The Pharmaceutical industry groups have expressed their disappointment over the compromise in the Trans-Pacific Partnership deal on biologics data exclusivity. The deal stumbled over issue of biologics exclusivity, it would either provide 8 years of exclusivity or 5 years of exclusivity + up to 3 years under a regulatory framework for the the 12 countries in the deal. US and Japan proposed up to 12 years of protection, but others like Australia fear that would delay entry of cheaper substitutes and raise the costs.
The Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Industry Organization (BIO) issued statements of disappointment over the compromise claiming it would prevent industry innovation. BIO President said that the US-proposed 12-year scheme would have fostered innovation and provided access to bio-similars in a reasonable time frame. He added that the failure of other countries to the length similar to that of US will slow development of breakthrough treatments for patients.
On the other side, Doctors without Borders (MSF) and Public Citizen were disappointed that the exclusivity was 8 years rather than five. Public Citizen said that the deal would expand monopoly protections for the pharmaceutical companies at the expense of people’s access to affordable medicines. MSF said that patients and treatment providers are the biggest losers in the TPP.
Both sides will argue their cases over next 90 days before Congress takes the final vote. US trade Representative Michael Froman praised the deal noting that this is the first trade agreement that assures minimum protections for biologics.