EBA insists on decriminalization of violations in clinical trials, medicine registration areas
The European Business Association (EBA) has pointed out the necessity of decriminalizing violations of the rules of preclinical study, clinical trials and the public registration of medicines.
The EBA Health Care Committee posted an open letter sent to the Ukrainian prime minister, heads of profile parliamentary committees – the healthcare committee and the committee for legislative support for law enforcement – on the EBA website.
According to the association, Article 321-2 of the Criminal Code, providing for criminal liability for violations of the order of preclinical study, clinical trials and public registration of medicines, was adopted primarily to improve the effectiveness of combating illicit drug trafficking and their falsification. The article "actually established the same criminal responsibility for violations with varying degrees of threat to public security" - illegal trafficking, falsification of medicines, as well as violations of the procedure for preclinical studies and clinical trials. These latter, in the opinion of the association, are procedural violations, and the envisaged criminal liability for them instead of administrative penalty on physicians, workers of pharmaceutical companies, experts in examination of registration materials, as well as materials of preclinical study and clinical studies, "the affordability of medicines on the territory of Ukraine and the image of Ukraine as a reliable country for the implementation of science-intensive projects of clinical research" depends on the quality of the work of whom.
At the same time, a reduction in the number of studies deprives critically ill patients of access to innovative medicines, and medical workers – of access to information about innovative methods of treatment.
In addition, the fact that there is a potential application of the article for procedural violations to the leading international manufacturers of innovative drugs and drug developers "rooted in the idea that the placement of clinical trials in our country carries very high risks." As a result, some pharmaceutical companies no longer consider Ukraine as a potential location for conducting clinical trial projects.