#Firstdonoharm IMMDS UK Review Report – Key Recommendations

#Firstdonhoharm Report – Key Recommendations

The outcome of a two year inquiry in the UK which investigated how the British Healthcare authorities responded to reports of patient concerns regarding the use of sodium valproate (epilim) in pregnancy to which OACS Ireland made significant contributions has today issued their long awaited report.

The inquiry’s report is entitled “First Do No Harm” and makes a series of recommendations for person’s who were impacted by sodium valproate in the past, as well as a number of recommended measures to be introduced in the UK in the future – to ensure the situation is not repeated. The specific recommendations in the report are as follows:

  • That the Government immediately issues a fulsome apology on behalf of the healthcare system to the families affected by Primodos, sodium valproate and pelvic mesh.
  • That a Patient Safety Commissioner is appointed. This person would be the patients’ port of call, listener and advocate, who holds the system to account, monitors trends, and demands action.
  • Separate schemes should be set up for Hormone Pregnancy Tests, valproate and pelvic mesh to meet the cost of providing additional care and support to those who have experienced avoidable harm and are eligible to claim.
  • A Redress Agency for those harmed by medicines and medical devices in future should be established.
  • The establishment of two types of specialist centres, located regionally – for mesh, and separately for those affected by medications taken during pregnancy.
  • The regulator of medicines and medical devices, the MHRA, needs to put patients at the heart of its activity, and to overhaul adverse event reporting and medical device regulation.
  • That a central database should be created by collecting key details including the patient, the implanted device, and the surgeon.
  • That the register of the General Medical Council (GMC) should be expanded to include a list of financial and non-pecuniary interests for all doctors, as well as doctors’ clinical interests and specialisms.
  • Finally, that the Government immediately sets up a task force to implement the Review’s recommendations.

The report also made a series of specific findings/recommendations regarding the use of Sodium Valproate (Epilim) in the UK which are listed below:

  • Sodium valproate was known to be teratogenic in animals at the time of licensing. Despite this, no long-term follow-up was conducted at that time.
  • As concerns emerged about the risk of congenital malformations and neurodevelopmental effects warnings given to patients lagged behind that given to doctors.
  • Many women were not given enough information about the risks and benefits of their epilepsy treatment and family planning options to make fully informed decisions.
  • It took over 40 years for the healthcare system to put into place measures to ensure that women were fully informed of the risk prior to becoming pregnant.
  • The Pregnancy Prevention Programme (PPP) sets out the conditions under which all girls and women of childbearing potential should be treated with valproate. Despite these measures, hundreds of women are still becoming pregnant on valproate while unaware of the risks.
  • An apology is due, and support is required for those who have suffered avoidable harm.
  • Those affected are not receiving adequate support. We recommend that specialist centres are established for all families affected by teratogenic medication, to provide integrated medical and social care expertise to enable those affected to access the services they need in one place.
  • We have discussed with NHSE&I that all women and girls of childbearing potential are written to, asking them to see their general practitioner or specialist to ensure they are receiving treatment in line with the PPP.
  • We also make recommendations to reduce the risk of exposure to suspected or known teratogens

The report which has been issued in the UK can be downloaded at the following link:


You can find comments from Chair of the inquiry, Baroness Julia Cumberlege on the inquiry’s recommendations at the link below:


We alongside our colleagues in Epilepsy Ireland are very pleased for our colleagues in the UK who now have more answers as to where the system failed them and are a step closer to justice. We would particularly like to acknowledge those in OACS UK who have been a constant source of support and guidance with regard to the situation here in Ireland.

We now need to see an independent inquiry ordered in Ireland so families affected here can receive answers to the many questions they have. In response to today’s developments in the UK, we have issued a joint statement with Epilepsy Ireland to the media demanding this inquiry.

You can read this statement at the link below:


Letter from OACS Ireland & Epilepsy Ireland in response to UK #Firstdonoharm report

In response to today’s developments in the UK regarding the publication of a two year inquiry into how the British healthcare system responded to reports from patients regarding sodium valproate – and which has subsequently recommended that the British Government apologise to those who have been impacted by exposure to sodium valproate in utero – we have immediately written jointly with Epilepsy Ireland to new Health Minister, Deputy Stephen Donnelly seeking an urgent meeting on three actions which must now happen in Ireland, namely:

  1. The establishment of an independent inquiry
  2. The establishment of a Ministerial-appointed valproate stakeholder group
  3. The need to activate measures proposed by HSE in 2019 to support families affected by foetal valproate syndrome.

Our letter in full can be viewed below. We look forward to receiving an urgent reply from the Minister on this most important matter.  You can also read our statement on today’s developments in the UK at the link below:


Letter to Minister Donnelly,  8th July 2020

Dear Minister Donnelly, 

We trust this finds you well in these unprecedented times for the country. We would like to congratulate you on your appointment as Minister for Health and we wish you every success for the years to come.   We are writing to you regarding the issue of sodium valproate and the need for an independent inquiry in Ireland.  As you know, children exposed to the drug in the womb are at a high risk of serious developmental disorders and congenital malformations. A 2019 HSE Rapid Assessment Report estimates that up to 1,250 children in Ireland have been affected by in-utero exposure to valproate between 1975 and 2015.

We welcomed your commitment prior to the general election – and that of your coalition partners in the Green Party – on the need for an independent inquiry to examine the historical licencing and use of valproate in Ireland and into its ongoing effects.

We are now requesting that this inquiry is now established as a matter of urgency.  

Today, the UK’s Independent Medicines and Medical Devices Safety (IMMDS) non-statutory inquiry issued their final report and recommended that the British Government issue a full apology on behalf of the healthcare system to all those impacted by valproate. The recommendation follows a two-year independent investigation which collected thousands of documents and hundreds of hours of testimony in concluding that “as data emerged on the risks of the use of sodium valproate over the decades, it took too long for action to be taken by the healthcare system to ensure that risks were minimised”.

Your colleague and predecessor Minister Harris noted in previous Dáil responses that he was monitoring the UK review closely before deciding on the next step for families impacted here in Ireland. You will also be aware that in 2018, the Oireachtas Committee on Health made 12 recommendations on the State’s response including that an independent inquiry be established to investigate the historical use of the drug.

Hundreds of families in Ireland, some of whom you have met already, are living every day with the ramifications of being prescribed this drug in pregnancy. They are caring for their children, many of whom are now adults, with serious irrevocable disabilities and the most complex of needs. They have questions as to how their situations were allowed to happen, despite growing evidence since the 1960s about the risks of the drug in pregnancy. They want to know why it took until 2014 for regulatory action and they want to know why they continued to receive sodium valproate, often without any discussion of the risks, throughout a period when the adverse effects were well documented. 

They cannot wait any longer to see these and other historical issues investigated. In light of today’s UK report findings, they too deserve answers and it is clear that the only pathway for them getting these answers is via an independent inquiry. On behalf of all families affected by sodium valproate, we hope and expect that that your commitment to an inquiry will now be honoured.

In addition to the above, we have serious concerns about the effectiveness of the State’s response to implementing measures aimed at reducing the risk of children being born with valproate-related disabilities in future. 

Since 2018, a range of welcome measures have been put in place by the HPRA and the HSE. For example, valproate must be initiated by a specialist and must not be used in girls and women who may be able to have children unless the terms of a pregnancy prevention programme (PPP) are followed. The HSE established a Valproate Response Project, which among other work during its term, issued direct correspondence to patients and their GPs.

Despite these and other steps, data collected this year by Epilepsy Ireland from service users prescribed valproate since 2018, has found that three in 10 women have never had a discussion with a health care professional about the risks of valproate in pregnancy and only one in four women had ever heard of the (mandatory) Pregnancy Prevention Programme. Most worryingly, one in six respondents were unaware that valproate increased the risk of birth defects while one-third were unaware of the risks of neurodevelopmental disabilities.

These are extremely concerning findings. They point to a devastating situation where children are potentially being born in Ireland in 2020 that have been exposed to valproate in-utero without their parents having any prior knowledge of the risks. Further action is required to ensure that no more children are born in Ireland with preventable valproate-related disabilities.

Alongside the establishment of an inquiry, we are also seeking that you establish a Valproate Stakeholder Group consisting of representatives from the HPRA, HSE, Department of Health, PSI, healthcare professional bodies, patient groups and other relevant stakeholders in order to collaboratively tackle and resolve issues of risk minimisation once and for all. 

Capacity within the HSE’s epilepsy service must also be increased to enable the mandatory annual consultations and risk acknowledgements to take place. For example, four out of six epilepsy specialist nursing posts, approved in 2018 for this specific purpose remain vacant today.

Finally, access to a range of community supports and services is of critical importance to families affected by foetal valproate syndrome. The HSE Valproate Response Team worked with OACS Ireland in 2018 and early 2019 to develop a community support package and a summary of the HSE Valproate Response Team’s proposal was included in their final report in March 2019. It stated that the “proposal and the funding required is currently under consideration by the HSE Community Operations”. To date, none of the measures proposed in the Community Operations sub-group proposal have been actioned or resourced and families today are no better supported than they were two years ago. 

Minister, while some good work has taken place since 2018, too many aspects remain incomplete or have not been as effective as originally intended.  

In conclusion, we are seeking an urgent meeting with you to discuss: 1) The establishment of an independent inquiry  2) The establishment of a Ministerial-appointed valproate stakeholder group 3) The need to activate measures proposed by HSE in 2019 to support families affected by foetal valproate syndrome.

Thank you for your time and attention to this matter. We look forward to your response and to discussing these matters with you shortly. 

Yours sincerely,

Karen Keely

Chair, OACS Ireland

Peter Murphy

CEO, Epilepsy Ireland







  1. Deborah Hogan on July 8, 2020 at 1:15 pm

    Welcoming but Way overdue development. Great work done by OACS but the government needs to take action.