What’s the difference between “advertising” and “information?”
Consider the interesting (but somewhat byzantine) decision from the Court of Justice of the European Union (CJEU) on the “advertising” of medicines.
The ruling in MSD Sharp & Dohme GmbH v. Merckle GmbH, handed down on May 5, seeks to define the boundaries of acceptable information provision so that compliant manufacturers of prescription medicines can avoid accusations of engaging in direct-to-consumer advertising. DTC is both illegal and unwelcome in the EU, the European Commission has time and again stressed.
The decision is restrictive — allowing companies to provide objective information that will in no way lead directly to a decision to purchase, leaving firms with few options beyond essentially providing the labeling online.
“A different classification must, however, be adopted where the information relating to the medicinal product is selected or rewritten by the manufacturer, since such manipulation of information can be explained only by an advertising purpose,” the court said.
MSD had put information on its website concerning its prescription-only products Fosamax (alendronate), Singulair (montelukast) and Vioxx (rofecoxib). (Vioxx was withdrawn worldwide in 2004; the product’s presence in the case stems from the long-simmering nature of the dispute.)
MSD’s site included images of the product packaging, the therapeutic indication and the leaflet containing instructions for use of the product. This is essentially information contained with the Summary of Product Characteristics (SmPC), which a company must file when applying for a marketing authorization.
Merckle complained that this constituted advertising to the public, as the site was not password-locked, and was anti-competitive. The CJEU, to whom the case was referred by the German Federal Court of Justice, dismissed the suggestion behind Merckle’s complaint that simply communicating this information was inherently promotional.
Indeed, “the possibility for the patient to access in advance, before a medical examination, objective information from reliable sources could, in some circumstances, contribute to the prescription of appropriate treatment, in so far as there may be a more fruitful dialogue between the doctor and the informed patient,” the court wrote.
The European Parliament adopted a position on a Directive on Information to Patients on November 24, 2010. It went before the Council of Ministers’ Employment, Social Policy, Health and Consumer Affairs Council on December 6-7, 2010. The Council has asked the Commission to amend parts of the proposal, and the next stages of the political debate will take place after those changes are complete.