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Generic Industry Welcomes Introduction of Access to Generic Medicines Bill
Details of full legal and regulatory package will determine practical effect

Toronto, November 6, 2003 – The Canadian Generic Pharmaceutical Association (CGPA) today welcomed the federal government's first steps to allow its member companies to provide low-cost, Canadian-made generic pharmaceuticals to developing countries in times of health crises.

“We are pleased that Canada is the first country to introduce legislation to allow generic drug makers to participate in the historic World Trade Organization agreement to provide generic medicines to developing countries where they are desperately needed,” said Jim Keon, President of the CGPA. “While the government's initiative is commendable, the details of the full legislative and regulatory package will determine its practical effect.”

He said that Canadian generic pharmaceutical manufacturers have several concerns about the implementation of this initiative, including provisions to provide brand-name drug makers a so-called “right of first refusal.”

Keon said that if generic manufacturers spend time and money arranging the details of an agreement only to have the brand company that holds the patent take over that agreement, they will quickly realize the futility of trying to make the agreement work.

“If the brands want to reduce their prices for developing countries they should just do it. They shouldn't be allowed to wait and see if a generic is going to produce it.”

Keon also pointed out that, even given the best-case scenario, it will take time for Canadian-made generic pharmaceuticals to reach the people in developing countries who need them.

“We are talking about patented medicines. By definition, our companies are not currently producing these products,” he said. “Health Canada has the highest standards in the world for generic drugs and the facilities in which they are researched and manufactured. It takes three to five years and millions of dollars to bring a generic product to market.”

Amendments to Canada's Patent Act are necessary to implement the WTO agreement on access to affordable medicines because the Act currently prohibits Canadian generic pharmaceutical companies from exporting products that are under Canadian patent protection even if there is no patent, or the patent has expired, in the country to which it is to be exported.

Canadian generic pharmaceutical producers have long argued that, along with preventing them from providing generic medicines to developing nations, these export restrictions force them to locate manufacturing facilities abroad. This results in diminished job creation and investment in Canada.

About the Canadian Generic Pharmaceutical Association

The Canadian Generic Pharmaceutical Association represents Canada's generic drug industry – a dynamic group of companies that specialize in the production of high quality, affordable generic drugs and fine chemicals and in conducting the clinical trials required for government approval of generic drugs. It plays an important role in helping control overall health-care costs by keeping the cost of medications down: generic drugs are priced, on average, 45% less than their brand-name equivalents.

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