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Maryna Slobodnichenko: European Commission expects Ukraine to strengthen its fight against counterfeit medical products

18 September 2023

Counterfeiting of medicines and medical devices is a serious problem that is widespread not only in Ukraine but also around the world. Low-quality medicines not only endanger patients’ lives and deprive them of the opportunity to receive effective treatment, but also undermine confidence in evidence-based medicine and the healthcare system in general.

Deputies, representatives of the Ministry of Health, the State Service of Ukraine on Medicines, the Prosecutor General’s Office, the Security Service of Ukraine, the National Police, patient organizations and business representatives gathered at a roundtable organized by the American Chamber of Commerce to discuss problematic issues and strengthen coordination in the fight against and prevention of counterfeiting of medical products. 

“Strengthening the fight against counterfeiting in the medical sector is one of the three main requirements of the European Commission to the Ukrainian pharmaceutical industry. This issue was a cross-cutting one during all our meetings in Brussels. We are moving in this direction both at the level of legislative norms and initiatives and at the level of implementation of practical solutions. Currently, we are working with the relevant committee to speed up the implementation of the new law “On Medicines”, which, among other things, provides for the establishment of a national system of verification of medicines in Ukraine. In addition, the committee is considering a very important draft law on improving liability for violation of the clinical trials procedure, which is very important for the resumption of international clinical trials in Ukraine, which were lost due to the full-scale military invasion,” said Maryna Slobodnichenko, Deputy Minister for European Integration, in her speech. 

Business representatives support the initiatives of the Ministry of Health, especially the creation of a national system for the verification of medicines and the introduction of 2D coding. They are convinced that this is one of the most effective methods of preventing drug counterfeiting. However, no law, electronic system or coding will be able to prevent counterfeiting unless a system of legal control and accountability is established in Ukraine. That is why it is very important that lawmakers, the relevant ministry and law enforcement agencies work in a coordinated manner. After all, despite the fact that Ukraine has criminalized the falsification and distribution of counterfeit medicines, there are very few cases of prosecution for these crimes.

To summarize, the Ministry of Health, together with the Verkhovna Rada Committee on National Health, Medical Assistance and Health Insurance, is currently working on several legislative initiatives to implement some of the provisions of the Council of Europe Convention on the Counterfeiting of Medical Products (Medicrime Convention), the first international legal instrument on global cooperation in combating counterfeiting of medicines and medical products.

Thus, two draft laws have been registered, which, in particular, aim to implement certain provisions of Medicrime: Draft Law No. 5815 on improving liability for violations of the procedure for conducting clinical trials and state registration of medicines in Ukraine and Draft Law No. 9500 on criminalizing illicit trafficking of medicines in Ukraine.

In addition, the government's draft law on medical devices is currently at the final stage of development in the Verkhovna Rada Committee on National Health, Medical Assistance and Medical Insurance. The adoption of the draft law will not only allow for the implementation of EU Regulations 2017/745 and EU 2017/746 into national law, but will also serve as the basis for the implementation of the Convention on the criminalization of counterfeit medical devices.