Assisted Reproductive Technologies: Ethical and Legal Issues

Introduction The field of human reproductive technologies illustrates the challenges posed by developments in medical science to social policy, ethics and the law. Breathtaking array of controversial issues. Commissions and consultations have generated lengthy reports with volumes of recommendations (and dissents). To date, no comprehensive legislation in Canada. Focus today is on a proposed piece of such legislation context in which it is situated.

3 A Few Numbers Infertility affects about 330,000 couples per year in Canada First baby born as a result of IVF in 1978 since then over 250,000 births worldwide IVF was extremely controversial in 1970s IVF outcomes

in U.K. (1998) live birth rate per IVF cycle 15-17, Intracytoplasmic sperm injection (ICSI) 21 no comprehensive registry in Canada

4 Some Issues Raised by AHR Who should have access to such technologies the medically infertile same sex couples single people Who should pay MCP the infertile couple What should be done with gametes/embryos that are no longer required by the donor couple for their own joint reproductive purposes Who should control their use what if the couple breaks up and one then wants to use a stored embryo Should individuals be allowed to profit from the sale of sperm, ova or embryos e.g., a model advertising ova for sale on e-bay

Regulating AHR Clearly, AHR raises many complex ethical legal issues. Some involve conventional issues in health law or medical ethics informed consent, standard of care, confidentiality e.g. ter Neuzen v. Korn (S.C.C. 1995) negligence law applied where woman contracted HIV infection from artificial insemination in 1985 case referred back to jury duties disclosure of risk, screening of donors (today, would include testing donated semen)

6 Current Legal Situation Existing Legislation AHR also raises distinct issues, hence the push for legislation dealing specifically and comprehensively with AHR Even so, some already existing statutes are/may be relevant Food and Drugs Act controls processing, testing and distribution of semen for donor insemination

Human Tissue Acts regulate exchange of human tissues, mainly for organ transplantation purposes these Acts may apply to gametes and embryos, but were not specifically designed for that purpose

7 Current Legal Situation Access to Reproductive Technologies In addition to already existing legislation, there is some case law concerning AHR E.g., most RTs not covered by provincial health insurance plans courts have addressed this Cameron v. Nova Scotia (N.S.C.A. 1999) lack of coverage for IVF, ICSI violates equality rights of the infertile, but this is justifiable infringement, given governments objective to control health care costs court not prepared to second-guess government decision on which health care services to insure

8 Current Legal Situation Professional Guidelines

Some professional guidelines policies also exist Society of Obstetricians and Gynecologists of Canada and the Canadian Fertility and Andrology Society produced joint policy statement (1999) on ethical issues to guide MDs practising in this field addresses access to RTs, informed consent, embryo research, use and transfer of embryos/gametes

9 The Long Road to Legislation As weve seen, AHR does not function in a legal vacuum, nonetheless there is a perceived need for legislation that deals specifically with AHR. Preparing and passing such legislation has proved extremely challenging. 1989-1993 Royal Commission on New Reproductive Technologies Final Report Proceed with Care (1993) Recommends banning human cloning, the creation of animal-human hybrids and commercial surrogacy

and establishing an independent regulatory body to govern permissible AHR activities.

10 Attempts at Regulation 1995 - Minister of Health introduces a voluntary moratorium on cloning and many other activities the Royal Commission objected to 1996 Bill C-47 proposes a series of prohibitions based on the voluntary moratorium Dies when parliament is dissolved for the 1997 federal election Public consultation on the issue followed. 2001 Bill C-56 presents an updated version of C-47 Dies when parliament is dissolved in September 2002

11 Bill C-13 (2002) Proposed Assisted Human Reproduction Act Introduced in October, 2002. After 2 readings in House of Commons, referred to

Standing Committee on Health Amended by Committee on Dec 12, 2002 Would prohibit certain activities Would create licensing regulatory scheme for other activities Would regulate privacy access to information issues Would create an expert regulatory agency

12 AHR Act - Guiding Principles Paramountcy of protecting health and well-being of children born through AHR, and individuals, especially women, using AHR Benefits of AHR and related research can be best achieved by protecting human health, safety, dignity and rights in their use Free and informed consent is a fundamental condition of use of reproductive technologies

13 AHR Act Guiding Principles (cont.) Non-discrimination in access to AHR, including

with respect to sexual orientation or marital status Health and ethical concerns re. commercialization of human reproductive capacity justifies its prohibition Human individuality and diversity and the integrity of the human genome must be preserved and protected

14 Proposed AHR Act Definitions Embryo human organism during first 56 days of its development following fertilization/creation, excluding time during which its development has been suspended Foetus human organism from 57th day following fertilization/creation until birth Human reproductive material sperm, ovum or other human cell or human gene, and includes a part of any of them

15 Proposed AHR Act Definitions Human clone an embryo that, as a result of manipulation of human reproductive material or an embryo, contains a diploid set of chromosomes from a single human being, foetus or embryo Surrogate mother female who with intention of surrendering child at birth to donor or other person, carries embryo/fetus that was conceived by AHR and derived from genes of donor(s)

16 Proposed AHR Act Prohibited Activities The proposed legislation would ban creating a human clone for any purpose (i.e. reproductive or therapeutic) creating an in vitro embryo for any purpose other than creating a human being, or improving assisted reproduction procedures creating an embryo from an embryo or fetus for the purpose of reproduction

maintaining an embryo outside a womans body beyond the 14th day of its development

17 Proposed AHR Act Prohibited Activities (cont.) identifying sex of embryo created for reproductive purposes, except for medical reason such as sex-linked disorder also attempting to influence sex transplanting non-human reproductive material/embryo into humans creating human being from reproductive material or embryo that was previously transplanted into an animal creating human/non-human combinations for reproductive purposes

18 Proposed AHR Act Prohibited Activities (cont.) changing DNA of human sperm, egg or embryo so that the change can be passed to subsequent generations (germ-line alternations) paying a woman a financial incentive to be a

surrogate mother (commercial surrogacy) counseling or assisting any woman under age 21 to become a surrogate mother paying a donor for their sperm or eggs, or providing goods or services in exchange selling or buying human embryos, or providing goods or services in exchange.

19 Proposed AHR Act - Regulated Activities Regulations would be developed to govern the collection, alteration, manipulation or treatment of any human reproductive material for the purpose of creating an embryo the storage, handling, use and destruction of reproductive materials and embryos the types of AHR research that would be allowed, and conditions under which research could be carried out

20 Proposed AHR Act Regulated Activities (cont.) the licensing of facilities where regulated

activities are performed the counselling services required to be provided to individuals donating or undertaking AHR the reimbursement of expenses of donors or surrogates

21 Proposed AHR Act Assisted Human Reproduction Agency Objectives promotion of health, safety, human dignity and ethical principles in relation to AHR Powers issuance of licences advise Minister re AHR (e.g. re regulations) collect, manage health reporting information provide information re AHR to public Membership Board of Directors, up to 13 people, diversity of relevant disciplines, at least 50 women

22 Proposed AHR Act Privacy and Access to

Information Health information registry to be maintained Health reporting information includes information respecting identity, personal characteristics, genetic information and medical history of donors of human reproductive material and embryos, and users of/persons conceived by AHR also includes information about the custody of donated human reproductive materials and in vitro embryos and the uses that are made of them. Restrictions on disclosure of health reporting information Access to non-identifying health reporting information by persons conceived by AHR

23 Provisions Governing Embryos Human Reproductive Material Many of the provisions of the AHR Act govern the retrieval and use of human embryos and human reproductive material Our focus for the remainder of the session will

be on what these provisions are and what sort of justification might be offered for or against them We begin with a fairly dramatic issue germ-line alteration

24 Why No Germ-Line Alteration The act forbids altering the genome of a cell of a human being or in vitro embryo such that the alteration is capable of being transmitted to descendants (5.1.f) But why not, e.g., allow permanent removal of the gene for sickle-cell anemia from a particular family line Consider this as a moral, rather than legal, issue

25 Genetic Engineering C-13 would thus ban what is often called genetic engineering May help to distinguish 2 kinds

negative correcting or avoiding defects positive making improvements Recall from Endocrinology session the problem with drawing the line between correcting defects making improvements Strongest arguments are for negative genetic engineering

26 Objection 1 Playing God / Unnaturalness To engage in germ-line alteration is playing God. Weak without some further explanation of how this instance of playing God or acting unnaturally is different than other apparently morally OK instances of playing God/acting unnaturally The further explanation is what will do the moral work here, so the playing God issue is beside the point

27 Objection 2 Uncertainty about Effects Our knowledge of what exactly the alteration will

do is incomplete. This objections force will decrease with time. We should be careful of identifying particular traits as definitively problematic, e.g., in some contexts, the gene for sickle-cell anemia confers an advantage (i.e., protection from malaria) This objections applicability shouldnt be overstated.

28 Objection 3 Historical Eugenics roughly, a science which aims to improve the overall genetic makeup of the human race. Term originates in 1883 with Francis Galton. The idea is ancient If we are to keep our flock at the highest pitch of excellence, there should be as many unions of the best of both sexes, and as few of the inferior as possible, and ... only the offspring of the better unions should be kept ... (Platos Republic) Eugenics movements have a troubling history, most vividly illustrated by the horrors of the Nazi

era

29 Objection 4 Commodification Why condemn genetic engineering by historical association with past problems with eugenics Because, to many, there is a fundamental flaw at the heart of genetic engineering which it shares with eugenics This alleged flaw is that genetic engineering involves seeing those who are engineered as things or commodities, not as things with intrinsic value. Commercialization is generally seen as a clear instance of commodification, although not the only such instance Recall discussions on Kant in first year

30 Commodification Concern with commodification is at the heart of many claims made about the ethics of NRTs many of C-13s provisions

7.1-3 No sale of embryo, sperm, ova No sale of a human cell or gene with the intention of using the it to create a human being or of making it available for that purpose. No person shall create an in vitro embryo for any purpose other than creating a human being or improving AHR techniques

31 Why is Commodification Bad Treating humans as mere means to an end is generally thought to be inconsistent with human dignity Every one of the prohibitions we propose is on that list of prohibitions because its inconsistent with human dignity. (Alan Rock, May 3, 2001)

32 When is a Thing Being Commodified To treat an embryo as a thing to be bought, sold or redesigned is generally claimed to involve treating it as a mere means to an end (i.e., as a

commodity) But this claim deserves to viewed with at least some skepticism Contrast genetic engineering with good diet, living in an unpolluted environment or violin lessons When is the line crossed and why

33 Why More than Embryos Why extend these worries about commodification beyond human organisms, i.e., why extend it to sperm ova Effectively, the worry is the same here. payment for human gametes is inappropriate, as it would constitute commercialization of human reproductive material (Royal Commission, p. 449) To commercialize parts of a human body is to commercialize humans themselves Consider tradition of treating bodies as something other than property

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Conclusion Clearly, AHR raises many more issues than we have had time to deal with here For further discussion see Text of AHR Act Presentation on Cloning at http//www.ucs.mun.ca/alatus/ISD2.html Background on AHR Act at http//www.hc-sc.gc.ca/en glish/ media/releases/2002/2002_34.htm SOGC Policy Statement at http//sogc.org/SOGCnet/ sogc_docs/common/guide/pdfs/psEthics.pdf