Public Health - Santé Publique

EMA: European Union agency responsible for the protection of public and animal health through the scientific evaluation and supervision of medicines.

 

Annual report 2015 see download here

The European Medicines Agency (EMA) and patients have been actively interacting since the creation of the Agency in 1995. This cooperation was extended to include consumer groups with an interest in medicines. Both of these stakeholder groups bring a ‘real-life’ experience as well as specific knowledge and expertise to scientific discussions on medicines and on the impact of regulatory decisions. Collaborating with these groups supports transparency and improves regulatory processes.

The framework for interaction between EMA and patients and consumers and their organizations outlines the basis for involving patients and consumers in Agency activities. EMA's Management Board endorsed a revised framework in 2014.

The framework aims at:

• supporting the Agency to access experiences of diseases, their management and information on current use of medicines;
• contributing to more efficient and targeted communication to patients and consumers;
• enhancing 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.

Patients and consumers are involved in a wide range of activities at the Agency, including:

• as members of the Management Board;
• as members of scientific committees;
• being consulted on disease-specific requests by the 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 the Agency's conferences and workshops.

Via rob halkes