In a post-Brexit overhaul, the UK government has introduced a human and veterinary medicines, clinical trials and medical devices bill, which could alter the regulatory framework at the end of the transition period.
The newly introduced bill delegates power to update the existing regulatory frameworks after the end of the transition period on 31st December 2020. It also introduces new safety measures, increases the range of healthcare professionals (HCP) that can prescribe low-risk medicines, and enables hospitals to develop personalised medicines.
NHS hospitals will be able to use patient tissue and DNA samples to tailor treatments to individual patients when other medicines fail. They will also be able to develop drugs with very short shelf-lives for immediate use, streamlining access to treatments for patients with rare cancers and diseases.
Broadening the range of HCPs that can prescribe low-risk medicines will help the NHS to make more efficient use of its highly skilled workforce, by reducing unnecessary GP appointment and saving patient waiting times. There will be increased safeguards and limits on the medications available for low-risk prescribing, to be determined by the NHS and other stakeholders.
After the transition period, the bill will ensure medical devices such as pacemakers, breast implants and ultrasound imagers, are subject to the highest standards of regulation, as seen with the incoming EU Medical Device Regulation (MDR).
“With a faster, more flexible system in place, regulators will be able to respond to changes in technology or patient safety concerns as soon as possible.”
It remains to be seen how the new bill will affect UK device manufacturers with regards to the incoming MDR and in-vitro diagnostic regulation (IVDR).