Challenges of the COVID-19 pandemic to pharmaceutical manufacturing: the EU and Ukraine’s response

Abstract

The global COVID-19 pandemic, which has caused a shortage of medicines and medical products, as well as pharmaceutical products, especially active pharmaceutical ingredients, has demonstrated Ukraine’s unpreparedness to face such challenges and threats. This encourages the search for effective mechanisms to reduce vulnerability, ensure stability and develop pharmaceutical activities. The purpose of the article is to draw on the experience of the European Union to justify the need to introduce measures of the policy of stimulating the development of pharmaceuticals in Ukraine in order to reduce the dependence of the sector and the healthcare system on imports. To achieve the goal of the article, the authors used analysis and synthesis, logic-dialectic and comparative analysis methods. The article shows the nature and extent of existing dependencies of pharmaceutical production; and identifies features of the EU policy. The EU has been found to have a long history of prioritising and promoting pharmaceutical industry. It is shown that the new EU strategic documents adopted in response to the COVID-19 crisis have laid the foundation for the elimination of the industry’s vulnerabilities and external trade dependencies. For the first time, a conceptual approach to the formation of a dualist state policy and strategy for the development of Ukraine’s high-tech pharmaceutical production was proposed, which is based on synergies and complementary policies between drug policy and industrial policy. This approach is aimed both at stimulating the development and production of new pharmaceuticals based on advanced technologies and reducing the dependence of this country’s healthcare system on imports. Also, the approach aims at enhancing the competitiveness of pharmaceutical production, increased localization through the use of locally produced products, intensifying related activities, ensuring stability of supply of pharmaceutical products and transforming the industry into a strategic asset of growth of the economy, employment, and national security. The authors propose a conceptual approach to defining the priorities and programme tasks of the policy for the development of Ukrainian high-technology pharmaceutical production based on the principles of multi-dimensionality and comprehensiveness, and covering the development and production not only of medicines and medical products, but also of pharmaceutical ingredients (chemical and biotechnological), fillers and packaging materials, equipment and apparatus for pharmaceutical production. The principles of the formation of a strategy for the development of the high-tech pharmaceutical production of Ukraine are justified based on the balance of interests of consumers and producers of pharmaceutical goods with the interests of the State, based on its following goals: to care for the health of the nation, ensure an efficient economic system and social stability; promote the emergence of new effective drugs based on advanced technologies; and reduce dependence on imports and threats to national security.