Trans-Pacific Partnership impasse on data exclusivity for biologics softens

Print 31 July 2015
EJ Lane / FeircePharmaAsia

Negotiations in Hawaii to reach an agreement on the Trans-Pacific Partnershiptrade pact appear to have made some headway on the thorny issue of data exclusivity for biologics with Australia and other countries opposed to the United States' 12-year standard now willing to consider 8 years, Nikkei Asian Reviewreports.

The exclusivity period for data related to the development of new drugs is part of broader intellectual property discussions under the 12-nation talks that have stoked opposition from civil society groups that say costs for innovative medicines will be costlier in countries that have lower, or no, exclusivity periods,Nikkei said.

Hope is high for the TPP talks to near an end if the biologics issue is settled. Negotiations that grew to include all current 12 members started in 2008 and are three years past a targeted 2012 deadline.

That is especially the case because the issue is key to many countries in the trade pact that are concerned the 12-year standard would price newer drugs outside of public reimbursement and most out-of-pocket reach.

A draft of the intellectual-property texts for the TPP leaked earlier this year suggested that the data exclusivity period for biologic medicines has been whittled down to 7 years. Under the U.S. Affordable Care Act, biologics enjoy a 12-year data exclusivity period and trade negotiators from the U.S. are under the requirement to broadly follow U.S. laws.

However, Nikkei said Australia and others have softened their positions on data exclusivity, citing sources close to the talks as saying 8 years is now the position.

Nikkei also said that Japan and other countries oppose any period exceeding 10 years and aim to settle on 8 years at the ministerial sessions. Whether the U.S. will go along remains to be seen, Nikkei said.

On the overall talks, Nikkei said four sticking points remain, including legal guidelines for enforcement actions.

A Republican-controlled Congress has granted President Barack Obama fast-track negotiation status for any agreement reached by negotiators, meaning an up-or-down legislative vote. Legislators in the other countries would also have to approve any agreement to carry it into force.

The current TPP members already account for a third of world trade and 40% of global production.

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