MEETING NOTES
ADVISORY COMMITTEE ON MANAGEMENT
THERAPEUTIC PRODUCTS DIRECTORATE (TPD),
BIOLOGICS AND GENETIC THERAPIES DIRECTORATE (BGTD),
INSPECTORATE
TPD Boardroom
Holland Cross, Tower B, 1600 Scott Street
Ottawa, Ontario
August 22-23, 2001
Members:
Jim Blackburn (Chair)
Luis Barreto
Andrea Baumann
John Blatherwick
Ruby Grymonpre
Mitchell Levine
Stuart MacLeod
Brenda Nunns-Shoemaker
John Parks
Bonnie Salsman
David Skinner
John Stewart
Pamela Zabe
Regrets:
Kenneth Michalko
Jack Rosentreter
Beverley Townsend
Secretariat:
Robert Peterson
OSPCQ Fern Levine
OSPCQDenise Quesnel
Presenters:
David Clapin
Ross Duncan
Brian Foster
Pauline Gaudry
Patricia Huston
Marion Law
Beth Pieterson
Karen Reynolds
George Samiotis
Observers:
Dennis Brodie
Vicky Hogan
Danièle Dionne
Jean Saint-Pierre
Siddika Mithani
Margaret Stockwell
Brian Gillespie
Paul Roufail
Susan Tessier
Sue Ann Blakely
• Opening Remarks (Jim Blackburn)
Dr. Blackburn welcomed everyone and initiated a roundtable of introductions.
David Skinner has replaced Malcolm Seath
on the Committee for this meeting.
• Review of Agenda and the May 8-9, 2001
Meeting Notes
(Jim Blackburn)
The meeting notes from May 8-9, 2001 were approved as presented.
• Realignment - Update (Robert
Peterson /David Clapin/Paul Roufail/
George Samiotis/Marion Law)
Dr. Peterson updated members on the progress of re-alignment
in each of the three new directorates, Biologics & Genetic Therapies
Directorate, Therapeutic Products Directorate and the Inspectorate.
The position of Director General, BGTD has been advertized. Interviews
are expected to be soon and an appointment will be effective early in
2002. The organizational chart for the new structure of the BGTD was
provided. In the TPD, Beth Pieterson has been appointed
Director of the Medical Devices Bureau.
Bureau of Pharmaceutical Assessment Reorganization
- (David Clapin & Paul Roufail)
The factors which are being taken into consideration and driving the
reorganization include:
- requirement for more coordination for the flow through of submissions.
- difficulties in staffing the position of Bureau Director.
- existing organization with many responsibilities.
- special responsibilities related to Clinical Trials and the Special
Access Program.
- challenges associated with synchronizing the activities of Safety
& Efficacy with Chemistry & Manufacturing.
Three models have been developed, using the input of staff. This will
be refined and further discussed at an upcoming BPA staff meeting.
The ACM discussion, which included Directorate representation, covered
the following:
• The comparison was made with the Therapeutic Goods Agency in
Australia. There, the preclinical, clinical and quality groups match
the Common Technical Document. It was agreed that it would be useful
to be able to make use of international information available from other
comparable regulators.
• Another key concern identified is that staff appear to be overloaded
with work and there may not be enough managerial training opportunities.
The new structure should attempt to address these issues.
• There is a need to establish the vision and clear plan for the
TPD. It was pointed out that human and financial needs may differ depending
on the structural model chosen. It is desirable to have the most efficient
model and this would be evident eventually through performance reporting.
The final model needs to allow for better communications to permit the
substantial 'horizontal' coordination that will be necessary.
It was suggested to examine the issues affecting performance - e.g.
is the handoff between Chemistry & Manufacturing and Safety &
Efficacy the biggest problem? Determine the drivers and how best to
set up project teams.
To better facilitate the coordination and integration of the review
streams there could be an additional management level. The end point
is to bring products to market sooner with appropriate safety and efficacy
review. Safety & Quality could be aligned along with processes such
as Research & Development, Manufacturing, Marketing as an overall
business process to link them together. It was suggested to review the
structures of the TGA, Sweden and the EMEA. It is hoped that the changes
made will look minimal but will be significant in terms of impact.
• Radiopharmaceuticals may fit better within the new reorganized
BPA. There are similarities between radiopharmaceuticals and small molecules.
Bureau of Licensed Product Assessment
- (George Samiotis)
Dr. Peterson provided an overview of the current activities. The Branch
intends to maximize the opportunity to improve post market surveillance
of all products regulated by the Health Products & Food Branch.
There is also a need to establish policies on how to engage external
groups to partner with us and take on aspects of this work e.g. collecting
drug utilization effectiveness data.
In January 2000 the BLPA released a study on how to improve
post market surveillance within the new realigned Branch. Various models
and options were presented and reviewed. At this time, the Branch Executive
Committee appears to support the centralized model but has not yet taken
a final decision.
In the discussion that followed several key issues were
raised and discussed, namely that the need for a Bureau Director, emphasis
on finding adequate resources (human and financial), the possibility
of partnering with other groups such as the Canadian Institute for Health
Information, the Population & Public Health Branch (currently conducts
vaccine surveillance), and provincial counterparts.
It must also be determined how to make the links from
HPFB to other parts of the Department that have an interest in post
market surveillance. First Ministers are pursuing issues around drug
cost effectiveness and there is a link with post-market surveillance.
The BLPA has established links with the FDA and the TGA. We need to
have access to their information as well as sharing Canadian data.
Common Services - (Marion Law)
Focus groups have begun to examine how to best reconfigure the Bureau
of Policy and Coordination and Common Services which includes all of
the Offices currently reporting to the Director General's Office
(Office of Strategic Planning, Communications & Quality, Office
of Knowledge Management and the Office of Management Services.) The
Office of Continuing Education is now providing services for the Branch.
The exercise of deciding which services could be shared among the three
new Directorates and which need to be replicated within each Directorate
is complete. The TPD must now focus on structuring these services for
its own use. The model currently developed would put all common service
in 2 new Bureaux - Policy and Management Services. A final decision
is expected soon.
The question arose about providing these services to
Natural Health Products Directorate. NHPD does not have the resources
to duplicate everything that the TPD has. There may be some potential
for a self-care initiative which would look at some low risk therapeutic
products (e.g. some non-prescription drugs).
It was proposed that the ACM address this to the Minister.
The NHPD should have the same support services as the rest of the Branch's
directorates and that this is the time to take the opportunity to set
it right in light of realignment.
Inspectorate responsibilities re:NHP: Currently NHPD
does not have much activity. When necessary, the TPD or Inspectorate
has taken some action and special measures but currently, NHPs are exempt
from most regulations. The NHP regulatory framework has not yet been
approved. It was suggested the ACM note to the Minister should include
past comments on NHPs by the ACM. (NB - previously there were 2 members
on the ACM from the NHP community).
ACTION: ACM to consider sending note to the Minister
regarding NHPD
4. Medical Devices Bureau Update - Beth
Pieterson
Beth Pieterson provided an overview on the current role,
responsibilities and structure of the MDB.
She also outlined some of the major accomplishments and
challenges facing the Bureau including that last year the Medical Devices
Bureau played a very active and influential role in the Global Harmonization
Task Force and continues to work closely with the FDA and the European
agencies. In 2003 the Quality Systems Requirements come into effect.
There is a concern in the industry that not every medical device manufacturer
will be compliant. However, a number of manufacturers are already having
two audits - one directed by the FDA and one directed by a recognized
body from the EU and the TPD is hoping that the European groups will
apply to receive recognition by Canada.
The Bureau faces a number of challenges including resourcing.
There are proportionately significantly less medical device reviewers
in the MDB than in other comparable regulatory agencies.
Another challenge is the increasing number and diversity
of combination products - devices with pharmaceuticals, devices with
biologics. The clarification of a product (drug or device) is often
based on the historic use and treatment (therapy) of the product. When
making a clarification decision, the MDB interacts with other agencies
and information is often exchanged but the decision is taken within
the Directorate/Branch. This is becoming more of a challenge as medical
devices and drugs become more complex.
5. Pharmaceuticals Management/Product Licensing - (Karen
Reynolds & George Samiotis)
The presentation put into context this new initiative and how it relates
to Product Licensing. This initiative stems from the First Ministers'
Action Plan for Health Renewal which holds Pharmaceuticals Management
as one of its highest priorities. The plan identifies four key areas
for collaborative work:
1. strengthening the surveillance of the therapeutic effect of drugs
that are approved for sale in Canada;
2. developing strategies for assessing the cost-effectiveness of prescription
drugs;
3. creation of an intergovernmental advisory process to assess drugs
for inclusion in provincial drug plans; and,
4. examination of best practices for prescribing, dispensing and administering
drugs.
It was indicated that under Legislative Renewal we will
require new regulations that will reflect the Product Life Cycle when
the new Health Act is approved. The TPD is trying to link the Pharmaceutical
Management Initiative and Product Licensing to take advantage of the
opportunity for funding. This will lead to more resources for policy
development, drug review, post-market surveillance, etc.
In response to the request from the TPD for the ACM to
provide input to this initiative, it was suggested that the Provincial
level is the real site of action and that the best way to move ahead
with this initiative would be by bringing in the academic centres: the
9 pharmacy schools, 16 medical schools and others. The academic centres
would focus on the issues, not the politics.
A gap with respect to capacity-building was identified,
e.g. as in the areas of Drug Safety, Pharmacoeconomics, etc. An HR plan
is required and it was suggested to look to the Canadian Institute of
Health Research (CIHR). It was also suggested to specify what type of
drug products would come under this scrutiny - High risk human prescription,
high cost human prescription, etc.
ACTION: Dr. Peterson - Commitment - 6 weeks from
now:
Follow up with the next significant document for comment by the ACM.
Following this, a teleconference may be organized.
ACTION: ACM
There was a suggestion that ACM meet with Roy Romanow (Romanow Commission
on the Future of Health Care in Canada) to provide input to the Commission.
The data gathering phase is until the 22nd of November 2001 and the
report is due November 2002.
The impact of new technologies on the health care system should be pointed
out. It was suggested that the ACM make a recommendation to establish
a Centre of Excellence for studying the impact of new technologies on
the health care system. The ACM send in a letter of intent indicating
willingness/intention to make a submission to Mr. Romanow. Romanow Commission
Terms of reference were provided by Andrea Baumann. See the website:
http://www.healthcarecommission.ca/
ACTION: NEXT WEEK Jim Blackburn will
send out an e-mail to the ACM members requesting key points to cover
in the letter and submission.
6. Product Monograph - (Ross Duncan)
An update on the Product Monograph (PM) project was provided. The four
broad principles of this project were presented: Public Access; Use
of the PM; Quality Information; and Shared Responsibility and progress
to date was discussed.
The ACM members generally agree that the consumers'
needs must be met and that this will take many forms with written information
as well as electronic. It was suggested that there could be a partnership
with existing sources which deal with patient information.
There are many reliable health websites and these should be examined
and could be used as references. The expectations from this project
are a functional database and a determination of the source(s) of funding
to support it.
The maintenance of Product Monographs was identified
as an issue, not just in terms of updating the PM but also the inclusion
of new indications and the recurring issue of off-label use of the drug.
There is a concern with the limitations of the PM for
clinicians. Currently the PM cannot include off-label use indications.
A suggestion to partner with clinicians to ensure that patients are
provided with appropriate information was encouraged. There is a view
that routinely providing patients with the entire PM could be too much
with the availability to interest patients.
A number of challenges were noted and discussed:
1. Ownership: The view was expressed that patient information should
come from the regulator who would ensure that the content is impartial.
2. Source of funding: The PM provides a value to the
health care system and an additional safety step for patient to know
of ADRs, contraindications, etc. therefore, there should be support
for government funding however, partnerships could be sought. The PM
has been the basis of the Compendium of Pharmaceutical Specialties as
well as the information put out by pharmacies.
3. Dissemination of the PM and costs involved: Electronic
submissions will make things easier. The PM is available through Access
to Information (ATI) but there is a high cost (both human and financial
resources) to the TPD associated with this route of access. Ownership
of the document is crucial for transparency and for distribution of
the information. There was a question about whether or not it could
be made mandatory to have the PM provided by the pharmacist.
4. Roll-out: Simple: pull up info from DPD (Drug Product
Database)
Complex: many sources of information
5. Conversion of old format to new format: The primary
objective is to develop a standard template for the PM. This is an ambitious
goal and it may be too ambitious to consider having manufacturers convert
old PMs because it would cause difficulties to pull resources from existing
activities. Therefore it may be best to develop the standard template
and to start from now on.
Process: It was suggested that broad consultation be part of the objective.
For the initial part of this process focus groups are being provided
with a sample PM and then asked what kind of information they would
want.
The focus group consultations indicate agreement on the type of content.
A standard format is being developed to ensure that it is a useable
product. The draft guidance document will be ready by the end of November
2001 and it will be available for comment.
Summary of the ACM Discussion and Recommendations - Ross Duncan
Partnerships with disease-oriented groups will be explored.
Functionality of the database will be ensured.
Clarity of the intent of this project will be explained
Government will pay for the PM although industry may be willing to pay
something.
ACTION: Ross Duncan will provide prototypes.
7. Tabled Reports - Preparation for agenda item
Summary reports were provided in advance on Cisapride Inquest Recommendations
/ Action Plan, Cost Recovery, Performance Measurement Framework, the
Quarterly Performance, HR Initiative, TPD All Staff Update. Time was
allocated to review the tabled reports to determine which managers should
be present for this agenda item scheduled for tomorrow. A request was
made for someone to come from the BGTD to address the reorganization.
However, there were no requests for managers for the specific tabled
reports.
Additional item: request was made to include discussion of the activities
of a group called 'Women in Health Protection' specifically
regarding illegal Direct-to-Consumer Advertising. It was pointed out
that this is where many consumer issues are raised.
8. Recap of Day 1
Reception for Robert Goyer was well-received. Congratulations to the
organizers.
9. Joint Health Canada/Canadian Institutes of Health Research
(CIHR) Initiative (Placebos in Clinical Trials) (Pat Huston
& Siddika Mithani)
Pat Huston presented this topic. Regulatory policy differs from research
ethics policy with respect to appropriate use of placebos in clinical
trials.
The goal of this initiative is to develop a unified placebo policy for
Canada that may inform future revisions to Canada's Tri-Council Policy
Statement as well as constitute the basis of a Canadian addendum to
the International Conference on Harmonization (ICH) guidance document
ICH E-10. To do this, representatives from the major stakeholders would
form a Working Committee to examine the facts, conduct public consultations,
complete an ethical analysis, and develop recommendations for a unified
placebo policy that would be presented at a Stakeholder's Workshop.
This project should take about 18 months to complete, once funding is
confirmed. The ACM was asked for comments on the proposed process for
dealing with this issue and for suggestions for appropriate candidates
for the Working Committee.
ACM Discussion with Clarifications from the TPD:
Placebos do have a place in assessing new treatments for conditions
that are not life-threatening. Criteria are needed to determine when
the use of placebos is appropriate: e.g. scientifically essential for
methodological reasons, ethically acceptable. The nature of the research
question must be determined; e.g. Gingko biloba vs Ritalin to treat
ADD.
It is worthwhile to review the outcomes of the 1998 meeting
for ICH E-10. The central issue there was on psychiatric studies.
If there is no distinction between the trivial risk vs
the important risk there may be a need to ask "who is the beneficiary?"
at the outset...is it the individual patient or the patient population/society
as a whole. One must consider - 'is it an individual patient'
or 'an individual patient in a clinical trial'. The goal
is to minimize the risk in the active and control groups. Alternative
trial designs may expose more patients to unproven treatments. There
is no ideal alternative to a placebo. If a non-inferiority trial is
used, the objective is to show no significant difference, which may
"lower the bar" for the approval of new drugs. If an active
control superiority trial is used, this could "raise the bar"
for the approval of new drugs which may limit the number of drugs that
have access to the market; such a policy may not pass the test of fairness
to the marketplace.
Related issues, such as rescue therapy and early exit
rules should be considered in the guiding principles.
Formation of the Committee: The public needs to have confidence in the
method to appoint the committee members. It is hoped that 8-12 members
would be adequate. It was suggested to develop criteria for membership
and put out the call to an adequate number of stakeholder groups for
nominees. A number of vulnerable patient groups: psychiatric, Alzheimer,
frail elderly, mentally handicapped, children, etc. could be considered.
A broad perspective should be considered including those who could be
pro or con (polarized). The definitions of terms must be made clear
as well as alternatives and how to consider them. Simulated trials,
in vitro studies, computer models, etc. should all be considered in
an effort to minimize placebo use.
It was proposed that a 2-day seminar or pre-workshop
be organized to ask for interested parties and would include the key
issues to set the agenda. The working group may be selected from this
workshop. There could be nominees for a core group and a reserve list
(working sub-group) which would be advisory members to the board.
Strong investigators on both the drug and vaccine sides
are needed because they may have different perspectives. It is difficult
to attract clinical trials to Canada because the infrastructure is insufficient.
This may worsen if studies conducted in Canada are not acceptable to
other regulatory bodies (e.g. a comparative study may be required in
Canada, but only a placebo study would be acceptable to the FDA). We
need to determine how we want to manage studies in Canada if they are
to be acceptable. This will promote the R&D structure in Canada.
For immunological and serological markers smaller populations will be
used in the studies. How acceptable will that be?
Suggestion of names: David Scheffield (Halifax - Dalhousie University)
and
Dr. Salim Yusuf, Professor of Medicine, Clinical Epidemiology &
Biostatistics and Director of Cardiology and the Population Health Research
Institute at McMaster University. Also mentioned was the Fogerty Institute.
Dr. Peterson invited anyone from the ACM to become
corresponding members of this issue.
Source of adequate funding is not known yet however, a precedent was
set by funding the Xenotransplantation consultations, etc. and although
the xeno issue affects only a small population, it has far reaching
consequences.
10. Drug Investigation and Children (Stuart MacLeod)
As background for this topic, there was a brief review of the case of
off-label use of the drug, Cisapride, which may have contributed to
the death of a 15-year-old girl. The FDA Modernization Act (FDAMA) includes
a section called the Paediatric Rule. This requires studies in children,
even for old drugs. Once approved for use in children, the FDA provides
the manufacturer with an additional 6-month exclusivity on the market.
The CIHR is encouraging the development of expertise in paediatric research.
The champion is the Canadian Paediatric Society with support from the
CIHR.
FDAMA is examining this issue and is proposing the Best Pharmaceuticals
for Children Act.
The TPD has assigned Dr. Margaret Stockwell to review
products approved to see if there are any paediatric indications and
to examine consistency in labelling.
The Patented Medicines Prices Review Board may be the
most appropriate body to look at incentives for paediatric studies.
The Canadian Regulator needs to develop a policy on this.
The options are:
- to continue to 'look the other way'
- to include contraindication (this is regressive but does address RISK)
- to actively develop policy to require studies for paediatric indications
The challenge is to determine the most meaningful incentive.
PMPRB could consider pricing incentives. TPD may consider fast tracking
the approval process. Other incentives could include scientific tax
credits.
Concern was expressed that the same argument can be made
for geriatric and other vulnerable populations. The key word is 'vulnerable'.
The TPD does have a guidance document. There is also
a project on the CPS and on Orphan therapeutics. Regarding ADR monitoring
in children, Bruce Carleton (UBC) has met with Vicky Hogan (BLPA) about
a project. He has received funding from the Bill Gates Foundation.
There was support expressed for writing a letter to the
Minister of Health.
ACTION: Stuart MacLeod to send e-mail
to members to get ideas. Vaccine side does have paediatric trials. There
is a lot to learn from that.
Jim Blackburn and Stuart MacLeod will
draft a letter.
11. Maximizing and Extending the Use of Advisory
Bodies (Brian Foster, David Clapin)
Brian Foster provided a short presentation outlining the 7 inputs and
10 outputs in the regulatory system decision-making process specifically
related to the Management of Drug Submissions Policy. The intention
is to use formal expert committees for advice prior to the issuance
of regulatory decisions such as Notice of Noncompliance (NON) or Notice
of Compliance (NOC). Several questions were put out for discussion by
the ACM: What are the priority areas for NON review? Should every NON
be reviewed?
At what stage would the review be most beneficial? Is a 15-person core
body large enough? Should industry expert representatives be part of
the process? Should there be honoraria?
The TPD would like to decrease the number of Appeals by virtue of using
this process. It would improve timeliness, due process and would provide
and opportunity for both sides to air their positions in view of the
experts.
ACM Discussion:
There was a question about whether or not honoraria could be paid if
the issue is sent out to members and there is no face-to-face meeting.
Currently, teleconferences are used and the information to be discussed
is sent out in advance.
There was a concern about security in the e-mail system.
Regarding Transparency: The minutes of these meetings are posted after
being screened by the Proprietary & Scientific Information Assessment
(Access to Information) division.
Regarding the divulging of proprietary information: By advertizing for
interested stakeholders to review why a NON was provided, this indicates
a submission for a specific product has been made.
The FDA Review Committees (open to Public) review i)
Drug substance specific ii) specific to general area in therapy; something
that can be used to develop policy, for example to set standards for
approvability or nonapprovability. This second aspect - general area
in therapy - would add a new dimension and may decrease the number of
NONs or clarifaxes.
Medical Devices Canada (MEDEC) comments on the establishment
of a cardiovascular EAC include: how to ensure timeliness when there
is a 90-day target; and concerning confidentiality and Conflict of Interest.
Should the clock stop? The best we can do now is to include the information
in the manufacturer's hands in our performance reporting.
Question regarding composition of an EAB - The FDA's
EABs are heavily weighted with clinicians who want new products. The
TPD would want other experts as well. However, this should not be a
delaying tactic. There will be an evaluation set up to track this.
Transparency & Time and Conflict of Interest: The
appearance of COI is difficult to resolve. One cannot operate behind
closed doors. The EAB could be made optional before a NON is completed
but the manufacturer would be advised that some disclosure would be
necessary.
There was general agreement on the following:
- no Bureau representatives on the panel
- no Industry reps on the panel
- honoraria should be paid or we may not be able to attract anyone
What would trigger a NON and use of this Panel?
- if clinical data do not adequately support the indication
- if safety issue
- biologics - assembled with devices
Suggestion for topic for EAB - Should biopsies be required
for 1 year following treatment with anti-cancer drugs.
What about NOC/C vs. Priority Review? It was explained
that an NOC/C is usually granted when reviewers don't have sufficient
confidence in the data set - but drug is promising. Priority Review
is for new chemical entities, New Drug Submissions.
The chair asked if the ACM members endorse this process.
They responded affirmatively. There was an invitation for anyone on
the ACM to act as liaison to develop this further. No response at that
time.
12. Advisory Committee on Management Objectives
(Jim
Blackburn/Robert Peterson)
Background information was provided and there was a brief overview of
the establishment of the Committee. The advice provided by the members
is valuable - e.g. for Clinical Trials. Natural Health Products Directorate
could be invited for specific issues. The Branch needs to determine
if the ACM should continue without BGTD and the Inspectorate as formal
members. Dr. Peterson has suggested that each Directorate form its own
ACM. The ACM members are here to represent the best interests of Canadians.
Can the expectations of the original ACM still be met?
Dr. Peterson indicated that we will do further work on the mandate and
invite Diane Gorman, ADM, to revisit this issue. He will continue to
drive this issue at the Branch.
There was a comment that it would be costly for each Directorate to
have its own ACM.
Another comment was that separate distinct units need separate advice.
Each Committee should identify Branch-wide concerns. The ADM could convene
semi-annual meetings with all the Chairs. This comment was endorsed
and it was suggested to expand the idea to a one-pager outlining what
has taken place in the past, what could be the future role (i.e. more
action-oriented committee).
Another comment was that the primary role is to advise the Director
General and other TPD Senior Management. Then if it goes beyond - it
may require additional action.
The Chair commended the staff for organizing this issue and meeting
to be discussed. Evaluation of the ACM status in December is
appropriate. No further action by the ACM at this time.
13. Workplace Health (Robert Peterson/Pauline
Gaudy)
The intent of this agenda item was for the ACM members to learn about
and provide their opinion on how the TPD is proceeding with the Workplace
Health Initiative in follow-up to the TPD All Staff Meeting held in
June. Pauline Gaudy provided a brief presentation.
ACM Discussion:
Elaboration of the progress made so far was requested. Dr. Peterson
explained that accommodations and space are priorities. The Division
of Pharmaceutical Quality was relocated downtown due to lack of space
at Tunney's Pasture. This problem is Branch and Departmental priority.
The personal approach is being used to alleviate disruption but the
effect of the move will be evaluated to find out how well it was handled
and identify any problems encountered. There will be follow-up and communication
of the results.
Awards: Suggestion by staff at the TPD All Staff Meeting
to create the TPD Awards Suggestion Box. Criteria for the TPD Awards
will be developed by the TPD Morale & Recognition Committee.
There was a positive response to the Action Plan and it is hoped that
there will be follow-up. A question was raised concerning a job satisfaction
survey so that improvement can be measured in the future. The recent
Departmental Survey was mentioned. Ginette Workman is coordinating the
Workplace Health Initiative at the Branch level. Communication is important.
Progress on this initiative will be reported to staff.
Tabled Reports:
The members requested to see any significant progress on the tabled
reports.
1. Cisapride: Some recommendations may be difficult to
accomplish without additional resources.
2. Performance Reports: BPA performance has some improvement. BGTD performance
has gone down somewhat.
3. Performance Measurement: good process
4. Human Resources Initiative: Medical Officer interviews on-going
5. Cost Recovery: Has Phase IV Report been finalized? The cost recovery
steering committee is now looking to see what we can do internally re:
fees, etc. and determining next steps. The CR Steering Committee - also
includes Food, NHP and Veterinary Drugs Representatives. There is a
need to determine how to tie in performance targets with Cost Recovery.
Phase IV for medical devices has just started. The Request for Proposal
is out and the contract is anticipated to be awarded in September. Question:
Is there an accepted ratio that is ideal, e.g. 50:50? Treasury Board
has been asked for guidance because currently the TPD, BGTD and Inspectorate
all have different ratios.
14. Meeting Evaluation:
It was remarked that the TPD listened to the comments from the last
meeting. This one was much better because the topics selected were ones
to which the members felt they could be of value.
The reception for Robert Goyer provided an opportunity to meet other
TPD staff. One of the members mentioned that he spoke with several people
and volunteered to work on some things with them.
It was suggested that the ACM may be interested in a tour of different
places with the idea of moving people around within the Directorate.
It would provide a good view of various staff and their work environments.
Committee members encourage TPD to consider utilizing their specific
interests and expertise in ways that may assist the TPD management in
specific situations.
The BPA reorganization: the 3 models do not provide a clear picture.
It would be better to get the models ahead of time.
External Advisory Bodies: too much detail but it became clearer with
an elucidation by Dr. Peterson.
BGTD: Some members wanted an explanation of the organization chart and
to discuss other issues, as well. The Chair will follow up with Julia
Hill, the Associate Director General, BGTD. Luis Barreto will discuss
with her and the ADM the idea of establishing an ACM for the BGTD. However
there should also still be some common ground with the TPD issues. There
was a suggestion to have other ACMs meet on the same date so that a
half-day could be organized to discuss common issues. It may be better
to have the Chairs meet. Another option could be to have a single committee
with spin-offs.
ACM in camera discussion
Meeting adjourned - 3:00 p.m.
15. Next meeting: December 5-6, 2001
(10:00 am start on December 5th)
TPD Boardroom, Room 2048, Holland Cross, Tower B
1600 Scott Street
Original signed by
Jim Blackburn
Chairperson
