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Government response full of good intentions but little certainty

23 May 2018

The Health and Social Care Committee responds to the Government's response to its report on Brexit: medicines, medical devices and substances of human origin.

The UK' s withdrawal from the European Union (EU) and the European Atomic Energy Community (Euratom) means new regulatory arrangements must be put in place from 29 March 2019 to guarantee the safe and effective supply of medicines, medical devices, medical products and substances of human origin in the UK. Patients, the NHS and the UK's life science industry need certainty about what the UK's regulatory arrangements will be after Brexit and a smooth transition towards them. There are also major implications for the future of medical research and development.

During our inquiry we heard evidence on the potential effect of Brexit on research and development; clinical trials; the manufacture, trade and supply of medicine, medical devices and substances of human origin; and the regulatory and pharmacovigilance arrangements in place to ensure safety and effectiveness of products available in the UK and across Europe.

Chair's comments

Dr Sarah Wollaston MP, Chair of the Health and Social Care Committee, said:

The Government's response to our report is full of good intentions, but does little to provide certainty for UK patients, the NHS and businesses.

Close regulatory alignment with the EU, along with an immigration regime that attracts the brightest and best scientists and healthcare professionals, are critical if UK patients are going to continue to receive timely and safe access to medicines, medical devices and substances of human origin after Brexit.

Immigration regime: attracting the brightest and best

The life science sector is built on great people, great science and access to capital. Without continued access to the brightest and best minds in Europe and the rest of the world the UK's science-base, a pipeline for medical innovations that offer a lifeline to patients, stands to become less attractive. The Government's forthcoming immigration bill should recognise this and take steps to mitigate the consequences.

Regulatory alignment

The UK outside the EU is only 3% of the global life science industry. Sir John Bell, architect of the UK's Life Science Strategy, set out clearly that the UK is too small, even with the most streamlined regulatory system in the world, to go it alone. Without close regulatory alignment, patients stand to wait longer for new innovative medicines and devices to be available in the UK, as companies choose to launch in the larger markets - the EU, the US and Japan - first.

The official response to our report explains that the Government is seeking a close working relationship with the EU, including how the UK can continue to participate in the European Medicines Agency. We've also had assurance that the current regulatory requirements will be maintained during a transition period. However, these statements do little to provide the certainty businesses, the NHS and UK patients need.

Contingency planning

The Government continues to assert that the publishing their contingency plans will damage the UK's interests. Our view remains that the publication of contingency planning would strengthen, rather than damage, the UK's negotiating position.

A no-deal may look increasingly less likely, but nothing agreed yet is legally binding. The agreements reached so far have been made on the principle that nothing is agreed until everything is agreed. The clock is ticking for businesses and NHS services who are already enacting plans, and doing so in the dark, to ensure that patients in the UK and Europe do not experience a disruption to the supply of medicines and medical products."

Further information

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