Brussels, 11/10/2011 (Agence Europe) - Patients are increasingly interested in learning more about the medicines they take, and want more of a say in how they are treated. At the same time, they are confronted with a growing volume of information from various sources and often find it difficult to identify reliable information about medicines. It was to resolve this problem that the European Commission decided, on Tuesday 11 October, at the behest of the European Parliament, to amend the proposal for a directive to clarify information available to the public on prescription medicines and pharmacovigilance, presented in December 2008.
In the proposals presented to the European Parliament and Council on Tuesday, the Commission maintains the current advertising ban on the prescription-only medicines and foresees that: - only certain information on prescription-only medicines would be allowed, for example, information on the label and on the packaging leaflets, information on prices, on clinical trials or on instructions for use; - information on prescription-only medicines would only be allowed through limited channels of communication. For example, information on officially registered internet websites, or printed information made available when specifically requested by members of the public; - the information must fulfil recognised quality criteria, for example, it must be unbiased, it must meet the needs and expectations of patients, and it must be evidence-based, factually correct and not misleading, and understandable; - and, as a general principle, information which has not been approved before needs to be verified by competent authorities prior to its distribution.
The Commission points out that the revised proposals further enhance patients' rights. A company holding marketing authorisation for a medicine will, for the first time, have not only the right but also the obligation to provide certain information such as that appearing on the label or directions for use of the medicine. Furthermore, the revised proposals also seek to further strengthen the current system for the monitoring of the safety of medicines within the EU, known as pharmacovigilance. The new provisions on pharmacovigilance have been developed by taking due account of the “Mediator” affair which recently hit the headlines, European Health Commissioner John Dalli said. He went on to affirm: “The revised proposals put rights, interests and safety of patients first. They oblige industry to provide certain key information to patients and set clear rules for additional, voluntary information on prescription medicines. In addition, they further strengthen the control of authorised medicines”.
The text of the revised proposals is available at: www.ec.europa.eu/health/human-use/information-to-patient/legislative-developments_en.htm. (OL/transl.jl)