The EMA assesses and oversees the safety of medicines in the EU. The announced public hearing is part of the EMA’s review into the use of valproate-based medicines in women who are pregnant or of childbearing age.
Valproate-based medicines are used to treat a number of conditions, including epilepsy. Sodium valproate can be very effective in treating epilepsy for some people. However, if taken by women during pregnancy, it can increase the risks of birth defects in babies.
Public hearings are a way in which the EMA can hear the experiences of members of the EU public into different topics.
The EMA is hoping to hear from people about their thoughts on the risks of taking valproate medicines during pregnancy. They also want people’s opinions on current measures to reduce the risk of women using these medicines during pregnancy and thoughts on future measures.
People can apply to attend the public hearing by filling out an application form which can be downloaded from the EMA website. To register your interest, you need to complete the application form and send it in to the EMA at firstname.lastname@example.org by 25 August 2017. The EMA has said that due to space restrictions, they can’t accept all applications. However, the public hearing will be broadcast live on 26 September on the EMA’s website.
You can apply to be a speaker or an observer at the public hearing. The EMA has provided a summary of the safety concerns around valproate medicines and a list of questions the public hearing will look into. There is also an information video about the public hearing process.
This is the first time the EMA has held a public hearing as part of a medicine review. EMA’s Camelia Enachioiu said: “Public hearings will give EU citizens a voice in the evaluation of the safety of medicines and empower them to express their views.”
She added that the EMA’s safety committee decided to organise a public hearing into valproate-based medicines as part of its review to listen directly to people’s experiences. “These contributions can be taken into account in the committee’s recommendation.”