Generic drugs online

Proposed amendments to Canada's drug patent ruleswill force consumers and taxpayers to pay monopoly drug prices on top-sellingprescription drugs for longer than they should by reopening loopholes thatallow brand-name drug companies to unfairly keep competition from lower-costgeneric prescription medicines off the market.

The Government of Canada published draft regulatory amendments to thePatented Medicines (Notice of Compliance) Regulations of Canada's Patent Acton Saturday, April 26, 2008. The changes would allow brand-name drug companiesto list patents that are irrelevant to their products and get an automaticinjunction preventing Health Canada's approval of lower-cost generic versions,even though the relevant patents have expired.

The proposed amendments would override a November 3, 2006 ruling by theSupreme Court of Canada. In the decision, the Supreme Court ruled thatbrand-name drug companies were being incorrectly allowed to abuse the patentsystem to the detriment of consumers and generic pharmaceutical manufacturers,a practice known as "evergreening." The proposed amendments would allow thatabuse to resume.

"Changes to stop evergreening came after years of study and calls forchange from the Supreme Court of Canada, Romanow Commission, Canada'sCompetition Bureau, Canada's First Ministers, seniors organizations,health-care groups, unions, and employers that sponsor drug benefit plans fortheir employees," said Jim Keon, President of the Canadian GenericPharmaceutical Association (CGPA). "Now, the government is proposing tooverride a Supreme Court Decision without prior consultation with the genericpharmaceutical industry or anyone in Canada who will have to pay higherprescription drug prices if these amendments are adopted."

The proposed amendments could lengthen market monopolies for someprescription drugs, for example, Lipitor and Norvasc, the two top-sellingprescription drugs in Canada.

The Government of Canada is allowing a mere 15 days for writtensubmissions on the proposed amendments and admits in its regulatory impactassessment statement (RIAS), that the proposals will lead to higher drug costsfor consumers and provincial governments by delaying the introduction oflower-cost generic drugs, stating:

"The Government recognizes that one possible consequence of the proposedamendments is that some generic drug companies may not be able to enter themarket with a generic version of a patented drug on the same date as had beenexpected if the Federal Court of Appeal's decision were left to stand. Whilethis could result in delayed savings to consumers and provincial drug plans,the Government considers these potential costs to be counter-balanced by theabove-mentioned benefits..."

"The brand-name pharmaceutical industry is the spoiled child of Canada'sintellectual property regime," Keon said. "Despite 20 years of governmentconcessions, Big Pharma's investments in research and development continue tofall below the levels they committed to when their government-grantedmonopolies were first increased in 1987. Now the Government of Canada isprepared to ignore the Supreme Court in order to let them continue their abuseof the patent system."

With the adoption of the 1987 amendments to the Patent Act thatlengthened their monopolies, brand-name drug companies made a publiccommitment to increase their annual research and development (R&D) expenditureto 10 per cent of Canadian sales. However, the 2006 Annual Report of thePatented Medicine Prices Review Board (PMPRB) shows that for the sixthconsecutive year, Big Pharma's R&D-to-sales ratio has fallen below that level.Brand-name drug companies spent only 8.1 per cent of their revenues onresearch and development in 2006, and less than 2 per cent on basic researchinto new drugs.

Keon also pointed out that the provinces of Quebec and Ontario haveexperienced crippling job losses in the manufacturing sectors in recentmonths. Unlike most brand-name drugs that are shipped into Canada, mostgeneric drugs sold in Canada are made domestically, primarily in Ontario andQuebec. "The Government of Canada is further threatening manufacturing jobs inthe country's industrial heartland by pandering to brand-name drug companies."

About the Canadian Generic Pharmaceutical Association

The Canadian Generic Pharmaceutical Association (CGPA) representsCanada's generic drug industry - a dynamic group of companies that specializein the production of high quality, affordable generic drugs and fine chemicalsand in conducting the clinical trials required for government approval ofgeneric drugs. The industry plays an important role in controlling health-carecosts in Canada. Generic drugs are dispensed to fill 49 per cent of allprescriptions but account for less than 21 per cent of the $19-billionCanadians spend annually on prescription medicines.