Precios de referencia, innovación y protección de la salud pública
El Global
Hace mucho tiempo que se está hablando de la necesidad de modificar el sistema de precios de referencia. Su rigidez ha empujado a muchos medicamentos innovadores a problemas de disponibilidad motivados por la falta de viabilidad económica resultante de un método de cálculo de los precios máximos de financiación que es poco flexible. Por otro lado,... Read More
Por una nueva regulación del medicamento que sea eficaz, segura y de calidad
El Global
La consulta pública que el Ministerio de Sanidad ha puesto en marcha en relación con el anteproyecto de ley de modificación de la Ley de Garantías es una formalidad exigida por la Ley 50/1997, del Gobierno; pero conviene darle toda la importancia que se merece; y es absolutamente recomendable que la sociedad civil presente sus... Read More
Faus & Moliner participates in the «Chambers Global Practices Guides – Product Liability & Safety 2022»
Xavier Moliner and Juan Martínez write the chapter on product liability in Spain
The “Chambers Global Practices Guides” publication is a practical reference that provides easily accessible information for browsing the legal system when conducting business in different jurisdictions. Leading lawyers in the sector explain local laws and practices in key transaction stages and for crucial aspects of doing business.
New public procurement models, value has a price tag
Resolution No. 199/2022, of 26 May, of the Central Administrative Tribunal of Contractual Appeals
Capsulas Nº 229
Defining the purpose of a contract in an innovative manner A new trend in the public procurement of medicinal products is timidly making headway. Both the industry and the public sector are interested in exploring new formulas to evolve from a traditional model to a new relationship based on different concepts. This would change the... Read More
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