European Pharma Industry Expresses Concern in Delay in Relocating EMA Post Brexit


From DCAT Value Chain Insights (VCI)

By Regulatory News posted 06-29-2017 19:28

  

The European Federation of Pharmaceutical Industries and Associations (EFPIA), which represents the pharmaceutical industry operating in Europe, expressed concern over a recent decision by the European Council, which is composed of the heads of the members states to the European Union (EU), to postpone a resolution on the relocation of the European Medicines Agency (EMA) until November 2017.

A new location is required for the now London-based EMA, which is the regulatory authority for EU countries, following the decision by the UK to exit the EU in the so-called Brexit move. On June 22, 2017, the European Council voted to postpone the decision on the move by the EMA until November 2017 and has provided until July 31, 2017, for member states to recommend locations for the agency.

The EFPIA is composed of 33 national pharmaceuticals associations and 42 pharmaceutical companies, and in a statement, the EFPIA outlined the need to move on the relocation and what key items should be considered in the relocation.

"It is imperative for the safeguarding of public health that we ensure future alignment between the UK and EU regulatory regimes in order to maintain capacity, processes, and timeframes for the introduction of new medicines for patients," said the EFPIA in a statement. "It will be critical to avoid divergence and duplication of regulatory standards and practices, so that patient safety is not put at risk."

The EFPIA emphasized that any future location of the EMA must have "world-class connectivity" to ensure that the agency is capable of managing and accommodating the 36,000 expert visits that it must facilitate currently on an annual basis, in addition to a great number of regulatory exchanges with the global pharmaceutical industry.

It also emphasized the need for the following: transport links (international, regional, and local transport); a building that will allow the EMA to host the vast number of essential expert meetings it organizes annually; and a location that offers a large number of hotel rooms needed to accommodate the necessary scientific and regulatory experts who engage with the agency. It also expressed the need to retain skilled staff and the resulting need for sufficient housing, access to international/ European schools for staff with children, and employment opportunities for spouses/ partners.

"We believe therefore that priority must be given to ending the uncertainty over the location of the EMA and to ensuring that transitional arrangements are in place for issues that may impact patient safety and patient health," said the EFPIA in its statement. "It is a serious concern that the Heads of State deliberations on the Agency’s future has not resulted in an early decision on the EMA’s relocation: in the event of obstruction or eventual failure, Europe possesses no backup option."

Source: EFPIA and European Council

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