Press Release:
For immediate release
December 17, 2004
Winnipeg, Canada

Mandatory Reporting of Adverse Drug Reactions:
An important first step

The Canadian Women's Health Network (CWHN) and the Women and Health
Protection Working Group welcome the announcement by Federal Health
Minister Ujjal Dosanjh calling for the introduction of mandatory
reporting of adverse drug reactions by physicians and other health
professionals.

This is an important step that we hope signals a new approach to the
regulation of prescription drugs.

Currently, health professionals are not obligated to inform Health
Canada
if they suspect a side effect from a prescription drug has caused a
patient
to become ill or die. We believe the present system fails to
adequately protect Canadians from the harms caused by medicine.

Although Canada is one of the few countries that allow reporting of
drug
reactions by patients, this avenue is not well known and therefore
infrequently used.

While we support mandatory reporting of harms caused by drugs by
health professionals, this cannot and should not replace adequate
pre-market testing and transparent evaluation and safety reviews.

Drugs should not be marketed unless they are safe, effective and offer
additional benefits to patients over similar drugs already available.
Although clinical trials are becoming more gender inclusive, there are
still
inadequate subgroup analyses, and too few comparative studies between
and
among drugs, non-medical interventions, and placebos.

Over the years women's health activists have been in the forefront of
alertng the public to the harms caused by the Dalkon Shield, breast
implants, DES and Depo Provera based on our own research and listening
to the experiences of women. Drug safety is a critical issue for
women. We are more likely to be prescribed drugs and to use drugs or
devices as contraceptives.  In pregnancy, the drugs we take can
directly affect the health of fetuses. Women experience more chronic
diseases that require medication. And women often have their life
experiences viewed as needing medical intervention.

We believe that instituting mandatory reporting of adverse reactions
by health professionals is a positive step in improving the
currentpost-market drug surveillance system, but this change alone is
not sufficient and should be seen as one in a series of initiatives to
improve the regulation of drugs and devices in Canada.

These include:

1.Increased support for adverse drug reaction reporing, outreach and
follow up by all relevant parties. This would include funding for
women's and community health groups that have demonstrated a history
of expertise in this area.

2.The allocation of resources to support an improved system for
consumer reporting of adverse drug reactions to Health Canada.

3.A transparent publicly managed process for analysis of the data
gathered from adverse drug reporting and from rigorous post-marketing
surveillance.

4.Improved product labeling that would allow consumers to have
information about the drug including links to information about the
research trials that supported the drug's release and access to the
adverse reaction database.

5.The introduction of probationary or provisional licensing for new
drugs before they are released onto a wider public.

Canadians are often unaware of their role as unwitting research
subjects when it comes to the use of new drugs. We deserve to have
confidence that the drugs doctors prescribe are safe.  Obliging health
professionals to report any and all adverse effects from medication is
an important first step in reaching this goal.

Contact:
Canadian Women's Health Network (CWHN)
Madeline Boscoe, Executive Director

Women and Health Protection (WHP)
Anne Rochon Ford  

For further information:
CWHN: www.cwhn.ca
WPH: www.whp-apsf.ca
PharmaWatch Adverse Drug Reaction Line: 1.604-687-6629