What happens next for UK medicines regulation?

What happens next for UK medicines regulation?

The announcement this week that Amsterdam had been selected as the new headquarters for the European Medicines Agency (EMA), brought both excitement and concern over the future of medicine regulation policy in Europe.

While detailed information on the transition is yet to be released, this news further entrenches Britain’s inevitable exit from the European Union. The EMA has 16 months to finalise the transition ahead of Theresa May’s proposed exit date of March 2019.

Employing 890 people, the EMA has been based in London since 1995. It provides and coordinates licensing, expertise, and support for medicines and medical devices throughout the EU.

The decision was not without controversy as eastern and central European countries were angered after Prague, Bratislava, Zagreb, Sofia, Warsaw and Bucharest did not make it past the first round of voting both for the EMA and European Banking Authority (EBA). There was also calls from Spain that the instability in Catalonia ruined their chances for the bid.

While the location is now confirmed there are still many questions regarding the relationship between the UK and the EMA post-Brexit. Following the announcement, the UK Government published a briefing paper on Brexit and medicines regulation. It outlined the possible relationships between the EMA and UK following Brexit including commentary on these options from stakeholders, like the MHRA, the Nuffield Trust, and the UK Government themselves. A smooth transition is desired by all parties but what this will look like is still unclear.

There are also other matters to consider.

Many business are based near the EMA’s offices in Canary Wharf because they work closely alongside of the agency. The EMA is also a major funder for scientific research. These relationships will need to be worked out and many other uncertainties lie ahead.

Yesterday was certainly a win for Amsterdam but a loss for London and the UK.

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