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. EMA is preparing to hold public hearings at its Pharmacovigilance Risk Assessment Committee (PRAC) in the course of 2017.
The EU’s pharmacovigilance legislation enables the PRAC to hold public hearings during certain safety reviews of medicines.
This is intended to support the committee's decision-making by providing perspectives, knowledge and insights into the way medicines are used in clinical practice.
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 can 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 will be 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 will be considered by the PRAC and inform the Committee’s decision-making.
The PRAC will decide 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.
Rules of procedure
The PRAC adopted the rules of procedure for public hearings in April 2016, after they were endorsed by EMA's Management Board:
They describe the process and practical arrangements for public hearings, including how the PRAC will decide when to hold a public hearing and how to participate either as a speaker or an observer.
Public hearings will be open to all members of the public. They will be 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 will be broadcast live on the EMA website. They will be held in English, although participants registering to speak may request translation from another official EU language.
EMA organised an internal dry run exercise to test these procedures at the July 2016 PRAC meeting. EMA is preparing to hold public hearings at the PRAC in the course of 2017.
EMA first published draft rules of procedure for public consultation in July 2014, which drew 200 comments from 22 stakeholder contributions representing 25 organisations.
Public hearings will 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.
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