2021-01-12 17:43:49
Last July, we reported on the Cumberlege Review which followed the PIP breast implant scandal. The Government has just published its response to the review https://www.gov.uk/government/speeches/update-on-the-governments-response-to-the-independent-medicines-and-medical-devices-safety-review . Points of note include:
- The Government has tabled an amendment to the Medicines and Medical Devices Bill to establish the role of an independent Patient Safety Commissioner, in line with Baroness Cumberlege’s second recommendation. The Bill reached its Report Stage in the House of Lords on 12 January 2021.
- The Commissioner will act as an independent advocate for patients, and strengthen the ability of our health services to listen to the voice of patients. The Commissioner will be established as a statutory office holder, appointed by the Secretary of State for Health and Social Care, and will act independently on behalf of patients.
- The Commissioner’s core duties will be to promote the safety of patients and the importance of the views of patients in relation to medicines and medical devices. To help in carrying out these duties, the commissioner will have a number of powers and functions, including the ability to make reports and recommendations to the NHS and independent sector, and to request and share information with these bodies.
- The Government did not accept the proposal to establish a redress agency as recommended by Baroness Cumberlege. Baroness Cumberlege had concluded that the MHRA needs substantial revision particularly in relation to adverse event reporting and medical device regulation, and it needs to ensure that it engages more with patients and their outcomes. The Government’s position is that the MHRAhas already begun a substantial programme of work to improve how it involves patients in all aspects of its work, to reform systems for reporting adverse incidents with medicines and medical devices, and to strengthen the evidence base for its regulatory decisions.
- The Medicines and Medical Devices Bill will give Ministers power to establish a UK-wide medical device information system. This system will mean that the MHRA can routinely collect medical device, procedure and outcome data from all NHS and private provider organisations across the UK.
Separately from the Government’s response to the Cumberlege report, the Government has responded to criticisms of the very wide powers in Medicines and Medical Devices Bill. The Government has introduced an amendment to the Bill, stipulating that an overarching objective of making regulations must be to safeguard public health for human medicines and medical devices. In the case of veterinary medicines, the overarching objective must be to promote the health and welfare of animals; the health and safety of the public; or the protection of the environment.