EU Regulators to act on epilepsy drug which damages unborn children

EU Regulators to act on epilepsy drug which damages unborn children

27 September 2017

EU Regulators to act on epilepsy drug which damages unborn children 
 
You might have seen stories in the media this week about an inquiry into Valproate, a drug used to treat epilepsy and bipolar disorders which is now known to cause serious physical and developmental abnormalities in children. The inquiry took the form of a public hearing at the European Medicines Agency (EMA) in London where mothers of children affected by the drug gave evidence to a panel of European experts about their experiences. This was the first ever public hearing on medicine safety at European level and I was invited to open it because I steered the new law on medicines safety or pharmacovigilance through the EU lawmaking process a few years ago. 
 
Having more openness about the side effects of medicines was one of my top priorities when I worked on the new law.  Too often in the past, experts met behind closed doors to discuss medicines safety, leading to allegations of cover-up and undue influence of the pharmaceutical industry.  So this new law, MEPs pushed for a mandatory system for patients to report any side effects directly to medicine regulators,  patient representation on the EU Medicines safety committee and hearings where regulators, companies and healthcare professionals meet in public with patients to hear the first-hand experiences of adverse reactions to drugs.    
 
The stories we heard about children affected by Valproate were heartbreaking. Many of the mothers said they had been given little information about the risks to their unborn children.  Some had two, three and even four children, all who developed problems before a link to their medicine was established.  In the past, investigations into the safety of valproate were left to individual countries which meant there was no overview of just how widespread the problem was. What these women want now is for the European Medicines Agency, which brings together regulators from the EU 28 countries, to quickly develop clear guidelines on the safety of valproate so that children are protected across all countries and no other mothers go through what they have suffered.      
 
Sadly for Britain the European Medicines Agency, which is EU funded, will leave London because of Brexit, taking with it around a thousand highly skilled jobs. I hope, however, that ministers will see sense and prioritise the continuation of work with the EMA, even after Brexit. Going it alone will not only be more costly for the taxpayer but also means we all lose the benefit of pooled knowledge and expertise on medicines safety from across Europe.     
 

 

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