Engaging with civil society: the successful example of the European Medicines Agency

This case study is about introducing patient and consumer representation in the regulatory process of the evaluation, supervision and safety monitoring of medicines. The UK based European Medicines Agency (EMA) was chosen as an example because of its outstanding importance for the EU pharmaceutical market including the industry, payers, citizens and patients. This chapter focuses on the involvement of CSOs, which are mainly health related, economic or represent professions. This case study demonstrates how civil society organizations can provide evidence, help build consensus on decision making and contribute to standard setting. They improve the governance by improving the overall quality of the decision making process and the quality and transparency of science based decision making. The case study also demonstrates that civil society participation adds to the credibility of the processes, the decisions and the institution itself. It shows the benefits of participation of CSOs in decision making. To facilitate orderly CSO engagement regulation was drafted and funding was secured. The authors concluded that this long standing structured engagement between EMA and patients and consumers’ organization is the key to successful NGO participation.