Nueva Ley de medicamentos y productos sanitarios
El Global
Finalmente, llegó la lectura de Semana Santa. El Ministerio de Sanidad ha publicado el Anteproyecto de Ley de medicamentos y productos sanitarios. Este nuevo texto está llamado a sustituir a la actual Ley de garantías y uso racional de los medicamentos y productos sanitarios. Una ley que, con el paso del tiempo, ha ido acumulando... Read More
Nueva Ley de medicamentos y productos sanitarios
El Global
Finalmente, llegó la lectura de Semana Santa. El Ministerio de Sanidad ha publicado el Anteproyecto de Ley de medicamentos y productos sanitarios. Este nuevo texto está llamado a sustituir a la actual Ley de garantías y uso racional de los medicamentos y productos sanitarios. Una ley que, con el paso del tiempo, ha ido acumulando... Read More
Más sobre intercambiabilidad y sustitución de medicamentos biológicos
CUADERNOS DE DERECHO FARMACÉUTICO Nº 95 JANUARY-MARch 2025
The selection, interchangeability and substitution of biological medicines have been hot topicsin Spanish pharmaceutical law for many years. In 2014, a Non-Legislative Proposal was presented toCongress urging the Government to ‘Approve, as soon as possible, specific regulations on the substitution and interchangeability of biosimilar medicines’. Since then, legal arguments for and against substitution have been... Read More
Aprovechar las oportunidades
El Global
La Agencia Europea del Medicamento (EMA) y los Jefes de las Agencias de Medicamentos (HMA) han publicado recientemente la Estrategia Europea del Medicamento hasta 2028. Bajo el título “Aprovechando las oportunidades en un panorama cambiante de medicamentos”, esta Estrategia tiene como objetivo guiar a la red reguladora europea en los próximos años para afrontar los... Read More
Faus Moliner recognized once again in the 2025 edition of The Legal 500 (Legalease)
Faus Moliner appears in Tier 1 in the area of Healthcare and Life Sciences
This year Jordi Faus is in the Hall of Fame and Xavier Moliner continues to appear as leading individual, while Lluís Alcover has been identified as a key lawyer of our firm. Thos interviewed by The Legal 500 highlight that Faus Moliner is “a firm with good litigation experience in the life sciences” and that... Read More
Apostar por la formación
El Global
El pasado miércoles se celebró el acto de clausura del Curso de Derecho Farmacéutico, organizado por el Ilustre Colegio de la Abogacía de Barcelona (ICAB), reafirmando así el compromiso de los colegios profesionales con la formación continua. La conferencia de cierre estuvo a cargo de la Directora de la Agencia Española de Medicamentos y Productos... Read More
Faus Moliner participates in the Chambers & Partners Guide to Pharmaceutical Advertising 2025
Anna Gerbolés and Laia Rull have contributed to the chapter dedicated to Spain
Anna Gerbolés and Laia Rull have contributed to the chapter dedicated to Spain, providing an analysis of the legal framework regulating the advertising of medicines and its practical application. The “Law & Practice” section offers key information to help companies operating in Spain navigate the legal system in terms of pharmaceutical advertising, transparency and anti-bribery... Read More
Promotion of approved products in Spain prior to completion of price and reimbursement procedures: a paradigm shift?
The rules on minimum content of advertising materials should not be an obstacle to promote an approved product even if its price and reimbursement decision is pending
Capsulas Nº 259
On Friday, 21 March, an important judgment was published by the Supreme Court (TS) resolving an appeal against a sanction imposed by the Region of Madrid (CAM) for infringement of Law 1/2015 on Medicines in relation to article 10.2 of Royal Decree 1416/1994. The sanction related to an activity related to product that had received... Read More
Clarifying the concept of medicinal product and pharmacological action
Judgment of the Court of Justice of the European Union of 13 March 2025, Casella-med and MCM Klosterfrau, C-589/23
Capsulas Nº 259
Background The Court of Justice of the European Union (CJEU) has again ruled on the concept of “medicinal product”, in particular on the criteria for determining when a substance exerts a pharmacological action and is therefore to be considered as such. Before focusing on the case at hand, it is useful to briefly recall the... Read More
Access to medicinal products authorised but not included in public pharmaceutical provision
Judgement of the High Court of Justice of the Canary Islands of 21 October 2024
Capsulas Nº 259
Background This judgment analyses whether the refusal of the Canary Islands Health Service (SCS) to fund and provide individual access to a medicinal product authorised but not included in the pharmaceutical provision of the National Health System (SNS by its Spanish acronym) is contrary to the principle of equality recognised in art. 14 of the... Read More