Transposing Directives through instruments having questionable legal value: “soft law”
Judgement of the Court of Justice of the European Union, of 11 June 2015, Case C-29/14
CAPSULAS Nº 162
Background Poland passed a Law to comply with its obligation to adapt its national legislation to the provisions of Directive 2004/23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. Directive 2004/23/EC provides that it should apply to reproductive cells (eggs, sperm)... Read More
Approval of the list of the European Commission on health claims made on foods
Judgment of the General Court, of 12 June 2015, Case T-296/12
Capsulas Nº 162
Background In 2012 the European Commission (EC) adopted Regulation 432/2012 authorising a list of health claims made on foods. Such list was issued in compliance with Regulation 1924/2006 which laid down the principle that such health claims need to be based on proper scientific evidence, entrusted the EC with the approval of a list of... Read More
Un gran sistema sanitario ¿no necesita juristas?
el global
Asumamos que en España se disfruta de un gran sistema sanitario, avalado por un grado de satisfacción de los usuarios superior al 60 por ciento. Somos conscientes y además sabemos que la tendencia que muestra el Barómetro que publica el Ministerio de Sanidad, Servicios Sociales e Igualdad cada año es negativa, pero aun así la... Read More
Un poquito de sentido común, por favor
El GLOBAL
Los automatismos en la toma de decisiones no suelen ser una política inteligente a medio y largo plazo. Ofrecen algunas ventajas inmediatas, qué duda cabe. Al principio nos ahorran quebraderos de cabeza, como tener que buscar soluciones alternativas más creativas y sofisticadas para ciertas situaciones particulares. Pero a la larga los inconvenientes suelen superar de... Read More
Faus & Moliner participates in the International Comparative Legal Guide to Pharmaceutical Advertising 2015
Jordi Faus and Carmela Losada write the chapter on Spanish law on advertising and promotion of medicinal products
International Comparative Legal Guide
The International Comparative Legal Guide on advertising of medicinal products has been designed in order to provide international practitioners and in-house counsel with a comprehensive worldwide legal analysis of the laws and regulations on pharmaceutical advertising. The guide includes a chapter for each major jurisdiction, in a practical Questions & Answers format that provides a... Read More
Substitution of medicinal products and individual rights of patients
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
Background This case begun when a doctor treating a patient with Parkinson came to the conclusion that, in this specific case, the generic medicinal product which the patient was getting from the pharmacy did not have the same effect as the branded product which the doctor had prescribed. The substitution had been carried out by the... Read More
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