What does the TPP say about data exclusivity and biosimilars?

Everyone seems to agree that one of the main hang-ups during the negotiation of   the Trans-Pacific Partnership (TPP) trade deal was data exclusivity(link is external) for biologics, a key factor in determining when biosimilars can get on the market.

But there’s a lot less agreement about what the TPP negotiators have actually agreed to. Full text of the agreement is not going to available for several weeks, so in the meantime there’s plenty of room for interpretation.

The Australian Financial Review(link is external) reported that the United States backed off its goal of 12 years of exclusivity and met Australian demands for five years.

But Julia Belluz(link is external) at Vox(link is external) reported that TPP sets a range for data exclusivity of between five years at a minimum and eight years.

Belluz’s piece depended on reporting by the New York Times. So here is what the Times news story summing up the TPP had to say:

The United States sought up to 12 years’ protection for drug makers to withhold data needed to produce generic “biosimilars,” as an incentive for their innovations, while Australia and Peru led most other nations in fighting for no more than five years of protection.

The compromise set a mandatory minimum of five years, without setting a maximum, leaving both sides to declare victory. “We do think we have a balanced result,” said Ms. Silva of Peru.

An editorial endorsing the TPP in this morning’s Wall Street Journal gave some details that may help clear up some of the confusion—presuming, of course, that the paper has got the details right (and there’s no reason to believe that it hasn’t, although this is the paper’s editorial page talking, so there’s license to spin).

In the Journal’s telling, the TPP gives individual countries a fair amount of discretion in setting their data exclusivity rules. The newspaper says countries can start with a minimum of five or eight years. But they can also decide to tack on three more years if the makers of the original biologics agree to some price and access commitments (what those might be is not spelled out). What’s more, according to the Journal, the TPP as currently negotiated allows the U.S. to keep its current rule of 12 years of data exclusivity.