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Medicines licensing

Any form of Brexit will hit UK healthcare, researchers warn

Leaving the EU could profoundly affect medicines licensing and leave the NHS struggling to keep staff, a health policy review published in The Lancet has said.

The review, written by researchers from the Universities of Oxford, Sheffield, Michigan, and the London School of Hygiene and Tropical Medicine, modelled three potential Brexit outcomes — hard (a free trade agreement between the UK and the EU); soft (a similar agreement to the European Economic Area); and failed (falling back on World Trade Organisation rules) — and in each case they concluded that there would be major risks to health, which should be considered in Brexit negotiations.

The authors noted that the EU governs nearly every aspect of medicines licensing, which offers “substantial benefits in terms of the cost and speed of bringing new medicines to the market”.

The EU medicines licensing process, said the report, was typically six months quicker than separate approval systems such as those in Canada and Switzerland.

Post-Brexit, the UK would have to develop its own regulatory system for licensing, or accept the decisions of other regulatory agencies such as the US Food and Drug Administration.

Also threatened is the UK’s part in the EU’s role in fighting the manufacture of counterfeit medicines and the rise of antimicrobial resistance. The report also said that while after Brexit the role of the Medicines and Healthcare Products Regulatory Agency (MHRA) will have to be strengthened, it is a body that currently receives substantial EU funding.

EU direct funding for research contracts in the UK and the legal frameworks that underpin scientific research are another complex issue that will be have to be dealt with post-Brexit, said the authors.

Regarding staff, the report quoted oral evidence on Brexit given to the House of Commons Health Select Committee, which suggested that 60,000 people from the EU currently work in the NHS and 90,000 in adult social care, with potential workforce losses particularly weighted towards London and the South East if staff cannot be recruited and retained after the UK leaves the UK.

Lead author, Nick Fahy, a senior researcher in the Nuffield Department of Primary Care Health Sciences at Oxford University, who was formerly employed by the European Commission, said: “Health is often thought to be a purely national matter, relatively insulated from the consequences of Brexit. That is not the case; as this analysis shows, leaving the EU will have wide-ranging impacts on health and the NHS. These must be addressed now if the consequences of Brexit are not to be borne by the sick and the vulnerable.”

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20203654

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