CANADIAN STUDY CONDEMNS LACK OF DRUG NOVELTY

Researchers based in the Canadian province of British Columbia have claimed that so-called "me-too" drugs -- which offer incremental improvements on older, off-patent pharmaceuticals -- account for an overwhelming share of Canada's rising drugs bill. The claims appear to support tighter criteria for drug novelty, a subject under lengthy consideration by Canadian regulators.

The study claims that of the 1,147 drugs approved in Canada between 1990 and 2003, just 5.9% represented a genuine therapeutic advance. However, the remainder accounted for 63% of the country's drug spending in 2003. Leading treatment categories in which such "artificial" patent extensions allegedly occurred are ACE inhibitors, statins, SSRIs and proton pump inhibitors.

A sceptical analysis of the study might point to the study's apt timing in political terms. Canada is currently revising its novelty criteria, and British Columbia is one of two Canadian provinces that currently require added patient co-payments in the public health sector. Canada recently proposed extending marketing exclusivity from five to eight years, and new benefits for paediatric indications.