News Releases

Letter to Prime Minister Chrétien re: access to generic drugs

January 29, 2003

The Right Honourable Jean Chrétien
Prime Minister of Canada
80 Wellington Street
Ottawa, Ontario K1A 0A2

Re: Bush to provide more funding for generic drug approvals

Dear Prime Minister:

I am writing today to bring to your attention the latest move by U.S. President George W. Bush to help lower prescription drug costs by providing faster access to generic pharmaceuticals.

You may recall that my last letter to you advised of President Bush’s move to stop abuse of drug patents laws that unfairly keep generic drugs off the market even after original 20-year patents expire. As I noted in my October 24, 2003 letter, the abuse described by President Bush in his October 21, 2002 announcement mirrors the abuse of the Patented Medicines (Notice of Compliance) Regulations of Canada’s Patent Act.

The Canadian Generic Pharmaceutical Association (CGPA) was very pleased that the Final Report of the Commission on the Future of Health Care in Canada recommended that the Regulations be immediately reviewed (Recommendation 41). We request that you support this Recommendation and take the necessary steps to ensure it is implemented in the timelines prescribed by Commissioner Romanow.

You will also be pleased to know that President Bush has not stopped at ending abuse of drug patent laws in his efforts to get lower-cost generic drugs on the market faster. On January 27, 2003, he said he will seek a $13 million increase in the budget for regulatory reviews of generic pharmaceuticals. President Bush is asking Congress to increase the current $40 million budget for the U.S. Food and Drug Administration’s generics program so that the agency can hire about 40 more people to evaluate applications.

President Bush’s announcement has relevance for Canada for two reasons. First, prescription drug costs are the fastest rising cost in Canadian health care. Second, because of a lack of resources at the Therapeutic Product Directorate at Health Canada, generic drug approval submissions often wait months before they are reviewed. These delays hold up the introduction of generic drugs and result in millions of dollars in lost savings every year for provincial governments, private insurers, the federal government’s employee drug-benefit plans, and those Canadians who pay out-of-pocket for their prescriptions.

While some steps have been taken to increase these resources, the average approval time for generic drugs is still almost double Health Canada’s own performance target of 225 days.

The CGPA was very pleased that the Speech from the Throne recognized the need for efficient approval of drugs in Canada. In further discussions with officials at Health Canada, I have confirmed that the Throne Speech commitment applies to all products approved by the Therapeutic Products Directorate, including generic pharmaceuticals. The CGPA encourages the Government of Canada to quickly implement the Throne Speech Commitment to speed drug approvals and looks forward to further details of its implementation.

I also wish to inform you that the French government has recently launched a large-scale campaign to convince the public of the benefits of generics pharmaceuticals. Entitled “Generic Medicines: Everybody Wins”, the campaign consists of 30-second television advertisements, a generics communications campaign involving posters in doctors’ offices and pharmacies, and the distribution of seven million eight-page brochures entitled “Everything you want to know about generics.”

The French campaign is similar to an initiative launched last year by the U.S. Food and Drug Administration (FDA) to promote the safety and efficacy of generic drugs. The FDA’s campaign consists of print and radio public service announcements. The pubic service announcements appear in magazines, other print publications, as well as space on buses and trains. I have attached copies of the FDA’s print public service announcements for your review.

Given the extreme cost pressures being placed on both government- and employer-sponsored drug benefit plans in Canada, the CGPA believes that efforts similar to those of the French Government and the United States FDA by Health Canada would be of great benefit to Canadians. As we have offered in the past, the CGPA would be pleased to work with Health Canada to implement a similar campaign in Canada.

As these examples illustrate, governments around the world are turning to generic drugs to help control rapidly increasing health-care costs. Given the demands being made on your government to increase health-care spending in order to help reform and sustain medicare, the CGPA strongly urges you to take similar action in Canada improve access to generic medicines.

If you have any questions about any of the examples I have provided, or if you would like to discuss how improving access to generic drugs can help control health-care costs, please do not hesitate to contact me.

Yours sincerely,

Jim Keon
President

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