Frequently Asked Questions

1. Is the Assisted Human Reproduction Act in force?
   
   
2. Why is it taking so long to develop the regulations under the Assisted Human Reproduction Act?
   
   
3. Under Section 19 of the Assisted Human Reproduction Act, "Information Available from the Agency", what kind of information will be made public?
   
   
4. What is meant by the transitional provisions of Section 71 of the Assisted Human Reproduction Act? Can I start a new service or open a new clinic in this time of transition?
   
   
5. Can Canadians continue to receive fertility treatment or is there a moratorium until the regulations are developed?
   
   
6. With the prohibitions on commercialization now in effect, are sperm/egg donors and surrogates be denied payment?
   
   
7. Will clinics be able to continue to use sperm already in storage which had been "paid for"?
   
   
8. Can clinics import sperm from paid donors?
   
   
9. What impact does the prohibition on payment to a surrogate have on surrogacy contracts?
   
   
10. What impact does the prohibition on arranging surrogacy services - for payment - have on Assisted Human Reproduction clinics, doctors and lawyers?
    
    
11. What is the relationship between the Assisted Human Reproduction Act and the Processing and Distribution of Semen for Assisted Conception Regulations (Semen Regulations)? Are the Semen Regulations still in effect?
    
    
12. Where can I find the most up-to-date information regarding the development of regulations under the Assisted Human Reproduction Act?

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1. Is the Assisted Human Reproduction Act in force?

The Assisted Human Reproduction Act (AHR) received Royal Assent on March 29, 2004. However, as a new licensing regime and regulations take time to implement, the coming into force of the AHR Act follows an approach that accounts for this.

On April 22, 2004, all of the prohibitions (sections 5 through 9) came into force except section 8 which pertains to the prohibition on the use of reproductive material or in vitro embryos without consent. Section 8 along with its supporting regulations came into force on December 1, 2007. An explanation of prohibited activities is available at the Health Canada Web site.

The "controlled activities" sections (10 to 12) set out the controlled activities related to AHR that may only be carried out with a licence and in accordance with the regulations. These include activities involving human reproductive material for the purpose of creating an embryo, and activities involving the use of an in vitro embryo. Section 13 requires persons who undertake controlled activities to do so in premises that are licensed. These provisions (with the exception of section 12 which deals with the reimbursement of receipted AHR-related expenses came into force on April 22, 2004, but until the licensing and regulatory framework is in place, the transitional provision in section 71 (the "grandfathering" provision) applies to allow for a continuation of AHR services (see Question 4 relating to section 71).

Provisions relating to the creation of Assisted Human Reproduction Canada were proclaimed on December 21, 2006, with the appointments of the President, Chairperson, and other members of the Board of Directors. Provisions relating to the full functioning of the Agency and all remaining sections will follow, once the regulatory/licensing regime is developed.

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2. Why is it taking so long to develop the regulations under the Assisted Human Reproduction Act?

Health Canada must follow the Cabinet Directive on Streamlining Regulation in developing options and recommendations for Assisted Human Reproduction. The Directive is designed to protect and advance the public interest by working with Canadians and other governments to ensure that its regulatory activities result in the greatest overall benefit to current and future generations of Canadians. The Directive includes clear requirements for the development, implementation, evaluation and review of regulations. The Government must weigh the benefits of alternatives to regulations - and of alternative regulations - against their cost, and focus resources where they can do the most good.

Regulations made under federal Acts have to meet the requirements of the regulatory process. By following this process, government departments can better ensure that Ministers have the appropriate information on which to base decisions regarding regulations.

The main steps of the regulatory process are the following:

• initiation of public consultations;
• conception and drafting of proposed regulations as well as other documents that constitute the regulatory submission package, such as the Regulatory Impact Analysis Statement (RIAS);
• review by the Department of Justice;
• Ministerial approval for prepublication;
• consideration by the Regulatory Affairs Secretariat at Treasury Board;
• prepublication of the proposed regulations and RIAS in Canada Gazette, Part I and comment period;
• parliamentary review of proposed regulations;
• analysis of comments received and departmental preparation of final proposal;
• final review by the Department of Justice;
• Ministerial approval for publication;
• consideration by Treasury Board;
• approval by the Governor in Council and registration by the Clerk of the Privy Council;
• publication of final regulations and RIAS in Canada Gazette, Part II;
• coming into force of regulations;
• parliamentary review by the Standing Joint Committee on the Scrutiny of Regulations.

The first set of regulations for section 8, regarding consent to use, came into effect on December 1, 2007.

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3. Under Section 19 of the Assisted Human Reproduction Act, "Information available from Agency", what kind of information will be made public?

This will be outlined in the regulations. Stakeholder interests will be taken into consideration in the development of these regulations, as will requirements of other legislation on information disclosure, such as the Privacy Act.

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4. What is meant by the transitional provisions of Section 71 of the Assisted Human Reproduction Act? Can I start a new service or open a new clinic in this time of transition?

The transitional provisions of section 71 allows persons (under the Act a person can be an individual, a partnership or a corporation) that had undertaken a controlled activity at least once in the year preceding the Act coming into force (in other words between April 23, 2003 and April 22, 2004) to continue to perform such activities and use any premises required for that purpose up to a date to be specified by regulation. This provision recognizes that an effective licensing regime takes time to develop and gives the Assisted Human Reproduction (AHR) community time to adjust to the requirements of the Act and the new regulations.

Accordingly, until the licensing scheme and applicable regulations are in place, a person - such as an AHR clinic or physician -- can conduct a controlled activity provided they had undertaken that activity at least once in the year prior to April 22, 2004, or that they employ someone who had undertaken the activity at least once in the year prior to April 22, 2004.

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5. Can Canadians continue to receive fertility treatment or is there a moratorium until the regulations are developed?

The manner in which the Act will be implemented ensures that Canadians can continue to visit Assisted Human Reproduction (AHR) clinics and undergo AHR procedures during the interim period while the regulatory and licencing frameworks are being developed. This flexibility is possible because of section 71 (the "grandfathering" clause) which prevents unnecessary interruptions to the provision of assisted reproduction services, such as in vitro fertilization (IVF), by allowing providers to continue to undertake their activities.

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6. With the prohibitions on commercialization now in effect, are sperm/egg donors and surrogates denied payment?

The prohibitions concerning the purchase of sperm/eggs (gametes) from donors and the payment or offer of compensation to surrogate mothers and those arranging for the services of a surrogate mother came into force on April 22, 2004. As a result, a person can no longer purchase sperm or eggs from a donor nor can payment be given to a woman providing surrogacy services.

Gametes donated prior to December 1, 2007, can still be used as long as consent for such use has been provided. Payments made in relation to a surrogacy agreement entered into before April 22, 2004, are not subject to the prohibition; however, any payments made in relation to a surrogacy agreement that was entered into after that date, are prohibited.

The Act allows for donors and surrogate mothers to be reimbursed for expenditures provided that the expenditures are receipted, and that they meet licensing and regulatory requirements. Regulations regarding reimbursement are currently being developed to clarify what types of expenditures will be allowed and how the activity will be licensed. Until the licensing scheme and regulations are in place, donors may be reimbursed up to the actual amount of their legitimate expenditures without a licence.

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7. Will clinics be able to continue to use sperm already in storage which had been "paid for"?

As the Assisted Human Reproduction Act (AHR) is not retroactive, AHR clinics will continue to be able to use any sperm they had in storage prior to April 22, 2004, even if provided by a paid donor, as long as the other requirements of the AHR Act are met (for example, section 71, consent to use, etc.).

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8. Can clinics import sperm from paid donors?

Only those persons who have imported sperm at least once in the year prior to April 22, 2004 may continue to do so until the regulations and licensing scheme are in place. Regulations relating to the importation of sperm are under consideration.

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9. What impact does the prohibition on payment to a surrogate have on surrogacy contracts?

The validity, including civil enforceability, of a surrogacy agreement is a matter of provincial law. However, one of the key principles of the Assisted Human Reproduction Act is that trade in the reproductive capabilities of women and men for commercial ends raise health and ethical concerns that justify their prohibition. Accordingly, section 6 of the Act prohibits anyone from paying or offering to pay a woman to act be a surrogate mother. It also prohibits anyone from making or accepting payment or an offer of payment for arranging or advertising to arrange for the services of a surrogate mother. Section 6 came into force on April 22, 2004.

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10. What impact does the prohibition on arranging surrogacy services - for payment - have on Assisted Human Reproduction clinics, doctors and lawyers?

Section 6 prohibits anyone from receiving payment for arranging, offering to arrange or advertising to arrange for the services of a surrogate mother. It does not, however, prevent:

• an Assisted Human Reproduction (AHR) clinic from being paid to provide AHR procedures to a surrogate mother,
• a doctor from providing medical care to a surrogate mother,
• a lawyer from being paid for providing legal advice or services to a surrogate mother or to a commissioning couple.

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11. What is the relationship between the Assisted Human Reproduction Act and the Processing and Distribution of Semen for Assisted Conception Regulations (Semen Regulations)? Are the Semen Regulations still in effect?

The Semen Regulations, promulgated in 1996 under the Food and Drugs Act, set out stringent health and safety requirements specifically concerning the processing and distribution of third party donor semen that is used or intended for use in an assisted conception. These requirements define procedures for donor screening (including testing), labelling, quarantine and record keeping before third party donor sperm can be used in assisted conception. The Semen Regulations remain in effect.

The Assisted Human Reproduction Act (AHR) establishes a legislative framework to address the health and safety issues raised by a wide range of AHR activities. The use of sperm to create an embryo using assisted reproductive technologies is subject to the AHR Act and its regulations. Since the Semen Regulations currently remain in effect, any person making use of third party donor semen in assisted conception must be in compliance with the requirements of both the AHR Act and the Semen Regulations.

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12. Where can I find the most up-to-date information regarding the development of regulations under the Assisted Human Reproduction Act?

For the most current information regarding all aspects of the Assisted Human Reproduction Act (AHR), please continue to monitor the Assisted Human Reproduction section of the Health Canada Web site. For those without Internet access, hard copies of this information can be obtained by calling 1-800-OCANADA. You may also wish to monitor the Web site of Assisted Human Reproduction Canada, as this federal agency is responsible for administering and enforcing the AHR Act.