European Parliament Calls for Relocation of European Medicines Agency in Wake of Brexit


From DCAT Value Chain Insights (VCI)

By Regulatory News posted 04-11-2017 16:37

  

The European Parliament has passed a resolution in early April 2017 that outlines the provisions for the UK’s exit from the European Union (EU) following the UK government’s invocation of article 50 in late March 2017, which gives formal notification of its intent to withdraw from the EU. Among the key provisions passed, the European Parliament has called for an agreement to be reached “as quickly as possible” on the relocation of the European Medicines Agency (EMA), which is headquartered in London, and for the process of relocation to begin as soon as practicable.

The UK’s decision to exit the EU in a referendum vote on June 23, 2016, a move widely known as Brexit, has raised several key questions for the global pharmaceutical industry, among them, the decision the EMA faces on where to locate its headquarters following the UK’s separation. The UK’s decision marks the first member state to leave the EU of its own volition, and the EMA recognizes that there is no precedent for this situation.

The EMA, which employs 890 employees, including 50 British staff, has stated that the decision on the seat of the agency will not be taken by the EMA itself, but will be decided by common agreement among representatives of the EU member states. The EMA has welcomed the interest expressed by several member states to host the agency in the future. A number of EU member states have made public their interest in housing the agency.

“The extent of the impact of Brexit on the Agency’s operations and location is uncertain and will depend on the future relationship between the EU and the UK. Depending on the outcome of the negotiations, this could cause significant disruption to the Agency’s operations and business continuity plans will need to be in place. As part of its preparedness, the Agency will continue carrying out impact assessments to identify the main risks and propose possible mitigating measures to maintain the Agency’s ability to protect public health,” the EMA said in a statement issued in December 2016.

The EU and the UK will need to negotiate a withdrawal agreement to define the country’s future relationship with the EU, which is expected to take around two years, triggered by the UK government’s invocation of article 50. Any agreement would have to be approved by both the European Parliament and the Council, according to the European Parliament.

Source: European Parliament and European Medicines Agency

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