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.

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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)

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no comprehensive registry in Canada

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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

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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)

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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

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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

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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

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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.

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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

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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

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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

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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

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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

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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)

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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

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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

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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.

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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

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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

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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

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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

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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

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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

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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

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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

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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.

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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

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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

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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

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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)

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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

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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