Rift over drug protections complicates TPP trade talks

Negotiators trying to wrap up the 12-nation Trans-Pacific Partnership trade agreement say the issue of how long to protect certain high-end drugs from lower-cost imitators has emerged as the leading obstacle.

Negotiators trying to wrap up the 12-nation Trans-Pacific Partnership trade agreement say the issue of how long to protect certain high-end drugs from lower-cost imitators has emerged as the leading obstacle. The drug debate continues to divide Australia and other countries from the United States in the high-level talks that began Wednesday in Atlanta. Backed by key lawmakers and leading pharmaceutical companies, U.S. negotiators are seeking an intellectual property rule in the pact that would grant brand-name biologic drugs a period of exclusivity of up to 12 years, during which time they are protected from generic imitations, consistent with U.S. law. Japan is also backing a long period of protection of biologic drugs. Countries such as Australia and New Zealand are pushing for just 5 years of exclusivity, worried that a longer period of protection for the big-ticket drugs could slow the arrival of generic imitators and add significantly to the budgets of their national health systems. Australian Trade Minister Andrew Robb has reportedly pushed back against a compromise proposal floated in the talks that would require countries in the trade agreement to give biologic drugs at least 5 years of basic exclusivity, plus an additional 3 years of protection while regulators monitor the drug’s safety.