Jordi Faus makes a presentation about the Royal Decree on the Reference Price System in the first Online Seminar organized by CEFI
Royal Decree 177/2014 of 21 March 2014 also regulates the information systems regarding financing and prices of medicinal products and medical devices
After long months of negotiation, this very important regulation on reference prices, the system of homogeneous groups, and certain information systems regarding pricing and reimbursement of medicinal products has been approved. The State Council, when reporting on the draft, already pointed out that this is a complex issue, difficult to understand for those who do... Read More
Royal Decree 177/2014 on the Reference Price System
Presentation at the CEFI online Seminar on Reference Prices
After long months of negotiation, this very important regulation on reference prices, the system of homogeneous groups, and certain information systems regarding pricing and reimbursement of medicinal products has been approved. The State Council, when reporting on the draft, already pointed out that this is a complex issue, difficult to understand for those who do... Read More
La innovación vuelve a estar contra las cuerdas
EL GLOBAL
En las facultades de derecho se enseña que la motivación de los actos administrativos es algo muy importante, tanto que la falta de la misma puede llegar a comportar su anulación. En las disposiciones como el recientemente publicado Real Decreto 177/2014 de precios de referencia, agrupaciones homogéneas y sistemas de información en materia de financiación... Read More
Ahora nos toca pagar a todos
EL GLOBAL
La publicación de la sentencia del Tribunal Supremo, confirmando la anulación de la Orden de Precios de Referencia de diciembre de 2009, ha levanta un revuelo lógico dadas sus posibles implicaciones económicas. El alto tribunal, como era de esperar, acoge el cambio de criterio jurisprudencial iniciado por la Audiencia Nacional en el 2010, confirmando que,... Read More
Introducción a la regulación del sector farmacéutico
Presentation at the Course on Regulated Areas in the Master in Professional Law Practice of Pompeu Fabra University
Jordi Faus lectures on pharmaceutical law at the master for graduate law students. The Universitat Pompeu Fabra in Barcelona has selected Faus & Moliner to participate in the course on regulated sectors that is part of the Master program for graduate law students. Faus & Moliner partner Jordi Faus has lectured on the rules that... Read More
Faus & Moliner collaborates with the Universitat Pompeu Fabra in Barcelona
Jordi Faus lectures on pharmaceutical law at the master for graduate law students
The Universitat Pompeu Fabra in Barcelona has selected Faus & Moliner to participate in the course on regulated sectors that is part of the Master program for graduate law students. Faus & Moliner partner Jordi Faus has lectured on the rules that apply to medicinal products in Spain and in the European Union. In his... Read More
El pacto
EL GLOBAL
Sin duda una de las noticias que ha acaparado la atención mediática en los últimos días ha sido el pacto por la sostenibilidad del Sistema Nacional de Salud, recientemente suscrito entre el Ministerio de Sanidad, Servicios Sociales e Igualdad y Farmaindustria. El acuerdo alcanzado ha levantado una expectación perfectamente legítima, pero para los que llevamos... Read More
Important fine to an investigator that promoted a clinical trial without administrative approval
The Judgment of the Superior Court of Justice of 19 December 2013 confirms a fine of 120.000 Euros imposed by the Autonomous Region of Madrid
CAPSULAS Nº 150
Background As a result of an anonymous complaint made before the Spanish Agency of Medicinal Products and Medical Devices (AEMPS in Spanish), an infringement procedure was initiated against a physician claiming that he had carried out a clinical trial, acting as sponsor and principal investigator, without obtaining prior approval, without having received a favorable ruling... Read More
A company bidding for the supply of consumable products may be obliged to offer measuring devices free of charge
Resolution No 88/2014, of 5 February 2014, of the Central Administrative Court of Public Procurement Appeals
CAPSULAS Nº 150
Background In a public tender procedure for the award of a supply agreement of test strips to measure parameters or indicators for the diagnosis, it is frequent that the winner be also obliged to supply, free of charge, measuring devices as well as any other equipment necessary for their use. This obligation was provided for... Read More
Biological medicinal products must be identified by their trademark in medical prescriptions
Royal Decree 81/2014, of 7 February, modifies Royal Decree 1718/2010, of 17 December, on medical prescription and dispensation orders
CAPSULAS Nº 150
Background Royal Decree 81/2014, of 7 of February, which establishes the rules to ensure cross-border healthcare assistance, and which modifies Royal Decree 1718/2010, of 17 of December, on medical prescription and dispensation orders came into force on 8 of February. The amendment of Royal Decree 1718/2010 is the result of incorporating Directive 2011/24/EU to our... Read More