Information to patients and the EU update
In 2008 the Commission made a proposal on information to patients/public on prescription-only medicines. The proposal aims at 'improving and harmonizing provision of non promotional high quality information on prescription only medicines' to European patients. Rapporteur Christian Felljner drafted two reports that are to be discussed in June in the Environment, public health and food safety (ENVI) committee of the European Parliament. Essentially he proposes to shift the focus on giving industry the right to provide information into patients’ right to have access to information and for patient groups to have a firm role in this.
The European Patients Forum (EPF), of which EFA is member, worked regularly on this topic from the consultation process to call for a proper comprehensive “information to patients” strategy, including access to quality information on medicines by the European Union. This request is now proposed by Fjellner to be included. EPF documents on this topic including consultation answers and position papers can be found here.
In addition, the European Medicine Agency launched a public consultation on the 23 of February on the revision of the product information for medicines’ package information leaflets for patients. It aims at making the leaflet requirements more flexible and to improve information for example on the balance of benefits and risks. The proposal and template for consultation can be found here.