On January 21 EBA Health Care Committee representatives held a meeting with the Head of VRU Committee on Public Health, Medical Assistance and Medical Insurance Mykhailo Radutskyy, the Chairperson of the Sub-committee on Pharmacy and Pharmaceutical Activities Serhii Kuzminykh and the Chairman of the Subcommittee on Prevention and Control of Oncological Diseases Valeriy Zub.
Summarizing 2021, business expresses its gratitude to VRU representatives for effective cooperation in development of the Draft Law No.5547 “On Medicines”, whereby the legislation on medicines circulation, clinical trials can be modernized to ensure quality, effectiveness and safety of medicines.
Among the priorities for 2022, the importance of the following 7 initiatives was highlighted.
First, the importance of joint work with business on the Draft Law “On Medical Devices” was noted, as it is the first integrated document in this field.
Second, continued complex update of pharmaceutical legislation, in particular the alignment of criminal legislation with the provisions of the MEDICRIME Convention, complete adjustment of powers of the new state control authority to be established under the Draft Law No.5547, liability for violation of verification system requirements, etc. Such initiatives were supported by representatives of the relevant VRU Committee.
Third, the issue of VRU registration of the new Draft Law No.6535 regarding applicant, marketing authorisation holder (MAH), initiated by MOH. Under the Draft Law is stipulated that MAH can be only a legal entity registered in Ukraine, with a transitional period of regulation implementation for less than 1 year. EBA has already expressed disagreement with this MOH initiative (the initiative appeared not for the first time). Such proposals also contradict the provisions agreed by the VRU Committee under the Draft Law No.5547 and do not comply with the EU regulations. Therefore, it is important to ensure coherence of the state policy in this matter.
Fourth, it was agreed that VRU representatives will assist in resolving the crisis situation in implementation of GMP confirmation procedure by the State Service of Ukraine on Medicines and Drugs Control, which unfortunately has not been resolved for almost 1.5 years. For its part, EBA has already submitted its proposals to stabilize the situation and the relevant draft amendments to the MOH Order No.1130 have already been posted on MOH website for public discussion, however, later another text appeared on the site, which undoes positive amendments.
Fifth, the issue of providing the citizens of Ukraine with necessary medicines under the Program of Medical Guarantees to be settled in the near future under the Draft Law No.6306 (with the relevant EBA proposals to postpone the entry into force of Article 10 – in order to have time for adoption of a new positive list of medicines, that will replace the current NLEM). EBA expresses hope, that it will be considered in the session hall soon.
Sixth – clinical trials issue (CT). In particular, the development of a separate Law of Ukraine “On Clinical Trials”whereby there are to be defined the general requirements for different CT types, unified and modernized their regulations. Apart from that, the recent changes in clinical trials in the EU (entry into force of EU Regulation №536/2014) are also to be taken into account. Thus, active actions are already needed for improvement of the national legislation to maintain the competitiveness of CT sector and prevent a decrease in CT number in Ukraine.
Seventh, an access issue of critically ill patients for the treatment with unregistered medicines in Ukraine (patient access programs for investigational medicines for continued treatment after CT and compassionate medicine programs), the procedure and terms of their application. It is regulated by the Draft Laws No.5736 and No.5737, developed on EBA HCC initiative. Therefore, we look forward to their adoption this year.
The European Business Association expresses its sincere gratitude to Mykhailo Radutskyy, Serhii Kuzminykh and Valeriy Zub for constructive dialogue and initiatives implemented. We look forward to continued effective cooperation for improvement of conditions for transparent business and establishment of a modern health care system in Ukraine.
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