ARCHIVED - Assisted Human Reproduction Canada - Report

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Section II - Analysis of Program Activities by Strategic Outcome

2.1 Strategic Outcome - Protection and promotion of the health and safety of Canadians against the risks associated with assisted human reproduction technologies.

Program Activity by Strategic Outcome

2.1.1 Program Activity: Licensing and Enforcement of a Regulatory Framework for Assisted Human Reproduction Technologies³

2009-10 Financial Resources ($ millions)			2009-10 Human Resources (FTEs)
Planned Spending	Total Authorities	Actual Spending	Planned	Actual	Difference
4.3	4.3	.8	14	3	11

³ Financial figures have not been adjusted to reflect the estimated expenditures under this Program Activity that are currently included in Program Activity 2.1.3, Internal Services

The table above summarizes AHRC's total spending for the 2009-10 fiscal year and actual FTE's employed during that period under this program activity.

Program Activity Summary

Expected Results	Performance Indicators	Targets	Performance Status	Performance Summary
An effective and efficient licencing and inspection framework.	As the regulations come into force, develop a documented licencing and inspection framework which is communicated to clinics and stakeholders and which sees inspections carried out consistent with the framework.	In advance of the regulations coming into force, and in collaboration with stakeholders, AHRC is concentrating on: - developing guidelines, processes and systems to support a licencing system - developing an inspection strategy that will ensure compliance with the AHR Act and regulations	Somewhat Met	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. The Agency completed defining its Regulatory Implementation Framework and initiated drafting all key guidance documentation in support of the licensing and inspection activities of the framework. AHRC formalized the process for receipt and assessment of allegations of non-compliance with the Act or regulations. All reported allegations of non-compliance were assessed, investigated as necessary and appropriate measures taken. Monitoring of websites for adherence to the legislation - particulary those related to payment for the purchase of gametes and the services of a surrogate mother - was initiated.
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: - attending professional forums and meetings to communicate the vision for the framework to key stakeholders - communicating to stakeholders through the website, newsletter and other outreach initiatives, key aspects of the framework	Met All	Continued to build productive relationships with stakeholders, through AHRC-sponsored working groups, formal and informal presentations. Responded to hundreds of questions from clinics, the public and other organizations via the toll free phone line and the AHRC central email regarding the AHR Act and its regulations. Continued to engage several partners to further the development of an integrated inspection and accreditation model to minimize administrative burden on regulated parties. Brought together approximately 75 researchers, clinicians and other national and international fertility experts for a scientific roundtable on the issues of multiple births related to AHR, resulting in a draft Canadian framework to prevent multiple births due to fertility treatments. Established the Healthy Singletons Committee, a continuation of the Multiple Births Roundtable steering committee. Worked with the Canadian Partnership Against Cancer (CPAC) as part of a symposium focused on Adolescent and Young Adult cancer issues. Increased overall understanding of the incidence of infertility among the Canadian population by requesting Statistics Canada to include questions relate to the issue in its 2009 Canadian Community Health Survey.

Performance Analysis

The mandate of this Agency is to protect and promote the health, safety, dignity and rights of Canadians who use or are born of assisted human reproduction technologies. Its mandate and responsibilities are set out in the Assisted Human Reproduction Act. These activities are overseen by the Board of Directors of the Agency.

AHRC promotes an environment in which ethical principles are applied in all matters related to assisted human reproduction (AHR), while supporting scientific advances that benefit Canadians.  The Agency is also a centre of AHR expertise for policy makers, health professionals and Canadians.

Activities under this mandate include:

• Conducting inspections and enforcement related to activities prohibited or controlled under the AHR Act and providing clarifications to clinics about the Act's requirements;
• Collecting and analyzing information relating to AHR;
• Transferring knowledge to health professionals and providing information to the public on AHR and associated matters, including risk factors associated with infertility;
• Consulting with individuals directly impacted by AHR matters and collaborating with organizations within Canada and internationally involved in AHR issues;
• Monitoring and evaluating AHR developments domestically and globally ;
• Providing advice to the Minister of Health on all matters relating to assisted human reproduction ; and
• Providing internal support services in accordance with governmental policies and regulations.

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, out of respect to the Court, 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. The Agency 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. AHRC also continued to build productive relationships with stakeholders, through AHRC-sponsored working groups, formal and informal presentations.

As part of its efforts to build an effective and efficient licensing and inspection framework, the Agency completed defining its Regulatory Implementation Framework and initiated drafting key guidance documentation in support of the licensing and inspection activities of the framework.  Guidance documentation is being drafted in a modular, "ever-greening" manner to synchronize with the phased regulatory development schedule of Health Canada.

AHRC completed work to formalize receipt and assessment of allegations of non-compliance with the Act or regulations.  All reported allegations of non-compliance were assessed, investigated as necessary with appropriate measures taken.

Monitoring of websites for adherence to the legislation - particularly those related to payment for the purchase of gametes and the services of a surrogate mother - was initiated in support of the Agency's compliance and inspection mandate.

Exploring and incorporating best practices in the areas of IT security, privacy and personal health information management continued to inform the Agency's regulatory database architecture and design.

Efforts to extend a well-informed and engaged stakeholder community continued as well. The Agency initiated new relationships with stakeholder groups, while continuing to support and collaborate with medical associations and patient groups to encourage the incorporation of as much expertise and as many perspectives as possible in the development of national guidelines for assisted human reproduction.

The Agency compliance staff received hundreds of questions from clinics, the public and other organizations via the toll free phone line and the AHRC central email seeking clarification on the AHR Act and its regulations.  All inquiries were responded to as completely as possible within the current regulatory environment.

AHRC continued to engage several partners, including Accreditation Canada, to further the development of an integrated inspection and accreditation model to minimize administrative burden on regulated parties.

In an effort to address the issue of multiple births the Agency brought together approximately 75 researchers, clinicians and other national and international fertility experts for a scientific roundtable on the issues of multiple births related to AHR.  The roundtable culminated in a draft Canadian framework addressing the prevention of multiple births due to infertility treatment.

The Healthy Singletons Committee, a continuation of the Multiple Births Roundtable steering committee, was also established to identify tangible and achievable targets and actions in support of the Multiple Births Framework.

Also, AHRC worked with the Canadian Partnership Against Cancer (CPAC), as part of a symposium focused on Adolescent and Young Adult cancer issues. AHRC organized a symposium "Oncofertility in Canada: Building Connections for the Improvement of Fertility Preservation Options", to facilitate knowledge transfer among reproductive scientists, oncology staff, fertility preservation specialists and patient advocates.  This event was successful in increasing understanding and encouraged research partnerships for the future - a further step in generating increased opportunities for cancer survivors to build families.

AHRC increased overall understanding of the incidence of infertility among the Canadian population by requesting that Statistics Canada include questions related to the issue in its 2009 Canadian Community Health Survey - the largest survey sample of its kind in roughly two decades since the Royal Commission on New Reproductive Technologies.

AHRC worked with the Canadian Institutes from the Health Research's (CCHIR) Institute of Gender and Health and Institute of Human Development, Child and Youth Health to facilitate a workshop that identified research priorities related to AHR.  As a next step, the collaborators supported a funding initiative through CIHR focused on psychosocial impacts of AHR.

Lessons Learned

While awaiting the coming into force of further regulations of the Assisted Human Reproduction Act the Agency continued to consult with key stakeholder groups and associations 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.

Benefits for Canadians

Through this program activity, AHRC contributes to fostering the health of 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.

2.1.2 Program Activity: Health Information and Knowledge Management for Assisted Human Reproduction Technologies⁴

2009-10 Financial Resources ($ millions)			2009-10 Human Resources (FTEs)
Planned Spending	Total Authorities	Actual Spending	Planned	Actual	Difference
2.6	2.6	.8	11	2	9

⁴ Financial figures have not been adjusted to reflect the estimated expenditures under this Program Activity that are currently included in Program Activity 2.1.3 Internal Services.

The table above summarizes AHRC's total spending for the 2009-10 fiscal year and actual FTE's employed during that period under this program activity.

Program Activity Summary

Expected Results	Performance Indicators	Targets	Performance Status	Performance Summary
A Personal Health Information Registry that complements an eventual 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	Somewhat Met	AHRC continued to concentrate on building the foundation for the Personal Health Information Registry. The business requirements for meta-data collection were documented and defined for the initial Health Canada regulatory package. In response to a priority for improved and additional information related to reproductive technology, identified by patients, fertility centres and researchers, AHRC began exploring, with the Canadian Fertility and Andrology Society and other experts, potential models around the measurement of outcomes. AHRC supported development of the 2009 Inventory of Health Surveillance Databases which collects information related to the health outcomes of AHR.
Policy makers, health professionals, patients, children born of AHR procedures, researchers and the Canadian public have access to information regarding AHR.	Number of printed information products distributed for external use Number of persons/organizations accessing the Web site (statistics)Results of periodic surveys to gauge utility of products	The Agency will establish baseline measures related to its information products in the first year, as the basis for setting targets in future years.	Somewhat Met	3 Information brochures produced and disseminated : Counselling and Assisted Human Reproduction; Reproductive Genetic Testing and Screening Options; and Cancer and Preserving your Fertility: a Guide for Patients. Other information products created and disseminated included: 2009 Inventory of Health Surveillance Databases; 2009 Winter Newsletter; and Annual Report - 2008-2009. Revisions to the AHRC website initiated in support of the evolving Stakeholder Outreach Strategy and the Information Dissemination Plan. Additional baseline data collection will be refined as the website redesign is completed

Performance Analysis

AHRC continued to concentrate on building the foundation for the Personal Health Information Registry. The business requirements for meta-data collection were documented and defined for the initial Health Canada regulatory package.

In response to a priority for improved and additional information related to reproductive technology, identified by patients, fertility centres and researchers, AHRC began exploring, with the Canadian Fertility and Andrology Society and other experts, potential models around the measurement of outcomes.

Adequate information is essential for both health policymakers and practitioners to plan and provide appropriate resources to health programs and allow confirmation that the programs are producing the intended results.

One of the means to accomplish this is through relevant and effective monitoring of health outcomes, an area that AHRC is actively advancing. Health researchers across the country collected and collated information related to assisted human reproduction, as well as reproductive, perinatal, infant and children's health in the 2009 Inventory of Health Surveillance Databases, which will help confirm the outcomes of AHR procedures.

As part of the work under the Agency's mandate to provide policy makers, health professionals, patients, children born of AHR procedures, researchers and the Canadian public with access to information regarding AHR, information brochures were produced and disseminated which shared news about the latest technological developments with Canadians. It is important to note that the development of all communications products benefits from the input of AHRC Editorial Committee members. The Committee is composed of representatives from stakeholder groups with knowledge of AHR issues, including a counsellor, a patient representative, a donor-conceived person, as well as an embryologist, a gynaecologist, a nurse and a physician.

AHRC developed a new brochure for prospective parents, which provides them with an overview of genetic testing and screening options that they may want to consider during the early stages of pregnancy.  This brochure, Reproductive Genetic Testing and Screening Options, briefly explains what genetic testing involves, how it is performed, and outlines advantages and limitations of this technology.

Knowing what to anticipate and how to deal with the uncertainty surrounding AHR is another subject explored in a recently-released brochure, Counselling and Assisted Human Reproduction.  The leaflet explains what AHR counselling entails for men, women and families.  It outlines the medical aspects of various procedures as well as the kinds of social, emotional, and ethical issues that are linked to reproductive technologies.  The leaflet reinforces that counselling can help individuals and couples cope with the many challenges associated with being unable to conceive without medical intervention, and with the complex decisions they may need to consider during different stages of AHR.

A third brochure was produced to raise awareness of advances in reproductive technologies that can increase the chances of conception among cancer survivors. Cancer and Preserving your Fertility: A Guide for Patients wasdistributed by mail and on the AHRC's website.

The Agency also disseminated other products in addition to the brochures mentioned, including the 2009 Winter Newsletter, and the Agency's Annual Report for 2008-09.

Revisions of the Agency's website were initiated in support of the evolving Stakeholder Outreach Strategy and the Information Dissemination Plan due to the site's role as an important tool for all stakeholders. These revisions, both technical and content-centric, will facilitate and enhance AHRC's dissemination capacity as well as introduce utilities for monitoring access to the various products AHRC makes available via the website. The redesign, scheduled for completion by summer 2010, will also incorporate refinements to the collection of relevant baseline data.

Lessons Learned

The Agency continues to actively consult and consider 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. The quality and reliability of information collected is attributable to the rigor and inclusiveness of the consultation with all stakeholders, including researchers, policy-makers, patients, industry, professional associations, and Canadians. 

Benefits for Canadians

The establishment of a Personal Health Information Registry (PHIR) will be useful in 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 access 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. This will allow Canadians to make more informed decisions related to the use of these technologies.

2.1.3 Program Activity: Internal Services

2009-10 Financial Resources ($ millions)			2009-10 Human Resources (FTEs)
Planned Spending	Total Authorities	Actual Spending	Planned	Actual	Difference
3.7	3.7	3.6	19	8	11

The table above summarizes AHRC's total spending for the 2009-10 fiscal year and actual FTE's employed during that period under this program activity.

Performance Analysis

Internal Services are groups of related activities and resources that are administered to support the needs of programs and other corporate obligations of an organization. These groups are: Management and Oversight Services; Communications Services; Legal Services; Human Resources Management Services; Financial Management Services; Information Management Services; Information Technology Services; Real Property Services; Material Services; Acquisition Services; and Travel and Other Administrative Services. Internal Services include only those activities and resources that apply across an organization and not to those provided specifically to a program.

Internal Services includes expenditures related to the Office of the President, activities of the Chief Science Advisor's Office (includes support to the Science Advisory Panel) and the Corporate Secretariat (which includes support to the Board of Directors). In addition, it includes a Memorandum of Understanding (MOU) with Health Canada (HC) for Human Resources, Finance and IT support, a MOU with HC Inspectorate for Inspection services and a MOU with the Department of Justice for legal services.

AHRC continued to build sustainable Internal Services by developing policies, processes and service delivery in the areas of finance, procurement, human resources, information management (including Access to Information and Privacy), and information technology. Wherever practical, the Agency reviewed best practice models and worked towards an integrated management system that considers human resources, risk management, performance management, and financial management.

The Agency also reviewed its Internal Services performance to ensure delivery of service in a transparent, cost effective, and timely manner, and worked to create an Internal Financial Control Framework to encompass financial management, risk management, financial delegation and contracting.

In the area of human resources, AHRC worked to integrate its business planning and human resource planning and its resourcing strategy in accordance with Public Service Commission and other relevant Central Agency policies. As regulations come into force, resourcing plans will be implemented to ensure that AHRC has the personnel and expertise required to fulfil its mandate that are appropriate to the anticipated broadening of activities as the regulations come into force.

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