E-DRUG: Meeting on Drug Regulation in Canada
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Announcement:
Public Panel Discussion, Toronto, Canada on November 3, 1998.
DRUG REGULATION IN CANADA: HOW SAFE ARE OUR MEDICINES?
Topics to be discussed:
- How accountable is Canada's regulatory system?
- Should the public have better access to information on the safety and
effectiveness of new drugs?
- Is faster drug approval needed? Whose interests would it serve?
- How does Canada's regulatory system compare to the US and Europe?
Speakers:
Dr Sidney Wolfe, Director of the Public Citizen Health Research Group, in
the United States, which he co-founded with Ralph Nader.
Dr Mich�le Brill-Edwards, Founder of the Canadian Coalition for Public
Accountability and a Health Canada drug reviewer who resigned when her
concerns about the safety of a heart medication were disregarded.
Ms Ellen 't Hoen, co-ordinator of the International Society of Independent
Drug Bulletins (ISDB) and co-founder of DES Action the Netherlands.
Moderator: Judy Rebick, past president of the National Action Committee on
the Status of Women, and host of the Canadian Broadcasting Corporation
Newsworld's show "Straight from the hip."
Tuesday, November 3, 7:00 pm
Hart House, University of Toronto - 7 Hart House Circle
Free admission - everyone is welcome
For more information contact: desact@web.net
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This meeting will take place just as Health Canada completes a series of
public consultations about proposed changes to health protection, formally
launched as the "Health Protection Transition".
To quote a recent editorial in a national newspaper: "The first tough
question is: transition to where? A growing band of critics would suggest
that Health Canada has begun the transit to irrelevancy when it comes to
its current responsibilities to protect Canadians from bad food, bad drugs,
bad pesticides and other health hazards." [Windsor H. Globe & Mail, Wed
Sept 9, 1998]
Plans to "modernize" national health protection legislation follow
large-scale funding cuts to the regulatory agency, down from a budget $237
million in 1993-1994 to a projected $118 million in 1999- 2000. In-house
drug research laboratories, which were responsible for investigating drug
quality, toxicity, bioequivalence and clinical applications, have been
quietly closed.
Changes to the health protection legislation are being proposed in the wake
of an investigation into the distribution of contaminated blood in Canada
during the 1980s, resulting in thousands of people being infected with HIV
and hepatitis C. No one has been subject to criminal charges in the
national tainted blood scandal. However, under existing health protection
legislation, if the Minister of Health and Departmental managers failed to
fulfill their duty to protect the public from hazardous products and fraud,
they could be liable for criminal prosecution. One of the proposed
legislative changes aims to restrict future government liability for
hazardous products.
At the same time as it has faced massive funding cuts, Canada's regulatory
agency has been shortening the average time needed to approve a new drug,
under intense pressure from the pharmaceutical industry for faster drug
approval. What does this mean for public safety? As Joel Lexchin pointed
out in his recent editorial in the Canadian Medical Association Journal
(summarized last week on e-drug), no one knows outside of the company
concerned and the regulatory agency, nor can anyone find out under current
conditions of limited access to the information on which regulatory
decisions are based.
The industry argues that drug approval is slow in Canada compared to Europe
and that regulations banning direct-to-consumer drug advertising are
restrictive compared to the U.S. The aim of the November 3rd meeting is to
examine the current regulatory situation in an international context and to
look at work underway in Europe and the U.S. towards drug regulation which
more fully reflects public interests and public health priorities.
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DES Action Canada is hosting this meeting to commemorate the
organization's 15th anniversary. DES (diethylstilbestrol) is a drug which
was widely used in pregnancy in Canada from 1941-1971, mainly to prevent
miscarriage and related pregnancy problems, a purpose for which it was
found to be ineffective as well as proving to be harmful. DES Action is a
non-profit consumer organization whose purpose is to identify, educate,
provide support to, and advocate for people exposed to DES. The
organization also works toward the prevention of similar public health
problems, particularly in the field of reproductive health care.
Barbara Mintzes,
Canada
Email: Bmintzes@compuserve.com
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