UK Pharma Industry Bracing for Possible Disruption

From FierceBiotech: GlaxoSmithKline CEO Andrew Witty fears that if the European Medicines Agency (EMA) is moved from London, it will cause a tremendous disruption for the UK’s pharma and biotech industry. Experts worry about the possibility of regulatory upheaval if Brexit happens.

The fate of the EMA is in the air. Brexit is currently in limbo in Great Britain as the House of Lords votes on the proposed Brexit plan. PM Theresa May needs Parliamentary approval to trigger Article 50 of the Lisbon Treaty to start the formal exit process and begin negotiations with the European Union (EU).

Researchers and manufacturers alike would love to see the EMA continue to have jurisdiction over new drugs and treatments originating from the UK. Without the EMA, Britain would need to set up its own new drug approval system, set up a reciprocity agreement with another regulatory agency (such as the U.S. Food and Drug Administration or the Swiss’ Swissmedic) and would still need EMA authorization to go to market.

Witty and other pharma CEOs in the UK believe the EMA remaining is the best outcome for patients. Not only would Pharma save money on drug development, but consumers and the National Health System (NHS) would need not bear the burden of higher prices due to an elongated regulatory hurdle. The uncertainty of UK’s pharma and biotech industry post-Brexit continues.

Regardless of whether or not the EMA departs Britain, the processes and documentation required for approval and manufacture remain relatively unchanged. Drug makers and producers must adhere to Good Manufacturing Practices (GMPs) and must provide records for all batches produced in order to ensure quality and consistency.

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