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Spain: Farmaindustria clears promotion of medicinal products awaiting a decision on public financing following judicial decision

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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.

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Author

Montserrat has extensive experience in pharmaceutical and health law, as well as in compliance, contract law, licensing, competition law and acquisitions in the pharmaceutical sector. She is the coordinator of the healthcare practice in the Barcelona office.
She assists healthcare companies throughout the life cycle of healthcare products (drugs, IVD and medical devices, combination products, cosmetics and food supplements), from R&D to commercialization and more specifically in the areas of clinical trials (agreements, regulatory procedures, processing of personal data), market access (pricing and reimbursement), products and companies regulations (MA/CE-marking, vigilances, required licenses, product classification, labelling), commercial relations between healthcare industries (distribution, (co)promotion, manufacturing, supply, licensing, partnership agreements), relations with healthcare professionals and/or patients including compliance (anti-gift and transparency laws); communication and advertising, e-health (connected devices, telemedicine, hosting of health data) and product liability. Her practice encompasses both advisory and litigation matters.
She also has considerable experience in the drafting of codes of professional ethics and conducting compliance audits, and advising on advertising and promotion of medicines and medical devices, including via the internet, online advertising and social media. Montserrat advises on a wide range of agreements related to the pharmaceutical industry, such as license and distribution agreements, clinical trial agreements, and supply and manufacturing agreements.

Author

Sheila Mendez is an Associate in Baker McKenzie Barcelona office.

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