The necessity to amend the Directive on the Information to Patients on Prescribed Medicinal Products (2001/83/EC) arose after the submission of the Commission, on 20 December 2007, of a Communication concerning the “Report on current practices with regard to the provision of information to patients on medicinal products” to the European Parliament and the Council.
The report concluded that Member States are heterogeneous in their adopted rules and practices with regard to the provision of information, resulting in a situation where patients and the public at large have unequal access to information. As a result, on 10 February 2012, and after over 18 months of discussions, the Commission adopted amended proposals for the Directive and Regulation regarding information to the general public on medicinal products that are subject to a medical prescription. The general policy objectives of the proposals to amend Directive 2001/83/EC and Regulation (EC) No 726/2004 are intended to ensure the better functioning of the internal market for medicinal products for human use and to better protect health of EU citizens.
The proposal aims to specifically provide a clear framework for the provision of information by marketing authorization holders about their prescription-only medicines to the general public. This is to be achieved by allowing marketing authorization holders to provide in understandable way impartial and non-promotional information about the benefits and the risks of their medicines. Lastly, this amended proposal further reinforces the rights of patients. In particular, marketing authorization holders will have the obligation, and no longer the possibility, to make available certain information, such as the labelling and the package leaflet.
In addition, the proposal sets out that the public database, EudraPharm, designed to facilitate access to information about medicines available in the European Union, should be made available in all EU languages. Furthermore, it should be actively promoted to European citizens, through the development of the European medicines web-portal established by Regulation (EU) No 1235/2010, as the central point of access to information about medicinal products.
Useful Links:European Commission Information to Patients Proposal to amend Directive 2001/83/EC Proposal to amend Regulation (EC) No 726/2004