MEETING NOTES THERAPEUTIC PRODUCTS PROGRAMME ADVISORY COMMITTEE ON MANAGEMENT

TPP Boardroom
Holland Cross, Tower B, 1600 Scott Street
Ottawa, Ontario
August 24, 2000

Members:

Jim Blackburn (Chair)
Luis Barreto
Andrea Baumann
John Blatherwick
Ruby Grymonpre
Stuart MacLeod
Brenda Nunns-Shoemaker
Bonnie Salsman
Beverley Townsend
Pamela Zabel

Regrets:

Raphaela Borenstein
Robert Goyer
John Parks
Malcolm Seath
John Stewart

Secretariat:

Robert Peterson
Jan Pound
Carolin Vaughn
Gail Gervais

Presenters:

Andy Butterfield
Brigitte Zirger

Observers:

Anwar Ali (item 6)
Barbara Benning
Brian Gillespie
Julia Hill
John Stewart Jean Lambert
Carole Langevin (item 6)
Jean Peart
Chris Turner
Roland Rotter

1. Opening Remarks (J. Blackburn)

Dr. Blackburn welcomed everyone which was then followed by a roundtable of introductions.

2. Review of the May 10-11 Meeting Notes (J. Blackburn)

The meeting notes of May 2000 were approved.

3. ACM Membership (J. Blackburn)

Ruby Grymonpre, a professor at the Faculty of Pharmacy, University of Manitoba, has joined the TPP Advisory Committee on Management (ACM), as a nominee from the Canadian Pharmacists Association.

As Lesia Babiak has left the Ontario government, the Pharmaceutical Issues Committee has been requested to submit nominations for a new provincial representative to sit on the ACM.

4. Realignment of Health Canada (R. Peterson)

Departmental and Branch level changes - The Health Products and Food Branch has seen the least amount of leadership change. In an effort to bring similar functions together, the TPP's Office of Controlled Substances and Drug Analysis Service has moved to the Healthy Environments and Consumer Safety Branch as has the Department's tobacco control initiative. The Population and Public Health Branch is a compilation of components from the former Laboratory Centre for Disease Control (LCDC) (e.g. blood surveillance) and the Health Promotion and Programs Branch. Memoranda of Understanding (MOU) are being developed where there are shared initiatives across the new Branch structure.

Directorate activities will be maintained although there are some operational areas that may be more efficient/effective if they are moved to the Branch level. For example, the TPP's Office of Continuing Education has been opened to the Branch to expand the training/curriculum opportunities for both the Foods Directorate and the Office of Natural Health Products.

Diane Gorman, Assistant Deputy Minister of the Health Products and Food Branch is interested in participating at senior advisory meetings within the Branch.

TPP Issues - A management retreat is being planned for the Fall and will focus on operational planning and budgeting. This exercise will be a prelude to getting the TPP's plans in place before the new fiscal year and will assist the Programme with determining its resourcing requirements. The implications of moving the Bureau of Biologics and Radiopharmaceuticals (BBR) into a new directorate needs to be fully assessed. Given the regional nature of the Bureau of Compliance and Enforcement serve numerous functions, it does not seem reasonable to replicate this group for Biologics and Genetics. An assessment will be done with regard to the best way to deliver this service within the HPFB. Similar to the Branch exercise, the TPP will need to examine the existing linkages between its Bureaux. Dr. Peterson estimated that it could take the better part of one year to look at splitting BBR from the Programme.

Concern was raised about realigning radiopharmaceuticals into the new directorate. Given the relative low risk that radiopharmaceuticals pose, it's felt they could get lost amongst the hot issues and may not receive the attention they require.

ACTION: Suggested that a one-day workshop with the relevant stakeholders be organized to discuss this issue further. P. Zabel/J. Peart

As a result of the changes that have occurred in the Department's structure, the ACM suggested that it may be appropriate to examine the role and reporting responsibilities of the Office of Biotechnology and Science, which currently reports directly to the Assistant Deputy Minister.

5. Financial Update (A. Butterfield)

The 2000-2001 expectations, appropriations base, and anticipated new funding were provided. The TPP is forecasting a revenue shortfall of $3.4 M. Cash management, realignment, and cost recovery were identified as issues effecting resources/funding.

Comment was made that the significant cash flow/management challenges such as transition, funding, and staffing facing the TPP have been repeating themselves since the inception of the ACM in 1996. Recognizing that these challenges are not unique to the TPP but also seen in other areas of the Department, they will be addressed through the Programme's operational planning activities. Activities in progress are not being stalled waiting for Treasury Board decisions and transfers.

6. TPP Human Resource Strategy (B. Zirger)

A presentation on the pressures and changes since the early 1990s and the resulting and emerging human resources challenge. An April 2000 report from the Auditor General made a number of observations regarding the Public Service's "unduly complex and outdated" HR management regime.

The TPP's Our Future - A Human Resources Discussion and Planning Document identified 10 major HR issues, two of which have been given priority status: 1) improving the infrastructure and process for recruiting – this item will be addressed through the TPP HR Initiative which will be looking at immediate staffing challenges and efficiencies through collective actions; and, 2) building top-notch staff – this issue is being addressed through training and continuing education.

ACTION:

Comments to be considered as the TPP HR Initiative develops: B. Zirger

• examine approaches to change the perception that the public service is not considered to be an optimal employer
• possibility that joint reviews could alleviate workload
• develop retention plans for current staff along with immediate recruitment of new staff
• salary scale for medical officers/health professionals is not adequate when compared to private sector
• promote the attractiveness of the nation's capital and the public service through University Career Days
• the ACM offered to be a network to provide contacts and links for recruiting and posting employment opportunities
• possibility of having resumés transferred from HR units of external organizations to the public service (TPP)

7. ACM and its relationship to other committees

An overview on the Programme's advisory committees and their mandates was provided, specifically the new Advisory Panel on the Product Licensing Review Process (AP-PLRP) and Public Advisory Committee (PAC). Dr. Peterson suggested that the concept of a PAC may be optimally situated at the Branch level once the Branch's Office of Consumer Affairs and Public Involvement (OCAPI) is firmly established. The possibility of broadening the scope of a PAC to the Branch was favourably received. The notion of establishing an Expert Advisory Committee (EAC) for paediatric therapy was raised. If the needs could be identified for such a committee, the Programme would certainly give it consideration. It was noted that there have been similar suggestions for women's/children's issues.

8. Canadian Institutes of Health Research (CIHR) (A. Baumann)

The programmatic structure for the institutes is now in place. A mechanism to develop new institutes is still required. The current institute structure addresses traditional disease group issues. The formation of an innovative institute to pull together the outlying research activities within/outside government is missing. It had been suggested that an institute on risk management/assessment could assist in research endeavours.

It is felt that the Department's Chief Scientist position is more of a networking/communications role and is missing the component of active research. The position is still somewhat vague and will be clarified during the staffing process. Science in the Department is very broad and research is only a part of its overall science capacity. A departmental science committee will be established and funded to work with the Chief Scientist. One proposal could be for the Deputy Minister to have the Chief Scientist lead the creation of an "institute" type structure within government which could eventually fall under the CIHR. Once on board, the Chief Scientist will address the various options.

ACTION: Draft a letter to the CIHR commenting on direction regarding recommendations on emerging needs for the development of new institutes.
A. Baumann

ACTION: ACM to write to the Chief Scientist (once appointed) to share its views and suggestions as to how the Office could potentially assist with integrating science and research within/outside the Department.
J. Blackburn/members

9. Meeting Evaluation and Closing

With fewer formal presentations on the agenda, the members appreciated the opportunity to have more in-depth discussions on the issues with the presenters. To ensure that the Programme is receiving valuable input from the Committee, it was suggested that focus questions be provided in advance with the agenda.

Future Agenda Items:

• Chemistry and Manufacturing Review Issue (previously identified as substantial backlog issue re timing)
• Update on Human Resources

Next meeting: January 17-18, 2001 (10:00 a.m. start on January 17th)
TPP Boardroom, Room 2048, 1600 Scott Street, Holland Cross, Tower B

Original signed by

Jim Blackburn
Chair