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Last June, the Superior Court of Justice of the Basque Country ("Court") delivered a decision with wide-ranging repercussions regarding the advertising of medicinal products by pharmaceutical companies. The decision ruled on an appeal filed by Farmaindustria (the Spanish trade association bringing together innovative pharmaceutical companies) against a regional order regulating the advertising of pharmaceutical products through medical sales representatives in the context of the Basque Health System.
The decision attracted a lot of interest, especially in regard to its reasoning on the lawfulness of the promotion of authorized medicinal products that have not yet received a decision concerning their public financing. Unlike the traditional stance of regional administrations in this regard, the Court found that applicable regulations do not foreclose the possibility of promoting medicinal products in such circumstances, since regulations require medical sales representatives to declare the financing conditions only "if applicable," i.e., only if that information is already available. The Court even stated that a different interpretation would be contrary to the purpose of the medical sales activity, which is to ensure that doctors and pharmacists receive timely technical-scientific information.
This decision was taken into consideration by the governing board of Farmaindustria, which decided to amend its previous stance on this issue, thereby allowing its member companies (and signatories of its code of ethics) to promote medicinal products pending a decision on public financing as long as this situation is disclosed to the addressees. This change has been effective since 23 September 2021 and it will apply within the framework of the disciplinary system of Farmaindustria. However, the control authorities of the different Spanish regions are not bound by the interpretation of the Court or by Farmaindustria's new position. Indeed, we are aware that the competent unit of the Catalan Ministry of Health will continue to operate according to its usual practice, i.e., requiring a decision on financing and effective marketing before the promotion of the medicinal product can begin.
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