Pro Life Campaign - Submission to Irish Medical Council Ethics Committee September 2007 by Pro Life Campaign

CONTENTS

Page INTRODUCTION

INDUCED ABORTION

Introduction

Present Guidelines

Approach to revising guidelines

General background:

Legal background The issues raised:

6 7

General

Legal and ethical permissibility

The clinical issues

The medical response

Would medical practice be impaired by total abortion ban

Negative Consequences of Abortion

Recommendations

EUTHANASIA (INCLUDING WITHDRAWAL OF FEEDING)

Introduction

General background:

Legal

Medical Council’s position

General background - withdrawal of feeding:

Legal

Medical Council’s position

Recommendations

IVF INCLUDING EMBRYO STORAGE AND FREEZING

Introduction

More recent developments

Are there particular issues to be addressed by the Council?

Control of IVF by Council

General considerations

Inadequacy of pre-1998 Guidelines

Treatment of certain embryos

Should embryo freezing or storage be permissible?

The 2004 Guidelines 24.1, 24.2, 24.3, 24.4, 24.5

Guidelines 24.5 on In Vitro Fertilisation

Recommendations

OTHER MATTERS

Abortion Assistance & Referral

Introduction

General background:

Legal

The Abortion Information Act, 1995

Abortion Information Act - provisions and interpretation

Contradiction

Dual Patient model

Recommendations

SUMMARY OF RECOMMENDATIONS

CONCLUSION

INTRODUCTION

The Pro-Life Campaign is a non-denominational lobby group drawing its support from a wide cross-section of Irish society. The Campaign promotes pro-life education and defends human life from unjust attack at all stages, from conception to natural death. It also campaigns for resources to support and assist pregnant women and those in need of healing after abortion.

This submission to the Ethics Committee of the Medical Council deals with five major areas: abortion, abortion assistance, euthanasia and the withdrawal of feeding and the protection of human embryos.

Each chapter of the submission is laid out in a similar format â&#x20AC;&#x201C; a short general introduction setting the background to the chapter topic, followed by more detailed background information and an ethical and legal appraisal of the issues raised therefrom.

Each chapter ends with a number of short recommendations that the Pro-Life Campaign would urge the Ethics Committee to adopt in its revision of the Medical Councilâ&#x20AC;&#x2122;s A Guide to Ethical Conduct and Behaviour and to Fitness to Practice.

INDUCED ABORTION Introduction In Ireland, the unborn child has for centuries been regarded as worthy of legal protection. The Offences Against the Person Act 18611 prohibits abortion under threat of penal sanction. In the 1983 referendum, the people approved the insertion of Article 40.3.3o (the Eighth Amendment) into the Constitution whereby â&#x20AC;&#x153;the State acknowledges the right to life of the unborn and, with due regard to the equal right to life of the mother, guarantees in its laws to respect and, as far as practicable, by its laws to defend and vindicate that rightâ&#x20AC;?. Given the circumstances of the insertion of this assertive amendment into the Constitution, it was considered at the time to copperfasten the legal prohibition on induced abortion. However, following the decision of the Supreme Court in the Attorney General v X and others (1992)2 it now appears that induced abortion, in certain circumstances, is lawful in this jurisdiction. However, the X case judgement is notoriously difficult to interpret as a basis for legislation. The commendable attempt to correct the situation in the March 2002 referendum failed, amid unparalleled public confusion, but the result clearly showed a national majority opposed to induced abortion in the Republic under any circumstances.

Present Guidelines The 1998 Ethical Guidelines of the Medical Council on induced abortion (Section 26.5) read:

The Child In Utero The deliberate and intentional destruction of the unborn child is professional misconduct. Should a child in utero suffer or lose its life as a side effect of standard medical treatment of the mother, then this is not unethical. Refusal by a doctor to treat a woman with a serious

Sections 58 and 59.

1992 1 IR 1.

illness because she is pregnant would be grounds for complaint and could be considered to be professional misconduct.

That guideline was a satisfactory and concise statement of the principles involved. It is unusual for guidelines to be changed in a Councilâ&#x20AC;&#x2122;s mid-term, especially when there is no pressing need to do so. However, after a bizarre series of divisive confrontations in 2001, the Council altered Section 26.5 of the 1998 Guide on 12th September 2001 to read as follows (which then became Section 24.6 of the 2004 Guidelines):

The Child In Utero The Council recognises that termination of pregnancy can occur when there is a real and substantial risk to the life of the mother and subscribes to the views expressed in Part 2 of the written submission of the Institute of Gynaecologists and Obstetricians to the All-Party Oireachtas Committee on the Constitution as contained in the Fifth Progress Report, Appendix IV, page A407.

This is reinforced by Clause 24.1 in the present 2004 Guidelines.

This is not as clear a statement of principle as what it replaced but is acceptable in light of the meaning of the Obstetricians and Gynaecologists statement on which it relies. It is important to note that termination of a pregnancy is not the termination of a life where the child is deliberately targeted, disregarding, of course, the common usage of that word. Births and caesarean sections terminate pregnancies as do interventions in eclampsia, pre-eclampsia et cetera, but they do not deliberately terminate lives.

Approach to revising Guidelines The PLC suggests to the Medical Council that the revision of the Ethical Guidelines be approached from the following standpoint:

1. The recognition that human life, born or unborn, is worthy of protection; 2. The presumption that in pregnancy the doctor has a duty of care towards two patients, the mother and the unborn child. 3. That the availability of induced abortion is a social question, not one of medical necessity; 4. That the onus of proof is upon those who propose induced abortion to produce evidence that there is no absolutely alternative.

In the light of this, the Pro-Life Campaign suggests that the following additions to the Guide may clarify the matter beyond even unreasonable doubt:

1. A positive re-statement of the line that in pregnancy the doctor has a duty of care towards two patients, the mother and the unborn child; 2. An affirmation of the principle that necessary treatments which carry a risk of unsought side effects are ethical even when the unsought effects are foreseeable, while procedures the purpose of which are to cause the death of a patient are unethical.

General Background The Legal Background Notwithstanding the statutory prohibition on abortion contained in the Offences Against the Person Act 1861 and the terms of the Eighth Amendment to the Constitution, in X – a 1992 case (involving a minor’s alleged suicidal intentions) – the Supreme Court concluded

“that the proper test to be applied is that if it is established as a 6

matter of probability that there is a real and substantial risk to the life, as distinct from the health, of the mother, which can only be avoided by the termination of her pregnancy, such termination is permissible, having regard to the true interpretation of Article 40.3.3. of the Constitution.”

The rest of the Supreme Court judgements in X offer no guidance as to how this opaque ‘test’ is to be applied in practice. Nor did the Court consider – nor did it have the opportunity to consider – the clinical reality of induced abortion known at that time and since articulated in Medical Council ethical guidelines.

Since that case, different Governments took different approaches to the issue. Following the rejection of the November 1992 referendum that allowed for direct abortion along the lines envisaged in X (excluding suicide threats); A commitment to legislate for X was later recognised as ‘very difficult, if not impossible’3 and the commitment was dropped from subsequent programmes for government. The narrow rejection of the 2002 Referendum indicated that there was a majority opposed to induced abortion being carried out in Ireland in any circumstances and also showed great concern for unimplanted human embryos.

The Issues Raised General It is widely accepted that good ethical medical practice must always be based upon principle. Ad hoc arrangements rather than responses based on principle and ethics for dealing with any given situation could readily lay the medical profession open to the charge of inconsistency at least and of being self-serving at worst and would threaten the profession’s deserved reputation for impartiality and the provision of medical care regardless of the class, creed, lifestyle and ethnic origins of the patient and the doctor’s own personal feelings towards him or her.

Health Minister Brendan Howlin, The Irish Times, 25 November 1994

Legality and Ethical Permissibility The rule of law aims to serve society at large, while simultaneously upholding the rights of the individual, insofar as they do not conflict with essential societal interests. Whereas some unethical acts may be illegal, legality alone does not determine whether a practice is ethical or not.

The Council’s 1994 Guidelines emphasised that: “In this whole area of conflicting attitudes [referring to reproductive medicine generally], doctors while obeying the laws of the State, must always be guided by their own informed consciences.”

And the 1998 & 2004 guideline, now in force, holds the same independent line: “Medical care must not be used as a tool of the State, to be granted or withheld or altered in character under political pressure. Doctors require independence from such pressures in order to carry out their duties. Regardless of their type of practice, the responsibility of all doctors is to help the sick and injured. They must practice without consideration of religion, nationality, gender, race, politics or social standing. They must not allow their professional actions to be influenced by any personal interest”.

The Clinical Issues The most frequent arguments for induced abortion in the debate since 1992 are the supposed risks to the health or life of the mother. Other arguments e.g. congenital handicap in the unborn child or the economic burden to society, raise broader issues. As such, although the Pro-Life Campaign similarly opposes such arguments, for the purposes of this submission, they fall outside the parameters of the medical debate on induced abortion and have no bearing on the right to life of the mother.

The Medical Response The issue of whether induced abortion is in some cases necessary to save a mother’s life or health has been discussed extensively. As the Medical 8

Council’s 1994 Guidelines pointed out, no evidence has been produced to support this position. The Pro-Life Campaign has continued to monitor the national and international literature on the topic, and is satisfied that this remains the case. By the word “abortion”, the Pro-Life Campaign means induced abortion directly and deliberately targeting the life of the unborn child, not where the unborn child is indirectly affected by proportionate and necessary treatment of the mother. Deliberately induced abortion has no place in the treatment of any maternal condition, either physical or psychological.

Would medical practice be inhibited by a complete prohibition on induced abortion? Concern was expressed that a medical practitioner may find himself/herself falling foul of a total professional or legal prohibition on induced abortion in the ordinary course of good ethical clinical practice. In our view, such concerns are unfounded.

Foreseeability is not the test of intention in a prohibition on induced abortion. In everyday clinical practice, harm or injury to a patient is readily foreseen as a consequence of medical intervention. Nevertheless, especially in instances of life-threatening conditions, it is perfectly permissible to use treatments that are associated with serious or even life threatening side effects. In such circumstances, the doctor’s judgement may well be that it is proper to incur grave risks in the management of grave conditions. For example, in the treatment of leukaemia, induced myelosuppression exposes the patient to risks of overwhelming sepsis and severe haemorrhage. Nevertheless, in the circumstances, such risks are assessed as acceptable in terms of the desired outcome of cure. However, the medical and ethical principle governing such decisions is that the therapeutic option chosen must be the most effective and least toxic. Thus, if there are two treatments, Treatment A and Treatment B, of equivalent therapeutic efficacy, the ethical obligation is to choose the one associated with the least severe side effects. This is an essential component of ethical practice but does not, of itself, preclude running serious risks in grave conditions.

In summary, the risks of treatment must be proportionate to the condition being treated. In pregnancy, where uniquely, there is a simultaneous duty to two patients, a fortiori, these considerations apply – with due regard to side effects not alone to the mother but also to her unborn child. In no circumstances, however, is it permissible to compromise the therapeutic objective merely by virtue of the mother’s pregnancy. In this regard, the Council’s current position on induced abortion reflects the reality but could be strengthened to make the principles more explicit and clarify them. .

Foreseeability, in effect, is merely a matter from which, depending on the circumstances, an inference of intention may be drawn. However, it does not follow that an act which causes the foreseeable death of a patient may be excused, merely because what was intended was the relief of some condition, e.g. severe pain or depression. Thus, if the death of the patient was a ‘treatment’ or an intrinsic part of the ‘treatment’ of the condition in question, liability, both ethical and legal, attaches. A clear judicial expression of the underlying principle, in a case involving a charge of attempted murder of a patient by her consultant physician, which encapsulates the essentials of ethical (and lawful) treatment was stated thus:

“We all appreciate … that some medical treatment, whether of a positive, therapeutic character or solely of an analgesic kind … designed solely to alleviate pain and suffering, carries with it a serious risk to the health or even the life of the patient. Doctors … are frequently confronted with, no doubt, distressing dilemmas. They have to make up their minds as to whether the risk, even to the life of their patient, attendant upon their contemplated form of treatment, is such that the risk is or is not medically justified. Of course, if a doctor genuinely believes that a certain course is beneficial to his patient, either therapeutically or analgesically, even though he recognises that that course carries with it a risk to life, he is fully entitled, nonetheless to pursue it. If sadly, and in those circumstances the patient dies, nobody could possibly suggest that in that situation the doctor was guilty of murder or attempted murder. …

There can be no doubt that the use of drugs to reduce pain and suffering will often be fully justified notwithstanding that it will, in fact, hasten the moment of death, but … what can never be lawful is the use of drugs with the primary purpose of hastening the moment of death. … It matters not by how much or by how little [a] death is hastened or intended to be hastened … even if [it be the case that death was only hours or minutes away] no doctor can lawfully take any step deliberately designed to hasten that death by however short a period of time. … Alleviation of suffering means the easing of it for so long as the patient survives, not the easing of it in the throes of and because of deliberate purposed killing.”4

There is no reason to suggest that the courts in this jurisdiction would differ from this statement of the law in its articulation of the underlying principles in relation to the death of an unborn child during the course of the treatment of an ill mother especially given the delimitation on the vindication of the right to life of the unborn by considerations of reasonable practicability. The approach that informs the Medical Council’s 1998 Guidelines on induced abortion also reflects the principles underlying this analysis and again urges its retention.

Negative consequences of abortion Rather than encourage abortion, the medical profession has a responsibility to take seriously the growing body of evidence showing the negative after-effects of abortion on women. Most early studies of the effects of abortion on women were limited to the immediate post-abortion period. Now long-term studies are giving a clearer picture. One such study was published in 2006 in the Journal of Child Psychology and Psychiatry.5 This was a 25 year longitudinal study which showed that women having an abortion had elevated rates of subsequent mental health problems including depression, anxiety, suicidal behaviours and substance use disorders. This association persisted after adjustment for confounding factors. The main author of this New Zealand

R v Cox 12 BMLR 38 (Winchester Crown Court per Ognall J and approved in Airedale NHS Trust v Bland 1993 1 All ER 821 (HL).

Fergusson DM, Horwood LJ, Ridder EM, Abortion in young women and subsequent mental health, Journal of Child Psychology and Psychiatry, 47 (2006), 1: 16-24.

study, Prof. David Fergusson admitted: “I’m pro-choice but I’ve produced results which, if anything, favour a pro-life viewpoint”. An earlier study in Finland6 examined data from 1987-2000 and highlighted the fact that the suicide rate was almost seven times higher in women who had abortions compared to those who gave birth. This is particularly relevant to the Irish situation given the calls for abortion to be legalised on grounds of threatened suicide. A recent Norwegian study found that women after induced abortions suffered more long-term after effects than those who had miscarriages. 7 These latest findings oblige medical practitioners to give full information to patients about the medical consequences of abortion.

Mika Gissler, Cynthia Berg, Marie-Hélène Bouvier-Colle, and Pierre Buekens, Injury deaths, suicides and homicides associated with pregnancy, Finland 1987-2000, The European Journal of Public Health 2005 15: 459-463.

Anne Nordal Broen, Torbjørn Moum, Anne Sejersted Bødtker and Øivind Ekeberg, The course of mental health after miscarriage and induced abortion: a longitudinal, five-year follow-up study, BMC Medicine 2005, 3:18

Recommendations That the revised Ethical Guidelines maintain the formulation of 12th September 200 1, Clause 24.6 and 24.1 in 2004 guidelines, but, in other clauses, assert: 1. The principle that in pregnancy the doctor has a duty of care towards two patients, the mother and the unborn child; 2. The principle that necessary treatments which carry a risk of unsought side effects are ethical, even when the unsought effect is foreseeable, while procedures the purpose of which are to cause the death of a patient are unethical. 3. Induced abortion does not constitute â&#x20AC;&#x153;medical treatmentâ&#x20AC;? in any circumstances. 4. Therapeutic convenience is never a sufficient justification for induced abortion and the adoption of such an approach is unethical. 5. Medical ethics do not follow each change in the law and mere legality is not equivalent to ethical practice.

6. A prohibition on induced abortion is both feasible and ethically necessary, and has not resulted in the treatment appropriate for the management of any ill mother

being compromised in any way.

EUTHANASIA Introduction In 1994, the Medical Council in A Guide to Ethical Conduct and Behaviour and to Fitness to Practise stated its position in relation to euthanasia as defined therein. The Pro-Life Campaign welcomes the evolution of the Council’s treatment of the issue over the past fifteen years and specifically endorses the approach, which firmly places a prohibition on a medical practitioner’s involvement in euthanasia within an ethical framework irrespective of what the current legal situation might be. The Pro-Life Campaign urges the Medical Council to re-assert the traditional opposition of the medical profession to euthanasia and to further strengthen the profession’s protection of chronically and terminally ill patients by stressing the relevance both of intention and directness in the prohibition of killing, or causing the deaths of, such patients. In the 1998 Guidelines, the principles are adequately covered in Sections 24 & 25 and in the 2004 Guidelines in Sections 22.1 and 23.1.

General Background - Euthanasia The Legal Background Euthanasia is, and has always been, illegal in Ireland. Involving, for medical practitioners, as it does, the direct and intentional killing of a patient, it falls within the general prohibition on homicide within the general law. Thus, briefly put, a person is guilty of murder if (s)he, while intending to kill another or to cause him or her serious injury, acts in a way that results in that other person’s death within a year and a day of the date upon which the injury was inflicted. However, because of a curious anomaly in the law, omissions that have the same effect, except in certain limited circumstances, do not result in criminal liability. In this regard, the law presumes (although it is a refutable presumption) that a person intends the natural and probable consequences of his or her actions8 (as distinct from omissions).

Criminal Justice Act 1964 s. 4.

However, that is not to say that foreseeability, in this context, is the test of intention. Interestingly, the principle which underlines the treatment of terminally ill patients is the same as that which governs the treatment of illness in pregnant women, and would equally benefit from an explicit affirmation that necessary treatments which carry a risk of unsought side effects are ethical, even when the unsought effect is foreseeable, while procedures which lead directly and intentionally to a patient’s death are unethical.

In this regard, the Pro-Life Campaign herein repeats the arguments advanced in considering procedures to save a pregnant woman’s life, which may indirectly damage the unborn child. Thus, in everyday clinical practice, harm or injury to a patient is readily foreseen as a consequence of each and every diagnostic or therapeutic intervention. Nevertheless, in instances of serious or life-threatening conditions, it is perfectly permissible to use treatments that carry a risk of serious or even life threatening side effects. In such circumstances, the doctor’s judgement may be that it is proper to incur grave risks in the management of grave conditions. Thus, for example, in the treatment of leukaemia, induced myelosuppression exposes the patient to the risks of overwhelming sepsis and severe haemorrhage. Nevertheless, in the circumstances, such risks are deemed acceptable in terms of the desired outcome. However, what is intrinsic to such treatment decisions is that the therapeutic option chosen must be the most effective and least toxic. Thus, if there are two treatments, Treatment A and Treatment B, of equivalent therapeutic efficacy, the ethical obligation is to chose that which is associated with the least severe side effects. This is an essential component of ethical practice but does not, of itself, preclude running serious risks in grave conditions. In summary, the risks of treatment must be proportionate to the condition being treated.

Foreseeability, in effect, is merely a matter from which, depending on the circumstances, an inference of intention may or may not be drawn. However, it does not follow that an act that causes the foreseeable death of a patient may be excused, merely because what was intended was the relief of some condition, e.g. severe pain or depression. Thus, if the death of the patient was a ‘treatment’ or an intrinsic part of the ‘treatment’ of the condition in question, the doctor would have moral and legal culpability for the death. 15

It has already been proposed in this submission that this principle might be usefully incorporated in the section of the Guide pertaining to Ethical Conduct. It is also worth reiterating the clear judicial expression of the underlying principle, in a case involving a charge of attempted murder of a patient by her consultant physician, which encapsulates the essentials of ethical (and lawful) treatment was stated thus:

the easing of it for so long as the patient survives, not the easing of it in the throes of and because of deliberate purposed killing.”9

As already suggested, there is no reason as to why the approach of the courts in this jurisdiction would differ from this statement of the law in its articulation of the underlying principles in relation to euthanasia, especially given the constitutional guarantees of the right to life of the citizen. Council’s Position The Medical Council, in A Guide to Ethical Conduct and Behaviour and to Fitness to Practise has repeatedly asserted the duties of medical practitioners in regard to dying patients. Thus, for example, in the 1984 edition of the guide, it asserted: “Where death is imminent, it is the doctor’s responsibility to take care that a patient dies with dignity and with as little suffering as possible. Euthanasia involves actively causing the death of a person and is illegal.”

In the 1989 edition the final sentence of this statement was amended to read: “Euthanasia, which involves actively causing the death of a person, is illegal in Ireland and is professional misconduct. In the 1994 edition, the final sentence was further amended as follows:

“Euthanasia, which involves deliberately causing the death of a patient, is professional misconduct and is illegal in Ireland.” This was strengthened in the 1998 edition.

In the 2004 edition, the prohibition on euthanasia is contained in two sections:

22.1 For the seriously ill patients who is unable to communicate or

R v Cox 12 BMLR 38 (Winchester Crown Court per Ognall J and approved in Airedale NHS Trust v Bland 1993 1 All ER 821 (HL).

understand, it is desirable that the doctor discusses management with the next of kin or the legal guardians prior to reaching a decision about the use or non-use of treatments which will not contribute to recovery from the primary illness. In the event of a dispute between doctors and relatives, a second opinion should be sought from a suitably qualified independent medical practitioner. Access to nutrition and hydration remains one of the basic needs of human beings, and all reasonable and practical efforts should be made to maintain both of them.

23.1. Where death is imminent, it is the responsibility of the doctor to take care that the sick person dies with dignity, in comfort, and with as little suffering as possible. In these circumstances, a doctor is not obliged to initiate or maintain a treatment that is futile or disproportionately burdensome. Deliberately causing the death of a patient is professional misconduct.

It is clear from both the precision of the definition of euthanasia which has evolved in the Medical Council’s guide over the past fifteen years, which avoids doubt as to the subject matter of the prohibition, and the firm placing of that prohibition within an ethical, as distinct from a solely legal, framework, that the Medical Council was properly concerned with euthanasia as an ethical issue, quite irrespective of what the prevailing law might happen to be.

Indeed, the Medical Council has gone further in this regard. In a statement issued by the Council after its statutory meeting on August 4, 1995, the Council drew attention to, and emphasised other provisions of the 1994 guide. Thus, the Council noted paragraph 13.01 which states inter alia:

“ … Doctors must do their best to preserve life and promote the health of the sick person … and paragraph 12.05; of the 1994 Guide as follows:

“Medical care must not be used as a tool of the State to be granted 18

or withheld or altered in character under political pressure, Regardless of the type of their practice, the responsibility of all doctors is to help the sick and injured. Doctors must practise without consideration of religion, nationality, race, politics or social standing. Doctors should not allow their professional actions to be influenced by any personal interest”

The Council also drew attention to the provisions of Article 2 of the Principles of Medical Ethics in Europe which states:

“In the course of his professional practice a doctor undertakes to give priority to the medical interest of the patient. The doctor may use his professional knowledge only to improve or maintain the health of those who place their trust in him; in no circumstance may he act to their detriment.”

and to Article 4 which states inter alia:

“ …The doctor must not substitute his own definition of the quality of life for that of his patient….”

General Background – Withdrawal of feeding On July 27, 1995, a majority of the Supreme Court upheld an earlier order of the High Court that it was lawful to withdraw feeding from a seriously handicapped woman – described as being in a ‘near permanent vegetative state’ - in order that she might die.10 Although similar problems had previously come before the courts in other jurisdictions, this was the first such case in Ireland and focused attention not alone on an intensely difficult human dilemma but also on conflicts between medical and legal analyses of the same issues. At its statutory meeting on August 4, 1995, the Medical Council considered the decision of the Supreme Court in re a Ward of Court. In a statement

In the matter of A Ward of Court (withholding medical treatment) (No. 2) [1996] 2 IR 100.

issued after the meeting, the Medical Council drew attention to A Guide to Ethical Conduct and Behaviour and to Fitness to Practise and, having emphasised a number of particular paragraphs, already set out above, in relation to a medical practitioner’s duty of care and euthanasia, stated:

“It is the view of the Council that access to nutrition and hydration is one of the basic needs of human beings. This remains so even when, from time to time, this need can only be fulfilled by means of long established methods such as nasogastric and gastrostomy tube feeding. The Council sees no need to alter its Ethical Guide.”

The Pro-Life Campaign wholly endorses the position adopted by the Medical Council and urges the express re-affirmation of the underlying principle in the revised Guidelines.

Recommendations That the revised Ethical Guidelines assert: 1. The prohibition on euthanasia, in the clear and robust terms of the 1998 and 2004 Guides. 2. A re-statement of the Medical Councilâ&#x20AC;&#x2122;s position on the withdrawal of feeding in line with its statement of August 4, 1995. 3. A continuation of the Medical Councilâ&#x20AC;&#x2122;s independent stance on the issues of euthanasia and the withdrawal of feeding notwithstanding the effective change in the law in relation to euthanasia consequent on the decision of the Supreme Court in the Ward case. 4. An express statement that any complicity of a medical practitioner in the withdrawal of feeding from a chronically ill patient with the intention or purpose that the patient will die as a result is unethical and will attract such sanctions as the Medical Council sees fit to impose. 5. An affirmation, (perhaps in the section on Ethical Conduct), of the principle that necessary treatments that carry a risk of unsought side effects are ethical, even when the unsought effect is foreseeable, while procedures intended to cause the death of a patient are unethical.

IVF INCLUDING EMBRYO FREEZING AND STORAGE Introduction On the 31st May 1985, it was reported in the medical press that three Irish women had been successfully implanted in Ireland with ova fertilised in vitro. The work, carried out by Prof. Robert Harrison, Consultant Gynaecologist, in St. James' s Hospital and Sir Patrick Dun' s Hospital involved two campuses, as equipment in each was essential.

In July 1985, the then Minister for Health, Barry Desmond, announced in the DĂĄil that his department would examine the issue with a view to legislation. One month later, in August 1985, a conference on the ethical and legal issues in IVF was held in Maynooth. The Board of St. James' s Hospital imposed a moratorium on further IVF work in St. James' s, pending the outcome of an inquiry by a Board sub-committee into the matter. The Medical Council, by a majority decision in December 1985 approved the guidelines on IVF promulgated by the Institute of Obstetricians and Gynaecologists of the Royal College of Physicians of Ireland.11 This effectively delayed the re-introduction of IVF in St. Jamesâ&#x20AC;&#x2122;s until January 1986 at which point, however, the IVF debate in Ireland, what little there was, had been effectively completed.

The Medical Council subsequently approved the therapeutic application to married couples of the revised guidelines on IVF of the Institute of Obstetricians and Gynaecologists of the Royal College of Physicians of Ireland.12

More Recent Developments By 1998, it increasingly appeared from the medical press that embryo storage was considered desirable from a clinical and patient standpoint. A sub-

A Guide to Ethical Conduct and Behaviour and to Fitness to Practise (Third Edition) approved by the Medical Council at its meeting on 7th October 1988 and published in March 1989.

A Guide to Ethical Conduct and Behaviour and to Fitness to Practise (Fourth Edition) approved by the Medical Council at its meeting on 1st October 1993 and published in January 1994

committee of the Institute of Obstetricians and Gynaecologists of the Royal College of Physicians of Ireland met to review its guidelines on IVF and as it reached no agreed conclusions its Report was not published. In the meantime the HARI Unit at the Rotunda Hospital in Dublin unilaterally proceeded with freezing human embryos and even allegedly had clients sign “agreements” that “unwanted human embryos” would be destroyed after five years. This would, of course, be clearly unethical, illegal and opposed to the present Guidelines. Clearly, the issue of freezing and storage of human embryos, as opposed to the freezing of sperm and ova, will have to be seriously addressed by the Medical Council and sanctions imposed. It is in this context and in the context of disturbing and uncontroverted media reports regarding abuses in IVF in Ireland that the Pro-Life Campaign makes this submission to the Medical Council.

The inadequacy of previous guidelines It is of great concern that the guidelines promulgated by the Institute of Obstetricians and Gynaecologists of the Royal College of Physicians of Ireland and approved by the Medical Council in 1994 were merely exhortatory in nature. The language, couched in subjunctives and in terms of proposed and recommended best practice, seemed devoid of any imperative force and apparently relied on a benign self-regulatory environment for adherence. There were significant changes between the guidelines in the 1989 and 1994 editions of the Medical Council’s Guide to Ethical Conduct and Behaviour and to Fitness to Practise. For example, guideline number 2 in the 1994 edition provided as follows:

“All fertilised embryos produced by IVF should be replaced, optimally this should be three in any treatment cycle”

whereas the previous guideline required that

“All fertilised embryos produced by IVF should be replaced in the potential mother' s uterus.”

Leaving to one side the slightly difficult concept of who constitutes a “potential mother” in this context, given what has gone before, the fact of the deletion to the ‘mother’s uterus’ cannot be wholly without effect.

Should embryo storage or freezing be permissible? Rapidly developing technologies and the willingness of certain practitioners to seek loopholes in the Ethical Guidelines make this revision particularly relevant.

A definitional problem arises in respect of what constitutes, what is unhappily referred to as, a ‘spare embryo’. Thus, it is unclear as to whether it represents the excess above the three that it is recommended be implanted in any given treatment cycle or an embryo which is simply surplus to requirements, at the election of either of the ‘parents’ or IVF medical specialist. Unfortunately, the exhortatory language used in 1994 made it difficult to interpret this provision. There was concern that the guidelines raised the possibility that there was a difference between a fertilised ovum and an embryo. There was further concern that the guidelines did not contain an express prohibition on research on embryos not produced specifically for that purpose and on the storage of embryos for any purpose.

In this context, any express and favourable consideration of proposals for the storage or freezing of human embryos by the Medical Council would compound the underlying unsatisfactory nature of the regulation of IVF in Ireland. Moreover, it would further compromise the right to life of countless further embryos by exposing them to conditions minimising or significantly reducing their chances of survival.

It is disingenuous to justify the storage or freezing of human embryos on the basis that it is either ‘pro-life’ or represents a ‘pro-life strategy’. Apart from the very dramatic lessons that can be learned from the British experience in this regard, the storage of a human embryo is not ‘pro-life’ – it merely tolerates the existence of the unborn human involved without respecting its right to life and, in circumstances where there is no guarantee that its right to life will ever be respected. In the circumstances, the storage of human embryos is fundamentally violative of the constitutionally protected right to life of the 24

unborn enshrined in the Eighth Amendment of the Constitution. The Medical Council might consider adopting, as a statement of ethical principle, the affirmation at its April 1996 Annual General Meeting by the Irish Medical Organisation that the freezing of embryos is inconsistent with the medical professionâ&#x20AC;&#x2122;s long-held tradition of respect for human life at all stages of development.

The R versus R case before the Supreme Court will examine the current legal status of frozen human embryos but, as stated already, the courts determine what is legal, not what is ethical. Hence whatever the decision of the court in this matter it will not negate the ethical requirement for respect of all life from conception to natural death.

THE CURRENT 2004 GUIDELINES

24.1

In this rapidly evolving and complicated area the Council reminds

doctors of Reproductive Medicine their obligation to preserve life and to

promote health. The creation of new forms of life for experimental purposes or the deliberate intentional destruction of human life already formed is professional misconduct.

24.4

Frozen Sperm and Ova

There is no objection to the preservation of sperm or ova to be used subsequently on behalf of those from whom they were originally taken. Doctors who consider assisting with donation to a third party must have regard to the biological difficulties involved and pay meticulous attention to the source of the donated material. Doctors who fail to counsel both donor and recipient thoroughly about the potential social, medical and legal implications of such measures and the possible consequences for the would-be parents and their baby could face disciplinary proceedings.

24.5

In Vitro Fertilisation (IVF)

Techniques such as IVF should only be used after thorough investigation has failed to reveal a treatable cause for the infertility. 25

Prior to fertilisation of an ovum, extensive discussion and counselling is essential. Any fertilised ovum must be used for normal implantation and must not be deliberately destroyed. If couples have validly decided they do not wish to make use of their own fertilised ova, the potential of voluntary donation to other recipients may be considered.

The last paragraph in the 2004 Guidelines contradicts the essence of the 1998 guidelines in that it implies acceptance of freezing embryos where the 1998 guidelines did not. This paragraph should be dropped from the new guidelines. The new guidelines should also clarify that using human embryos as a source of stem cells either for research or therapeutic purposes is unethical as it constitutes an attack on the life of the embryo.

After all, there can be no doubt that the human embryo is alive and unborn. The embryo is not potential human life - it is human life with potential, albeit fragile and dependent. The suggestion that an embryo should only enjoy protection rights when implanted in a woman' s womb is arbitrary and ignores the fact that each of us began our life as a human embryo.

Recommendations That since IVF is at present under-regulated and its control is left to the vagaries of the individual practitioners whose activities cannot be controlled, the revised Ethical Guidelines, should include the content of 24.2, 24.3 and 24.7 should also assert 1. A prohibition on freezing and deletion of last paragraph of current Clause 24.5: 2

A prohibition on the placing of embryos in a part of the womanâ&#x20AC;&#x2122;s body where it is anticipated that they will not survive.

A prohibition on embryo storage or freezing, accompanied by notice of appropriate powers of inspection and applicable sanctions.

4 A prohibition on embryo research or the use of human embryos as a source of stem cells for research or therapy.

OTHER MATTERS Abortion Assistance and Referral Introduction All editions of the Medical Council’s Guide to Ethical Conduct and Behaviour and to Fitness to Practise are opposed to induced abortion. In this submission, the Pro-Life Campaign sets out why opposition to induced abortion should logically apply also to abortion assistance and referral. There is a clear ethical and logical, if not legal, dichotomy between having abortion in Ireland unethical and at the same time allowing medical practitioners to actively assist having unborn children aborted outside the State.

In 1995 the Oireachtas passed the Regulation of Information (Services Outside State for Termination of Pregnancies) Bill 1995 (referred to as the Abortion Information Act). The President referred the Bill to the Supreme Court to consider its constitutionality, which subsequently ruled that it was constitutional.

The Act provides for the giving of ‘Act information’, i.e. information likely to be required by a woman to avail of services provided outside the State for the termination of pregnancies. This information relates to such services and to the persons who provide them,13 given by a person who engages in, or holds himself out as engaging in, the activity of giving information, advice or counselling to individual members of the public in relation to pregnancy.14 ‘Termination of pregnancies’ is defined as the intentional procurement of miscarriages of women who are pregnant’

Although the Act provides that it is unlawful for a person, upon a request to give information, advice or counselling in relation to the particular circumstances of a pregnant woman, to advocate or promote the termination of her pregnancy, the giving of ‘Act information’ is perfectly lawful, subject to certain conditions. In this regard, the Supreme Court noted that:

s. 2.

s. 1.

“Constitutional justice requires that in the giving of such information, counselling and advice regard be had to the rights of persons likely to be affected by such information, counselling and advice.”15

Furthermore, it provides that whereas it is unlawful for the persons giving the ‘Act information’ to make an appointment or any other arrangement for, or on behalf, of a woman with a person who provides abortion services outside the State, it was held by the Supreme Court that this provision

“ ... does not preclude [a doctor] once such appointment is made from communicating in the normal way with such other doctor with regard to the condition of his patient provided that such communication does not in any way advocate or promote and is not accompanied by any advocacy of the termination of pregnancy’16

Giving to the woman a written copy of, or the medical, surgical, clinical, social or other records or notes, which he has in his possession relating to her, is not prohibited by this provision. The conscientious objection to the giving of ‘Act information’ is permitted. Breach of the provisions of the Act constitutes an offence, punishable summarily by a fine not exceeding £1,500. Abortion Information Act 1995 – An Ethical Appraisal Contradiction There is an inherent contradiction in a system which permits a medical practitioner, who on the one hand is required to subscribe to a professional ethical guide that obliges that (s)he shall endeavour to preserve life and health, to, at the same time, counsel and/or refer for the destruction of that life.

The fundamental principle of medical practice is primum non nocere – “first, do no harm”. Because of the intimacy and dependency that underpin the doctor-

In Re Article 26 and the Regulation of Information (Services Outside State for Termination of Pregnancies) Bill 1995.

patient relationship, adherence to this principle is essential to the proper practice of medicine, breaches being punishable by professional sanction and at law. In general, therefore, to assist in, or refer for, the destruction of the life of any patient is ethically and legally prohibited.

Dual Patient Model A doctor, when dealing with a pregnant mother, has two patients - the mother and her unborn baby, and has a duty of care, both ethical, and enforceable at law, simultaneously to each. As in any other clinical situation, a medical practitioner cannot ignore his or her responsibilities to one patient in order merely to satisfy the wishes of another. To deny the existence of such a duty is to ignore the teaching of generations of obstetricians, the clear, almost intuitive, knowledge of all parents and the reality of ever increasing medical malpractice premia. If it is bad medicine to do, or fail to do, something which results in damage to an unborn child en ventre sa mere how can it be good medicine to do something which assists in procuring that childâ&#x20AC;&#x2122;s death? To consider or counsel (however this counselling is done) abortion as merely one option, from among many, which may be legitimately chosen, or to assist in, or refer for, the destruction of the life of one patient is surely an abrogation of a doctorâ&#x20AC;&#x2122;s duty to that patient.

Recommendations That the revised Ethical Guidelines assert: 1. An ethical prohibition on abortion referral and assistance by doctors.

2. The duty of a medical practitioner to give full information to patients about the medical consequences of having an abortion.

SUMMARY OF RECOMMENDATIONS

Induced Abortion That the revised Ethical Guidelines, while maintaining the revised Section 24.6 and 24.1of the 2004 Guidelines and assert in other clauses: 1. The principle that in pregnancy the doctor has a duty of care towards two patients, the mother and the unborn child; 2. The principle that necessary treatments which have a risk of unsought side effects are ethical, even when the unsought effect is foreseeable, while procedures the purpose of which are to cause the death of a patient are unethical. 3. Induced abortion does not constitute “medical treatment” in any circumstances. 4. Therapeutic convenience is never a sufficient justification for induced abortion and that adoption of such an approach is prima facie unethical. 5. Medical ethics do not follow each change in the law and that mere legality is not equivalent to ethical practice. 6. A prohibition on induced abortion is both feasible and ethically necessary, and has not resulted in the treatment appropriate for the management of any ill mother being compromised in any way. Euthanasia That the revised Ethical Guidelines assert: 1. The prohibition on euthanasia, in clear and robust terms of 1998 and 2004 Guide. 2. A re-statement of the Medical Council’s position on the withdrawal of feeding in line with its statement of August 4, 1995. 3. A continuation of the Medical Council’s independent stance on the issues of euthanasia and the withdrawal of feeding notwithstanding the effective change in the law in relation to euthanasia by withdrawal of feeding consequent on the decision of the Supreme Court in the Ward case. 4. An express statement that a medical practitioner’s complicity in the withdrawal of feeding from a chronically ill patient with the intention that the patient will die as a result is unethical and subject to disciplinary procedures by the Council. 30

5. An affirmation of the principle, perhaps in the section of the Guide pertaining to Ethical Conduct, that necessary treatments which have a risk of unsought side effects are ethical, even when the unsought effect is foreseeable, while procedures intended to cause the death of a patient are unethical.

Right to Life of the Human Embryo (freezing and storage) That since IVF is at present under-regulated and its control is left to the vagaries of individual practitioners whose activities cannot be monitored, the revised Ethical Guidelines, should retain in essence the content of the2004 Guidelines 24.2, 24.3, and 24.7, including the prohibition on deliberate destruction of the fertilised ovum and also assert: 1. A prohibition on freezing embryos and deletion of final paragraph of 24.5 2

A prohibition on the placing of embryos in a part of the womanâ&#x20AC;&#x2122;s body where it is anticipated that they will not survive.

An explicit prohibition on embryo storage or freezing, accompanied by notice of appropriate powers of inspection and applicable sanctions.

A prohibition on embryo research or the use of human embryos as a source of stem cells for research or therapy.

Other Matters Abortion Assistance That the revised Ethical Guidelines assert: 1. An ethical prohibition on abortion referral and assistance by doctors. 2. The duty of a medical practitioner to give full information to patients about the medical consequences of abortion.

CONCLUSION

The medical Council has an enormous responsibility to promote the ethos of care in the medical profession that respects all human life. In our democracy based on equality before the law, some values, some rights are nonnegotiable. First among these is the right to life. Without it, all other rights are meaningless. If the Guide to Ethical Conduct lacked clarity regarding that most basic right, it would undermine the basis for all other self-evident rights we cherish. Even where there is disagreement, the just response is to err on the side of life.

Submission To Medical Councilâ&#x20AC;&#x2122;s Ethics Committee

Pro-Life Campaign 34 Gardiner Street Upper Dublin 1 T: 01-8748090, F: 01-8748094, E: prolife@indigo.ie 6th September 2007