Brexit and the UK pharmaceutical industry: regulatory measures, accessibility of medical technologies and experience for Ukraine

Abstract

The issue of legal regulation of the pharmaceutical sector is highly relevant today, as it affects not only economic stability of the country, but also public health and safety of its citizens. Following its withdrawal from the EU, the United Kingdom faced the need for a restructuring of the regulatory system, which was previously based largely on European legislation. After Brexit, the country encountered the challenge of developing an autonomous framework that takes into account national interests and international obligations.

The aim of the study is to analyse the transformation of the legal regulation of the pharmaceutical industry in the United Kingdom after Brexit and to identify the possibilities of adapting this experience to improve Ukrainian legislation in the field of pharmaceuticals.

Materials and methods. The empirical basis includes UK and EU legislation, international standards (ICH, PIC/S), as well as scholarly publications and reports from regulatory authorities (MHRA, EMA) and international organizations. Data were retrieved from eur-lex.europa.eu and legislation.gov.uk using the key terms “Brexit,” “pharmaceutical activity,” and “regulatory activity.” A combination of systemic, comparative, historical, and content analysis enabled the identification of post-Brexit legal changes and the assessment of their impact on the pharmaceutical industry.

Results. It is proved that the legal framework governing the pharmaceutical sector in the UK at the beginning of Brexit, which had been formed over many years, was stable and effective. The authors analyse the legal status of the main regulator of the UK pharmaceutical sector – UK Medicines and Healthcare products Regulatory Agency (MHRA). It is emphasised that despite political and economic changes, the MHRA has maintained its independence and efficiency in issuing licences, controlling the circulation of medicines and introducing innovative approaches to regulation. It is thanks to this that British pharmaceutical companies have been able to adapt to the new conditions, maintain their competitiveness and even expand their influence in international markets. At the same time, the process of regulating the industry has not been without problems, on the contrary, numerous difficulties have arisen. Attention is paid to the interaction of the MHRA’s interaction with European regulators, in particular the EMA. Based on the analysis, ways of using the UK’s experience to improve Ukrainian pharmaceutical legislation are proposed.

Conclusions. Brexit has had a significant impact on the UK pharmaceutical market, creating both opportunities and challenges for the regulatory system. The UK’s experience in adapting its pharmaceutical legislation after leaving the EU can be applied by Ukraine in some areas. For example, the creation of a more flexible registration system based on international standards will help reduce the bureaucratic burden. Integration with international regulators, such as the FDA and EMA, will facilitate the export of Ukrainian medicines and increase confidence in the national quality control system