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/EC, as amended by Directive 2004/27/EC), 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:
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:
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:
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 consultation
- Summary of the responses to the public consultation
- 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 1 - volume 2.
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.
Additional information:
European citizens are increasingly attentive towards new developments in public health which can positively affect their well-being. What is more, information can be easily collected by people, through different channels, such as newspapers, the mass media and the internet. As people play a leading role in the decisions about their own treatment, the dissemination of appropriate high-quality information has became of primary importance.
To ensure adequate information to patients on diseases and treatment options, the European Commission has been looking at different ways of improving the quality and accessibility of information within the High Level Pharmaceutical Forum and with the adoption of legal proposals on information to patients.
- A non-legislative approach
- A legislative approach
- Further information on EU activities in this area in the Health EU Portal
The EU legal framework for medicinal products guarantees high standards of quality and safety. It also promotes the functioning of the internal market, with measures that encourage innovation and competiveness in Europe. It is based on the principle that medicinal products may be placed on the market only following a marketing authorisation granted by the competent authorities. A large body of legislation has developed around this principle with the progressive harmonisation of requirements implemented across the whole European Economic Area.
Today, medicinal products are authorised at EU level by the European Commission or at national level by the competent authorities of EU countries. Special rules exist for the authorisation of medicinal products for paediatric use, orphan medicines, traditional herbal medicines, vaccines and clinical trials. Once placed on the market, the safety of a medicinal product continues to be monitored throughout its entire lifespan through the EU system of pharmacovigilance.
The European Medicines Agency, established in 1995, underpins the centralised authorisation procedure and supports coordination between national competent authorities. The Agency is the hub of a European medicines network comprising over 40 national regulatory authorities guaranteeing a constant exchange and flow of information regarding the scientific assessment of medicinal products in the EU.