EFPIA Voices Fresh Concerns on EMA Relocation


Applied Clinical Trials

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has provided further evidence of the potential health risks posed by the upcoming relocation of the European Medicines Agency (EMA).

In a statement, EFPIA says its latest survey underlines the scale and importance of the issues posed by the Brexit discussions and shows how much Europe’s integrated supply chains rely on the U.K. The key findings are as follows:

• There are over 1500 clinical trials being conducted in multiple EU member states that have a UK-based sponsor. Over 50% of these trials are scheduled to continue beyond March 2019.

• 45% of EFPIA members expect trade delays if the U.K. and Europe fell back to WTO rules. To prevent these delays, the EU and UK should agree a comprehensive agreement that ensures maximum alignment between EU and UK pharmaceutical laws, it states.

• Over 12,000 centrally authorized marketing authorizations (MAs) for medicines will require a separate MA in the U.K. in order for the medicine to be prescribed to patients. Approximately 17% of centralized MAs are held in the UK.

• Over 2600 final medical products have some stage of manufacture based in the U.K.

• 45 million patient packs are supplied from the U.K. to other European countries each month. Over 37 million patient packs are supplied from the rest of Europe to the U.K. each month.

“The survey underlines the scale of the task ahead,” commented EFPIA Director General Nathalie Moll. “For life-saving and life improving medicines, the EU and U.K. cannot afford to wait any longer to ensure that the necessary cooperation on medicines is in place from the day the U.K. leaves the EU.”

The findings emphasize the importance of scientific research collaboration between the U.K. and EU, according to EFPIA.

“Even in the context of the Brexit negotiations, where all sectors are looking for clarity on the future, it is important to recognize that the medicines sector is different. The medicines we make impact directly on peoples’ health,” she said. “Securing ongoing cooperation on medicines regulation between the U.K. and EU is the best way of ensuring that patients across Europe continue to have access to safe and effective medicines.”

A summary of the EFPIA survey results is available here.

Philip Ward is the European Editor for Applied Clinical Trials.

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