The Supreme Court is reluctant to allow criminal proceedings against failure to act by administrative authorities
Judgement of the Supreme Court, of 29 April 2015, on the financing of new treatments for Hepatitis C Virus (HCV)
Capsulas Nº 161
This judgment rules on the criminal complaint filed by patients and relatives of persons who were affected by the hepatitis C virus on account of the obstacles they found to access new treatments against this pathology. Given that among the defendants there was a person with privileged jurisdiction, the initial assessment of the complaint in relation to... Read More
Application of the proportionality principle in cases affecting public health
Judgment of the Court of Justice of the Basque Country of 3 February 2015 on the substitution of a branded medicinal product by a generic medicinal product
CAPSULAS Nº 161
In the information society the decisions affecting sensitive matters immediatelycapturethe attention of media and public. Theimmediacy of digital media and summarizing very complex mattersina mere headline or 140 characters sometimes prevents us from forming an accurate opinion on the issue. This seems to occur with this judgement regarding the prohibition of blood donation for sexualityreasons.... Read More
The defect in a medical device manufactured in series presumes the existence of such defect in all the units from the same series
Judgment of the European Court of Justice (ECJ), of 5 March 2015, Case C-503/13 (Boston Scientific), regarding liability for defective medical devices
Capsulas Nº 161
Background A manufacturer of pacemakers and automatic implantable cardioverter defibrillators realized that a component for the hermetic seal used in the pacemakers could undergo a progressive degradation that might lead to an early battery rundown, resulting in loss of telemetry and/or in loss of output without warning. He also verified that the proper working of... Read More
Pan para hoy…
El GLOBAL
Al hilo de las declaraciones del Gobierno sobre los planes que se están barajando para compensar a los servidores de la función pública, colectivo del que se han exigido sacrificios indudables, no ha faltado quien ha puesto el dedo en la llaga y se ha preguntado si también empezarán a pensarse medidas para aliviar la... Read More
A propósito de las comisiones andaluzas
El GLOBAL
Supongamos que alguien nos pida una explicación del entorno legal y administrativo en el cual opera la industria farmacéutica en España. Para llevar a cabo un ejercicio de este tipo suele ser bueno pensar que el destinatario de nuestra explicación será un extranjero, por ejemplo, alguien del departamento médico de una compañía americana que acaba... Read More
The International Comparative Legal Guide to Product Liability 2015: Chapter 31 – Spain
A practical cross-border insight into product liability work
THE INTERNATIONAL COMPARATIVE LEGAL GUIDE
Recently the 2015 issue of The International Comparative Legal Guide to Product Liability was published. This Guide offers a practical insight into product liability issues across the world, and includes both general articles on novelties in the field of product liability and country specific Q&A chapters. Just like last year, Xavier Moliner and Irene van... Read More
El utilitarismo ha muerto
El GLOBAL
En la filosofía política y jurídica, los utilitaristas se caracterizan por defender que la actuación correcta es la que causa un mayor beneficio o placer a un mayor número de personas. Las instituciones, para los utilitaristas, actúan de forma irreprochable si gestionan los recursos en beneficio del mayor número de personas. Conceptos como la sostenibilidad... Read More
¿Agrupación de biológicos en un mismo lote?
EL GLOBAL
En los procedimientos de contratación pública que tienen por objeto la adquisición de medicamentos biológicos se produce con demasiada frecuencia el problema de cómo el órgano de contratación configura los lotes de la licitación. Motivada posiblemente por un excesivo celo en la contención y control del gasto, la administración tiende a agrupar en un mismo... Read More
Holders of marketing authorizations are entitled to judicially appeal against the approval of a generic medicinal product
Cuadernos de Derecho Farmacéutico número 52, Enero-Marzo 2015
Summary: In Spain and in other EU Member States, holders of marketing authorizations for reference medicinal products face obstacles when trying to bring national authorities to court in connection with the grant of generic approvals. In many cases, Spanish Courts have denied locus standi claiming that the interest that the claimant is not sufficient to... Read More
Aspects to be considered in the future regulation on public financing and prices of medicinal products
Judgment of the European Court of Justice, of 26 February 2015, and Report of 28 April 2015, of NCMC, on the Draft of the Revised Text of the Law on Guarantees
CAPSULAS Nº 160
Drafting the new Royal Decree on financing and price of medicinal products is, without question, a complex process. The two documents to which we refer in this article bring valuable ideas that should be considered in future regulations. Transparency It is particularly convenient to talk about transparency. The Spanish National Commission for Markets and Competition... Read More