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Brexit could leave NHS patients unable to access new drugs and medical devices

Brexit could have serious implications for patients’ access to medicines and medical technologies.

The UK’s plans to leave the EU, and the subsequent disruption in trade, and the potential lack of cooperation in the regulation of medicines and devices, could result in NHS patients facing long delays to gain access to new drugs and devices.

A report by the Brexit Health Alliance explains that the regulation of medicines and medical technologies is managed by EU-wide systems, and the arrangements are complex.

It says: “Changes to this regime may have an impact on supplies across Europe. ‘No deal’ or a deal between the UK and the EU that does not address future cooperation on medicines and medical technologies could put public health at risk.”

The report outlines a series of problems as a result of its loss of membership of the European Medicines Agency (EMA), a body of experts which approves all new pharmaceutical products so they can be given to patients in the EU.

The organisation is moving its headquarters and 900 staff from Canary Wharf in London to Amsterdam due to Brexit.

The report says the future of European clinical trials could be jeopardised.

There are currently 1,500 registered clinical trials including multiple EU member states with a UK sponsor (lead).

Fifty per cent of those trials will be ongoing as of March 2019. After March 2019, the continuing conduct of these trials could be jeopardised due to the lack of the same regulatory framework.

There is no guarantee that the UK will be able to access the new EU infrastructure for the management and authorisation of clinical trials.

The report also raises concerns about the availability of medical devices.

Medical devices rely on international supply chains, both for finished products and product components. And new barriers to trade between the UK and Europe could affect their supply.

As the EU and the UK are moving to phase two of the Article 50 negotiations, the report says it is critical that arrangements for the regulation of medicines and medical devices is addressed.

Future cooperation on medical devices and medicines must be prioritised in the negotiations, so that patients and the wider public are not negatively impacted from disruptions in the supply of medicines and other health technologies, or from a reduction in standards or safety, it says.

It concludes that patient safety and public health should be guaranteed post Brexit through aligning the UK as much as possible with the EU’s regulation of medicines and medical devices, and by close regulatory cooperation between the EU and UK.

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