In early November 2020, the Minister for Health Stephen Donnelly committed to holding an inquiry into the historical licensing and use of the anti-epileptic and Bipolar treatment drug sodium valproate (Epilim) in Ireland, following a meeting with representatives from Epilepsy Ireland and the Organisation for Anti-Convulsant Syndrome (OACS) Ireland.
As the Minister himself accepted at the time, this decision followed “years” of fighting by parents and children for an inquiry into the licensing and use of this drug.
He also went on to say at that time that he had asked the officials in his department “to begin work on this as a priority” and that he had “emphasised the need for a fair and fast inquiry.”
Unfortunately for the parents and children however there is still no sign of that inquiry beginning. All we know from a recent PQ submitted by Deputy Carol Nolan is that details of the proposed inquiry are “currently being considered by officials within the Department of Health.”
What makes this lethargy worse is that the previous Minister for Health Simon Harris had already made it clear in May of 2019 that he had been aware of the issues surrounding sodium valproate use in pregnancy since early 2017.
So, it is not as if the department is somehow in the dark on this matter.
An outline of the history of the issue should help to make this clear
Let us begin in April 2018 when the Foetal Anti-Convulsant Syndrome (FACS) Forum, appeared before the Joint Oireachtas Committee on Health to discuss the risks associated with the Epilepsy and Bipolar treatment drug Sodium Valproate, marked and licensed in Ireland as Epilim.
The Forum members informed the Committee that FACS is a syndrome that affects children born to women who were prescribed Epilim during pregnancy and that children exposed to this drug in the womb have an 11% chance of malformations at birth compared with a 2% to 3% in the general population.
Malformations include neural tube defects, malformation of limbs, digits and organs, cleft palate among “many, many more physical conditions”.
An additional 40% of children experience developmental delay and have a three to five times greater risk of developing autism, autistic spectrum disorder and ADHD.
It later emerged in Committee that there was some dispute as to the number of children affected in Ireland.
This was only clarified on May 21st, 2019, when then Minister for Health, Simon Harris, confirmed that an assessment conducted by the HSE has estimated that between 153 and 341 children will have experienced a major congenital (genetic) malformation due to exposure to Sodium Valporate or Epilim.
Minister Harris also confirmed that up to 1,250 children will have experienced some form of neurodevelopmental delay following exposure to Sodium Valproate in utero between 1975 and 2015.
The question is of course, were pharmaceutical companies and the Irish health and regulatory authorities aware of the dangers to pregnant women and if so what did they do about it?
This is where matters take a much more alarming turn.
According to a statement made at the Committee by Mr Peter Murphy, CEO of Epilepsy Ireland, information on the risks to pregnant women was first included in UK in 2002.
The same information did not appear in Ireland however until 2008.
Even more alarming is the fact that according to Mr Murphy, from 2001, in the UK it was recommended that Epilim be used in women of childbearing age only in severe cases or in those resistant to other treatment but a similar recommendation was not in place in Ireland until 2012.
In what can only be termed a significant understatement, Mr Murphy also went on to say that “there were a number of other discrepancies” on the information difference between the UK and Ireland.
Let us recall here that Simon Harris has already officially confirmed to the Dáil that 2001-2012 is part of that time span when hundreds of children were born with major congenital malformations and developmental delays.
It is also important to note, as the Forum representative at the Committee made clear, that in 2014 the European Medicines Agency (EMA) had strengthened the warnings and restrictions on the use of valproate in women and girls.
However, in 2017 the agency had to review how these recommendations were being implemented due to concerns that EU member states, including Ireland, were not implementing the recommendations properly.
In February of 2018, the EMA had to issue additional instructions aimed at further reducing risks for women and girls of childbearing age.
When asked who was responsible for the fact that information on risks were given in the UK years before they were given in Ireland, Dr. Almath Spooner of our own Health Products Regulatory Authority-stated that responsibility lay with “the marketing authorisation holder.”
The Marketing Authorisation Holder (MAH) in this case is the producer of Epilim, the pharmaceutical company, Sanofi.
According to the European Patients Agency, once a medicinal product is marketed and in use by patients, the company continues to be responsible for monitoring safety.
That is not the end of the story however, because as The European Patients Agency also say that any suspected adverse reactions must be reported to the body which granted the marketing authorisation which in this case would be Irelands Health Regulatory Authority (HPRA).
As the Report of the Health Committee on this matter made clear, “further examination is required to establish liability.”
The shape that this further examination was to take was that of a full inquiry.
This is absolutely critical for two reasons. The first is that families and children who have had their lives devastated by FACS must be supported and if necessary fully compensated.
The second relates to the fundamental importance of being able to have confidence in the regulation of medicines in this State.
This scandal makes it absolutely clear what is at stake when things go wrong, but it also makes the case for an immediate inquiry absolutely compelling.
It is to the everlasting shame of this government and the previous one that it has left parents begging for information on when exactly this inquiry will begin.