Reconfiguring Pharmaceutical Competitiveness in the Post-Brexit Era: A Comparative Analysis of the UK and European Union
Main Article Content
Abstract
Objective: To compare pharmaceutical competitiveness in the United Kingdom (UK) and European Union (EU) after Brexit, with emphasis on regulatory pathways, marketing authorisation, medicine access, innovation, industry operations, and regulatory divergence.
Methods: A comparative descriptive approach was used on secondary data from official sources including the Medicines and Healthcare products Regulatory Agency (MHRA), European Medicines Agency (EMA), European Commission, and scientific literature. Pre-Brexit and post-Brexit regulatory systems were assessed using indicators such as marketing authorisation routes, approval timelines, reliance procedures, clinical-trial requirements, pharmacovigilance, market access, and industry trends. Comparative and trend analyses were conducted to identify changes in regulatory performance and competitiveness.
Results: The findings showed greater regulatory separation between the UK and EU after Brexit. The UK established an independent, MHRA-led framework incorporating national and reliance-based pathways, while the EU maintained its centralised and coordinated regulatory system. This divergence created additional administrative, documentation, compliance, and market-entry requirements for companies operating in both jurisdictions. However, UK reforms also introduced greater flexibility and opportunities for streamlined assessment in certain situations. Differences emerged in approval procedures, clinical-trial regulation, pharmacovigilance obligations, and market-access strategies. The EU retained the advantages of regulatory integration across member states, whereas the UK gained greater regulatory autonomy.
Conclusion: Brexit has reshaped pharmaceutical competitiveness by creating a balance between regulatory independence and the advantages of harmonisation. Continued UK–EU cooperation, reliance mechanisms, regulatory convergence, and international harmonisation could reduce duplication, improve efficiency, support timely medicine access, and promote innovation in both pharmaceutical markets
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