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In brief

Last June, the Superior Court of Justice of the Basque Country delivered a decision with wide repercussion with regards to 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.


A closer look

The decision attracted a lot of interest especially as regards its reasoning on the lawfulness of promotion of authorized medicinal products which do not yet have a decision concerning its 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 inform on the financing conditions only “if applicable”, i.e., only if that information is already available. The Court even ventured to state that a different interpretation would be contrary to the purpose of the medical sales activity, which is to ensure that doctors or 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 as from 23 September 2021 and it will apply in the framework of the disciplinary system of Farmaindustria. However, 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 per their usual practice, thus requiring a decision on financing and the effective marketing before the promotion of the medicinal product can kick off.

Author

Montserrat Llopart is a Partner in the International Commercial & Trade department and leads the Compliance and Healthcare Law practices in the Barcelona office. Her practice focuses on advising clients on regulatory, compliance, commercial contracts, consumer and acquisitions issues. She is a regular speaker and contributor to specialist conferences and publications and she is recognized by the leading legal directories as Chamber, Legal 500 and Best Lawyers and as InspiraLaw Top 50 Women List for Spain and Portugal. Montserrat headed the Barcelona office and the Firm's pharmaceutical law group in the EMEA region.

Author

Sheila Mendez is an Associate in Baker McKenzie Barcelona office.

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