Last-minute deal on drug exclusivity wraps up TPP negotiations

The Trans-Pacific Partnership pact is wrapped. After a last-ditch wrangle between the U.S. and Australia on pharma protections, the trade deal won backing Monday from its 12 member nations.

Pharma's market protections have been an issue in TPP negotiations from the beginning, with the U.S. pushing for drug-IP protections similar to its own, and other nations in the trade group pushing back. The U.S. wanted 12 years of protections for biotech drugs; most of the other countries, including Australia, wanted to limit data exclusivity to 5 years.

The generics industry and a variety of advocacy groups also opposed the longer data-exclusivity term.

That dispute held up the final agreement over the weekend, until Australia and the U.S. came to a compromise agreement. Under that compromise, biologic drug data would be protected for between 5 and 8 years, The New York Times reported.

U.S. Trade Representative Michael Froman

"This is one of the most challenging issues in the negotiations," U.S. trade rep Michael Froman said about biologics (as quoted by The Guardian). He said member countries believe the TPP "incentivizes the development of these new live-saving drugs while ensuring access to these medicines."

The Biotechnology Industry Association (BIO) said it was "disappointed" by reports about the shorter-than-desired data exclusivity.

But Doctors Without Borders/Medecins Sans Frontieres (MSF) said the agreement still goes too far in the U.S.'s direction, lengthening protections for biotech meds in the TPP's developing countries, such as India.

"Although the text has improved over the initial demands, the TPP will still go down in history as the worst trade agreement for access to medicines in developing countries, which will be forced to change their laws to incorporate abusive intellectual property protections for pharmaceutical companies," the not-for-profit group said in a statement.

Of course, the TPP has to be ratified by lawmakers in each country, and the fight in the U.S. Senate could be difficult. Republicans have promised to bring down any deal that fell short of the U.S. position on drug exclusivity. Meanwhile, some lawmakers in Australia have made similar promises about a deal that extended protections beyond the 5 years currently applicable in that country.

- see the NYT story
- get the MSF statement
- read The Guardian's piece

Special Report: Top 15 pharma companies by 2014 revenue

Suggested Articles

Sixteen years after it was approved, the FDA has ordered that heartburn drug Zantac and its generics be removed from the market.

In a non-randomized study in China, Avigan cleared virus after a median 4 days, significantly shorter than the 11 days observed for AbbVie's Kaletra.

Pfizer's 1.1-million-square-foot sterile injectables plant in Visakhapatnam has been criticized by the FDA for poor quality testing.