Transformation of the Ukrainian pharmaceutical market – new opportunities and potential Pharmaceutical Industry Review, September No 4 (97) 2023
of medicines. This is a very serious reform of the Ukrainian pharmaceutical sector, so we are also considering the possibility of joining the Twinning program and are already preparing terms of reference for such a project for the European Commission. This tool helps to get acquainted with the regulatory processes of one of the EU countries and integrate its practices into the national system. Not only European Commission institutions but also EU countries share their experience. We have already signed a memorandum of cooperation with the French Ministry of Health and held consultations on their European integration experience in the pharmaceutical industry in early September.
Are there any prospects for visa-free travel for Ukrainian products? What difficulties do you see and how can they be overcome?
When we talk about "pharmaceutical exports", we must, first of all, decide which paths are possible for Ukraine and which of them we will ultimately choose. There are two of them. This is either simplification of regulatory procedures by agreeing on mutual recognition of conformity assessment and acceptance of pharmaceutical products (MRA agreement) or expansion of the ACAA agreement through amendments to the Association Agreement with the EU, including pharmaceutical products in the Annex on conformity assessment. The first way is faster in terms of time and simpler in terms of procedures, but in practice, only one country – Israel – has been able to implement it. By the way, consultations are also planned with the Ministry of Economy of Israel on the country's experience in concluding MRAs. Which of the options we will ultimately choose and consolidate as a political decision needs to be discussed with the European Commission.
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Europeans also expect Ukrainians to simplify regulatory mechanisms. They want Ukraine to get authorized access to the Eudra GMDP database to be able to check inspections carried out abroad on companies that have already been issued GMP certificates. We are also working on this and plan to discuss it during our planned visit to the European Commission. But our unwavering position is that recognition of GMP certification should be reciprocal. Perhaps this argument will increase the EU's loyalty to the issue of extending the ACAA agreement to pharmaceutical products. However, we should not expect this to happen shortly. After all, the process of expanding the ACAA agreement is quite lengthy, as it depends on many procedures, especially on the part of the EU.
What can Ukrainian producers offer their EU partners? What government initiatives are contributing to this?
This is a question for our pharmaceutical manufacturers rather than for the Deputy Minister for European Integration. After all, it is the manufacturers who know their capacities, capabilities, and development plans in the medium and long term. I am sure that they can offer not only raw materials, co- production of medicines, or the sale of their production facilities to launch the production of European pharmaceutical companies in Ukraine, as Biopharma did in the past. As for the state's interests, we are interested in promoting the development of the pharmaceutical industry as much as possible, as it means new jobs, investments, and good opportunities for the post-war economic recovery of the country. The potential of our pharmaceutical industry is based, among other things, on the national regulatory system and its recognition by other countries. To this end, we are currently conducting a benchmarking
procedure using the WHO Global Benchmarking Tool. Our goal is to raise the national regulatory system to the third of the fourth levels of maturity, as well as to show that Ukraine has not lagged in regulatory procedures and has a well- established quality system. By the way, if we receive the third level of maturity from the WHO, it will give the green light to national manufacturers to produce vaccines for export. We are planning to conduct a similar assessment with the EMA – in early July, we received a questionnaire from them and will consider starting an audit according to EU standards next year. The results of the audit will also help us understand how to better integrate into the EU's single regulatory pharmaceutical space. This is important not only in the context of Ukraine's aspirations to join the EU but will also open up new opportunities for businesses to enter European markets. The same requirements for products and services, as well as regulations, will reduce the time, financial, and human resources required to export Ukrainian products to the EU. This is not an easy process, but our specialists, experts, and civil servants demonstrated high professionalism during a similar audit conducted by WHO standards (which is still ongoing) and once again confirmed the regulator's readiness to meet new challenges and implement best European practices. In the context of opportunities, Ukrainian pharmaceutical manufacturers can also offer their foreign partners to work together to develop innovative medicines. Investing in a progressive country that is rebuilding and creating better than it was before is quite promising. By the way, at the Ukraine Recovery Conference held in London at the end of June, it was announced that risk insurance mechanisms were being developed to attract investment in Ukraine. This may potentially interest foreign investors
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