Feliz día Europa
El Global
Este lunes 9 de mayo celebramos el Día de Europa, coincidiendo con el aniversario de la histórica “Declaración Schuman” de 1950, considerada el comienzo de lo que hoy es la Unión Europea. En estos más de 70 años se han producido numerosos avances en la consecución del mercado único, pero en sectores como el de... Read More
Contratación pública, competencia e incentivos
El Global
Cuando aparecieron en el mercado en España los genéricos, las dinámicas competitivas del mercado farmacéutico cambiaron de forma sustancial. Al ponerse en marcha el sistema de precios de referencia en 1999, se produjo un nuevo cambio. El sistema de agrupaciones homogéneas previsto el Real Decreto 177/2014 podía haber generado también cambios sustanciales en la forma... Read More
CMDh developments regarding marketing authorisations processed through decentralised procedures
Minutes of the CMDh meetings of 25-27 January 2022
Capsulas N 226
On 18 March 2022, the amended minutes of the CMDh meetings held in January 2022 were published. In these meetings, the CMDh discussed, among other issues, a case regarding an appeal against a Dutch marketing authorisation (MA) which had been processed through a decentralised procedure (DCP) with Netherlands as Reference Member State (RMS). The minutes... Read More
Public procurement of biosimilars
Resolutions of the Central Administrative Court of Public Procurement (TACRC) of 27 January 2022 and of 24 February 2022
Capsulas Nº 226
Introduction During the first quarter of 2022, the Central Administrative Court of Public Procurement (TACRC) published several resolutions that may be of interest to the biological medicines sector. Such resolutions address the possibility of favouring biosimilar medicines in tenders (resolution of 27 January) and some issues regarding the INGESA framework agreement (resolutions of 24 February... Read More
The importance of procedural aspects in damage claims regarding clinical trials
Judgment of the Court of Appeals of Madrid of 22 December 2021
Capsulas Nº 226
Claims for damages are often brought against companies that are not the ones that allegedly caused the damages; but rather against companies of the same group which are closer to the plaintiff’s territory. On many occasions, claims are filed against Spanish subsidiaries, even if they have not participated in the events leading to the claim.... Read More
Faus & Moliner participates in the «International Comparative Legal Guide to Drug & Medical Device Litigation 2022»
Xavier Moliner and Juan Martínez write the chapter dedicated to drug and medical device litigation in Spain
INTERNATIONAL COMPARATIVE LEGAL GUIDE
The 2022 edition of the International International Comparative Legal Guide to Drug & Medical Device Litigation magazine is now available. The Guide offers a practical insight into drug and medical devices litigation issues across the world. Xavier Moliner and Juan Martinez were in charge of chapter 16 dedicated to drug and medical device litigation.
Sobre lo que dicen algunos Informes
El Global
En los últimos días se han hecho públicos dos informes relacionados el acceso a los medicamentos. La Dirección General de Cartera Común de Servicios del SNS y Farmacia ha presentado un informe titulado “Evolución de la financiación y fijación de precio de los medicamentos oncológicos en el SNS (2016-2021)” y la EFPIA ha hecho lo... Read More
Faus & Moliner continues to lead the pharmaceutical law in Spain
Jordi Faus, the best lawyer for pharmaceutical law in Spain according to the Chambers & Partners Guide 2022
Chambers and Partners has published the 2022 edition of the Chambers Europe Guide, in which, based on opinions of clients and other lawyers, the leading lawyers and law firms in Europe are identified and classified and Faus & Moliner appears once again as the leading law firm in pharmaceutical law in Spain. Those consulted by the Chambers... Read More
La regulación del cannabis medicinal ¿una realidad?
El Global
La regulación del cannabis medicinal es una tarea pendiente en España. Tenemos unas pocas normas, antiguas (la Convención Única sobre Estupefacientes de 1961 y la Ley 17/1967, por la que se actualizan las normas vigentes sobre estupefacientes y adaptándolas a lo establecido en la convención de 1961), que lo único que establecen es que el cannabis es una... Read More
Nuevas normas para los acuerdos verticales. Algunas ideas aplicables a contratos típicos del sector de “Life Sciences”
CUADERNOS DE DERECHO FARMACÉUTICO, NUM. 80, JANUARY-MARCH 2022
In July 2021, the Commission published drafts of the new revised vertical block exemption Regulation and its vertical Guidelines. The previous Regulation and Guidelines had been in force since 2010 and have been very useful tools for the self-assessment of verticalagreements by companies. However, changes in the market and new online marketing models have made... Read More