Public hearings are a new tool allowing the European Medicines Agency (EMA) to engage with European Union (EU) citizens in the supervision of medicines and listen to their views and experiences.
The EU's pharmacovigilance legislation enables the Pharmacovigilance Risk Assessment Committee (PRAC) to hold public hearings during certain safety reviews of medicines. They support the committee's decision-making by providing perspectives, knowledge and insights into the way medicines are used.
The hearing was broadcast live. A video recording is available:
For more information on the public hearing and the outcome of the safety review, see Quinolone- and fluoroquinolone-containing medicinal products.
The table below shows public hearings previously held by the PRAC. For each public hearing it holds, EMA publishes a video recording, a summary report, written interventions and other materials. Click on the topic link for further information.
|Valproate and related substances||26 September 2017|
EMA has published detailed guidance on how to participate in a public hearing, including what to expect, how to register and how EMA selects speakers:
The guidance describes the process and practical arrangements for public hearings, including how to participate either as a speaker or an observer.
The PRAC adopted the rules of procedure in April 2016, which are the basis for public hearings, after they were endorsed by EMA's Management Board. These are available in all EU languages:
Public hearings are expected to give EU citizens a voice in the evaluation of the safety of medicines and empower them to express their views on issues related to the safety of certain medicines and the management of risks.
By engaging those most concerned by PRAC recommendations, public hearings help to improve public understanding of benefit-risk considerations, thereby contributing to increased public confidence in regulatory decisions.
The main aim is to hear the public's views on the risks associated with a medicine, particularly in relation to:
- its therapeutic effects and available therapeutic alternatives;
- the feasibility and acceptability of proposed measures to manage or minimise risks.
This input is of particular value once the PRAC has assessed all available data and is considering regulatory options to manage or minimise risks with a medicine in a wider public health context. Contributions at public hearings inform the committee's decision-making.
The PRAC decides when to hold public hearings on a case-by-case basis, depending on the urgency of the matter and other grounds as set out in the rules of procedure.
Public hearings are open to all members of the public. They are announced in advance on the EMA website, with a list of questions and information on how to take part. For organisational reasons, participants must register in advance.
All hearings are broadcast live on the EMA website. They are held in English, although participants registering to speak may request translation from another official EU language.
Public hearings add to EMA's existing channels for engaging with stakeholders in the assessment of medicines, such as stakeholder submissions during safety reviews and the involvement of patients and healthcare professionals in EMA expert meetings.