Assisted Reproductive Technologies: Ethical and Legal Issues

1
Assisted Reproductive TechnologiesEthical and
Legal Issues

• ISD II Womens Health
• Drs. A. Latus, B. Barrowman
• February 2003

2
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

5
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 ..." (Plato's 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 it's
  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

34
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