Because it appears that in any FTA signed before mid-2007 the US Trade Representative is legally obliged to obtain US-similar
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 established the use of trade-related
aspects of intellectual property rights (TRIPS) agreements and reinforced the importance of access to medicines while reaffirming
the ability of governments to use the flexibilities available in TRIPS to ensure the affordability of medicines.
Now the United States is pushing for what is commonly referred to as "TRIPS-Plus" allowing for a period of data exclusivity
of up to 11 years beyond the date a generic version of a product would normally begin to compete with the patent holder.
According to a letter highlighting a Thai survey and sent by the president of a Malaysian consumers association to the Malaysian
Minister of Health in March 2006, "The Thai Ministry of Health has done a study of the predicted impact of the TRIPS-Plus
provisions found in US FTAs. It found that if generics were prevented by data exclusivity from entering the market for a period
of ten years beyond the date when patents normally expire, this would cost an extra $5400 million (at wholesale prices) per
year which is 77% of the current total Thai health expenditure."
Furthermore, the adoption of TRIPS-Plus provisions would greatly harm the development of the local pharmaceutical industry,
which relies on being able to produce bioequivalent products for its markets under the current protection of the TRIPS system
and the other intellectual property protection mechanisms.
This will be a sticky situation if the negotiation favor international originators as opposed to local generic manufacturers
in Southeast Asia. It is also a test of the ability of the industry to mobilize itself across the region, while facing a common
threat. Beyond this issue lies opportunities to strengthen what is today a multitude of medium-size players with different
business agendas into a more solid, forward-thinking and opportunities-grabbing industry. In turn, this should offer plenty
of areas of possible cooperation between international companies, particularly US and European, and the movers and shakers
who will emerge from these trying times. For once, casting originators against generic players might end up strengthening
the industry across the board.
This report was prepared by Executive Country Reviews. Authors are Gilles Valentin email@example.com
Emmanuelle Berthemet firstname.lastname@example.org
Marco Parigi email@example.com
Amicie de Bodinat firstname.lastname@example.org
and Yaz Yazicioglu email@example.com