Involving general practitioners in regulatory decisions on medicines

News 28/04/2016

EMA workshop with general practitioners and family doctors kicks off strengthened collaboration

The European Medicines Agency (EMA) organised a workshop with representatives of general practitioners and family doctors in order to explore new ways to engage with these providers of primary care in EU Member States and further involve them in EMA activities.

“General practitioners and family physicians play a key role in patient care; they often have the first contact with the patient and accompany them throughout the life of their condition,” explained EMA's Executive Director Guido Rasi during the workshop that took place on 19 April 2016. “This is why we want to engage them more in our activities as their knowledge and experience on how a medicine is used and addresses patient needs in real life can greatly inform our decision making.”

Twenty representatives from three major organisations – the European Forum for Primary Care (EFPC), the European Union of General Practitioners (GPs) / Family physicians (UEMO) and the World Organization of National Colleges, Academies and Academic Associations of General Practitioners / Family Physicians (WONCA) Europe - attended the workshop.

All participants agreed that strengthened interaction will:

  • help EMA gain a better understanding of how medicines are being used in real life and the potential impact of specific regulatory actions on patient care;
  • raise awareness amongst general practitioners on how they can inform regulatory discussions on the benefits and risk of medicines so that decisions take into account the reality of clinical practice.

The workshop led to the creation of an expert group of general practitioners initially composed of the 20 representatives who attended the meeting, who will in turn act as facilitators and communicate to their broader communities.

As with representatives of specialty care providers this new group will be involved in a wide range of EMA activities whenever their specific feedback is needed. This includes contribution to EMA's scientific advice to medicine developers, input on feasibility and impact on patients of risk minimisation measures and review of product information and dissemination of information to their national networks and patients.

EMA and the three organisations will also develop a joint position statement outlining concrete areas of collaboration as well as long-term recommendations. All activities are in line with EMA's overall framework for interaction with healthcare professionals' organisations.

EMA has published today the list of participants and the presentations from the workshop on the workshop's event page. A full workshop report will be published on the EMA website in the next few weeks.

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