Assisted Reproductive Technologies Ethical and Legal Issues by kmw98023

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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.

 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…

 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
 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)
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
 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
 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
 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
 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
 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

 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.)

 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

 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 – 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
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.)
  – 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 (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

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.)

  – 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
 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
 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
 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?

 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
 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
 „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

 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
 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’
 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
 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?

 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?

 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 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

 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

								
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