House of Lords Library

Safety of Medicines and Medical Devices

Published Thursday, February 21, 2019

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.

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The regulations for medicines and medical devices in the UK are currently set at a European level. All medicines must be authorised by either the European Medicines Agency (EMA) or the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) on the basis of EU standards. In practice, the two bodies work together to assess medicines before authorisation and to monitor them afterwards. Medical devices must also conform to EU standards.

Medicine regulation in the UK will be affected by its departure from the EU. Under the draft withdrawal agreement, during the transition period, cooperation between the MHRA and the EMA will continue, and following the transition period, the political declaration stated that the UK and EU would “explore the possibility of cooperation”. If the UK leaves with no deal, all products authorised at the European level would automatically be authorised in the UK, and the MHRA will take on the functions of the EMA for the UK.

Ongoing developments in medicine safety include the role of technology, for example in analysing multiple databases on patient and drug experiences. Others include new methods of introducing drugs, new processes for clinical trials and enhanced education and training on safety regulation.

In February 2018, following incidents of side effects from three products, the Government launched the Independent Medicines and Medical Devices Safety Review to recommend improvements to the response to patient reports about harmful side effects. The review has so far taken evidence from a variety of sources, but has not announced a date for the publication of its main findings.

Finally, medicine safety can be seen in the context of wider patient safety initiatives. Several government and non-governmental bodies are working in this area, most prominently NHS Improvement, which is developing a new patient safety strategy.

Lords Library notes LLN-2019-0024

Author: Chris Smith

Topics: EU institutions, EU law and treaties, Medicine, Patient rights and complaints, Regulation, Research and innovation

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