Directive 2001/83: proposal creating legal framework for provision of information from the pharmaceutical industry

15 December 2009

Machteld Hiemstra

Recently, the biggest consumer association in The Netherlands offered a widely supported petition to the Dutch Minister of Health, requesting a ban on disease awareness or symptom awareness advertisements.

Currently, advertising ‘prescription only’ medicinal products is subject to the rules set out in Title VIII of Directive 2001/83. However, dissemination of information relating to human health or diseases without reference to medicinal products is excluded from the ban on advertisement, and is therefore not subject to EU rules.

There can be little doubt that it is in the overall interest of patients and consumers that objective and reliable information on medicines is available. In this context it is important to realise that patient representation groups, hospitals and healthcare providers or other parties benefit from this exclusion to communicate about healthcare and diseases for educational or counselling purposes outside of a treatment relationship. Also, a complete prohibition as suggested in The Netherlands would be against the fundamental principle of freedom of speech. All in all there seems to be no reasonable justification to exclude the provision of objective and unbiased information on medicinal products to consumers, regardless of the source of information. However, the ECJ recently decided[1] that dissemination of information about a specific medicinal product by an independent third party may be regarded as advertising even when the third party is acting on his own initiative.

Due to a lack of description as to what constitutes information as opposed to unlawful advertisement, divergent interpretations exist throughout the Member States of the EU. The mere fact that information about diseases is being communicated by the pharmaceutical industry should, as such not make such information promotional of character. However in some Member States that is the overall assumption. In other Member States the content of information provided is determinative.

From the "Report on current practices with regard to the provision of information to patients on medicinal products" it has become clear that restrictions on what information can be available and by which sources varies greatly among the EU Member States. The European Commission considers access to reliable information on medicines important as it will help EU consumers to make more informed decisions whilst being protected against hidden advertisement.

As part of the “pharmaceutical package” a proposal for the amendment of Title VIII was issued. Whilst maintaining prohibition of direct to consumer advertising the proposal seeks to achieve the following aims:

  • to lay down clear rules on information provided by pharmaceutical companies

  • to ensure a high level of quality, objective, reliable and non promotional character of information

  • ensuring (and limiting) the use of appropriate distribution channels

  • ensuring compliance by pre and post monitoring and enforcement measures

Important changes allowing far wider possibilities for marketing authorisation holders to communicate about their products include:

  • Information that presents the medicinal product in the context of the condition to be prevented or treated will be allowed;

  • Information may not be distributed via (web) television or radio;

  • The information shall not include comparisons between medicinal products;

  • The source of information must be revealed as well as statements indicating the prescription-only status and that the information is not intended to replace healthcare contact;

  • Initiating direct consumer contact is not allowed. However providing written answers to unsolicited questions is permitted. Notably, information must include contact details allowing consumers to send comments to marketing authorisation holders. Maybe, this route of contact also provides a platform for wider direct communication with consumers; and

  • Content is subject to prior approval by national competent bodies, which control may also be executed on the basis of self regulation by self regulatory bodies. Further, internet websites are subject to approval by the national competent authorities where the website is registered. The principle of mutual recognition applies in sofar as translated information disseminated in other countries is the same as the approved information.

It is likely that this proposal will be further discussed in the first quarter of 2010.

[1] C-421/07, 2 April 2009