The Call for Evidence for the Independent Medicines and Medical Devices Safety Review is now open
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 clinical interventions be they medicines or medical devices.
The Review will specifically be looking at:
- Primodos and other Hormone Pregnancy Tests
- Sodium valproate and other valproate medications for women of child bearing age
- Synthetic mesh for use in abdominal and vaginal pelvic mesh procedures
You can read more about the what the Review covers in the Terms of Reference.
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 includes: affected individuals, their family, friends and carers; regulators; NHS bodies and private health care providers; health professionals; manufacturers and suppliers.
The Review will be assisted by hearing from anyone affected by any of the three interventions, whether their experiences were positive, negative, or mixed. This will support different aspects of the investigation and report process, including understanding what happened, and making recommendations for what should happen next. Some individuals and organisations 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.
We will be accepting evidence as part of this Call for Evidence up to and including Wednesday 24th October 2018*. After this period, we will be holding a series of oral evidence gathering sessions in London. These will commence in late November and will then be spread out and continue over the coming months through to spring 2019. The first provisional dates, which may be subject to change, are 20th, 21st, 26th and 27th November. Details of the oral hearings, including a leaflet setting out what to expect on the day, will be posted on the website in due course. It is anticipated that only a minority of those who submit written evidence to the Review will be invited to attend. Patient groups, manufacturers/ distributers, regulators, relevant public/private healthcare organisations, professional bodies or experts with a relevant interest may expect to receive an invitation. Invitations to attend will be sent out giving plenty of notice of the date and time of the specific oral hearing session. More detailed information about the Review process can be found here.
If you choose to submit evidence to the Review, we ask that you tell us about your/your organisation’s experience and actions in relation to the area under review in as much detail as possible, to help the Review team make the best use of the information you provide us.
If writing in as a patient affected or family member this might include a chronology of what happened, which organisations you interacted with, your condition, symptoms and side-effects, what advice you were given at each stage and whether and how consent to treatment was sought.
In particular, if you think there were instances where things went wrong, or were not handled in the right way, we would like you to tell us. We would also like to know if you think any opportunities for correcting a situation or making it better were missed.
Finally, if you have opinions about what needs to be done differently in future to prevent similar occurrences happening to others, we would like to hear it from you. This might be in relation to how things were communicated, processes that were followed, or people or organisations you interacted with.
If there are any documents relating to your experience that you think would be useful for us to see, please also share them with us.
More detailed information about the Review process, the way we handle information you provide us, the Review’s Privacy Information notice and the Redaction and Anonymity Framework can be found here.
If you submitted information to the Review prior to the Call for Evidence, please use the webform or email the Review Team at email@example.com to outline this information, confirm that you wish this material to be considered as part of the evidence, and agree that you are happy for this to be held according to our information handling policies. You may also use this form to provide further information or documents.
The Review has also put in place an off line remote counselling service for individuals affected by any of the three interventions and who feel they would benefit from the support of such a service to help them in engage with the Review. Details of the service provided and how it can be accessed can be found here.
* We want to give people directly affected by Primodos, sodium valproate taken by women of child bearing age and surgical mesh as much opportunity as possible to submit their views. If you have been affected by any of these interventions and feel that you need more time to send us your evidence, please contact the Review team by email at firstname.lastname@example.org or by phone on 0207 848 6386 who will be pleased to arrange that.