most of us, were really afraid, you know, the stigma that is involved – because you hear what people have to say about it, you know, there’re many myths about this thing and stuff like that – but because of these prizes, you know, euhmmm ... like for me, I speak personally, I don’t know for the oth­er people, but really it did a big thing, ... in going for the testing.’

‘Yes exactly, you will and like people who’s going, you can even talk about it [work­place HCT], you can even ask, you can even like make some jokes, you know, about it, so it’s like, it’s more confident, like you are confident about this. It becomes easier, every day, every day, it is easier.’

‘She [the partner] did very much encourage me, she said go for it, do it.’

The following quotes illustrate how the HCT campaign, in the context of the lottery incentives, was transformed into a group ‘project’ where mutual encouragement and strong peer pressure to test played a role in the uptake of HCT: ‘Because if one person sees, boy there’s lots of people going, they gonna go.’

‘No, there was no one who exactly was pushing me. But, at first when I heard about this programme, no I was just OK I will see, but I wouldn’t go for testing, but as I see the majority of people go, coming in there, testing, coming out, excited, wonder­ful, they discuss it and all that stuff. I was like, hey, it’s like I was the only one who didn’t go for testing but, I wasn’t planning to go to do testing this year. I was plan­ning to do maybe ... like next year ... but I, I felt pressurised ... They didn’t say ... but I did go for testing.’

Therefore, following a utilitarian line of argument, the use of lotteries to encourage workplace HIV testing can be deemed morally justifiable, as it seems that the vast majority of the employees were

in favour of the lotteries, and that far more benefits than harm may stem from workplace HCT when lottery incentives are offered.[12] The above findings are in line with Cameron and Van der Merwe’s[16] findings that indicated that there was no detrimental issue with using lotteries to encourage HIV testing among students. The vast majority of the students surveyed were in favour of the lotteries. The thought of winning a prize was an encouragement, but students also felt they were able to act in their own best interest and did not feel they were being coerced in any way.[17] From a deontological perspective, autonomy is a first-order human right, enshrined in SA’s Constitution. If a person’s autonomy is to be respected, companies have to allow individuals to make decisions and to act upon them.[25] It can be argued that the offering of financial incentives to a person in desperate need could be seen as inherently exploitative and not consistent with the principle of autonomy.

Although HCT counsellors have to be specially trained to ensure that they are able to counsel people properly and enable employees to make autonomous decisions, the legitimacy of the written consent needed for HCT can be of concern when lottery incentives are involved. However, the use of lotteries can be found to be ethically correct when companies make sure that employees are in a position to make an autonomous choice, and that substantial risk of serious harm is prohibited.[26] To control the risk of serious harm, a deontologist would want to limit the use of lotteries to environments where individuals have been offered sufficient awareness opportunities and have been properly informed about the consequences of being tested HIV positive, and about their rights, as well as how to access treatment and care. This should be the case in companies where comprehensive HIV and AIDS workplace programmes are implemented as per the requirements of SA legislation.[27,28]

Conclusion The results show that the use of lotteries to encourage HIV testing in the workplaces of the automotive industry in the Nelson Mandela Bay Municipality can be deemed morally acceptable. There seems to be a small risk of the incentive influencing employees in financial need to participate in HIV testing, when they would not do so otherwise. The principle underpinning people’s rights may not be trampled on merely because one anticipates good results. This tenet cannot be put aside when one considers the situation of HIV- and AIDS-infected and -affected employees in SA. However, if incentives are used in companies that have implemented comprehensive HIV and AIDS WPPs, and if companies have ensured that counsellors are informed about the use of incentives, then employees should be in a position to make autonomous and beneficent choices. This – and the fact that participation in HCT did not seem to hinge only on the likelihood of winning a prize – sheds a positive light on lottery incentives as used in comprehensive HIV and AIDS WPPs’ HCT drives. Lotteries could help companies to fight HIV and AIDS more efficiently, and so be of benefit to all.

Acknowledgements. We are grateful to the companies and employees who participated in the study. We would also like to thank the AIDC EC, the GIZ GmbH and the HSRC for supporting the research.

1. South African Business Coalition on HIV/AIDS. HIV and Business Overview. South African Business Coalition on Health and AIDS. 2015. http://www.sabcoha.org/ hiv-business-overview/ (accessed 5 May 2015).

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ARTICLE 2. Setswe GKG. Best practice workplace HIV/AIDS programmes in South Africa: A review of case studies and lessons learned. Afr J Prim Health Care Fam Med 2009;1(1):1-6. http://dx.doi.org/10.4102/phcfm.v1i1.30 3. George G, Quinlan T. ‘Health management’ in the private sector in the context of HIV/AIDS: Progress and challenges faced by company programmes in South Africa. Sustain Dev 2009;17(1):19-29. http://dx.doi.org/10.1002/sd.366 4. Shisana O. HIV/AIDS in South Africa: At last the glass is half full. Plenary Session 3, 20 June 2013, 6th SA AIDS Conference, Durban. 2013. http://www.hsrc.ac.za/ en/media-briefs/hiv-aids-stis-and-tb/plenary-session-3-20-june-2013-hiv-aidsin-south-africa-at-last-the-glass-is-half-full (accessed 5 May 2015).

5. Global Business Coalition, International Finance Corporation. Fighting HIV/AIDS in the Workplace: A Company Management Guide. Global Business Coalition on HIV/ AIDS, Tuberculosis and Malaria (GBC) and the International Finance Corporation (IFC), 2010. http://www.businessfightsaids.org/report/2355/ (accessed 13 June 2015).

6. United Nations Programme on HIV and AIDS. The Private Sector Responds to the Epidemic: Debswana – A Global Benchmark. Geneva: Joint UNAIDS, 2002. http:// data.unaids.org/publications/irc-pub02/jc769-debswana_en.pdf (accessed 5 May 2015).

7. Lee R, Cui RR, Muessig KE, Thirumurthy H, Tucker JD. Incentivizing HIV/STI testing: A systematic review of the literature. AIDS Behav 2014;18(5):905-912. http:// dx.doi.org/10.1007/s10461-013-0588-8 8. Department of Health. The National Health Promotion Policy and Strategy 2015 - 2019. Pretoria: National Department of Health, 2014.

9. South African National AIDS Council. The National Strategic Plan (NSP) 2012 - 2016. Johannesburg: South African National AIDS Council, 2012. http:// sanac.org.za/resources/cat_view/2-nsp (accessed 29 October 2016).

10. Kaiser Health News. Wall Street Journal Examines Brewing Company SABMiller’s Campaign to Increase HIV Testing Among its South African Employees. KHN morning briefing. 2006. http://khn.org/morning-breakout/dr00039281/ (accessed 9 August 2015 ).

11. Weihs M. The influence of lottery incentives on workplace HIV testing in the automotive industry in the Nelson Mandela Bay Municipality. PhD thesis. Durban: University of KwaZulu-Natal, 2016.

12. Weihs M, Meyer-Weitz A. A lottery incentive system to facilitate dialogue and social support for workplace HIV counselling and testing: A qualitative inquiry.

SAHARA J 2014;11(1):116-125. http://dx.doi.org/10.1080/17290376.2014.937739 13. Weihs M, Meyer-Weitz A. Do employees participate in workplace HIV testing just to win a lottery prize? A quantitative study. South Afr J Hum Resour Manag 2016;14(1):1-8. http://dx.doi.org/10.4102/sajhrm.v14i1.722 14. Connelly P, Rosen S. Provision of antiretroviral therapy by the private sector. Lancet 2005;365(9475):1925-1926. http://dx.doi.org/10.1016/S0140-6736(05)66654-8

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15. George G. Workplace ART programmes: Why do companies invest in them and are they working? Afr J AIDS Res 2006;5(2):179-188. http://dx.doi. org/10.2989/16085900609490378 16. Cameron DA, Van der Merwe H. Are students being coerced into testing for HIV? Ethical considerations related to offering incentives for HIV counselling and testing at tertiary institutions in South Africa. S Afr J Bioeth Law 2012;5(2):95-97. http://dx.doi.org/10.7196/SAJBL.197 17. Haisley E, Volpp KG, Pellathy T, Loewenstein G. The impact of alternative incentive schemes on completion of health risk assessments. Am J Health Promot 2012;26(3):184-188. http://dx.doi.org/10.4278/ajhp.100729-ARB-257 18. Van Niekerk AA, Kopelman LM, eds. Ethics & AIDS in Africa: The Challenge to our Thinking. Cape Town: New Africa Books, 2005.

19. Ajzen I. The theory of planned behaviour. Organ Behav Hum Decis Process 1991;50(2):179-211. http://dx.doi.org/10.1080/17437199.2014.883474 20. Kane RL, Johnson PE, Town RJ, Butler M. A structured review of the effect of economic incentives on consumers’ preventive behaviour. Am J Prev Med 2004;27(4):327-352. http://dx.doi.org/10.1016/j.amepre.2004.07.002 21. Marcus AC, Crane LA, Kaplan CP, et al. Improving adherence to screening followup among women with abnormal Pap smears: Results from a large clinic-based trial of three intervention strategies. Med Care 1992;30(3):216-230. http://dx.doi. org/doi: 10.1097/00005650-199203000-00004 22. Melnikow J, Paliescheskey M, Stewart GK. Effect of a transportion incentive on compliance with the first prenatal appointment: A randomized trial. Obstet Gynecol 1997;89(6):1023-1027. http://dx.doi.org/10.1016/10.1016/S0029-7844(97)00147-6 23. World Bank. A cash transfer program reduces HIV infections among adolescent girls.

The World Bank Development Research Group. http://siteresources.worldbank. org/DEC/Resources/HIVExeSummary(Malawi).pdf (accessed 19 September 2015).

24. Botes A, Otto M. Ethical dilemmas related to the HIV-positive person in the work­place.

Nurs Ethics 2003;10(3):281-294. http://dx.doi.org/10.1191/0969733003ne606oa 25. Emanuel EJ. Ending concerns about undue inducement. J Law Med Ethics 2004;32(1):100-105. http://dx.doi.org/10.1111/j.1748-720X.2004.tb00453.x 26. Department of Labour. South African Code of Good Practice on HIV and AIDS and the World of Work in Employment Equity Act, No. 55 of 1998. Republic of South Africa: Department of Labour, 2012. http://www.labour.gov.za/DOL/downloads/legislation/ acts/employment-equity/hivaidstechnicalguide.pdf (accessed 5 May 2015).

27. Department of Labour. Technical Assistance Guidelines on HIV and AIDS and the World of Work. Pretoria: Department of Labour Republic of South Africa Chief Directorate of Communication, 2012. http://www.labour.gov.za/DOL/documents/ useful-documents/employment-equity/technical-assistance-guidelines-on-hivand-aids-and-the-world-of-work-2012 (accessed 23 June 2015).

ARTICLE

Routine referrals: A possible solution for transplantation shortages M Slabbert,1 BA (Hons) HED, B Proc, LLB, LLD; B Venter,2 LLB, LLM 1 2

Department of Jurisprudence, School of Law, University of South Africa, Pretoria Faculty of Law, Pearson Institute of Higher Education, Midrand, South Africa

Corresponding author: B Venter (bonnie.venter@pearson.com)

Transplantation is the only therapeutic option for terminal organ failure. The principle that donation should be a routine component of endof-life care is recognised in many countries, but only 38% of them have official deceased-donor programmes, and South Africa (SA) does not have one. Scrutinising the policies in countries such as Spain, the UK and the USA (Pennsylvania), where official referral programmes exist, could help to determine which option will be best suited to SA. It is concluded that the best basic step to start with in SA would be if the Department of Health could implement a routine-referral policy document, compelling physicians to refer every death to be evaluated for the possibility of organ retrieval.

S Afr J Bioethics Law 2017;10(1):15-19. DOI:10.7196/SAJBL.2017.v10i1.498

There is a dire need for transplantable human organs worldwide, and South Africa (SA) is no exception. Organ transplantation is a unique operation, as a patient can only become the recipient of a transplant because another human has donated the organ, either in life or after death. There are not nearly enough available transplantable organs to supply the demand; therefore, all countries and regions of the world are encouraged to work towards self-sufficiency, with as much emphasis on disease reduction as on increasing donation.[1] According to the Declaration of Istanbul on Organ Trafficking and Transplant Tourism, ‘legislation should be developed and implemented by each country or jurisdiction to govern the recovery of organs from deceased and living donors and the practice of transplantation, consistent with international standards. Policies and procedures should be developed and implemented to maximise the number of organs available for transplantation, consistent with these principles.’

While the demand for transplants in SA is steadily increasing, the supply of deceased donors has remained mainly stagnant or it has declined. There are currently 1 349 patients waiting for a solid organ transplant, while only 364 transplants of solid organs were performed in 2015.[2] Of these 364 transplants, 215 organs came from deceased donors. This number is very low if a population of 55 million is taken into account. According to Statistics SA,[3] 458 933 deaths were recorded in 2013. Not all deaths will lead to potential organ usage, but the numbers could be an indication of possibilities, as 5 698 people died owing to motor vehicle accidents alone. A total of 21 937 of the recorded deaths were people between the ages of 15 and 24, the biggest pool of organ donors. It is also interesting to note that 23 393 people died in 2013 because of renal failure.[3] It therefore seems worthwhile to investigate the potential to increase the deceased-donor rate in order to try and fulfil the demand.

Transplantation is the only therapeutic option for terminal organ failure. The principle that donation should be a routine component of end-of-life care is recognised in many countries, but only 38%

of them have official deceased-donor programmes, of which SA is not one.[4] By scrutinising the policies in countries where an official referral programme exists, it could be determined which option will be best suited for SA. When evaluating deceased-donor programmes elsewhere, two ethical principles underpinning the procurement of organs for transplantation should constantly be kept in mind. These principles are the deceased-donor rule and informed consent. The deceased-donor rule states that vital organs can only be retrieved after an individual has died. The rule also emphasises that retrieval of donated organs must not cause the donor’s death. SA adheres to this principle. According to the World Health Organization (WHO), explicit consent is defined as a system in which cells, tissue or organs may be removed from a deceased person if the person has ‘expressly consented to such removal during his or her lifetime’.[5] In this regard, SA disregards the express will of the donor as indicated by a donor card (or any other means), as the family of the deceased are always routinely asked in practice for permission to remove possible transplantable organs. This happens because having a donor card or being registered with the Organ Donor Foundation is not legally enforceable, as the National Health Act 61 of 2003 (NHA) requires a signed document that has been attested by two competent witnesses. Registering as an organ donor does not require any attestation at this point. The donor’s explicitly stated wish to donate can therefore be overruled by family members, who have the right to veto a potential donor’s wish.

Organ donations in SA are regulated by the NHA and the regulations regarding the general control of human bodies, tissue, blood, blood products and gametes. In this article the process of organ procurement in SA is briefly explained, as well as the determination of brain death. Furthermore, the issue of who may give consent is highlighted. The focus is on deceased donors only.

There are three deceased organ donation pathways in practice. The first two are more relevant to intensive care, while the third is more commonly facilitated from an emergency department:

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ARTICLE • donation after brain death (DBD) – neurological criteria • donation after circulatory death (DCD) – cardiorespiratory criteria • uncontrolled (DCD) – an unexpected cardiac arrest and death is confirmed using cardiorespiratory criteria after resuscitation efforts have been unsuccessful.

To avoid a perceived conflict of interest, it is imperative that there is a disconnection between decisions about treatment withdrawal and subsequent discussions about the potential for organ donation.[6] On average, 3.8 organs are transplanted successfully after retrieval from brain-dead patients compared with 2.7 organs from DCD donors.

In SA it is mainly brain-dead people who are used as organ donors.

In conclusion, it is argued that all end-of-life cases in SA should, by means of routine referral, be recommended for potential organ donation.

Deceased-donor organ retrieval in SA The NHA defines ‘death’ as brain death. The Act itself does not indicate how brain death should be determined. In the regulations to the Act it is stated that the death of a person shall be established by at least two medical practitioners, one of whom shall have been practising as a medical practitioner for at least 5 years, and none of the medical practitioners should be part of the team performing the transplant.

The tests done by the physicians to determine whether the brain stem is dead are of a neurological nature only. Once a person is declared brain dead, the option of organ donation may then be addressed. This is not common practice in SA; it happens on an ad hoc basis depending on workload, the availability of resources and time and whether the hospital staff have knowledge of or are in favour of organ donation. In other words, not all brain-dead patients are routinely referred to a transplant co-ordinator, who would be a direct contact point between the potential organ donor and the potential organ recipient on a waiting list. In many cases the ventilators are switched off, and healthy organs that could have been transplanted go to waste.

Section 62 of the NHA concerns the donation of human bodies and tissue, which includes organs of deceased persons. The section states that a person who is competent to make a will (16 years old or more) may donate his or her organs in a will or in a document signed by him or her and at least two competent witnesses. The person may also, while alive, state orally in the presence of two competent witnesses (14 years or older) that his or her organs may be used for transplantation after death. SA therefore follows a system known as ‘opting in’, meaning an individual indicates a wish to be an altruistic donor after death, while still alive. Section 62(2) further states that if the deceased has not expressed a decision on organ donation before death, the spouse, partner, major child, parent, guardian, major brother or sister, in this specific order, might be asked for a possible donation. This is the usual practice in all SA hospitals. The family is asked for consent to remove usable organs for transplantation into a patient irrespective of the deceased not having a donor card or any other indication that he or she is a donor. If none of the above is possible, the Director General of the Department of Health may donate any specific tissue after all steps have been taken to locate family members.

The regulations to the Act state in section 8 that all donated tissue must be removed from a deceased body within 24 hours, whereafter the body may be claimed for burial or otherwise by family members.

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The Act and the regulations are silent on circulatory death, and it is therefore assumed that it is left in the hands of the treating physician to establish death using cardiorespiratory criteria. It seems in the case of cardiac arrest that even fewer routine referrals for organ harvesting take place. Including this way of determining death in a routine referral policy for organ retrieval could have a significant influence on the number of organs available for transplantations. All that is needed is for the treating physician to routinely and timeously refer such a possible death to the transplant co-ordinators. Time is a bigger issue in cardiac arrest than with brain-stem death. In brain-stem death, blood circulation continues via machines, and the organs therefore do not deteriorate, but in cardiac arrest, the blood circulation stops the moment the heart stops beating and the organs start deteriorating immediately, which complicates the transplant process. Other countries and authors have included DCD as a major possibility to increase the availability of transplantable organs.

International deceased-donor organ retrieval World Health Organization In March 2010, the third World Health Organization (WHO) global consultation on organ donation and transplantation (The Madrid Resolution) called on countries to pursue self-sufficiency in transplantation in compliance with the WHO guiding principles on human cell, tissue and organ transplantation.[7] This included a call to maximise donation by incorporating it in all appropriate end-of-life care programmes.[8] In relation to the guiding principles of the WHO, Dominguez-Gil et al.[9] list 10 changes that could help improve the donor rate: 1. Routine referral: Successful donation programmes have a fundamental reliance on the timely identification, referral and assessment of all possible donors. Patients identified as possible organ donors should be routinely referred to the transplant co-ordinator. The advantage of this system is that assessment of the patient as a potential donor can begin earlier, reducing subsequent delays for both the intensive care unit (ICU) and the donor family. The approach to the donor family can also be planned better.

2. Clinical triggers for donor identification: This should be developed by a panel of experts, and be simple, clearly defined and easy to audit.

3. Accurate donor assessment: All possible donors should be referred regardless of apparent medical contraindications, with decisions about medical suitability being made by the transplant co-ordinator and the transplant teams, not the treating physician.

4. Systematic brain-death testing.

5. Goal-directed optimisation of brain-dead donors.

6. Appropriate family approach to discuss the option of organ donation: Only professionals specifically trained should be in charge of the family approach. Organ donation should never be requested until the family has understood and accepted the inevitability of death.

7. Education and training: ICU staff should receive comprehensive training on organ donations.

8. Audit and performance management: Accurate audits of practices are a prerequisite of any attempt to improve donation processes.

ARTICLE 9. Clinical champions for organ donation: The identification of an ICU clinician to arrange organ donations has many benefits.

The designated person could raise awareness and provide education.

10. D onation as part of end-of-life care: The primary duty of a physician caring for a patient is to preserve life. However, when brain death has occurred or it has been recognised that further active treatments are no longer in the best interest of the patient, the duties of a doctor shift to palliation and end-of-life care.

When this happens, the doctor should immediately see the possibility of benefiting another patient through the process of an organ transplant.

These 10 changes could have an enormous effect on the availability of organs for transplantation. SA could benefit hugely should these changes become national policy, as currently there is no routine referral system and there is a lack of education and training, not only for physicians but also ICU personnel in general. Martesanz[10] argues: ‘[f ]or the physician in charge of the potential donor the easiest thing is to find an excuse for not considering the patient as a donor, which will allow him or her to close the case as quickly as possible, thus avoiding a long and complicated procedure.’ The authors are of the opinion that this is specifically true in the SA public sector, where the general attitude of physicians is that the living have a higher priority than end-of-life patients due to a lack of resources (e.g. bed availability in ICU). This leads a physician to generally close a case as fast as possible after the confirmed brain or circulatory death of a patient. A required referral policy could slow the physician down for a few moments to save valuable, healthy and life-saving organs.

To increase organ availability, SA still follows the ‘classic approach’, which includes publicity campaigns, a donor registry (which is only for statistical purposes), donor cards and stickers on drivers’ licences.

This has proved not to be sufficient in supplying the demand. Other countries such as Spain and the UK, and Pennsylvania in the USA, have tried the 10 proposals (more or less) and are already making a difference in the numbers reflecting organ transplantations.

Spain Spain is the only example of a large country that has seen a continuous increase in deceased organ donation for over 20 years.[11] Spain is also the only country in the world (excluding those who pay living donors, such as Iran)[12] with a progressive decrease in the renal transplant waiting lists.[13] In 2014, 4 360 transplants were performed, with a deceased organ donation rate of 36 per one million inhabitants.[14] The Spanish model includes a National Transplant Organisation (ONT) as part of Spain’s health ministry, the early referral of possible donors to transplant co-ordinators, a family-based approach and the development of additional training courses aimed at specific groups of professionals. Spain has had a system of ‘opting out’ since 1979. In an ‘opting out’ system, every citizen is considered an organ donor unless he or she has, while still alive, indicated that he or she is not willing to be a donor.[12] Despite having this system of organ procurement, relatives are always approached for consent before the organs of the deceased are harvested, and they have the right to a final veto. It is not the system of ‘opting out’ that has increased the donors in Spain; it is rather having a systematic and organisational approach to the process of deceased donation.

Apart from having a routine referral system, a transplant co-ordinator is appointed at each hospital, and they are usually in-house professionals[11] supported by nurses. Both the physicians and the nurses are totally independent of the transplant teams. ‘If you want more donors, you should involve intensive-care specialists in the process of organ donation. If they are not involved, you will not get donors.’[15] Training is essential, as well as the reimbursement of hospitals for their donation and transplant activities.[13] The ONT had, up to 2015, trained 16 000 health workers from top to bottom, so that everyone is aware of the opportunities to gain donors and follow the right protocols to protect organs and tissue.

The Spanish government came to the realisation that a lack of transplantable organs is not the result of a lack of potential donors, but rather a failure to convert potential donors into actual donors.[16]

United Kingdom The UK has one of the lowest rates of organ donation in Western Europe. In reaction to this, the UK’s Department of Health created an Organ Donation Taskforce in 2007 to investigate organ donations.

This taskforce reported back to the department in 2008. According to them, there are two factors known to militate against success in increasing donor rates: firstly, physicians’ unwillingness to refer patients for a possible organ donation, and secondly, the lack of brain-death testing.[17] The taskforce also recommended that nonheart-beating donors should also be included in the possible pool of available organs, and found that ‘the key to success was incorporating donation as a normal part of end-of-life care: there has to be an acceptance by all staff responsible for the care of potential donors that organ donation is a normal part of end-of-life care and that the option of donation must be explored in all suitable circumstances.’[18] The referrals should be made regardless of the impression of the clinical staff as to the suitability of the patient for donation. In September 2014, the UK’s Department of Health published UK (NHS) Blood and Transplant: Timely Identification and Referral of Potential Organ Donors: A Strategy for Implementation of Best Practice. According to this document, any successful deceased organ donation programme has a fundamental reliance on the identification and referral of all potential donors. Organising safe and effective organ retrieval takes time. It requires detailed assessment of the potential donor, careful evaluation of potential recipients and mobilisation of the relevant retrieval team(s), who might be some distance away. Recipients must be admitted to the transplanting centre before retrieval begins, and delays should be kept to the minimum.

Every hospital should have a written policy for the identification and timely referral of all potential donors. This must be a standard operating procedure.

United States of America Due to the increasing success of transplantations, the number of patients waiting for an organ has increased tremendously in the USA, yet the number of organ donors has not kept pace with the need. The shortage of organs poses a public health crisis that need not exist.[19] Federal government accepted that the problem of an inadequate supply of transplantable organs should be addressed at state legislation level.[20] Only the state of Pennsylvania is discussed, as their legal framework resonates with the arguments in this article. Pennsylvania has

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ARTICLE legislated routine referrals, which determine that all patients at or near the time of death, regardless of age or disease, must be referred to a transplant co-ordinator.[21] The Department of Health monitors compliance via retrospective reviews of medical records, and imposes a fine of up to $500 for each instance of hospital noncompliance.[19] The nursing staff are mainly responsible for referrals, and hospital compliance must be recorded in the patient’s medical records. The Delaware Valley Transplant Program was developed by an organ procurement organisation to develop a strategy to implement hospital protocols required by law. Intensive training was conducted. Meetings were organised with the practitioners who were most closely involved in possible donations, namely neuroscientists, trauma surgeons, intensivists and critical care nurse managers. The total potential organ donor referrals of ventilator-dependent and neurologically impaired patients dramatically increased from 528 in 1994 (prior to the legislative change) to 824 in 1996 (post the implementation of the law) – an increase of 56%. Referrals of braindead patients increased from 342 to 427 (a 25% increase) and the number of organ donations increased from 175 to 217 (24%) over the same period. ‘[R]outine referral law with aggressive implementation effectively changed staff behaviour and procedures.’[22]

SA – the way forward There are a number of challenges faced by SA concerning organ retrieval.

If the success of Spain is taken into consideration, it seems as if it is not the system of ‘opting in’ that is the problem. Spain, even with an ‘opting out’ system, still asks the relatives of the deceased for consent before organs are removed. The system of organ procurement is therefore not the key to increase the donor pool. It seems as if the ten changes proposed by Dominguez-Gil et al.,[8,9] in tandem with the vision of the WHO, are a better way of addressing organ retrieval.

A major shortcoming in SA is that there is no national organ procurement organisation.[12] It is argued that such an organisation would be hugely beneficial. An SA National Organ Procurement Organisation (SANOPO),[23] functioning as a not-for-profit company, could assist with promotion, education and the organisational structures required to increase the numbers of referred donors. The SANOPO should function like the SA National Blood Service, by charging a fixed service fee per transplant to cover the significant costs of donor care, organ procurement and the transport of organs to the transplant facility.

Medical schemes, the government or individuals should pay such fees as they pay for blood or blood products. An improved contact process such as a national call centre should ensure that the expected increase of referral is managed efficiently. Transplant co-ordinators should also be affiliated to the SANOPO to ensure an efficient service and to ensure their independent practice in the management of potential donors. In such a system, hospitals, whether private or public, will know whom to contact in the case of a potential donor.

In addition to an organ procurement agency, there should be a drive for massive educational and awareness programmes to be instituted amongst medical students[23] as well as practising physicians and nursing staff. Government should also implement a routine legislated referral policy to be followed by all hospitals, and there should be a fine for non-compliance, as is the case in Pennsylvania.

SA is a member of the WHO and a signatory to the Declaration of Istanbul. There is therefore a governmental duty to develop policies and procedure to maximise the number of organs available

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for transplantation. Unfortunately, the current position is not in conformity with these ideals. Referrals happen on an ad hoc basis, and it depends on the staff of a hospital whether a transplant co-ordinator is contacted or not. Many potential donations go to waste because no formal policy is in place.

Conclusion This article has sought to examine the current practices followed

by Spain, the UK and Pennsylvania to improve their current organ shortage situation to guide SA in their attempt to adopt similar practices. SA can learn a number of lessons from the countries discussed above. If one looks at the current organ donation practices followed by Spain, it is evident that an opt-out procurement system will not make a significant difference to the current acute shortage.

However, Spain has experienced great success with their routine referral process system. The UK serves as a perfect example to illustrate that organ shortage numbers can be improved by incorporating potential organ donation discussions as part of general end-of-life care. Once the process of routine referral has been adopted within the SA sphere, it will even be possible to follow in the steps of Pennsylvania, which legislated routine referral and even added a fine for non-compliance. It is clear that the current altruistic system of organ procurement in SA is not successful, as the number of organs available for transplantation purposes remains stagnant. The best basic step to start with at this point would be for the Department of Health to implement a routine referral policy document compelling physicians to refer every death to be evaluated for the possibility of organ retrieval. This would create a strong incentive to create a SANOPO to efficiently respond to the expected increase in referrals.

SANOPO would ensure the promotion and application of the other principles suggested by Dominguez-Gil et al.[8,9] to ensure an efficient process from referral to procurement to transplant.

Acknowledgements. The authors would like to thank Dr Errol Gotthlich (paediatric nephrologist) for his contributions with regard to this publication. Furthermore, the authors would like to acknowledge the fact that he conceived the original idea of the concept of SANOPO.

1. Rudge C, Matesanz R, Delmonico FL, Chapman J. International practices of organ donation. Br J Anaesth 2012;108(1):i48. http://dx.doi.org/10.1093/bja/aer399 2. The Organ Donor Foundation. Transplant Statistics. www.odf.org.za (accessed 26 August 2016).

3. South African Government. Statistics South Africa on Mortality and Causes of Death 2013. 2014 www.gov.za/mortality-and-causes-death-2013 (accessed 30 August 2016).

4. Citerio G, Cypel M, Dobb GJ, Dominuez-Gil B, et al. Organ donation in adults: a critical care perspective. Intensive Care Med 2016;42(3):306. http://dx.doi. org/10.1007/s00134-015-4191-5 5. Citerio G, Cypel M, Dobb GJ, Dominuez-Gil B, et al. Organ donation in adults: a critical care perspective. Intensive Care Med 2016;42(3):308. http://dx.doi. org/10.1007/s00134-015-4191-5 6. Citerio G, Cypel M, Dobb GJ, Dominuez-Gil B, et al. Organ donation in adults: a critical care perspective. Intensive Care Med 2016;42(3):309. http://dx.doi. org/10.1007/s00134-015-4191-5 7. World Health Organization. Guiding Principles for Transplantation. 2016 http:// www.who.int/transplantation/Guiding_PrinciplesTransplantation_WHA63.22en. pc (accessed 30 August 2016).

8. Dominguez-Gil, Murphy P, Procaccio F. Ten changes that could improve organ donation in the intensive care unit. Intensive Care Med 2016;42(2):264. http:// dx.doi.org/10.1007/s00134-015-3833-y 9. Dominguez-Gil, Murphy P, Procaccio F. Ten changes that could improve organ donation in the intensive care unit. Intensive Care Med 2016;42(2):265. http:// dx.doi.org/10.1007/s00134-015-3833-y

ARTICLE 10. Martesanz R. A decade of continuous improvement in cadaveric organ donation: The Spanish model. Nefrologia 2002;15(1):22-28.

11. Soyama A and Eguchi S. The current status and future perspectives of organ donation in Japan: learning from the systems in other countries. Surg Today 2016;46(4):388. http://doi.org/10.1007/s00595-015-1211-6 12. Venter B, Slabbert M. Rewarding a living kidney donor: A comparison between South Africa, Singapore and Iran. Obiter: 2013;34(2):185.

13. Martesanz R. A decade of continuous improvement in cadaveric organ donation: the Spanish model Nefrologia 2002;15(1):61.

14. Badcock J. How Spain became the world leader in organ donation. 2015. http://europe.newsweek.com/spain-has-become-world-leader-organdonations-305841 (accessed 30 August 2016).

15. Martesanz R. A decade of continuous improvement in cadaveric organ donation: the Spanish model Nefrologia 2002;15(1):65.

16. Miranda B, Fernandez L, de Felipe C, Naya M, Gonzalez-Posada JM, Matesanz R. Organ donation in Spain. Nephrol Dial Transplant 1999;14(3):21.

17. Murphy F, Cochran D and Thornton S. Impact of a bereavement and donation service incorporating mandatory ‘required referral’ on organ donation rates: A model for the implementation of the Organ Donation Taskforce’s recommendations. Anaesthesia 2009;64(8):822. https://doi.org/10.1111/j.13652044.2009.05932.x

18. Murphy F, Cochran D and Thornton S. Impact of a bereavement and donation service incorporating mandatory ‘required referral’ on organ donation rates: a model for the implementation of the Organ Donation Taskforce’s recommendations. Anaesthesia 2009;64(8):823. https://doi.org/10.1111/j.13652044.2009.05932.x 19. Robertson VM, George GD, Gedich PS, Haz RD, Kochik RA and Nathan HM. Concentrated professional education to implement routine referral legislation increases organ donation. Transplantation Proceedings 1998;30:214. https://doi. org/10.1016/S0041-1345(97)01241-4 20. Pollard S. The impact of state legislation on organ donation – results of a US pilot scheme. Nephrol Dial Transplant 1997;12(12):2511. https://doi.org/10.1093/ ndt/12.12.2510 21. Pennsylvania. Act 102 of 1994. Robertson VM, George GD, Gedich PS, Haz RD, Kochik RA and Nathan HM. Concentrated professional education to implement routine referral legislation increases organ donation. Transplant Proc 1998:(30):216. https://doi.org/10.1016/S0041-1345(97)01241-4 22. Sobnach S, Borkhum M, Millar AJW et al. Attitudes and Beliefs of South Africa medical students toward organ transplantation. Clin Transplant 2012;26(2): 192. https://doi.org/10.1111/j.1399-0012.2011.01449.x

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ARTICLE

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

A global bioethical perspective on organ trafficking: Discrimination, stigmatisation and the vulnerable R Rheeder, BA, THM, THD Unit for the Development of Reformed Theology, Faculty of Theology, North-West University, Potchefstroom, South Africa Corresponding author: R Rheeder (riaan.rheeder@nwu.ac.za)

Organ trafficking is a growing global phenomenon that not only has abusive consequences, but is also, as far as can be determined, discriminatory and stigmatising. Currently, there is no national or global declaration that rejects organ trafficking because of the discriminatory and stigmatising results of the medical practice involved. The Universal Declaration of Bioethics and Human Rights by the United Nations Educational, Scientific and Cultural Organization (UNESCO) addresses the problem by relating organ trafficking (art. 21.5) to discrimination and stigmatisation (art. 11). Until a global declaration and an accompanying project come into existence, the UNESCO declaration can be used as an influential appeal to the world community to combat these activities together.

S Afr J Bioethics Law 2017;10(1):20-24. DOI: 10.7196/SAJBL.2017.v10i1.528

Global organ trafficking Global discrimination against and stigmatisation of individuals and groups in the health environment are continually reported.[1] In 2014, the International Bioethics Committee (IBC) of the United Nations Educational, Scientific and Cultural Organization (UNESCO), published the Report of the IBC on the Principle of Non-discrimination and Non-stigmatisation.[2] According to this report, discrimination and stigmatisation continue unabated. On the one hand, these two phenomena are found in globally recurring issues such as neglected tropical diseases, HIV/AIDS, organ donation and trafficking; on the other hand, they surface in new developments such as biobanks, nanotechnology and neuroscience.[1,3] The actuality and necessity of a global bioethics and continuous discourse on discrimination and stigmatisation are evident when referring to global organ trafficking. In most instances, this illicit practice, along with other ethical problems, is inherently discriminatory, and in many instances, the participants are stigmatised, as the IBC’s in-depth study clearly shows.[3] In his recent dissertation, which studies organ trafficking as a social problem in Israel, Shidlo-Hezroni also shows that the practice is discriminatory and stigmatising in nature.[4] Without doubt, discrimination and stigmatisation are also found in legal organ donation programmes,[2,3] but the focus in this article is on trafficking. In the early eighties, a new form of human trafficking as a global phenomenon developed in the Middle East, Latin America and Asia, namely, global trafficking in the kidneys of living persons.[5] It is accepted that ~5 - 10% of all kidneys that have been transplanted since that time can be traced back to organ trafficking.[3,6] Trafficking in kidneys (and other organs) is found in more or less 50 countries over the world today.[5,6] It happens that ‘medical tourists’ from richer countries get hold of organs in poorer countries.[6-8] Organ sellers are frequently sent to richer countries to undergo the necessary procedures there.[6] In 2004, a syndicate transferring patients and organ sellers from Brazil to South Africa (SA) for kidney transplants was exposed in SA.[6] Although organ trafficking is a global issue and prohibited by most

countries, global efforts have not been successful in stopping the practice,[2,6] especially because the involvement of several countries in a single incident complicates prosecution.[5] A strong suspicion exists that organ trafficking is increasing every year;[6] this idea is strengthened by recent newspaper reports to which this study refers.

Any search on Twitter with the keyword ‘organ trafficking’ affirms the suspicion and actuality of this global problem. The reasons for organ trafficking are: the shortage of organs; the absence of a postmortem donation practice; packages of some medical fund organisations to cover the transplant procedures abroad (for example, the USA), a highly profitable practice;[5] complaisant medical personnel;[8] the cost of kidney dialysis; the lack of national and international regulation and enforcement of existing laws; and the alleged involvement of governments.[9] Mafia-related organisations and intermediaries have come into existence and have used the opportunity to target vulnerable human beings, which has led to an increasingly large black market. Precise and recent information on this matter is scarce, for the very reason that the practice is illicit and underground. The suspicion is that the extent of the problem is underestimated;[3,6] therefore, illicit organ trafficking is not expected to be eradicated soon.[6]

Discrimination and stigma In discussing organ trafficking, the focus is usually only on the exploitative results of this malpractice, but the fact that it is inherently discriminatory and stigmatising receives little attention.

Discrimination occurs against non-related living kidney sellers in several ways. The first is that the preference of brokers for potential sellers is not based on the medical benefit and wellbeing of the sellers, but is almost exclusively directed at persons in vulnerable social conditions.[6,9,10] This becomes clear when people and populations such as the illiterate, the poor, undocumented immigrants, political and economic refugees, and prisoners are predominantly exploited as sellers.[3,5,11] The social conditions render the people and populations very vulnerable when they are under duress (because of poverty,

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ARTICLE power relationships, etc.) and ‘convinced’ by false information (possible harm to health is grossly misrepresented).[3,11,12] Secondly, organ sellers also experience discrimination in their communities. Organ sellers are regularly marginalised in the broader community, and are consciously excluded from activities of the community.[4] Research in India by Acharya et al.[10] has shown, for example, that organ sellers are consciously excluded from positions such as being members of local committees, and that nongovernmental organisations give medical preference to people who are not organ sellers. It has also been ascertained that discrimination is found against sellers’ children in school, where they are treated differently. The following is a poignant description of the situation: ‘Victims gathered in the interaction program conducted in Dhuli­ khel recounted some bitter experiences in their villages. One victim said neighbours and relatives now treated him as untouchable and discriminated against him by not including him in social gatherings such as marriages and other ceremonies. Another victim encountered such hostility in the village that he left to live in Kathmandu Valley.’[10] Thirdly, discrimination further exists at the workplace against sellers of organs.[3] Employers do not take organ sellers back, or society excludes them from practising certain vocations because of their choice to sell their organs and health.[13,14] Fourthly, there is evidence that education, gender, race, ethnicity and religion also play a role in the selection of sellers. Some recipients refuse to buy the kidneys of women sellers for sexist reasons.[3,5] Discrimination also takes place against the recipients of organs.

Almost exclusive preference is given to wealthy patients on the waiting list; in this way, there is discrimination against the poorer vulnerable patients, who may need the organ immediately. In other cases, age, single status and certain diseases of recipients are used as exclusion criteria, because some medical teams’ desire for success is stronger than their concern for the wellbeing of the patients.[2] One of the dangers associated with selling organs is that the seller runs the risk of stigmatisation in society.[3,4] This fact is confirmed by research.[10] Organ sellers are frequently stigmatised as ‘half people’ or ‘bodies without organs’ and are regarded as ‘untouchables’ (filthy, immoral) who do not belong in a ‘normal’ society.[3,11,14] There is also evidence that male sellers are stigmatised as ‘male prostitutes’, who disgrace the community.[5,15] Sellers as well as recipients of organs are stigmatised as ‘criminals’ on returning to their countries, and find it difficult and sometimes impossible to be reintegrated into society, because they are regarded as violators of the law and the existing system.[2,3] The result of stigmatisation is that the victims experience rejection, isolation, hatred and avoidance by the community. In some cases, stigmatisation could lead to physical maltreatment and assault.[14] The position of the sellers is aggravated by the fact that they do not have the courage to go for medical help after they have undergone the relevant medical procedure.[2,11]

Problem statement It is clear that addressing the problem requires global action, and that solving it cannot be effected unilaterally. During the past few years, several international projects have come into existence with a view to address the practice of organ trafficking (and other ethical problems associated with legal organ donations) at a moral and human rights level, and to appeal to governments to act according to principles and rights.[3] In this regard, one can refer to the recommendations

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of the Asian Task Force on Trafficking (2008),[15] the Declaration of Istanbul on Organ Trafficking and Transplant Tourism,[16] the World Health Organization (WHO) Guiding Principles on Human Cell, Tissue and Organ Transplantation[17] and the Madrid Resolution on organ donation and transplantation[18] (which only reaffirmed the WHO principles), as well as the High-level International Conference on the Fight against Trafficking in Human Organs (2015).[19] However, the following comments reflect the crux of the research problem:[3] ‘Contrary to the ethical principles explicitly stated in the inter­ national and national declarations adopted to regulate organ transplants, the principles of non-stigmatisation and nondiscrimination have never been clearly highlighted. Indeed, stigmatisation and discrimination were not explicitly addressed in the 2010 WHO Guiding Principles on Human Cell, Tissue and Organ Transplantation, the 2008 recommendations of the Asian Task Force on Organ Trafficking, the 2008 Declaration of Istanbul on Organ Trafficking and Transplant Tourism as well as the 2010 Madrid resolution on organ donation and transplantation … The current international initiatives have built their arguments mostly based on exploitation inherent in organ sales and trafficking, but none of those initiatives has considered the perspectives of vulnerable patients as organ recipients and poor people as organ providers, and the discrimination and stigmatisation they experience.’[2] These international initiatives ground the rejection of organ trafficking mainly in the exploitative nature of the practice, which is characterised by violations of the principles of equality, justice and human dignity, but they do not refer to the principles of nondiscrimination and non-stigmatisation at all.[2,3] The research question of this study is therefore whether an authoritative universal bioethical instrument exists that connects organ trafficking and specifically discrimination and stigmatisation to each other to fill the abovementioned gap, until a more comprehensive global instrument and project has been developed. The necessity of the study is motivated by the following statement from Bagheri:[3] ‘It should be noted that all previous efforts have not yet been effective enough to stop the rapid growth of organ markets and trafficking.’

The research question will be answered by pursuing two aims: first, it will be pointed out that the Universal Declaration on Bioethics and Human Rights (hereafter UDBHR) of UNESCO[20] can be used as an authoritative instrument to fill the gap. Secondly, the gap will be directly addressed by expounding article 11 of the UDBHR as a grounding principle in judging (condemning) global organ trafficking. The article reads: ‘Non-discrimination and non-stigmatisation. No individual or group should be discriminated against or stigmatised on any grounds, in violation of human dignity, human rights and fundamental freedoms.’[21] This discourse could be instrumental and contributory in creating an awareness of the global bioethical problem of organ trafficking and in preventing it; therefore, it could promote the protection of vulnerable people.[3]

Global authority and scope Attention will now be given to the first aim of the research question by referring to articles 11, 26 and 21.5 of the UDBHR (2006). It is clear that article 11 emphasises condemnation of all discrimination and stigmatisation that violate human dignity, human rights and

ARTICLE fundamental freedoms. Furthermore, all principles, according to article 26, are interconnected and complementary. If one takes into account that the UDBHR was published a long time before the declaration of Istanbul on organ trafficking and transplant, it is remarkable that article 21.5 calls for international commitment: ‘States should take appropriate measures, both at the national and international levels, to combat bioterrorism and illicit traffic in organs, tissues, samples, genetic resources and genetic-related materials.’[21] What authority can be attached to the UDBHR and therefore to articles 11, 26 and 21.5? UNESCO is a specialist organisation within the United Nations (UN), which is a global organisation consisting of 193 member states, i.e. one more than the number of members of the general assembly of the UN in New York. The UN is currently the only platform where all nations can engage in a discourse and eventually agree on normative instruments.[21] The UDBHR was accepted unanimously by all member states,[22,23] which implies that the declaration with its 15 bioethical principles was the first, and currently is the only bioethical (political) text to which almost all the governments in the world, including SA, have committed themselves.

[23] It is of utmost significance that all the member states of UNESCO were able to agree on all the principles of the declaration, thus attaining a special achievement for universal bioethics.

Declarations – such as the UDBHR – accepted by UN agencies form part of the ‘soft law’ instruments. They are weaker than conventions because they are not enforceable according to international law;[24] for this reason, the word ‘should’ instead of ‘would’ is found in the declaration.[25] Nevertheless, the fact that the general assembly of the UN unanimously accepted the instrument with its universal aim, without any notated dissentient vote, reserves or qualifications, means the value of the instrument is not merely symbolic. It is indeed meant and accepted as an instrument that would have moral authority, and put its signatories under obligations, features that have to be regarded very seriously.[25] The fact that the bioethical principles and norms are presented in terms of human rights strengthens the moral appeal of the declaration.[26] What is the scope of the UDBHR in which article 11 appears? From the title, aims and ethical principles of the instrument, a global ethical purposefulness can be deduced. The aims of the declaration are discussed in article 2, and the following aim is relevant: ‘The aims of this declaration are: (a) to provide a universal framework of principles and procedures to guide states in the formulation of their legislation, policies or other instruments in the field of bioethics.’[21] From the aims statement, it is clear that states should use the instrument as a universal guideline in formulating legislation and policy, which implies legislation and policy should reflect the contents of the declaration and consider other countries, specifically developing countries.

In the above discussion, it has been shown that the UDBHR of UNESCO is meant as an authoritative instrument, and therefore it can be used to fill the gap in the relation between organ trafficking and the principles of non-discrimination and non-stigmatisation at a global level until a comprehensive declaration and project comes into being.

Human dignity and equality Attention will now be given to the second aim of the research question. Because article 21.5 states that organ trafficking should

be combated authoritatively, it will be shown here that the practice ought to be rejected outright, and combated not only because of the consequences of possible harm (according to article 4 of the UDBHR), but also because of the violation of article 11. In this way, the global gap could be addressed. The question of the specific meanings of the concepts of non-discrimination and non-stigmatisation now come to the fore.[2,27] UNESCO has no authoritative and final interpretation of article 11 that can be evaluated and applied. To construe a ‘UNESCO understanding’ of article 11, the focus will have to be exclusively on UNESCO sources and authors that specifically interpret the UDBHR. With the help of interpretations, the meanings of the concepts of nondiscrimination and non-stigmatisation in the UDBHR are investigated below.

In the first place, the UDBHR relates ‘human dignity’ to the norms of non-discrimination and non-stigmatisation.[1] This connection is upheld by article 2, which states that the aim of the declaration is, among others, ‘to provide a universal framework of principles’, with the specific aim ‘to promote respect for human dignity’; article 26, which describes all the principles as ‘complementary and interrelated’, also applies. ‘Nevertheless, in order to use “dignity” in our lives, some practical principles were established’, UNESCO[28] declares in a document used for education. The recognition and application of the principles of non-discrimination and non-stigmatisation express human dignity and where these principles are respected, people are treated with human dignity.[29] In the second place, the principle of equality, as expressed in article 10, can be regarded as the foundation of article 11. The IBC confirms this viewpoint, and Guessous[29] commenting on article 11 explains it as follows: ‘Fighting against discrimination and stigmatisation represents the recognition of equality between human beings, their dignity and the principle of justice in their relations … It requires the equal treatment of an individual or group irrespective of their particular characteristics.’

The principle of equality states the obligation of equal treatment of all individuals or groups, irrespective of their specific characteristics; therefore, there may be no discrimination against anyone and no person may be stigmatised.[30]

Non-discrimination From the principle of equality flows the principle of nondiscrimination. It is important to draw attention to the fact that UNESCO does indeed distinguish between negative and positive discrimination. The concept of negative discrimination is a juridical and social concept that has a long history in international and national human rights legislation. The word ‘discrimination’ is derived from the Latin ‘discriminare’, which means ‘distinguish between’.[30] Garrafa[1] contends that the verb ‘to discriminate’ also means ‘to separate’ or ‘to select’; the noun ‘discrimination’ includes these meanings in their noun forms, but it also means ‘segregation’. In searching for a definition of discrimination that can also be used in explaining article 11, Rivard[27] finds the definition of the International Convention on the Elimination of All Forms of Racial Discrimination of the UN (1965) the most suitable (see also paragraphs 5 and 6 of the foreword of the UDBHR). Article 1(1) of the Convention defines the concept of discrimination (based on race): ‘The term “racial discrimination” shall mean any distinction, exclusion, restriction or preference based on race, colour, descent, or national or

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ARTICLE ethnic origin, which has the purpose or effect of nullifying or impairing the recognition, enjoyment or exercise, on an equal footing, of human rights and fundamental freedoms in the political, economic, social, cultural or any other field of public life.’

Important concepts flowing forth from these efforts to define discrimination are separation, distinction, exclusion, restriction, preference, selection and segregation. In the light of the theme of this study, the focus will be on negative discrimination. Two aspects of discrimination will be discussed, namely exclusion and inclusion. Both phenomena minimalise the human dignity of a person or group and put them at a disadvantage.[30] On the one hand, people are excluded from political, economic, social or cultural contexts, which will necessarily lead to their disadvantage. On the other hand, discrimination is not only interpreted as an action of exclusion, but also as a behavioural pattern of preference for or inclusion of certain people or populations, precisely because their human dignity is minimalised. It must be reiterated that UNESCO recognises positive discrimination, which gives preference to historically disadvantaged groups with the aim of eradicating inequality.[1] However, the organisation also recognises that in some cases, inclusion not grounded on the health and wellbeing of the persons or groups involved can be disadvantageous to those persons, and should therefore also be regarded as ‘negative discrimination’.

The recommendations of article 11 with regard to the inclusion of participants in research also apply when considering the vulnerability of organ sellers: ‘The principle of article 11, however, will also give guidance to the resolution of a wider range of bioethical issues. In the context of research, for example, the selection of research subjects should not be influenced by a belief that members of a given group are less deserving of protection from the risks associated with research than others.’[28] Additionally, Bagheri[3] is of the opinion that the preference for and inclusion of vulnerable people with a view to organ sales are discriminatory actions. The practice of inclusive discrimination necessarily accepts some people as ‘below the level of the other individuals who make up society’ and that they have ‘diminished dignity’.[1] It is important to point out that article 11 of the UDBHR does not present an elaborate list of causes of discrimination (and stigmatisation), but rather indicates that discrimination (and stigmatisation) ‘on any grounds’ is unacceptable.[28] The general point of departure of the IBC is the following: ‘The lottery of social and biological life should not be grounds for disadvantages or advantages.’ [2] It is clear that the declaration recognises and turns down inclusive and exclusive discrimination that take place for economic gain in global organ trafficking. Because organ trafficking is discriminatory, the sellers experience unequal treatment and their human dignity is violated.

Non-stigmatisation What is the meaning of stigmatisation? As shown, no other global or international document that addresses organ trafficking morally relates it to stigmatisation. However, the situation is changed when non-stigmatisation is accepted as a universal principle and human right in article 11 of the UDBHR, according to Guessous.[30] This use of the concept of stigmatisation is a unique contribution by UNESCO in

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general, but a special contribution in the context of organ trafficking: ‘In the field of bioethics, UNESCO recognises stigmatisation as a distinguished kind of discrimination that may have a serious impact on the right to health and benefit of scientific research.’[30] Rivard,[27] Guessous[29] and the Bioethics Core Curriculum[30] do not use international human rights documents or manuals to formulate a definition of the concept of non-stigmatisation as found in article 11 of the UDBHR, but utilise dictionaries and encyclopaedias, namely the Oxford English Dictionary Online, Encyclopedia Britannica and MerriamWebster Online Dictionary. ‘Stigma’ is a complex concept that indicates a disparaging name (verbal label or sticker) for an individual or group because of physical, psychological, moral, medical or social conditions.

The name has the purpose of characterising a person or group negatively, and denotes inferiority. The tag further suggests that the bearer of the label is useless, unreliable, dangerous, dirty, full of evil and destructive in many ways.

The disparaging naming connected with stigmatisation has a purpose.

Some UNESCO commentators state or suggest that stigmatisation should not be regarded as an independent concept but rather as a sub-norm or part of discrimination to justify discrimination.[2,30] As has been shown, Guessous[29] refers to ‘stigmatisation as a distinguished kind of discrimination’. Garrafa[1] comments on article 11: ‘it is essential to emphasise that there is a close and interdependent relationship between discrimination and stigma. Discrimination is an inherent part of stigma, because there would not be any stigma if there were no discrimination. Discrimination is the manifestation of stigma.’The purpose of stigmatisation is judgement, discrimination, rejection and exclusion of the individual or group.[2] It is clear that the declaration recognises and turns down stigmatisation that takes place in global organ trafficking. Because organ trafficking is stigmatising, the sellers experience unequal treatment and their human dignity is violated.

It is evident that the UDBHR regards organ trafficking as an illicit medical practice, and that it exhorts states and civil society to fight against it. The practice has to be combated because it violates the norms of non-discrimination and non-stigmatisation, disturbs equality and encroaches upon human dignity.

Conclusion Organ trafficking is a growing global phenomenon that not only has exploitative consequences, but is also as far as can be ascertained discriminatory and stigmatising. Currently, there is no national or global declaration that rejects and combats organ trafficking because of the discriminatory and stigmatising results of the medical practice involved.

The UDBHR addresses the problem by relating organ trafficking (article 21.5) to discrimination and stigmatisation (article 11). Until a global declaration and an accompanying project come into existence, the UDBHR can be used as an authoritative appeal to the world community to combat these activities co-operatively.

1. Garrafa V. Ethics of Discrimination. In: Ten Have H, ed. Encyclopedia of Global Bioethics. Cham, Switzerland: Springer International Publishing, 2016.

2. International Bioethics Committee of United Nations Educational, Scientific and Cultural Organization. Report on the Principle of Non-discrimination and Nonstigmatisation. Paris: UNESCO, 2014.

3. Bagheri A. The risk of discrimination and stigmatisation in organ transplantation and trafficking. In: Bagheri, A, Moreno J, Semplici S, eds. Global Bioethics: The Impact of the UNESCO International Bioethics Committee, Advancing Global Bioethics, 5. Cham, Switzerland: Springer International Publishing, 2016.

ARTICLE 4. Shidlo-Hezroni V. Organ Trafficking: The Construction of a Social Problem in Israel.

ProQuest Information and Learning, 2016. https://indigo.uic.edu/bitstream/ handle/10027/19534/Shidlo-Hezroni_Vered.pdf?sequence=1 (accessed 4 October 2016).

5. Scheper-Hughes N. Human Traffic: Exposing the Brutal Organ Trade. New Internationalist, 2014. https://newint.org/features/2014/05/01/organ-traffickingkeynote/#footnote-2-ref (accessed 1 November 2016).

6. Ten Have H. Bioethiek Zonder Grenzen: Mondialisering van Gezondheid, Ethiek en Wetenschap. Antwerpen: Valkhof Pers, 2011a.

7. Dunlevy S. 2016. Australians Turn to Black Market for Human Organs. http://www. news.com.au/national/australians-turn-to-black-market-for-human-organs/ news-story/06905df7ffc5337cb53927c9de1cce3a (accessed 4 October 2016).

8. World Israel News. Police Bust Organ Trafficking Network. 2016. https:// worldisraelnews.com/police-bust-organ-trafficking-network/ (accessed 26 October 2016).

9. Okunola D. Gov Okorocha Implicated in Human Trafficking Mess. 2016. https:// www.naij.com/720362-governor-rochas-okorocha-alleged-involved-humanorgan-trafficking.html (accessed 3 November 2016).

10. Acharya BR, Ghimire R, Silwal R. Kidney trafficking in Nepal: Study of selected VDCs in Kavrepalanchowk District. In: Sharma S, ed. Forum for Protection of People’s Rights Nepal, Kathmandu, Nepal: Forum for Protection of People’s Rights, 2016.

11. Maher A. Iraqi families sell organs to overcome poverty. BBC Arabic, 2016. http:// www.bbc.com/news/world-middle-east-36083800 (accessed 5 October 2016).

12. Ali N. Of Human Organs, Desperate Poverty and Greed. DAWN, 2016. http://www. dawn.com/news/1283926/of%ADhuman%ADorgans%ADdesperate%ADpovert y%ADand%ADgreed1/16 (accessed 4 October 2016).

13. Scheper-Hughes N. The market for human organs is destroying lives. The Washington Post: In Theory, 2016. https://www.washingtonpost.com/news/ in-theory/wp/2016/01/05/the-market-for-human-organs-is-destroyinglives/?utm_term=.681a31147fe0#comments (accessed 4 October 2016).

14. Yea S. Masculinity under the knife: Filipino men, trafficking and the black organ market in Manila, the Philippines. Gender Place Culture J Fem Geog 2015;22(1):123-142.

15. Asian Task Force on Organ Trafficking. Recommendations on the Prohibition, Prevention and Elimination of Organ Trafficking in Asia, 2008. http://www.jcb. utoronto.ca/publications/documents/Asian%20Task%20Force%20on%20%20 organ%20trafficking%20.pdf (accessed 5 October 2016).

16. The Declaration of Istanbul on Organ Trafficking and Transplant Tourism, 2008. http://www.declarationofistanbul.org/ (accessed 5 October 2016).

17. World Health Organization. Annex 8: Guiding principles on human cell, tissue and organ transplantation. In: 63rd World Health Assembly, Geneva, 17 - 21 May, Resolutions and Decisions, Annexes, 2010a;137-144. WHA63/2010/REC/1. http:// www.who.int/transplantation/en/ (accessed 5 October 2016).

18. World Health Organization. Third WHO Global Consultation on Organ Donation and Transplantation: Striving to Achieve Self-Sufficiency, March 23 - 25, Madrid, Spain, 2010b. https://www.edqm.eu/sites/default/files/3rd_who_global_consultation_ striving_to_achieve_self_sufficiency_2011.pdf (accessed 21 November 2016).

19. Council of Europe. European Committee On Crime Problems. Conclusions. In: International High-Level Conference on the Fight against Trafficking in Human Organs, Santiago de Compostela, Spain, 25 - 26 March. 2015. http://www.coe. int/t/dghl/standardsetting/cdpc/conference/Santiago_de_Compostela_en.asp (accessed 5 October 2016).

20. United Nations Educational, Scientific and Cultural Organization. Universal Declaration on Bioethics and Human Rights. 2006. http://unesdoc.unesco.org/ images/0014/001461/146180e.pdf (accessed 18 November 2013).

21. Ten Have H, Jean M. Introduction. In: Ten Have H, Jean M, eds. The UNESCO Universal Declaration on Bioethics and Human Rights: Background, Principles and Application. Ethics Series. Paris: UNESCO Publishing, 2009.

22. International Bioethics Committee of UNESCO. 2008. Report on Consent. 2008. http://unesdoc.unesco.org/images/0017/001781/178124e.pdf (accessed 18 November 2013).

23. United Nations Educational, Scientific and Cultural Organization. Records of the General Conference, 33rd session Paris, 3 - 21 October, Vol. 1: Resolutions, 2005. http://unesdoc.unesco.org/images/0014/001428/142825e.pdf (accessed 18 November 2013).

24. Ten Have H. Foundationalism and principles. In: Chadwick R, ten Have H, Meslin DH, eds. The SAGE Handbook of Health Care Ethics: Core and Emerging Issues, 20.

London: SAGE Publications, 2011b. http://dx.doi.org/10.4135/9781446200971.n3 25. Kirby M. Article 1: Scope. In: Ten Have H, Jean M, eds. The UNESCO Universal Declaration on Bioethics and Human Rights: Background, Principles and Application, Ethics Series. Paris: UNESCO Publishing, 2009.

26. Ten Have H. Global Bioethics: An Introduction. Abingdon: Routledge, 2016.

27. Rivard G. Article 11: Non-discrimination and non-stigmatisation. In: Ten Have H, Jean M, eds. The UNESCO Universal Declaration on Bioethics and Human Rights: Background, Principles and Application, Ethics Series. Paris: UNESCO Publishing, 2009.

28. United Nations Educational, Scientific and Cultural Organization. Casebook on Human Dignity and Human Rights, Bioethics Core Curriculum. Casebook Series, No 1, 2011. http://unesdoc.unesco.org/images/0019/001923/192370e.pdf (accessed 18 November 2013).

29. Guessous N. Non-discrimination and stigmatization. In: Ten Have HAMJ, Gordijn B, eds. Handbook of Global Bioethics. Dordrecht: Springer Science and Business Media, 2014.

30. United Nations Educational, Scientific and Cultural Organization. Bioethics Core Curriculum, Section 1: Syllabus Ethics Education Programme Sector for Social and Human Sciences, Division of Ethics of Science and Technology, 2008. http://unesdoc. unesco.org/images/0016/001636/163613e.pdf (accessed 18 November 2013).

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ARTICLE

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

Dare we rethink informed consent?

M de Roubaix, MMed, MD, DPhil Centre for Applied Ethics, Department of Philosophy, Stellenbosch University, Cape Town, South Africa Corresponding author: M de Roubaix (malcolmderoubaix@gmail.com)

Current informed consent practices conform to the informed consent paradigm (ICP). Our intention is finally to promote patient autonomy through the provision of information intended to remove the information (i.e. power) differential between doctor and patient. ICP is fundamentally flawed, since it is impossible to comprehensively and explicitly inform. A fundamental problem is our reliance on the containerconduit metaphor of informing. As a linguistic act, this metaphor conceptualises the process of informing as passive, when in reality informing and consequent sense-making are parts of an individualised, personal and active process. The difficulties of the ICP are discussed, as are possible alternative strategies (reverting to paternalism, retaining the illusion of autonomy, and de-linking informing/consent, or the moral and legal aspects of consent). Alternative models are also discussed (e.g. Manson and O’Neill’s notion of informed consent as a transaction).

Concluding suggestions include drawing on an ethics of responsibility, incorporating the notion of informed consent as a transaction, debating the issues raised here and promoting the ethical empowerment of practising doctors.

S Afr J Bioethics Law 2017;10(1):25-28. DOI:10.7196/SAJBL.2017.v10i1.507

Modernity – that phase of societal history from the discovery of science (let’s say, the discovery of the telescope) to the detonation of the Hiroshima bomb – is characterised by the overarching belief in one final and universal truth, be it about science, religion or human behaviour. In contrast, postmodernity defies this notion, and describes the current phase of human societal development as fundamentally complex, truth as something provisional and contextual, and ethics as something to be created in the quagmire of vibrant human interaction.[1] This echoes a haunting note spanning more than two millennia – the Socratic injunction to constantly re-examine societal truth claims in the light of newer developments. With these thoughts in mind, I take a fresh and provocative look at the accepted paradigm of informed consent in clinical and research settings.

The informed consent paradigm In the normal run of human affairs, and particularly in matters medical, whatever we do to others should be governed by their freely given and informed consent. This has both legal and ethical foundations.

Legally, we may face criminal or civil litigation on grounds of assault or crimen injuria if we so much as touch a patient without her consent.[2] Patient consent is based on what a patient knows and understands about the given medical situation/proposed treatment/envisaged research. In litigation against doctors, it is often contended that information provided was inadequate in that complications had not been disclosed; only rarely is frank negligence argued (it might also be more difficult to prove). There are numerous laws and guidelines that address both the mandatory nature and extent of informed consent in clinical and research practice, such as the SA Bill of Rights[3] and the National Health Act No 61 of 2003,[4] to name but two in South Africa (SA). The ethical foundation to informed consent is that by gaining it, we show our respect for others as moral agents, and promote their personal autonomy – the ultimate aim of informed consent.[2] The autonomy argument goes as follows: the information/knowledge

asymmetry between the two parties implies a corresponding power differential, promoting paternalism and coercion, and problematising free choice. The way to correct this is to provide or supply information to the patient, which (theoretically) eliminates the power differential, thereby empowering the patient to rationally deliberate and make free and informed decisions. This is the essence of the so-called informed consent paradigm (ICP). A consequence not generally appreciated is that the doctor/researcher-patient/parti­ cipant interaction assumes characteristics of a contractual agreement, and its moral content consequently diminishes (the only moral aspect of a contract or agreement once it has been agreed to is the responsibility that it be honoured).[5] But there are many problems inherent in this notion, and the demands made upon us in order to justify an authentic consent process are onerous. In this short reflection I aim to focus on one problematic issue only: the nature of and the transfer of information.

My arguments are loosely based on a provocative book by Manson and O’Neill,[6] although others have voiced similar concerns.

The container-conduit metaphor: The process of informing The metaphors we generally use when talking (and thinking) about information and the process of informing describe our general conceptions of the matter. We conceive of information as content passing from one person to another like contents flowing passively via a conduit from one vessel to another (the container-conduit metaphor).[6] Other metaphors we commonly use (some are italicised above to show just how pervasive their usage is) support this notion, implying that we conceive of information as contents – tangible, contained or containable, packaged or like data on a memory stick/ hard drive and by implication as readily and passively transferable.

Grady[7] illuminates the container metaphor for communication: our ideas (objects) are put into words (containers) and sent (via conduits

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ARTICLE like our voices) to listeners who extract the ideas/objects out of the words/containers. In this explication, extracting information is an active, creative process. The essence of my argument is that the ideas packaged by medical practitioners in the informed consent communication and delivered verbally are most likely vastly dissimilar from those extracted, understood and eventually internalised by the patient – upon which she eventually decides.

The container-conduit metaphor was originally presented by Reddy in 1979,[8] and served as inspiration for Lakoff and Johnson,[9] who laid down the principles for the current theory of conceptual metaphors.

Human linguistic communication is well-nigh inconceivable without the use of metaphors, the usage of which is essential and so pervasive as to pass unnoticed unless specifically studied. Conceptual metaphors are not the passive linguistic adornments we often conceive them to be, but cognitive speech-acts; metaphors reveal not only what, but also how we think about matters, and also how knowledge discloses itself to us.[10,11] So, in conceiving of information as ideas readily packageable into words, easily transferred to patients and as easily and clearly extracted and understood by them, we reveal our belief that the process of informing is passive and simple, as simple as pouring content from one container to another, or transferring digitally stored data, or, well, simply telling someone.

Informing is an active, not passive process But what then is the nature of ‘informing’ (Manson and O’Neill use the word information as a verb), and how does the patient/ research participant make sense of the words she hears (i.e. extract information and turn it into knowledge)? The original meaning of the verb ‘to inform’ (to shape, like a sculptor) illustrates the multifaceted, complex and active process that informing really is, starting with sense-making.[11] But first, ideas have to be extracted from their word packages, and the ability to do this depends on individual linguistic ability and familiarity with the subject matter. Limitations in these respects are bound to lead to difficulties in reconstructing the original ideas as understood by the informant. But let us accept that there is sufficient understanding by the patient to extract the gist of the ideas originally packaged by the medical professional (normally not an expert in the art/science of communication). The next step is to make sense of these ideas. Subjective issues now come into play. Disease has changed the circumstantial and emotional environment of the patient, resulting in experiential discontinuity. Each individual patient has previous individual experience or knowledge that provides a unique matrix in which any new information is organised and laid down. There is selective retention of newly compounded experience for immediate or future use and sense is made through enactment – a sort of data-interpretation-action (Moore, W. Unpublished PhD, 2010, Stellenbosch University). The process is unique and contextual within each patient’s own frame of reference, cognitive ability and past experience, culture and understanding through language proficiency.

Remaining gaps in the existing knowledge matrix are plugged with new knowledge, which is created or transformed from implicit, explicit (provided) and cultural knowledge. Therefore, knowledge so newly created and internalised is likely to differ considerably from that understood by the doctor, and the same information imparted in the same way to different patients is likely to be interpreted differently.

Add to this that no two doctors would package the same ideas in the same words, or deliver them in the same way.

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The eventual aim of becoming informed is rational deliberation in the face of existing choices. A prerequisite to rational deliberation is being informed: having a clear understanding of all relevant facts and opinions expressed by the doctor, in the absence of which the notion of informed consent is doomed.

The process referred to above not only takes place within the mind of a person with a particular frame of reference and acculturalisation, but is influenced by emotions and other extraneous influences (e.g. the opinions and emotions of family members). It is a journey or process rather than an instantaneous act. Thus meaning is individually, contextually and actively created.

Prerequisites for the ICP The prerequisites for the ICP to succeed in both clinical and research informed consent are that informing must be both fully comprehensive and explicit, which Manson and O’Neill[6] argue it can never be. If these two conditions are not met, it follows that the information requirement fails; thus the notion that we promote autonomy by empowering patients/participants through informing them and diminishing the information-based power differential also fails (at least, partially) simply because we are not really informing them, at least not comprehensively and explicitly.

Not all clinical medical acts of informing are so complex as to justify this concern. If, for example, an abscess requires drainage, the nature of the subject matter, ready reference to visible pathology and relatively simple surgery imply an uncomplicated informed consent process (consent for the anaesthetic is sought separately and might be more complex). However, imagine a common occurrence in the SA public health system: informed consent has to be obtained but neither of the parties is fluent in the other’s home language and the patient may need to undergo a complex procedure such as transarterial cannulisation and cryo-ablation of an aberrant intra-cardiac conduction path that causes ventricular tachy-arrythmias or irritable focus that initiates atrial fibrillation. How does one understandably package in words the information you need to transfer, and how is this information eventually recreated by the recipient? How authentic is autonomy-based informed consent? Secondly, in medical, particularly clinical drug-related research, the process and nature of informing can be very complex (drug study informed consent documents are extremely complex and may be more than 20 typewritten pages in length; even research ethics committee (institutional review board (IRB)) members may struggle to fully understand these complexities) and the concerns raised above are fully justifiable. Again, we may question the authenticity of eventual informed consent. For this reason Moore (Moore, W. Unpublished PhD, 2010, Stellenbosch University) has argued that there is space for a dedicated information therapist/ethics consultant to facilitate the process of informed consent. On top of this, informed consent in the clinical situation should be contextually (i.e. subjectively) tuned to the patient’s frame of reference and level of understanding, in a way justifying diminished informing.[4]

Alternatives to the ICP However, informing patients and obtaining their uncoerced prior, socalled informed consent, flawed as it might be, remains an undeniable moral and institutionalised legal requirement. So if the ICP fails, what alternatives do we have? There are several possibilities:

ARTICLE Revert to paternalism Respectfulness of human life and respect for humans are fundamental philosophical and legal tenets and non-negotiable practice guidelines (think for example of the Kantian dictum to treat others always so that their own interests are also served[12], or the South African Bill of Rights[3] and the National Health Act[4]). If paternalism implies exerting control over others, it is therefore not an option. One could argue for a benign form of paternalism (in the original meaning of the word, as a father would care for his children), but this may be as problematic as arguing for the notion of benign dictatorship. Besides, ‘prejudging that the sick are not fully autonomous is biased’ and unsubstantiated, and for most practitioners, technical expertise ‘does not include the ethical qualifications and prerogative to decide for others’.[13]

Retain the illusion of autonomy I argue that we effectively and unwittingly often practise some limited degree of autonomy combined with some degree of paternalism (flawed but ‘good-enough’ or ‘minimalist’ informed consent). This is unsatisfactory and poses several questions, for example, how reflective should choices be? How do we define acceptable informed consent? Why should limited autonomy be honoured and override other important principles?[6] Manson and O’Neill[6] call this minimal autonomy intended to secure a form of rational autonomy. But to call choices made on this basis reflective may justify too much (when patients elect dangerous choices) or too little (when dealing with complex interventions). Furthermore, if autonomy is equal to mere choice, equal protection for irrational choices is mandatory. Vice (Vice S. Unpublished paper and personal communication: March 2004.

Used with consent) has argued that autonomy for its own sake is void of any ethical purpose (for her, respecting autonomy and autonomous choice should serve a purpose – instantiating the ‘good life’ according to individual dictates). If comprehensive and explicit informing is impossible, it implies that we accept that many patients de facto have limited competence, and should either be denied treatment or treated with paternalism.

De-link the information and consent components of informed consent This defensive mode of practising entails informing as well as possible, realising its limitations and obtaining consent for legal purposes, with limited emphasis on truly autonomous choice. Similarly, we may also de-link the moral and legal aspects of informed consent while emphasising moral obligations and sincerely attempting to treat others as a moral agents even if this is not fully autonomous informed consent. The legal requirement for informed consent is again met as a defensive practice strategy (to prevent litigation or complaints to the Health Professions Council of South Africa).

Evaluate alternative models of informed morally acceptable doctor patient relationships I discuss only two:

An ethics of responsibility This notion expresses, perhaps a bit more coherently, the essence of the third options above, and may be developed from the work of Jonas[14] and Bauman.[5] Jonas emphasises the responsibility humans have for others, responsibility that spans time and space, and Bauman

describes the moral nature of this responsibility. Recognition of need in others and an ability to respond appropriately to that need and consequent action legitimate one as a moral agent, and are the foundations of morality. This responsibility is awesome in scope and content. It is not limited, and not based on nor demands reciprocity.

Without assuming that such an onerous notion is appropriate to medical practice, any serious attempt at this form of practice would ensure prime care and prime attention to ethical responsibility, and would be incompatible with practices that do not take patient interests and consent seriously, but would not necessarily be as onerous as the ICP.

Informed consent as a transaction Informed consent as a transaction can be defined as ‘a communicative action or activity involving two parties or things that reciprocally affect or influence each other’.[6] This notion is unique in recognising that informing can never be comprehensively explicit and specific.

Consequent consent would therefore not satisfy the arduous demands of the paradigm model, or fundamentally promote autonomy. Instead of promoting paternalism, we de facto rely on a (limited and contextual) waiver of the legal and ethical claims attendant to treatment without so-called fully informed consent.[6] The scope of the waiver is determined by the scope and nature of the legal/ethical norms that need to be waived in order to treat (i.e. the scope and nature of treatment). The notion emphasises the type of communicative action that the process of informing should be: reciprocal flow between two moral agents. It legitimises relative instead of absolute explicit/specific informing. But there are certain protective norms inherent to effective communication, for example comprehensibility, relevance and accuracy, and these are the foundations of this type of interaction.[6] In the final instance certain undertakings are made – contextually about treatment/research. This notion also responds to several characteristics of communication obscured by the container-conduit metaphor. Communication is context- and norm-dependant, propositional, a rational action (and therefore rationally evaluable), allows agents to be aware of the bigger picture and assists them in making a wide range of inferences, depending on personal circumstances and frames of reference. But fundamental to this notion is accepting that the dictates of the ICP are simply impracticable.

Quo vadis? Four practical suggestions So what does this mean in our daily practice? I’ll restrict myself to four concluding suggestions: Bauman’s[5] notion of responsibility is probably too onerous for general medical practice (although, perhaps, it is not for the research environment, owing to its peculiar dynamics). There have nevertheless been suggestions that an ethics of responsibility might be the only coherent approach to bioethics, given the unusual inherent moral demands. This ethic ‘ruthlessly demands justification and responsibility for our moral actions even if not moulded in conventional moral argumentation’.[15] It demands that we accept unconditional and nonreciprocal responsibility, and be empowered with the tools of moral debate.[16] This ethic is no lame excuse for paternalism, which develops from a totally different mind-set. As Jonas puts it: the ultimate ‘purpose’ is the ‘ever-transcendent possibility’ of human dignity.[14] There can be no better aim in medicine.

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ARTICLE Seeing the informed consent process as a communicative action emphasises our moral responsibilities and the continued importance of values such as the trust placed in medical caregivers: that even if I can’t know/understand everything, even if I am anaesthetised or on a ventilator, I can rely on the integrity of my doctor, and may be assured that my best interests will always predominate. This should apply to the research situation as well; in fact, more so, since research may hold risks absent from clinical settings, is not essential to the wellbeing of the patient and may hold little if any advantage for individual participants.

A solid debate of the theory v. the practicalities of informed consent along the lines argued before seems appropriate, although we will only make progress if we admit the incoherence of the current paradigm, and convince others – lawyers, lawmakers, theoretical ethicists – of our argument. Manson and O’Neill[6] argue that what we do in practice probably corresponds more with their views than with current laws and guidelines. Furthermore, those responsible for formulating laws and guidelines concerning the practice of informed consent should tone down their increasingly onerous demands.

We should take the suggestion of empowering ourselves with the tools of moral debate seriously. Medical (clinical) ethics has to do with daily patient-directed doctor-patient relational/therapeutic issues and decisions, including informed consent, and the practitioner should be confident in making these decisions. These often apply to clinical research as well. Appropriate ethics courses and continued professional development events with more ethics and less medicolegal material may further serve to empower clinicians.

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1. De Roubaix JAM, Cilliers P. Complexity, postmodernism and the bioethical dilemma. Acta Academica UOFS, 2008;40(2):84-11. (not available online) 2. Carstens PA. Informed consent in South African medical law with reference to legislative developments. In: Carstens PA, The South African Medico Legal Society. http://new.samls.co.za/node/410 (accessed 11 November 2011).

3. South Africa. Bill of Rights. In: Constitution of the Republic of South Africa, 1996 http://www.info.gov.za/documents/constitution/1996/96cons2.htm#10 (accessed 12 January 2016).

4. South Africa. National Health Act No. 61 of 2003. Chapter 2, Section 6(2).

5. Bauman Z. Postmodern Ethics. Blackwell: Oxford and Malden, 1993;17-31.

6. Manson C, O’Neill O. Rethinking informed consent. Cambridge: Cambridge University Press, 2007.

7. Grady, J. The ‘conduit metaphor’ revisited: A reassessment of metaphors for communication. In: Koenig, J. ed. Discourse and Cognition, Stanford: CSLI Publications, 1998:205-218.

8. Reddy MJ. The conduit metaphor – A case of frame conflict in our language of language. In: Ortony A, ed. Metaphor and Thought, Cambridge: Cambridge University Press, 1979:284-324.

9. Lakoff G, Johnson M. Metaphors we live by. Chicago: Chicago University Press, 1980.

10. Ricoeur P. 1973. Creativity in language: Word, polysemy, metaphor. Philos Today, 17(2);1973:97-111.

11. Ricoeur P. The Rule of Metaphor. (Tr. by R. Czerny) London: Routledge and Kegan Paul, 1978.

12. Kant I. Grounding for the Metaphysics of Morals. Translated Ellington JW 3rd ed..

Hackett Publishing Inc, Indianapolis, 1785.

13. Kottow M. The battering of informed consent. J Med Ethics 2004;30(6):565-569. http://dx.doi.org/10.1136/jme.2003.002949 14. Jonas H. The Imperative of Responsibility. University of Chicago Press: Chicago and London, 1984.

15. De Roubaix JAM, Van Niekerk AA. Separation-survivability as moral cut-off point for abortion. S Afr J Philos 2006;25(3)206-223 (not available online).

16. Van Niekerk AA. Ethics for medicine and medicine for ethics. S Afr J Philos 2002;21(1):35-43. http://dx.doi.org/10.4314/sajpem.v21i1.31334

ARTICLE

A constitutional critique on the regulations relating to artificial fertilisation of persons D W Jordaan, BLC, LLB, MPPS, PGDipSI, PhD School of Law, Howard College, University of KwaZulu-Natal, Durban, South Africa Corresponding author: D W Jordaan (JordaanD@ukzn.ac.za)

It is constitutionally impermissible for legislation to over-medicalise, that is, to legally enforce medical influence and supervision over certain actions, without good reason why such medical influence and supervision are required. Various parts of the regulations relating to artificial fertilisation of persons made in terms of the National Health Act over-medicalise aspects of artificial fertilisation and gamete donation. These offending parts of the regulations are accordingly unconstitutional and invalid. The article calls for a thorough review of the regulations from a constitutional perspective.

S Afr J Bioethics Law 2017;10(1):29-31. DOI:10.7196/SAJBL.2017.v10i1.497

It is a basic constitutional requirement that all legislation must be rational rather than arbitrary.[1] Generally, the rationality requirement states that government must be able to substantiate any legislative provision, and that the reasons tendered in substantiation must be aligned with our Constitution[2] and its underlying values; in the absence of such reasons, a legislative provision would be unconstitutional and invalid. More specifically, the rationality requirement requires that the rules of logic must be applied to any substantiation of a legislative provision. For instance, a conclusion that is based on a generalisation is illogical and would not pass the rationality requirement.

This article considers the regulations relating to artificial fertilisation of persons (‘the regulations’)[3] made in terms of the National Health Act No. 61 of 2003.[4] I show that the regulations are premised on the notion that all gamete donation and all artificial fertilisation should involve a healthcare practitioner – in particular, a specialist in reproductive medicine. I call into question the rationality of this premise. I suggest that a more rational premise on which to build future regulations would be to recognise that certain kinds of gamete donation and certain kinds of artificial fertilisation require the involvement of healthcare practitioners for good reasons; but also to recognise that other kinds of gamete donation and artificial fertilisation do not require the involvement of healthcare practitioners, and hence do not require the law to enforce such involvement.

Hypothetical case study In the following hypothetical case study, a lesbian couple, A and B, wish to have a child. They decide that B should become pregnant with the sperm of C, A’s twin brother. C agrees to provide his sperm. They agree that the child will be in the care and under the guardianship of A and B, and that C will enjoy contact rights with the child and will be the child’s godfather. They Google ‘how to inseminate at home’, quickly get an answer (in brief, masturbation followed by insertion of the semen by syringe), and follow the steps. B becomes pregnant, and after 9 months gives birth to a healthy baby girl, D. On A and

B’s request, both A and B are indicated as D’s parents on her birth certificate.[5] Although one’s moral intuition would suggest that A, B and C have done nothing wrong – they were living their lives and did not harm anyone – the regulations in their current form criminalise their actions.

The regulations The regulations’ definition of artificial fertilisation reads as follows (reg. 1): ‘Artificial fertilisation’ means the introduction other than [by] natural means of a male gamete or gametes into the internal reproductive organs of a female person for the purpose of human reproduction and includes artificial insemination, in vitro fertilisation, gamete intrafallopian tube transfer, embryo intrafallopian transfer or intracytoplasmic sperm injection’.

Key to understanding the provisions of the regulations is the definition of a ‘competent person’, which reads as follows (reg. 1): ‘‘competent person’ means a medical practitioner registered with the Health Professions Council of South Africa (HPCSA) with expertise in specialist gynaecologist [sic] and sub-specialist in Reproductive Medicine, or a trainee in Reproductive Medicine in a training unit under the supervision of a registered HPCSA sub-specialist’.

All the kinds of artificial fertilisation must be effected by a ‘competent person’ (reg. 10(2)): ‘Only a competent person may effect artificial fertilisation’. Accordingly, it is clear that A, B, and C’s actions are in contravention of the regulations. This is not a trivial matter, given that contravention of the regulations is criminalised (reg. 21): ‘Any person who contravenes or fails to comply with any provision of these regulations commits an offence and is liable on conviction to a fine or imprisonment for a period not exceeding 10 years, or to both such fine and imprisonment’.

B (who was artificially fertilised) can be prosecuted as perpetrator, and A (B’s partner, who involved her brother, C) and C (the sperm donor) can be prosecuted at least as accomplices, given that they actively assisted B, the perpetrator.

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ARTICLE This is not the only crime for which A, B, and C can be prosecuted. The regulations also stipulate that a ‘competent person’ must be involved in the sperm donation (reg. 4(1)): ‘No person, except a competent person, may remove or withdraw a gamete or cause a gamete to be removed or withdrawn, from the body of a gamete donor for the purpose of artificial fertilisation’.

The terminology ‘removed or withdrawn’ is not only applicable to an egg donor, but to any gamete donor in general. This is made clear by the definition of ‘gamete donor’ that employs this terminology (reg. 1): ‘‘‘Gamete donor” means a living person from whose body a gamete or gametes are removed or withdrawn, for the purpose of artificial fertilisation.’

Accordingly, given that A, B, and C all caused sperm to the donated without the involvement of a ‘competent person’, they are all liable to be prosecuted on this additional criminal charge as well.

Involving a ‘competent person’ would only have been the first step towards legal compliance, as the regulations require that the ‘competent person’ must, before donation, obtain several pieces of information from the donor and ensure that, among other things, the donor has recently undergone a test for sexually transmitted diseases (STDs) (reg. 8(g)). Moreover, in cases where the donor and the intended mother are known to each other, both parties must submit to psychological evaluation (reg. 8(j)).

Discussion Zola[6] defines ‘medicalisation’ as the ‘process whereby more and more of everyday life has come under medical dominion, influence and supervision’. I suggest that the way in which the regulations deal with artificial insemination (AI), with gamete donation by a known donor, and with sperm donation is a case of over-medicalisation. The problem with the regulations is that they fail to treat different kinds of artificial fertilisation and gamete donation differently.

Artificial fertilisation The definition of artificial fertilisation is broad and encompasses a number of techniques. These range from a technique such as intracytoplasmic sperm injection, that requires among other things an embryology laboratory and skilled embryologists, to – on the other side of the spectrum – AI that can be done at home,[7] as per the hypothetical case study. There is no reason to legally require that the entire spectrum of artificial fertilisation techniques be medicalised.

A possible counter-argument may be that there is a risk that diseases, such as HIV, could be transmitted through AI.[8] However, the risk of such transmission is not sufficient reason to legally medicalise AI. If it were sufficient reason, unprotected consensual sexual intercourse should be medicalised for the same reason. The state surely has an interest in avoiding the transmission of disease, but it would be an obvious infringement on persons’ privacy to require the involvement of a ‘competent person’ (or any other type of healthcare practitioner) each time a person decides to have sexual intercourse.

The state has other means at its disposal to promote the avoidance of the transmission of disease, such as awareness campaigns. The same rationale applies to disease in the case of AI. Not only are privacy rights at stake, but also the right to establish a family (which is part of the right to human dignity),[9] and the right to protection against unfair discrimination. To add to the

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case study: consider a fertile heterosexual couple E and F, who are allowed to procreate without being legally obliged to spend time and money on having a ‘competent person’ involved in any way.

Why should A, B and C be expected to expend time and money on such a ‘competent person’ to perform the AI if they can perform the procedure themselves, in the privacy and comfort of home? The regulations obstruct the right of persons who use AI to establish a family; moreover, the regulations make it more difficult for lesbian persons to establish a family, which constitutes unfair discrimination.

Gamete donation Gamete donation can be categorised along two main lines: sperm v. eggs, and known donor v. unknown donor. I discuss the latter differentiation first. In cases where an intended mother must rely on an unknown donor, it makes sense – in the interests of the intended mother – to require the donor to provide relevant information, including the results of relevant medical tests, to the ‘competent person’. Such information is a substitute for knowing the donor personally. However, when the donor is known to the intended mother, the rationale for such information in principle falls away.

Consider, for instance, an intended mother who cannot conceive sexually with her husband, but who intends to use her husband’s sperm for in vitro fertilisation. Had she been fertile, she could have consented to using her husband’s sperm via sexual intercourse without her husband first having to provide certain information. This raises the issue of equal treatment of fertile and infertile persons.

While it can be argued that having access to her husband’s STD test results is to the benefit of the intended mother, this is an excessively paternalistic way to treat consenting adults. Given that the intended mother knows her husband (in the sense that he is not an unknown anonymous donor), she can request him to undergo STD tests as a precondition to using his sperm – irrespective of whether the couple plans to procreate via sexual intercourse or via artificial means. A rational approach would therefore dictate that, in the case of a donor that is known to the intended mother, the requirement that such a known donor must provide certain information to the ‘competent person’ should be suspended.

Instead of suspending this legal requirement, the regulations do the exact opposite, by in addition requiring that both the donor and the intended mother must submit to psychological evaluation.

This is a clear case of over-medicalisation. With reference to the case study, why should A, B and C be legally required to submit to (and spend the time and money on) an evaluation by a psychologist, if E and F (a fertile heterosexual couple) are allowed to procreate without having to be psychologically evaluated? The fact that in the case of a donor that is known to the intended mother, the regulations still require that such a known donor must provide certain information to the ‘competent person’ constitutes arbitrary legislation and unfair discrimination against lesbian persons; the additional requirement of the psychological evaluation adds fuel to the fire of unconstitutionality.

A further weakness of the regulations is that they fail to treat egg donation and sperm donation differently. While the process of retrieving eggs is a medical process – minor surgery – the retrieval of sperm for donation, by means of masturbation, is non-medical in nature. Accordingly, while egg donation requires the involvement of a relevantly qualified healthcare practitioner to effect the donation,

ARTICLE sperm donation does not require such involvement. In fact, a sperm donor’s right to privacy may require the opposite, namely that no person – including a healthcare practitioner – may be in the room while he is masturbating to donate sperm. There is no reason to legally require that sperm donation should be medicalised.

A possible counter-argument may be that the number of offspring from a single sperm donor should be limited, hence the need to involve a ‘competent person’. This counter-argument is paternalistic, as it assumes that sperm donors cannot abide by the law (the offspring limitation) by themselves, and need a healthcare practitioner to ensure such compliance. Such paternalism is clearly untenable in our constitutional dispensation that ascribes to the value of autonomy.

The fact that the regulations make the involvement of a ‘competent person’ incumbent for sperm donation is again a case of overmedicalisation.

Conclusion My argument should not be understood as advising against the involvement of a healthcare practitioner at the behest of the intended mother and the donor. This properly falls within the domain of autonomy of the intended mother and the donor. What I am arguing against is the over-medicalisation of artificial fertilisation and gamete donation – legally enforcing medical influence and supervision over artificial fertilisation and gamete donation without good (constitutionally aligned) reason. In other words, A, B and C should be free to make use of healthcare practitioners to assist them if

they so choose. However, the current regime that legally forces them – and all persons who are similarly situated – to submit to various kinds of medical influence and supervision is clearly without good reason, and hence unconstitutional and invalid.

In this article I have focused on the logical error of generalisation regarding artificial fertilisation techniques and the kinds of gamete donation that permeate the regulations, and the legal consequences such that the relevant aspects of the regulations that were discussed above fail the basic rationality requirement of the Constitution. I should note that this article is not exhaustive of all the unconstitutional and generally problematic aspects of the regulations. The regulations are in need of thorough review – especially from a constitutional perspective.

1. Pharmaceutical Manufacturers Association of South Africa and Another: In re Ex Parte President of the Republic of South Africa and Others, 2000 (2) SA 674, paras 84-86.

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

3. South Africa. National Health Act No. 61 of 2003. Regulations Relating to Artificial Fertilisation of Persons. GN R1165 GG 40312, 30 September 2016.

4. The National Health Act No. 61 of 2003.

5. J and Another v Director General, Department of Home Affairs and Others 2003 (5) SA 621 (CC).

6. Zola IK. Socio-Medical Inquiries. Philadelphia: Temple University Press, 1983;295.

7. Wikler D, Wikler NJ. Turkey-baster babies: The demedicalization of artificial insemination. Milbank Q 1991;69(1):5-40. http://dx.doi.org/10.2307/3350118 8. Guinan ME. Artificial insemination by donor: Safety and secrecy. JAMA 1995;273(11):890-891. http://dx.doi.org/jama.1995.03520350072033 9. Certification of the Constitution of the Republic of South Africa, 1996, 1996 (4) SA 744 (CC), para 100.

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ARTICLE

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

Strange (and incompatible) bedfellows: The relationship between the National Health Act and the regulations relating to artificial fertilisation of persons, and its impact on individuals engaged in assisted reproduction C van Niekerk, LLB, LLM Department of Private Law, Faculty of Law, University of the Western Cape, Cape Town, South Africa Corresponding author: C van Niekerk (cavanniekerk@uwc.ac.za)

Individuals are increasingly having recourse to assisted or artificial reproduction in order to realise their desire for offspring. This field is currently regulated by the National Health Act No. 61 of 2003 (NHA, or the Act) and the regulations relating to artificial fertilisation of persons, which form the framework legislation for assisted reproduction. Individuals having recourse to assisted reproductive technologies are therefore forced to engage with this legislation in one way or another. The challenge posed by the current legislative framework is that both the Act and the regulations are unclear and confusing. One could even go so far as to say that they are incompatible in some respects. Matters are further complicated when the Act and the regulations have to be applied alongside legislation such as the Children’s Act No. 38 of 2005.

The result is that legislation that is intended to provide legal certainty and clarity has the opposite result. This article considers the Act, its regulations and legislation that has bearing on assisted forms of reproduction. The aim of this analysis is to identify flaws and to provide suggestions for remedying potential defects, in order to produce legislation that not only creates legal certainty, but that is up to date and on par with advances in science and technology.

S Afr J Bioethics Law 2017;10(1):32-35. DOI:10.7196/SAJBL.2017.v10i1.524

The desire to produce offspring is as old as time. It is, in some instances, even considered integral to our identity as human beings. However, the reality exists that not everyone who desires offspring is able to reproduce naturally. There are those who are forced to resort to assisted reproduction to fulfil this desire. For them, the process of becoming parents is often not a smooth one. A road paved with a myriad of choices awaits them.

These include decisions regarding doctors, procedures and possibly donors. This process is further complicated by the existence of legislation which, instead of providing clarity on the options available to them, has the opposite effect. The legislation in question is the National Health Act No. 61 of 2003 (NHA, or the Act)[1] and the regulations relating to artificial fertilisation of persons (‘the regulations’)[2] promulgated under the NHA. This Act has been characterised as ‘flawed law’,[3] and the regulations are no different. What makes matters worse is the fact that some acts are reliant on these regulations in order to give them content. What follows is therefore an analysis of the NHA, the regulations and the Children’s Act No. 38 of 2005,[4] the aim of which is to identify flaws and to provide suggestions for remedying potential defects, in order to produce legislation that not only creates legal certainty, but which is up to date and on par with advances in science and technology.

The NHA The NHA was promulgated as a replacement for ‘the last vestige of apartheid in health policy’. It: ‘provides a framework for a structured and uniform health

system under which the various elements of the South African

(SA) national health system may be united in the common goal of improving universal access to quality health’.[5] The Act, consisting of 12 chapters, relies heavily on regulations to supplement its provisions. Chapter 8 alone has produced no less than 14 regulations[3] since it first entered into force on 1 March 2012. The reason for this is attributed to the fact that the NHA is: ‘framework legislation. This means that it sets out broad legal and operational principles that must be fleshed out in regulations’.[5] While this may be true, what is alarming is the fact that the numerous regulations were promulgated within a relatively short period of 5 years, which is both excessive and unacceptable.[3] This ‘proverbial flooding of the legislative plain’ is indicative of the fact that chapter 8 is ‘fatally flawed’.[3] It is further: ‘outdated and lags behind scientific development and progress, … contains factual errors, creates lacunae and hands the minister of health excessive authority and power’.[3] The first flaw identified can be found in section 55. This section, titled the ‘removal of tissue, blood, blood products or gametes from living persons’ states that ‘[a] person may not remove … gametes from the body of another living person’. It is interesting to note that while this provision requires consent from the donor, it limits the removal of gametes to living persons only. The challenge posed by this provision and the flaw inherent herein is discussed with reference to section 56.

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ARTICLE Section 56 provides that tissue, blood, blood products or gametes removed or withdrawn from living persons may only be used for such medical and dental purposes as may be prescribed. Artificial fertilisation is presumably a prescribed medical purpose. This assumption is drawn from the existence of an entire set of regulations dedicated to artificial fertilisation. Given the fact that it is medically possible to remove or withdraw tissue, blood, blood products or gametes from both the living and the dead (within certain time frames), it is interesting that section 55 limits the removal of gametes to the living. It is in this respect that chapter 8 of the NHA is ‘outdated and lags behind scientific development and progress’.[3] Evidence of this can be found in developments pertaining to assisted reproduction. Katz,[6] for example, observes that: ‘[f ]or over 30 years it has been possible to retrieve sperm from males who are deceased, brain dead, comatose or in a persistent vegetative state for use in procreation by the recipient’.[6] In fact, the first reported case of posthumous sperm retrieval occurred in 1980, which is more than 20 years prior to the promulgation of the NHA. That it is still not permitted under the NHA either confirms that the Act is outdated, in comparison with countries such as Israel, Belgium and the UK, where posthumous reproduction is allowed, or alternatively, it suggests that there are other reasons for ignoring the possibilities offered by these scientific developments.

Another criticism levelled against this section pertains to the ministerial authorisation for the removal or withdrawal of tissue, blood, a blood product or gametes. The problem with this provision is that: ‘ministerial approval is not ideal as the minister, or the delegated person acting on his or her behalf, often lacks the necessary knowledge regarding [assisted reproduction and assisted reproductive technologies to make an informed decision].

This may inhibit decision-making and ultimately has negative repercussions on the development of this branch of science in South Africa.’[3] It has been suggested, within the context of stem-cell research, that an independent body or specialist regulatory board be established to deal with such matters. [3] This recommendation applies equally to assisted reproduction and developments involving assisted reproductive technologies (ARTs). An independent body would be beneficial as this body could objectively assess which new developments within ART should be permitted, without undue influence from any entity with a vested interest in the outcome. Furthermore, all legislation involving technical areas such as ART should not be drafted exclusively by legal ‘experts’. The obvious lack of understanding displayed in the existing legislation suggests that medical expertise is a necessity in legislation of this nature, something which is clearly lacking. It has been suggested that: ‘[t]he importance of interdisciplinary co-operation in the drafting, interpretation and implementation of legislation in this area cannot be overemphasised’. [7] Section 57 serves as a prohibition on reproductive cloning. This term is defined in section 57(6)(a) as: ‘the manipulation of genetic material in order to achieve

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the reproduction of a human being and includes nuclear transfer or embryo splitting for such purpose’.

The problem posed by this provision is that other forms of genetic manipulation have developed that are not performed for the purpose of reproductive cloning. Mitochondrial donation or transfer is one such development. This treatment allows for the removal of DNA ‘from a patient’s egg or embryo containing unhealthy mitochondria to a donor’s egg or embryo containing healthy mitochondria’.[8] Based on the definition provided, there is a degree of manipulation of the genetic material, as well as activity involving nuclear transfer.

Such activity is ostensibly a violation of section 57. Bredenoord et al.,[9] however, disagree. They are of the opinion that a transfer of mitochondria does not produce genetically identical offspring.

As such, mitochondrial transfer does not constitute reproductive cloning[9] and should therefore be permitted.

What is evident from the current framing of section 57 is that it leaves unanswered the status of newer developments involving assisted reproduction. In this respect, the legislator would do well to amend the provision to provide clarity on the status of genetic manipulation conducted for reproductive, non-cloning purposes.

Such an amendment could specifically define and identify permissible forms of genetic manipulation conducted for reproductive, noncloning purposes.

Section 62(1)(a)(iii) of the NHA states that: ‘a person who is competent to make a will may ... donate his or her body or any specified tissue thereof to be used after his or her death’.

While this provision could have been interpreted as allowing posthumous gamete retrieval and subsequent reproduction, this possibility is quashed by the definition in the act that defines tissue as ‘human tissue … [which] excludes blood or a gamete’. This particular provision therefore puts paid to the possibility of posthumous reproduction.

The regulations Considering that: ‘the Act is flawed [a] person would thus wish to see these flaws addressed in the numerous regulations made in terms of the NHA. This is, however, not the case as the regulations have, rather than [clarified] some of the ambiguities and solved some of the issues, caused even further complications.’[3] This is sadly the case regarding the regulations relating to the artificial fertilisation of persons, despite the fact that these regulations have recently been amended. A number of flaws have been identified, which raises some concern for the use of assisted reproduction.

The first apparent flaw can be found in the title. The use of the term ‘artificial’ suggests that the process is an unnatural one. For individuals who pursue this option, it may be a last resort – and often a painful and difficult one, which should not be laden with negative connotations in the terminology used. It is suggested that the title be amended to the ‘regulations relating to the assisted reproduction of persons’.

A revision would clearly indicate the purpose for which these forms of ART are used. The term ‘assisted’ is also broad enough to include newer technologies that do not involve fertilisation but which are still integral to reproduction.

ARTICLE The second set of flaws lies in the definition section. This section defines artificial fertilisation as ‘the introduction by other than natural means’. Once again, this is a value judgement from persons who may not have grappled with infertility[10,11] or subfertility.[12] Additional definitions that are a cause of concern include ‘deceased’. This term is not used anywhere in the regulations, except in the definition section. Furthermore, the NHA defines ‘death’ as being brain dead. In contrast, the regulations define ‘deceased’ as meaning ‘somatic death’. While these terms mean the same thing, it is interesting to note that the regulations on more than one occasion opt for a more complex definition that does nothing in the way of providing clarity or understanding.

Furthermore, in the definition of gamete donor, reference is made only to living persons. This once again suggests that a gamete donor may not be a deceased person, regardless of whether consent has been obtained or not. The option of posthumous reproduction is thus ostensibly excluded.

The third flaw pertains to section 2 of the regulations, which unequivocally links the regulations to the withdrawal of gametes from living persons. The existence of this provision suggests that gametes may not be retrieved from deceased persons. Sadly, the exclusion of posthumous gamete retrieval (regardless of whether consent was given prior to death) means that for some individuals (such as a spouse who desires offspring that are biologically related to the deceased), this may represent a lost opportunity to reproduce entirely.

Section 13 deals with pre-implantation and prenatal testing for sex selection. This provision indicates that this procedure is prohibited (except in clearly defined instances), but is silent on the issue of whether it is permitted in other instances such as pre-implantation genetic diagnosis (PGD), for the purpose of creating saviour siblings.

However, this is potentially covered in the regulations regarding the use of human DNA, RNA, cultured cells, stem cells, blastomeres, polar bodies, embryos, embryonic tissue and small-tissue biopsies for diagnostic testing, health research and therapeutics.[13] What is interesting to note is that while these regulations relate to diagnostic testing, the creation of saviour siblings involves ‘artificial fertilisation’,[13] and is performed for the purpose of reproduction. The issue of PGD should as such be covered in the regulations, if only to advise prospective users of ‘artificial fertilisation’ that this option is not permitted by law.

Section 17 of the regulations deals with those instances where it comes to the attention of the parents that a child born as a result of ART suffers from an illness or defect. Presumably this provision relates to those instances where donor gametes have been used. This provision states that these defects or illnesses must be brought to the attention of the institution that effected the artificial fertilisation. The purpose of this notification is unclear. It raises the important question of whether liability will ensue and if so, who will be held liable: the institution or the donor? While the institution may be covered against financial claims of this nature, the possibility of delictual or contractual damages against donors may impact on the use of ART to facilitate reproduction.

Section 18 deals with the issue of the ownership of gametes, zygotes and embryos. This provision states that ownership of a zygote or embryo, after fertilisation has occurred, vests in the recipient regardless of whether the donor is male or female. The

challenge posed by this provision is that a zygote or embryo is the genetic product of two individuals. It is thus unclear whether the recipient is the male donor or female donor. Furthermore, in instances where zygotes or embryos have been cryopreserved and there is no identified recipient, in other words, where the genetic parents are uncertain whether they will use the zygote or embryo themselves, who does ownership belong to? The regulations on this score are unclear, and there is definitely room for legislative reform. While the regulations state that embryos will be discarded if a period of 10 years has passed and the embryos have not been claimed, the situation regarding the ownership of embryos where there is a dispute between the parties is similarly unclear.

Clearly the regulations are as perplexing as chapter 8 of the NHA is ‘confusing and incomplete’.[14] That said, the 2016 regulations are an improvement on the 2012 regulations[15] in at least two respects. Firstly, the term ‘surrogacy’, as defined in the 2012 regulations, has been omitted. The definition of this term had served as a source of confusion, as it did not appear to contemplate traditional or partial surrogacy. This was inconsistent with the Children’s Act, which provides for full or gestational as well as traditional or partial surrogacy. The definition was further problematic as it referred to ‘contractual parents’, which was a deviation from the ‘commissioning parents’ referred to in the Children’s Act. What is interesting to note in this regard is that the 2012 regulations were drafted after the Children’s Act was promulgated, and yet this appeared to have been done in isolation and without any regard for the legislation that would impact on them.

Secondly, section 6 of the 2012 regulations was a flawed and outdated provision. This section restricted the donation of gametes to a maximum of six children being conceived using the same gamete donor. The problem with this limitation was twofold. Firstly, there is a difference between the conception of six children, and six live births.[16] If the intention of the legislator was the latter as opposed to the former, then this intention was not relayed in the wording of section 6. Secondly, the number six was arbitrary and inconsistent with international trends.[16] The UK, for example, currently limits the use of donor gametes to 10 live births, while the Netherlands limits their use to 25.[16] In both these instances, the number arrived at was the result of country-specific population data.[16] Fortunately, this provision has since been replaced by section 7 of the 2016 regulations, which restricts the donation of gametes to 12 live births, and even permits this number to be exceeded to allow a family to have an additional child from the same donor. This is a marked improvement on the previous position.

Despite the improvements listed above, the incompatibility between the NHA and the regulations does not end there. The Children’s Act refers to certain forms of assisted reproduction in its provisions, which further highlights the lack of compatibility mentioned above.

The Children’s Act As the Children’s Act was promulgated after the NHA and before the regulations entered into force, one would expect that the Children’s Act would complement the NHA or that the regulations would complement the Children’s Act. While this is seemingly the case with all the provisions dealing with assisted reproduction, namely sections 40 and 41 of the Children’s Act, which relate to children

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ARTICLE conceived by artificial fertilisation, and chapter 19, which deals with surrogacy, it is not the case as far as the definitions are concerned. For example, artificial fertilisation is defined differently in the Children’s Act than it is in the regulations. In the Children’s Act, the emphasis is more on the way in which reproduction can occur than it is on the procedures by which it can occur. In addition, the term ‘surrogate’ in the Children’s Act is wide enough to accommodate both full and partial surrogacy, which was not the case in the definition provided for in the 2012 regulations. As mentioned, the now-removed definition of surrogate referred to ‘contracting parents’. This was inconsistent with the preferred term of ‘commissioning parents’ in the Children’s Act. Interestingly, the 2016 regulations omit the term entirely. This is worrying, as the NHA makes no reference to the term, and surrogacy involves artificial fertilisation. At the very least, this term should have been included in the 2016 regulations, although in an amended form.

While these inconsistencies are not fatal as far as assisted reproduction is concerned, they do suggest an incompatibility in the existing legislative framework, one which has the potential to frustrate those who engage in this form of reproduction.

Recommendations One of the challenges posed by assisted reproduction or the use of ART is the issue of how best to regulate it. In some instances, countries such as the UK have a system of regulation in place that attempts to address all concerns involving the use of ART.[17] In contrast, countries such as the USA adopt a very different approach, where there is minimal federal legislation.[17] Instead, there is a heavy reliance on guidelines that serve as guideposts for matters pertaining to ART. SA appears to be midway between these two extremes, and yet the legislation that exists is not comprehensive enough to adequately address the concerns raised, or to deal with newer developments in this field. What is therefore needed is a review of all legislation dealing with ART. The purpose of this would be to create comprehensive legislation that adequately governs this area. A model similar to that adopted by Canada is proposed. While the Canadian Assisted Human Reproduction Act of 2004 was struck down by the Supreme Court of Canada for ‘invading provincial jurisdiction’,[18] there is much that can be learnt from this model. One of the striking features of the Assisted Human Reproduction Act was the fact that it ‘addressed five of six major areas that constitute the typical policy space with respect to ARTs’.[18] These included embryonic research, reproductive cloning, assisted conception, surrogacy and offspring engineering. The only area omitted relates to the parentage policy, an area that is included in the UK’s ART legislation.[19]

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The second recommendation relates to the creation of an independent regulatory body, similar to the UK’s Human Fertilisation and Embryology Authority, which would have oversight over matters related to ART, and in particular, new technological advancements.

These two changes alone would go a long way toward creating legal certainty for those engaged in assisted reproduction, and toward ensuring that SA stays abreast of developments in the field.

1. South Africa. National Health No. Act 61 of 2003.

2. South Africa. National Health No. Act 61 of 2003. Regulations Relating to Artificial Fertilisation of Persons. Government Gazette No. 40312, 30 September 2016.

3. Prinsen L. Flawed law: A critical analysis of the faults and shortcomings of Chapter 8 of the National Health Act of 2003. Obiter 2013;34(3):522-532.

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

5. Ministry of Health. Briefing by Minister of Health, Dr Manto Tshabalala-Msimang on the National Health Act, 19 August 2004. http://www.polity.org.za/article/ tshabalalamsimang-national-health-act-19082004-2004-08-19 (accessed 7 March 2017).

6. Katz KD. Parenthood from the grave: Protocols for retrieving and utilizing gametes from the dead or dying. Univ Chic Leg Forum 2006;1:289-316.

7. Pepper MS. Medicine and the law: Partial relief from the regulatory vacuum involving human tissues through enactment of chapter 8 of the National Health Act and regulations thereto. S Afr Med J 2012;102(9):736-737. https://doi. org/10.7196/samj.5940 8. Human Fertilisation and Embryology Authority. Mitochondrial donation: An introductory briefing note. United Kingdom: Human Fertilisation and Embryology Authority, 1 October 2014. http://www.hfea.gov.uk/docs/201410-01_Mitochondrial_donation_an_introductory_ briefing_note_-_final.pdf (accessed 16 June 2016).

9. Bredenoord AL, Pennings G, de Wert G. Ooplasmic and nuclear transfer to prevent mitochondrial DNA disorders: Conceptual and normative issues. Hum Reprod Update 2008;14(6):669-678. http://dx.doi.org/10.1093/humupd/dmn035 10. World Health Organization. Infertility Definitions and Terminology. World Health Organization, 2016. http://www.who.int/reproductivehealth/topics/infertility/ definitions/en/ (accessed 7 March 2017).

11. Kruger TF, Botha MH. Clinical Gynaecology. 4th ed. Cape Town: Juta, 2011:337.

12. Gnoth C, Godehardt E, Frank-Herrmann F, Friol K, Tigges J, Freundl G. Definition and prevalence of subfertility and infertility. Hum Reprod 2005;20(5):1144-1147. http://doi.org/humrep/deh870 13. Du Plessis E, Govindjee A, van der Walt G. A legal analysis of ‘saviour siblings’ and ‘benefactor children’ in South Africa. Obiter 2014;35(2):224-253.

14. Pepper MS. Cell-based therapy – navigating troubled waters. S Afr Med J 2010;100(5):286-288. https://doi.org/10.7196/samj.4131 15. South Africa. National Health No. Act 61 of 2003. Regulations Relating to Artificial Fertilisation of Persons. Government Gazette No. 35099, 2 March 2012. (Published under Government Notice R175).

16. Dhai A. Editorial: Limiting donor conceptions to six: Time for change. S Afr J Bioeth Law 2014:7(1):2-3. https://doi.org/10.7196/sajbl.322 17. Stenger RL. The law and assisted reproduction in the United Kingdom and United States. J Law Health 1994;9(1):135-160.

18. Snow D, Knopff R. Assisted reproduction policy in federal states: What Canada should learn from Australia. University of Calgary: School of Public Policy, 2012. http://www.policyschool.ucalgary.ca/sites/default/files/research/dave-snowart-final.pdf (accessed 29 June 2016).

19. United Kingdom. Human Fertilisation and Embryology Act of 1990. United Kingdom, Parliament, 1990. http://www.legislation.gov.uk/ukpga/1990/37/ contents (accessed 7 March 2017).

ARTICLE Retraction Ethical issues in health promotion The article ‘Ethical issues in health promotion’, by J Gardner, which appeared in the South African Journal of Bioethics and Law in 2014 (SAJBL, 7(1):30-33), is hereby retracted due to terms of misunderstanding with regards to referencing style. The online version of the article was retracted on 26 January 2017.

S Afr J Bioethics Law 2017;10(1):36. DOI:10.7196/SAJBL.2017.v10i1.532

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CPD QUESTIONNAIRE

June 2017 True (A) or false (B): After Life Esidimeni: True human rights protections or lip service to the Constitution?

1. Negative attitudes towards people with mental disability as a result of prejudice and misinformation are major obstacles to providing care for them.

2. The Bill of Rights of the SA Constitution establishes the right to freedom and security of persons.

A global bioethical perspective on organ trafficking: Discrimination, stigmatisation and the vulnerable 10. International initiatives ground the rejection of organ trafficking mainly in the exploitative nature of the practice.

11. The principle of non-discrimination does not flow from the principle of equality.

Liver transplantation for non-resectable colorectal liver metastases at a single centre in South Africa: A report of the ethics and regulatory approval process 3. In SA, a relatively large number of organ transplants are performed annually.

4. It is not essential for research ethics committees

to identify who will bear the financial costs of clinical research.

Dare we rethink informed consent?

12. Freely given and informed consent is a purely legal requirement.

13. Legally, we may face litigation on grounds of assault if we manage a patient without her consent.

14. The ethical foundation of informed consent is that this shows respect for others as moral agents.

Incentives for HIV testing at the workplace in the auto­motive industry in the Nelson Mandela Bay Municipality: Ethical considerations 5. Most people living with HIV are in the most productive period of their lives.

6. Following a utilitarian line of argument, the use of otteries to encourage workplace HIV testing can be deemed morally justifiable.

Routine referrals: A possible solution for transplantation shortages 7. SA does not have an official deceased organ-donor programme.

8. The availability of transplantable organs is not nearly enough to supply the demand.

9. Organ donations in SA are regulated by the Human Tissue Act.

A constitutional critique on the regulations relating to artificial fertilisation of persons 15. Not all kinds of artificial fertilisation are required to be effected by a competent person in South African (SA) law.

16. SA regulations treat different kinds of artificial fertilisation and gamete donation differently.

17. SA regulations fail to treat egg donation and sperm donation differently.

Strange (and incompatible) bedfellows: The relationship between the National Health Act and the regulations relating to artificial fertilisation of persons, and its impact on individuals engaged in assisted reproduction 18. Posthumous reproduction is allowed in countries such as Israel, Belgium and the UK. 19. Section 57 of the National Health Act serves as a prohibition on reproductive cloning.

20. The Children’s Act provides for partial surrogacy only.

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: MDB015/171/02/2017 (Ethics)

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