Information
April 22, 2004
An Overview of Key Provisions of the Assisted Human Reproduction Act Coming Into Force on April 22, 2004
On March 29, 2004, the Assisted Human Reproduction Act ("AHR Act") received Royal Assent.
The coming into force of the provisions of the Act will follow a staged approach.
All of the prohibitions, sections 5 through 9 (except for section 8), are coming into force on April
22, 2004. Publication in Part II of the Canada Gazette is expected in early May 2004. The
one exception, section 8, which pertains to the prohibition on the use of reproductive material and
the in vitro embryo without consent, will be brought into force at a later date because
its enforcement depends on regulations that will soon be developed.
As with all other provisions of the Act, the prohibitions do not apply retroactively. You may wish
to consult the document entitled "Frequently Asked Questions - The Assisted Human Reproduction Act (March 2004)" on
this website for further information regarding the prohibitions.
All of the "controlled activities" provisions, sections 10-13 (except for section 12), and section
71 (the "grandfathering" provision) will come into force at the same time as the prohibitions, on
April 22, 2004. The one exception is section 12 which deals with the reimbursement of receipted expenditures,
which is expected to come into force in 2005.
This document is intended to highlight some key provisions of the Act will come into force on April
22, 2004 to assist those directly affected by the Act. This document is not intended to represent
a comprehensive overview of all of the provisions of the Act.
Human Cloning - Paragraph 5(1)(a)
- No person shall knowingly...create a human clone by using any technique, or transplant a
human clone into a human being or into any non-human life form or artificial device;
For purposes of this legislation, a human clone is defined in section 3 of the Act as:
- an embryo that, as a result of the manipulation of human reproductive material or an in vitro
embryo, contains a diploid set of chromosomes obtained from a single - living or deceased - human
being, foetus or embryo.
Paragraph 5(1)(a) prohibits the creation of a human clone for any purpose (for example, for reproduction,
research or therapeutic use), using any technique. There are currently a number of techniques used
to create cloned embryos, such as somatic cell nuclear transfer, embryo splitting, and parthenogenesis.
As science evolves, any new cloning techniques developed will also be prohibited.
Creating an in vitro embryo - Paragraph 5(1)(b)
- No person shall knowingly...create an in vitro embryo for any purpose other than creating
a human being or improving or providing instruction in assisted reproduction procedures;
Pursuant to this provision, there are limited reasons for which an in vitro embryo may
be created. An in vitro embryo may not be created unless it is for one of the following
three purposes:
To create a human being: This would be carried out within the context of an AHR
procedure, for example, in vitro fertilization (IVF) or intracytoplasmic sperm injection
(ICSI).
To improve AHR procedures: Tightly controlled research into facilitating human
reproduction is required to ensure that women, men and any resulting offspring are not subjected
to AHR procedures that have not been validated. In order to validate AHR procedures, embryo creation
would sometimes be a consequence of work in this area. Strict regulations will be developed to address
this type of work.
To provide instruction in AHR procedures: While most training for AHR procedures
involves non-human reproductive materials, there are circumstances where human reproductive materials
are used and their manipulation would result in the creation of an embryo. Strict regulations will
be developed to address this type of work.
Creating an embryo from an embryo or foetus - Paragraph 5(1)(c)
- No person shall knowingly...for the purpose of creating a human being, create an embryo from
a cell or part of a cell taken from an embryo or foetus or transplant an embryo so created into
a human being;
This paragraph prohibits the creation of an embryo using a cell or any part of a cell taken from
another embryo or foetus, if its purpose is to create a human being.
14 day in vitro limit - Paragraph 5(1)(d)
- No person shall knowingly...maintain an embryo outside the body of a female person after
the fourteenth day of its development following fertilization or creation, excluding any time
during which its development has been suspended;
This paragraph prohibits ectogenesis - the development of an in vitro embryo outside the body of
a woman past the 14th day of its development.
The phrase, "excluding any time during which its development has been suspended" recognizes
the biological fact that once an embryo is frozen, its development is halted until such time that
it is thawed. In other words, if an embryo is frozen during its third day of development and is kept
frozen for a certain period of time, it would still be at its third day of development once thawed.
Sex selection - Paragraph 5(1)(e)
- No person shall knowingly...for the purpose of creating a human being, perform any procedure
or provide, prescribe or administer any thing that would ensure or increase the probability that
an embryo will be of a particular sex, or that would identify the sex of an in vitro embryo,
except to prevent, diagnose or treat a sex-linked disorder or disease;
This paragraph prohibits, for the purposes of creating a human being, anyone from promoting or ensuring
that an embryo is of a particular sex (for example, using a sperm sorting technique). It also prohibits
the identification of the sex of an in vitro embryo, except for purposes of preventing,
diagnosing or treating a sex-linked disorder or disease.
Germ line alteration - Paragraph 5(1)(f)
- No person shall knowingly...alter the genome of a cell of a human being or in vitro embryo
such that the alteration is capable of being transmitted to descendants;
This paragraph prohibits germ line alteration which is an alteration to the human genome that can
be passed on to a subsequent generation.
Transfer of non-human gametes, embryo, foetus into a human being - Paragraph 5(1)(g)
- No person shall knowingly...transplant a sperm, ovum, embryo or foetus of a non-human life
form into a human being;
This paragraph prohibits the transfer of a non-human gamete, embryo, or foetus into a human being.
Transfer of human gametes or in vitro embryo into a non-human - Paragraph 5(1)(h)
- No person shall knowingly...for the purpose of creating a human being, make use of any human
reproductive material or an in vitro embryo that is or was transplanted into a non-human life
form;
This paragraph prohibits the use of human reproductive material or an in vitro human embryo
that was previously transferred into a non-human life form to create a human being. This prohibition
does not prevent research involving the transfer of human reproductive material or an in vitro human
embryo into a non-human life form provided that the material is not subsequently used for reproductive
purposes.
Chimera - Paragraph 5(1)(i)
- No person shall knowingly...create a chimera, or transplant a chimera into either a human
being or a non-human life form;
For purposes of this legislation, a chimera is defined in section 3 of the Act as:
- (a) an embryo into which a cell of any non-human life form has been introduced; or
- (b) an embryo that consists of cells of more than one embryo, foetus or human being.
The creation of a chimera as defined in the Act involves the introduction of non-human cells, or
human cells from more than one human embryo, foetus, or human being into an early stage human embryo.
This paragraph prohibits the creation of a chimera for any purpose, including both reproductive and
research purposes.
Hybrid - Paragraph 5(1)(j)
- No person shall knowingly...create a hybrid for the purpose of reproduction, or transplant
a hybrid into either a human being or a non-human life form;
For purposes of this legislation, a hybrid is defined in section 3 of the Act as:
- (a) a human ovum that has been fertilized by a sperm of a non-human life form;
- (b) an ovum of a non-human life form that has been fertilized by a human sperm;
- (c) a human ovum into which the nucleus of a cell of a non-human life form has been introduced;
- (d) an ovum of a non-human life form into which the nucleus of a human cell has been introduced;
or
- (e) a human ovum or an ovum of a non-human life form that otherwise contains haploid sets
of chromosomes from both a human being and a non-human life form.
Under the AHR Act, a hybrid is an egg, human or non-human, which contains both human and non-human
chromosomes. This paragraph prohibits the creation of a hybrid for reproductive purposes. Its creation,
however, would be permitted when its sole purpose is that of research.
Advertising and payment - Subsections 5(2) and (3)
- (2) No person shall offer to do, or advertise the doing of, anything prohibited by this section.
- (3) No person shall pay or offer to pay consideration to any person for doing anything prohibited
by this section.
These subsections prohibit a person from offering to do, advertising to do, paying or offering to
pay for anything prohibited by section 5 of the Act.
Surrogacy - Section 6
This section, comprised of 5 subsections, addresses the prohibitions on the commercialization of
surrogacy. As with all other provisions of this Act, section 6 is not retroactive and applies on
the day it comes into force. The term "surrogate mother" is defined in section 3 of the Act as:
- A female person who - with the intention of surrendering the child at birth to a donor or
another person - carries an embryo or foetus that was conceived by means of an assisted reproduction
procedure and derived from the genes of a donor or donors.
Payment to a surrogate mother - Subsection 6(1)
- No person shall pay consideration to a female person to be a surrogate mother, offer to pay
such consideration or advertise that it will be paid.
It is prohibited for a person to pay, offer to pay, or advertise to pay a woman to become a surrogate
mother.
Accepting payment as an intermediary - Subsection 6(2)
- No person shall accept consideration for arranging for the services of a surrogate mother,
offer to make such an arrangement for consideration or advertise the arranging of such services.
It is prohibited for a person to accept consideration for arranging, offering or advertising to
arrange, the services of a surrogate mother.
Making a payment to an intermediary - Subsection 6(3)
- No person shall pay consideration to another person to arrange for the services of a surrogate
mother, offer to pay such consideration or advertise the payment of it.
It is prohibited for a person to pay, offer to pay, or advertise to pay consideration to another
person to arrange for the services of a surrogate mother.
Minimum age of surrogate - Subsection 6(4)
- No person shall counsel or induce a female person to become a surrogate mother, or perform
any medical procedure to assist a female person to become a surrogate mother, knowing or having
reason to believe that the female person is under 21 years of age.
The minimum age for a woman to become a surrogate is 21 years. As such, it prohibited for a person
to counsel or induce a female person under the age of 21 to become a surrogate mother or undertake
an AHR procedure to assist her to become a surrogate mother.
Validity of a surrogacy agreement - Subsection 6(5)
- This section does not affect the validity under provincial law of any agreement under which
a person agrees to be a surrogate mother.
The AHR Act does not affect the validity of a surrogacy agreement. The validity, including civil
enforceability, of a surrogacy agreement is a matter of provincial law. Once in force, the prohibitions
in section 6 apply, notwithstanding the validity of a surrogacy agreement.
Purchase of gametes and purchase and sale of embryos from a donor - Section 7
Section 7, which is comprised of 4 subsections, addresses the prohibitions on the commercialization
of human reproductive material and the in vitro embryo. In general, this section makes it
a criminal offence to purchase or offer to purchase human reproductive material from a donor and
purchase or sell an in vitro embryo. However, AHR clinics, sperm banks and other business
operations engaging in exchanges of sperm or ova not involving the donor would be able to sell and
purchase sperm or ova between one another. As with all other provisions of this Act, section 7 is
not retroactive and applies on the day it comes into force. A donor, as defined in Section 3 of the
Act, means:
- (a) in relation to human reproductive material, the individual from whose body it was obtained,
whether for consideration or not; and
- (b) in relation to an in vitro embryo, a donor as defined in the regulations.
Purchase of gametes - Subsection 7 (1)
- No person shall purchase, offer to purchase or advertise for the purchase of sperm or ova
from a donor or a person acting on behalf of a donor.
It is an offence for anyone to pay a donor, or a person acting on their behalf, for the donation
of their of sperm or ova. This subsection also prohibits advertising for the purchase of sperm or
ova.
Purchase or sale of in vitro embryos - Subsection 7 (2)
No person shall:
- (a) purchase, offer to purchase or advertise for the purchase of an in vitro embryo; or
- (b) sell, offer for sale or advertise for sale an in vitro embryo.
It is prohibited to purchase or sell, offer to purchase or sell, or advertise for the purchase or
sale of an in vitro embryo.
Purchase of other reproductive material - Subsection 7 (3)
- No person shall purchase, offer to purchase or advertise for the purchase of a human cell
or gene from a donor or a person acting on behalf of a donor, with the intention of using the
gene or cell to create a human being or of making it available for that purpose.
Subsection 3 makes it an offence for a person to purchase, offer to purchase or advertise to purchase
a human cell or gene from a donor or a person acting on behalf of a donor, if these materials are
intended to be used to create a human being.
Note: As per subsection 7(4), the terms "purchase" or "sell" includes
to acquire or dispose of in exchange for property or services, for all of section 7.
Gametes obtained from a donor under 18 years of age - Section 9
- No person shall obtain any sperm or ovum from a donor under 18 years of age, or use any sperm
or ovum so obtained, except for the purpose of preserving the sperm or ovum or for the purpose
of creating a human being that the person reasonably believes will be raised by the donor.
It is an offence to obtain or use gametes from a person under the age of eighteen years, unless
the gametes are obtained for preservation or where there is a reasonable belief that they will be
used to create a human being that will be raised by the donor from whom the gametes were obtained.
Use of human reproductive material and the in vitro embryo - Section 10
- (1) No person shall, except in accordance with the regulations and a licence, alter, manipulate
or treat any human reproductive material for the purpose of creating an embryo.
- (2) No person shall, except in accordance with the regulations and a licence, alter, manipulate,
treat or make any use of an in vitro embryo.
- (3) No person shall, except in accordance with the regulations and a licence, obtain, store,
transfer, destroy, import or export
- (a) a sperm or ovum, or any part of one, for the purpose of creating an embryo; or
- (b) an in vitro embryo, for any purpose.
Section 10 governs controlled activities that may be carried out in accordance with the conditions
set out in the legislation and the future regulatory and licensing regimes. In the interim period
until the regulatory and licensing regimes are established in relation to section 10, the requirements
outlined in section 71 of the Act apply.
Transgenic research - Section 11
- (1) No person shall, except in accordance with the regulations and a licence, combine any
part or any proportion of the human genome specified in the regulations with any part of the
genome of a species specified in the regulations.
A licence will be required to undertake a transgenic experiment only if it involves
combining those parts or proportions of the human and non-human genome which will be specified
in future regulations. Not all transgenic experiments will require a licence.
"Grandfathering" controlled activities - Section 71
- Notwithstanding sections 10 to 13, a person who undertakes a controlled activity at least
once during the period of one year preceding the coming into force of those sections may subsequently,
without a licence, undertake the controlled activity and use any premises required for that purpose
until a day fixed by the regulations.
Given that the controlled activity provisions are coming into force before the regulatory and licensing
regimes are established, section 71 allows for a person to continue to undertake a controlled activity
without a licence until the regulations specify a date by which all persons undertaking that activity
must have a licence. This is provided that the person has undertaken the activity at least once in
the year prior to the controlled activity provisions coming into force.
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