Patient Safety Commissioner for England – an update

The role and powers of the Patient Safety Commissioner are now in law, contained in the Medicines and Medical Devices Act 2021.  The government agreed to include this in the Act following pressure from Baroness Cumberlege, Co-Chair of the First Do No Harm All-Party Parliamentary Group, and a range of other parliamentarians of all parties.

Further legislation is now required to set out all the details of how the Patient Safety Commissioner will operate – staffing arrangements, budgets, office accommodation and the appointment process for the Commissioner herself or himself. This is known as secondary legislation, and it takes the form of regulations or statutory instruments.  This type of legislation is prepared by the government and is subject to approval by both the House of Commons and House of Lords before it can become law. 

The Department of Health & Social Care expects soon (likely in May 2021) to launch a public consultation on the matters that will be contained in the secondary legislation.  After the consultation has concluded, and comments received have been considered, the process to appoint the Commissioner will begin.  We do not yet know when the appointment will be made, but we hope it will be before the end of 2021.

The Department of Health & Social Care is keen to encourage anyone with an interest to respond to the consultation.  We will post details of how to do so as soon as they are available, and we will provide further updates of progress towards appointing the Commissioner here on our website. 

Officers meeting of the APPG for First Do No Harm

Last Thursday (11th March), officers of the All-Party Parliamentary Group for First Do No Harm met to discuss the Group’s activity since launching in December, and to agree on a programme of work going forward.  This will include:

  • Seeking a backbench business debate about the First Do No Harm report in the House of Commons Chamber to maintain parliamentary pressure on the Government to move more swiftly to implement the outstanding recommendations of the report
  • Arranging a public meeting on the topic of establishing a register of financial and pecuniary interests for doctors, as recommended in First Do No Harm. The Group intends to hold this with the British Medical Journal and will invite a range of speakers.
  • Writing to the Department for Work and Pensions (DWP) to seek an update on the use of manuals used by DWP PIP assessors when assessing individuals affected by mesh complications, sodium valproate and Primodos.  This action arises from continuing concerns among patients about difficulty obtaining PIP. 

 The Group will publish further updates as this work progresses. 

Answers from the Minister to questions raised at APPG meeting

At the Group’s meeting on 26 January 2021 with the Minister for Patient Safety, Nadine Dorries MP, attendees asked a large number of questions, not all of which could be answered by the Minister due to time constraints. We therefore submitted the unanswered questions to the Minister’s office at the Department for Health and Social Care for a written response. The Department has now provided answers which we have posted here.   


Recruitment for patient reference group

The Department of Health & Social Care (DHSC) has announced its intention to appoint 15 people to a patient reference group. This group will work with DHSC as it develops and implements the Government’s response to First Do No Harm.

The following information has been copied from the website of Traverse External-link, an independent research and engagement consultancy that has been appointed by DHSC to recruit this patient reference group:

If you require any further information about this patient reference group, please email

What will the group be doing?

  • Meeting online to share experiences, ideas and recommendations
  • Helping to shape the Government’s response to the IMMDS Review, ensuring that patient voices are heard in the process
  • Providing advice, challenge, and scrutiny as the Government implements its response

We are looking for people who:

  • Have a personal experience of or understand the context of the IMMDS Review
  • Are committed to improving the experience of patients
  • Want to engage with others on the group and DHSC representatives to support the development and implementation of the Government’s response to the IMMDS Review
  • Can consider complex and emotive issues in a balanced and sensitive way
  • Have good communication skills, and want to build strong working relationships with the rest of the group

If you are interested in getting involved, please contact us at for a recruitment pack and more information on how to apply.

We’re also looking for a co-chair to support group members contribute to the group and make sure group members are heard. If you know the English healthcare system well and are comfortable working on sensitive issues, take a look at the recruitment pack to find out more about the co-chair role and how to apply.


Baroness Cumberlege’s op-ed in The Times

In an op-ed published in The Times Red Box today, and on the day the Medicines and Medical Devices Bill returns to the House of Lords, APPG Co-Chair Baroness Cumberlege restates the case for an independent Patient Safety Commissioner.  The text from the article is copied below – to view the article in full click hereExternal-link

Patients need a voice if we are to avoid the medical harm caused in the past

In July last year, the Independent Medicines and Medical Devices Safety Review – which I chaired — published its landmark report, First Do No Harm. It followed a two-year review of harrowing patient testimony and a large volume of other evidence concerning three medical interventions: Primodos, sodium valproate and pelvic mesh.

Last month, Jeremy Hunt – who commissioned the review as health secretary – joined me in launching an all-party parliamentary group whose aim is to achieve the implementation of the review’s recommendations. At our first meeting before Christmas we were joined not only by a wide array of parliamentarians but by more than one hundred patient group representatives. Their knowledge, passion and dignity in the face of great suffering is inspirational.

Over the course of our work, my team and I observed a healthcare system that was disjointed, unresponsive and defensive. Our report set out in no uncertain terms how the system does not adequately recognise that patients are its raison d’être, and that it has failed to listen to their concerns and when, belatedly, it has decided to act it has too often moved glacially.

One of the nine wide-ranging and radical recommendations we made was to establish in statute an independent patient safety commissioner. This person would be the patients’ port of call, their listener and advocate, who holds the system to account, monitors trends, and demands action. It is our hope that this commissioner would be the golden thread tying this fragmented system together.

To see the benefits this new, independent and powerful voice brings, one only has to look at the work of existing commissioners in different policy areas in England. Anne Longfield, the children’s commissioner, for example, has spent the past year highlighting the dreadful impact of the pandemic on children’s safety and development, while Dame Vera Baird, the victims’ commissioner and Nicole Jacobs, the domestic abuse commissioner, have both lent their weight to the campaign to introduce a crime of non-fatal strangulation so that domestic abusers face more punitive sentences. This is, unquestionably, valuable work indeed.

In respect of medicines and medical devices, a truly independent patient safety commissioner would do similar: listen to patients and their families; look for trends and patterns that give rise to safety concerns; and require the healthcare system to act to reduce or remove the risk of avoidable harm. Had a patient safety commissioner existed before now, my team and I are in no doubt that much suffering could have been avoided.

I am pleased to say that the government has now accepted the need for a patient safety commissioner for England. It has brought forward its own amendment to the Medicines and Medical Devices Bill, which is being considered in the House of Lords today. I hope it will swiftly become law.

This is a topic upon which the government has listened and acted, and I thank them for it, but a full response to the review’s report is still outstanding some six months after publication. Action is urgently needed to ensure we help those who have already suffered and reduce the risk of harm to patients in future.

Baroness Cumberlege is a Conservative peer and was chairwoman of the Independent Medicines and Medical Devices Safety Review (2017-2020)

Baroness Cumberlege’s Letter to the Editor in The Times

In a Letter to the Editor published in The Times today, APPG Co-Chair Baroness Cumberlege argues in favour of the work of the Independent Medicines and Medical Devices Safety Review and its report, First Do No Harm. The text from the letter is copied below – to view the article in full click hereExternal-link


Sir, It was unreasonable to suggest in your news report that none of the inquiries set up by Theresa May’s administration has completed a final report (“£300m bill for May public inquiries before any of them produce report”, Jan 1). I was commissioned by Mrs May to investigate the harm done to women by two medications taken during pregnancy, and the life- changing pain experienced by many women fitted with vaginal mesh. Our report “First Do No Harm” cost about £1 million — modest for two and a half years’ work by a small team.

Of the nine recommendations that we made, one, an apology, has been achieved; a second recommendation, the appointment of a patients’ safety commissioner, is promised; vaginal mesh is now seldom used; and a First Do No Harm all-party parliamentary group has been established with private funding, to fulfil the other recommendations and bring justice to those harmed women.

Inquiries are only as good as the change for the better that results from their work. We are getting there.

Baroness Cumberlege
House of Lords

Virtual Launch Speech 16 December 2020

This morning, Baroness Cumberlege led a virtual event to launch the All-Party Parliamentary Group for First Do No Harm, in which she introduced the Group, restated the case for the implementation of the recommendations in First Do No Harm and provided an update on recent developments regarding the Review’s recommendations.

The text of her remarks can be accessed here – this text should be checked against delivery. 

A video of her remarks is available here

APPG launched to campaign for implementation of landmark report, First Do No Harm

16, November 2020: Baroness Cumberlege and Jeremy Hunt MP have today launched an All-Party Parliamentary Group (APPG) to raise awareness of and build support for the recommendations in First Do No Harm, the landmark report of the Independent Medicines and Medical Devices Safety (IMMDS) Review.

The publication of First Do No Harm in July 2020marked the culmination of a Review that, over two years, heard harrowing patient testimony and received a large volume of other evidence concerning three medical interventions: Primodos, sodium valproate and pelvic mesh. The IMMDS Review was Chaired by Baroness Cumberlege and commissioned by Jeremy Hunt MP in February 2018, during his tenure as Secretary of State for Health and Social Care.

First Do No Harm set out nine major recommendations to bring much-needed help and support to those who have suffered as a result of these interventions, and to reduce the risk of avoidable harm from medicines and medical devices in the future. There is a widespread consensus in favour of its recommendations, among all the patient groups concerned with the issues and among royal colleges, professional bodies, public institutions and others.

The APPG for First Do No Harm (APPGFDNH) will campaign to raise awareness of and build support for the implementation of the nine recommendations, eight of which remain outstanding after fulsome apologies were given by the Secretary of State for Health and Minister for Patient Safety on the day First Do No Harm was published. 

Positive discussions have been had with the Government on the need for a Patient Safety Commissioner for England, which it has now accepted and intends to bring forward as an amendment to the Medicines and Medical Devices Bill at the Report Stage. APPGFDNH  is encouraged by this progress and will work to ensure the Commissioner is truly independent.

Baroness Cumberlege, Co-Chair of the All-Party Parliamentary Group for First Do No Harm, said:

“While it is welcome that the Government has so far addressed one of the nine recommendations, when First Do No Harm was published in July we had hoped that more progress would have been made by now. We understand that its recommendations were indeed wide-ranging , but the scale of the suffering the Review observed over its two years of work means that nothing short of profound change is urgently required.

“The Government has the power to harness the consensus in favour of the report’s recommendations and deliver change for those patients affected by the issues the Review examined, as well as for future patients. Members of the newly-constituted APPG for First Do No Harm will be the first to express our gratitude when they do.”

The Rt Hon Jeremy Hunt MP, Co-Chair of the All-Party Parliamentary Group for First Do No Harm, said:

“When I commissioned the Independent Medicines and Medical Devices Safety Review in 2018 it was already clear that our healthcare system was still too closed, defensive and focused on blame rather than learning lessons.

“The case for change has been powerfully made in First Do No Harm.  There is literally nothing more tragic than a death or disability that didn’t need to happen, so the recommendations are a matter of great urgency to ensure other families are spared similar heartache. This APPG will work relentlessly to make sure this seminal report is implemented in full and without delay: lessons must be learnt once and for all.”

The Group’s officers include parliamentarians with a track record of campaigning for patient safety, as well as the Chairs of the APPGs on the interventions covered by the IMMDS Review: Emma Hardy MP, APPG on Surgical Mesh; Cat Smith MP, APPG for Valproate and other Anti-Epileptic Drugs in Pregnancy; and Yasmin Qureshi MP, APPG on Hormone Pregnancy Tests. Its full list of offices is as follows:

  • Baroness Cumberlege CBE DL, Co-Chair
  • The Rt Hon Jeremy Hunt MP, Co-Chair
  • Lord O’Shaughnessy, Vice-Chair
  • Lord Patel, Vice-Chair
  • Lord Hunt of Kings Heath, Vice-Chair
  • Sharon Hodgson MP, Vice-Chair
  • Emma Hardy MP, Vice-Chair
  • Cat Smith MP, Vice-Chair
  • Yasmin Qureshi MP, Vice-Chair

The Group was constituted in September and has been registered with the parliamentary authorities. It will announce its programme of activity in due course. The Minister for Patient Safety, Nadine Dorries MP, has been invited to the Group’s first public meeting to provide an update on the Government’s thought process and activity since the report’s publication, and to share her insight regarding next steps.

The IMMDS Review’s major recommendations include:

  • That the Government immediately issues a fulsome apology on behalf of the healthcare system to the families affected by Primodos, sodium valproate and pelvic mesh.
  • That a Patient Safety Commissioner is appointed. This person would be the patients’ port of call, listener and advocate, who holds the system to account, monitors trends, and demands action.
  • Separate schemes should be set up for Hormone Pregnancy Tests, 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.
  • A Redress Agency for those harmed by medicines and medical devices in future should be established.
  • The establishment of two types of specialist centres, located regionally – for mesh, and separately for those affected by medications taken during pregnancy.
  • The regulator of medicines and medical devices, the MHRA, needs to put patients at the heart of its activity, and to overhaul adverse event reporting and medical device regulation.
  • That a central database should be created by collecting key details including the patient, the implanted device, and the surgeon.
  • That the register of the General Medical Council (GMC) should be expanded to include a list of financial and non-pecuniary interests for all doctors, as well as doctors’ clinical interests and specialisms.
  • Finally, that the Government immediately sets up a task force to implement the Review’s recommendations.


For more information visit the Group’s website at or contact the Secretariat on 02076189189, 07947477460 or