Statement to Parliament: Update on the government’s response to the Independent Medicines and Medical Devices Safety Review

Statement to Parliament: Update on the government’s response to the Independent Medicines and Medical Devices Safety Review

The report of the Independent Medicines and Medical Devices Safety Review (IMMDS Review) was published on 8 July last year. I would like first to sincerely thank Baroness Cumberlege and her team for their work on the review. I also pay tribute to the women and their families who bravely shared their experiences and brought these issues to light. Without their tireless efforts to have their voices heard, this review would not have been possible.

The overriding question investigated by the review is how the health and care system listens and responds to patient concerns raised by patients, and women in particular. We must not forget that the Cumberlege Review, alongside other independent inquiries including the Paterson Inquiry, was commissioned because women did not feel listened to or their concerns acknowledged today is another step towards righting this.

On the Paterson Inquiry, I would also like to provide a very brief update. Work on the government response was temporarily paused last Spring due to the first wave of the COVID-19 pandemic. Efforts have since resumed at pace, and I can confirm today that I will announce and publish the governments initial response in Parliament shortly.

Returning to the IMMDS Review, many of the reports recommendations have already been discussed in detail during the committee stage of the Medicines and Medical Devices Bill, and this has helped us to determine our future direction. We are very grateful to members from both Houses who have worked with us on this.

I am today updating the House on the governments response to the report of the IMMDS Review, taking each recommendation in turn.

In July, when I introduced this report to the House, I made an unreserved apology on behalf of the health and care system to those women, their children and their families for the time the system took to listen and respond. I assure those affected that the government has listened, and will continue to listen.

The central recommendation in the report is for the establishment of an independent Patient Safety Commissioner. This recommendation has rightly ignited much interest and debate in both Houses, and the government has listened carefully to the arguments made for a commissioner, and how this might sit within the wider patient safety landscape.

Patient safety is a key priority for the healthcare system. In my role as Minister of State for Patient Safety, I often hear from and meet with people who have been affected by issues of patient safety. Their stories have common themes of suffering avoidable harm, of not being listened to and of a system that is then difficult to navigate when things go wrong. We want to make the NHS as safe as anywhere in the world, and we must retain an absolute focus on achieving this goal.

I can therefore confirm that the government tabled an amendment to the Medicines and Medical Devices Bill before the Christmas recess to establish the role of an independent Patient Safety Commissioner, in line with Baroness Cumberleges second recommendation.

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 commissioners 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 looks forward to working with members of both Houses to ensure this new post acts as a beacon for listening and reflecting the safety concerns of patients, so that we can drive positive culture change in our healthcare system.

Recommendation 3: a new independent Redress Agency for those harmed by medicines and medical devices should be created based on models operating effectively in other countries. The Redress Agency will administer decisions using a non-adversarial process with determinations based on avoidable harm looking at systemic failings, rather than blaming individuals.

The government has no current plans to establish a redress agency as set out in recommendation 3. The government and industry have previously established redress schemes without the need for an additional agency.

Recommendation 4: separate schemes should be set up for each intervention hormone pregnancy tests (HPTs), valproate and pelvic mesh to meet the cost of providing additional care and support to those who have experienced avoidable harm and are eligible to claim.

Recommendation 4 on redress schemes for sodium valproate, mesh, and HPTs remains under consideration.

Recommendation 5: networks of specialist centres should be set up to provide comprehensive treatment, care and advice for those affected by implanted mesh; and separately for those adversely affected by medications taken during pregnancy.

Good progress is being made on establishing specialist mesh services, which are the fifth recommendation in the report. NHS England is working with NHS hospitals to establish specialist mesh services which are currently planned to go live from the Spring this year.

These services will bring together leading experts to provide multi-disciplinary care and treatment for all women who have experienced complications due to vaginal or abdominal mesh procedures.

With a centre in every NHS region, these new services will ensure nationwide provision, and centres will work together to hone their expertise and share best practice.

We continue to consider the second part of recommendation 5, which is for specialist centres for those adversely affected by medicines in pregnancy.

Recommendation 6: the Medicines and Healthcare products Regulatory Agency (MHRA) needs substantial revision particularly in relation to adverse event reporting and medical device regulation. It needs to ensure that it engages more with patients and their outcomes. It needs to raise awareness of its public protection roles and to ensure that patients have an integral role in its work.

Patient safety is the MHRAs top priority. The MHRA recognises that the major changes highlighted by the report, particularly recommendation 6, are very important.

The MHRA has already begun a substantial programme of work to improve how

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