Vol. 139, No. 39 — September 24, 2005

(Erratum)

Assisted Human Reproduction (Section 8) Regulations

Statutory authority

Assisted Human Reproduction Act

Sponsoring department

Department of Health

Notice is hereby given that the Regulatory Impact Analysis Statement to the Assisted Human Reproduction (Section 8) Regulations published in the Canada Gazette, Part I, Vol. 139, No. 38, Saturday, September 17, 2005, on pages 3037 to 3057, contained paragraphs in an incorrect sequence. The corrected Regulatory Impact Analysis Statement is as follows. The proposed Regulations are being re-published for ease of reference.

REGULATORY IMPACT
ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Description

On March 29, 2004, the Assisted Human Reproduction Act received Royal Assent. On April 22, 2004, various provisions of the Act were brought into force including most of the prohibitions, and some provisions relating to controlled activities. The Act seeks to protect the health and safety of Canadians using certain assisted human reproduction (AHR) technologies to help them build their families by regulating AHR activities and related research and prohibiting unacceptable activities such as human cloning.

The Act was built upon a framework of ethical principles consistent with the values of Canadians. These principles include the protection and promotion of human health, safety, dignity and rights, as well as the need to protect women and children from possible misuses of AHR technologies. The importance of free and informed consent is also a fundamental principle of the Act which supports the reproductive autonomy of donors. In order to uphold the principle of free and informed consent, the Act requires that written consent be obtained before using a person's reproductive material or an in vitro embryo.

The Act deals with informed consent in a number of provisions and in different contexts. These provisions provide the basis for the consent framework under the Act. Section 8 of the Act, which is not currently in force, is one component of this framework. This section and the proposed Regulations deal with consent obtained from a donor for the use of human reproductive material or an in vitro embryo. (see footnote 1) The proposed Regulations also include a definition for "in vitro embryo donor" in accordance with the regulation-making authority under the Act. Section 3 of the Act already provides definitions for "donor" in relation to human reproductive material, "consent," "embryo," and "in vitro embryo."

The purpose of the proposed Regulations is to specify the basic requirements necessary to activate the section 8 prohibitions under the Assisted Human Reproduction Act and, in so doing, help to protect the reproductive autonomy of donors of human reproductive material and in vitro embryos. These prohibitions, approved by Parliament through its passage of the Act, would not be enforceable without regulations.

Section 8 will prohibit the use of human reproductive material (e.g. gametes) for the purpose of creating an embryo and the use of in vitro embryos for any purpose unless the donor has given prior written consent to that use or purpose in accordance with the Regulations. More specifically, the following three activities will be offences under the Act unless the donor has given written consent to them:

1. using human reproductive material for the purpose of creating an embryo;
2. removing human reproductive material from a donor's body posthumously for the purpose of creating an embryo; and
3. using an in vitro embryo for any purpose.

The proposed Regulations will mostly affect the following groups:

• donors of human reproductive material and donors of in vitro embryos;
• establishments and persons involved in collecting human reproductive material for the purpose of creating an embryo;
• survivors of deceased persons where the deceased has consented to the removal of human reproductive material following death for the purpose of creating an embryo; and
• establishments and persons who make use of an in vitro embryo, whether in an AHR procedure or for research.

Dynamic risk analysis

Identifying the risk

One of the core principles of the Act is the principle of requiring free and informed consent which supports the concept of respecting one's reproductive autonomy—that is, only individuals can make decisions regarding whether or not to reproduce. Therefore, one of the key areas of risk addressed in the Act is the possibility that human reproductive material or in vitro embryos might be used for purposes for which consent was not given by the individuals involved.

Section 8 of the Act and the supporting proposed Regulations are designed to uphold the principles of the Act. In so doing, they are intended to help manage the intangible but real risk of harm that arises should reproductive materials or in vitro embryos be used without consent. The risks in such a circumstance are different in nature than the risks associated with not obtaining consent to a medical procedure (e.g. physical harm). Physicians are required by law to obtain informed consent of competent patients before providing any medical treatment. Section 8 of the Act does not address obtaining consent for a medical procedure. Rather, the section 8 Regulations are intended to protect the rights of gamete and in vitro embryo donors and the well-being of children conceived with the assistance of AHR technology. As well, the section and the Regulations protect the societal interest in protecting human dignity in reproduction and associated research.

Based on what has been learned from AHR service providers and experts in the field, Health Canada believes that the rate of conformity with the principle of obtaining written consent for the use of human reproductive materials and in vitro embryos has increased over time and is currently quite high. At the same time, however, it is unlikely that there are high rates of conformity associated with providing donors with the information required by the proposed Regulations. In other words, consent may be obtained but it may not be fully informed for the purposes of section 8. It is also reasonable to assume that there is some variation in the practices surrounding the obtaining of consent as, for example, in the case of the posthumous use of gametes to create an embryo.

Understanding what causes the risk to change

Risk arising from behaviour that does not conform to the proposed Regulations will change over time, whether or not a regulation is made. Dynamic risk in this context comprises two elements: (1) the likelihood that non-conforming behaviour will occur, and (2) the consequences that could result from non-conforming behaviour. Key variables that influence these elements over time include supply of third party donated gametes, infertility rates, advances in technology, AHR success rates, AHR service price, AHR service capacity, and disposable income. Although it may be relatively easy to identify influencing variables and the direction of their impact on risk, it is much more difficult to quantify their effect accurately. Therefore, this analysis is aimed at describing relative dynamic risk.

This analysis does not attempt to assign dollar values to, or otherwise measure consequences of, non-conforming behaviour, namely the amount of pain and suffering that could be incurred by affected individuals where proper written consent under section 8 is not obtained. The analysis focuses instead on the factors that influence the level of risk, how they interact, how risk may evolve over time, and how the proposed Regulations can be expected to change the evolution of risk in the future.

Defining regulatory benefits in terms of risk reduction

The benefit from the proposed Regulations is equivalent to the cumulative reduction of the risk from non-conforming behaviour attributable to the existence of the regulatory requirements. As long as the risk level under regulation is less than the risk level that would have occurred in the absence of regulation, some measure of public benefit has been achieved. In addition, the greater the difference in risk outcomes over a period of time, the greater the magnitude of the benefit generated from the regulation.

Evolution of risk

Although there is little recorded data regarding consent risk, there are good reasons to assume that conformity rates are high. First, no evidence indicating widespread non-conformity was presented during Parliamentary review of the Assisted Human Reproduction Act. Second, in consultations on the proposed Regulations, there have been few questions raised regarding the requirement to secure consent; AHR practitioners recognize the importance of ensuring written consent and have already taken steps to incorporate this into their daily practice.

Health Canada believes that several factors have caused conformity rates for AHR consent to be generally high and to have improved over the last ten years. Although, again, there is no quantitative supporting data, it seems reasonable to assume that the most significant influences have probably been

• increasingly stringent professional ethical standards relating to patient consent;
• a growing awareness among health care professionals about the value of obtaining informed patient consent;
• increased activity in the sector to promote communication, cohesion and the promotion of best practices;
• the promotion of accreditation of clinics;
• growing litigiousness and potential for legal liability;
• the potential impact on professional liability insurance costs; and
• increasing awareness among patients about their rights.

Taken together, the effect of all these influences has been to promote greater, not less, likelihood of conformity with the consent requirements articulated in the proposed Regulations.

Health Canada's assessment is that, without the section 8 Regulations, the likelihood of conforming behaviour would remain relatively stable in the short term. However, it is possible that, in the absence of a regulatory regime, conforming behaviour might experience some decline in the future due to advances in technology. For example, with improvements of AHR procedures, in particular in the area of cryopreservation, it is likely that there would be an increase in the use of gametes or in vitro embryos following a donor's death. While it is not anticipated that gametes or in vitro embryos, in such cases, would be used without donor consent, it is anticipated that cases where this consent was not written, or where donors were not provided with all the necessary information requirements, would increase.

Changing number of AHR procedures carried out each year

Based on data from the Canadian Fertility and Andrology Society, (see footnote 2) the Department believes that the number of AHR procedures subject to the proposed consent Regulations has been growing at a rate of about 3 percent compounded per year. Although this rate of increase may seem low, if continued for a number of years, it would generate substantial growth in the number of AHR procedures carried out each year.

For the ten-year period covered in this analysis, it is assumed that the 3 percent rate of increase will continue, although it is likely that it would decline at some point in the future. This assumption is based on several factors. First, in Canada, like other western countries, there is significant unmet demand for AHR services. Second, technological advances may improve the success rate of AHR procedures, particularly in vitro fertilization, making the procedures more viable to couples. Third, technological advances could reduce costs, thereby resulting in an increase in demand and greater AHR service capacity in Canada. Fourth, assuming that infertility rates do not decline over the next ten years, continued growth in the Canadian population will increase the number of infertile individuals and couples who then may seek AHR services.

How risk will likely change in the future without regulatory intervention

As explained above, Health Canada believes that, even if the section 8 Regulations were not made, conformity of prevailing consent practices with the proposed regulatory requirements would remain high because the same forces that have historically fostered informed consent practices would continue to operate. However, although the rate of conforming behaviour might remain high, the overall level of AHR consent risk would grow because of the increasing number of AHR procedures growing at a compound rate of 3 percent.

Anticipated risk management performance with regulatory intervention

Under the proposed Regulations, it is likely that conforming behaviour will improve initially and will then stabilize at a new higher rate. This increase would result from the existence of legal consent requirements coupled with government compliance measures and the efforts of health care professional organizations who will likely encourage and facilitate compliance among their members. Therefore, it is expected that the overall level of consent risk will decline, as conformity outpaces the increase in the number of AHR procedures. In order to maintain risk reductions, however, there will be a need to have an active promotion and enforcement program.

Figure 1 shows a graph of the risk model illustrating the relative change in AHR consent risk over a ten-year period. The graph does not provide numerical estimates of AHR procedures since there is currently insufficient data. However, the trends and relative changes in risk shown are believed to be indicative of future conditions with and without regulatory intervention for the reasons and under the assumptions discussed above.

Instrument choice

Section 8 of the Act can only address the unauthorized use of human reproductive material and the unauthorized use of in vitro embryos. These prohibitions, approved by Parliament through its passage of the Act, would not be enforceable without the Regulations. The use of guidelines, voluntary approaches, monetary instruments or other non-regulatory alternatives would not enable the coming into force of this section of the Act, since the statute itself is dependant upon the Regulations in order to be implemented.

As previously stated, the purpose of the proposed Regulations is to specify basic requirements necessary to activate the section 8 prohibitions and, in so doing, help to protect the reproductive autonomy of donors. Specifying only the essential information required to be provided to donors was deemed necessary to give effect to the section 8 prohibition while ensuring that potential penalties under the Act were proportional to the obligations imposed by that section and the proposed Regulations.

The section 8 Regulations are performance-type regulations and, as such, do not prescribe specific wording to be used in a consent form. This approach, as opposed to a prescriptive approach, gives regulatees the flexibility to tailor their forms based on their own circumstances provided that they conform with the requirements described in the Regulations. The flexibility afforded by this approach allows AHR service providers to seek efficiencies where available.

It should be noted that section 14 of the Act, not in force at present, is another component of the overall consent framework. It sets out the statutory requirement to inform a donor in writing of the requirements of the Act respecting the retention, use, provision to other persons and destruction of the human reproductive material or in vitro embryos. Section 14 also mandates the provision and receipt of counselling services prior to accepting a donation. Consent for research and clinical trials will be addressed by section 40 of the Act. Once implemented, these sections, along with a licensing system authorized under the Act, will further contribute to the consent framework.

It is intended that the above sections, along with their supporting regulations where required, will be rolled out over the next few years. Each will build upon the other until the complete consent framework is in place. This approach will allow various components of the consent framework to be implemented in a complementary but independent manner and will allow time for the sector to adapt to the changing requirements.

In order for government intervention to be effective, it is recognized that regulation alone is not enough. To support the proposed Regulations, Health Canada is developing two non-regulatory instruments, including an interpretation or user's guide and a sample consent form that clinics can use or adapt for their own purpose. The purpose of these documents is to facilitate understanding of the Regulations and to facilitate compliance with the legal requirements. These documents will be made available once the final Regulations are made.

Costs

The Department believes that a large proportion of AHR service providers already engage in practices that are similar in nature to what is proposed in the Regulations. Therefore, it is believed that changes to current business practices will be minimal, thus increasing compliance costs to AHR service providers only slightly.

There are two categories of compliance expenditures for AHR service providers: non-recurring compliance expenditures and recurring compliance expenditures. The following sections examine the economic impacts on AHR service providers caused by the implementation of the section 8 Regulations. All expenditure projections are for the major 25 AHR clinics and practices in Canada but do not include smaller practices where less complex procedures may be performed (e.g. physicians performing artificial insemination). In order to reduce costs for these smaller practices, Health Canada is studying the feasibility of developing a voluntary generic consent form that would meet the requirements of the proposed Regulations and that could be used where less complex services are sought from smaller practices.

All monetary estimates are in constant dollars (2005) and are not discounted. The model assumes that the section 8 Regulations would be implemented in 2006 and is extrapolated over a ten-year period.

Non-recurring AHR service provider compliance expenditures

Non-recurring compliance expenditures are temporary, one-time expenses incurred due to the implementation of regulations. When new regulations are introduced, initial investments are often required to adjust administrative methods and procedures to comply with regulatory requirements. These investments cause compliance-related expenditures to increase in the short term. However, once methods and procedures are modified, costs rapidly decline and eventually become minimal (i.e. are nonrecurring).

Two types of non-recurring compliance expenditures for AHR service providers have been identified: the additional expenditure required to adapt existing consent forms and procedures to comply with the Regulations and the additional expenditure required to develop training materials and to train staff on the regulatory requirements. Although training occurs periodically after the implementation of the Regulations, the expenditure model treats training as a non-recurring compliance expenditure, since a large portion of the cost would be incurred during the initial implementation of the Regulations.

The total non-recurring compliance expenditure for developing forms and procedures for the AHR sector (i.e. all 25 clinics) is estimated at approximately $31,000 in 2006. This reflects the initial investment required to assess and revise current practices, modify consent forms and procedures and have them reviewed by a legal advisor to ensure conformity to the section 8 regulatory requirements. This component of compliance costs would decrease to $0 in 2007 and would remain at that level.

Incremental training expenditures to implement the proposed Regulations for the AHR sector are estimated at approximately $12,400 in 2006. The expenditure increase is due to the development of additional training materials and the delivery of additional staff training on the new regulatory obligations. The training expenditure is expected to decline to near $0 in 2007 and should remain constant at this level. It is expected that, after a short transition period, training on the new requirements will become routine and be incorporated into a clinic's standard operating procedures.

Recurring AHR service provider compliance expenditures

Recurring compliance expenditures are continuous expenditures incurred by the regulatee in order to meet regulatory requirements. For the proposed Regulations, the aggregate level of recurring compliance expenditures is dependent both on the incremental costs associated with regulatory compliance and also on the amount of AHR activity to which those costs apply.

Three recurring compliance expenditures for AHR service providers have been identified: the additional expenditure required to obtain written consent from patients as specified in the Regulations; the additional expenditure required to print and store the modified consent forms; and the additional expenditure required to verify the consent prior to the use of human reproductive material or an in vitro embryo. The expenditure model assumes that all recurring expenditures will equal $0 until the section 8 Regulations are implemented in 2006.

Health Canada estimates that recurring compliance expenditures for AHR service providers will increase throughout the period that the Regulations are in force at a rate proportionate to the increase in the number of consents per year. For the purpose of this analysis, a 3 percent per annum increase (compounded) is assumed, which reflects the rate of growth in AHR procedures in recent years.

The most substantial recurring compliance expenditure for the AHR sector is for obtaining consent. The total value for this expenditure for the AHR sector is estimated at approximately $72,000 in 2006. The is due in large part to the investment of extra time, assumed to be an average of 15 minutes, required by a staff member to inform donors and to obtain their written consent in accordance with the proposed Regulations. The expenditure for obtaining consent would increase over the next ten years at a rate of 3 percent per annum, an increase that is proportionate to the estimated rate of growth in the number of consents per year. In 2015, the expenditure model estimates that the obtaining consent expenditure would be approximately $94,000 for the AHR sector in Canada. Therefore, as the number of consent forms accumulates over the years, the expenditure on storage will also increase accordingly.

The consent form printing and storage expenditure is the smallest recurring AHR service provider compliance expenditure. This is due to a very low increase in costs associated with the printing and storage of an estimated additional two pages to be included with or integrated into existing consent forms. The consent form printing and storage expenditure would be approximately $1,600 for the entire AHR sector in Canada in 2006. Expenditures will increase to about $6,000 by 2015. This increase results from the cumulative cost associated with storing the consent forms. Each year, the storage expenditure includes all costs associated with consent forms filed for that year, plus costs associated for storing all consent forms filed from previous years.

As section 8 and the proposed Regulations impose a legal obligation that human reproductive material or in vitro embryos cannot be used unless consent from the donor is obtained, it is anticipated that AHR practitioners will verify the consent form prior to using the material or embryo. Costs are associated with the time investment required to verify consent forms, assumed to be an additional increase of one minute per verification. The expenditure model estimates that in 2006 the total consent verification expenditure for the AHR sector in Canada would be approximately $33,000. The total AHR consent verification expenditure is projected to increase by 3 percent per annum over the next ten years, rising to about $44,000 by 2015.

Total compliance expenditures for AHR caused by regulatory implementation

As shown in Figure 2, the expenditure model estimates that the total compliance expenditure for AHR service providers in Canada will be about $150,000 in 2006 with the implementation of the Regulations.

This will decline in 2007 to about $110,000 due to the decline in non-recurring compliance expenditures. The total compliance expenditure will increase thereafter due to increases in the number of AHR activities and the associated costs for obtaining consents, printing and storing consents, and verifying consents. The total compliance expenditure for the AHR sector is projected to be around $143,000 by 2015. Based on the expenditure projections, Health Canada believes that the proposed Regulations will not impose significant cost burdens on AHR service providers.

Government expenditure on regulatory program administration

The expenditure model assumes that government expenditures on implementation of the proposed consent regulations will be $0 until the Regulations come into force in 2006. The annual rate of expenditures will then increase to $120,000 per year and, for the purposes of this analysis, are projected to remain at that level until 2015. This expenditure includes all costs associated with staff salary, operating and maintenance expenses, inspection and other compliance-related activities.

Aggregate AHR sector and government expenditure on regulatory implementation

The 2015 projected aggregate AHR sector and government expenditures required to implement and comply with the proposed Regulations is estimated to be in the range of $240,000 and $290,000.

Consultation

Public involvement activities

A number of public involvement activities were conducted prior to the development of the proposed Regulations. These activities consisted of (1) a series of technical briefings held with provincial officials; (2) the publication of a Notice of Intent in the Canada Gazette, Part I; (3) a separate series of technical briefings held for stakeholders and the general public; and (4) the distribution of a discussion paper for comment (see footnote 1).

Provincial and territorial technical briefings

Formal technical briefings were conducted with provincial officials between September 2004 and January 2005. The main purpose of these sessions was to explain the regulatory components set out in the Act and to outline the regulatory development process with a focus on the section 8 Regulations.

Notice of Intent

On October 30, 2004, a Notice of Intent was published in the Canada Gazette, Part I, advising that the Department intended to start developing the components of the regulatory framework under the Act. The Notice indicated that the Department planned to undertake public involvement activities and to provide interested parties with the opportunity to participate. The Notice also informed the public that the Department would soon post a discussion paper on the proposed Regulations concerning section 8 of the Act (Consent) and the section 3 definition of an in vitro embryo donor. The document was posted on the Health Canada Web site on November 8, 2004.

Discussion paper

The consultation discussion paper "Seeking Input on a Proposed Approach for Regulations Concerning Section 8 (Consent) and the Section 3 Definition of an In Vitro Embryo Donor under the Assisted Human Reproduction Act" was distributed on November 8, 2004, by email and courier to all provincial and territorial officials identified as of November 1, 2004. At the same time, the paper was mailed to 376 individuals and organizations identified with the Department as interested parties. Additional copies of the document were distributed as part of the technical briefings held across Canada and the document was consulted on 622 occasions on Health Canada's Web site. In total, 43 written submissions were received in response to the discussion paper.

Comments

Who provided comments

Responses to the discussion paper were received from a broad range of interested Canadians, including individuals working in the field of AHR (physicians, nurses, counsellors, clinic administrators); provincial governments; 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. Below is a summary of the key comments received and Health Canada's response.

1. Language

Some respondents expressed concern with the proposal in the discussion paper that "donors . . . be informed prior to giving consent, that his or her donation of reproductive material or any resulting in vitro embryo may not be used due to the presence of disease, lack of viability, or for some other reason in which case the human reproductive material or in vitro embryo may be disposed of."

Respondents felt that such language was too vague and appeared to place the control of reproductive material outside of the hands of the donor. There was also concern that such broad language could open the door to unethical or discriminatory selection practices. Of those who supported the requirement, many felt that donors should be told why the reproductive material or in vitro embryos were not used and that they should also be involved in the decision-making process regarding use or non-use.

Health Canada response

Health Canada agrees that the proposed language was broad and subject to interpretation. Further, upon careful consideration of the scope and authority granted under section 8, it was determined that this clause would not be appropriate for this section, as it deals with the issue of destruction. The section 8 Regulations do not address the storage or destruction of human reproductive material or in vitro embryos, as these are not considered "uses." Future regulatory proposals under other sections of the Act will address when and how human reproductive material or in vitro embryos may be disposed of. The clause was therefore removed and the issue will be addressed in a subsequent regulatory proposal under another section of the Act.

2. Assigning and the right to withdraw consent for third party donation and to research

Some respondents raised concerns over the concept of "assigning" human reproductive materials or in vitro embryos to third parties for reproductive use and "assigning" in vitro embryos to researchers. Respondents felt that the concept was not specific enough and questioned when assignment would be deemed to have occurred.

Health Canada response

It is Health Canada's position that donors providing consent for the use of their reproductive material or in vitro embryos be told whether and when they can withdraw their consent.

Health Canada agrees that the term "assignment" is broad and subject to interpretation. The proposed Regulations are now more specific with respect to the withdrawal of consent. A withdrawal of consent must be in writing and is only effective if it is received by the person intending to make use of the material.

In most situations, the withdrawal of consent can occur at any point prior to the material being used. There are, however, two exceptions: (1) where reproductive material is donated to a third party, consent cannot be withdrawn once the material has been provided by the donor; and (2) where an in vitro embryo has been donated for either third party reproductive use or research use, consent cannot be withdrawn once the third party or researcher acknowledges in writing that the in vitro embryo has been designated for their respective use.

3. Mutual consent

There was clear support for the requirement that mutual consent be obtained for the use of an in vitro embryo where the donor is a couple (regardless of whose gametes were used to create the embryo). However, respondents expressed concerns with respect to those situations where mutual consent is not obtained and questioned how such a situation would be resolved.

Health Canada response

Health Canada agrees that the Regulations must be clear regarding the need for mutual consent in the use of an in vitro embryo. Resolving conflicts involving mutual consent requires consideration of all relevant issues and interests. These primarily relate to storage, destruction, and the nature of the dispute itself, all of which fall outside the regulatory-making authority of section 8. While the factors around the dispute itself cannot be addressed in regulation, forthcoming regulatory proposals under section 10 will address in vitro embryo storage time limits and destruction, which will provide further clarity and perhaps aid in the resolution of any disagreement.

4. Embryo research

Respondents supported the principle that written consent be obtained for the research use of an in vitro embryo. However, some expressed concern that the regulatory proposal would allow a "blanket" consent to research. Some respondents felt that donors should be informed of the specific purpose and goals of the research, particularly in the case of embryonic stem cell research.

Health Canada response

Health Canada recognizes the concerns of respondents and agrees that, when consenting to the research use of an in vitro embryo, donors should be informed of the possible purposes of that research. However, given the regulatory authority under section 8, it is not possible to specify the particular types of embryo research. Future regulatory proposals will deal with embryo research and will serve to complement the consent obtained under section 8.

The Act is clear that, with respect to embryo research to derive stem cells, consent must conform to the provisions of the Human Pluripotent Stem Cell Research Guidelines released by the Canadian Institutes of Health Research (CIHR) in March 2002. These guidelines state that "at the time when embryos are to be used for research to derive and study embryonic stem cells . . . , consent of the embryo provider must be reiterated. A renewal of consent of the gamete provider (if the gamete providers are not the same individuals as the embryo providers) is not required, provided that appropriate consent for unrestricted research use of the embryo was given at the time of donation."

The proposed section 8 Regulations are compatible with the CIHR guidelines. The Regulations require that donors of human reproductive material be informed that there may be in vitro embryos created in excess of reproductive needs and that in vitro embryos created for third party use will be used in accordance with the consent of the third party, which could include research.

5. The definition of an in vitro embryo donor

Respondents found the definition of an "in vitro embryo donor" unclear because the definition includes individuals or couples donating embryos created with their own gametes for their own reproductive purposes.

Health Canada response

Health Canada acknowledges that the term "donor" is generally understood to mean a person who provides human reproductive material or an in vitro embryo for third party use. In section 3 of the Act, "donor" is defined as, "in relation to human reproductive material, the individual from whose body it was obtained, whether for consideration or not." This definition includes individuals making use of their gametes for their own reproductive purposes. In line with this concept, the definition of an "in vitro embryo donor" includes individuals using in vitro embryos created from their own gametes for their own reproductive use. Health Canada recognizes that this definition will require a conceptual adjustment and will work with clinics and others to ensure clarity of this term.

6. Donation of human reproductive material or creation and donation of an in vitro embryo for third party use

In Health Canada's regulatory proposal, the in vitro embryo donor becomes the donor with respect to any further disposition of the in vitro embryo, regardless of whose gametes were used to create the embryo. Individuals or couples consenting to donating their supernumerary in vitro embryos for third party reproductive use are informed that their consent includes consent to all possible future uses, as authorized by the Act. That is, once an in vitro embryo is donated to a third party, it is up to the third party to decide how the in vitro embryo should be used.

A few respondents felt that donors of human reproductive material or in vitro embryos should be allowed to place conditions on their donation and restrict the allowable future uses of the in vitro embryo. For example, a couple who made use of third party sperm for in vitro fertilization may want to donate their supernumerary in vitro embryos for research purposes. If the original third party sperm donor placed a condition on his donation that research not be done, the couple, for whom the in vitro embryo was created, would not be able to allow it.

Health Canada response

This alternative model of conditional consent would create a situation where the recipient of the reproductive materials is not the full custodian of the in vitro embryo. Future decisions relating to the disposition of supernumerary in vitro embryos would be limited by a party that is not involved in that person's reproductive decisions. This approach is inconsistent with Health Canada's view that a donor of gametes or of in vitro embryos, who donates for third party reproductive use, should not have any rights to the in vitro embryos and to any children born as a result of the donation. The person for whom the embryo was created or to whom the embryo was donated should always assume full custodianship. The alternative approach would also create a complex mandatory system of matching and tracking consents, over a long period of time in some cases, which would create an increased burden on clinics and increase the likelihood of contraventions arising from unintentional errors.

7. Comments outside the scope of section 8

In response to the discussion document, Health Canada received a number of comments that, while related to the issue of consent, cannot be addressed specifically under section 8.

Respondents felt strongly that counselling is an important component to ensure that consent is fully informed and freely given. In particular, respondents commented that fully informed consent and counselling should be mandatory for the posthumous retrieval of gametes for the reproductive purposes of the donor's spouse. Respondents also commented on the types of information that should be provided to donors before they are allowed to provide consent to the use of their reproductive material or in vitro embryo.

Health Canada response

Health Canada agrees that fully informed consent and counselling are important. Informed consent is a core principle of the AHR Act, and the Act addresses consent in a number of provisions that provide the basis for the overarching consent framework. In particular, section 14 of the Act will require that before accepting a donation of human reproductive material or an in vitro embryo and before performing any controlled activity on a person, the licensee must ensure that the person has received counselling, has been informed of all the requirements of the Act, and has provided health reporting information. Therefore, in the scenario mentioned above, before retrieving gametes posthumously from the person, the licensee would have to ensure that the person had received counselling, had been informed of all the requirements of the Act, had provided health reporting information, and had signed a consent as required by the section 8 Regulations.

Therefore, while it is Health Canada's intent that the complete AHR regulatory framework promote fully informed consent of donors, section 8 can only address the unauthorized use of human reproductive material and the unauthorized use of in vitro embryos. Specifying only the essential information required to be provided to donors was deemed necessary to give effect to the section 8 prohibition while ensuring that obligations and potential penalties were proportional. Forthcoming regulatory proposals under other sections of the Act will complement the section 8 Regulations. It is also anticipated that once the Assisted Human Reproduction Agency of Canada has been established, it will work to further support the regulations in this area, through, for example, educational materials.

Compliance and enforcement

At the time the Regulations come into force, Health Canada will have an enforcement framework in place. The framework would be consistent with the approaches used to seek compliance with other acts that are administered under the health portfolio, such as the Food and Drugs Act. The framework will consist of a range of possible actions including information, education, investigation, voluntary cooperation, public alerts, seizures and prosecution.

Performance could be measured using a number of tools including tracking of complaints, surveys, inspections and investigations.

Contact

Francine Manseau, Manager — Policy Development, Assisted Human Reproduction Implementation Office, Health Canada, 200 Promenade du Portage, Suite 350, Address Locator 7002A, Gatineau, Quebec, (819) 934-1830 (telephone), (819) 934-1828 (fax), ahr-pa@hc-sc.gc.ca (email).

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to subsection 65(1) of the Assisted Human Reproduction Act (see footnote a), proposes to make the annexed Assisted Human Reproduction (Section 8) Regulations.

Interested persons may make representations with respect to the proposed Regulations within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Francine Manseau, Assisted Human Reproduction Implementation Office, Department of Health, 200 Promenade du Portage, 2nd Floor, Address Locator 7002A, Gatineau, Quebec K1A 0K9 (tel.: (819) 934-1830; fax: (819) 934-1828; e-mail: ahr-pa@hc-sc.gc.ca).

Persons making representations should identify any of those representations the disclosure of which should be refused under the Access to Information Act, in particular under sections 19 and 20 of that Act, and should indicate the reasons why and the period during which the representations should not be disclosed. They should also identify any representations for which there is consent to disclosure for the purposes of that Act.

Ottawa, August 30, 2005

EILEEN BOYD 
Assistant Clerk of the Privy Council 

ASSISTED HUMAN REPRODUCTION (SECTION 8) REGULATIONS

INTERPRETATION

1. (1) The following definitions apply in these Regulations.

"Act" means the Assisted Human Reproduction Act. (Loi)

"common-law partner", in relation to an individual, means a person who is cohabiting with the individual in a conjugal relationship at the relevant time, having so cohabited for a period of at least one year. (conjoint de fait)

(2) In these Regulations, the term "spouse" does not include persons who, at the relevant time, live separate and apart because of a breakdown in their marriage.

(3) In these Regulations, a written consent of a donor means a consent signed by the donor and attested by a witness.

PART 1

CONSENT GIVEN UNDER SUBSECTION 8(1) OF THE ACT

2. In this Part, "third party" means

(a) an individual other than the donor or the donor's spouse or common-law partner; or

(b) a couple in respect of whom neither of the spouses or common-law partners is the donor.

3. This Part applies in respect of a consent under subsection 8(1) of the Act to use human reproductive material for the purpose of creating an embryo.

4. Before a person makes use of human reproductive material for the purpose of creating an embryo, the person shall have a document signed by the donor stating that, before consenting to the use of the material, the donor was informed in writing that

(a) subject to paragraph (b), the human reproductive material will be used in accordance with the donor's consent to create an embryo for one or more of the following purposes, namely,

(i) the donor's own reproductive use,

(ii) following the death of the donor, the reproductive use of the spouse or common-law partner of the donor at the time of the donor's death,

(iii) the reproductive use of a third party,

(iv) improving assisted reproduction procedures, or

(v) providing instruction in assisted reproduction procedures;

(b) if the material is to be removed from the donor's body after the donor's death, the human reproductive material will be used in accordance with the donor's consent to create an embryo for one or more of the following purposes, namely,

(i) the reproductive use of the spouse or common-law partner of the donor at the time of the donor's death,

(ii) improving assisted reproduction procedures, or

(iii) providing instruction in assisted reproduction procedures;

(c) if the donor wishes to withdraw their consent, the withdrawal must be in writing;

(d) a withdrawal of consent by the donor is effective only if the person who intends to make use of the human reproductive material is notified in writing of the withdrawal before the material is

(i) used, if the material is to be used to create an embryo for a purpose described in paragraph (a) or (b), other than subparagraph (a)(iii), and

(ii) provided by the donor, if the material is to be used to create an embryo for the purpose described in subparagraph (a)(iii);

(e) the number of in vitro embryos created with the material may be in excess of the immediate reproductive needs of the individual or couple for whom they were created;

(f) if the material is to be used to create an in vitro embryo for a third party's reproductive use, the in vitro embryo will be used in accordance with the consent of the third party, which may permit research; and

(g) if the material is to be used to create an in vitro embryo for the reproductive use of the spouse or common-law partner of the donor at the time of the donor's death, the in vitro embryo will be used in accordance with the consent of that spouse or common-law partner, which may permit research.

5. Before a person makes use of human reproductive material for the purpose of creating an embryo, the person shall have the written consent of the donor of the material stating that the material may be used for one or more of the following purposes:

(a) the donor's own reproductive use;

(b) following the death of the donor, the reproductive use of the spouse or common-law partner of the donor at the time of the donor's death;

(c) the reproductive use of a third party;

(d) improving assisted reproduction procedures; or

(e) providing instruction in assisted reproduction procedures.

6. (1) If a donor wishes to withdraw their consent, the withdrawal must be in writing.

(2) The withdrawal is effective only if the person who intends to make use of the human reproductive material is notified in writing of the withdrawal before the material is

(a) used, if the material is to be used to create an embryo for a purpose described in paragraph 5(a), (b), (d) or (e); and

(b) provided by the donor, if the material is to be used to create an embryo for the purpose described in paragraph 5(c).

PART 2

CONSENT GIVEN UNDER SUBSECTION 8(2) OF THE ACT

7. This Part applies in respect of a consent under subsection 8(2) of the Act to remove human reproductive material from a donor's body after the donor's death for the purpose of creating an embryo.

8. Before a person removes human reproductive material from a donor's body after the donor's death for the purpose of creating an embryo, the person shall have a document signed by the donor stating that, before consenting to that removal, the donor was informed in writing that

(a) the human reproductive material will be removed in accordance with the consent of the donor to create an embryo for one or more of the following purposes, namely,

(i) the reproductive use of the spouse or common-law partner of the donor at the time of the donor's death,

(ii) improving assisted reproduction procedures, or

(iii) providing instruction in assisted reproduction procedures;

(b) if the donor wishes to withdraw their consent, the withdrawal must be in writing;

(c) a withdrawal of consent by a donor is effective only if the person who intends to remove the human reproductive material is notified in writing of the withdrawal before the removal of the material; and

(d) human reproductive material removed from the donor cannot be used for a purpose set out in paragraph (a) unless the person who intends to make use of the material has the written consent of the donor under Part 1 respecting its use.

9. Before a person removes human reproductive material from a donor's body after the donor's death for the purpose of creating an embryo, the person shall have the written consent of the donor respecting the removal of the material and the written consent of the donor under Part 1 respecting the use of the material.

10. (1) If a donor wishes to withdraw their consent respecting the removal of human reproductive material after their death, the withdrawal must be in writing.

(2) The withdrawal is effective only if the person who intends to remove the human reproductive material is notified in writing of the withdrawal before the removal of the material.

PART 3

CONSENT GIVEN UNDER SUBSECTION 8(3) OF THE ACT

11. (1) In this Part, "donor" means the following persons for whose reproductive use an in vitro embryo was created or donated, as the case may be,

(a) the individual who has no spouse or common-law partner at the time the in vitro embryo is created, regardless of the source of the human reproductive material used to create the in vitro embryo,

(b) the couple who are spouses or common-law partners at the time the in vitro embryo is created, regardless of the source of the human reproductive material used to create the in vitro embryo; or

(c) the third party who, at the time the in vitro embryo is donated, is

(i) an individual who has no spouse or common-law partner, or

(ii) a couple who are spouses or common-law partners.

(2) For the purpose of this Part, if an in vitro embryo is donated for the reproductive use of a third party, the individual or couple who made the donation is no longer the donor in respect of the in vitro embryo after the donation.

(3) If the donor is a couple, the consent of each spouse or common-law partner must be compatible in order for the consent of the donor to comply with the requirements of this Part.

12. This Part applies in respect of a consent under subsection 8(3) of the Act to make use of an in vitro embryo.

13. Before a person makes use of an in vitro embryo, the person shall have a document, signed by the donor of the in vitro embryo, stating that, before consenting to that use, the donor was informed in writing that

(a) the in vitro embryo will be used in accordance with the consent of the donor for one or more of the following purposes, namely,

(i) the donor's own reproductive use,

(ii) the reproductive use of a third party, or

(iii) research;

(b) if the donor wishes to withdraw their consent, the withdrawal must be in writing;

(c) a withdrawal of consent by the donor is effective only if the person who intends to make use of the in vitro embryo is notified in writing of the withdrawal

(i) in the case of an in vitro embryo to be used for the purpose set out in subparagraph (a)(i), before the use of the in vitro embryo, and

(ii) in the case of an in vitro embryo to be used for the purpose set out in subparagraph (a)(ii) or (iii), before the third party or researcher acknowledges in writing that the in vitro embryo has been designated for their reproductive use or for research, respectively; and

(d) if an in vitro embryo is donated for the reproductive use of a third party, the in vitro embryo will be used for one or more of the purposes set out in section 14, in accordance with the consent of the third party, who is to be considered the donor of the in vitro embryo.

14. Before a person makes use of an in vitro embryo, the person shall have the written consent of the donor stating that the in vitro embryo may be used for one or more of the following purposes:

(a) the donor's own reproductive use;

(b) the reproductive use of a third party; or

(c) research.

15. (1) If a donor wishes to withdraw their consent, the withdrawal must be in writing.

(2) The withdrawal is effective only if the person who intends to make use of the in vitro embryo is notified in writing of the withdrawal

(a) in the case of an in vitro embryo to be used for the purpose described in paragraph 14(a), before the use of the in vitro embryo; and

(b) in the case of an in vitro embryo to be used for the purpose described in paragraph 14(b) or (c), before the third party or researcher acknowledges in writing that the in vitro embryo has been designated for their reproductive use or for research, respectively.

(3) If the donor is a couple, the consent of the donor may be withdrawn by one of the individuals who gave the consent.

COMING INTO FORCE

16. These Regulations come into force on the day on which they are registered.

[39-1-o]

Footnote 1

For a more thorough discussion of the consent framework see section 3.4 in "Seeking Input on a Proposed Approach for Regulations Concerning Section 8 (Consent) and the Section 3 Definition of an In vitro Embryo Donor under the Assisted Human Reproduction Act." Health Canada, November 2004. Cat. H39-4/56-1-2004. ISBN 0-662-68551-2

Footnote 2

Canadian Assisted Reproduction Technologies Register 1999-2001, Canadian Fertility and Andrology Society.

Footnote a

S.C. 2004, c. 2

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