Hungarian pharmaceutical authority publishes Q&A regarding promotion of medicines

At the end of July, the National Institute of Pharmacy and Nutrition (“OGYÉI”) published new questions and answers regarding the promotion of medicinal products which may affect the daily operation of Hungarian pharmaceutical companies who carry out promotional activities concerning medicines or medical aids in Hungary.

I. Renting a stall qualifies as a "support"

In the recently published Q&A, OGYÉI established that not only does renting a stall for exhibition qualify as support under the wording of the law, such service also contributes indirectly to the realisation of a given event, ensures revenues and therefore, verifies the support of the event. The Q&A opinion strengthens OGYÉI’s previous decision from the March 2016, Ferring Magyarország Ltd. Case, where it previously addressed this issue.

As these services qualify as support, our understanding is that the obligation to notify the authority will now apply to such services. We note, however, that OGYÉI has still not clarified whether the support limit applies.

II. No prior review of healthcare professionals’ (HCP) presentations at hospital referrals is permitted

OGYÉI concluded that no right for prior review of an HCP’s presentation by a company is acceptable. The presentation may not be drafted by the company instead of the HCP. Upon the expressed, written request of the presenter, professional material may be sent to him/her, however complete slides may not be provided. The HCP’s presentation constitutes his intellectual property and thus the company may not override the content.

OGYÉI also laid down that only a HCP who is suitable as a professional may be requested to deliver a presentation. Therefore, certain prior criteria should be outlined in the contract with HCPs which should be taken into consideration when drafting the presentations. The authority also requires documentation of what the company requested of the HCP and what the HCP provided.

We find this interpretation slightly conservative and too general; it can be reasonable for a company to require prior review of a presentation, for instance to check compliance with the law. However, due to the above interpretation, our view is that companies must now review the related contracts (e.g. speaker agreements) and possibly insert text on the prior criteria regarding the compliance of the content of the presentation.

This interpretation also stresses the importance of the documentation and archiving obligations regarding the process of “selecting doctor – communicating with him/her regarding the presentation – certifying the realisation of the service”.

III. Presentations at hospital referrals are not part of doctors’ work duties

OGYÉI emphasized that it may not be generally established that delivering presentations at hospital referrals is the work duty of the presenter doctor.

We welcome this standpoint but we still believe that companies should exercise special care in these cases and evaluate them on a case-by-case basis, with respect to all circumstances.

If you would like to discuss how the Q&A affects your business, please contact us.