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European Board of Intensive Care Medicine

Information to Patients directive

The "Information to Patients" proposed directive is one of the most controversial files currently debated in the European Parliament. The basic aim of the legislation drafted by the Commission is to ensure the availability of good-quality, objective, reliable and non-promotional information on medicines.

EP Environment Committee voted 28/09/10 to emphasise patients' rights to information rather than making the provision of information an option for the pharmaceutical companies, as the Commission suggested. The committee wants to specify which data must be made available to the public by pharmaceutical firms, which information is optional and through which channels it is to be supplied. It also wants Member States to be required to give citizens objective and unbiased information on medicines.

Update December 2010

EU lawmakers overwhelmingly adopted two reports by Swedish MEP Christofer Fjellner (European People's Party) on the revision of existing EU legislation on patient access to health and medicine information. The proposals now go to the member states for approval. EU health ministers (Council) will discuss the proposed rules on 6 December. If approved, they will then become law.

According to the Parliament's version of the bill, pharmaceutical firms would have to provide information about drug characteristics on labels and package leaflets.
They also would have to publish a drug assessment report as well as information on diseases and health conditions to be treated by the product. These requirements would be mandatory instead of optional, as originally proposed by the Commission. All of the information would be screened by national health authorities within 90 days. The member states would also create websites so patients can have objective and unbiased facts about the drugs. Printed material would be available on request.

Update 03 March 2011

The proposals went to the Member States for approval and Employment, Social Policy, Health and Consumer Affairs Council 6 & 7 December 2010.

Council stated in its press release that the Commissioner in charge of Health and Consumer Policy, John Dalli, expressed the Commission's willingness to modify its proposals concerning information to the general public on medicinal products for human use which are subject to prescription in order to take into account the concerns of the member states. The incoming Hungarian Presidency announced its willingness to address this file as a matter of priority as soon as the modified proposal has been presented.

Update 18 July 2011

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.

To address this issue the Commission adopted on 10 December 2008 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.

Next steps

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

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