Medicines and Medical Devices Bill - Second Reading Briefing
The Medicines and Medical Devices Bill had its Second Reading yesterday evening.
A common theme throughout the debate was the need for clarification on how the UK will collaborate and align with the European Union after the transition period and how this will affect patient safety and access to the latest technologies and medicines. Of note to BIVDA members:
Following Health and Social Care Secretary’s introductory remarks where he stated that the new Bill would finally allow the MHRA to share information on medical devices in response to concerns around patient safety, it was noted that the MHRA was already providing updates on dangers around medical devices and drugs (Dr Philippa Whitford)
In response, Matt Hancock MP said that it was possible to share that information but not in all cases, as MHRA is currently limited in the information that it can share with other NHS bodies
Ministers were urged to strengthen the Bill by reflecting provisions in existing EU regulations and to ensure there are unique device identifiers, such as serial numbers on medical devices that are labelled with tracking information, as well as the power to track the use of those devices, so that the NHS can find and notify affected patients if and when problems arise (Jon Ashworth MP). Several MPs made similar points:
The Bill should request an explanation from the clinician at the time of device implementation to explain rationale behind implementation (Dr Luke Evans MP)
Will the Bill address duty of care for patients undergoing genetic testing by providing counselling before, during and after? (Dr Luke Evans MP) (Ben Everitt MP)
Will the Minister provide clarification about the exact role that the MHRA will play in constructing and maintaining a register of approved devices? (Chris Green MP)
In response, Jo Churchill MP said that the MHRA will be able to conduct inspections for manufacturing, distributions, clinical trials, laboratories and pharmacovigilance.
BIVDA will keep tracking the Bill and keep members updated on any key points.