Spain: Farmanddustria authorizes the promotion of medicines pending a public funding decision following a court decision

In short

Last June, the Superior Court of Justice of the Basque Country issued a decision with wide repercussions on the advertising of medicines by pharmaceutical companies. The decision ruled on an appeal filed by Farmaindustria (the Spanish professional association of innovative pharmaceutical companies) against a regional decree regulating the advertising of pharmaceutical products by medical representatives within the framework of the Basque health system.

The decision has aroused a great deal of interest, particularly with regard to its reasoning on the legality of the promotion of authorized drugs which have not yet been the subject of a decision concerning its public funding. Contrary to the traditional position of regional administrations in this regard, the Court considered that the applicable regulations do not exclude the possibility of promoting medicinal products in such circumstances, since the regulations require that medical representatives do not provide information on the conditions of financing. only “where applicable”, that is to say, only if this information is already available. The Court even ventured to assert that a different interpretation would be contrary to the purpose of the medical sales activity, which is to ensure that doctors or pharmacists receive technical and scientific information in good time.

This decision was taken into consideration by the board of directors of Farmmaindustria, which decided to modify its previous position on this issue, thus allowing its member companies (and signatories of its code of ethics) to promote medicines while waiting. a decision on public funding as long as this situation is communicated to the recipients. This change is effective since September 23, 2021 and will apply within the framework of the disciplinary system of Farmindustria. However, the supervisory authorities of the different Spanish regions are not bound by the interpretation of the Court or by the new position of Farmanddustria. Indeed, we are aware that the competent unit of the Catalan Ministry of Health will continue to operate according to its usual practice, thus requiring a decision on funding and effective marketing before the promotion of the drug can start.