An Executive Country Review: South East Asia An ... - EC Reviews

For once, casting originators against
generic players might end up strengthening
the industry across the board.
ing a flex-twinning system among countries
with similar setups. These efforts will
bring many opportunities to the region
and its players, even if they will be taken
primarily by those who had the foresight
to turn their organizations into globally
able companies. A unified market of more
than 500 million potential customers is
clearly a mouth-watering prospect for
most regions leaders and their challengers,
but it might come with strings attached.
Exclusivity versus AFTA
While the application of a free-trade
agreement is being discussed on a bilateral
level between Malaysia and the United
USEFUL CONTACTS
Indonesian Pharmaceutical Association
Jakarta, Indonesia (GP FARMASI)
Tel: +62 21 420 3040
www.gpfarmasi.org,
Malaysian Organization of Pharmaceutical
Industries, Petaling Jaya, Malaysia, (MOPI)
Tel : + 603 7957 3070/1004
www.mopi.org.my
Singapore Association of Pharmaceutical Industries,
Singapore (SAPI)
Tel: +65 67 38 0966
www.sapi.org.sg
The Singapore Pharmaceutical Manufacturer’s
Council, Singapore, (SPMC)
Tel: +65 6826 3000
www.smafederation.org.sg
Philippine Chamber of the Pharmaceutical Industry,
Inc. Manila, Philippines, (PCPI),
Tel: +63 2 535 4835
www.pcpi-org.com
Thai Pharmaceutical Manufacturers Association,
Bangkok, (TPMA),
Tel: +66 28 63 5106
States, future members of AFTA (who
must review their existing agreement with
the United States before full entry into
AFTA) have looked at their Malaysian
neighbors with apprehension as the issue
of data exclusivity has been brought forward
by the United States during the discussion.
These issues has triggered a wave
of concerns across the Southeast Asian industry.
The data at stake are all the test
data (i.e., clinical data) that were produced
by the originators in the course of the new
molecule’s development.
Because it appears that in any FTA
signed before mid-2007 the US Trade Representative
is legally obliged to obtain USsimilar
standards of intellectual property
protection with the signatory country, the
threat lurking in the almost exclusively
generic industry is clear. The United
States has the highest and most onerous
intellectual property standards in the
world, so Malaysia and other Southeast
Asian countries would need to raise their
intellectual property protection standards
significantly. Following the latest round of
trade talks undertaken by the World Trade
Organization, the Doha declaration estab-
88 Pharmaceutical Technology SEPTEMBER 2006 www.pharmtech.com