EMA settles Brexit dispute; issues drug shortages guidance

The European Medicines Agency (EMA) has ended a Brexit legal dispute over its Canary Wharf, London headquarters.

In an announcement issued on Thursday, July 4, the regulatory agency said that it had agreed with British property company Canary Wharf Group that it will withdraw its appeal against an English High Court decision.

In February this year, the court held that Brexit wouldn’t frustrate the EMA’s 25-year lease, which is due to expire on June 30, 2039, and so the contract had to be fulfilled.

Instead of continuing its appeal against the High Court’s decision, the agency has now sublet its offices to shared workspace company WeWork.

The EMA, in November 2017, announced that it would relocate from its London headquarters to Amsterdam in the Netherlands, following the UK’s vote to leave the EU.

‘Medicine shortage’ definition

On the same day, a task force established by the European Medicines Agency (EMA) published documents aimed at addressing potential problems with the supply of medicines.

The EMA issued two documents, both of which are aimed at laying the foundations for an “improved and harmonised” EU approach in communicating shortages and available issues.

The first document from the task force, which was set-up by the EMA and the Heads of Medicines Agencies, provides guidance to the pharmaceutical industry to facilitate the detection and early notification to competent authorities.

“An essential element to a harmonised approach for reporting and managing shortages is the use of a harmonised definition of a shortage. The lack of a common definition has meant that the detection and coordination of the management of shortages in the Union (EEA) has been inconsistent,” said the guidance.

Based on a common definition of the term ‘shortages’ (“a shortage of a medicinal product for human or veterinary use occurs when supply does not meet demand at a national level”), the EMA says the guidance should enable a more harmonised and timely approach in the detection and management of issues with supply.

The guidance and a proposed template for shortage notification will be implemented in a pilot phase, which is currently planned to start in the last quarter of 2019.

In the second document, which is addressed to EU national competent authorities and the EMA, principles and examples of good practices for communication on shortages to the public are laid out.

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