Doing what we are told

Thanks to Scott Sinclair for bringing a couple items to my attention. Below are two recent articles from the trade journal, Inside US Trade, Canada Moves Toward Ending Wheat Monopoly As Sought By U.S., and Canada Changes Drug Rules To Meet U.S. Demand On Data Exclusivity. It is interesting that capitulation to the US is not limited to softwood lumber. Scott points out that neither of these changes “sought by US” require approval of Parliament.

Inside US Trade

CANADA MOVES TOWARD ENDING WHEAT MONOPOLY AS SOUGHT BY U.S.
_______________________________________________
Date: October 27, 2006

A Canadian task force plans to complete a report by today (Oct. 27) on how best to implement the Conservative government’s plan to eliminate the grain marketing monopoly operated by the Canadian Wheat Board (CWB), according to the task force chairman. The U.S. government for years through the WTO has tried to eliminate the monopoly powers of the CWB, which it argues gives Canadian wheat growers the ability to underprice U.S. growers.
CANADA CHANGES DRUG RULES TO MEET U.S. DEMAND ON DATA EXCLUSIVITY
_______________________________________________
Date: October 27, 2006

Canada last week amended its drug safety and patent regulations in a way that should end the ability of generic companies to obtain marketing approval for drugs that are bioequivalent to brand name drugs without having to wait for the end of a five-year period in which clinical trial data generated for brand name companies is protected. These bioequivalent generic drugs are often engineered to avoid patent infringement but without a major change in the chemical composition, which ensures they can prove their safety and efficacy based on clinical data generated for brand name companies.

The U.S. had charged that using the data this way amounted to unfair commercial use of clinical test data in violation of the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

Under Canada’s new system, generic companies cannot apply for marketing approval with Canadian authorities until six years after a brand name drug has entered the market, and cannot obtain marketing approval for eight years after brand name market entry. Under the new policy, if a brand name company performed a study on the effects of a drug on children, it would receive another six months of data exclusivity after the eight years, regardless of the outcome of the study, sources said.

Leave a Reply

Your email address will not be published. Required fields are marked *