EMA takes yet another step in public engagement with its first public hearing
Summary report now published
Patients, carers, doctors, pharmacists and academia shared their experience with valproate - a medicine that treats epilepsy, bipolar disorder and migraine - at the first public hearing held by the European Medicines Agency (EMA) at its offices in London on 26 September 2017.
“The European Parliament insisted on including public hearings in the EU law on medicines safety,” said Linda McAvan, Member of the European Parliament. “The positive experience from EMA's first public hearing confirms that giving patients a platform to tell their story was the right thing to do.”
The hearing gave an opportunity to EU citizens representing a wide range of groups to make their voices heard to complement the available scientific evidence in the evaluation of this medicine. The total number of attendees was 65, including 28 patients and patient representatives, 19 healthcare professionals and academics, 11 from pharmaceutical industry and 7 from media. There were a total of 25 speaker contributions, grouped into 16 speaker slots.
“The hearing today went absolutely well, beyond expectations. There was an open, non-judgemental atmosphere that allowed all participants to talk with equal credibility,” explained François Houÿez from EURORDIS. “The hearing was carried out in a special ambiance characterised by solemnity, seriousness, and openness.”
The public hearing is part of a review of the safety of using valproate-containing medicines in women and girls who are pregnant or of childbearing age by EMA's Pharmacovigilance Risk Assessment Committee (PRAC). There is a risk of malformations and neurodevelopmental problems in babies who are exposed to valproate in the womb, and the review follows concerns that European Union (EU)-wide risk minimisation measures currently in place do not seem to be sufficiently effective.
“The public hearing was a great opportunity to hear many different views in a relatively short time on a problem of high complexity,” stressed Martin Brodie from the International Bureau for Epilepsy. “Discrepancies in the healthcare systems between EU countries and huge challenges that lie ahead when it comes to restrictions in the use of valproate make this topic a wise choice for a first hearing in Europe.”
“I very much welcome EMA's efforts to engage with the 'real world' when making regulatory decisions. It was a great opportunity to share experience and ideas with PRAC members on how community pharmacists could play an increased role in raising awareness about the risks of valproate in women of childbearing age,” added Jūratė Švarcaitė, Pharmaceutical Group of the European Union (PGEU).
There was agreement among the participants on the undeniable risks of valproate to unborn babies, if used during pregnancy. Many speakers confirmed that the improved information resources that had been developed in some Member States after PRAC's previous recommendations were not reaching the targeted audiences, and the importance of the dissemination, implementation and acceptance of this information was stressed.
In response to the question of what other measures should be taken to reduce the risks of using valproate during pregnancy, the speakers provided important ideas such as including visual reminders of the risks on the outer packaging of valproate medicines and the need for regular reviews for all women receiving valproate long-term, to ensure that, in future, no woman taking this medicine is unaware of the risks.
More information on the deliberations made during the hearing can be found in the summary report .
The PRAC will take into account every single input received during the hearing. It will also consult two EMA scientific advisory groups (12 October 2017) and a stakeholder forum (13 October 2017) to further discuss these proposals. At the end of this review, the Committee will publish an assessment report on measures to reduce the risk of valproate-containing medicines during pregnancy and in women of childbearing potential, in accordance with the published timetable.
- The review of valproate was initiated on 9 March 2017 at the request of the French medicines regulator ANSM, under Article 31 of Directive 2001/83/EC.
- The review will be carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which will make recommendations. The PRAC recommendations will then be sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), which will adopt a position. The CMDh is a body representing EU Member States as well as Iceland, Liechtenstein and Norway. It is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
- The public hearing follows the adoption of rules of procedure on the organisation and conduct of public hearings and a simulation training in 2016.