European Medicines Agency launches public consultation on rules of procedures for public hearings
The European Medicines Agency (EMA) has today launched a public consultation on draft rules of procedures for public hearings held by its Pharmacovigilance Risk Assessment Committee (PRAC). The rules of procedures describe the process and practical arrangements for the preparation, conduct and follow-up of public hearings.
Citizens are invited to review the proposed draft rules and send their comments to the Agency by 15 October 2014. Comments should be sent to firstname.lastname@example.org using the comments submission form.
Public hearings are a new tool for the EMA to engage European Union (EU) citizens in the regulatory process of the supervision of medicines and to listen to their views and experiences. The pharmacovigilance legislation has given the PRAC the possibility to hold public hearings as part of certain safety reviews of medicines, particularly in relation to their therapeutic effects and therapeutic alternatives available, as well as the feasibility and acceptability of proposed risk management and minimisation activities.
The contributions made by the public during a public hearing will be considered by the PRAC and inform the Committee’s decision-making.
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 opening up the evaluation process and engaging in a dialogue with the communities most concerned or affected by certain recommendations, public hearings can improve the public’s understanding of the benefit-risk considerations that are a part of regulatory decision-making, thereby contributing to increased public confidence in regulatory decisions.
Adding value to the regulatory process
Public hearings allow the PRAC to access perspectives, knowledge and insights into the way medicines are used on the ground that would not otherwise be available to the Committee. They are expected to enrich the scientific assessment with new ways of learning and thinking about issues.
Existing channels of stakeholder engagement already invite the contribution of the public to the gathering of evidence from users of medicines to allow for better characterisation of benefits and risks of a medicine during the early stage of a safety review, e.g. through stakeholder submissions or through inclusion of patients and healthcare professionals in expert meetings. The value of a public hearing is considered to be greater in that phase of the process, where the PRAC has assessed the available scientific evidence from different sources and where different regulatory options to manage or minimise risks are considered in a wider public health context.
Public hearings will be held on a case-by-case basis, where appropriate and where the urgency of the matter under review allows it, in the context of certain safety review procedures conducted by the PRAC.
The public consultation is open until 15 October 2014. Following review of all comments, the Agency will present the final rules of procedure to its Management Board for adoption. After that, they will become operational.
- The legal basis for public hearings is Article 107j of Directive 2001/83/EC which gives the PRAC the possibility to hold public hearings for safety reviews conducted by the Committee under Article 20 of Regulation (EC) No 726/2004, and Articles 31 or 107i of Directive 2001/83/EC.
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- Draft rules of procedures on the organisation and conduct of public hearings at the Pharmacovigilance Risk Assessment Committee (PRAC) (24/07/2014)
- Submission of comments on 'Draft rules of procedures on the organisation and conduct of public hearings at the Pharmacovigilance Risk Assessment Committee (PRAC)' (EMA/624809/2013) (24/07/2014)
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