Tough medicine: Ensuring access to affordable drugs requires fixing trade agreements starting with NAFTA

Abstract

The negotiation of trade agreements, which is conducted in secret, poses serious risks for the generic/biosimilar industry as the originator industry uses them as a tool to ratchet up the protection of intellectual property rights to broaden and extend their monopolies, and forcing changes in the laws and regulations of the countries as international law supersede national law. The Trans Pacific Partnership (TPP) demonstrated that the constructive engagement of the generic/biosimilar industry can make a difference in these negotiations to strike a balance that both fosters innovation while ensuring patients’ expedited access to more affordable drugs. The industry needs to be vigilant in the ongoing negotiations for the modernisation of the North American Free Trade Agreement (NAFTA) between Canada, Mexico and the United States, which will not only affect those three pharmaceutical markets, but also set a precedent for future trade negotiations.

Keywords

Trade negotiation intellectual property pharmaceuticals patents biologics generic access to medicines linkage exclusivity

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Biologic drugs are highly complex drugs originated from living organisms. Biosimilar drugs are biological products approved by the Food and Drug Administration (FDA) that are highly similar to an FDA-approved reference biological product.

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