Harmonisation of guidelines for the use of scientific data in advertising to healthcare professionals
New monograph of the Medicines Advertising Bulletin of Catalonia
Capsulas Nº 252
On 29 April 2024, the Medicines Advertising Bulletin of Catalonia issued a new notice outlining revised guidelines for using scientific publications and data into promotional materials for medicines. The document is based on Royal Decree 1416/1994 which regulates the advertising of medicinal products for human use, the Farmaindustria Code, the resolutions of the Jury of... Read More
Conformity with the SmPC is a “per se” rule in advertising of medicinal products
Decisions of the Jury of Advertising of Autocontrol of 29 February 2024 and 12 April 2024 in the Fasenra® case
Capsulas Nº 252
Background These decisions stem from a complaint by GSK against AstraZeneca for promotional materials related to the medicinal product Fasenra® that had been presented at several satellite symposia during national scientific congresses. AstraZeneca markets Fasenra® (benralizumab) which is indicated as an add-on maintenance treatment in adult patients with severe eosinophilic asthma (“AGE” by its Spanish... Read More
The transfer of administrative and criminal liability in mergers and acquisitions
Judgement of the Constitutional Court of Spain of 11 December 2023 (n. 179/2023)
Capsulas Nº 252
Background This important judgment of the Constitutional Court of Spain (“TC” by its Spanish acronym) rules on the constitutional appeal filed by Banco Santander against a 2019 sanctioning resolution of the Council of Ministers. This resolution imposed on the bank Banco Santander, the successor entity of Banco Popular, a fine for the commission of a... Read More
Faus Moliner participates in the EU Pharmaceutical Law Forum
Jordi Faus participated in the dialogue Market Access Challenges and Developments for Pharmaceutical Firms
The 33rd edition of the European Pharmaceutical Law Forum, organized by Informa Connect, took place in Brussels from May 21-23, 2024. As in previous editions, several round tables have addressed key issues and developments in EU Pharmaceutical Law. Jordi Faus, together with Ilja Moree (Novartis AG) and Christian Jervelund (Copenhagen Economics), addressed the challenges faced... Read More
Flexibilizar controles en la publicidad de productos sanitarios favorece la innovación
El Global
La CNMC ha publicado recientemente su Informe de Proyecto Normativo (IPN) sobre el proyecto de Real Decreto de publicidad de Productos Sanitarios. Con este proyecto de Real Decreto, que fue presentado a consulta pública el pasado mes de febrero, se busca actualizar las reglas aplicables a la promoción de productos sanitarios. Actualmente, estas reglas se... Read More
Avanza la nueva Propuesta de Directiva de responsabilidad por producto
El Global
La Unión Europea da un nuevo paso en la elaboración de la Propuesta de Directiva del Parlamento Europeo y Consejo sobre responsabilidad por los daños causados por producto defectuoso, que pretende derogar la actual Directiva 85/374/CEE. Mediante resolución de 12 de marzo de 2024, el Parlamento Europeo ha aprobado en primera lectura el texto de... Read More
Sobre la calidad y cantidad de las normas
El Global
La semana pasada comentábamos sobre la importancia de la calidad de las normas, algo que ya sabéis que es una especie de obsesión en Faus Moliner. Nosotros no dejamos de pensar que la capacidad de las personas y de las empresas de afrontar adversidades incluye la capacidad de adaptarse a cualquier norma que aprueben el... Read More
Un gran reto para los próximos 1.100 números
El Global
La tribuna de esta semana es ciertamente especial: El Global cumple 1.100 números. Sin duda contribuyen a su longevidad, además del factor humano, lo apasionante del mundo del medicamento y la farmacia. Por ello esta semana nos permitirán que nos desmarquemos de la actualidad de la semana para mirar hacia el futuro. Tal vez no... Read More
Access to medicinal products and constitutional rights
Three new judgements, two from the Supreme Court and one from the High Court of Justice of Galicia, provide new insights on this matter
Capsulas Nº 251
Gutron® Case (High Court of Justice of Galicia): reimbursement of expenses and right to health protection Judgment 756/2024 of the High Court of Justice of Galicia of 7 February 2024 deals with a request for reimbursement of expenses made by a patient to the Galician Health Service (“Sergas”). The claim was for payment of the... Read More
Impartiality and procedural flaws in the EU
Judgment of the Court of Justice of the European Union of 14 March 2024 (C-291/22)
Capsulas Nº 251
Background The origin of this judgment refers to the European Commission’s Implementing Decision not to grant a marketing authorisation for Hopveus®, a medicinal product intended to treat alcohol dependence. The refusal to grant marketing authorisation was based on an unfavourable opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines... Read More