French government to assist the Ministry of Health in implementing European directives and reforming the pharmaceutical sector

The main purpose of the consultations is to get advice and assistance in the European integration processes, in particular for the successful implementation of mandatory directives and regulations in the pharmaceutical sector. The French experts will share their experience on how their national regulatory system monitors compliance with EU requirements for medicines in practice, and will provide recommendations on specific steps that the Ministry of Health should take in the status of a candidate country. The first such meeting is scheduled for the end of August.

“The self-assessment of national legislation in accordance with EU law showed that about 50% of the norms of EU law in the pharmaceutical sector have been implemented so far, that is, there is still a lot of regulatory work to be done. In addition, the European integration of the pharmaceutical industry involves the creation of a single regulatory authority in the field of medicines. This is a prerequisite for connecting the national pharmaceutical system to the EU’s unified drug regulatory system. Currently, we understand the general functionality and tasks of the future body, but the detailed business processes have not yet been defined. In order for the future national regulator to be as effective as possible, it is important for us to familiarize ourselves with the practical functioning of the pharmaceutical regulatory authorities of the EU countries and implement the most relevant practices for us,” said Maryna Slobodnichenko, Deputy Minister for European Integration.

In the process of preparing for the reform of the pharmaceutical industry, the Ministry of Health is seeking to join the Twinning program. That is why one of the objectives of the planned consultations is to help prepare for this program - French experts will advise on how to use the opportunities of the Twinning program correctly and successfully.

It should be recalled that on 15 April 2023, the Ministry of Health of Ukraine and the Ministry of Health and Prevention of France signed a declaration of cooperation. One of the priority areas of cooperation is to support Ukraine’s integration into the EU healthcare system, in particular, to maintain a regular dialogue on issues related to Ukraine’s accession to the EU.

For reference: The introduction of the Twinning instrument was launched by the European Commission in 1997 in the context of the European Union’s enlargement. This new institution-building tool was created to integrate EU legislation into the legislation of the beneficiary countries. To date, more than two thousand Twinning projects have been implemented.

Twinning aims to help beneficiary countries improve and strengthen the administrative functioning of public authorities, their structure, human resources, and management capacity, which should facilitate the implementation of the EU acquis (EU law).

The defining feature of the Twinning project is the direct exchange of specific experience in a particular area of state regulation with a view to implementing EU norms and standards. Twinning projects include such activities as consulting (on drafting laws, organizational and informational issues, etc.), trainings, study tours, and internships.