European Patients’ Academy on Therapeutic Innovation Aspects of pharmacovigilance: Public hearings

European Patients’ Academy on Therapeutic Innovation  A public hearing is a forum to which the public is invited to express its views and concerns on a pre-defined set of questions on issues related to the safety of a particular medicine while also considering its therapeutic effects.  It is a channel for the Pharmacovigilance Risk Assessment Committee (PRAC) to take the public’s views and concerns into account – particularly once all available data and evidence have been assessed, and options for regulatory actions and risk management activities will need to be considered in a wider public health context. 2 What is a public hearing?

European Patients’ Academy on Therapeutic Innovation  To seek public opinion, suggestions, and recommendations on the acceptability of the risks associated with the medicine or class of medicines concerned; particularly in relation to the medicine’s therapeutic effects and any available therapeutic alternatives, as well as the feasibility and acceptability of risk management and minimisation activities  To inform the debate of the PRAC, which continues to have the sole responsibility for giving its scientific recommendation on the safety of the medicine concerned. 3 Why hold a public hearing?

European Patients’ Academy on Therapeutic Innovation Increase transparency by opening up the scientific evaluation process Empower EU citizens by giving them a voice in the evaluation of the safety of medicines Improve the public’s understanding of the scientific and regulatory process throughout the product’s lifestyle Add value to the evaluation process beyond existing channels of stakeholder engagement 4 Overall aim: Trust

European Patients’ Academy on Therapeutic Innovation 5 PRAC decision to hold a public hearing Proposal for a public hearing Referral in accordance with Art. 20 of Regulation EC 726/2004; Art. 31 or Art. 107i of Directive 2001/83/EC Proposal to hold a public hearing can be submitted by any PRAC member Content of proposal: Purpose of the public hearing Specific questions on which public opinion should be sought Any additional information as appropriate Evaluating the need PRAC evaluates the need for a public hearing Agreement to hold a public hearing PRAC agrees to hold a public hearing either by consensus or by majority vote

European Patients’ Academy on Therapeutic Innovation Participants can attend in person to speak Participants can submit their contributions in writing Participants can watch via a live video stream 6 How to participate in public hearings

European Patients’ Academy on Therapeutic Innovation  Public hearings are open to all members of the public. For organisational reasons, participants must register in advance.  The questions asked by the PRAC to be addressed during the hearing determine the target audience and are expected to be directed to the general public.  The PRAC may proactively invite representatives of patients, consumers, healthcare professionals, or researchers with specific expertise.  The Marketing Authorisation Holder(s) has the opportunity to present their view(s) to the participants of the public hearing  The media may follow the public hearing as observers. 7 Who can attend a public hearing?

European Patients’ Academy on Therapeutic Innovation A summary of the safety concerns A list of specific questions Information on date, time, and location Registration information Information on how to submit written contributions Contact address and phone number Information about live-broadcast/web stream Announcement of the public hearing 8 Before the hearing (1)

European Patients’ Academy on Therapeutic Innovation Name and affiliation (for instance, patient, carer, doctor) Name of the organisation/group being represented (if applicable) Contact information Outline of the planned presentation/intervention, specifically how it addresses the questions on which the PRAC is seeking public opinion Declaration of interest pertaining to the medicine(s) to be discussed at the public hearing Submitting a request to speak 9 Before the hearing (2)

European Patients’ Academy on Therapeutic Innovation All requests will be reviewed Efforts made to accommodate all speaking requests Speaking requests may e declined only if clearly unrelated to the subject matter of the public hearing Priority to speakers representing groups, organisations, or institutions Confirmation of attendance as a speaker at least 10 days in advance of the public hearing. Review of requests to speak 10 Before the hearing (3)