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ARCHIVED - Assisted Human Reproduction Canada

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Section I: Overview

Minister's Message

Photo of the Honourable Leona Aglukkaq, Minister of Health As Canada’s new Minister of Health, it is my pleasure to present Assisted Human Reproduction Canada’s 2007-08 Departmental Performance Report.

Assisted Human Reproduction Canada (AHRC) was created to protect and promote the health, safety, dignity and rights of Canadians who use or are born of assisted human reproduction (AHR) technologies. AHRC was also created to foster the application of ethical principles in their use and development.

As the federal regulatory body that oversees the area of AHR and related research, AHRC has a valuable role to play.

The importance of AHRC's work for the thousands of Canadians across the country who need help in having the children they want cannot be understated. AHRC works to ensure that the gift of life made possible by assisted human reproductive technologies happens in a safe, healthy and dignified way.

In 2007-08, AHRC continued the important work of building strong and productive partnerships with organizations working in the field of assisted human reproduction in Canada and around the world.

Moving forward, the Agency remains committed to becoming a centre of expertise and focal point on AHR information for policy makers, practitioners, researchers, patients, offspring and interested Canadians.

The Honourable Leona Aglukkaq

Minister of Health

President's Message

Photo of Dr. Elinor Wilson, President, Assisted Human Reproduction Canada Assisted human reproduction (AHR) is a complex field that challenges our very understanding of what it is to be human, and poses risks and opportunities for individuals and communities. Beyond the health and safety considerations associated with these technologies, AHR touches on issues related to the dignity and rights of Canadians.

To effectively regulate this complex area requires the full engagement, involvement and commitment of all parties with a role to play in these vitally important issues. With this in mind, a major focus of our Agency's work is reaching out to all Canadians who want to contribute to these matters.

We have also made significant progress in establishing the infrastructure and the networks necessary to safeguard the health and safety of Canadians who wish to build their families through reproductive technologies. At the same time, we are focusing on monitoring and enforcing compliance of the AHR Act and Section 8 Regulations.

AHRC is committed to working closely with Canadians to build a strong and open relationship based on doing what is right for the health, safety, rights and dignity of individuals who turn to AHR to produce the children they desire.

Dr. Elinor Wilson
President

Management Representation Statement

I submit for tabling in Parliament, the 2007-08 Departmental Performance Report for Assisted Human Reproduction Canada.

This document has been prepared based on the reporting principles contained in the Guide for the Preparation of Part III of the 2007-08 Estimates: Reports on Plans and Priorities and Departmental Performance Reports:

It adheres to the specific reporting requirements outlined in the Treasury Board Secretariat guidance;
It is based on the Agency's approved Strategic Outcome(s) and Program Activity Architecture that were approved by the Treasury Board;
It presents consistent, comprehensive, balanced and reliable information;
It provides a basis of accountability for the results achieved with the resources and authorities entrusted to it; and
It reports finances based on approved numbers from the Estimates and the Public Accounts of Canada.

Name:
Dr. Elinor Wilson

Title:
President
Assisted Human Reproduction Canada

Summary Information

Department's Reason for Existence - The Assisted Human Reproduction Agency of Canada (AHRC) was established in 2006 under the authority of the Assisted Human Reproduction Act. The AHR Act seeks to protect and promote the health, safety, dignity and rights of Canadians in the use of assisted human reproduction (AHR) technologies, prohibits unacceptable activities such as human cloning and places controls over AHR related research and activities. The Agency is responsible for the issuance and review of licences, the collection and analysis of health reporting information, and for carrying out inspections and enforcement related to activities controlled under the Act.

Financial Resources (in $ thousands)

Planned Spending	Total Authorities	Actual Spending
	2007-08
13,476	13,476	4,898

Human Resources

Planned 44		Actual 7		Difference 37
		2007-08
				2007-08
Status on Performance				Planned Spending	Actual Spending
Strategic Outcome: Strategic Outcome: Protection and promotion of the health and safety of Canadians against the risks associated with assisted human reproduction
Priority No. 1	Program Activity - Licencing and Enforcement of a Regulatory Framework for Assisted Human Reproduction Technologies Expected Results: an effective and efficient licensing and inspection regime; compliance in respect of prohibitions and controlled activities; and improved safety and success of the controlled activities undertaken.		Performance Status: Met some expectations. In anticipation of the AHR regulations coming into force, focused on developing core AHRC capacity: Recruited an Executive Director, a Director and regulatory officers for Licensing, Inspection and Personal Health Information Registry (PHIR); Signed a Memorandum of Understanding (MOU) with the Health Canada (HC) Inspectorate to provide inspection, compliance and enforcement services under the AHR Act; Developed a protocol for responding to complaints under the AHR Act; Liaised with key stakeholders across Canada and internationally; Initiated development of an inspection strategy to promote compliance with the AHR Act; and Developed a user-friendly information package to interpret and implement the "Consent to Use" Regulations.	6,076	3,051
Priority No. 2	Program Activity - Health Information and Knowledge Management for Assisted Human Reproduction Technologies Expected Results: a confidential and secure Personal Health Information Registry; improved information for decision-making by practitioners and prospective users of Assisted Human Reproduction procedures; improved access by children born of Assisted Human Reproduction procedures to information on their genetic history; and increased awareness of the Canadian public of AHR issues.		Performance Status: Met some expectations. In anticipation of the regulations coming into force, AHRC: Initiated work on expectations and requirements for the Registry; Recruited a Senior Advisor for Strategic Surveillance Planning; Contracted a Senior Advisor for PHIR ; and Began technical work on PHIR system architecture, quality and security. In addition to the above: Established a formal, long term partnership with the Canadian Fertility and Andrology Society (CFAS) and the Society of Obstetricians and Gynaecologists of Canada (SOGC) to share information and make recommendations to their respective organizations on current and future initiatives, and explore opportunities for working together; Consulted with patient groups on key issues; Liaised with other key stakeholders across Canada and internationally; and Began technical and content work on the AHRC Web site.	7,400	1,847

Departmental Context

In 1993, the Royal Commission on New Reproductive Technologies issued its report entitled. "Proceed with Care." Commissioners spent four years examining assisted human reproduction (AHR) activities in Canada. They heard from 40,000 Canadians, including doctors, medical organizations and ordinary citizens, before issuing their final report. The report called on the Government of Canada to ban activities such as human cloning, payment for sperm or eggs, and commercial surrogacy. It also recommended the creation of an independent regulatory body to govern permissible AHR activities.

The Assisted Human Reproduction Agency of Canada (AHRC) was established in January, 2006 to administer the Assisted Human Reproduction Act. The President took office in February, 2007. The Agnecy's mission is to protect and promote the health and safety of donors, patients and offspring born of assisted human reproduction (AHR) technologies. Its mandate is to administer a comprehensive legislative and regulatory framework that enforces prohibitions and regulates acceptable controlled activities in Canada. In fulfilling its duties, AHRC may exercise powers in relation to licenses; designate inspectors to enforce the Act; maintain relationships with stakeholders including health practitioners, patients and researchers; collect, analyse and manage health reporting information relating to controlled activities.

The Agency may also provide information to the public and to professionals regarding AHR; monitor technological advances and trends in AHR; and advise the Minister of Health on issues related to AHR.

Health Canada is responsible for developing policy and completing Canada's regulatory framework under the Act. Core components of the regulatory framework to enable AHRC to begin licensing and inspections of facilities are being developed. Therefore, no licences are being issued at this time. Accordingly, the immediate priorities for AHRC's management team and Board of Directors have been the start-up of the Agency's operations, developing the core capacity to administer the regulations once they come into force, engaging key stakeholders and participating in outreach initiatives with the public.

Members of the Board of Directors have participated in sessions to familiarize themselves with pertinent issues related to assisted human reproduction. The Board also adopted by-laws which provide a definition of their roles and responsibilities as well as an operational structure for the Agency.

Overview of Agency Performance

Creating the infrastructure

AHRC is awaiting the 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. AHRC is engaged in the following activities:

Signed an MOU with Health Canada's Health Products and Food Branch Inspectorate to provide inspection, compliance and enforcement services for the Assisted Human Reproduction Act under the direction of AHRC;
Developed an interim compliance and enforcement strategy;
Established roles and responsibilities of AHRC and the RCMP in relation to the enforcement of the AHR Act, including the prohibited activities; and
Initiated the development of a Personal Health Information Registry which is a key piece of the Agency's infrastructure.

Until the regulations are in place, AHRC will continue to only staff positions that meet immediate organizational requirements.

Building productive partnerships

Established a Tripartite Committee, made up of representatives of AHRC, the Canadian Fertility and Andrology Society (CFAS) and the Society of Obstetricians and Gynaecologists of Canada (SOGC). This Committee provides a forum for discussion on matters of mutual interest, for sharing information on emerging issues, and for making recommendations on future initiatives such as clinical practice guidelines;
Consulted with the CEOs and Presidents of the Canadian Medical Association (CMA), the Canadian College of Family Physicians (CFPC), the Infertility Awareness Association of Canada (IAAC), the Infertility Network (IN) and the Lesbian, Gay, Bisexual and Trans (LGBT) Parenting Network. The objectives are to build partnerships and assess how these organizations and AHRC can work together; and
Liaised with international organizations such as the Human Fertilisation and Embryology Authority of the United Kingdom, Agence de la biom�decine (France) and the National Institutes of Health of the United States of America.

Reaching out to Canadians

Activities of the President and Chair included making presentations to, or attending, numerous meetings and conferences to explain AHRC's mission and mandate, and to share best practices in the field;
Launched a newsletter to keep stakeholders and the public apprised of the latest activities of the Agency and the Board of Directors. The inaugural issue of the newsletter was released in Winter 2007-2008; and
Initiated content and technical work on the Agency's Web site.

Implementing the Regulations - "Consent to Use"

The first set of regulations developed by Health Canada came into force on December 1, 2007. These regulations fulfill legislative requirements under Section 8 of the Assisted Human Reproduction Act. This section states that written consent is required from a donor to use human reproductive material to create an embryo or to use in vitro embryos for any purpose. The regulations specify the type of information that the donor must receive before giving their consent, the requirements for consent and the withdrawal of consent.

AHRC engaged in the following activities:

Developed and disseminated an information package to assist donors and clinics in understanding and implementing these regulations; and, conducted workshops to assist stakeholders; and
Commenced a compliance verification process regarding Section 8.

Departmental Link to Government of Canada Outcome Areas

AHRC contributes to a "Whole of Government" approach of fostering Healthy Canadians.

Specifically, the Agency will protect the health, safety and dignity of Canadians using AHR technologies by enforcing regulations.

AHRC protects the health and safety of Canadians using AHR technologies by providing them with information to make informed decisions about the use of AHR technologies.

Offspring born of AHR technologies will have access to the genealogical and medical histories of their genetic donors.

Program Activity Architecture (PAA) Crosswalk

The program for 2007-08 was unchanged from 2006-07. Consequently there have been no changes to the PAA strategic outcomes and activities.