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EBA and Medicines for Europe signed a memorandum of agreement to accelerate Ukraine's integration into the EU pharmaceutical market


22 Jun 2023


Health & Consumers

EBA and Medicines for Europe signed a memorandum of agreement to accelerate Ukraine's integration into the EU pharmaceutical market

At the Ukraine Recovery Conference in London, the European Business Association and Medicines for Europe signed a Memorandum of Agreement to accelerate Ukraine's integration into the EU pharmaceutical market.

The Memorandum is aimed at identifying strategic areas of cooperation between the parties on opportunities to increase investment in pharmaceutical research and production, remove trade barriers between Ukraine and the EU (including through the conclusion of the ACAA Agreement on Medical Devices and GMP for medicines) and support the restoration of Ukraine's healthcare infrastructure.

In June 2022, Ukraine received the status of a candidate for EU membership. Since then, the obligations regarding the healthcare system in general and the pharmaceutical market in particular have become more stringent than they were under the Association Agreement between Ukraine and the European Union.

The Memorandum, among other things, covers such areas for further cooperation as approximation of Ukraine's regulatory environment to EU standards in the pharmaceutical sector, promotion of cooperation of national regulators, acceleration of Ukraine's integration into EU safety and quality systems, such as the European Medicines Verification System (EMVS, anti-falsification), EudraVigilance (pharmacovigilance), Eudra-GxP (quality compliance), integration into other relevant initiatives in the EU pharmaceutical industrial policy, and digitalisation of the industry. Special attention is proposed to be paid to the development of R&D and support for the development of clinical trials in Ukraine.

Thus, the regulation of the pharmaceutical sector in Ukraine is gradually moving towards EU standards. In 2022, the Ukrainian parliament approved the new Law of Ukraine "On Medicinal Products", which, among other things, aims to prevent the circulation of falsified medicines.

It should be noted that one of the steps on this way will be the introduction of a 2D-coded medicinal product verification system in Ukraine. Falsified medicines are a problem around the world, posing a serious risk to human health and safety. The Ministry of Health supports the implementation of a reliable and effective system that will prevent counterfeit drugs to enter the country's market.

Thus, for 2023, it is planned to sign a Memorandum of Agreement and cooperation between the Ministry of Health and market operators; finalise and approve a resolution of the Cabinet of Ministers of Ukraine that will regulate the verification of medicines with 2D coding; establish the National Organisation for the Verification of Medicinal Products (NOVMP); communicate with the European Commission on joining the Eurohub - which is actually what we are talking about.

"The implementation of the new drug verification system needs high-quality organisational preparation on the part of both the state and business. Therefore, the joint work continues. This is a very important instrument in many countries to guarantee the quality of medicines and prevent the spread of falsified products," said Maria Karchevych, Deputy Minister of Health for Digital Development, who is taking a part in the Ukraine Recovery Conference and was present when the associations signed the Memorandum.

Implementation of the medicines verification system in Ukraine is extremely important for the safety and quality of medicines for patients, protection of the interests of all stakeholders. And it is, as they say, doing our homework as part of our European integration aspirations.

«Businesses in Ukraine support the European integration of the industry and look forward to deepening cooperation with the Ministry of Health, regulatory authorities and the European side to implement EU best practices in this area and remove all bilateral regulatory barriers. Currently, the priority is to negotiate and conclude an ACAA agreement on medical devices and extend it to mutual recognition of GMP certificates for medicines. In addition, the key to the success of the post-war recovery of the pharmaceutical industry in Ukraine may be the priority in attracting and developing innovations in Ukraine, including clinical trials,» - said Anna Derevyanko, Executive Director of the European Business Association, during the signing of the memorandum.

«Since the onset of the invasion, generic, biosimilar and value-added medicines manufacturers have mobilised without hesitation to support the Ukrainian people. Medicines for Europe Members have donated over 1200 trucks loaded with urgently needed medicines to treat patients in Ukraine, while also engaging in several initiatives to aid displaced refugees. While we wish for a swift and just resolution to the conflict, we are also looking towards the future. We believe that Ukraine’s destiny lies with the European Union and we are ready to play our part in the accession process, as we had the opportunity to support several Member States in the previous EU enlargements. The partnership with the European Business Association is excellent and this Memorandum represents an important step towards an even closer cooperation aimed at improving health outcomes in Ukraine, promoting regulatory convergence and bolstering Ukraine’s recovery and competitiveness» said Adrian van den Hoven, Director General of Medicines for Europe.