Advertising of rx medicinal products to the general public The case MSD Sharpe & Dohme GmbH vs. Merckle GmbH (C-316/09) Judgment of the ECJ of 5 May 2011

Facts è MSD presented –without password protection-on its website information (SPC, package leaflet) on its prescription only medicinal products (VIOXX, Fosamax, Singulair) è Merckle sought order requiring MSD to desist from disseminating this information è Lower courts followed Merckle: broad interpretation of the definition of „advertising“ è German Federal Supreme Court: request for a preliminary ruling to the ECJ è Request concerns the interpretation of Article 88(1)(a) of Directive 2001/83/EC

Referred Question „Does the scope of application of Article 88(1)(a) of Directive 2001/83/EC (…) extend to the advertising to the general public of medicinal products which are available only on prescription where that advertising contains only information which was placed before the authorising authority in the course of the marketing authorisation procedure and which is accessible in any event to every person acquiring the product, and where that information is not made available to an interested party on an unsolicited basis but can be accessed only through internet when the party concerned takes steps to do so?“

Publishing SPC= Advertising ? è Article 88 (1) (a) of Directive 2001/83/EC advertising to the general public of prescription- only medicinal products is prohibided è Article 86 (1) of Directive 2001/83/EC ‘advertising of medicinal products’ shall include any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products;`...

Article 86 (2) of Directive 2001/83/EC è Rules for advertising do not apply to u labelling and u accompanying package leaflets u correspondence,... u factual, informative, announcements u information relating to human health or diseases

Article 87 of Directive 2001/83/EC è advertising must be in compliance with SPC è advertising shall encourage the rational use of the medicinal product è shall not be misleading

Advertising è „any form“: very broad understanding è Distinction is made by the purpose of the message è national court has to undertake a detailed examination of all relevant circumstances of the case

Information è objective information disseminated by the MAH is not in principle advertising although its financial interest is not disputable è general communication policy of the company è necessary and essential information about the product è avoids as far as possible risk of self medication è to be informed is a public desire è the impact on physicians to prescribe rx medicinal products upon request of a patient is possible, but not sufficient to show promotional intent of the MAH è physician is required not to prescribe a medicinal product that doesn`t fit for the therapeutic treatment of his patient

No advertising è solely the faithful reproduction of approved packaging è literal and complete reproduction of the approved package leaflet or SPC è no other additional elements which supports its classification as advertising

Benefits of information è encourage fruitful dialogue between doctor and patient è improves compliance /avoids uninformed self medication by a patient who has lost package leaflet è packaging, package leaflet and SPC are approved by CA

Information through Internet Pull / Push Service è no password protection è pull service: consulting requires an active research step by the internet user, no unwillingly/unintentional confrontation with that information e.g. „passive presentation plattform“ è push service: user is confronted with information without searching for it, „pop-ups“

Advertising √ è : Indications for advertising u selecte or rewritten information u push-service, e.g pop-ups critical

Conclusions è Judgment is in line with the COM proposals on information to patients è Judgment is in line with the overall political demand for more transparency and more information for patients u E.g. the future opening of the EudraCT-database as regards results of clinical trials u According to German Drug Law, MAH and sponsors are obliged to publish the results of clinical trials 6 months after the granting of the MA or 12 months after the end of the clinical trial u New PhV-legislation: PAR shall include a summary understandable to the public (Art. 21 para. 4)

To discuss è In view of the COM proposals on information to patients: u should rewritten or abbreviated package leaflets or SPCs be excluded from the scope of application of Art. 88(1)(a) of the directive? area of conflict: comprehensibility /risk of manipulation

Thanks for your attention