Transformation of the Ukrainian pharmaceutical market – new opportunities and potential Pharmaceutical Industry Review, September No 4 (97) 2023
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.
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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.
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