A two-year-old lawsuit that argues against rules governing the entrance of generics into the Canadian marketplace goes to a federal court today, theCanadian Press reports. At issue - generic drugmakers want to shorten the amount of time given brand-name drugmakers for patent protection.
The generic drug makers argue that eight years of protection costs consumers $115 million in extra drug costs every year. The regulations, implemented in 2006 under the Food and Drugs Act, were designed to protect the extensive and expensive data brand-name drugmakers need to seek approval for a drug. The data include the results of studies and clinical trials.
The rules prohibit Health Canada from licensing a generic version until after the eight-year period for those drugs where patent protections have lapsed. The "data exclusivity" is extended for a further six months if pediatric trials were involved in the development.
"Basically, it's just a ban on competition," Jeff Connell, a spokesman for the Canadian Generic Pharmaceutical Association, tells the Press. "It's got nothing to do with data. It's all about market exclusivity."
Russell Williams, president of Canada's Research-Based Pharmaceutical Companies, says generics are waging a "fear-mongering campaign. These changes, which were approved after years of consultation with governments, industry and health stakeholders, represent a tangible step forward and will result in a wider range of potentially life-saving medicines and vaccines," Williams says in a statement. "The amendments brought Canada into compliance with international trade rules, which helps us to compete globally for investment dollars and research and development initiatives."
The generics argue the North American Free Trade Agreement only affords a maximum of five years' protection for the brand-name drug makers, and they claim the government exceeded its authority in proclaiming regs they called a "kick in the shins" because they go well beyond what's called for in the trade deal. "We're asking the court to rule them unlawful and have them thrown out," Connell says.
The federal government maintains the changes were designed to clarify rules and cut litigation costs.
The generics point to lower-cost equivalents of popular meds such as the Zoloft and Wellbutrin antidepressants, or the Pravachol cholesterol pill, as examples that would not have been readily available to consumers had the rules been in place before 2006.
But brand-name makers that develop prescription drugs in Canada says the European Union protects brand names for 10 years, so Canada is not out of line.
"Since the new rules came into effect in 2006, Canadians are continuing to receive excellent value for their patented prescription medicines which are, on average, seven per cent below the international price median," Williams says. "In contrast, several studies have shown that Canadian generic drug prices are among the highest in the world."
The latest data from IMS Health, the market research firm, indicate generic drugs are now dispensed in just over half of all prescriptions in Canada. At the same time, they account for 22.5 per cent of the roughly $20 billion Canadians spend on prescription drugs.
Brand-name drugs enjoy 20 years of patent protection, but their manufacturers argue patents lapse or can be challenged in court.