Terms of Reference


Background to the Review

In February 2018, the former Secretary of State for Health and Social Care, the Rt Hon Jeremy Hunt MP, announced a review into how the healthcare system in England responds to reports from patients about harmful side effects from medicines and medical devices. The announcement in the House of Commons followed patient-led campaigns on the use of the hormone pregnancy test Primodos, the anti-epileptic drug sodium valproate for women and girls of child bearing age and pelvic mesh.  The Review will be chaired by Baroness Julia Cumberlege and will be independent of the Government, NHS, regulatory and other public bodies, and the pharmaceutical and medical devices industries.

A report of the Review’s work will be published.

Scope of the Review

The purpose of the Review is to make recommendations for improving the healthcare system’s ability to respond where concerns have been raised about the safety of particular clinical interventions, be they medicines or medical devices.

The Review will assess the historic evidence relating to the science of what was known, (in the case of Primodos during its lifetime and now, and in respect of sodium valproate and pelvic mesh up to the current date) and the decision making and actions taken, based on that scientific knowledge, by the manufacturers, regulators, clinicians and policy makers. If there appear to be flaws in the gathering of that scientific evidence, or questions over its independence or interpretation, the Review will comment accordingly.

The Review will also consider the practice of obtaining patients’ consent to each of the three clinical interventions, historically in the case of Primodos, and up until the present day for sodium valproate and pelvic mesh, including appropriate practice (taking into account the historical context) in explaining to patients the potential benefits and the associated risks of any intervention.

The Review will focus on whether the processes pursued to date when safety concerns have been raised by patients, their families and others have been sufficient and satisfactory in relation to Primodos, sodium valproate and pelvic mesh. 

In each of the three areas, the Review will investigate:

  • the robustness, speed and appropriateness of those processes and actions followed by the relevant pharmaceutical/ medical device manufacturers and applicants for and holders of licenses to manufacture and sell pharmaceutical products and medical devices, the regulatory authorities, healthcare providers, public and clinical bodies and policy makers;
  • whether problems could have been recognised by the relevant bodies, authorities, manufacturers and license holders and others sooner and more effectively;
  • whether the same bodies could, and should, have acted upon concerns sooner and if they did not, the reasons why.

In all its work, the Review will consider, and take account of, the historical context, including the requirements of any regulatory or licensing régimes for medical devices and medicines in force at the appropriate times.

In addition to the above, there are questions of interest to the Review in relation specifically to:

A. Primodos

  1. where the science is not broadly acknowledged or accepted, whether the available historic and scientific evidence (and its assessment to date) can reasonably preclude ‘a possible association’ between Hormone Pregnancy Tests and their teratogenic effects, and/or needs to be revisited, in the opinion of the Review;
  2. given the knowledge on Hormone Pregnancy Tests available to the manufacturers, regulators and clinicians at the time, the consideration, advice and practice with regard to the use of alternative, non-invasive pregnancy tests.
B. Sodium Valproate
  1. the circumstances of the pharmaceutical licensing of Sodium Valproate and treatment to date for women and girls of child bearing age based on the growing body of agreed scientific evidence as to its teratogenicity;
  2. how that scientific knowledge was, or should have been, communicated between the manufacturers, regulatory authorities, clinicians and patients and subsequently acted upon;
  3. whether a consensus has been reached on defining the characteristics of the conditions referred to as Fetal Valproate Spectrum Disorders and the implications of this for proper diagnosis and assessment of the lifetime needs of those affected.
C. Abdominal and vaginal pelvic mesh procedures1
  1. whether the scientific evidence underpinning current regulatory and clinical practice fully and properly reflects:
    1. the long term quality of life impact where there are adverse complications following these pelvic mesh procedures;
    2. the innate properties of the polymeric material currently in use in the manufacture of pelvic mesh products and what is known about how those properties change once the mesh has been implanted in the human body and over time; and
    3. the risks associated with the procedures themselves in comparison with the alternative available options.
  2. the circumstances of the synthetic pelvic mesh medical device regulation, approval and adverse effects reporting to date.

It is not the intention of the Review to re-do the work recently undertaken by other Reviews/ Expert Working Groups into each of the three interventions here and in other jurisdictions. The Review will, however, take account of them in addressing these questions and in developing their narrative from the perspective of the healthcare system’s response to patients’ safety concerns raised over time.

The Review recognizes that, over time, there is likely to have been significant differences in the quality and robustness of the evidence bases that support the use of medicine and medical device technologies. Taking this into account, the Review will make recommendations on what should happen in future in relation to Primodos, sodium valproate and pelvic mesh, including:

  • whether further action is now required;
  • what that action should consist of; and
  • whose responsibility it is to act.

These recommendations will be specific to each of the three clinical interventions and the patient groups affected and will reflect their different needs and the issues they face.

The Review will consider and make recommendations more broadly, based on its assessment of any lessons to be learned, on what could be done in the future to:

  • identify and acknowledge problems with medicines and medical devices effectively and quickly;
  • strengthen the voice of patients and their families and others so that their concerns are heard in an open, fair and accessible way;
  • ensure that those concerns are recognized and acted upon appropriately, as swiftly as possible and in a coordinated fashion; and
  • ensure that those adversely affected receive the care and support they need.

The Review may make additional recommendations that bear on the healthcare system’s response to, and responsibility for, patient safety issues, having considered the effectiveness of the relationships between those public bodies and commercial interests that have a role to play in bringing safe medicines and medical devices to market, in post-marketing surveillance and in responding speedily and appropriately to safety concerns when they need to. Whilst not seeking to redesign the regulatory framework, the Review may comment on aspects of it, including how the reporting of patient safety concerns may be improved.

The Review will not undertake, or otherwise commission, new evidence in relation to the science behind each of the three clinical interventions, although it may make recommendations to that effect.

Nor will the Review’s work include consideration of whether, or how much, compensation may be due to an individual who has suffered harm.

It will, however, consider whether as a priority a wider system of redress, including forms of care and support, should be developed. The Review may make recommendations on any forms of redress, including recommendations as to whether there is a moral, social or ethical responsibility to consider a system of compensation, if it concludes that there has been avoidable harm suffered as a result of the medical interventions it has considered, or any of them. It will not make findings upon whether, in an individual’s case, such harm has been suffered.

It may also make recommendations on the proper and fair processes that should be followed, either in these three cases or others in the future, to ensure public confidence in the healthcare system, its decision making and practice, is maintained and strengthened.

Approach

Our Review will listen, learn and recommend.

We will listen to those who have suffered harm. Their voices, their experiences and views will be at the heart of our Review.   

We will also take evidence from regulators, NHS bodies, health professions, healthcare providers, manufacturers, suppliers and others to understand what happened, how they have responded to the concerns raised and what they think needs to happen.

We will seek to learn from the three cases so that we can form our own independent and objective views on what has happened and make recommendations about what needs to happen now.

The Review will not seek to determine, and has no power to determine, any person or body's civil or criminal liability.  But it will seek to examine processes and safeguards designed to avoid harm to patients, and whether they were effective.

Where safety concerns leading to avoidable harm do arise in future, we will seek to ensure that those affected are heard and supported in a swift and sensitive manner and the appropriate, co-ordinated response processes are identified.

We will make ourselves accessible so that we can hear as many views and experiences as possible.  We will use meetings, events, correspondence and social media to facilitate this.    

We know that many people will take an interest in our Review and be keen to know our conclusions. We cannot at this stage indicate when the Review will report but we undertake to work with all due speed and thoroughness.

Correspondence list

You can download a list of organisations that have been sent the terms of refererence here.

1.These include treatment for stress urinary incontinence (SUI) and abdominally inserted pelvic organ prolapse (POP) procedures including for example (but not limited to) sacrocolpolpexy, hysteropexy and rectopexy. We recognise that vaginally placed mesh for POP has been restricted to research only since December 2017.