The first quarter of 2009 saw considerable change in the regulation on the promotion of medicines. Changes included modifications to Act XCVIII of 2006 on the General Provisions Relating to the Reliable and Economically Feasible Supply of Medicinal Products and Medical Aids and on the Distribution of Medicinal Products (the Medicine Promotion Act). New rules on the detailed regulation of the promotion of medicines also came into force from the Health Ministry in the shape of regulation no. 3/2009, which supersedes Health Ministry Regulation no. 11/2007. The changes were triggered by the advertising law reform in September 2008 (consisting of the amendment of the Competition Act and of the Consumer Protection Act and the entering into force of the new Advertising Act and Unfair Commercial Practices Act). The terminology of the provisions on medicine advertisements and detailing has therefore been brought in line with the general legal provisions of advertising. The modification affected the definition of detailing, the administrative and payment obligations of the detailing companies, and the rules on liability.
The former notion of the term 'detailing of medicines' raised some doubt. The obvious interpretation of this term is that, as opposed to usual advertising, detailing refers only to communications that are (i) addressed to professionals (doctors and pharmacists) who are entitled to order and distribute medicines, and (ii) which contain information on ingredients, effects and application. In practise however, things are very different. The Health Insurance Supervisory Authority (HISA) considered several activities as detailing, when in fact these were, in practice, business/commercial activities (provision of information on medicines' prices, taking promotional orders, etc.) The new definition of detailing puts the law-abiding public into a difficult position because it defines detailing as a 'commercial practice', when this includes any kind of information, activity, visualisation method, marketing, or other commercial communication aimed at the promotion of the medicine's ordering, purchasing, selling or consuming. The only exception contained in regulation no. 3/2009 is that commercial communications that are applied also towards consumers are not considered detailing of medicines.
Pursuant to the modified rules, medicine detailing companies are no longer obligated to report to the HISA the gifts and sponsorship they provided to doctors and pharmacists in the last year and which are planned to be provided next year.
The reinstated 'registration fee' places a further significant burden on detailing companies. While previously annulled by the Constitutional Court, the fee was reinstated by the Medicine Promotion Act (with distinctions as demanded by the Constitutional Court). Detailing companies must therefore pay the state HUF 416,000 per month per employee that carries out detailing of medicines.
Lastly, the rules of liability regarding the provisions on detailing have changed. It must be noted in these new provisions that both the person carrying out detailing and his/her employer are only liable for the infringements of the rules pertaining to themselves. This rule is objectionable on two grounds. On the one hand, it is unusual in Hungarian law for employees or permanent agents to be liable towards third parties (in this case the HISA); it is more usual that the employer or principal is liable. On the other hand, it is questionable on constitutional grounds whether a fine of HUF 25 million can be imposed on a private person pursuant to the general provisions of the Administrative Proceedings Act and not in accordance with the rules on misdemeanour proceeding, which is now possible according to the Medicine Promotion Act.
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