Research Briefing
Safety of Medicines and Medical Devices
This Briefing has been prepared in advance of the debate due to take place in the House of Lords on the motion moved by Lord O’Shaughnessy that “this House takes note of the steps being taken to improve the safety of medicines and medical devices”. It outlines the current regulatory regime, which is based on EU law, and the roles of the main European and UK agencies. It then describes an ongoing independent review into medicinal product safety, which is tasked with recommending improvements to responses to patient reports about harmful side effects. The Briefing then considers the impact of the UK’s departure from the EU, both under the draft withdrawal agreement and if the UK leaves with no deal. Finally, it discusses ongoing developments in medicine safety, such as the greater use of technology, and sets the issue of medicine and medical product safety within the context of wider patient safety initiatives in the NHS.