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Biologics and Biosimilars: A Primer

Canada’s comparatively weak intellectual property protections limit access to life-saving drugs



VANCOUVER—Because Canada’s protection of intellectual property in the life sciences—including biology and biochemistry—lags behind other industrialized countries, Canadian patient access to potentially life-saving biologic medicines is comparatively limited, finds a new study released today by the Fraser Institute, an independent, non-partisan Canadian public policy think-tank. “Cutting-edge biologic drugs are treating previously untreatable conditions, often with fewer adverse effects, improving the health of patients and saving lives worldwide,” said Kristina Acri, associate professor of economics at Colorado College, senior fellow at the Fraser Institute and author of Biologics and Biosimilars: A Primer.

Canada’s current intellectual property laws are weak compared to laws in other jurisdictions including the U.S. and EU

According to the study, as of December 2018 (the latest month of comparable data), Canada has approved only 10 “biosimilars,” which are versions of biologic drugs, compared to 15 in the United States, 20 in Australia and 62 in the European Union. Biologic drugs are produced from (or contain elements of) living organisms. They are more complicated—and more expensive—to develop, produce, distribute and dispense than other medicines. Subsequently, the ability of drug companies to protect their intellectual property—for example, through data exclusivity, which essentially prevents competing firms from producing generic versions of the drugs for a period of time—is essential for incentivizing the development of biologics, particularly because biopharmaceutical innovations are easily copied and sold by competitors. Unfortunately, Canada’s current intellectual property laws are weak compared to laws in other jurisdictions including the U.S. and EU. For example, Canada has one of the shortest terms of data exclusivity for pre-clinical and clinical trials. “If Canadian policymakers want to improve access to state-of-the-art drugs in Canada, they must strengthen protections for intellectual property,” Acri said. Media Contact: Kristina Acri, Senior Fellow, Fraser Institute To arrange media interviews or for more information, please contact: Mark Hasiuk, Fraser Institute mark.hasiuk@fraserinstitute.org

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Fraser Institute——

The Fraser Institute is an independent Canadian public policy research and educational organization with offices in Vancouver, Calgary, Toronto, and Montreal and ties to a global network of 86 think-tanks. Its mission is to measure, study, and communicate the impact of competitive markets and government intervention on the welfare of individuals. To protect the Institute’s independence, it does not accept grants from governments or contracts for research. Visit fraserinstitute.org.

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