Russian accord on human bio-exports

1 July 2007

The Russian Ministry of Health and the country's customs service (FTS) have published a new agreement defining the rules for the export of human biological specimens from Russian and ending a controversial ban which health care specialists said threatened the health of patients.

Russian drug enterprises, together with other sectors of health care, had argued that, in cases where diagnosis or analysis for treatment could only be done in western countries and in cases of clinical trials, patients faced dangerous delays and disruption to their treatment. The new rules effectively end the ban on the export of specimens used for clinical trials of new drugs, those forming part of an international exchange and specimens for laboratory analysis.

Pharmaceutical companies will have to wait a short time for the new regime to come into full operation, as the new regulations have to be processed by the Justice Ministry. However, the industry has welcomed the "U-turn" which enables a large number of Russian people to get new and innovative drug treatments under clinical trial conditions.

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