The Ministry of Health has completed the first stage of the assessment of EU legal acts under the self-screening procedure

In total, the Ministry’s experts have reviewed more than 1500 EU acquis in the field of healthcare. In the process of studying, 347 EU regulations were identified that require mandatory implementation into Ukrainian legislation.

“We have completed the initial self-assessment of the implementation of EU legislation. There is definitely a lot of work ahead. We are now starting consultations with partners, experts, and business to set priorities and draw up the most optimal roadmap for the implementation of EU directives and regulations,” said Maryna Slobodnichenko, Deputy Minister for European Integration. 

During the self-screening procedure, the Ministry of Health conditionally divided all EU healthcare legislation into 4 areas: public health, pharmaceutical regulation, medical services and medical education.

EU acquis that are subject to implementation

• Total: 347
• Public health: 259
• Pharmaceutical branch: 70
• Medical services: 16
• Medical education: 2

Most of the EU legal acts to be implemented into Ukrainian legislation are in the area of public health, with a total of 258 EU regulations and directives. Of these, 39 have already been fully implemented as part of the implementation of the EU-Ukraine Association Agreement. A significant part of the implementation of the EU acquis at the level of bylaws depends on the adoption of specialized laws, 24 acts have varying degrees of implementation, and work has begun on 5 acts of EU law.

In order to regulate the pharmaceutical sector in accordance with EU standards, a total of 71 acts of EU law must be implemented into Ukrainian legislation. Currently, 6 of them have been fully implemented, 27 acts have varying degrees of implementation, and 7 directives have been taken into account.

A total of 16 directives and regulations were identified in the area of medical services. Currently, 5 of them are fully implemented and another 5 are partially implemented.

The fewest acts of EU law requiring mandatory implementation were identified in the area of Medical Education – only 2 acts, one of which has already been implemented.

You can learn more about the results of the MoH self-screening in the presentation.

For reference:

Self-analysis of the level of compliance of national legislation with European acts is a key stage of preparation for EU accession negotiations. Self-screening allows the state to identify and eliminate weaknesses in its legal and administrative systems.

In general, the self-screening stage of national legislation during EU accession is a critical mechanism for ensuring legal compatibility, promoting harmonization, building institutional capacity, assessing progress, and promoting mutual understanding with the European side.

The next step is to prepare a report with proposals for the priority of implementation of EU regulations and directives based on the results of the self-screening. The government has provided 2 months for this – until 30 August 2023.