Information to Patients - Legislative approach

Based on the analysis of current practices and of risks and benefits for patients, the Commission believes the time has come to improve the quality of information available to patients on medicinal products. The balance between the benefits and risks of providing information indicates the need for clear rules that apply to information, ensuring its objectivity and avoiding any promotional character.

Today, patients play an increasingly active role in the pharmaceutical area. Interest in health issues has greatly increased over the years with patients becoming ever more health conscious and wanting to be informed about existing medicines that are available, the grounds on which they have been approved, and how they are monitored.

The Commission fully recognises the patients' right to have access to information on medicines. A political response concerning the various issues related to the provision of information to patients is necessary to address current and future needs. The information available on medicinal products should be accurate, substantiated by evidence, up-to-date and objective. In addition, with the increased use of the Internet over recent years, the need to address reliable and good quality information available on websites has become essential.

The review of the EU pharmaceutical legislation which entered into force in 2005 introduced a number of measures to promote patient access to information on medicines, namely by improving the quality of patient leaflets and requiring the publication of summary reports on the evaluation of authorised medicines. Furthermore, the review of the EU pharmaceutical legislation has provided the basis for access to information on pharmacovigilance and clinical trials, and also for the creation of a European Database on Medicinal Products - EudraPharm. The legislation fundamentally maintained the rules applying to the advertising of medicines in the European Union.

However, the current legal framework ( Directive 2001/83/ECpdf , as amended by Directive 2004/27/ECpdf ), does not provide for sufficient harmonised rules on the provision of information about medicines to patients. This situation has led to a variety of approaches and understandings in the Member States regarding the provision of information on medicinal products. Information provided by public authorities currently varies considerably amongst Member States, and media such as the Internet may not always provide reliable or understandable data. This situation does not ensure the conditions for equal access to information to all citizens in the EU, allowing simultaneously for risks resulting from unreliable or even illegal sources of information publicly available.

To address this issue on 10 December 2008 the Commission adopted two legal proposals on information to patients as part of the pharmaceutical package. The overall objective of the legal proposals is to harmonise current practices across the EU and ensure that all EU citizens have equal access to reliable and quality information on existing medicines.

For more information on the legal proposals see below:

Press releasepdfDeutschfrançais

Brief background informationpdf(24 KB)

Summary of the proposalspdf(21 KB)

The proposals

The Commission "proposal for a Directive of the European Parliament and of the Council amending Directive 2001/83/EC as regards information to the general public on medicinal products subject to medical prescription, Directive 2001/83/EC on the Community code relating to medicinal products for human use" was adopted on 10 December 2008.

Text of the proposal (Directive) - COM(2008) 663 finalpdf

The Commission "proposal for a Regulation of the European Parliament and of the Council amending, as regards information to the general public on medicinal products for human use subject to medical prescription, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency" was adopted on 10 December 2008.

Text of the proposal (Regulation) - COM(2008) 662 finalpdf

Public consultation

A public consultation on the key elements of a legal proposal on information to patients was launched by the Commission on 5 February 2008. Text of the public consultationpdf(127 KB) Choose translations of the previous link français (fr) .

Summary of the responses to the public consultationpdf(37 KB) .

Responses from stakeholders

Impact assessment report

The Commission carried out a study to assess the economic, environmental and social impact of the proposal. The final impact assessment report was adopted by the Commission on 10 December 2008 and is available here: Volume 1pdf(503 KB) - Volume 2pdf(817 KB) Choose translations of the previous link interlingua (ia)

Executive summary of the impact assessment report

Next steps

The proposals have been submitted to the European Parliament and the Council which will engage in the co-decision procedure.

To follow the proposal at the different stages of the procedure, please consult the "legislative observatory" of the European Parliament or PreLex, the EU-database on interinstitutional procedures.