Mexico trade deal impacts biologicals exclusivity

Home/Policies & Legislation | Posted 21/09/2018 post-comment0 Post your comment

The US announced a new ‘understanding’ on trade with Mexico on 27 August 2018.  The announcement comes as part of efforts to re-negotiate the North American Free Trade Agreement (NAFTA) between the US, Canada and Mexico, which first came into force in January 1994.

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The new ‘understanding’ includes a bullet point on data protection for drugs that could have big implications for the pharmaceutical sector and could potentially hinder competition and access to biosimilars. The point strengthens intellectual property protection in the pharmaceutical and agricultural sectors and provides for 10 years of exclusivity for biologicals. The previous NAFTA specified that data should be protected for five years [1].

This is not the first time the US has pushed to extend the exclusivity period for pharmaceuticals. In its negotiations for the Trans-Pacific Partnership (TPP) the country tried to push for inclusion of intellectual property provisions consistent with US biologicals exclusivity standards, i.e. 12 years of data exclusivity [2]. The final agreement included five years of market exclusivity.

Canada sat out the last leg of discussions to enable the US and Mexico to iron out their bilateral differences, but the country is now coming under pressure to agree to the new terms on trade to remain part of the three-nation treaty.

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1.  GaBI Online - Generics and Biosimilars Initiative. Data protection provisions in CETA []. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Sep 21]. Available from:
2.  GaBI Online - Generics and Biosimilars Initiative. Debate over biosimilars exclusivity period in free trade agreement []. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Sep 21]. Available from:

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Source: Axios, CBC, USTR, VOA News

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