Member States may prohibit marketing cosmetics that resemble foodstuffs
Judgment of the Court of Justice of the European Union (Second Chamber), of 2 June 2022, Case
Capsulas Nº 229
Background In August 2019, Lithuanian authorities withdrew certain cosmetics from the market on the grounds that they were unsafe for consumers, as they resembled foodstuffs; and therefore, according to Directive 87/357, could entail risks to consumers’ health and safety, especially children. The authorities based their decision on Directive 87/357 concerning products with misleading appearances that... Read More
Judicial protection of trade secrets
Judgment of the Provincial Court of Barcelona, of 20 May 2022
Capsulas Nº 229
The purpose of trade secret regulations is to ensure the competitiveness of innovative companies and to improve the conditions for the protection of undisclosed information with business value (trade secrets). In recent months, a number of noteworthy court decisions regarding the protection of trade secrets have been handed down. The importance of non-disclosure agreements Firstly,... Read More
Health technology assessment, where are we?
About Regulation (EU) 2021/2282
Capsulas Nº 229
Background No medicinal product can be marketed without obtaining a prior marketing authorization (MA). MAs are granted based on scientific criteria regarding the quality, safety and efficacy of the medicinal product concerned. If an MA is granted for a medicinal product, this means that the product has a favourable risk/benefit balance, it is effective for... Read More
Amendment of Spanish law on medicines and medical devices
The Ministry of Health opens a public consultation on the first draft of the law that will amend the current laws on guaranties and rational use of medicines and medical devices
Capsulas Nº 228
Introduction In Spain, the procedure to elaborate a law is established in Law 50/1997 of the Government. This law states that before drafting the project of any new law, a public consultation must be carried out for the purposes of obtaining the opinion of the persons and entities that could be affected by the future... Read More
El cannabis medicinal: ¿una realidad cercana?
El Global
El pasado 21 de junio, la subcomisión del Congreso de los Diputados, creada al objeto de analizar las experiencias con el uso medicinal del cannabis, emitió su informe favorable a la regulación del uso medicinal del cannabis. Aunque todavía no tenemos reflejo normativo sobre las posibilidades de uso del cannabis medicinal, el informe de la... Read More
It´s our anniversary
On June 10, 2022 we celebrated the 25th Anniversary of Faus Moliner at the Art Nouveau Site of the Hospital de Sant Pau in Barcelona.
The evening began with a dialogue on “The future of medicines in Europe” with the participation of Mª Jesús Lamas, Director of the Spanish Medicines Agency; Rui Santos Ivo, President of Infarmed (the Portuguese National Authority for Medicines and Health Products); and Stefano Marino, Director of the Legal Service of the European Medicines Agency. Afterwards,... Read More
La primacía del derecho de la Unión Europea y su aplicación al ámbito del medicamento
CUADERNOS DE DERECHO FARMACÉUTICO, NUM. 81, APRIL-JUNE 2022
On 2 December 2021, the Spanish Audiencia Nacional issued a ruling where it partially accepted an appeal filed by Farmaindustria against the Order SBC/953/2019 of 13 September, which updated, for 2019, the reference price system that applies in the Spanish National Health System.The judgement annuls the inclusion, in reference price group H35, of the medicinal... Read More
Contratos del mundo real
El Global
El análisis de datos generados por la práctica clínica en el mundo real -Real World Data (RWD) o Real World Evidence (RWE)- va ganando progresivamente mayor importancia en el sector farmacéutico y sanitario. Gracias a este análisis es posible obtener información valiosa que ayude a mejorar los tratamientos e intervenciones sanitarias y, en definitiva, la... Read More
Faus Moliner participates in the “International Comparative Legal Guide to Product Liability 2022”»
Xavier Moliner and Juan Martínez write the chapter dedicated to the product liability regime in Spain
INTERNATIONAL COMPARATIVE LEGAL GUIDE
The 2022 edition of the magazine International Comparative Legal Guide to Product Liability is now available. The Guide offers a practical insight into product liability issues across the world, and includes general articles on novelties in the field of product liability and country specific Q&A chapters. Xavier Moliner and Juan Martínez were in charge of... Read More
Todo tiene un precio
El Global
Soplan nuevos vientos en la compra pública de medicamentos. Existe un interés tanto desde la industria como del propio gestor público en explorar nuevas fórmulas que permitan evolucionar de un modelo tradicional de compra de un mero producto, a otro que apueste por poner el paciente en el foco, contratando soluciones y servicios complementarios al... Read More