Hungary's recently published Omnibus Act (Act CI of 2021) contains numerous amendments to the Medicines Thrift Act (Act XCVIII of 2006).
Relating to promotional activities of the pharmaceutical companies, the amendments address the following issues:
- The definition of commercial practices;
- The scope of a promotion;
- Promotional events;
- Hospitality limits;
- Prohibited benefits;
- Event notification obligations; and
- Patient support programmes.
Definition of commercial practice: not only any information, but any professional or scientific information can constitute commercial practice. In addition, the listed activities do not only need to be aimed at promoting the prescription, procurement, sale or consumption of a medicinal product, dietary supplement or medical aid, but now it is even sufficient if such activities are likely to reach such a result.
The scope of promotion is extended in the following ways: any commercial practices concerning medicinal products, dietary supplements and medical aids for healthcare professionals (HCPs) can be considered as promotion; and the given subjects of a commercial practice are only examples that, in particular, constitute promotion. The category of products that are subject to promotion is also clarified so that certain products (e.g. dietary supplements for special medicinal purposes) are only subject to promotion when they are publicly funded.
Prohibited benefits: in addition to the limitations applicable to material benefits (including gifts), the amendment lays down that material benefits must be provided, offered or promised by promoter companies to HCPs only if it is carried out within the framework of the company’s commercial practice. Promoter companies must not provide, offer or promise monetary benefits or financial advantages to HCPs, except the fee for scientific activities or activities protected by copyright that are independent of commercial practices.
Promotional events: it is expressly stated in the amendment that events arranged for HCPs by promoter companies are such events that support the promotion and may be arranged solely for professional, scientific and educational reasons. The amendment also states that from now on the "legal limit" of such events applies not to the hospitality, but to the cost of the event, which shall be inexpensive with the reference being the daily amount calculated per persons.
Event notification: promoter companies are obliged to notify the healthcare authority in case of all scientific events and training courses, which they support or have arranged. The submitted data in the notification shall also contain the online nature of the event, if applicable.
Patient support programmes: in the context of patient support programmes, it is prohibited to collect, process data, in a way that is suitable to identify a person relating to disease or medication habits, and to encourage, remunerate or reward in any way the transmission of these.
Finally, the amendment also modifies the promoter companies’ rights and obligations during the promotional investigation carried out by the healthcare authority.
For further information on the Hungarian pharmaceutical industry, contact your regular CMS advisor or local CMS experts.
Article co-authored by Diana Galambosi.