New therapeutic indications and generics approved under centralised procedure
Judgment of the General Court of the European Union, of 15 September 2015, Case T-472/12, Novartis v. European Commission
CAPSULAS Nº 163
Background This case originated when Novartis brought an action seeking the annulment of the European Commission (EC) decision which granted a marketing authorisation (MA) to Teva for “Zoledronic acid Teva”. Novartis argued that this decision was unlawful because it infringed its data exclusivity period in respect of its medicinal product Aclasta®. In addition to addressing... Read More
The complicated path of prescription by nurses
Judgment of the Supreme Court, of 26 June 2015, on the regulation of nursing activities in the Balearic Islands’ healthcare system
CAPSULAS Nº 163
Background In 2009, an amendment to the Law on Guarantees and Rational Use of Medicinal Products and Medical Devices gave nurses the option of prescribing some medicinal products. The aim of the lawmaker was to regularise an activity that was already an everyday routine in for treating minor symptoms or preventing the interruption of a... Read More
“El RD de Precios debería facilitar el acceso y, por definición, no regular los precios libres”
El Global
En abril de 2014, Jordi Faus presentó en el Seminario online CEFI sobre Precios de Referencia algunas ideas para el Real Decreto de precios y financiación. EG ha hablado con él para ver si el proyecto ha cumplido sus expectativas. Pregunta. A su juicio, el Real Decreto debía limitarse a dar respuesta a qué medicamentos... Read More
The “new” law on guarantees and rational use of medicinal products and medical devices
The Government approves the consolidated text of the law on Medicinal Products and Medical Devices
CAPSULAS Nº 162
Background In accordance with article 82 of the Spanish Constitution and by virtue of the delegation that was granted under Law 10/2013, the Government has approved the consolidated text of Law 29/2006 on Guarantees and Rational Use of Medicinal Products and Medical Devices. This “new” law aims to consolidate in one text the various provisions of Law 29/2006, which have been subject... Read More
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