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Trade pact disappoints biotechnology companies and campaigners for better access to drugs

BMJ 2015; 351 doi: https://doi.org/10.1136/bmj.h5360 (Published 06 October 2015) Cite this as: BMJ 2015;351:h5360
  1. Michael McCarthy
  1. 1Seattle

Industry groups representing US pharmaceutical and biotechnology companies said on Monday 5 October that provisions in the new Trans-Pacific Partnership that limit data exclusivity protections for new biologics to 5-8 years instead of the 12 years sought by the industry will discourage investment and impede development of new treatments.

In the United States, manufacturers of biologics are granted a 12 year data exclusivity period for new products, and the industry had pressed US trade negotiators to secure similar protections in the new 12 nation trade agreement.

In a statement John Castellani, president and chief executive officer of the Pharmaceutical Research and Manufacturers of America, said that a 12 year exclusivity period provided the appropriate balance between the need to create incentives for research and development investment and the need to provide access to new treatments. “While we await the final details, it appears that the ministers missed the opportunity to encourage innovation that will lead to more important lifesaving medicines …

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