Submitting evidence

The Call for Evidence for the Independent Medicines and Medical Devices Safety 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 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.

The Call for Evidence provided 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 is 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 have received a specific Call for Evidence, including a series of focussed questions. 

We accepted evidence as part of this Call for Evidence up to and including Wednesday 24th October 2018*. Written evidence received by the Review is available to view here

From November 2018 we have been holding a series of oral evidence gathering sessions in London. These are expected to continue until spring 2019. Further information on our hearings can be found here

Only a minority of those who have submitted written evidence to the Review will be invited to attend an oral hearing. Patient groups, manufacturers/ distributors, regulators, relevant public/private healthcare organisations, professional bodies or experts with a relevant interest should 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.  More detailed information about the way we handle information you provide us, the Review’s Privacy Information notice and the Redaction and Anonymity Framework can be found here.

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 have not submitted written evidence but would like to do so, please contact the Review team by email at reviewteam@kcl.ac.uk or by phone on 0207 848 6386.