MPs urge government to set out plans for post-Brexit medicines regulation

Bill will go through Parliament to allow the National Institute of Health and Care Excellence (NICE) to use off-patient drugs to be licensed for new purposes

MPs have urged the government to set out its plans for regulatory functions currently delivered by the European Union (EU), including those relating to medicines safety, as soon as possible.

In its first report, the House of Commons’ Exiting the European Union Committee says it is up to the government to decide whether it wants the UK to remain part of EU-run regulatory agencies — including the European Medicines Agency (EMA) — after Brexit, adding that future relationships will need to be defined during negotiations.

The committee was set up to examine the expenditure, administration and policy of the Department for Exiting the European Union and public bodies.

The report, published on 14 January 2017, follows the committee’s inquiry into the UK government’s process for exiting the EU and its negotiating objectives.

“It will be essential to provide clarity as soon as possible, and certainly by the time the UK leaves the EU, about the government’s preferred option for the UK’s future participation in EU regulatory bodies,” the report says.

“If it is decided, however, not to seek to maintain membership of these bodies then the government must set out the new arrangements it proposes to put in place to ensure that these functions are carried out in future,” it adds.

The report and the need for clarity on the future of regulation was welcomed by the Association of the British Pharmaceutical Industry (ABPI), which gave evidence to the inquiry.

Mike Thompson, chief executive of the ABPI, says: “We are confident that government understands that any transitional arrangements should not put patient access to medicines under threat. We will continue to work with government to make sure this happens as smoothly as possible.”

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Citation
The Pharmaceutical Journal, January 2017;Online:DOI:10.1211/PJ.2017.20202198