Health Products and Food Branch (HPFB) Public Advisory Committee (PAC)
May 28-29, 2004
"Enabling Innovation for Better Health Outcomes"
Hilton Bonaventure Hotel, Montreal, Quebec
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Attendance
PAC Members: Adam Andruschak, Dominic Bergeron (Vice
Chair), Nadine Blum, Wayne Busch (Chair), Thomas Connor, Jocelyn Côté,
Neil Faulkner, Robert Girard, Robert Grose, Don Holloway, Lena Hozaima,
Daniel Lazaric, Tina Martin, Nancy McColl, Sandra Wood.
Office of Consumer and Public Involvement (OCAPI): Roger
Farley (Director General), Sylvie Cantin (Director, Public Involvement
and Outreach), Sameena Khan (Program Officer), Shari Silber (Senior Public
Involvement Officer), Julie Bernier (Quebec Regional Public Involvement
Officer).
Facilitator: One World Inc. - Jacquie Dale.
Guests:
HPFB Food Directorate: Luc Bourbonnière (Scientific
Evaluator, Novel Foods Section), Mireille Prud'homme (Acting Director,
Bureau of Food Policy Integration), Nora Lee (Acting Section Head, Novel
Foods Section), Theresa Paolasini (Regulatory Policy Officer, Bureau of
Food Policy Integration), Johanna Jennings (Scientific Evaluator, Novel
Foods Section), Marie-Josée Bolduc (Regional Liaison Officer, Quebec Region).
HPFB Office of Biotechnology and Science: Dr. Pierre
Charest (Director General), Ryan Hum (Science Policy Analyst), Dr. Irene
Hay (Biotechnology Policy Analyst).
Quebec Region: Lucie Myre (Quebec Regional Director
General, Health Canada), Jean Lambert (Director General, Inspectorate,
HPFB).
Minutes of the Proceedings
The Public Advisory Committee provided advice on Somatic Cell Nuclear
Transfer (SCNT) cloning and its use in food producing livestock animals.
SCNT is the form of cloning used to produce "Dolly" the sheep.
The members provided advice on what should be Health Canada's key considerations
in regulating this technology. In addition, the PAC provided concrete
examples on how the Food Directorate should move forward with public awareness
activities for this issue.
1. Issues regarding SCNT Cloning of Food Production Livestock
As part of this consultation, the Public Advisory Committee was asked
to identify concerns that PAC and other Canadians may have regarding SCNT
cloning of food production livestock.
The PAC indicated that health and safety of both animals and humans
are paramount. PAC highlighted the importance of Health Canada to regulate
in this area and to monitor developments on this issue. The members noted
that there are many different interpretations of the meaning of "safe"
in the public domain.
Ethical considerations were frequently voiced by the members. In addition,
PAC indicated that there needs to be consideration and analysis of consequences
that may occur (e.g. potential increased costs to consumers if added costs
assumed by industries are passed onto consumers).
PAC members wanted assurance that diversity in the food supply would
be protected and that consumers would be able to make informed product
choices.
2. Considerations in Regulating Food Derived from SCNT Cloned Animals
and their Offspring.
The PAC members re-iterated the importance of Health Canada maintaining
its key role in regulating and monitoring food derived from SCNT cloned
animals and their offspring, in the event these products are allowed on
Canadian market shelves.
The PAC also advised that ethical aspects be considered in the regulatory
process.
Other considerations include the impact on diversity of the food supply
and the need to monitor the impact of unintended consequences.
It was suggested that Canada take a lead role in the international regulatory
community and consider international research activities in this area
when further developing the Canadian position on this issue.
To enable consumers to make informed choices, the PAC members recommended
the Branch take into account the education and scientific literacy of
the public when communicating on regulations and safety.
3. Public Awareness and Communication Messages to the Public at this
Stage
The PAC felt that the principles of openness and transparency should
be inherent in communications messages to the public.
Members suggested that balanced information should be provided to the
public as early as possible. The concept that "knowledge is not dangerous"
was mentioned.
Communications messages from Health Canada should not indicate a promotion
of cloning or its technologies, but rather include information about:
what is known about the technologies and their impacts, what is unknown
and that Health Canada is working on the issues. The public should also
be informed about the differences between types of technologies, such
as between genetic modification and cloning.
The PAC advised that since health and safety are paramount, communications
messages should focus on Health Canada's role to protect the health of
Canadians.
It was suggested that television be used as the medium to communicate
messages to the public.
4. Tour of the Food and Drug Laboratories in Longueuil, Quebec
The Public Advisory Committee visited Health Canada's headquarters in
Longueuil, Quebec. Lucie Myre, Health Canada's Regional Director General
for Quebec, delivered a presentation to the PAC on the role of Health
Canada in Quebec. Jean Lambert, Director General of the HPFB Inspectorate
of Health Canada, also presented an overview of the roles and responsibilities
of the Inspectorate.
The Inspectorate manages the licensing processes for regulated establishments
and the industry inspection, product investigation and enforcement activities
related to the manufacturing, importation and sale of marketed health
products in Canada. To support these activities, the Inspectorate operates
the Pharmaceutical Microbiology and Chemistry Labs that the PAC members
toured. The PAC members also toured the Food Microbiology and Chemistry
Labs (Food Directorate) and the Drug Analysis Service Lab (HECS). The
PAC appreciated their first hand opportunity to view the work taking place
in all of these laboratories.
5. Plant Molecular Farming
The PAC identified their concerns regarding plant molecular farming (PMF).
PMF involves using genetically modified plants to produce substances that
the plants typically do not produce naturally, such as industrial compounds
or therapeutics. Members also provided advice on whether they thought
Health Canada's proposed regulatory approach is sufficient.
5.1 Benefits and Risks of Plant Molecular Farming
The Public Advisory Committee commented that plant molecular farming
is an innovative technology with medical and economic potential because
it can serve as a possible remedy to current production limitations in
bioreactor vats by yeast or mammalian cells. Other benefits cited by PAC
members include the introduction of new compounds for new cures, a revival
and diversification of the agricultural economy, broader availability
and advancement of therapeutic/pharmaceutical products that may possibly
reduce costs. However, the PAC stated that any savings in production costs
for pharmaceutical companies must be passed on to Canadian consumers.
The members raised concerns about the unknown effects and risks that
PMF may pose such as implications of cross-contamination of existing food
crops, impurities in drugs, risks of mutations, bioterrorism and potential
contamination of the food supply.
It was also highlighted that there may be a significant impact to the
farming industry in Canada as a shift away from food production to pharmaceutical
production by farmers may take place, with an added risk of increased
control over farming by patent-holders.
5.2 Plant Molecular Farming in Food Crops
The PAC was presented with the following argument: "There is a wealth
of biological and genetic information on food crops, which some people
argue makes food crops the best choice for molecular farming because so
much is known about how they interact with the environment". Based on
this statement, PAC members discussed whether PMF should be allowed in
food crops or not.
The PAC concluded that the preference is not to allow PMF in food crops,
but if PMF in food crops was allowed, there should be strict containment
according to international standards to prevent cross-contamination and
to demonstrate that the government is in control.
5.3 The Proposed Regulatory Approach
Members identified that the regulatory approach taken by Health Canada
must benefit all Canadians.
There is a need to identify who will be controlling production as well
as a need to review the patent process. The PAC suggested that Health
Canada should also hold some patents to ensure public benefit. They also
advised that Health Canada scientists and regulators try to steer corporate
developers toward other non-food crops whose genetics and growing habits
are also well-known, such as horticultural and row crops such as cotton
and flax.
PAC members voiced the importance of federal government departments to
work collaboratively to maximize the benefits while minimizing any risks
to Canadians.
6. Health Canada Framework for Biotechnology
The PAC was provided with an overview and examples of challenges facing
Health Canada and the federal government related to biotechnology. They
were presented with the draft Health Canada Framework for Biotechnology.
This document provides an operating framework for Health Canada in biotechnology
as it defines the Department's regulatory roles and responsibilities,
opportunities, challenges and priorities. Based on this information, the
PAC members gave advice on the Framework and its applicability at the
federal government level. The PAC also shared their views on the usefulness
of this document to a general public audience.
6.1 Balance between Ensuring Safety while making Promising Technologies
available to Canadians.
The members stated that in the Framework, overall, the balance is not
clear. The PAC provided advice on how Health Canada can move forward in
enhancing the balance in the current Framework. For example, they suggested
additional text to include: greater emphasis devoted to health and safety;
further details on ethical and social issues; and a clarification of the
purpose of the document stating clearly that it is a working document
designed for the federal government's internal use.
The PAC's key message was that health and safety are paramount and should
be prominent throughout the Framework. They felt that the basic pillars
are present, but noted that balance would need to change depending on
each issue. The members also asked that the Branch consider how resources
devoted to biotechnology would impact on the health system.
6.2 The Framework's Handling of Ethical, Social and Cultural Issues
The PAC members had varied opinions on how well the Framework handles
product safety issues that are not strictly science related. A key message
from the PAC was that the Framework requires more explicit details about
the mechanisms to be used that would involve ethical, social and cultural
considerations in decisions. They suggested, for example, the Branch could
consider an ethical and cultural advisory committee in addition to scientific
advisory committees.
There were varied opinions on whether or not scientific considerations
should precede ethical considerations, but overall, members felt that
ideally, scientific considerations should be considered at the same time
as ethical, social and cultural considerations as this could generate
better health outcomes.
6.3 The Required Guidance towards Regulating Biotechnology
Overall, the PAC commented that every technology has its own set of applicable
values and that there is a need for some general guidelines. In regards
to whether the Framework provides the right guidance, PAC members felt
that there are voids in the Framework about Health Canada's role in steering
the issues. They suggested the inclusion of a checklist or guidance criteria.
They also agreed that safety measures, outcomes and benefits should be
stated clearly. Members reiterated that while innovation is important,
safety should not be compromised.
The PAC suggested that guidance information related to implementation
of the Framework, such as regulations on biotechnology-derived products,
would be useful to include in the document.
Members also highlighted that there should be a means to identify the
necessity for a particular technology since there are many technologies
already available for use. The guidance should help identify a particular
technology that will prove to be most beneficial and most cost-effective.
6.4 Usefulness of the Health Canada Framework on Biotechnology to the
General Public in Understanding how Health Canada Manages Biotechnology
The PAC felt that the Framework is very broad and attempts to cover a
complexity of issues that relate to both the realms of biotechnological
applications in addition to research and development related to biotechnological
innovations.
The PAC had a wide range of views towards the usefulness of this document
to the public audience. In general, members agreed that this material
would not address the specific information that would be helpful. PAC
suggested that a summary of the document and greater information focusing
on concrete examples of what Health Canada (in particular Health Products
and Food Branch) does with respect to biotechnology (e.g. development
of regulations, evaluation of biotechnology-derived products) would be
beneficial.
7. PAC Membership Renewal
Members agreed on a proposed renewal process that was outlined at the
meeting.
Initial ideas for a recruitment process were also identified. Members
agreed that OCAPI should keep an ongoing list of potential members. Members
also agreed that there be a recruitment committee. Further details about
a recruitment process will be discussed at a future PAC meeting.
8. Tenure Announcement for PAC Chair and Vice Chair
Robert Grose placed a motion forward during an in-camera session for
PAC members.
It was proposed that Wayne Busch, PAC Chair, and that Dominic Bergeron,
PAC Vice Chair, retain their current positions for the remainder of their
first three year term, ending November 2005.
The proposed motion was seconded by Sandra Wood and accepted unanimously
by all PAC members present.
9. Regional Update
- In Western Canada, the Avian flu and BSE are still having considerable
economic and environmental impacts.
- In Eastern Canada, nurse practitioners, midwives and pharmacists are
now being allowed to prescribe certain medications. This has raised
concerns for other professional groups.
- Water quality and concerns about the de-listing of health services
were cited as key health issues in Ontario and in the Outaouais region.
- Members also identified the rapid expansion of biotechnology innovation
in Canada. Biotechnology firms in Canada seem to now be moving their
focus from research and development to the creation of products.
- There is a growing trend in the U.S.A. towards metabolic syndrome
(obesity associated with heart disease, stroke, diabetes, etc.). Prevalence
of obesity in Canada is high and if left uncontrolled, the impact of
metabolic syndrome could potentially have devastating health effects
in the future among Canadians.
- The health status of Aboriginal Peoples in Canada, measured by life
expectancy and several other health indicators such as infant mortality,
birth weight, suicide and injury and tuberculosis, is significantly
worse than the health status of the general Canadian population.
Action Items
- OCAPI and the involved Directorates will brief the Assistant Deputy
Minister and the Branch Executive Committee on the advice from PAC.
- The Chair will canvas members for items for the next agenda and will
share the suggestions with the OCAPI Secretariat.
- Feedback received by OCAPI from consultations attended by PAC members
will be distributed to the rest of the PAC prior to the next meeting.
- OCAPI will prepare a rationale for hosting some future PAC meetings
in a smaller community setting. OCAPI will review practices by other
committees.
- The Chair will continue to forward items of information to PAC members,
as he has been regularly, related to areas where the PAC has had an
impact.
- The Food Directorate will develop a short communication document for
the general public on the issue of animal livestock cloning for food
use. On behalf of the Food Directorate, OCAPI will submit the document
to the PAC for comments prior to the next PAC meeting (to be held October
1-2, 2004)
- The PAC members indicated they would appreciate some background information on the roles and responsibilities of Health Canada as compared to the Canadian Food Inspection Agency. OCAPI will prepare some background information and distribute this at the next meeting.
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