Korean drugmakers and biopharma manufacturers are bracing for possible change in the Korea-U.S. free trade agreement amid ongoing negotiations whether to revise the five-year-old trade deal.
The Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) 한국제약바이오협회 said it is collecting opinions from its members on how an FTA renegotiation will affect the domestic pharmaceutical industry and what kind of demands its members should present if the two sides agree to amend the deal.
KPBMA asked its members to submit their opinions to the association by Oct. 31. Questions include what kind of concerns Korean pharmaceutical companies have over a renegotiation of the FTA, what kind of demands they want to make, and what issues they have in exporting their products to the U.S.
Concerns of the local pharmaceutical industry include a change in the duration of protection of materials for drugs and biological medicines and a revision of the patent approval linkage system that have a direct impact on Korea. The association also wants to check Korean drugmakers’ additional demands in case of a renegotiation.
The association plans to hold a meeting for members on Nov. 9 to discuss preparatory works.
Before the Korea-U.S. free trade deal went effect in 2012, the Korean pharmaceutical industry raised concerns that the FTA would hurt Korean drugmakers. However, it had little impact in reality because local pharmaceutical firms “made a good defense,” according to KPBMA.
However, any change in the approval-patent linkage system is expected to create a substantial impact on the local market, some experts said.
It has been only two years since Korea adopted the system, which bans the sale of a generic for nine months when an original drug developer registers its patent to the Ministry of Food and Drug Safety. The system, however, allows an exclusive sale of a generic for nine months if the generic manufacturer wins a patent lawsuit against the original drugmaker.
However, others say it is too early to predict how a change in the system might affect Korea yet.
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