UK Introduces Post-Brexit Medicines and Devices Legislation

Peter Russell

February 17, 2020

The Government intends to legislate to allow more NHS staff to prescribe certain drugs to patients.

The Medicines and Medical Devices Bill also introduced new safety measures and would allow hospitals to develop personalised medicines.

The Bill:

  • Introduced targeted delegated powers in the fields of human medicines, veterinary medicines and medical devices to enable the existing regulatory frameworks to be updated following the UK's departure from the EU

  • Consolidated the enforcement provisions for medical devices and introduces sanctions

  • Provided an information gateway to enable the sharing of information held by the Secretary of State for Health and Social Care about medical devices, for example to warn members of the public about safety concerns

Medicine and Healthcare in a Post-Brexit Era

Following Brexit, the UK is currently in a transition period during which it continues to follow EU law. However, after 31st December 2020, the UK will no longer be able to update its regulatory schemes for human medicines, clinical trials of human medicines, or veterinary medicines through secondary legislation.

The Bill will give powers to update the existing regulatory frameworks.

The Department of Health and Social Care (DHSC) said it would also increase the range of professions able to prescribe medicines in low-risk circumstances, reducing unnecessary GP appointments.

It said the change in the law would mean that hospitals could use patient tissue and DNA samples to tailor treatments to individual patients when other medicines failed, or to develop drugs that have a shelf-life of minutes and would otherwise be unavailable to them.

It had the potential to streamline access to treatments for patients with rare cancers and brain tumours, the DHSC said.

Patient Safety

The Government promised to ensure medical devices were subject to the highest standards of regulation, bolstering patient safety, and ensuring the UK could develop pioneering health technology. Companies would have to register medical devices with the Medicines and Healthcare products Regulatory Agency, ensuring suppliers followed strict safety checks and enabling tough enforcement action if anything went wrong.

The Health and Social Care Secretary would have the power to disclose specific information about devices to members of the public and the healthcare system, subject to appropriate safeguards, in cases of serious patient safety concerns.

The legislation would allow a wider range of health professionals, including midwives, paramedics, and physiotherapists, to prescribe medicines in low-risk situations. Safeguards would be put in place to limit what medications could be included, the DHSC said.

Baroness Blackwood, the health minister, said: "I am determined to help everyone who uses our world-leading NHS to access pioneering, cutting-edge treatments as soon as possible.

"The new bill will give our most treasured institution further freedom to innovate to improve the lives of countless people and protect patient safety to the highest standards.

"It will slash red tape, support uptake of treatments for people with rare diseases, and empower those in the NHS who know what's best for their patients to deliver the best quality care."

Expert Reaction

Dr Malcolm Finlay, consultant cardiologist at Barts Heart Centre, Queen Mary University of London, welcomed the Government's approach to improving access to cutting edge medicines, "giving opportunity to patients as well as a boost to the incredibly important biotech sector of the economy".

However, he told the Science Media Centre: "There is a mixed message for medical devices though, with the Government indicating that they will seek to increase the regulatory burden required.

"The big fear in the sector is that the new Medicines Device Regulation 2020, which is coming into force right now, prevents much needed leads in innovation and technology access to patients in the UK. It's not clear if a further severe hurdle would be introduced by this bill that would further throttle UK lead innovation for patients."

Dr Finlay welcomed the move to change how healthcare was provided to patients.  "Already many hospitals are moving to offering virtual clinics, and nurse prescribing", and he said that backing from central Government would "move these from local innovations to centre stage in delivering efficient and effective health care to our NHS users".

The Bill was introduced into the Commons on Thursday 13th February.

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