The European Medicines Agency (EMA) has been interacting with European healthcare professionals in various areas of its work since it was founded in 1995. As prescribers and handlers of the medicines that the Agency evaluates, healthcare professionals are key stakeholders in the Agency's work and have specific knowledge and expertise to offer. The Agency is committed to maintaining a strong working relationship with this group.
In December 2016, the EMA Management Board endorsed the revised framework for interaction between EMA and healthcare professionals and their organisations:
- Revised framework for interaction between the EMA and healthcare professionals
- Annex I - Revised framework for interaction between the EMA and healthcare professionals
- Annex II - Revised framework for interaction between the EMA and healthcare professionals
The framework describes the objectives and the terms of reference for this interaction and aims to:
- support the Agency in accessing the best independent expertise in any matter related to medicines;
- contribute to more efficient and targeted communication to healthcare professionals;
- enhance understanding of the role of the EU medicines regulatory network.
This framework is in line with EMA's overarching framework for stakeholder relations management, which the EMA Management Board adopted in June 2016:
EMA and the two major organisations representing general practitioners (GPs) and family physicians in Europe – the European Union of General Practitioners (UEMO) and the European section of the World Organization of Family Doctors (WONCA) – and the major organisation representing primary care professionals in Europe, the European Forum for Primary Care (EFPC), have signed a joint statement committing to strengthening interactions:
It contains an action plan until 2020, which includes involving GPs and family physicians in EMA evaluations, developing relevant communication activities and exploring further collaboration with research networks in primary care, with a focus on generating real-world evidence. It also identifies opportunities for cooperation in regulatory science training.
Healthcare professionals are involved in a wide range of activities at the Agency, including:
- as members of the Management Board;
- as members of its scientific committees;
- responding to specific requests from the Agency's scientific committees and working parties;
- taking part in discussions on the development and authorisation of medicines;
- reviewing written information on medicines prepared by the Agency;
- being involved in the preparation of guidelines;
- taking part in Agency conferences and workshops.
EMA is helping ICH to ensure that the perspectives of European patients, healthcare professionals and clinical researchers are taken into account in the ongoing revision of its International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) E6 good clinical practice (GCP) guideline, by coordinating the stakeholder engagement process in Europe on the behalf of ICH.
As a first step, EMA held a workshop with its Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties in June 2020 to gather their views and experiences. The workshop summary report is available:
ICH is revising this guideline to make it more responsive to advances in clinical trial design and conduct. It has committed itself to engaging stakeholders from the outset of the revision process, particularly patient representatives and academic clinical researchers. This is to ensure that the revised guideline will meet the needs of those conducting or participating in clinical trials.