[Ip-health] New Straits Times Online: Malaysia imposes terms on data exclusivity for US pharmaceuticals

[Thiru Balasubramaniam]

http://www.nst.com.my/Article/pp_index_html?did=3D20070419170049

FTA: Malaysia imposes terms on data exclusivity for US pharmaceuticals
By BERNAMA

20 April, 2007

Malaysia has set some conditions in agreeing to the U.S. request for
data exclusivity (DE) for new pharmaceutical products in the bilateral
free trade agreement (FTA) negotiations, Health Minister Datuk Seri Dr
Chua Soi Lek said today. Among the conditions: DE is for a five-year
period effective from the time a product obtains a DE from its country
of origin, and it can only be granted by Malaysia=92s National
Pharmaceutical Control Bureau (NPCB).

=93The U.S. wants DE for five years for pharmaceutical products and three
years for new clinical information,=94 he said.

=93The Malaysian government has adopted a stand, approved by the Cabinet
last year, that for new products the DE should only be for five years
and should be given at the same date as at the country of origin.

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Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)
voice +41.22.791.6727
fax +41.22.723.2988
mobile +41 76 508 0997
thiru@keionline.org