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Section II – Analysis of Program Activities by Strategic Outcome

2.1 Strategic Outcome #1 - Protection and Promotion of the Health and Safety of Canadians against the Risks Associated with Assisted Human Reproduction Technologies

2.1.1 Program Activity: Program Activity: Licensing and Enforcement of a Regulatory Framework for Assisted Human Reproduction Technologies



Program Activity:
2008-09 Financial Resources
($ thousands)		 2008-09 Human Resources
(FTEs)
Planned
Spending		 Total
Authorities		 Actual
Spending		 Planned Actual Difference
7,803 7,803 2,803 22 7 15


Expected
Results		 Performance
Indicators		 Targets Performance
Status		 Performance
Summary
An effective and efficient licensing and inspection framework. Once the regulations are passed, a documented licensing and inspection framework which is communicated to clinics and stakeholders and which sees inspections carried out on a basis consistent with the framework. Develop guidance documents, administrative policies and electronic tracking systems for the licensing and inspection of AHR clinics and facilities. Somewhat met
  • It is important to note that publishing of draft regulations under the AHR Act is being deferred by Health Canada until after the Supreme Court of Canada releases its opinion on constitutional issues related to the AHR Act.
  • Building on its interim compliance and enforcement strategy, which addresses compliance with respect to the prohibitions and controlled activities of the AHR Act, the Agency defined business requirements for controlled activity and premises licenses and initiated license application design work.
  • AHRC formalized its process for dealing with allegations of violation of the AHR Act and regulations, through its Memorandum of Understanding (MOU) with the Health Canada Inspectorate.
  • In accordance with this process, the Agency responded to all allegations brought to its attention. It also initiated and completed an assessment of AHR clinic compliance with Section 8 of the AHR Act and its regulations.
  • Through interactions with other Health Portfolio partners, AHRC identified best practice regulatory database models that may be customized for AHRC's system infrastructure.
A well-informed and engaged stakeholder community. Communication of the framework to the stakeholders by various means including direct contact, presentations at professional forums, literature and electronic means such as a website. Participate in or support key stakeholder groups, professional associations, colleges, and licensing and accreditation bodies in the development of other relevant supporting policy instruments (e.g., standards, national guidelines, accreditation models, etc.). Mostly met
  • AHRC continued to build productive relationships with stakeholders, through AHRC-sponsored working groups, formal and informal presentations.
  • AHRC began collaborating with several partners, including Accreditation Canada, to develop an integrated inspection and accreditation model to minimize administrative burden on regulated parties.
  • AHRC continued to support and participate in working groups of the Canadian Fertility and Andrology Society (CFAS) and Canadian Standards Association (CSA) to develop national guidelines for AHR.
  • AHRC made several formal presentations on its mandate, regulatory role and activities for stakeholders and AHR clinics.
  Implement a research agenda pertaining to AHR. Partner with Canadian Institutes for Health Research (CIHR) to ensure research pertaining to AHRC's mandate is conducted in a timely, rigorous, transparent and cost-effective manner. Met all
  • AHRC and CIHR co-hosted an expert workshop with CIHR to develop a national research agenda for AHR.
  • AHRC also partnered with CIHR in an AHR knowledge transfer initiative and to plan for the launch of a research funding opportunity on psychosocial issues related to AHR.
  • AHRC officials attended CIHR meetings of the Stem Cell Oversight Committee, National Cohort Studies and Health Gametes workshops.


Benefits for Canadians

Through this program activity, AHRC contributes to a "Whole of Government" approach to fostering Healthy Canadians. Specifically, the Agency protects the health and safety, dignity and rights of Canadians using AHR technologies by monitoring compliance with the AHR Act and its regulations.

Performance Analysis

While Health Canada's development of regulations and policies continued, this work was affected by an opinion of the Quebec Court of Appeal on the constitutionality of certain provisions of the AHR Act. The Government of Canada appealed that opinion to the Supreme Court of Canada and decided not to pre-publish regulations while the constitutional issues were before the Court. In the interim, AHRC directed its efforts to meeting those targets within its control. It continued to solicit, assess and compare advice and models from its counterparts and stakeholders in order to build an effective and appropriate framework for licensing and inspection of AHR clinics and facilities across the country.

The Agency also initiated new relationships with stakeholder groups and Canadian licensing and accreditation bodies, while continuing to support and collaborate with medical associations, to encourage the incorporation of as much expertise and as many perspectives as possible in the development of national guidelines for assisted human reproduction. Finally, it worked to ensure that all other associated systems and resources needed to deliver on its current operational priorities were in place.

Lessons Learned

As AHRC awaits further regulations necessary to give effect to key elements of the Assisted Human Reproduction Act that give it the authority to implement and enforce the legislation's provisions, the Agency continued to consult with key stakeholder groups and associations in order to incorporate best practices from other jurisdictions, compliance and enforcement agencies, and accreditation bodies into the licensing and inspection policies and procedures related to assisted human reproduction

2.1.2 Program Activity: Health Information and Knowledge Management for Assisted Human Reproduction Technologies



Program Activity:
2008-09 Financial Resources
($ thousands)		 2008-09 Human Resources
(FTEs)
Planned
Spending		 Total
Authorities		 Actual
Spending		 Planned Actual Difference
4,615 4,615 2,486 22 9 13


Expected
Results		 Performance
Indicators		 Targets Performance
Status		 Performance
Summary
A Personal Health Information Registry that complements an eventual AHR surveillance network Develop a Personal Health Information Registry that is integrated into an overall surveillance network, once the regulations are developed Develop a Personal Health Information Registry that may function as a component of a broader AHR surveillance network Somewhat met
  • Worked with Health Canada to develop the regulations that will specify the health reporting information required to be collected and maintained by the Agency in the Personal Health Information Registry (PHIR).
  • AHRC continued to refine the business requirements for the systems and databases required for the Personal Health Information Registry through broad and inclusive consultation with key stakeholders.
  • AHRC engaged the Canadian Fertility and Andrology Society (CFAS), to review, evaluate and make recommendations to improve its collection of treatment cycle information provided voluntarily by Canadian fertility centres using assisted reproduction technology. The aim is to provide high quality reporting information on assisted reproduction technology activities in Canada to meet AHRC's regulatory requirements once the regulations come into force.
  • AHRC also engaged CFAS and other stakeholders in the identification of measures that would inform health surveillance related to assisted reproduction technology.
Access to information about assisted human reproduction by policy makers, health professionals, parents, children born of AHR procedures, researchers and the Canadian public. Establish a Science Advisory Panel. Establish a Science Advisory Panel that can provide AHRC with value-added council and advice in relation to advances and emerging scientific issues related to AHR. Met all
  • A 13-member Science Advisory Panel (SAP) was established to provide ongoing and timely advice to AHRC's Board of Directors on current and emerging research and science issues relating to AHR and embryo research in Canada and internationally, including diagnostic and treatment options, new technologies, and standards and procedures.
  • Chaired by Dr. John Collins, an internationally recognized AHR authority, the SAP is comprised of world-renowned experts in the field of AHR research, with representatives from basic and social science as well as clinical researchers from leading Canadian and American universities.
  • The SAP developed its work plan and priorities, as well as a process to deal with innovative practice and future scanning for developments in the AHR field.
  Engage in direct contact with counterpart international AHR agencies Liaise with counterpart AHR agencies around the world with a view to sharing best practices and encouraging common approaches to regulating the safety and effectiveness of AHR consistent with ethical principles. Met all
  • AHRC hosted the first invitational International Forum on Cross-Border Reproductive Care in Ottawa in January 2009. More than 50 delegates, including regulators from Australia, India, Belgium, the United Kingdom, the European Commission, France and Italy, attended the working meeting. The goal of the forum was to share experiences and build agreement among participating countries and organizations on the principles underpinning safe, quality care when patients seek and obtain reproductive care outside the country in which they reside.
  • AHRC negotiated a staffing interchange agreement with the UK's Human Fertilisation and Embryology Authority (HFEA) to provide an operational perspective of the HFEA licensing and inspection model.
  Create an AHRC website and other tools to disseminate information. Develop and maintain a website with relevant information for patients, providers, practitioners and children born of AHR. Met all
  • The AHRC website was launched in September 2008, with work ongoing to enhance the information offerings.
  • The Agency also established a contact email and 1-800 number to respond to any questions or concerns from the public.
  Increase the flow of information on AHR to stakeholders and public via a range of outreach vehicles and partnerships. Provision of information for health professionals and the public on AHR matters or issues via newsletters, presentations at conferences, annual reports, brochures and reports in journals. Met all
  • AHRC promoted the engagement of stakeholders and research community members in undertaking and communicating results of findings on topics such as incidence of multiple births and the implications of the use of AHR technologies at conferences, seminars and academic forums.
  • The Tripartite Committee, composed of representatives from AHRC, Canadian Fertility and Andrology Society (CFAS) and Society of Obstetricians and Gynaecologists of Canada (SOGC), met regularly to share information and make recommendations to respective organizations on current and future initiatives.
  • An editorial committee was established with representatives from different stakeholder groups to help AHRC identify information needs and ensure effective messages.
  • Two newsletters and an annual report were developed and disseminated to stakeholders, providing information on AHRC's activities and AHR matters.
  • Two patient information pamphlets were produced and distributed, one regarding the AHR Act, the second on genetic counselling, produced in partnership with the Canadian Association of Genetic Counsellors (CAGC).
  Increase the coordination and collaboration on AHR issues across jurisdictions. Work collaboratively with the provinces and territories to identify and reconcile issues of common concern and develop an effective, efficient and seamless AHR regime that protects the health and safety of all Canadians and children born of AHR. Somewhat met
  • AHRC initiated exchanges with provincial and territorial vital statistics and family law officials.
  • AHRC also held discussions with CFAS about the harmonization of data collection pertaining to assisted reproduction technology.


Benefits for Canadians

The eventual establishment of a Personal Health Information Registry (PHIR) will be critical for monitoring and improving the safety and effectiveness of AHR procedures. The registry will also provide a valuable resource to children born of reproductive technologies to enable them to find out about their medical and genetic information. The PHIR will eventually become a key component of a larger AHR health surveillance system capable of providing information needed to determine health outcomes relating to persons undergoing certain AHR procedures and children born as a result of those procedures. AHRC, through its website and other information products, is establishing itself as a focal point of AHR information for policy makers, practitioners, patients, offspring born of AHR procedures, researchers and the Canadian public. These information sources will allow Canadians to make more informed decisions related to the use of these technologies.

Performance Analysis

Through its extensive outreach initiatives, the Agency continued to solicit and consider the perspectives and best practices shared by policy makers, practitioners, patients, researchers and Canadians who use or are born of reproductive technologies. In doing so, it extended its national and international networks of experts and agencies involved in the area of assisted human reproduction, while expanding its information offerings through new tools and technology. The Agency is making steady and solid progress toward its goal of serving as Canada's centre of expertise for matters related to assisted human reproduction.

Lessons Learned

Just two years into its mandate, the Agency has actively consulted and considered practices, procedures and standards from national and international experts and organizations working in the rapidly changing field of assisted human reproduction, in order to learn from the experience of its international counterparts, and to inform its planning and development of policies and procedures related to AHR in Canada.

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