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Lawyer for families affected by Epilim highlights deadline for review evidence

The deadline for submitting evidence to the Independent Medicines and Medical Devices Safety (IMMDS) Review is fast approaching, with the review team accepting evidence up until Wednesday 24th October 2018.

2 October 2018

The review, which is chaired by Baroness Cumberledge, is intended to look at ways to improve the experience of patients and their families where concerns have been raised about the safety of clinical interventions - both medicines and products.

It will focus on three different medical products including Sodium Valproate, commonly known in the UK as Epilim, which is used to treat epilepsy.

Leigh Day, working with family support groups including the Organisation for Anti-Convulsant Syndrome (OACS) and FACSAware, made a formal submission to the Review in April 2018 setting out the moral and legal case for those children injured by in utero exposure to Epilim to receive compensation, and for the circumstances of how and why Epilim was permitted onto the UK market, with allegedly inadequate labelling, to be the subject of a full public inquiry.

This formal submission will form part of the evidence considered by the review team.

The review team have now published further details about how the process will run. Key points are as follows:
  • Formal evidence can now be submitted using an electronic form available via the IMMDS website.
  • Anyone with evidence to share concerning Epilim, including those directly affected by exposure to Epilim and their families, is invited to use this form.
  • The Review have set a deadline of Wednesday 24th October 2018 by which all further evidence must be submitted.
  • There will be a series of oral evidence gathering sessions in London, from late November until ‘spring 2019’. The first provisional dates, which may be subject to change, are 20th, 21st, 26th and 27th November. Further details of how this will run will be published by the review team in due course.
  • Attendance at these oral hearings will be by invitation only.
  • All oral hearings will be videoed and will be available online within 5 days of each session.
  • All evidence submitted through the website prior to 24th October 2018 will be available on the website for all to read after that date.
  • The list of experts who will be appointed to review the evidence will be published in due course.

The review team have not yet published a full timetable setting out the different phases of the protocol, or the target date by which their final recommendations will be announced. Correspondence with the review team indicates that such a timetable is unlikely to be made available.

Sarah Moore, a solicitor at Leigh Day who has been working with families affected by Epilim, commented:

“We are encouraged by the fact that the review team are moving the process forward. However, we remain concerned that the review team have not committed to a timetable indicating a target date for publication of their recommendations. Some families who have steadfastly cared for children injured by their in utero exposure to Epilim, have waited for more than 30 years for answers. By failing to commit to a clear timetable, it might be said that the review team are failing to recognise the urgency still felt by these families who struggle daily with the emotional and financial impact of children affected by Foetal Valproate Syndrome.”

The review will publish further information about the experts commissioned to consider the evidence submitted to the review in the coming weeks. As this and further information becomes available, updates will follow.

We would encourage anyone with an interest in providing evidence to the IMMDS Review to contact the review team directly via the IMMDS website ahead of the 24th October deadline.

Information was correct at time of publishing. See terms and conditions for further details.

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