The European Medicine Evaluation Agency (EMEA) is a decentralised body of the European Union with headquarters in London.
EMEA’s main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use.
The EMEA is divided in different Committees. The most relevant for human health is the Committee for Medicinal Products for Human Use (CHMP). In 2002 the EMEA organised a workshop with Patients and Consumer Organisations to establish communication links, develop common understanding and define future actions. Building on the conclusions of the workshop, the EMEA/CHMP Working Group with Patients and Consumers Organisations was created. The group has issued recommendations in March 2005.
Members of this working group are mainly patients’ groups, a consumer organisation (BEUC), EPHA and the European AIDS Treatment Group (EATG), an EPHA member. In 2005, the group decided that it was time to clarify the membership criteria, the rules of procedure and to be set up as an official working group of the EMEA.
Therefore the group is now deciding on the definition and criteria to become a member, the rules of procedure and the guidelines for interaction between patients and consumers organisations and other EMEA Committees and Groups.
At the September meeting, the EMEA distributed a draft strategy of interaction between EMEA and patients and consumers’ groups. Members of the working group were given until the 20 September to comment on the strategy (you can find EPHA’s Secretariat comments below). Please note that given the tight deadline for responding, EPHA was not able to consult all its members, therefore the response was drafted with the imput of the EPHA Secretariat and one EPHA member who usually attends the meetings on behalf of EPHA.
The discussion at the last working group meeting in December was followed by consultation with Health Action International’s members. It focused on the European Public Assesment Report (EPAR) summary documents
The EPARs are short reports which originally intended to provide information understandable to the general public on a given medicine.
Two major points were discussed:
1. The inclusion of information about comparative advantage of the new drug / treatment over already existing ones;
2. and the replacement of the "benefit / risk" terminology by "benefit / harm", since it clarifies what is meant by "adverse drug reactions".
EPHA representatives at the working group meetings
EPHA was represented by Jeremy Smith, from HAI, in the working group meeting of June 2005.
Paul Belcher from the Royal College of Physicians of London represented EPHA in the September meeting. Please contact Paul for a detailed report of the meeting.
Andreas Wulf represented EPHA at the November meeting where the new EMEA database on information about medicinal products in Europe (previously known as "Europharm" but to be launched shortly with a different name) was discussed with representatives of consumers and patients organisations.
Lara Garrido-Herrero represented EPHA at the December meeting.
Meetings for 2006: 15 February, 1 June, 15 September and 8 December.
