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Assisted Reproductive Technologies: Ethical and Legal Issues. ISD II – Women’s Health Drs. A. Latus, B. Barrowman February 2003. Introduction. The field of human reproductive technologies illustrates the challenges posed by developments in medical science to social policy, ethics and the law.

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assisted reproductive technologies ethical and legal issues

Assisted Reproductive Technologies:Ethical and Legal Issues

ISD II – Women’s Health

Drs. A. Latus, B. Barrowman

February 2003

introduction
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.
a few numbers
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
some issues raised by ahr
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
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)
current legal situation existing legislation
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
current legal situation access to reproductive technologies
Current Legal Situation –Access to Reproductive Technologies
  • In addition to already existing legislation, there is some case law concerning AHR
  • E.g., most RT’s 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 government’s objective to control health care costs
  • court not prepared to second-guess government decision on which health care services to insure
current legal situation professional guidelines
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 MD’s practising in this field
    • addresses access to RT’s, informed consent, embryo research, use and transfer of embryos/gametes
the long road to legislation
The Long Road to Legislation
  • As we’ve 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.
attempts at regulation
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
bill c 13 2002 proposed assisted human reproduction act
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
ahr act guiding principles
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
ahr act guiding principles cont
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
proposed ahr act definitions
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
proposed ahr act definitions15
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)
proposed ahr act prohibited activities
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 woman’s body beyond the 14th day of its development;
proposed ahr act prohibited activities cont
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;
proposed ahr act prohibited activities cont18
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.
proposed ahr act regulated activities
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;
proposed ahr act regulated activities cont
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
proposed ahr act assisted human reproduction agency
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
proposed ahr act privacy and access to information
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
provisions governing embryos human reproductive material
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
why no germ line alteration
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
genetic engineering
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
objection 1 playing god unnaturalness
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
objection 2 uncertainty about effects
Objection 2: Uncertainty about Effects
  • Our knowledge of what exactly the alteration will do is incomplete.
    • This objection’s 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 objection’s applicability shouldn’t be overstated.
objection 3 historical
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: "[I]f 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 ..." (Plato's Republic)
  • Eugenics movements have a troubling history, most vividly illustrated by the horrors of the Nazi era
objection 4 commodification
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
commodification
Commodification
  • Concern with commodification is at the heart of many claims made about the ethics of NRTs & many of C-13’s 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
why is commodification bad
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 it's inconsistent with human dignity." (Alan Rock, May 3, 2001)
when is a thing being commodified
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?
why more than embryos
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
conclusion
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/english/

media/releases/2002/2002_34.htm

    • SOGC Policy Statement at http://sogc.org/SOGCnet/

sogc_docs/common/guide/pdfs/psEthics.pdf