Since 2009, the US Government has been negotiating a free-trade agreement known as the Trans-Pacific Partnership (TPP) with 11 other countries across the Asia-Pacific and Latin American regions. This agreement could have major impact on the pharmaceutical market, including generics and biosimilars.
The TPP is a multilateral free trade agreement currently being negotiated by Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, the US and Vietnam. When finalized it will be the largest free trade agreement in history, impacting up to one-third of world trade and representing nearly 40% of the US global gross domestic product.
The deal has attracted criticism from various groups regarding access to generics and proposed regulations for biologicals in participating countries. With respect to biologicals, critics have been concerned about the length of exclusivity being proposed, with many being concerned that this would delay access to biosimilars. However, new proposals seem to have addressed these concerns.
For the 11 countries besides the US that are involved in the TPP, current exclusivity protections for biologicals range from zero in Brunei to eight years in Japan. The Office of the United States Trade Representative (USTR), however, originally proposed a 12-year period of exclusivity for biologicals, which is in line with US healthcare reform legislation [1].
The US Generic Pharmaceutical Association (GPhA) has in the past expressed its concerns over the TPP negotiations. The GPhA has previously stated that the intellectual property provisions being proposed for inclusion in the TPP agreement would hinder competition and access to generic medicines [2].
The 12-year exclusivity period was subsequently dropped to eight years, but this still left some countries, including Australia, unhappy. In the end the US has bowed to pressure and met Australia’s demands for only five years of exclusivity for biologicals. This means that some countries will provide eight years and others five years of exclusivity, but with a provision for three more years under a regulatory framework in the TPP.
The GPhA is also much happier with this turn of events, stating on 5 October 2015 that ‘the GPhA and its Biosimilars Council‘ strongly support efforts to improve worldwide patient access to affordable medicines’. They add that ‘we are optimistic that the agreement announced today on the Trans-Pacific Partnership (TPP) brings us closer to achieving that goal by embracing competition from safe, effective biosimilar therapies’.
Médecins Sans Frontieres (MSF, Doctors Without Borders) and Public Citizen, however, were disappointed that the exclusivity was set at eight years, rather than five. Brand-name drugmakers are also unhappy, with both the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Industry Organization (BIO) expressing disappointment over the compromise and warning that it will discourage innovation in the pharmaceutical industry.
Related articles
GPhA comments on generics’ legislation and Trans-Pacific Partnership
Access to generic medicines undermined in free trade agreement
References
1. GaBI Online - Generics and Biosimilars Initiative. More debate over the exclusivity period for biological in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Oct 9]. 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 2015 Oct 9]. Available from: www.gabionline.net/Biosimilars/News/Caution-over-IP-provisions-for-biologicals-in-TPP
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Source: BIO,GPhA,MSF,PhRMA,Public Citizen,USTR
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