Public hearings

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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.  

Registration open: public hearing on valproate-containing medicines (updated)

The application process is open for the public hearing on valproate and related substances to be held on 26 September 2017 at the Agency's premises in London. The hearing will start at 13:00 (UK time). 

EMA's PRAC is seeking input from the public on a list of specific questions. These are set out in the document below, together with a summary of the safety concerns with this medicine:

If you are considering taking part, please read the full guidance on how to participate:

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Public hearings - 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

EMA has also made an information video

 

To register your interest in taking part, please complete and return the application form below to publichearings@ema.europa.eu by 25 August 2017.

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Application form to attend the public hearing on valproate on 26 September 2017

EMA will write to all applicants within two weeks after the application deadline to confirm whether they can attend. 

 

 

The hearing will also be broadcast live on 26 September 2017 on EMA's website. 

For more information on the ongoing assessment, see Valproate and related substances.

For more information on the PRAC meeting where the public hearing will take place, see: PRAC: 25-28 September 2017.


Key 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.

Rules of procedure

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: 

bg - balgarski,

cs - čeština,

de - Deutsch,

el - ελληνικά,

es - español,

et - eesti keel,

lt - lietuvių kalba,

fr - français,

hr - Hrvatski,

hu - magyar,

it - italiano,

lv - latviešu valoda,

mt - Malti,

nl - Nederlands,

pl - polski,

pt - português,

ro - romana,

sk - slovenčina,

sl - slovenščina,

fi - suomi,

sv - svenska.

 EMA organised an internal dry run exercise to test these procedures at the July 2016 PRAC meeting. 

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Related EU legislation

Video: public hearings at EMA

Guidance for participants

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