[Ip-health] EU demanded 10-year data exclusivity in FTA talks with Korea

[heeseob nam]

Reportedly, Mr. Kim, Korean chief negotiator, said on Thursday
(September 20) that the EU demanded 10 year exclusivity on test data
submitted for drug approval.

Korean position is strong in rejecting the EU's proposal, Mr. Kim said.

Currently, data exclusivity in Korea is 6-yar for new drug and 4-year
for new clinical information. The Korea-US FTA, still waiting for
congressional ratifications of both parties, requires "at least" 5-3
year system.

The 6-4 year system was introduced in Korea under pressure from EU.
When bilateral negotiation on intellectual property rights was reached
between US and Korea on July 1987, EU pressed Korea to provide the
same benefits as US got. EU used GSP (Generalized System of
Preferences) leverage by stopping the GSP application to Korean
products from January 1, 1988. After a series of bilateral talks, the
GSP applicability was renewed in exchange of Korean adaption of 6-4
year data exclusivity on September 1991.

The third round of the FTA talk between EU and Korea began this Monday
in Brusesels, but little progress mainly due to dissatisfaction of
both sides on offered tariff concessions.

--
HeeSeob Nam
IPLeft (www.ipleft.or.kr)
hurips@gmail.com
Tel.: +49 89 7240 2314
Geitauerstr. 4
81379 Munich, Germany