Greater pressure against anti-competitive practices: the Public Administration can also claim compensation
On the February 2023 report of the Catalan Competition Authority (ACCO) on damages claims against public administrations for anti-competitive practices
Capsulas Nº 236
Competition law in the life sciences sector In recent years, competition authorities have intervened in a number of cases in the life sciences sector. In Spain, for example, sanctions have been imposed for abuse of a dominant position, for selling orphan drugs at excessive prices, for allegedly taking unjustified legal action against a competitor, or... Read More
Updating the rules for conducting medical device studies in Spain
Instructions of the Spanish Agency for Medicinal Products and Medical Devices (AEMPS) for the conduct of clinical investigations with medical devices in Spain, dated 30 January 2023
Capsulas Nº 236
The AEMPS has recently issued guidelines clarifying the requirements applicable to clinical research of medical devices conducted in Spain. The guidelines provide practical information on the aspects regulated by the Regulation (EU) 2017/745 on medical devices. In addition, they provide a higher level of detail on all matters that the regulation allows to be developed... Read More
Something is going on in product liability
On the Proposal for a Directive of the European Parliament and of the Council on liability for defective products
Capsulas Nº 236
The proposal for a Directive on liability for defective products is currently being prepared. If finally adopted, this proposal will repeal the existing Directive 85/374/EEC and will significantly change the legal regime for claims under product liability law. Purpose of the proposal and main features The proposal aims to address a number of shortcomings identified... Read More
Ratification of the principle of primacy of application of the legal regime on medicinal products
Judgment of the Court of Justice of the European Union of 19 January 2023 in cases C-495/21 and C-496/21
Capsulas Nº 236
Background On 19 January 2023, the Court of Justice of the European Union (CJEU) issued a new judgement answering some questions on the definitions of medicinal product and medical device, at the request of the German Supreme Administrative Court. The case concerned two products (nasal drops and nasal spray) marketed in Germany as medical devices.... Read More
Agencia Estatal de Salud Pública: mejorando la respuesta a los retos en materia de salud
El Global
En las últimas semanas la nueva normalidad postpandemia vuelve a ser aquella en la que no llevábamos mascarilla en el transporte público y las vacunas no estaban tan presentes en nuestras vidas. Sin embargo, la crisis de la COVID-19 ha puesto de manifiesto los retos y dificultades a los que se enfrenta el sistema para... Read More
Faus Moliner participates in the conference on Proposals for innovation in access to medicines in the National Health System organized by the CEFI Foundation
Lluís Alcover and Joan Carles Bailach participate in the panel of experts and make interesting proposals during their intervention.
Lluís Alcover and Joan Carles Bailach together with a group of leading experts present their proposals to innovate access to medicines in the National Health System. Lluís Alcover reflects on the conditions of access to non-financed medicinal products. He makes a brief analysis of the current situation and suggests two proposals to improve the access... Read More
Acceso a medicamentos por la vía judicial
El Global
Lo que les voy a explicar hoy es com el dios Jano, tiene dos caras. Una positiva y otra negativa. Empecemos por la negativa: es lamentable que un ciudadano al que se prescribe un producto tenga que someterse al calvario de litigar contra la administración para tener acceso al mismo. Especialmente, si el producto está... Read More
Whistleblowing channel: mandatory for all companies with over 50 employees and for public sector entities
Spain approves Law 2/2023 on the protection of persons who report breaches of the law and on fight against corruption
Capsulas Nº 235
The context According to experts, the best way to detect irregular behaviour in companies is to have reliable mechanisms that allow their employees and third parties with whom they have work-related activities to report such behaviour. This is the best way to detect undesirable behaviour that might otherwise go unnoticed by the usual supervisory and... Read More
Canales de denuncias y sector farma …keep calm
El Global
Este pasado martes se publicó en el BOE la Ley 2/2023, conocida como ley de protección de los informantes, que traspone a nuestro ordenamiento la directiva sobre “whistleblowing” (Directiva (UE) 2019/1937). A partir de ahora las empresas de más de 50 personas trabajadoras vendrán obligadas a implantar un sistema interno de información, conocido como canal... Read More
Acceso a medicamentos huérfanos
El Global
La semana pasada tuve el privilegio de participar en el European Rare Disease Summit 2023 organizado magistralmente por la Fundación Bamberg. Compartí un panel con María José Sánchez, presidenta de Aelmhu; Tina Taube (EFPIA), Thomas Bols (PTC), Elisabetta Zanon (European Alliance for Regenerative Medicine) y Sumeya Bekri (Hospital Center University Rouen); bajo la moderación de... Read More