Network of Primary Health Care to European Medicines Agency (EMA) - EFPC Working Group

The EMA Working Group is chaired by Walter Marrocco and Pieter van den Hombergh. The WG has started from a joint initiative of the Italian EFPC member FIMMG and the EFPC secretariat and was welcomed and approved by the EMA management in summer 2014. Since 27 May 2016 the EFPC is an official member of the Health Care Professional Working Party (HCPWP).

The report of the 2016 EMA Workshop on the collaboration with General Practitioners/Family Physicians organized by the EMA in close collaboration with the EFPC secretariat and the EMA Working Group is now available on the EMA website.

 Since then the WG has grown with a number of experts from different professional and geographical background. It now comprises more than 15 experts who can be consulted for providing specific expertise to the EMA. Please find an updated list with specialities of the different members.

Interested to contact or to join? Please send a message to the EFPC secretariat.

Background

In  support of the work of the EMA Health Care Professionals Working Party and its’ five main tasks:

  1. Support the Agency to gain a better understanding of how medicines are being used in real clinical practice and how EU regulatory decisions impact clinical practice
  2. How the Agency can best communicate with healthcare professionals to support their role in the safe and rational use of medicines
  3. Contribute to the Agency’s scientific work intended to continuously improve benefit-risk assessment of medicines throughout their life-cycle 
  4. Enhance healthcare professionals’ organisations understanding of the mandate and work of the Agency and of the EU Regulatory Network
  5. Monitor the implementation of the objectives identified in the “Framework for interaction between the Agency and healthcare professionals”.

The specific focus of this network will be on task 1,2 and 4, in particularly the support for safe and rational use of medicines supported by a wide range of Primary Care professionals.

Objectives

Primary objective: to create more attention among Primary Care professionals for a “rational and appropriate use of medicines at community level”

Activities

EMA consultations

  • Current consultation: Risk minimisation measures and assessment of their effectiveness
    • EFPC has been identified as a relevant stakeholder to input into the following case studies:

      • risk of osteonecrosis of the jaws with parenteral bisphosphonates/denosumab
      • risk of medication errors with high strength insulins
      • risk of teratogenicity with valproate

Send a message to the EFPC secretariat if you can contribute to one of these case studies before the 30th of June.

Practice

  • Development of specific tools, based on EMA material, which can instruct PC professionals on safe and rational use of medicines
  • Dissemination of tools among EFPC members, in particularly using the network of Community Health Centres
  • Webinars through the web based EFPC portal with postgraduate teaching courses

Policy documents

  • Development of a Position Paper introducing the strength of Primary Care for achieving a safe and rational use of medicines

Meetings

A first onsite meeting took place at the EFPC 2014 Barcelona conference with the involvement of EMA. To explain the working of the EMA and to inform the group on what they could develop to be of an added value for the EMA.

With a year later a second onsite meeting of the group and a key-note of Ms Isabelle Mouton at the EFPC 2015 Amsterdam conference followed by her presence at the WONCA Europe conference in Istanbul, autumn 2015.

The last meeting was in London at EMA headquarters on the 19th of April with the presence of 20 General Practitioners at which clear collaboration objectives has been agreed on which the WG will continue to work.