Amendments have been made to the German Drug Advertising Act (Heilmittelwerbegesetz/HWG) (Act) by the so-called "Second Act Amending Drug Law and other provisions" (Zweites Gesetzes zur Änderung arzneimittelrechtlicher und anderer Vorschriften), which entered into force on 26 October 2012. These amendments were necessary to adapt the Act to the jurisprudence of the European Court of Justice (ECJ) and they result in further deregulation of German drug advertising law.
Amongst the changes, two paragraphs have been added to Section 1 of the Act providing for cases in which the Act is not applicable, namely:
- to sales catalogues and price lists for medicinal products, if the sales catalogues and price lists do not contain information going beyond that necessary to the determination of the respective medicinal product.
- the dissemination of information regarding prescription drugs on a website may not be prohibited if (i) the information is only accessible to the person who strives to receive this information, and (ii) the information consists only of the original reproduction of the medicinal product’s packaging, a literal and complete reproduction of the package leaflet’s wording or the summary of product characteristics approved by the competent authority. According to the legislator’s explanations, the availability of these documents takes account of patients’ growing need for reliable drug-related information. The information must be available as so-called "pull service"; that is, the internet user has to search actively via mouse clicks.
Up until the amendments were made, the Act prohibited advertising of medicinal products for insomnia or of medicinal products intended to influence the mood, if this advertising was aimed at consumers. From now on, any advertising of these medicinal products is only prohibited if the respective products contain psychotropic active ingredients with a risk of addiction. This amendment was necessary to adapt the Act to the German Federal Supreme Court’s (Bundesgerichtshof/BGH) jurisprudence, which had previously held that the Act does not prohibit advertising for mild herbal medicinal products.
Further, several amendments have been made to Section 11 of the Act, which governs advertising addressed to consumers and relates to OTC products. Amongst other things, due to the lack of a respective provision at a European level , the provision prohibiting advertising with pictures of persons in working clothes or with pictures of a person pursuing the activities of a health care professional has now been deleted.