TPP Deal Cuts Biologic Exclusivity Period, Potentially Eliminates Medical Device Tariffs

Although the final text of the Trans-Pacific Partnership (TPP) deal has not yet been released, media sources have been speculating about important provisions regarding biologics and medical devices. Fortune magazine has reported that the signatory countries will be able to sign up for one of two different biotech exclusivity options. The first allows 8 years of total exclusivity, while the second would permit 5 years of data exclusivity plus 3 years of semi-exclusivity. According to The Wall Street Journal, it is unclear whether these options will be modified before a final version is signed by the 12 nations participating in the TPP negotiations.

CTV, a Canadian News Network, reported late last month that the TPP deal will also remove existing tariffs on medical device equipment. While this information has yet to be verified, the medical device industry could stand to benefit if tariffs on medical device equipment are eliminated in a final version of the TPP deal.

The TPP aims to push for strengthened relationships among the signatory countries, and engagement and growth in Asia. The 12 participants of the partnership consist of 7 APAC countries (Singapore, Brunei, Vietnam, Malaysia, Japan, Australia, and New Zealand), 3 North American countries (U.S., Canada, Mexico), and 2 South American countries (Peru and Chile).