Cheaper, generic copies of prescription drugs take up to four years on average to get government approval because of red tape and federal provincial overlaps that cost taxpayers millions of dollars a week, a new study says. The Health Canada branch that checks the safety and effectiveness of no name medicine is seriously under funded, often lingering over applications for years after the brand name patent has expired, said the study, carried out by Queen's University researchers for the generic drug industry.

The provinces are next in the approval process, and the time it takes them to allow the generic medication on to their subsidized drug plans varies dramatically. Despite its much-vaunted campaign to cut red tape, Ontario takes by far the longest, while B.C. is the speediest of the provincial regulators, said the report.

The researchers tracked a sample of 34 generic products between 1995 and 1999. Just for those medications, Canadians were spending $5.8 million extra on pricier brand name medicine for every month of delay in getting the generics on store shelves. "Resources must be redirected from other parts of the health care system to pay for more expensive branded medications, or the Canadian public must be prepared to pay more for their health care privately," "It makes little sense."

The authors recommend that the federal and provincial approval processes be merged to reduce duplication and expense and make new medication available at the same time everywhere in Canada.

Federal and Ontario government officials said they had made great strides in reducing the delays. They said the report's figures don't reflect current reality.

The Canadian Drug Manufacturers Association, whose members is generic pharmaceutical makers and stands to profit from speedier approvals, commissioned the study. It notes that drugs represent one of the fastest rising expenses in the health care system, costing Canadians $9 billion a year.

Health Canada's Therapeutic Products Directorate ensures the drug is safe and a faithful copy of the original. Based on the 34 generic drugs that were followed over five years, that process takes an average of 1160 days--more than three years. The agency's budget was cut more than 30% in the mid 1990's. Even though it now charges drug companies fees when they apply for approval, it still doesn't have enough staff and the turnover rate is high, researchers say. But a Health Canada spokes-man said the directorate has cut the delay at its level from an average of almost four years in 1995 to 17 months last year. "Significant process has been made and continues to be made in reducing the review time,"

After getting federal approval, the generic firms must apply to have their drugs listed on provincial plans, which offer free or low cost medication to some or all of their citizens and account for about 49% of drug sales. The drug plan listings are important for other reasons, too, since they influence which drugs are covered by private insurers and, in effect, determine when a drug gets on the market. The 34 generic products examined took an average of 466 days after federal approval to get listed in Ontario. The best was by British Columbia at 84 days.