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Outdated and uncompetitive regulations limiting patient access, stunting investment in cutting-edge medicines in Canada

The Fraser Institute
By The Fraser Institute
July 12th, 2016

Canada’s protection of intellectual property (IP) for biologic medicines — used to treat cancer and other maladies — lags behind other countries, limiting access and stunting investment, finds a new study released todayby the Fraser Institute, an independent, non-partisan Canadian public policy think-tank.

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. 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,” said 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. Subsequently, the protection of intellectual property is particularly important in biologics given the costs of research, development and manufacturing.

Unfortunately, Canada’s IP protections are relatively weak compared to other countries such as the United States, Japan and the European Union (EU). Crucially, 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,” Lybecker said.

To address Canada’s comparatively weak IP protections, the study 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 said.

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