Second anniversary of First Do No Harm: Our campaign for redress

8th July marks two years since the publication of First Do No Harm, the landmark report of the Independent Medicines and Medical Devices Safety (IMMDS) Review.

Since then, there has been welcome progress in implementing some of the recommendations – the Government issued an apology to victims and last month we saw the announcement of the Government’s preferred candidate for the position of the Patient Safety Commissioner. There nevertheless remains a concern that the Government will not deliver on some of the remaining recommendations.

There must now be a renewed focus on implementing the remaining recommendations, so that we can deliver the change that thousands of affected individuals and their families need and deserve, and to ensure we minimise the risk of patients suffering avoidable harm in future.

A priority must now be delivering redress for those who have suffered avoidable harm, given the potential it has to improve the greatest number of lives immediately.

The Government has suggested that those affected should seek compensation through NHS Resolution or through litigation in court. This is an adversarial process that has not served affected individuals and their families well. Having seen the avoidable harm people have suffered and continue to suffer, we are firmly of the view is that there is a strong moral and ethical responsibility to provide redress.

Mythbusting redress

Redress

  • …is not the same as compensation.
  • …will require no legal action or admission of responsibility by manufacturers, clinicians or the Government.
  • …is within the Government’s power to deliver, as it did in the case of Thalidomide and the vCJD Trust.
  • …would not be costly.

Our position on redress is based on the conclusion of the IMMDS Review that women, their children and families have suffered years of severe physical pain, financial hardship stress, anxiety and feelings of guilt – all through no fault of their own and brought about by the healthcare system’s lack of openness and its unwillingness or inability address the avoidable suffering that has occurred.

We understand the Government is working on an update detailing its progress in implementing the recommendations of the IMMDS Review. Ahead of that update, you can help maintain momentum and join our campaign by:

Click here to download our pledge card
Click here to find your local MP

Letter to the Minister for Patient Safety

Baroness Julia Cumberlege CBE, Rt Hon Jeremy Hunt MP and other supporters of the APPG First Do No Harm have written to the Minister for Patient Safety, calling for the government to reconsider its continued advocacy for a litigation route for those harmed by Primodos, sodium valproate and mesh. The signatories of the letter are calling for a meeting with the Minister to discuss the need for redress schemes, as initially recommended by the First Do No Harm report.

Read the full letter to Maria Caulfield MP, Minister for Patient Safety and Primary Care below.

Click here to view.

Statement from Baroness Julia Cumberlege CBE and the Rt Hon Jeremy Hunt MP

Statement from Baroness Julia Cumberlege CBE and the Rt Hon Jeremy Hunt MP

Responding to the publication of a Written Ministerial Statement on the Independent Medicines and Medical Devices Safety Review, Baroness Julia Cumberlege CBE and the Rt Hon Jeremy Hunt MP said:

“We welcome the government’s acceptance of four of the Review’s nine recommendations and a further one in principle.  We are particularly pleased there will now be a Patient Safety Commissioner, and we urge the government to move swiftly to appoint the person and establish the post. We are confident that the Commissioner will be able to reduce the risk of avoidable harm in future, and spare individuals and families from the appalling consequences witnessed by the IMMDS Review. 

“But we are deeply disappointed the government has rejected calls for an independent redress agency or any redress for families whose lives have been devastated by medicines or medical devices. For those families justice has not been done today.”

 

ENDS

Notes for Editors

Jeremy Hunt MP is Chair of the House of Commons Health and Social Care Select Committee.

Baroness Cumberlege was Chair of the Independent Medicines and Medical Devices Safety Review.  

She and Jeremy Hunt MP are Co-Chairs of the First Do No Harm All-Party Parliamentary Group www.firstdonoharmappg.org.uk.

For more information contact the Group’s Secretariat at Luther Pendragon via fdnh@luther.co.uk.

 

House of Commons debate on 8th July

On 8 July there will be a debate on the floor of the house on the following motion tabled by Emma Hardy MP and Alec Shelbrooke MP:

“That this House notes the publication of the Independent Medicines and Medical Devices Safety Review, First Do No Harm; notes the Government’s refusal to implement the recommendations of that review in full; further notes the significant discrepancy between the incidence of complication following mesh surgery in the Hospital Episode Statistics and the British Society of Urogynaecology databases, as highlighted in the Royal College of Obstetricians and Gynaecologists’ Project Report, Hospital Episode Statistics as a source of information on safety and quality in gynaecology to support revalidation; notes that a Government promise to publish a retrospective audit to investigate the links between patient-level data to explore outcomes has not been fulfilled; notes that the moratorium on mesh implant procedures should not be lifted until that audit has been undertaken and the true scale of suffering established; notes Ministers’ continued refusal to acknowledge recommendations relating to victims of Primodos; and calls on the Government to fully implement the recommendations for victims of mesh, sodium valproate and Primodos without further delay.”

Download - Briefing for Parliamentarians

The Group’s Secretariat at Luther Pendragon have produced a briefing for parliamentarians ahead of Thursday’s debate. Click on the link above to download.

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 IMMDSRPatientGroup@traverse.ltd.

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 IMMDSRPatientGroup@traverse.ltd 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 here. External-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)