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PROGRESS STALLED ON ARGENTINE DRUG PATENT REFORM

January 17, 2005

Although Argentina's pharmaceuticals market is widely estimated to have stabilised in recent months, following the country's comparatively rapid recovery from its recent economic crisis, regulatory reform appears deadlocked. Further, it appears that despite improving conditions, the government is likely to continue to cite the possible impact of reform on the poor, largely for political purposes.

The concept of patent protection is a relatively new one in Argentina, with the filing of pharmaceutical patents permitted only since 1995. Although a number of steps have since been taken to improve patent protection for pharmaceuticals, the issue remains the cause of much tension between the government and the international drug industry. A key area of contention is generics, with companies questioning the legality of much generic output, as unauthorised copying is common. Further, current regulations oblige doctors to prescribe drugs according to their chemical names, which although originally intended as a familiarisation exercise, may have eased penetration of nonbranded products.

The Office of the US Trade Representative and the US research-based pharmaceutical trade association PhRMA have continued to lead criticism of drug industry legislation. Argentina is listed as a "priority watch" country by the former, a status which has remain unchanged in recent years, suggesting little development in the area. Although the government has amended regulations to protect products obtained from a process patent, implementing a May 2002 US-Argentina agreement, and has put in place fast-track procedures for patent applications, many industry groups claim patent law fails to comply with the country's international obligations.