ISSUES OF IMPROVING THE INSTITUTE OF CIVIL-LEGAL LIABILITY FOR VIOLATION OF LEGISLATION ON PHARMACEUTICAL ACTIVITIES

Abstract

This article systematically examines theoretical and practical issues of improving the institution of civil liability for violations of legislation on pharmaceutical activities. The relevance of the study is justified by the tragic situations resulting from the consumption of low-quality medicines in our country, the rapid growth of the pharmaceutical market, and the strategic tasks set to align the industry with international standards. Using the comparative legal method, the Product Liability Directive of the European Union, German legislation, the US doctrine, and special no-fault insurance models of Sweden and Japan aimed at compensating for damage caused by medicines were analyzed. As a result of the study, it was found that the mechanisms for protecting the rights of consumers of pharmaceutical products through tort liabilities in the national legal system are insufficient. As a result of the study, scientific and practical proposals aimed at improving the Civil Code and the Law “On Medicines and Pharmaceutical Activities” were developed. In particular, the introduction of a special strict liability regime for the manufacturer for the damage caused by the drug, the easing of the burden of proof in favor of the victim in courts, the insurance of the mandatory professional liability of pharmaceutical entities, and the introduction of the institution of collective claims protecting the rights of consumers are justified.