ARCHIVED - Evaluation of The Prion Diseases Program

3.0 Relevance

This portion of the evaluation contains an assessment of the relevance of the Prion Disease Program in meetings PHAC and Government of Canada vision and mandate. It examines the existing vision and mission for clarity and continued relevance to government-wide priorities. Findings are derived primarily from the document reviews, staff and management interviews as well as the steering committee focus group.

3.1 Vision

Is there a clear and relevant vision and are there clear objectives for activities under PDP?

The Prion Diseases Program current mission is to:

“… continually assess, mitigate, and ultimately eliminate risks to human health posed by infectious prion diseases in Canada, through surveillance, laboratory services, research and education.”

Source: Annual Report Template for National Microbiology Laboratory Programs Reporting Period – April 1, 2005 – March 31, 2006, Module B

This mission has been clearly stated in the PDP NML Annual Reports since then; however, there is limited documentation of mission statements prior to this date.

A vision for the CJDSS component appears to be developing in terms of:

“The overarching goal of the CJDSS is to establish and lead an integrated Canadian CJD Public Health Network” Source: Overview of Rationale, Purposes, Goals and Operations of the CJDSS August 27, 2008.

The PDP program was managed as two sub-projects prior to 2005, split between the surveillance system and the laboratory services (laboratory reference services and research combined) with some deliverables for both groups. These two halves were brought together under one NML Director in 2005. Improved documentation of mission and specific objectives started with the development of NML business planning annual reporting processes in 2005-2006. Documentation, which was scant prior to that date, has since improved considerably. Specific objectives are identified on an annual basis in the NML business planning process.

It appears that distribution and communication of the mission and objectives may be limited as PDP managers and staff expressed a general concept of the basic purpose of the PDP program, however, had limited awareness of formal mission, objectives or future directions.

Conclusions: There is a clear, documented mission statement and specific objectives for the PDP program since 2005-2006. A vision for the CJDSS component is developing, while an overall vision statement for the PDP is not evident. There is limited awareness of the formal mission and objectives by PDP managers and staff.

3.2 Mandate

How has the mandate changed since program inception and what internal and external factors have contributed to the identified changes?

The mandate for the PDP has changed over time in response to a variety of external factors. Initially the program was linked to blood safety (post–Krever Inquiry) and the potential for a pandemic outbreak. As such, its design was based on a case-study approach, with a strong research rationale to address the many facts that remained unknown at that time, including the identification and transmission of classical CJD.

The current mandate now incorporates risks related to vCJD as well as more elements of a public health surveillance system. As a result, the emphasis has shifted from an international focus to domestic surveillance and the research mandate has increased.

The factors contributing to this change include the discovery of BSE in Canada, the peaking of vCJD in the UK, and the spread of CWD to Canada. With an improved understanding of the blood borne risks for CJD and vCJD, appropriate policy measures were developed and implemented. The response of public health to the SARS outbreak is a contributing factor. The creation of PHAC has resulted in a greater emphasis on public health and related surveillance. The integration of the program in 2005 has also been a factor.

Conclusions: The mandate of the program has shifted over time in response to significant changes in the environment, such as disease factors, scientific developments and organizational restructuring.

3.3 Consistency

Does the initiative continue to be consistent with the PHAC mandate and government-wide priorities?

Broadly, the PDP activities are consistent with PHAC mandate and priorities. The PHAC Mission and Vision are:

Mission:
“To promote and protect the health of Canadians through leadership, partnership, innovation and action in public health.”

Vision:
“Healthy Canadians and communities in a healthier world. “

Source:www.phac-aspc.gc.ca/about_apropos/index-eng.php

Within the Management Resources and Results Structure (MRRS) of PHAC, the PDP falls under the Program Activity “Infectious Disease Prevention and Control”.

The 2008-2009 Report on Plans and Priorities for PHAC identifies as a specific priority:

“To develop, enhance and implement integrated and disease-specific strategies and programs for the prevention and control of infectious disease.”

Source: www.tbs-sct.gc.ca/rpp/2008-2009/inst/ahs/ahs-eng.pdf (PDF Document)

Interviewees consistently reported that PDP surveillance and reference service activities are linked well to the public health mandate. To a lesser degree, some reservations were raised regarding the amount or focus of primary research for the PDP or more generally, the federal government. The PHAC Strategic Plan 2007-2012 ^{Footnote 1} makes the alignment of programs and research with Agency priorities a clear objective. From the document review, research appears to be aligned with the program mission and PHAC mandate.

There was a strong consensus in the Steering Committee focus group that prion disease research is necessary within PHAC in order to develop and maintain expertise, knowledge, and credibility internationally and domestically.

Conclusions: The initiative is consistent with PHAC mandate. Research activities also appear consistent; however, research priorities are not well articulated among the PDP areas.

3.4 Continued Need for the Program

Is there a continued need for the program? Do current client needs and risk environment indicate a continued need?

The interviewees consistently indicated that basic CJD surveillance is a necessary, “obligation” for PHAC to be proactive in relation to a disease for which many unknowns remain. Due to its rarity and highly specialized knowledge for diagnosis, a Federal government role is required since it would be difficult for the provinces and territories to replace the service locally.

While the opinion on the importance of continuing basic prion research in Canada was universal, the direct role the Federal government should play was mixed though the case for research with a public health focus was made. In addition, research is viewed as critical in order to develop and maintain expertise, knowledge, and credibility internationally and domestically.

The overall opinion expressed in interviews and the Steering Committee focus group was that the actual risk environment had not changed significantly in the last five years. Critical factors mentioned include:

• CWD cross-over is an unquantifiable risk at this time;
• SRM feed ban in 2003 and Enhanced Feed Ban in 2007 will not show results for another five years;
• Still finding BSE cases in Canada;
• Peaking of UK vCJD cases;
• Hospitals procedures improved, however, perceived uneven application in smaller institutions;
• Increased use of single-use instruments; and
• Extent and impact of sub-clinical carriers unknown in Canada.

During internal and stakeholder interviews the following question was asked of all interviewees using a five-point Likert scale:

Overall, the most common opinion is that the risk environment has not changed significantly in the last five years. However, there was a great deal of variation in the responses, attributed to a number of the factors identified above. The responses of 30 interviewees are summarized below. Caution must be exercised in interpreting these responses due to the small sample size.

A second question was also asked of all interviewees using the same scale:

The opinions on perceived risk environment are evenly spread, indicating a diverse range of opinions. This is demonstrated in the summary below.

A survey of 11 health care professionals who have had contact with the surveillance services of the PDP in recent years was conducted to determine how satisfied they were with the contact. In summary, the survey found that the health care professionals broadly value the diagnostic and support services. Some concerns were expressed with the level of resources expended for a relatively rare disease compared to other more common and higher risk diseases.

The Steering Committee focus group concluded that continued, direct Federal participation in each of the three main activity areas is necessary. In particular, the rarity of prion diseases and specialized expertise required to diagnose them indicate a need for ongoing federal involvement in the surveillance services. The reference services were viewed clearly as a federal role due to the specialised skills required. In addition, the focus group viewed it as very important to maintain research activities to ensure ongoing skills and expertise within PHAC related to prion diseases given the uncertain risk environment.

Conclusions: There is a continued need for core PHAC involvement in human prion diseases based on public health need for disease surveillance, the rarity of the disease, the uncertain risk environment, the specialized nature of the technical requirements and expertise, and the need to maintain and develop skills and expertise at the federal public health level.