Mexico trade deal impacts biologicals exclusivity

Generics and biosimilars Initiative

Building trust in cost-effective treatments

Inscribirse
eng / esp

Mexico trade deal impacts biologicals exclusivity

INICIO/Políticas y legislación | Posted 21/09/2018 0 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.

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.

Malaysia objects to patent terms in free trade agreement

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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Source: Axios, CBC, USTR, VOA News