Almost six months ago you started your work as Deputy Minister of Health of Ukraine for European Integration. A lot has already been done during in such a short time, but there is still a lot to be done. Please tell our readers more about the roadmap for adapting Ukraine's current healthcare legislation to the requirements of EU directives and regulations. What is the current stage of its development and implementation?
On 30 June, we completed a serious stage of work - a self-analysis of the level of compliance
of national healthcare legislation with European acts. Initially, we identified about 600 acts that the Ministry of Health had to analyze, but in the course of the review, the number of acts increased
to more than 1500.
In general, the results of the self-screening were pleasing. We have seen a positive trend: 319 EU acts require mandatory implementation, of which 43 directives and regulations have already been fully implemented into national legislation as part of the implementation of the Association Agreement, and another 60 are currently in progress. This means that more than 30% of EU law is already part of Ukrainian healthcare regulation. We have divided the entire array of EU acts into four groups in order to systematize them: public health, pharmaceutical regulation, medical services, and education. The largest number of directives and regulations that have not been implemented in Ukrainian legislation at all belong to the public health system. It is worth noting here that even though public health is a very broad concept that covers many areas, we face a serious but not impossible task. For example, about 150 EU acts deal exclusively with biocides. This means that a single order is enough to implement all these standards and requirements.
The scope of "Europharmaceutical regulation" covers the specifics of registration of medicines
and recognition of Good Manufacturing Practice (GMP) certificates, which is our goal for obtaining a "pharma visa", as well as directives and regulations governing such industry issues as clinical trials, pharmacovigilance, medical technology assessment, Good Laboratory Practice (GLP), medical devices, cosmetic products, etc. The good news is that about 50% of the EU legislation regulating the pharmaceutical industry has already been partially implemented. In order to take into account all possible risks of the rapid process of bringing Ukrainian legislation in line with the European one, we have launched a series of consultations with business representatives, international partners, and healthcare experts. We have already held three meetings with representatives of the pharmaceutical industry to discuss further steps to implement EU directives and regulations, in particular those related to the verification of medicines, medical devices, and clinical trials. We look forward to effective cooperation to ensure that the roadmap for European integration changes and reforms is not a surprise for everyone but truly meets the industry's capabilities. The first outlines of the roadmap were provided
to the Government in a report on the results of the self-screening on 30 August this year. Based
on such reports received from all ministries, the Government will develop a detailed National Programme for the Implementation of EU Legislation.
What initiatives by European regulators will help accelerate the European integration of the pharmaceutical sector?
The three years of the COVID-19 pandemic have highlighted the vulnerability of the European healthcare system – its dependence on imports of basic medicines and ingredients for the manufacture
of medicines from China and India. When these countries imposed export restrictions to supply their domestic markets, Europe faced a shortage of medicines.
The EU reached the relevant conclusions, which in turn prompted the European Commission to review its entire pharmaceutical policy – this year in April it announced the launch of an unprecedented reform. The reform is primarily aimed at increasing access to medicines and supporting innovation, competitiveness, and development of the pharmaceutical industry. The EU is also talking about alternative sources of supply of medicines and raw materials. In this regard, our country is not only geographically attractive but also has a fairly strong pharmaceutical industry. At least three areas are promising in Ukraine: export of generic medicines produced in Ukraine, development of clinical trials, and formation of a strategic hub for investment in the construction of pharmaceutical plants.
The EU's interest will contribute to the European integration of the Ukrainian pharmaceutical sector, as this fact will encourage the European Commission to pay attention to the quality system of Ukrainian producers and regulatory authorities. The role of a pharmaceutical exporter to the EU and investments in the development of medicines production will strengthen our economy, so this issue will also be a priority for the Ukrainian government.
What promising areas of cooperation do you see and will you pay attention to?
I would like to note that the Ukrainian pharmaceutical sector is quite powerful because it is thanks to the domestic production of medicines that we did not face a shortage of medicines either during the pandemic or at the beginning of the full-scale invasion.
The national pharmaceutical industry is focused on the production of generic drugs. Ukrainian generics are correspond to high quality standards affordable and therefore can be competitive on the European market. However, we currently face a very serious obstacle – the non-recognition of Ukrainian GMP certificates in the EU. As a result, our pharmaceutical companies need to undergo a double GMP audit – first in Ukraine, and then at the level of EU member states. The sale of Ukrainian medicines in European countries and is significantly complicated and is resulted in a significant increase in the price of medicines, which makes Ukrainian pharmaceutical products uncompetitive in the EU market.
But despite this obstacle, Europe is interested in having access to Ukrainian generic drugs. That is why one of our top priorities for the pharmaceutical industry is to expand the ACAA agreement to cover pharmaceutical products and mutual recognition of GMP certificates. As an alternative, faster option, a separate conclusion of the Conformity Assessment Recognition Agreement (MRA) may be possible – Israel, for example, has such experience of cooperation with the EU.
Coming back to the EU's pharmaceutical reform, another promising area for establishing cooperation is attracting investment in the construction of plants in Ukraine, as well as joint contract manufacturing.
We are open to attracting investment in global projects and helping our pharmaceutical market expand into larger export markets. These are additional opportunities for the post-war economic recovery of our country.
Another promising industry is clinical trials. Ukraine has every chance of becoming a center for researching new drugs for international pharmaceutical companies. After all, our country has many attractive factors for sponsors: a developed and extensive clinical trials infrastructure, qualified personnel, a large pool of patients, and relative cost-effectiveness of conducting trials compared to other European countries. We strive to develop this area and that is why we plan to promote Ukraine as a place where clinical trials can be conducted safely and efficiently.
The state has a dual interest in the development of clinical trials: firstly, it is an investment in the pharmaceutical industry and the Ukrainian economy, and secondly, it enables to expand access to innovative treatment, which is completely free of charge for Ukrainian patients within the framework of trials.
You have held many meetings with businesses and regulators. What requirements and suggestions should be taken into account in the first place? What changes to the legislation should be made?
My main tasks at the Ministry of Health are to address the issues of European integration of the healthcare system in line with EU norms and standards. As soon as we complete the self-screening procedure and understand which legal acts still needed to be implemented, we will start holding regular meetings with business representatives, international partners, and healthcare experts. Together we are working on a roadmap for the implementation of EU acts into national legislation, analysing all the benefits and risks of accelerating this process. Such contacts are very important for businesses to have time and opportunity to prepare for the new requirements and standards that apply in the EU, and for the Ministry of Health to solve all problems and take into account the nuances that the industry may face when all the innovations come into effect.
By the way, thanks to such meetings, we also feel that we have a priority, for example, enforce several provisions of the new law "On Medicines". I would like to note that many important provisions contained in this law were frozen during the war. We are talking about the creation of a new regulatory body and a national system for the verification of medicines. We need to work on this now, so it may be worth reconsidering the timing of the law's entry into force.
Another important area that we are actively working on is the new Law on Medical Devices, and the implementation of regulations on medical devices is also under active development. Work is underway
to bring the regulation of dietary supplements closer to European integration.
How do you involve representatives of regulatory authorities from other countries?
Currently, we have prioritized our efforts to establish cooperation not only with the regulatory authorities of other countries but also with the main EU institutions. In September, we plan to make our first working visit to Brussels and Amsterdam to meet with the relevant agencies and directorates of the European Commission, in particular the European Medicines Agency (EMA), the European Health and Digital Agency (HADEA), the Directorate-General for Internal Market, Industry, Entrepreneurship, Small and Medium-sized Enterprises (DG GROW) and the Directorate-General for Health and Food Safety (DG SANTE).
Our objectives are to strengthen interaction and discussions on Ukraine's participation in the Instrument for Pre-Accession Assistance (IPA) program, exchange of experience and coordination with EMA committees, recognition of GMP certificates and simplification of regulatory procedures, transition of Ukraine to the electronic format of submission of registration dossiers for medicinal products (eCTD), and strengthening cooperation in conducting clinical trials.
We are also planning to discuss the creation of a single regulatory authority to control the circulation 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 visaВfree 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.
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 in localizing the production of their pharmaceutical products in our country and in establishing cooperation with domestic pharmaceutical manufacturers in other areas.
What is the current stage of development of the medicines verification program? Which healthcare experts are involved in this process?
As you know, in early July, the Ministry of Health and representatives of the pharmaceutical industry signed a memorandum on the implementation of a national drug verification system. As part of this agreement, we expect to cooperate with businesses actively. Establishing cooperation and dialogue with the European Medicines Verification Organisation (EMVO), which I am working on, will help to create a system for verifying medicines by EU standards. In particular, it will be very important to interact with them when writing the terms of reference for the creation of a national electronic system for the verification of medicines. At present, while Ukraine is still a candidate for EU membership, we cannot immediately join the single European verification system, which is why our task at the development stage is to take into account all the technical nuances that will allow us to integrate the national system into a single data exchange space with the EU in the future. By the way, this is exactly how the system for exchanging information on the verification of medicines between EU countries is structured: each country has its national electronic verification system, which is synchronized with a single European hub.
Ukraine will definitely join this hub. Perhaps it will be possible to do so even faster than gaining EU membership. However, there are certain difficulties because joining this hub entails financial costs. Usually, countries bear these costs for the pharmaceutical business, so it is important to understand how much it will cost the pharmaceutical industry as a whole and when the pharmaceutical business will be technically ready to join this hub. We see that Ukrainian manufacturers are eager to associate with a European verification organization. The main thing is to develop a roadmap and get confirmation from the Europeans that they are waiting for us now, not when we become full members of the EU.
In your opinion, is export development on the agenda?
Of course, the development of exports is quite timely. The Ukrainian pharmaceutical industry has high-quality production processes, and the system of state regulation is also at an appropriate level.
The focus on exports is not just timely, it is a necessity. Today, as long as we are in a state of war, the state must ensure both the strengthening of military capabilities and plan for the reconstruction of the country. All of this requires money, i.e. a capable economy for all Ukrainian businesses. The country's export orientation means increasing our GDP, i.e. the funds that the country needs right now. In addition, export development implies expansion of production capacities, and thus the creation of new jobs, which has also become particularly important due to the consequences of the war – reduction of production in large industry and the agricultural sector, forced internal resettlement.
There are also quite pragmatic business motivations that confirm the relevance of export development. Europe and other countries have lost a major exporter of medicines – russia – due to the war and sanctions. So now they are looking for those who can fill this market deficit, especially in terms of basic generic drugs. This is where Ukraine is a very powerful player and has enough quality medicines and production capacities.
There are other sectors where the Ukrainian pharmaceutical industry can successfully develop. There is interest in the future import of Ukrainian-made vaccines. We are already holding talks with Guatemala, Egypt, and African countries, which are seeking to meet their needs for vaccines, insulin, immunoglobulins, and other basic drugs. Establishing cooperation with such countries by the Ministry of Health will be a solid foundation for expanding Ukrainian exports. These countries are looking for producers and are potentially interested in establishing exports from Ukraine.
And finally, what are your wishes and advice to representatives of business?
The tips are simple, but they require a comprehensive and strategic approach – increase your capacity, develop the skills and competencies of your specialists, establish links with international business communities and specialized associations, participate in conferences, invest in innovation and research.
The pharmaceutical industry, as well as the production of medical devices, is growing extremely strongly and rapidly. Every year, it presents new methods and approaches to treatment and diagnostics and introduces innovative drugs. What does this mean? Our globalized world is constantly evolving, life expectancy is increasing, and the quality of life is becoming more important, including in the area of health.
By the way, the EU also focuses on innovation. In 2022 alone, EU countries spent more than
EUR 9.7 billion on research and development in the healthcare sectors, which is 11.5% more than in 2021. This is the fastest-growing sector in the EU in terms of research investment. After all, research and development are crucial for increasing business competitiveness, developing the economy, and improving the well-being of citizens.
