Final TPP Agreement Draws Ire from Both Sides over Biologics Exclusivity

Regulatory NewsRegulatory News
| 05 October 2015 | By Zachary Brennan 

Pharmaceutical industry groups and nonprofits expressed disappointment Monday over a compromise in the Trans-Pacific Partnership (TPP) on biologics data exclusivity.

The deal, which has previously stumbled over the issue of biologics data exclusivity, would either provide eight years of exclusivity to biologic drugs, or provide five years of exclusivity, plus up to three more years under a regulatory framework for the 12 countries in the trade bloc, which includes the US, Australia, New Zealand, Canada, Japan and Malaysia. All parties still need to agree on the final language of the deal.

Trade representatives from the US and Japan favored a longer period of protection – up to 12 years -- while others, such as Australia, expressed fears that delaying the entry of biosimilars for that long would raise costs.


Both the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Industry Organization (BIO) issued statements of disappointment over the compromise, claiming it will prevent industry innovation.

"The [US] Congress set 12 years as the appropriate period to both foster innovation and provide access to biosimilars in a reasonable timeframe," BIO President and CEO Jim Greenwood said. "While the TPP agreement will not impact the US data protection period, we believe the failure of our Asian-Pacific partners to agree to a similar length of protection is remarkably short-sighted and has the potential to chill global investment and slow development of new breakthrough treatments for suffering patients."

Eight Years Too Long?

On the other side of the spectrum, Doctors without Borders (MSF) and Public Citizen were disappointed that the exclusivity was set at eight years, rather than five.

Public Citizen said the deal would "expand monopoly protections for the pharmaceutical industry at the expense of people’s access to affordable medicines."

Similarly, MSF said: "The big losers in the TPP are patients and treatment providers in developing countries. Although the text has improved over the initial demands, the TPP will still go down in history as the worst trade agreement for access to medicines in developing countries, which will be forced to change their laws to incorporate abusive intellectual property protections for pharmaceutical companies."

Both sides will argue their cases over the next 90 days before Congress decides whether to sign off on the deal. Republicans, such as Sen. Orrin Hatch (R-UT), seem so far to be taking the side of industry, while Democrats, such as Rep. Rosa DeLauro (D-CT), are taking the side of Public Citizen and MSF.

US Trade Representative Michael Froman praised the deal in a press conference on Monday, noting this is the first trade agreement that assures minimum protections for biologics and ensures "both innovation and access."

BIO Statement


Public Citizen



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