Canada’s negotiators extended data protection on biologics without knowing impact on prices
BY MARY BOYD
AND JOEL LEXCHIN
There is now a clearer understanding of what Canada traded away in the United States-Mexico-Canada (USMCA) trade agreement but it is too early to know what the effect will be on the cost of drugs. Health coalitions have always maintained that health should not be part of any trade agreement. However, trade negotiators and countries continue to include it. In the United States-Mexico-Canada (USMCA), Canada agreed to extend data protection on biologics from eight to 10 years.
Biologics are usually expensive medicines made from living cells that have to be injected; otherwise their large molecules won’t be absorbed. They are used to treat autoimmune diseases, such as rheumatoid and psoriatic arthritis, multiple sclerosis, Crohn’s disease and other serious diseases and should be distinguished from the small molecule chemical-based drugs that come in the form of tablets. These latter are not part of the data extension in the USMCA.
Data protection is information from clinical trials on the safety of drugs and how well they work, that companies compile for drug approval.
It looks as if Canada’s negotiators extended the data protection on biologics without knowing what the impact would be on prices because that information is yet to be determined. Experts have no idea what the two-year extension of data protection will mean for the cost of drugs. It depends on what percentage of the market the drug captures – the range could be from 25 percent or lower to 100 percent – and whether patent protection expires before data protection. The additional cost could be from zero to several hundred million dollars.
The Comprehensive Economic Trade Agreement (CETA) which Canada signed with Europe, dealt with patent protection, the length of time the manufacturer has a monopoly on selling the drug before generics appear. The additional cost of extending this protection in CETA is thought to be in the range of $800 million per year.
What the effect of the USMCA data extension will be on our hopes for a universal pharmacare program is not quite clear. If the price of biologics increases because of extending data protection, it could make a stronger case for a universal pharmacare program because the current cost of medicines in Canada is the third highest in the industrialized world and is causing much hardship for many people.
A single payer for pharmaceuticals would mean stronger bargaining power and lower drugs prices for all Canadians. Experts tell us that the high cost of medicines is already detrimental to the health of many Canadians. This grates on our sense of fairness and justice because a universal pharmacare program would save lives, improve peoples’ well-being and save billions of dollars. Why are governments so slow to recognize this and act?
- Mary Boyd, P.E.I. Health Coalition; Joel Lexchin MD, Professor Emeritus, School of Health Policy and Management, Faculty of Health, York University. (The P.E.I. Health Coalition is a member of Trade Justice P.E.I.)