EFPIA Calls on EU Institutions to Reform Patient Information Rules Without Further Delay

European industry does not support TV, radio and print mass media for prescription medicines

BRUSSELS, 7 April 2008 – The research-based pharmaceutical industry in Europe today welcomed the European Commission’s plans to reform rules on information provision to patients. An earlier Commission report on “current practice” in EU Member States had revealed that EU citizens have unequal access to health and medicines information, which may result in uninformed choices and thus have negative effects on public health.

In its contribution to the Commission’s public consultation on a future legal proposal on information to patients submitted today, EFPIA supports the Commission’s objective to harmonise practices on information provision to patients and create a framework for the industry to provide certain information on its medicines to the public.

However, EFPIA has different views on certain key issues proposed by the Commission, such as the idea to allow “push” communication through television, radio and print media for prescription medicines.

“EFPIA has repeatedly stated that the industry is not advocating Direct-to-Consumer Advertising as a suitable model for Europe and therefore is of the opinion that such mass media would not be appropriate means for the industry to communicate information on specific prescription medicines to European citizens”, said Arthur Higgins, President of EFPIA and CEO Bayer HealthCare AG. “Existing partnerships in some Member States demonstrate the value that the industry can bring to improve citizens’ understanding of its medicines. Meeting European citizens’ growing demands for accessing high-quality information concerning their own health should remain our common goal. After years of debate, we call on all European institutions to develop a patient-centred EU framework for information provision without further delay.”

EFPIA proposes a different model, where information, which is provided unsolicited to the public, should be limited to general health information on diseases, e.g. covering awareness, prevention etc. but not mentioning specific medicines. On the other hand, when information is “pulled” by the patient, companies should be able to provide high-quality medicines information e.g. on internet sites, in response to enquiries from patients and in the context of compliance programs. The information provided should be based on authorised information and comply with clearly defined standards for high-quality information.

As regards the Commission’s ideas about a governance system for the monitoring of information provided by the industry, EFPIA is concerned that the proposed model could potentially lead to a “patchwork” of very different interpretations and implementations in national laws (as it is currently the case) and thus fail to adequately address the European dimension of the current shortcomings. EFPIA proposes an alternative system based on a European-wide “health information” Code of Conduct, including effective quality assessment procedures for information, ex-post control mechanisms (with involvement of third/independent parties) as well as robust enforcement procedures in case of breaches including sanctions as well as fines. Such a Code could work alongside and complement the legislative change envisaged by the European Commission later this year.

“A European solution to an existing European challenge remains outstanding. At present, many Europeans are still disadvantaged in accessing health information they need. We believe that the industry has a legitimate role and the responsibility to provide non-promotional information on its medicines to patients, and thus should be recognised as a valuable high-quality information source among others” said Dr. Alessandro Banchi, responsible for information to patients within the EFPIA Board and CEO of Boehringer Ingelheim.

“Whilst agreeing with the broad policy objectives, we must now look into the details to make sure that we achieve a modern and truly European reform of health information provision, which really benefits public health in general and each individual citizen in particular”, Dr. Banchi concluded.

ENDS

Useful links
European Commission Public Consultation on a legal proposal on Information to Patients - EFPIA contribution (April 2008)
Views & position on Information to Patients
For Press Enquiries, please contact:
newsroom@efpia.org
Tel: (+32) 2 626 25 71

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