ARCHIVED - Assisted Human Reproduction Canada

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Minister's Message

I am pleased to present Assisted Human Reproduction Canada's Departmental Performance Report for 2008-2009.

Assisted Human Reproduction Canada (AHRC) commenced operations in early 2007 to protect and promote the health, safety, dignity and rights of Canadians who use or are born of assisted human reproduction (AHR) technologies, and to foster the application of ethical principles in their use and development.

Establishing a regulatory agency, especially in the complex and quickly evolving field of assisted human reproduction, requires careful planning. In the past year, the Agency continued to seek as many perspectives as possible to inform its work of ensuring the safety and ethics of AHR activities and research in this country.

By consulting and collaborating with stakeholder groups, and monitoring developments in AHR scientific practices and international trends, the Agency continued to develop and refine the infrastructure and networks that support the delivery of its mandate.

This rigorous groundwork is key to building the Agency's capacity for safeguarding the health and safety of Canadians who use reproductive technologies to build their families; its meticulous and inclusive approach to fulfilling its responsibilities will benefit all Canadians affected by or interested in assisted reproduction.

President's Message

With increasing frequency, national and international media reports are telling the stories of people around the world affected by the use of assisted human reproductive technologies and new developments in this field. These reports confirm what we at Assisted Human Reproduction Canada already know: while these technologies offer hope to many families, their complexity also requires regulators, practitioners and users to be mindful of the associated risks and implications of evolving practices.

To provide effective leadership in this rapidly changing area of human activity, the Agency must be in close contact with its various stakeholders. Consequently, outreach and collaboration were at the heart of the Agency's initiatives in the past year.

In our exchanges with policy makers, practitioners, researchers, AHR patients, offspring and interested Canadians, the Agency continued to seek input on the risks and opportunities for those who use and are born of assisted human reproduction technologies. The Agency consulted broadly on the scientific, legal and social considerations of oversight agencies, and continued to monitor international AHR activities and standards.

In anticipation of the development of additional regulations by Health Canada, the Agency also solidified its plans and priorities for research, monitoring and compliance activities that will support the delivery of its mandate as the federal regulatory agency in the field of reproductive technologies.

I am pleased with the progress made in strengthening the Agency's relationships, systems and resources over the past year. Canadians will continue to benefit from the Agency's careful and collaborative approach to building a professional and transparent agency to serve those who use and are born of assisted reproductive technologies.

Section I – Overview

1.1 Summary Information

Raison d’être

Responsibilities

AHRC is the federal regulatory agency responsible for protecting and promoting the health, safety, dignity and rights of Canadians who use or are born of assisted human reproductive technologies.

The Agency is also responsible for fostering an environment in which ethical principles are applied in all matters relating to assisted human reproduction, while allowing scientific advances that benefit Canadians.

AHRC's mandate and responsibilities are set out in the AHR Act. The Agency's key responsibilities include:

• Implementing and administering a licensing framework for controlled activities, including AHR procedures and related research;
• Developing an inspection strategy to ensure compliance with the AHR Act and its regulations;
• Developing and maintaining a national Personal Health Information Registry (PHIR) on AHR that can become a key component of a more comprehensive AHR health surveillance strategy;
• Becoming a centre of expertise on AHR by collecting and disseminating public information;
• Communicating with and engaging stakeholders on AHR issues; and
• Advising the Minister of Health on AHR issues.

Strategic Outcomes

In order to effectively pursue its mandate, the Agency aims to achieve the following strategic outcome:

Program Activity Architecture

The chart below illustrates Assisted Human Reproduction Canada's complete framework of program activities, which roll up and contribute to progress toward the Agency's strategic outcome.

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1.2 Performance Summary

Financial Resources ($ thousands)

Planned Spending	Total Authorities	Actual Spending
12,418	12,418	5,289

The total authorities were $12.4 million, due partly to re-profiling of unspent funds from previous years prior to the establishment of the Agency. Actual spending was $5.3 million. The spending shortfall was as a result of the incremental implementation of the Agency's mandate, in parallel with the development of the regulations by Health Canada.

Human Resources (FTEs)

Planned	Actual	Difference
44	16	28

Significant progress was made during the year on staffing. Staffing was undertaken at a pace consistent with the incremental implementation of the Agency's mandate.

Strategic Outcome 1: Protection and promotion of the health and safety of Canadians against the risks associated with assisted human reproduction technologies

Performance Indicators	Targets	2008-09 Performance
*As the regulations come into force, develop operational guidelines to administer the Assisted Human Reproduction Act and its associated regulations.	*In advance of the regulations coming into force: Develop the groundwork to implement a licensing framework for controlled activities and Personal Health Information Registry. Develop an inspection strategy to ensure compliance with the AHR Act and regulations. Develop and progressively implement a stakeholder outreach strategy and information dissemination plan.	The Agency made considerable progress in developing the systems, policies and procedures necessary to implement a licensing and inspection framework for activities related to assisted human reproduction in Canada. It also worked in collaboration with key stakeholders to refine its capacity to collect, store and analyze information to be contained in the Personal Health Information Registry. With an interim compliance and enforcement strategy in place, the Agency undertook to educate and collaborate with other enforcement and accreditation agencies, while continuing to respond to allegations of violation and to monitor compliance with Section 8 of the AHR Act. Finally, it increased its outreach efforts on a number of fronts, by establishing an expert science advisory panel, initiating international information exchanges, collaborating with national organizations working in AHR, and launching a comprehensive website for the benefit of all Canadians interested in or affected by reproductive technologies.

*The performance indicator and targets at the strategic outcome level have been incorporated from the approved Departmental Performance Measurement Framework (December 2008) and the 2009-10 Report on Plans and Priorities.

($ thousands)

Program Activity	2007-08 Actual Spending	2008-09				Alignment to Government of Canada Outcomes
		Main Estimates	Planned Spending	Total Authorities	Actual Spending
Licensing and Enforcement of a Regulatory Framework for Assisted Human Reproduction Technologies.	3,051	7,803	7,803	7,803	2,803	Healthy Canadians
Health Information and Knowledge Management for Assisted Human Reproduction Technologies.	1,847	4,615	4,615	4,615	2,486	Healthy Canadians

Contribution of Priorities to Strategic Outcome(s)

Operational Priorities	Type	Status	Linkages to Strategic Outcomes
1. To protect and promote the health and safety of Canadians who use, and offspring who are born of, AHR technologies.	Ongoing	Mostly met (within current regulatory framework) See performance summary for Strategic Outcome 1.	Strategic Outcome 1 Will ensure Canadians using AHR technologies are aware of and protected from the associated risks.
2. To contribute to the development of Health Canada's AHR regulations.	Intermediate term	Met all AHRC actively contributed to Health Canada's regulatory development process.	Strategic Outcome 1 Will provide necessary authority to protect and promote health and safety of Canadians by enforcing compliance with regulations.
3. To increase the awareness of Canadians and health professionals about AHR and the Agency's role.	Ongoing	Mostly met See performance summary for Strategic Outcome 1	Strategic Outcome 1 Protects the health and safety of Canadians by providing them with information to make informed decisions about AHR technologies, and the Agency's role in regulating AHR practices.

Management Priorities	Type	Status	Links to Strategic Outcome(s)
1. To create the capacity in AHRC to implement the regulations.	Intermediate term	Somewhat met See performance summary for Strategic Outcome 1.	Strategic Outcome 1 To protect and promote health and safety of Canadians, the Agency must have adequate resources and systems to enforce compliance with AHR regulations.
2. To develop the tools to disseminate information on AHR.	Ongoing	Mostly met See performance summary for Strategic Outcome 1.	Strategic Outcome 1 Will better promote the health and safety of Canadians by providing them with more accessible information to make informed decisions about AHR technologies, and the Agency's role in regulating AHR practices.

Risk Analysis

AHRC has been actively monitoring and managing its risks since the Agency was established. It recently launched a systematic review of its risks to fully document its plans to manage those risks, and to integrate a risk monitoring and reporting process into its planning cycle. This will serve as the Agency's interim corporate risk management framework, which will be updated and revised as the full regulatory framework is implemented.

Few fields are changing faster than assisted human reproduction. Each technological innovation brings with it health, ethical, social and economic implications. AHRC is putting in place the resources and mechanisms to enable it to keep abreast of a rapidly changing environment, in terms of both science and international developments. One such mechanism is the recently established Science Advisory Panel, which brings together recognized experts in the field.

As a new Agency, AHRC is working to put in place the infrastructure (i.e., policies, procedures and systems) to effectively and efficiently manage its operations, as well as the specialized systems that will be required to implement the regulatory process once the regulations come into force. The Agency is implementing an information management framework that will ensure the continuity and safeguarding of corporate information, currently and when the move of operations to the Agency headquarters in Vancouver is completed. The systems that will be required to administer the regulations and Personal Health Information Registry are being developed on a task-based and modular basis, using a best-practices approach to ensure operational alignment with the regulations being developed by Health Canada. Specialized resources are being retained to ensure the appropriate analysis and safeguarding of the personal health information the Agency will eventually be collecting.

From the outset, AHRC has recognized the importance of collaborating with various stakeholder groups to deliver on its mandate. The Agency worked on the development of a comprehensive stakeholder outreach strategy that will build on its successful efforts to identify and ensure appropriate engagement of stakeholders. Fostering public and stakeholder awareness and understanding will be key to successfully meeting Agency objectives.

Resource planning is a challenge for the Agency, as it must take into account the completion of the establishment of the organization, the anticipated timing of the regulations coming into force, and plans to complete the move of operations to Vancouver. A human resources strategy was developed, key positions were staffed with indeterminate employees, and integrated business and human resource plans are being reviewed and updated on a regular basis.

Expenditure Profile

Voted and Statutory Items
($ thousands)

Vote # or Statutory Item (S)	Truncated Vote or Statutory Wording	2006-07 Actual Spending	2007-08 Actual Spending	2008-09 Main Estimates	2008-09 Actual Spending
15	Operating expenditures.	130	4,616	11,783	4,932
(S)	Contributions to employee benefit plans.	4	282	635	357
Total		134	4,898	12,418	5,289

Parliament approved resources of $12.4 million for the Agency, as per its Report on Plans and Priorities for 2008-09. The Agency's total actual spending for 2008-09 was $5.3 million.

The only statutory item for AHRC pertains to contributions to employee benefit plans in the amount of $357,195.

Spending Trend

AHRC spent $5.3 million to meet the expected results of its program activities and contribute to its strategic outcome in 2008-09.

The figure below illustrates the Agency's spending trend from 2006-07 to 2008-09.

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AHRC began operations in February 2007, and spending over its first few months of existence in 2006-07 totalled $134,000. In 2007-08 and 2008-09, AHRC's spending increased to $4.9 million and $5.3 million respectively, as the Agency has been fit up, staff have been hired and the infrastructure necessary to fulfill its mandate has been put in place.

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