Maryna Slobodnichenko: Successful reform of the pharmaceutical sector directly depends on Ukraine’s integration into the EU healthcare system

The Ukrainian healthcare system is facing an ambitious goal to reform the pharmaceutical sector: to implement EU legislation and create a new single regulatory authority in line with the best European standards.

Regular dialogue between Ukraine and the EU Member States and relevant EU institutions in this regard is currently one of the Ministry’s priorities. This was stated by Maryna Slobodnichenko, Deputy Minister of Health of Ukraine for European Integration, during the first meeting of the Ministry of Health’s working group on strategic advice on the establishment of a state control body in the pharmaceutical sector (hereinafter also referred to as the SCB), which will serve as an Advisory Board.

“Implementation of European practices and standards in Ukraine is of utmost importance. European integration of the pharmaceutical industry involves both harmonization of Ukrainian legislation with EU legislation and creation of a single regulatory body in the pharmaceutical sector. Our pharmaceutical industry has quite a lot of potential, so the creation of a single national regulatory authority in line with the best European standards will have an effective impact on its development. This will make it possible to integrate the national pharmaceutical system into the EU’s unified drug regulatory system. In addition, it is necessary to introduce transparent rules of the market, ensure the fight against counterfeiting of medicines and guarantee compliance with European values and standards. The Ukrainian healthcare system is ready to share experience and implement the most relevant EU practices,” said Deputy Minister of Health Maryna Slobodnichenko.

The establishment of the state control body implementing the state policy in the field of creation, market authorization, quality control, safety and efficacy of medicinal products is provided for by the European Integration Law “On Medicinal Products” and defined by the recommendations of the European Commission as a prerequisite for Ukraine to become an EU member state. This will ensure the establishment of European standards for the system of market authorization and control over the circulation of medicines, medical devices and other medical products.

During the meeting, the participants determined the next steps in establishing a state control body in the pharmaceutical sector, in particular:

• determining the scope of regulation — medicines, medical devices, cosmetic products, blood donation and blood components, blood system functioning, narcotic drugs, psychotropic substances and precursors, etc;
• ensuring transparency of work — advice on building a proper transparent structure of the authority’s work;
• balance between the interests of business and the regulatory authority in determining the cost of the authority’s services — determining the optimal model of financing and costing of services.

The main goal of the Advisory Board’s activities in the process of establishing the SCB is to take into account the position and recommendations of international experts, to attract European and global experience to create a transparent and independent state control body in the pharmaceutical sector.

Through dialogue with European partners and consulting with the Ukrainian side, it will be possible to inform the European community about the reform of the pharmaceutical sector in Ukraine and the results of the work. The position of the experts during the Advisory Board meetings will be the basis for further steps in establishing the SCB and will be taken into account by the Ukrainian side.

Currently, the Ministry of Health is actively working on the preparation of the legislative acts necessary for the implementation of the reform. It is expected that in the future, the exchange of the required knowledge and regulatory experience will begin to implement EU norms and standards within the framework of the Twinning project, etc.

For reference. The Advisory Board consists of: Emer Cooke (Executive Director of the EMA (European Medicines Agency), Lembit Rago (MD, PhD, Secretary General of the Council of International Organizations of Medical Sciences (CIOMS)), Rainer Becker (Director for Medical Products and Innovation, Directorate-General for Health and Food Safety, European Commission (DG SANTE)), Krzysztof Landa (Advisor to the Minister of Health of Ukraine, former Deputy Minister of Health of Poland), Robin Martz (Director of the USAID Office of Health in Ukraine), Mykhailo Radutskyi (People’s Deputy of Ukraine, Head of the Verkhovna Rada Committee on National Health, Medical Assistance and Medical Insurance), Olha Stefanyshyna (People’s Deputy of Ukraine, Head of the Subcommittee on Adaptation of Ukrainian Legislation to EU Law, Verkhovna Rada Committee on National Health), Roman Vashchuk (Business Ombudsman).