A draft amendment to the Advertising Regulation Act has recently been published and is now due to be discussed by the Government and Parliament. It proposes a number of changes, including in the area of advertising of medicinal products. The attentive reader will be in for many surprises when reading the draft.
For example, it is proposed to explicitly regulate patient programmes and the provision of information materials to patients. Ironically, both of these activities are expressly referred to as advertising of a medicinal product. This is indeed quite surprising, as SUKL has, as a rule, previously assessed these activities as non-advertising activities on condition that they are carried out after the prescription of the medicinal product. There is no doubt that these activities do not in substance amount to advertising. It is thus unclear why the Ministry of Health (as the author of the draft) deems it necessary to state that they do amount to advertising.
In addition, the draft stipulates as one of the conditions for permissibility of a patient programme that it must be organised by a healthcare provider (e.g. a hospital), a learned society, or a patient organisation. Yes, phaurmaceutical companies are indeed not mentioned among the permissible organisers of patient programmes, even though they are the ones organising patient programmes in practice.
The Explanatory Memorandum is quite uncompromising in stating that patient programmes that do not comply with the stipulated conditions “will be considered as illegal advertising for prescription-only medicinal products for human use and will be penalised as such.”
Hopefully, during the legislative process, the draft will be modified to reflect current market practice. Otherwise, it would significantly complicate the organisation of patient programs.
