TPP is a multilateral free trade agreement currently being negotiated by Australia, Brunei, Chile, Malaysia, New Zealand, Peru, Singapore, USA and Vietnam.

The House Representatives stated in the letter that they were concerned that some of the ‘goals and approaches’ being proposed as part of the intellectual property chapter of TPP could delay generics market entry and ‘limit, rather than expand, access to medicines in poor countries’.

They want US Trade Representative Mr Ron Kirk to adopt policies that limit exclusive marketing rights for brand-name drugs to one five-year period. And they suggest this could run concurrently with similar legal protection in the US. Other suggestions include resolving patent disputes through the legal system instead of the drug approval process and including wording in TPP that makes it clear that TPP does not and should not ‘prevent countries from taking measures to protect public health by promoting access to medicines for all’.

This is not the first time TPP has been accused of hindering access to medicines. Proposed provisions in TPP for 12 years of biologicals exclusivity have also been criticised [1].

The US Generic Pharmaceutical Association (GPhA) has also expressed its concerns over the TPP negotiations. GPhA believes that the intellectual property provisions being proposed for inclusion in the TPP agreement would hinder competition and access to generic medicines [2].

Editor’s Comment
The debate seems set to continue over the period of exclusivity allowed in the TPP for both small molecule and biological originator drugs.

Please feel free to share your thoughts via email to editorial@gabionline.net or in the comments section below. What are your views on the inclusion of intellectual property rights in TPP? How do you think this will affect access to medicines in the Asia-Pacific region?

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Debate over biosimilars exclusivity period in free trade agreement

References

1. GaBI Online - Generics and Biosimilars Initiative. More debate over the exclusivity period for biologicals in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 October 28]. Available from: www.gabionline.net/Biosimilars/General/More-debate-over-the-exclusivity-period-for-biological-in-the-US

2. GaBI Online - Generics and Biosimilars Initiative. Caution over IP provisions for biologicals in TPP [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 October 28]. Available from: www.gabionline.net/Biosimilars/News/Caution-over-IP-provisions-for-biologicals-in-TPP