The United States is not likely to accept South Korea's latest proposal on pharmaceutical policies, one of the most contested sectors in the bilateral free trade agreement (FTA) negotiations, a trade journal reported Friday.
Seoul officials have linked the U.S.-demanded drug reimbursement appeals mechanism with gaining approval of South Korea's manufacturing practices, the weekly Inside Trade Journal said. The approval would ease procedures for marketing new drugs in the U.S.
The FTA talks have entered a critical stage of negotiations where the two sides have settled the easier issues and must now tackle the core contentions. The goal is to wrap up the talks by early next year, a deadline dictated by the expiration of the Trade Promotion Authority in the U.S. in July. The authority requires the Congress to vote up or down on a trade bill without seeking amendments.
South Korea in January will implement a revised drug reimbursement system to determine prices on a case-by-case basis, ending the automatic eligibility of new drugs. The U.S. argues the new system would discriminate against innovative drugs, produced mostly by American manufacturers.
U.S. negotiators want an independent appeals mechanism to challenge any unfair decisions under the system.
According to inside sources, Seoul has linked this issue with its demand for mutual recognition on good manufacturing practices (GMP) and good laboratory practices (GLP), saying South Korea could accept an appeals mechanism if the U.S. agrees to the recognition.
In order to get a new drug approved in the U.S., the Food and Drug Administration (FDA) has to approve the production and laboratory practices of the manufacturing companies.
"However, one U.S. source said it would be highly unlikely the FDA would accept mutual recognition of GMP and GLP as a matter of principle, given its stated desire to maintain control over these decisions as an independent regulator," the weekly journal said.
"This source also noted that attempts by the Office of the U.S.Trade Representative to get FDA to negotiate such a mutual recognition deal with the European Union failed."
Washington, Nov. 24 (Yonhap News)
U.S. unlikely to accept Korea's proposal on pharmaceuticals: weekly |
