Public hearings

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.

Latest public hearing

EMA held a public hearing on quinolone and fluoroquinolone antibiotics on 13 June 2018, as part of the PRAC's review of these medicines.

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.

Summary of the EMA public hearing on quinolone and fluoroquinolone antibiotics

Previous public hearings

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.

Topic	Date
Valproate and related substances	26 September 2017

Guidance for participants

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:

Public Hearing - Guidance for participants

Public Hearing - Guidance for participants

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:

Rules of procedure on the organisation and conduct of public hearings at the Pharmacovigilance Risk Assessment Committee (PRAC)

Reference Number: EMA/11523/2023 Rev.2Summary:

The PRAC has the possibility to hold public hearings in the context of safety referral procedures under Article 20 of Regulation (EC) 726/2004, Article 31 or Article 107i of Directive 2001/83/EC. The Committee takes the decision to hold a public hearing on a case-by-case basis, where the urgency of the matter in question permits and after considering that this is appropriate on justified grounds particularly with regard to the extent and seriousness of the safety concern.

Objectives and benefits

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.