Nancy Pelosi is circulating a “New Trade Policy For America,” which contains certain key provisions designed to “expand and shape trade in ways that spread the benefits of globalization here and abroad by raising standards.” This is the section that describes proposed changes concerning generic drugs:

1 - Change the “data exclusivity” provision (period in which a generic manufacturer may not use clinical test data of an innovative drug manufacturer) to allow generics to enter the market quickly than under the old provision (by having “concurrent period” of data exclusivity).

2 - Include exception in FTAs that the data exclusivity provision does not preclude FTA countries from taking measures to protect public health and from utilizing the WTO “health solution.

3 - Eliminate requirement that a drug regulatory agency withhold approval of a generic until it can certify that no patent would be violated if the generic were marketed; strengthen and expedite judicial processes in countries to ensure patent rights of innovative drug companies are respected.

4 - Eliminate requirement that an FTA country extend the term of a patent on a pharmaceutical product for delays in the patent and regulatory approval process. Instead, ensure expeditious patent and regulatory approval process.

Note that there is no specific mention for support of compulsory licensing, which is the hot issue at the heart of the controversy between big pharma and Thailand and Brazil. Those countries are in the process of breaking patents for certain drugs, primarily AIDS meds, citing world trade rules that allow such moves for national emergencies.

You can read the rest here.[tags]Compulsory Licensing, Free Trade, Generics, Nancy Pelosi, Patents[/tags]