No dejes para mañana lo que puedas hacer hoy
El Global
Durante los próximos meses/años se aprobarán cambios normativos que definirán las reglas del juego del sector farmacéutico. Un “tsunami normativo”, dicen algunos. El proceso de elaboración de estas normas genera un debate intenso, reflejo de la complejidad del sector y la pluralidad de intereses y stakeholders que lo componen. Cuando no hay consenso (lo habitual),... Read More
The Supreme Court confirms that companies have locus standi to challenge the marketing authorisation granted to a competitor
Judgments of the Supreme Court, Nos. 827/2024 and 1241/2024, of 14 May and 10 July
Capsulas Nº 255
Background Both judgments have been issued in proceedings initiated in Spain by an innovator company that challenged the marketing authorisations (“MAs”) granted to certain competing medicinal products. The Spanish Agency for Medicines and Medical Devices (“AEMPS”) granted these MAs through a decentralised procedure, in which the Netherlands acted as reference Member State and Spain as... Read More
Faus Moliner participates in the Colloquium “Two great novelties: hospital exemptions and transferable exclusivity vouchers” organized by Diariofarma
Jordi Faus and Lluís Alcover participated in the meeting held in Madrid on September 17
Jordi Faus and Lluís Alcover participated in this interesting meeting on transferable exclusivity vouchers and hospital exemptions organized by Diariofarma with the purpose of discussing the key issues of the regulation, analyzing the changes in the legislation and promoting dialogue between agents on the European pharmaceutical legislative package. Jordi Faus was in charge of presenting... Read More
Ensayos orientados al paciente
El Global
España está en el top mundial en investigación biomédica y ensayos clínicos. Esto se debe a la conjunción de diversos factores de muy variada índole. El establecimiento de un adecuado marco normativo, sin duda, ayuda a la creación de este ecosistema propicio. Pero siempre hay aspectos susceptibles de mejora. Uno de ellos, en mi opinión,... Read More
Super Mario
El Global
El pasado 9 de septiembre la Comisión presentó el Informe sobre el Futuro de la Competitividad Europea, encargado al ex primer ministro de Italia y ex presidente del Banco Central Europeo, Mario Draghi. Se trata de un extenso documento, de unas 400 páginas, donde se analizan las causas de la brecha de competitividad en la UE... Read More
Global Legal Insights to: Pricing & Reimbursement 2024
Global Legal Group
The seventh edition of Pricing & Reimbursement has been recently published and as in previous years Jordi Faus, with the collaboration of Lluís Alcover and Joan Carles Bailach, has been in charge of the chapter dedicated to pricing and reimbursement in Spain. GLI Pricing & Reimbursement 2024 includes the following sections for each of the... Read More
Suerte, perseverancia y abogados entusiastas
El Global
El pasado 1 de agosto, con la entrada en vigor del Reglamento de inteligencia artificial (AIA), se puso en marcha la cuenta regresiva para ajustar los sistemas de IA a la nueva normativa antes de que ésta sea aplicable. Realizar este ejercicio de adecuación en el campo de la salud exige, entre otras cosas, que... Read More
Progress in the regulation of health technology assessment
The Ministry publishes the Draft Royal Decree, and the deadline for submitting allegations is 20 September
Capsulas Nº 254
Work to regulate health technology assessment (HTA) activities specifically aimed at informing government decisions on incorporation, financing, pricing, reimbursement or disinvestment is coming to an end. In this capsulas we present some thoughts on aspects of the proposal that we believe could be revised: Relationship between evaluation and price and reimbursement procedure We believe that... Read More
Which aspects of personal data protection should be included in the patient information sheet and informed consent form?
Report of the Legal Department of the Spanish Data Protection Agency (AEPD) of 12 March 2024
Capsulas Nº 254
Following the entry into force of Royal Decree 1090/2015, regulating clinical trials with medicinal products, the AEMPS issued an instruction document for the conduct of clinical trials in Spain. This Q&A format document provides useful information on practical aspects derived from the application of this Royal Decree. The instruction document is updated periodically, as well... Read More
Valoraciones sobre el proyecto de reforma de la publicidad de productos sanitarios
REVISTA COMUNICACIONES EN PROPIEDAD INDUSTRIAL Y DERECHO DE LA COMPETENCIA Nº 102
The purpose of this article is to analyse the current regulatory framework for the advertising of medical devices and the changes that will be generated by the adoption of the new Royal Decree on the advertising of medical devices, which was submitted for public consultation in February 2024. It also analyses the impact that the... Read More