Contrary to the general approach taken by unfair competition law, gifts – either to professionals or to the general public – are heavily regulated in the healthcare sector.
In this respect, two recent important (and contradictory) developments in Germany need to be taken into account by the pharmaceutical industry: on the one hand, the code of conduct of a pharmaceutical industry association was tightened and now prohibits promising, offering or granting gifts to healthcare professionals; on the other hand, a recent decision of the German Federal Court of Justice (Bundesgerichtshof, ‘FCJ’) has liberalised promotion with gifts to healthcare professionals.
Tightening of the FSA Code of conduct on the collaboration with healthcare professionals
With effect from 1 July 2014, the provision of the FSA Code of Conduct on Collaboration with Healthcare Professionals (‘Code of Conduct’) governing gifts to healthcare professionals has been tightened. The Freiwillige Selbstkontrolle für die Arzneimittelindustrie e.V. (‘FSA’) is an industry association of around 60 pharmaceutical companies that, as a result of their membership, agree to comply with the FSA codes of conduct.
Apart from some very limited exceptions, the amended provision of the Code of Conduct prohibits promising, offering or granting gifts to healthcare professionals, irrespective of whether or not the promotion is related to a specific product. Violations of the Code of Conduct can be referred to an arbitration board.
The Code of Conduct applies to promotions directed at healthcare professionals and not those directed at the general public. Furthermore, it only applies to the promotion of prescription-only medicinal products for human use (Rx) and does not regulate the promotion of over-the-counter (OTC) medicinal products.
Liberalisation of law governing gifts to healthcare professionals
In contrast with the changes introduced by the industry Code of Conduct, the FCJ rendered a decision that effectively liberalises the law in relation to gifts granted to healthcare professionals (FCJ, Case I ZR 83/12 – ‘Testen Sie Ihr Fachwissen’).
The FCJ had to assess a pharmaceutical company’s promotion for a medicinal product by means of a competition. Pharmacy technicians could win wallets valued at €12 each, if they correctly answered a set of questions relating to the (OTC) medicinal product advertised. The answers could be found in an information lealet on the medicinal product provided by the pharmaceutical company. The questionnaire was printed on the last page of the lealet.
Contrary to the decisions of the lower courts, the FCJ held that there was no violation of the statutory prohibition against giving promotional gifts contained in the German Act on Advertising in the Healthcare Sector (Heilmittelwerbegesetz). According to the FCJ (and contrary to previous practice), the prohibition on gifts did not apply as the promotional contest did not trigger an economic interest in recommending or prescribing the medicinal product advertised, and therefore did not create any relevant risk of non-objective inluence on those targeted by the promotion.
Whereas in the Rx sector promotion with gifts has been prohibited, the possibilities for promotions in the OTC-sector have been expanded. With respect to the Code of Conduct, former practices will have to be carefully re-evaluated with a view to safeguarding important tools for providing legitimate information on medicinal products.
With respect to the relaxation of the statutory prohibition of gifts, there appears to be scope to develop a new approach. Provided that the granted beneit is neither directly nor indirectly connected with certain expected behaviour of the healthcare professional, there can be good arguments in favour of gifts to such professionals being more generally permitted.
As the FCJ’s decision only concerned a promotion by means of a competition directed at professionals, it remains open as to the extent to which the courts will apply the liberalised concept to other cases of promotion not involving competitions or even (but less likely) in relation to promotion directed at the general public.