What is the purpose of the Review?
The Review will focus on what has happened in response to safety concerns raised about three medical interventions: surgical mesh, Primodos and sodium valproate. We will consider whether the processes pursued and actions taken by the healthcare system to date in relation to these concerns have been sufficient and satisfactory. We will make recommendations for action, as we deem necessary.
The Review will also make recommendations for improving the healthcare system’s ability to respond in future when concerns are raised about the safety of treatments or technologies, be they medicines or medical devices.
Who is being consulted during the Review?
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 and other public bodies, health professions, manufacturers, and the private sector to understand what happened, how they have responded to the concerns raised and what they think needs to happen.
Who is carrying out the Review?
Baroness Julia Cumberlege is the Chair of the Review.
Sir Cyril Chantler is the Review’s Vice Chair.
Simon Whale is the third member of the Review panel and the Review's Communications Lead.
Valerie Brasse is Secretary to the Review.
How can I find out about the progress the Review is making?
Updates on the Review’s work will be published in the News section of the website and on social media.
Will the Review hold meetings in public?
The Review will be conducted in as open and transparent a manner as possible, while recognising the sensitivity and personal nature of the matters we are considering. In particular, we will respect the wishes and privacy of the patients and families we meet. We intend to publish a record of the meetings we hold with public bodies and other healthcare organisations.
How can I send evidence to the Review?
Evidence is welcomed from anyone with an interest in the matters we are considering. Details on how to submit evidence can be found here.
When will the Review conclude?
We cannot yet confirm when the Review’s work will be completed and its report published. As soon as we are able, we will make that known on the Review’s website. We will conduct our work with all due speed and thoroughness.
What will happen once the Review is completed?
Once all evidence gathered by the Review has been considered, a report will be published containing the Review’s findings and recommendations. Recommendations will seek to improve the healthcare system’s response when safety concerns have been raised about medicines or medical devices. The Review will also recommend further action specific to each of the three areas under consideration, as it deems necessary.
Is there going to be a public inquiry once the Review’s report has been published?
In each of the three areas within the Review’s scope, we will recommend any actions we deem necessary having reviewed the evidence, in addition to making recommendations designed to improve the healthcare system’s response to safety concerns about medicines or medical devices in the future.
Where will I be able to find the Review’s report once it’s been published?
The report will be published on the Review’s website.
Why should I provide evidence?
This call for evidence is an opportunity for all of those with an interest in the matters being considered by the Review to share their experiences and views. This will support different aspects of the investigation and report process, including understanding what happened, and making recommendations for what should happen next.
Who can provide evidence for the Review?
We are inviting anyone with an interest in any of the three interventions or other areas set out in the Terms of Reference to submit evidence to the Review. This includes: affected individuals, their family, friends and carers; regulators; NHS bodies and private health care providers; health professions; manufacturers and supplies. At the heart of the Review will be the experiences and views of those who have suffered harm.
Can I provide information anonymously?
If you are personally affected by any of the three interventions we are looking at in the Review, or are a family member, friend or carer, you can provide as much or as little personal information as you feel comfortable with. You can do so anonymously too should you wish (although this may limit our ability to follow up any issues you have raised). You can see our policies on anonymity and redaction here.
If you are submitting information in a professional capacity you will need to provide personal details including a point of contact.
What sort of information can I send?
We are inviting evidence that relates to the areas set out in the Terms of Reference.
This could include:
Some individuals and organisations, including relevant public bodies, and manufacturers, will receive a specific call for evidence, including a series of focussed questions. If you have not received an email from the Review Team, please use the web form to provide us with any relevant information.
Can I send information by post or talk to someone on the phone?
You can provide evidence by post. Send any information to:
Independent Medicines and Medical Devices Safety Review
Room 3.25b Shepherd’s House
King’s College London
Guy's Campus
London
SE1 1UL
If you do not wish to provide return contact details we will not be able to confirm receipt of your evidence, however please be assured that we will be carefully considering all evidence submitted.
Unfortunately we do not have a facility to take personal testimony over the phone. However, the Review team are visiting a number of places around the country if you would like to share your experiences with them in person. You can see the list of completed and planned visits here. If you are unable to attend a patient engagement event or submit your testimony in writing, please contact the Review at reviewteam@kcl.ac.uk to discuss alternatives means.
The Review Team are unable to accept information on electronic external devices such as CD or USB. Please submit electronic files directly through the web form. If you are unable to do this, contact the Review Team.
Can I change or withdraw the information I provide?
If you have something that you wish to add to the evidence you provided, please contact the Review team quoting your reference number, or use the online portal.
If you wish to change, or delete, information held, please contact the Review’s Data Protection Officer Priyesh.patel@kcl.ac.uk.
How long will I have to submit evidence?
The call for evidence will close at 23.59 on 24th October 2018. If you have provided any personal testimony or evidence before this time and you no longer wish it to contribute to the Review please let us know.
Any information submitted after this time will not be included as part of the evidence unless agreed or part of the Review process, for example, as part of our meetings around the country with affected individuals or networks, information and documentation that is requested by us, and oral hearings.
What will happen to the information I provide?
The Review team will use the information provided to investigate the issues set out in the Terms of Reference. That is: to assess whether the actions taken when safety concerns have been raised have been satisfactory; and to address specific questions in relation to each of the three areas: hormone pregnancy tests, the use of sodium valproate and other valproate medications during pregnancy; and pelvic mesh.
The personal testimony of those affected is important to understand your experiences and views. Issues raised may be used to question other individuals, however identifiable personal details will not be used.
Many people have already shared deeply personal accounts of their experiences, and we know that many more will do so. Please be assured that the Review will store this information safely, and will use this information only for the purposes that we have set out in the Terms of Reference. More detailed information about the Review process, the way we handle information you provide us, the Review’s Privacy Notice and the Anonymity and Redaction Framework can be found here.
Please note, that although the Review will be making recommendations in relation to the medicines and medical devices, and how to improve the ability of the healthcare system in future, the Review will not seek to, and has no power to determine, any legal liability.
Who will be able to read the information I send?
Any personal information will only be read by those working on the Review. We will not share this with any external individuals or organisations, except in a few limited circumstances. More details of when we might wish to share information are set out in the Review’s Privacy Notice. But if this happens, we will not share your personal information without writing to you first, and seeking your views or your permission.
If information has been supplied in a professional capacity, it will be published on the Review’s website. You can read more about the publication of evidence in the Review Process Protocol.
We may use personal information provided in some form, for example, an anonymised quote or summary, for the purposes of fulfilling the Review’s terms of reference, such as in our final report or other published material.
Will the Review contact me after I submit information?
If you have provided an email address, you will receive an email with a reference number to confirm we have received your evidence. If you send evidence by post, please let us know the best way to contact you to confirm receipt of the information, if you wish for us to do so.
We will not be routinely contacting individuals and their families during the evidence collecting process. However, we may ask follow-up questions to patient groups, manufacturers, suppliers, clinicians, regulatory bodies, NHS and other public bodies and persons of interest.
If you have something that you wish to add to the evidence you provided, please contact the Review team through the web form quoting your reference number or email us directly quoting your reference number.
You can follow the progress of the Review here on the website.
Will I be able to see the evidence submitted by others?
The following information will be published on the Review’s website:
Do I need legal representation?
The Review aims to be an open and transparent process. You do not need legal representation to engage with the Review Team or the evidence gathering process.
I find talking about my experiences difficult, is there any support available?
Yes, a telephone counselling service is available to anyone who needs support as a result of engaging with the Review.
This free service can be reached by phone on 0121 314 7075.
A call to the service during their office hours of Monday – Friday 8am – 6pm, will be answered and managed by a real person who will either provide a free session there and then, or at the caller’s convenience. Calls are charged at standard rates, but the service will call users back if the cost is a problem. Calls outside of office hours will be responded to within 24 hours.