Transcript Slide 1

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 wellbeing 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 sexlinked 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