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UK must align with EU medicine rules after Brexit to avoid disruption, health group says

Patients’ access to life-saving medicines and medical devices could be disrupted unless the UK stays aligned with EU regulations after Brexit, a group of leading health organisations says


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Patients’ access to life-saving medicines and medical devices could be disrupted unless the UK stays aligned with EU regulations after Brexit, a group of leading health organisations says.

Complex EU-wide systems regulate medication and medical technologies, ensuring they are safe to trade in the single market.

Without those regulations safety could be affected, as could the speed it takes for drugs to reach patients in the UK and the EU, the Brexit Health Alliance says in a briefing paper.

It could also affect hundreds of studies led by UK organisations and running across multiple European countries, says the alliance, which aims to safeguard the interests of patients, healthcare and research in Brexit talks.

Priority in negotiations

Research and development on drugs for rare conditions and for children, which have been boosted by EU regulations, could be particularly affected, it says.

The group calls for the regulation of medicines and devices to be a priority in Brexit negotiations, and for the future UK regulation system to be closely aligned with that of the EU.

Without robust plans, many new drugs will have their marketing authorisation submissions to the UK delayed compared with the EU, the briefing paper says.

Maximum co-operation

Alliance co-chair Niall Dickson, who is chief executive of the NHS Confederation, said: 'We want to make sure that patients continue to benefit from early access to new health technologies and cutting-edge medicines, and that includes being able to take part in international clinical trials.

'This can be achieved if the will is there – what patients need is maximum co-operation and alignment between the EU and the UK on the regulation of medicines and medical devices, and we very much welcome the UK government’s commitment to close collaboration with our European partners.'

The alliance comprises representatives of the NHS, medical research, industry, patients and public health organisations.


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