Fletcher Announces Post-Market Drug Safety and Effectiveness Network

July 14, 2008

WINNIPEG — Steven Fletcher, Member of Parliament for Charleswood–St. James–Assiniboia and Parliamentary Secretary to the Minister of Health, on behalf of the Honourable Tony Clement, Minister of Health, today announced that the Government of Canada intends to invest $1 million this year to support the establishment of a Drug Safety and Effectiveness Network. Further investments are anticipated in the future as the network becomes operational. The network reflects the Government’s commitment to drug safety and effectiveness and is a key element of the Food and Consumer Safety Action Plan.

“This Government is committed to promoting the health and safety of Canadians and enhancing Canada’s reputation as a country whose product safety standards, including those for pharmaceutical products, are second to none,” said Mr. Fletcher. “This network will give Health Canada an important additional source of evidence for the ongoing, proactive assessment of drug products throughout their lifecycle and will provide better post-market safety and effectiveness information on pharmaceuticals.”

The Drug Safety and Effectiveness Network is a virtual network that will link existing centres of excellence in post-market pharmaceutical research across Canada and coordinate a common research agenda to increase knowledge about the safety and effectiveness of drugs based on their use in the "real world" by diverse patient groups, outside the controlled experimental environments of clinical trials.

“The drug research network will collect vital evidence about the real-world risks and benefits of what happens when people use these drugs after they are marketed,” said Dr. Noralou Roos, founding Director, Manitoba Centre for Health Policy, University of Manitoba. “It will be linked to universities to build on existing Canadian research capacity and provide a high level of independence and objectivity in the research findings for use by government regulators and other decision-makers.”

In addition to direct benefits to the federal regulator, the new, independent evidence generated will support public decision-making on appropriate access to and prescribing and use of drugs within the Canadian health care system.

The Network will also:

• link pharmaceutical researchers with experts to answer policy relevant questions about the real world safety and effectiveness of drug products;
• leverage greater value from existing investments in post-market research; and
• fund new research to fill the most pressing gaps in after-market pharmaceutical safety and effectiveness evidence.
  

The Drug Safety and Effectiveness Network will complement a number of other recent Health Canada initiatives to strengthen its post-market surveillance of health products, such as the recent improvements to its adverse reaction reporting system (Canada Vigilance) and the ongoing activity to promote adverse reaction reporting and keep Canadians informed of risks related to the health products they use (MedEffect TM Canada).

Today’s announcement of the Drug Safety and Effectiveness Network is part of the Food and Consumer Safety Action Plan (http://healthycanadians.ca/pr-rp/action-plan_e.html ) announced by Prime Minister Harper on December 17, 2007. One of the first steps in this action plan was the introduction of food and consumer product safety legislation in the House of Commons, on April 8, 2008, which will enable a modernized product life-cycle approach to drug regulation in Canada.