Drug policies lag behind

A new study finds that Canada’s protection of intellectual property for biologic medicines, used to treat cancer and other maladies, lags behind other countries.

According to the study by the Fraser Institute, a Canadian public policy think-tank, this is limiting access and stunting investment.

The study, The Biologics Revolution in the Production of Drugs, spotlights the emerging science of biologic medicines, which involve genetically engineering living cells to produce needed proteins.

The Fraser Institute claims biologics have shown great promise in the treatment, diagnosis and prevention of more than 250 diseases including a variety of cancers.

“Biologic medicines represent one of the most promising frontiers in medicine, but Canada’s IP regime is hampering, not facilitating, development of these medicines,” says Kristina Lybecker, study author, Fraser Institute senior fellow and associate professor of economics at Colorado College.

Compared to traditional pharmaceutical treatments, biologic medicines are extremely complicated to develop and manufacture.

The Fraser Institute claims that the protection of intellectual property is particularly important in biologics given the costs of research, development and manufacturing.

Its study claims that Canada’s IP protections are relatively weak compared to other countries such as the United States, Japan and the European Union (EU), and that these deficiencies in IP protection have been shown to limit patient access to medicines and stunt investment.

“These drugs literally save lives, so it’s vital that Canada has a vibrant and well-protected biologics sector to supply Canadian patients with the drugs they need,” adds Lybecker.

To address the institute's concerns, the study also offers a number of recommendations, including extending the time period for “data exclusivity” which protects information relating to a drug’s development and testing.

Such information is necessary for generic companies to replicate the original biologics.

Currently, Canada has one of the shortest data exclusivity time periods (eight years) in the industrialized world, compared to the EU (10 years) and the United States (12 years).

“If Canada wants to ensure access to and promote the development of an emerging medical field, it must maintain competitive regulations,” Lybecker says.

For more information on the study, click here.