Backgrounder
Section 8 (Consent)
Assisted Human Reproduction Act

The Assisted Human Reproduction Act provides a mechanism to oversee acceptable activities such as in vitro fertilization, and prohibits ethically unacceptable activities such as human cloning. The Act helps protect the health and safety, human rights and dignity of Canadians, and provides a mechanism to oversee research related to assisted human reproduction (AHR)

Health Canada is responsible for developing regulations that support the AHR Act. As part of this process Health Canada undertakes public involvement activities to provide interested parties with an opportunity to present their views, concerns and recommendations on proposed components of the regulatory framework of the AHR Act.

The regulations for section 8 were developed with input from Canadians. Regulatory proposals were pre-published in the Canada Gazette, Part I, in September 2005. As required by the AHR Act, the proposed regulations were also tabled for review in the House of Commons and the Senate by the Minister of Health. Comments provided by interested stakeholders, parliamentary committees and provincial and territorial counterparts, were considered in developing the final section 8 regulations. These regulations were published in the Canada Gazette, Part II, on June 27, 2007, and can be accessed at the Canada Gazette web site: http://canadagazette.gc.ca/index-e.html.

Overview of section 8 regulations

Informed consent is a core principle of the Assisted Human Reproduction Act. The Act addresses consent in a number of provisions and in different contexts. These provisions provide the basis for the consent framework of the Act. The purpose of section 8 is to ensure that human reproductive material for creating embryos and in vitro embryos are used only with the donor's written consent.

Section 8 is a prohibition under the Act. It is the last prohibition to be brought into force and the only one that required the development of regulations. All other prohibitions were brought into force on April 22, 2004.

Section 8 of the AHR Act prohibits the following activities unless a donor has given written consent:

• using human reproductive material to create an embryo;
• removing human reproductive material from a donor's body posthumously for the purpose of creating an embryo;
• using an in vitro embryo for any purpose.

Scope of the proposed regulations

The regulations for section 8 outline the following:

• who must provide consent
• the uses for which consent is needed
• the type of information required to be provided prior to consent
• the conditions for the withdrawal of consent.

The section 8 regulations focus on "use" as the essential element of consent. They do not address other aspects of consent regarding, for example, the storage or destruction of human reproductive material or in vitro embryos, or the collection of health reporting information. Future regulatory proposals under the Act, which are currently in development, will address these issues.

Section 8 will come into force on December 1, 2007

In most instances these regulations formalize an approach to consent already in place across the AHR community. Nevertheless, they are detailed and may require some changes to process, consent forms and staff training. The regulations will come into force on December 1, 2007, to allow a period of transition for those affected, that is all individuals who make use of sperm or eggs to create embryos, or who make use of in vitro embryos for any purpose, including research. Health Canada is sending a notification to Provinces and Territories, affected establishments and professional organizations to advise of the new regulations.

Assisted Human Reproduction Canada is the Agency responsible for administering the AHR Act, and as such will be responsible for the implementation and enforcement of these regulations. It is expected that the Agency will be contacting affected establishments, professional organizations and Provinces and Territories in the near future with further information and consultation on an implementation plan.

June 2007

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AHR (Section 8) Regulations - Questions and Answers