TPP Signing Sets Stage for New Exclusivity Standard

With 12 nations signing off on the Trans-Pacific Partnership on Wednesday, the clock has started on ratification of the treaty providing up to eight years of exclusivity for biologics.

Patient advocacy groups protested the signing of the TPP agreement by marching outside PhRMA headquarters. Public Citizen and Doctors Without Borders asserted that the agreement expands “monopolies” on brand-name pharmaceuticals and inhibits access to cheaper generic and biosimilar drugs.

The key contentious provision involves exclusivity for brand manufacturers, which provides up to eight years of exclusivity for companies that obtain marketing approval for a new biologic in one of the 12 signatory nations — the U.S., Australia, Brunei, Canada, China, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore and Vietnam.