ARCHIVED - Assisted Human Reproduction Canada - Report

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Section II: Analysis of Program Activities by Strategic Outcome

Strategic Outcome

Protection and promotion of human health, safety, dignity and rights in relation to assisted human reproduction and related research, within a sound ethical framework.

Program Activity: Licensing and Enforcement of a Regulatory Framework for Assisted Human Reproduction (AHR)

Program Activity Descriptions

The Assisted Human Reproduction Agency of Canada (AHRC) would achieve this objective by the following means: issuing licences for controlled activities and for facilities used by qualified persons or organizations; assessing applications against licence requirements, including scientific and ethical considerations; conducting periodic inspections of assisted human reproduction (AHR) clinics, service providers or research to ensure compliance; and enlisting the participation or support of other recognized organizations in the development of other supporting policy instruments, for example, standards, guidelines and accreditation models.

Please note that Financial and Human Resource allocations were undertaken at a pace consistent with the incremental implementation of the Agency's mandate as defined by Health Canada's policy and regulatory development timelines.

2010-11 Financial Resources ($ millions)

Planned Spending	Total Authorities	Actual Spending
4.2	4.2	0.8*

* While AHRC was authorized to spend $4.2 million in 2010 - 2011 the actual spending was $0.8 million in keeping with the incremental implementation of the Agency's mandate.

2010-11 Human Resources (FTEs)

Planned	Actual	Difference
14	3*	11

* The Agency was authorized a complement of 14 Full Time Equivalent positions (FTEs) in 2010 - 2011, and yet maintained 3 FTEs in keeping with the incremental implementation of the Agency's mandate.

Expected Results	Performance Indicators	Targets	Performance Status
An effective and efficient licensing and inspection framework.	As the regulations come into force, develop a documented licensing and inspection framework which is communicated to clinics and stakeholders and which sees inspections carried out on the basis consistent with the framework.	In advance of the regulations coming into force, and in collaboration with stakeholders, AHRC will focus on: Developing guidelines, processes and systems to support a licensing system; Developing an inspection strategy that will ensure compliance with the AHR Act and regulations; Addressing complaints and possible contraventions to the AHR Act and regulations	A comprehensive set of guidelines, processes and supporting systems continued to be prepared for implementation of the licensing system in synchronization with Health Canada's policy and regulatory development timelines. Collaborations continued with national and international accreditation and regulatory bodies in order to harness best practices and leverage their extensive expertise in inspecting, accrediting and regulating the area of AHR. AHRC introduced a compliance continuum model, which focused on compliance promotion while engaging in monitoring, verification and enforcement activities as issues and complaints were identified and brought to the Agency's attention. All complaints and possible contraventions brought to the attention of AHRC were dealt with and resolved according to AHRC's standard complaint management process.
A well-informed and engaged stakeholder community.	Prior to the regulations coming into force, communicating the framework to the stakeholders by various means including direct contact, presentations at professional forums, literature and electronic means such as a web site.	In advance of the regulations coming into force, AHRC is concentrating on: Communicating the vision for the framework to key stakeholders through the website, newsletter, conferences and other outreach initiatives; Conducting baseline assessments, horizon scanning and established practice updates, to produce reliable evidence that will inform decision -making by the Board of Directors; Working with international stakeholders to facilitate information exchange and identify and address issues of mutual concern.	AHRC has enhanced the communication and outreach activities in consideration of stakeholder needs and expectations. Some examples include: Communicating the vision for AHRC's implementation of various sections of the Act and regulations with clinics, the public and other organizations through the many questions posed via the toll free phone line and the AHRC central email in addition to provision of information via AHRCs website and newsletter. Incorporating the horizon scanning work of the Science Advisory Panel to promote and support evidence-based best practices among professional communities. Most pertinent were: The development and implementation of the Canadian Framework for the prevention of AHR related multiple births; The development of a Canadian framework for AHR/ART outcomes measurement. Presentations and information exchanged at events nationally and international allowed AHRC to exchange information and identify and advance key issues of mutual concern.

Performance Summary and Analysis of Program Activity

In 2010-11, AHRC entered its third year of administering and enforcing the AHR Act and related regulations, a year which culminated in the Supreme Court of Canada (SCC) opinion. During the time leading up to the SCC opinion, AHRC had established and incrementally implemented a comprehensive compliance and enforcement program to manage the potential risks faced by Canadians who use or are born of assisted reproduction treatments (ART). This program was based on the recognition that compliance could only be achieved within a new regulatory system when the requirements were clearly understood by all those subject to the legislation. AHRC introduced a compliance continuum model, which focused on compliance promotion while engaging in monitoring, verification and enforcement activities as issues and complaints were identified and brought to the Agency's attention.

Throughout 2010 - 2011, AHRC compliance and enforcement staff interacted frequently with health professionals, patient support groups and individual Canadians on a one-on-one basis and in small group and conference settings to educate and inform them of the regulatory requirements of the AHR Act. These interactions allowed the Agency to better understand and appreciate the challenges associated with regulating a field as scientifically complex as AHR, and were also used to promote compliance with the Section 8 Consent to Use regulations. Collaboration also continued with international accreditation and regulatory bodies in order to harness best practices and leverage their extensive expertise in inspecting, accrediting and regulating the area of AHR.

AHRC continued to receive allegations of violations of the AHR Act, particularly with respect to the prohibitions on payment for gametes and surrogacy services. As in previous years, these allegations were assessed on the facts, and resolved through a transparent and standardized process in accordance with the guiding principles of the AHRC Compliance and Enforcement Policy (available at: http://www.ahrc-pac.gc.ca/v2/aaa-app/alt-formats/pdf/wwd-qnf/C-E-Policy-eng.pdf), and in conjunction with law enforcement and disciplinary authorities where warranted.

Building upon work from the previous year, AHRC also continued with its efforts to promote evidence-based best practices among the professional communities. In 2010 - 2011, AHRC provided support for the ongoing development and implementation of the Canadian framework for the prevention of AHR-related multiple births. AHRC continued to facilitate the implementation of this framework using the three pillars of Professional Education, Patient Education and Data Collection and Analysis.

In 2010 - 2011, AHRC was able to keep abreast of the rapidly-evolving AHR landscape through the ongoing efforts of the Science Advisory Panel (SAP). Created by the AHRC Board of Directors, this Panel provided the Agency with invaluable input on many AHR initiatives. Throughout the year, some SAP committee members, along with AHRC staff, were also actively engaged with personnel at the Statistics Canada's Health Analysis Division in the interpretation and preparation for dissemination of findings from the 2009 - 2010 survey data on infertility.

In 2010, AHRC hosted a workshop on AHR / ART - related outcomes at the annual Canadian Fertility and Andrology Society (CFAS) meeting. From this workshop evolved a Canadian framework for outcomes measurement, detailing the need for multi-disciplinary cooperation across the many levels of health care provision and governance. The need for the involvement of many stakeholder areas in this endeavour was reflected in the composition of the workshop planning committee, which consisted of representatives from the CFAS, the Society of Obstetricians and Gynaecologists of Canada (SOGC), the Public Health Agency of Canada, the Canadian Paediatric Society, the Canadian Perinatal Surveillance System, several provincial Ministries of Health, and members of the AHRC Science Advisory Panel.

The Tripartite Committee, consisting of representation from AHRC, the CFAS and the SOGC, and Health Canada as an observer, has been a unique forum in which member organizations address areas of shared interest to enable consensus on standards of practice across Canada and to improve the patient's journey through reproductive care. The shared interests of these groups have led to the formation of additional sub-committees and initiatives for the improvement of information dissemination and for addressing collaborative goals.

AHRC was able to provide accurate and up-to-date information to stakeholders regarding current practices in AHR and innovations on the horizon of this rapidly-evolving area. In addition, committee members provided AHRC with valuable insight to issues of interest to the clinical and scientific communities represented, allowing the Agency to facilitate initiatives to enhance knowledge transfer among the various professional fields.

Lessons Learned

The Agency consulted with key stakeholder groups and associations to incorporate best practices from other jurisdictions in accordance with the regulations being developed by Health Canada. AHRC maintained its focus on activities that support the delivery of its compliance and enforcement mandate, and strengthened its role to oversee and enforce the prohibitions of the AHR Act.

Strategic Outcome

Protection and promotion of human health, safety, dignity and rights in relation to assisted human reproduction and related research, within a sound ethical framework.

Program Activity: Health Information and Knowledge Management for Assisted Human Reproduction (AHR)

Program Activity Descriptions

The Assisted Human Reproduction Agency of Canada (AHRC) would achieve this objective by the following means: maintaining a personal health information registry to consolidate health reporting information concerning donors, patients and offspring born of assisted human reproduction (AHR) procedures to allow for a look-back and trace-back mechanism; providing ongoing reports of AHR controlled activities, including success rates by AHR clinics and results of research, to enable prospective AHR users to make informed decisions; and providing public information on AHR matters or issues via a public website or in other forms such as brochures.

Please note that Financial and Human Resource allocations were undertaken at a pace consistent with the incremental implementation of the Agency's mandate as defined by Health Canada's policy and regulatory development timelines.

2010-11 Financial Resources ($ millions)

Planned Spending	Total Authorities	Actual Spending
2.6	2.6	1.0*

* While AHRC was authorized to spend $2.6 million in 2010 - 2011 the actual spending was $1.0 million in keeping with the incremental implementation of the Agency's mandate.

2010-11 Human Resources (FTEs)

Planned	Actual	Difference
11	4*	7

* The Agency was authorized a complement of 11 Full Time Equivalent positions (FTEs) in 2010 - 2011, and yet maintained 4 FTEs in keeping with the incremental implementation of the Agency's mandate.

Expected Results	Performance Indicators	Targets	Performance Status
A Personal Health Information Registry that complements an AHR surveillance network.	The successful development of a Personal Health Information Registry that is integrated into an overall surveillance network, once the regulations come into force.	In advance of the regulations coming into force, AHRC is concentrating on: Initiating a pilot project using voluntary information to build the foundation for a Personal Health Information Registry.	In synchronization with Health Canada's policy and regulatory development activities, AHRC: Explored best practices in registry development and identify models for pilot implementation pending the Supreme Court opinion. Supported the efforts of professional communities in order to enhance the quality of their data collection and reporting.
Policy makers, health professionals, patients, children born of AHR procedures, researchers and the Canadian public have access to information regarding AHR.	Total number of information items produced. Total number information requests responded to by type. Volume and Pattern of Website Use. Website enhancements completed. Results of periodic surveys to gauge utility of products.	6 information items produced per year. 100% of information requests are responded to within 48 working hours of receipt. 10% increase in website visits per year. Report of enhancements prepared annually.	AHRC published several informational products in 2010 - 2011 including a biannual Newsletter, several brochures such as "Your guide to infertility and Assisted Human Reproduction (AHR)" and "Coping with the implications of genetic testing: A brochure for Canadians seeking assisted reproduction procedures". 93% of the information requests received at AHRC were responded to within the target timeframe. Launched Phase II of its public website to better apprise Canadians of the latest AHR-related innovations and scientific research. This information was contained in over 1000 web pages dedicated to the myriad issues and stakeholder needs relating to AHR and AHRC. AHRC acted as a catalyst in uniting patient groups to join efforts to prevent multiple births due to AHR.

Performance Summary and Analysis of Program Activity

In modern approaches to health promotion, there are many mechanisms that can be used to effect change. In this regard, AHRC has worked to enhance stakeholder education and promote high professional standards. AHRC continued to provide a strong leadership role within Canada, working diligently to catalyze positive changes in AHR by forming collaborative partnerships, sharing knowledge, and facilitating the uptake of best practices and guidelines based on sound scientific evidence and strong ethical principles. In addition, AHRC continued to address many complex issues related to AHR, such as the support of data collection efforts for the long-term assessment of health risks and benefits in order to provide Canadians with the information needed to make informed choices.

Over the last year, AHRC maintained many knowledge transfer and outreach activities, including the launch of Phase II of its public website. AHRC also published several informational products, including the brochures "Your guide to infertility and Assisted Human Reproduction (AHR)" and "Coping with the implications of genetic testing: A brochure for Canadians seeking assisted reproduction procedures" - the third instalment in a series of brochures developed in partnership with the Canadian Association of Genetic Counsellors.

In past years, AHRC has worked closely with regulators, professionals and patient groups, both within Canada and abroad, to successfully disseminate relevant information and promote informed decision-making on the part of those who provide or make use of AHR services.

Lessons Learned

AHRC attained many measurable achievements in 2010 - 2011 to catalyze positive change within the Canadian AHR community. The quality and reliability of information collected and distributed is attributable to the rigor and inclusiveness of the consultation with all stakeholders, including researchers, policy-makers, patients, industry, professional associations, and Canadians.

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