Leaders of the European pharmaceutical industry have once again stressed that they are not seeking, and have never sought, direct-to-consumer advertising for prescription medicines to be permitted within the European Union.

The European Federation of Pharmaceutical Industries and Associations emphasises this point in its contribution to the European Commission’s public consultation on its future legal proposal covering the provision of prescription drug information for patients. The consultation closed yesterday (April 7).
In its response, EFPIA says it supports the Commission’s aim of harmonising practices on information provision to patients and creating a framework for the industry to provide certain information on its medicines to the public. An earlier Commission report had found unequal access to health and medicines information throughout the EU, which it said could be harmful to public health.

But the industry group takes issue with the Commission’s proposal to allow “push” communication through television, radio and print media for prescription medicines.

The Commission consultation document suggests that: “a distinction should be made between the cases where the patient is passively receiving the information (‘push’) or actively searching for the information (‘pull’) in terms of the monitoring mechanism.”

However, EFPIA has “repeatedly stated” that the industry is not advocating DTC 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, EFPIA president and chief executive of Bayer HealthCare AG. “After years of debate, we call on all European institutions to develop a patient-centred EU framework for information provision without further delay,” he added.

'Push and pull' information to public
Under the model proposed by EFPIA, information which is provided unsolicited to the public should be limited to general health information on diseases, covering awareness and prevention, for example, but not mentioning specific medicines. When information is “pulled” by the patient, companies should be able to provide high-quality medicines information, for example on websites, 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,” it says.

EFPIA is also concerned at the EU proposals for a governance system for monitoring the information provided by the industry. The Commission suggests that the structure of enforcement could take place on three different levels – an EU advisory committee, the EU national authorities and national “co-regulatory” bodies – but EFPIA believes that this 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. Instead, the industry proposes an alternative system based on an EU-wide “health information” Code of Conduct, including effective quality assessment procedures for information, ex-post control mechanisms (with involvement of third/independent parties) and 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, it says.

DTC advertising of prescription drugs is now permitted in the USA and New Zealand only. In its response to the consultation document, made public last month, the UK-based patient advocacy group The Picker Institute accused the Commission of seeking allow drugmakers in the EU to provide DTC information on their products to consumers, and claimed that the proposal was “clearly driven by the pharmaceutical industry’s interests, not by the interests of patients.”