Advertising of medicinal products before a financing decision by the National Health System

Superior Court of Justice of the Basque Country, Judicial Review Chamber, Judgment 246/2021 of 30 June resolved positively on a question widely debated in the sector: the possibility of advertising medicinal products that have been approved for sale but have yet to receive a decision on their financing.

This judgment is in line with the position upheld in the European Union, where Directive 2001/83/EC on marketing of medicinal products for human use only establishes the limit for marketing authorisation to be able to advertise medicinal products.

This interpretation goes beyond the position of the marketing requirement that, moreover, is not supported by Spanish or autonomous community regulations, which only require medicinal products to have marketing authorisation regardless of whether other administrative formalities need to be completed later. Nor can it be extended to actually marketing the product and then communicating it to the administration.

Having health care workers be familiar with the medicinal product is in the interest of patients, who will receive prescriptions and dispensation of the product more quickly, because it is already known.

This is the method in the magnificent article by Angel García Vidal, Professor of Commercial Law at the University of Santiago de Compostela. Academic advisor of Gómez-Acebo & Pombo and Irene Fernández Puyol, Partner. Coordinator of the Life Sciences Division of Gómez-Acebo & Pombo.

A must read! Available this week at: https://cefi.es/categoria-producto/publicaciones/revista-cuadernos/

Just to complete this information, it should be noted that the Board meeting of Farmaindustria 23 September 2021 passed the modification in this regard to Q&A no. 10 of “Annex V Consultations (Q&A) on the interpretation of the Code of Good Practice”. This change came into force on 24 September.

This post is also available in: Spanish

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