EAMSP - European association of mail service pharmacies

Package inserts on the Internet: illegal advertising?

This is a question which has in parallel exercised both the European Court of Justice and the European Parliament. Both have now presented their rulings.

Upon closer inspection it is evident that the two bodies are not in complete agreement.

The ruling of the European Court of Justice has its origins in legal proceedings that took place in Germany. Manufacturer of pharmaceuticals MSD Sharp & Dohme had published on its website three package inserts pertaining to prescription-only drugs. Access to the Internet was open to all. The web page was not password protected. The competition was unhappy about this and filed a complaint on the basis that the freely accessible publication of the package inserts represented illegal consumer advertising for prescription-only drugs as defined in the law on the advertising of medicines (Heilmittelwerberecht). Their argument was that only over-the-counter medicines may be advertised to consumers. Their contention was that advertising for prescription medicines was only permissible in respect of specialist groups. During the hearing at the Higher Regional Court in Hamburg, the presiding judge asked if it could genuinely be supposed that someone who had read a package insert would subsequently develop a serious interest in the preparation. Speaking personally, it was his experience that reading a package insert generally had an off-putting effect instead. The German Federal Court of Justice, charged with the task of examining the appeal, suspended the proceedings and submitted legal questions to its European counterpart (case number C-316 ⁄ 09).

The Advocate General, Verica Trstenjak, was of the same opinion as the presiding judge from Hamburg, citing the same reason. A package insert did not constitute advertising. It did after all contain only such data as had been officially approved in the context of the licensing procedure. Furthermore, the current form of presentation would mean that a consumer would only come across the package insert if he or she were actually looking for it on the Internet. The package insert would in any case become accessible to all at the latest at the point of prescription of the preparation. Nor would the style or presentation of the package insert strengthen the case for it to be categorised as advertising. The conclusion was, therefore, that the publication of the package inserts did not represent a violation of competition law. Such a violation would arise only if the package insert were to be passed on unsolicited to the consumer. However, in the form under discussion, the Advocate General's view was that its publication was not subject to the provisions of the non-competition clause. The Advocate General is therefore basically speaking in favour of the unrestricted publication of package inserts, including publication on the websites of pharmaceutical product manufacturers.

This view was shared by the judges hearing the case at the European Court of Justice. They maintained that the publication of the inserts did not constitute advertising because the information on the Internet was available only to those who actively sought it out. It was, however, also their view that the information given should do no more than restate the information stated on the packet, the package insert or the summary of the properties of the medicine approved by the official authority for medicines. They went on to say that this would amount to the prohibition of the dissemination of any information on a medicine that was the subject of a selection or reconfiguration undertaken by the manufacturer which could only be explained in terms of an advertising purpose. The European Court of Justice has declined to specify in which circumstances the latter would be deemed the case.

The European Parliament does not share this view. It does admittedly speak out in favour of improved and more readily comprehensible Internet-supported access to information concerning the use and risks of prescription-only medicines. It also shares the opinion of the Advocate General that the information should only be shared with consumers on demand and not passed on unsolicited. Its view is, however, that the information should be provided independently of the pharmaceutical industry as manufacturers of medicines. The European Court of Justice arrived at its ruling before the Council of Ministers had had the opportunity to vote on the draft legislation on information for patients. This ruling may perhaps reinvigorate the discussions. What might also follow is the implementation of a policy of openness of information supported by the Parliament. This will not, however, extend too far. There can be no doubt that the ban on advertising for prescription-only drugs will remain in place come what may. The ruling of the European Court of Justice marks the final nail in the coffin of the challenge mounted by former EU commissioner Verheugen.

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