Russian Patent Laws Concern for Multinationals

Patent protection remains a major area of contention between the government and the international drug industry in Russia. Although improvements have been made in recent years, with a new bill on intellectual property protection passed in June 2002, heavy criticism continues.

Leading the criticism is the Office of the US Trade Representative (USTR) and PhRMA, the US research-based pharmaceutical trade association. The former has listed Russia as a "watch" country on its 2004 Special 301 Report on Intellectual Property Protection. In its submission, the USTR is strongly critical of the existing patent law, highlighting deficiencies in data exclusivity, enforcement and counterfeiting. Copy and counterfeit drugs are becoming an increasingly sizeable problem in Russia, with the government seemingly failing to stem the expansion of the illegal drug sector.

The abolition of the Department of Pharmaceutical Inspection as a result of the restructuring of the Ministry of Health in June 2004 does not provide grounds for optimism. The Ministry of Health was replaced by the Ministry of Healthcare and Social Development, and the new ministry has commented that no pharmaceutical inspection department is envisaged. The development comes as a notable blow to sector progress as the department had spearheaded the fight against counterfeit drugs, being responsible for the capture and withdrawal of hundreds of batches of banned and fake drugs.