May 3, 2012 - In today's Windsor Star, MLI author Kristina Lybecker recommends changes to Canadian legislation that would help strengthen pharmaceutical intellectual property protection. Lybecker says, "By adopting  global legislative best practices, specifically those that characterize  innovation-intensive nations, Canada could attract additional pharmaceutical research and development investment and gain the research jobs that would follow." The full op-ed is copied below. It is based on "Intellectual Property Law and the Pharmaceutical Industry: An Analysis of the Canadian Framework," Lybecker's contribution to The Economics of Intellectual Property Protection in the Pharmaceutical Sector, the second instalment in MLI's Pharmaceutical Series.


Property rights debate

By Kristina Lybecker, Windsor Star, March 3, 2012

Canada enjoys great benefits from the pharmaceutical industry, including jobs  and investment. However, the pharmaceutical industry is characterized by a  research and development process that is lengthy, expensive, uncertain and  risky.

Canada's complacency in intellectual property is threatening its relative  position in the global pharmaceutical industry and changes are needed in IP  protection to re-establish Canada as a global competitor.

Adjustments need to be made to patent term extensions, price regulation of  patented drugs and basic patent linkage with automatic injunction. Updating our  IP laws would open up trade relationships worth billions.

The proposed reforms offer the opportunity to increase investment and  employment in this thriving sector as well as reduce trade frictions to get more  access to foreign markets.

Compared to Canada, the European Union can approve new drugs faster and  provide earlier access to innovative medical therapies. The future of Canadian  IP architecture is critical to the potential of our pharmaceutical industry.

In the current negotiations toward a Comprehensive Economic and Trade  Agreement with the 27 nations of the European Union, Canada is being urged to  strengthen its intellectual property framework.

Specifically, Canada ought to implement patent term restoration, which would  provide innovative pharmaceutical firms up to five years of additional product  exclusivity to compensate for the lengthy regulatory approval process as well as  extended data protection for the data from the clinical trials of brand name  pharmaceutical companies.

With these changes, Canada could attract more life science research  investment, create additional research jobs and speed the development of new  medicines. The agreement could significantly increase bilateral trade with  Europe and provide a boost of billions of dollars to the Canadian economy.

Putting aside the trade con-troversy, Canada would still benefit from strengthening pharmaceutical intellectual property protection. By adopting  global legislative best practices, specifically those that characterize  innovation-intensive nations, Canada could attract additional pharmaceutical research and development investment and gain the research jobs that would  follow. Three changes in Canadian legislation are recommended.

First, Canada should facilitate more expansive data exclusivity protection.  Currently, innovative drugs are protected from generic competition for eight  years. Strengthening data exclusivity laws will give innovative firms the  incentives to produce the data required for regulatory approval, facilitating  the research process and encouraging additional investment.

Second, in stark contrast to the United States and the European Union, Canada  fails to provide an extra period of patent protection as compensation for time  lost during regulatory approval delays. The restoration of a patent term  extension of zero to five years, as in other countries, would lengthen the  effective patent life of innovative therapies, increasing the incentives to  invest in the research and development costs that these treatments require.

Finally, Canada should strengthen its anti-counterfeiting legislation.  Criminal sanctions in concert with regulatory provisions will protect Canada  from the threat of fraudulent medicines, safeguarding the health of patients and  defending the innovative pharmaceutical industry from the theft of intellectual  property.

Protection of the industry's research and development investments would encourage additional investments and innovation.

While not without opposition, these proposed changes generate discussions  critical to improving health in Canada and to sustaining the excellence of the  Canadian health care system.

Kristina Lybecker is a professor of economics at Colorado College and author  of the recent Macdonald-Laurier Institute paper on intellectual property  protection, which can be downloaded at macdonaldlaurier. ca


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