Request for Letters of Intent (LOI) for Synthesis Research RFLOI 019: Regulation in a Changing World
Funding and General Information
- Deadline for Letters of Intent: March 1, 2004.
- Up to $1.5 million has been set aside in this competition.
Maximum funds per project: $200,000.
- Funding is expected to begin in Fall, 2004. Projects must be
completed and final reports submitted within 12 - 18 months.
- Synthesis is the identification, review, collective analysis
and appraisal of the best available existing knowledge.
- In this competition, projects must:
- include published research and non-research literature,
internet and additional "grey" (unpublished)
literature, the practical experience of policy/decision
makers and the knowledge of experts in the field;
- include international knowledge sources and are not restricted
to English and French language resources if appropriate.
Objective
The objective of this synthesis research is to provide
evidence on policy options for health legislation in the theme
areas of:
- General safety requirement (GSR);
- Risk-based regulatory framework;
- Instrument Choice: Compliance and Public Health Outcomes;
and
- Regulatory framework for novel tobacco products and smoking
cessation products.
Background
The health sector in Canada makes considerable use of regulation
to achieve its objective of protecting the health of Canadians.
However, Health Canada's regulatory framework faces a number of
challenges, including:
- keeping pace with rapid changes in science and technology
including the development of new health products, and diminishing
distinction among products;
- recognizing the role of increased flow of information and
informed individuals; and
- adapting to global approaches to social and economic issues.
In order to meet these challenges and continue to protect the
health and safety of Canadians, synthesis research in these areas
is needed to guide the development of regulations that will meet
and continue to serve the interests of the public. Health Canada
regularly reviews its current regulations and adopts new ones and,
in doing so, the Department relies on the most current synthesis
of information and approaches to health regulatory issues.
As one example, Health Canada is conducting a comprehensive review
of its health protection legislation, and has released a detailed
proposal for a new health protection regime (Health Canada, 2003).
The proposed Canada Health Protection Act (CHPA)
is intended to better meet and keep pace with changes in society,
including new and emerging health risks, changing public expectations
and attitudes, and changes in the regulatory policy environments.
Description and Research Questions for Theme
Areas A - C
A. General Safety Requirement
One of the elements proposed for new health protection legislation
is the concept of General Safety Requirement (GSR)
(Health Canada, 2003). A GSR is
a bundle of legal obligations imposed on the maker of a product
and other participants in the chain of supply, making it illegal
to manufacture, promote or market a product that could present
an undue risk to health during its foreseeable use or its disposal.
It would apply to virtually all consumer products, including health
related products. In order to keep the marketplace safe, a GSR would
allow Health Canada to take preventive action before death or injury
occurs, instead of relying primarily on the victims of harm to
take civil action after an injury has occurred.
A GSR would
eliminate the current need to try to apply standards of one regulatory
category to other products in the absence of specific safety standards.
Under a GSR,
Health Canada would be able to act against an unsafe product as
soon as evidence demonstrates that the product could present an
undue risk to people. Once the risk is discovered, Health Canada
could use the full enforcement powers of the Act. Those powers
include prosecution, seizing the product, ordering a halt to its
manufacture or sale or requiring appropriate corrective action
like recalling the product, sending a warning or providing a protective
part. Under the Act, it would be an offense to fail to carry out
any of the legal obligations that make up the GSR.
The implementation of GSR in
Canada would aid in the harmonization of our activities globally.
Internationally, various models of a GSR are
currently in use in some countries (U.K. since 1987; U.S. has long
imposed an after-the-fact GSR through
its Tort Law). Additionally, GSR is
one of the elements of the new and revised European Union General
Product Safety Directive (GPSD)
(European Parliament and Council of the European Union, 2002) that
will be implemented into the national law of the EU member states
by January 15, 2004. The experiences of these jurisdictions would
be valuable in guiding the development of options for effective
implementation, including instrument choices and best practices
for implementing a GSR.
B. Risk-based Regulatory Framework
Under the current regime, most products are readily identifiable
as foods, natural health products, drugs, cosmetics, medical devices,
biologics, veterinary drugs, etc. Each is clearly subject to the
appropriate regulatory regime based on the definitions set out
in the Food and Drugs Act and Regulations administered
by Health Canada. Increasingly, however, new products are coming
forward which do not readily fit within the existing definitions,
due to their form or function, or new proposed uses, and thereby
challenge the regulatory capability of the Food & Drugs
Act and Regulations. Examples include a medicated wound
dressing, a bone cement containing an antibiotic, or a toothpaste
containing fluoride.
A risk-based approach to product regulation would mean the level
of regulatory control exercised over a given product would be proportional
to the risk posed by that product, rather than the statutory or
regulatory definition that the product may fall under. Under such
a framework, mechanisms would need to be developed to determine
the categorization of products according to their class of risk.
The proposals for a new CHPA include
sufficiently broad authority to move to a regulatory framework
based on risk rather than product definition.
C. Instrument Choice: Compliance and Public Health Outcomes
For decades now governments have been developing laws and regulations
that exert a degree of control over citizens' access to an array
of products that have possible health risks, including pesticides,
human and veterinary drugs, medical devices, natural health products
and biological and related biotechnology products.
As governments, both in Canada and elsewhere, face the issue of
'modernizing' current regulatory frameworks, they are increasingly
considering the issue of instrument choice: that is whether the
traditional regulatory instrument is appropriate. Instruments can
be seen as lying along a continuum, based upon the level of state
coercion exercised. The voluntary end of the spectrum tries to
develop cooperative relationships between regulators and
the regulated, with governments using information and exhortation
as policy tools, possibly accompanied by monitoring. The objective
is to engender a compliance culture. The opposing end of the spectrum
encompasses regulations, a more ardent application of state coercion.
In order to effectively ensure adherence to regulatory approaches,
governments must have applicable monitoring, compliance and enforcement
mechanisms.
The challenge for Health Canada lies in choosing an appropriate
instrument, or combination of instruments, along this continuum.
In one sense the objective is to maximize compliance with pertinent
legislation and regulations. In a broader sense, the objective
is a health outcome: maintaining and enhancing public health and
safety. The traditional enforcement/compliance activity has been
largely focussed on the former, although with health always the
ultimate objective. Yet, more explicit integration of public health
outcomes could yield more cost-effective approaches to the same
ends. That is, based on appropriate risk management principles
and best science, an outcomes-oriented compliance and enforcement
strategy could still maximize safety and quality and ensure the
availability of products, while also reducing administrative burden
on both providers and government. A broader health outcomes metric
can also help refocus assessment of how Health Canada is performing
its own responsibilities. Governments are increasingly coming to
recognize that compliance is best facilitated when legislative
and regulatory requirements are clearly identified and understood
in public health terms by all stakeholders. Incorporating outcomes
in monitoring and compliance activities can also support that enhanced
transparency.
Research Questions
These questions pertain to theme areas A - C above. Applicants
must focus on one of the three theme areas and may answer any
one or a combination of the following research questions. Please
include a comparison of at least two jurisdictions and/or other
countries (not including Canada), with preference given to the
U.S., the EU or other OECD countries.
- How have other jurisdictions structured their regulatory frameworks,
tools and mechanisms? What considerations were taken into account
in selecting and developing these strategies/approaches? If there
is harmonization in selecting and developing these strategies/approaches
among these countries, how was it achieved? What lessons can
Health Canada learn?
- How have other jurisdictions implemented regulatory strategies/approaches?
If there is harmonization in the implementation strategies/approaches
among these countries, how was it achieved? What lessons can
Health Canada learn?
- What are the impacts of the implementation on other industries
and the public? How have other jurisdictions assessed the effectiveness
of their activities, particularly in contributing to public health
outcomes? If there is harmonization in the evaluation approaches
taken by these countries, how was it achieved?
Description and Research Questions for Theme
Area D
D. Regulatory framework for novel tobacco products and smoking
cessation products
In recent years, foreign markets have seen the introduction of
novel tobacco products whose purported intent is to reduce harm
to the users. It is foreseen that they will enter the Canadian
market in the coming years. Smoking cessation products have already
been introduced in Canada. For instance, transdermal nicotine patches
and other smoking cessation products deliver nicotine more slowly,
with no (or fewer) collateral toxic chemicals.
There has been much discussion of the need for a "level playing
field" for nicotine products. Pharmaceuticals must go through
an extensive review of safety and effectiveness before being allowed
on the Canadian market, while tobacco products do not. The application
of more consistent standards of regulation and oversight across
all nicotine products, such that less toxic nicotine-delivering
products (for example, nicotine gum and patches) would be more
easily accessible than more addictive and toxic products such as
cigarettes and cigars, has been suggested by health advocates,
who also point out that the science involved in their evaluation
is the same.
Health Canada is interested in examining evidence to inform policy
options for the establishment of a new regulatory framework to
control these products.
Research Questions
These questions pertain to theme area D above.
- What scientific and policy evidence must be considered in
developing a suitable nicotine regulatory framework?
- What options are available to establish an effective regulatory
framework for the assessment and control of novel tobacco products
and smoking cessation products?
- What challenges are the EU, other jurisdictions and/or other
countries facing in evaluating smoking cessation products and/or
novel tobacco products under their respective regulatory regimes?
What is the potential or real impact of these challenges on tobacco-related
population health objectives?
Requirements
1) Policy Contacts
Applicants must get in touch with the policy contact at least
once during the development of the letter of intent. The policy
contact is responsible for ongoing interaction with researchers
on the policy issues and context.
A. General safety requirement
Inquiries should be directed to Rachelle Yazdani, Senior Legislative
Affairs and Policy Advisor, Policy and Programme Services, Product
Safety Programme, Healthy Environments and Consumer Safety Branch,
Health Canada (tel.: (613) 952-9241, email: rachelle_yazdani@hc-sc.gc.ca).
B. Risk-based regulatory framework
Inquiries should be directed to Robert Asare-Danso, A/Director,
Office of International and Regulatory Affairs, Health Products
and Food Branch, Health Canada (tel.: (613) 941-9379, email: robert_asare-danso@hc-sc.gc.ca).
C. Instrument Choice: Compliance and Public Health Outcomes
Inquiries should be directed to Kim Dayman-Rutkus, A/Manager,
Policy and Regulations Division, Health Products and Food Branch,
Health Canada (tel: (613) 954-6785, email: kim_dayman-rutkus@hc-sc.gc.ca)
D. Regulatory framework for novel tobacco products and cessation
products
Inquiries should be directed to Denis Choinière, Director,
Office of Regulations and Compliance, Tobacco Control Programme,
Healthy Environments and Consumer Safety Branch, Health Canada
(tel.: (613) 941-1560,
email: denis_choiniere@hc-sc.gc.ca).
2) How to Apply
Applicants are required to register in order to obtain the Letter
of Intent form. Letters of Intent must be submitted by fax to (613)
954-7363 before 2:00 pm (E.S.T) on February 9, 2004. Only researchers
with Letters of Intent found to be eligible and relevant to the
identified policy research priority will then be invited to submit
a full proposal.
Applicants must consult the HPRP Guide
to Research Project Funding before registering.
Inquiries regarding registration, eligibility/ineligibility, administrative
questions about timeframes and budgets, application formatting
and content, the review process, and terms and conditions of the HPRP should
be directed to Gail McQuaid-Bohémier (tel: (613) 946-3163
;
e-mail: gail_mcquaid-bohemier@hc-sc.gc.ca).
References
European Parliament and Council of the European Union. (2002).
Directive 2001/95/EC of the European Parliament and of the Council
of 3 December 2001 on General Product Safety. Official Journal
of the European Communities. Retrieved November 26, 2003, from
http://europa.eu.int/eur-lex/pri/en/oj/dat/2002/l_011/l_01120020115en00040017.pdf
Food and Drugs Act, R.S. 1985, c. F-27. (Online). Retrieved November
26, 2003, from http://laws.justice.gc.ca/en/F-27/text.html
Food and Drug Regulations, F-27 -- C.R.C., 2003, c. 870. (Online).
Retrieved November 26, 2003, from http://laws.justice.gc.ca/en/F-27/C.R.C.-c.870/text.html
Governor General of Canada. (2002). The Canada we want: Speech
from the Throne to open the second session of the thirty-seventh
Parliament of Canada - September 30, 2002. Retrieved November
26, 2003, from http://www.pco-bcp.gc.ca/sft-ddt/hnav/hnav07_e.htm
Health Canada. (2003). Health and Safety First! A Proposal
to Renew Federal Health Protection Legislation. Retrieved
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