ARCHIVED - Assisted Human Reproduction Canada

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Section I: Overview

Minister's Message

It is my pleasure to present the Assisted Human Reproduction Agency of Canada's (AHRC) first Departmental Performance Report. This Report summarizes the Agency's progress in meeting the objectives outlined in the 2006-2007 Report on Plans and Priorities.

The Agency formally began its operations in February 2007, with the appointment of the President and Board of Directors. In the 6-week period covered by this Report, the Agency initiated work on a number of fronts in order to develop the necessary capacity to fulfil its mandate.

The Agency has made significant progress in a short period of time. In terms of organizational development, this has included delineating its core functions, initiating recruiting actions for key consultants and staff to support implementation and engaging key system stakeholders, both within and outside of government. In March, the Agency's Board of Directors held their inaugural meeting where I personally had the opportunity to share with them the Government of Canada's perspective on the AHR environment. In addition, priority Memorandum of Understanding with other federal departments and agencies involved in the regulation, monitoring and enforcement of assisted human reproduction were initiated.

The Government of Canada is committed to protecting the health, safety and dignity of those individuals who access these technologies of assisted human reproduction (AHR), while recognizing that the benefits of encouraging the advancement of science in this area should ultimately benefit all Canadians.

Health Canada is continuing to develop regulations on AHR that will form the basis of AHRC's licensing, monitoring and compliance activities. Once the regulations are in place, the Agency will licence AHR controlled activities, ensure compliance with the regulations, monitor trends and developments, build a national AHR Registry that collects and safeguards personal health information and provide me with timely and comprehensive advice on these matters

Tony Clement
Minister of Health

Management Representation Statement

I submit for tabling in Parliament, the 2006-2007 Departmental Performance Report for the 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 2006-2007 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 department'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 under the authority of the Assisted Human Reproduction Act. The Act seeks to protect and promote human health, safety, dignity and human rights in the use of assisted human reproduction (AHR) technologies, prohibits unacceptable activities, such as human cloning and places controls over AHR related research. 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 ($ thousands)

	2006-2007
Planned Spending	Total Authorities	Actual Spending
9,681	9,681	134

Human Resources¹

		2006-2007
Planned		Actual		Difference
44		1		43
					2006-2007
Status on Performance					Planned Spending	Actual Spending
Strategic Outcome: Protection and promotion of the health and safety of Canadians against the risks associated with assisted human reproduction
Priority No. 1 New	Program Activity - Licencing and Enforcement of a Regulatory Framework for Assisted Human Reproduction Technologies Expected Result -an effective and efficient licensing and inspection regime; -compliance by medical practitioners and researchers 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: Initiated recruitment for an Executive Director for Licensing, Inspection and Public Health Information Registry (PIHR) and a Senior Advisor for Strategic Surveillance Planning Contracted a Senior Advisor for PIHR Initiated discussions on key Memorandum of Understanding (MOU), including with the Health Canada (HC) Inspectorate Initiated planning for a protocol for processing complaints Liaised with key stakeholders Initiated a review of international "best-practices" Completed relevant technical briefings and related orientation activities for the President, the Chair of the Board and Board Members		4,320	60
Priority No. 2 New	Program Activity - Health Information and Knowledge Management for Assisted Human Reproduction Technologies Expected Result -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 or problems.		Performance Status:Met some expectations: In anticipation of the regulations coming into force and providing clear direction on Registry expectations and requirements, AHRC: Initiated recruitment for an Executive Director for Licensing, Inspection and Public Health Information Registry (PIHR) and a Senior Advisor for Strategic Surveillance Planning Contracted a Senior Advisor for PIHR Launched the process to enable AHRC to assume responsibility for the Registry Development Project Began preliminary technical work in relation to system architecture, quality and security Met with officials from the office of the Ethics Commissioner and the Access to Information program Liaised with key stakeholders		5,361	74

Operating Environment

Formally established by Orders in Council on January 12, 2006, AHRC is mandated to administer the Assisted Human Reproduction Act (Bill C-6: an Act Respecting Assisted Human Reproduction and Related Research) on behalf of the Minister of Health. Its mission is to protect and promote the health and safety of donors, patients and offspring born of AHR technologies by becoming a centre of expertise in administering a comprehensive legislative and regulatory framework that enforces prohibitions and regulates acceptable controlled activities in Canada. The AHRC President assumed her duties in February of 2007 and the AHRC Board met for the first time in March 2007.

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; provide information to the public and to the professions regarding assisted human reproduction and other matters to which the Act applies; monitor technological advances and trends in assisted human reproduction; and advise the Minister of Health on assisted human reproduction.

Health Canada's Assisted Human Reproduction Implementation Office (AHRIO) is responsible for the development of the elements of the regulatory framework under the Act. Core components of the regulatory framework to enable AHRC to begin licensing and inspections of facilities are still being developed and over a year away. As such, no licences for controlled activities are being issued at this time. Accordingly, the immediate priorities for AHRC's new management team and Directors have been the start-up of the Agency's operations, developing the core capacity to administer the regulations once they come into force and engaging key system stakeholders.

Overview of Agency Performance

Building Core Capacity

As a start-up Agency, the initial focus for AHRC management was on four complementary sets of activities:

• to recruit a core team to develop on a fast-track basis the Agency's capacity in key functional areas;
• to obtain initial direction from the AHRC Board on establishing priorities;
• to manage stakeholder expectations in regard to the Agency's role and mandate and its eventual approach to implementing the regulations; and
• to identify and fit-up facilities.

In regard to building a core team, contractors and administrative support personnel were engaged and assigned to key functions, pending formal recruitment of the Agency's permanent staff. Interim work plans for each functional area were also developed, pending a more formal planning retreat pursuant to the inaugural meeting of the AHRC Board of Directors

In regard to obtaining Board direction, a Board orientation session and meeting was convened in March. At the orientation session, Board members received technical briefings from various federal officials on the current context for AHR in Canada, on the specific functions, duties and accountabilities of AHRC and of its members. The Minister of Health also met with the Board and provided a broad overview of the policy environment within which the Board was operating. At their inaugural meeting, Board members approved the President's proposed work plan, elected a vice-chair, adopted initial by-laws, approved a set of Guiding Principles and a Communications Protocol and established a meeting schedule for the coming 24-months.

In regard to managing stakeholder expectations, the President and Chair of the Board met bilaterally with key stakeholder groups to outline AHRC's interim work plan, to review the status of the AHR regulations and to discuss other issues. They also accepted media interview requests to enable them to raise awareness of the Agency's mandate and work plan. Finally, the AHRC communications advisor worked with Health Canada to establish procedures to coordinate the flow of information to the public and media concerning AHRC activities and AHR generally.

In regard to facilities and fit-up, AHRC established facilities in both the National Capital Region and in Vancouver, British Columbia.

Licensing and Enforcement

Once they are completed and come into force, the AHR regulations will provide for an effective and efficient licensing and inspection regime that facilitates compliance by medical practitioners and researchers in respect of prohibitions and controlled activities. This will serve to improve the safety and success of the controlled activities undertaken. In anticipation of this, over its first 6-weeks, AHRC has:

• Initiated recruitment for an Executive Director for Licensing, Inspection and Public Health Information Registry (PIHR) and a Senior Advisor for Strategic Surveillance Planning
• Initiated recruitment a Senior Advisor for PIHR
• Initiated discussions on key Memorandum of Understanding (MOU), including with the Health Canada (HC) Inspectorate
• Initiated planning for a protocol for processing complaints
• Liaised with key stakeholders
• Initiated a review of international "best-practices"
• Completed relevant technical briefings and related orientation activities for the President, the Chair of the Board and Board Members

While initiating recruitment for its permanent staff, AHRC has contracted the services of expert consultants to deliver essential support and capacity development services in key functional areas.

During the period covered by the review, AHRC has completed or identified priority MOUs. This has included initiating discussions on an MOU with the Health Canada Inspectorate.

In terms of stakeholder engagement, the Agency's President and Board Chair have met with key AHR system stakeholders in discuss the Agency's work plan and priorities and to ascertain their views on key issues, including the proposed Consent Regulation, the Personal Health Information Registry and other issues pertaining to the effective regulation of AHR in Canada.

In anticipation of being apprised of prohibited activities under the Act occurring, or of receiving formal complaints regarding prohibited AHR activities, the Agency began development of a protocol for processing these inputs. This protocol will ensure that allegations or instances of prohibited activities are carefully assessed or fully investigated, as appropriate.

Finally, the Agency initiated a review of international best-practices in relation to Board governance, committees and external advisory structures in order to identify how other similar Boards and Agencies manage relevant issues.

Information and Knowledge Management for AHR Technologies

A priority for AHRC is to create a confidential and secure Personal Health Information Registry (PIHR). A comprehensive registry that tracks the relative success of different AHR techniques or processes, and maintains secure information on donors, recipients and those born of AHR, will be a invaluable decision-support tool for regulators, practitioners and prospective users of AHR procedures. The registry will also improve access by children born of AHR procedures to information on their genetic history and contribute to improved public awareness of AHR issues. However, the registry's architecture and design is dependent on the eventual direction of the AHR regulations. This caveat aside, the Agency has undertaken a number of steps to ensure the registry will be operational once the regulations come into force. To that end, the Agency has:

• launched the process to enable AHRC to assume responsibility for the Registry Development Project
• initiated technical work in relation to system architecture, quality and security
• met with officials from the Office of the Ethics Commissioner and the Access to Information Program.
• sought Board direction at the inaugural AHRC Board Meeting
• liaised with key stakeholders in regard to their priorities and expectations with respect to AHRC

In terms of building the registry for which it will ultimately be responsible, the Agency initiated the process to assume from Health Canada responsibility for the Registry Development Project. Agency staff began scoping options for the design of the system's architecture, including its interface with HC-IT platforms. Potential registry quality and security standards were also reviewed.

Program Activity Architecture (PAA) Crosswalk

This is a new program for 2006-2007. The Agency was established by Governor-in-Council on January 12, 2006 and the program activities planned for 2006-2007 have no carryover from 2005-2006.

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