PROTECTION OF INFORMATION ON THE RESULTS OF PRECLINICAL AND CLINICAL TRIALS: LEGAL ASPECTS

The author made a systems analysis of the legal nature of the juridical mechanisms enshrined in Russia’s legislation, which protect information on the results of preclinical and clinical drug trials. He concretely defined their general characteristics and comparatively analyzed the main mechanisms for juridical protection of the above information – a commercial secret regime and an information exclusiveness regime. There was evidence for the conclusion that the above regimes had varying legal nature and were independent of each other (their erroneous identification may be encountered in the legal literature), which can give rise to different legal implications in their violations. The main requirements to be followed when introducing the commercial secret regime are detailed. The ratio of drug designers’ commercial interests to public interest in citizens’ health care regarding information on the results of studies is considered.