AHR Regulations for Section 8 - Consent to Use - Questions and Answers

1. What are the consent to use regulations?
2. How will these regulations affect the medical and research communities?
3. Under these regulations, can consent to use be withdrawn?
4. Why do the regulations not allow the posthumous removal of gametes for third party use?
5. These regulations do not address other aspects of consent, such as obtaining counselling. How can you ensure that fully informed consent is given if these aspects are not covered?
6. Do these consent to use regulations address the storage and destruction of human reproductive material or in vitro embryos?
7. How did Health Canada consult with Canadians before drafting the consent to use regulations?
8. Who provided comments on the consultation document and the proposed regulations? How did Health Canada use these comments?
9. How are these regulations different from the ones published in the Canada Gazette, Part I, on September 24, 2005?
10. When did these regulations take effect?
11. Are these the final regulations? Can changes still be made?
12. What about human reproductive material or in vitro embryos that are already in storage, can the material or embryos still be used? Do the donors need to provide a new consent to use?
13. What about human reproductive material imported from another country, does it still need to comply with section 8 of the AHR Act?
14. What are the penalties for violating section 8?
15. Why is section 8 of the AHR Act a prohibition?

Q1 What are the consent to use regulations?

The consent to use regulations specify the basic requirements necessary for informed consent to use gametes to create an embryo or to use an in vitro embryo for any purpose, as required by section 8 of the Assisted Human Reproduction Act (AHR Act).

Section 8 of the AHR Act prohibits the following activities unless a donor has given written consent in accordance with the regulations to:

• 8(1) use human reproductive material to create an embryo;
• 8(2) remove human reproductive material from a donor's body posthumously for the purpose of creating an embryo; and
• 8(3) use an in vitro embryo for any purpose.

The consent to use regulations correspond to these three subsections in section 8:

• Part 1 relates to the consent given by a donor to use their human reproductive material to create an embryo;
• Part 2 relates to the consent to remove human reproductive material from a donor's body after their death, in order to create an embryo; and
• Part 3 addresses the consent to use an in vitro embryo for any purpose.

The consent to use regulations outline the following:

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

The complete consent to use regulations can be found by visiting the Assisted Human Reproduction (Section 8 Consent) Regulations.

Q2 How will these regulations affect the medical and research communities?

Health Canada believes that current medical and research practices do not differ markedly from what is set out in these regulations. However, there may be variations in the form of consent, the information provided to the donor, the point at which consent to use can be withdrawn, who is currently considered to be an in vitro embryo donor, and whether mutual consent is required for a couple to use an in vitro embryo. These regulations will ensure uniformity across the country and provide clarity to donors of human reproductive material and in vitro embryos, persons undergoing assisted reproduction technologies and the medical and research communities.

In order to comply with the regulations, depending on previous practices, there may have been some necessary process changes, such as modifying consent forms to encompass the requirements of the regulations and ensuring staff are aware of and comply with the regulatory requirements. For a detailed cost analysis of the consent to use regulations, please refer to the Risk Impact Analysis Statement in the Canada Gazette.

Q3 Under these regulations, can consent to use be withdrawn?

These regulations require that donors of human reproductive material and donors of in vitro embryos be informed that they can withdraw their consent to use and that the withdrawal must be in writing. There are, however, some timing considerations that donors must be informed about before they give consent to use.

Generally, consent to use can be withdrawn up until the material or in vitro embryo is used. However, there are certain circumstances (such as human reproductive material donated for third party use) where consent to use cannot be withdrawn once the third party has acknowledged in writing that the material has been designated for their use. With respect to possible research uses of in vitro embryos, the regulations provide additional details around the timing for the withdrawal of consent to use.

Q4 Why do the regulations not allow the posthumous removal of gametes for third party use?

Part 2 of the regulations allows for the posthumous removal of gametes for three purposes only: for the reproductive use of the surviving spouse or common-law partner; to improve assisted reproduction procedures; and to provide instruction in assisted reproduction procedures. The posthumous removal of gametes for third party reproductive use is not permitted for health and safety reasons. Most notably, with respect to sperm, this use would not be allowed under the current Processing and Distribution of Semen for Assisted Conception Regulations (Semen Regulations), promulgated under the Food and Drugs Act. The Semen Regulations impose screening criteria on the donation of semen for third party use in assisted conception requiring donors to be retested for transmissible diseases and infection six months after the donation was made. This mandatory quarantine period prevents the use of sperm removed posthumously for third party use. Similar health and safety concerns would apply with the use of eggs donated for third party use.

Q5 These regulations do not address other aspects of consent, such as obtaining counselling. How can you ensure that fully informed consent is given if these aspects are not covered?

The AHR Act deals with informed consent in a number of provisions and in different contexts. Other components of the AHR Act that, once in force, may impact additional aspects of consent include the requirement in section 14 for licensees to make counselling services available to the person donating human reproductive material or an in vitro embryo, or providing health reporting information. The AHR Act also requires that before accepting a donation of human reproductive material or an in vitro embryo, or accepting health reporting information regarding a person, a licensee must first obtain written consent indicating that the person was informed of the requirements of the Act regarding the retention, use, provision to other persons and destruction of human reproductive material or in vitro embryos.

Future regulatory proposals are expected to complement the consent to use regulations.

Q6 Do these consent to use regulations address the storage and destruction of human reproductive material or in vitro embryos?

The scope of consent under section 8 pertains to "use". Specifically, the focus is on the requirement for written consent to: use human reproductive material for the purpose of creating an embryo; remove human reproductive material posthumously to create an embryo; and, use an in vitro embryo for any purpose.

The storage and destruction of human reproductive material and in vitro embryos will be dealt with in future regulations.

Q7 How did Health Canada consult with Canadians before drafting the consent to use regulations?

On October 30, 2004, Health Canada published a Notice of Intent in the Canada Gazette, Part I, advising the public and stakeholders that it planned to undertake public involvement activities and to provide interested parties the opportunity to participate in the development of components of the regulatory framework under the AHR Act.

Health Canada further held public technical briefing and information sessions in
St. John's, Montreal, Toronto, Winnipeg, Saskatoon, Edmonton and Vancouver between December 2004 and January 2005. In addition, two cross-Canada teleconference calls were held for individuals unable to attend the public sessions. The main purpose of these sessions was to explain the regulatory framework set out in the Act and to outline the regulatory development process with a focus on section 8 of the AHR Act. Approximately 180 representatives of non-governmental and voluntary organizations and members of the general public attended these sessions. Technical briefings with a similar purpose were conducted with provincial officials between September 2004 and January 2005.

On November 8, 2004, Health Canada issued the consultation discussion paper entitled Seeking Input on a Proposed Approach for Regulations concerning Section 8 (Consent) and Section 3 Definition of an In vitro Embryo Donor under the Assisted Human Reproduction Act.

The discussion paper was distributed by mail to 376 individuals and organizations who identified themselves as interested stakeholders. Additional copies of the document were supplied by request and the document was also available in a variety of formats on Health Canada's Web site. It is estimated that over 1000 copies of the document were accessed by the public.

On September 24, 2005, the proposed regulations were published in Canada Gazette, Part I, and interested Canadians were given 75 days to provide their written comments. In total, Health Canada received 53 written responses to the regulatory proposal and in some cases followed up with stakeholders to obtain further information or clarification.

As required by the AHR Act, the proposed regulations were also tabled in the House of Commons and the Senate by the Minister of Health. In general, support was indicated for the majority of the policy proposals presented. Minor revisions were made to the proposed regulations to add clarity and to better reflect the views of Canadian stakeholders.

Q8 Who provided comments on the consultation document and the proposed regulations? How did Health Canada use these comments?

By the end of the consultation and comment period on the proposed regulations, 53 written submissions were received from a broad range of interested Canadians, including individuals working in the field of AHR (physicians, nurses, counselors, clinic administrators), provincial governments, federal parliamentary committees, professional associations, research groups, and individuals with an interest in areas of human rights, health law and religion. In general, support was indicated for the majority of the policy proposals presented.

Based on the comments received, Health Canada modified some of the policy proposals and clarified the language. For more detailed information on Health Canada's response to the comments received, please refer to the consultation section of the Risk Impact Analysis Statement that can be found by visiting the Assisted Human Reproduction (Section 8 Consent) Regulations.

Q9 How are these regulations different from the ones published in the Canada Gazette, Part I, on September 24, 2005?

Health Canada has made a few changes to the proposed regulations that were published in the Canada Gazette, Part I. For instance, modifications were made to the requirements for the withdrawal of consent to use, particularly for those donating in vitro embryos for research purposes. Regarding consent to research use, modifications were also made to require donors consenting to third party reproductive use to specify whether in vitro embryos created with their human reproductive material but not used for reproductive purposes, can be used for other purposes including research.

Also, the revised regulations provide transitional provisions for human reproductive material obtained and in vitro embryos created prior to section 8 coming into force.

For more detailed information on these changes and Health Canada's response to the comments received, please refer to the consultation section of the Risk Impact Analysis Statement that can be found by visiting the Assisted Human Reproduction (Section 8 Consent) Regulations.

Q10 When did these regulations take effect?

Section 8 of the Act and its regulations came into force on December 1, 2007. The regulations were published in June 2007 in the Canada Gazette, Part II, and are available to the public by visiting the Assisted Human Reproduction (Section 8 Consent) Regulations.

Q11 Are these the final regulations? Can changes still be made?

These regulations have the force and effect of law. Regulations are continually reviewed and re-assessed to ensure that they result in the greatest net benefit to Canadians.

Q12 What about human reproductive material or in vitro embryos that are already in storage, can the material or embryos still be used? Do the donors need to provide a new consent to use?

Part 4 of the regulations address the transitional period for human reproductive material obtained to create an embryo and in vitro embryos created prior to December 1, 2007. Human reproductive material or in vitro embryos to be used for one's own reproductive use must meet all of the regulatory requirements effective December 1, 2007. In all other cases, such as third party reproductive use, human reproductive material obtained and in vitro embryos created prior to December 1, 2007, could be used without necessarily meeting all of the requirements of the regulations, as long as there is written consent from the donor stating that the material or in vitro embryo can be used for that purpose.

Q13 What about human reproductive material imported from another country, does it still need to comply with section 8 of the AHR Act?

Yes. Section 8 and its regulations apply to all human reproductive material used to create an embryo and all in vitro embryos used for any purpose, in Canada, regardless of where they were originally obtained. The regulations do provide transitional provisions for human reproductive material obtained or in vitro embryos created prior to December 1, 2007 (see previous Question & Answer).

Q14 What are the penalties for violating section 8 of the AHR Act?

Section 8 of the AHR Act is a prohibition, therefore a violation constitutes a criminal offence. Section 60-64 of AHR Act sets out the maximum penalty for offences under the Act.

However, Health Canada's aim is to foster an environment that protects the health and safety of Canadians and that sees ethical principles applied in all matters relating to AHR, while allowing scientific advances which benefit Canadians.

Q15 Why is section 8 of the AHR Act a prohibition?

One of the key objectives of the AHR Act is to protect the health, safety, dignity and rights of all Canadians, particularly those undergoing AHR treatments in Canada. A core principle of the Act includes free and informed consent. In order to respect reproductive autonomy, only donors themselves can consent to the use of their gametes or in vitro embryos. The Parliament of Canada felt so strongly about this key principle that the requirement for written consent to use merited the protection afforded by the prohibition provisions of the Act.