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Experts Worried UK’s Pharma Industry Under-prepared for Brexit

The date for the United Kingdom’s exit from the European Union (EU) looms closer and experts are worried that the British pharma industry is woefully under-prepared for the withdrawal. As a member of the EU until March 2019, UK pharma companies comply with the European Medicines Agency (EMA) regulations. 

From an article by the European Pharmaceutical Manufacturer, the EMA recently released a survey finding that only 58% of pharma companies are on track to retain their centrally authorized products (CAP) in the EU. CAP is essentially unrestricted drug approval throughout the EU that encompasses numerous member states.

Britain is a pharmaceutical powerhouse and officials worry that with only more than half of the market authorized companies in compliance with post-Brexit regulations, drug supplies, and availability threatened.

For the other 42%, they must comply with the EMA’s rules to retain their market authorization. The Brexit process for the pharma industry did not go as smoothly as many hoped. Numerous executives and experts joined a council tasked with creating a regulatory framework that satisfies the EU. The committee encountered upheaval and other logistical issues.

Additionally, the UK worries about disruption in funding for research and development and supply chain issues. With Brexit, the EU is losing a significant drug anchor, and likewise, the UK is losing a vast market. To read the full survey results, be sure to check out this document.

Regardless of Brexit, many regulatory agencies across the world share commonality (sometimes reciprocity) of requiring compliance with Good Manufacturing Practices (GMPs). GMPs are fundamental quality, safety, and efficacy standards for manufacturers and distributors.

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