[Ip-health] Inside U.S. Trade: PhRMA Pushing USTR For Six-Year Access Window In TPP Proposal

Thirukumaran Balasubramaniam thiru at keionline.org
Fri Apr 20 07:56:12 PDT 2012

Inside U.S. Trade 
PhRMA Pushing USTR For Six-Year Access Window In TPP Proposal

Posted: April 19, 2012

The Pharmaceutical Research and Manufacturers of America (PhRMA) is urging the Office of the U.S. Trade Representative to propose a length of six years for the "access window" that is provided for in USTR's proposal on access to medicines in the Trans-Pacific Partnership (TPP) negotiations, an industry source said.

The exact length of the access window is a key missing detail from the U.S. proposal and will determine how long after receiving initial marketing approval, most likely in the U.S., a brand-name drug company has to pursue marketing approval in other TPP countries if it wants to be guaranteed the strongest patent protections available in those markets.

In particular, the access window creates a period of time during which companies can seek marketing approval for their drugs in other TPP countries. If they act during that window, those companies would be guaranteed the strongest protections in the areas of patent term extensions, patent linkage and data exclusivity (Inside U.S. Trade, March 9).

The USTR access window proposal is intended to "drive" companies to quickly market their products in other TPP countries, paving the way for the speedier introduction of cheaper generic drugs. One source close to the generics industry has suggested the window could be as short as six months long.

Companies acting within this access window would benefit from protections similar to those outlined in the U.S.-Korea free trade agreement, whereas companies that do not would only be guaranteed TPP protections similar to those contained in U.S. bilateral trade deals with Peru, Panama and Colombia.

The PhRMA proposal for a six-year window length is based on research the organization compiled on the average time it takes U.S. pharmaceutical companies to file a marketing approval application in not only TPP countries, but a broader range of Asia-Pacific nations, the industry source said.

Based on PhRMA's assessment, six years was found to be an adequate time for most companies to meet the window requirement and, therefore, have a chance at enjoying the strongest patent protections, this source said.

Public health advocates and generic manufacturers have stressed that they prefer the TPP contain pharmaceutical patent protections on a level similar to U.S. trade agreements with Peru, Panama and Colombia. However, these groups say a short window would do more to encourage drug companies to bring their products to market in other countries quickly -- the whole point behind the access window concept -- and would thereby help ensure quicker introduction of generics and promote access to medicines.

The other major missing piece from the U.S. proposal on access to medicines is the data exclusivity period for biologic drugs. PhRMA is pushing USTR to table 12 years of protection for biologic drugs, whereas generic drug manufacturers argue that USTR should not table any period of data protection at all.


Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)

thiru at keionline.org

Tel: +41 22 791 6727
Mobile: +41 76 508 0997

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