Biologic exclusivity provisions could scupper U.S. plan for TPP

As expected and as FiercePharmaAsia reported in October 2015, provisions in the torturously negotiated Trans-Pacific Partnership (TPP) trade pact that deal with the exclusive period on biologics look set to derail plans to have the deal approved by the U.S. Congress as early as May or June.

Biologics, as the name implies, are made from biological material instead of chemicals and are one of the hottest areas in pharmaceutical development today.

They take years to develop and test and can costs tens of millions of dollars--or more--and drug companies say they need at least 12 years of exclusivity protection in order to make the treatments affordable and worth developing.

That's why most drug companies were disappointed with the "compromise" made by negotiators for the 12-nation pact. Currently, laws on the books in the United States include 12 years of exclusivity for biologics and U.S. negotiators wanted that same time limit in the TPP deal.

Other countries though, balked at that and groups like Médecins Sans Frontières said such a long exclusive period would drive up costs for people around the world in countries like India and in countries in Africa that could not afford the prices that would come with such a long exclusive period, according to a report in the Financial Times. Countries like Australia, Peru and others wanted a 5-year exclusive period.

The negotiating teams finally agreed at the final session in Atlanta that exclusive periods would range from 5 to 8 years "depending on the circumstances," according to the FT.

As FiercePharmaAsia reported in October, the compromise managed to please no one other than the negotiators and was slammed by NGOs on the left who said it would leave drug companies with blood on their hands and corporations on the right who said the compromise would make it financially unfeasible to invest in developing new biologics.

The fight moved on from TPP negotiators and is now being taken up by Congress, which is controlled by Republicans, and nothing would make them happier than sticking it to President Barack Obama and slamming the deal overall.

Sen. Orrin Hatch  

Republican Senator Orrin Hatch from Utah has gone on record several times and says he does not like the intellectual property terms of TPP, and several candidates currently running for president of the U.S. have also slammed the provisions and according to the FT report, Republican Senator Mitch McConnell, who controls the Senate, said he thinks TPP should be voted on after the elections in November.

- here's the story from the FT (sub. req.)