Business welcomes registration of the draft law on differentiation of liability for violation of the procedure of clinical trials and drug registration
On July 21, the Verkhovna Rada of Ukraine registered a draft Law on Improving Liability for Violation of the Established Procedure for Preclinical Study, Clinical Trials, and State Registration / Re-Registration of Medicines (№5815), initiated by the EBA Health Care Committee. It should be noted that the document is long-awaited in the pharmaceutical industry.
The development of new drugs, their clinical trials, and the rapid registration of innovative drugs are the driving force in providing the latest health technologies. Bringing clinical trials of innovative drugs to Ukraine, as well as developing domestic products in medicine and pharmacy are necessary for Ukrainian health care and is also important for access of patients, in particular with severe or rare diseases, to effective modern drugs.
According to the EBA Health Care Committee and Clinical Trials Subcommittee experts, the formal violation of the procedure for conducting preclinical studies, clinical trials, state registration, for which Article 321-2 of the Criminal Code of Ukraine introduces criminal liability, does not correspond to domestic and international practice. Also, it does not have positive consequences for citizens and the state, as it does not fulfill the declared purpose and has no direct connection with the possible sales of counterfeit medicines or with a threat to human life and health or harm to the state.
The existence of criminal liability for formal procedural violations creates undesirable pressure on physicians, employees of pharmaceutical companies, subjects of clinical trials in the public and private sectors, public experts. This in turn creates obstacles for individuals and institutions, involved in clinical trials or in the registration / re-registration of medicinal products, to assume responsibility for the consequences of such a procedure. It also slows down the development of innovative drugs in Ukraine by both international pharmaceutical companies and domestic manufacturers, which is endangering, especially for patients with severe diseases related to cancer, hematology, orphan diseases, etc., for whom participation in clinical trials is the only opportunity to receive high-quality treatment of the European level and to be treated free of charge with innovative drugs.
To date, the body of a criminal offense under Article 321-2 of the Criminal Code is formal. Thus, the prosecution of a person does not require the occurrence or real threat of socially dangerous consequences, just the fact of any violation of preclinical studies, clinical trials, and state registration medicines, which may manifest itself even in certain technical or editorial inconsistencies.
Meanwhile, it should be noted that judicial statistics from 2012 to 2020 under Article 321-2 of the Criminal Code are missing. That is, under this article, there was no one convicted at all for a certain period. So, this article is in fact ineffective but can be used to put pressure on the industry workers.
Based on the provisions of the Law of Ukraine “On the National Program for Adaptation of Ukrainian Legislation to European Union Legislation” concerning the compliance of Ukrainian legislation with the European Union in priority areas, EBA experts draw attention to the lack of criminal liability for procedural violations in this area following the European practice. Instead, in the EU countries, administrative liability is provided for such actions.
It is expedient to clearly define in Article 321-2 of the Criminal Code that a person is subject to criminal liability under this article only in the case of intentional acts that caused the death of the victim or other serious consequences. In case of negligent actions that led to such consequences, the person will be liable under other articles of the Criminal Code, the punishment of which will correspond to the severity of the crime. Besides, it is advisable to clearly state in the disposition which actions are criminally punishable without the possibility of their ambiguity, as well as to give a clear definition of the “falsification” concept.
Making amendments to Article 321-2 of the Criminal Code with a view to properly differentiate the degree of punishment for relevant offenses, specify the actions that fall under the sanction of this article, and determine alternative types of punishment for procedural violations, will also have a positive impact on harmonization of Ukrainian legislation with the Council of Europe Convention on the counterfeiting of medical devices and similar crimes threatening health care, dated 28 October 2011 (MEDICRIME Convention).
In view of the above, the EBA Health Care Committee together with the Subcommittee on Cancer Prevention and Control of the Verkhovna Rada Committee on National Health, Medical Care and Health Insurance, as well as legal partners, Arzinger and CMS CMNO, developed proposals for amendments to Article 321-2 of the Criminal Code. They concern the harmonization of terminology, some new wording, as well as amendments to the Code of Administrative Offenses of Ukraine in order to improve liability, establish alternative penalties for violation of the established order of preclinical study, clinical trials, and state registration / re-registration of medicines and bringing Ukrainian legislation into line with international law, as well as practices and legislation of the European Union.
We thank the People’s Deputy of Ukraine Valery Zub, the Chairman of the Subcommittee on Prevention and Control of Oncological Diseases for developing the draft, the MPs, and the profile Committee of the Verkhovna Rada for support and registration of EBA proposals in the Verkhovna Rada. We hope that the Parliament will support this draft law.
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