Un proyecto en vía muerta
El Global
Se agota la legislatura. Y con ella, parece cada vez más obvio, la posibilidad de que asistamos en las próximas fechas al nacimiento del nuevo real decreto que regulará inclusión de medicamentos y productos sanitarios en la prestación farmacéutica del Sistema Nacional de Salud. El proyecto destinado a consagrar estas nuevas reglas del juego ha... Read More
La vacunación obligatoria
El Global
La semana pasada, entre los días 4 y 9 de octubre, se celebró en Viena la reunión anual dela International Bar Association, una organización internacional que reúne a abogados, operadores jurídicos, colegios profesionales de abogados y asociaciones de Derecho de diferentes nacionalidades. En el encuentro anual del Colegio de Abogados Internacional participaron más de 6.000... Read More
Faus & Moliner participates at the IBA Annual Conference
Jordi Faus speaks about compulsory vaccination at the Annual Meeting of the Internationnal Bar Association
At this year’s Annual Meeting of the International Bar Association, the Healthcare and Life Sciences Law Committee has organized a Session under the title “Plagues! From the Black Death to Ebola”. Faus & Moliner founding partner Jordi Faus has taken part with a presentation on vaccination, dealing with questions such as whether vaccination should be... Read More
La proyección individual del derecho a la salud
El Global
Esta semana he tenido la oportunidad de participar como ponente en el IX Foro de Sanidad organizado por el Centro de Estudios de Políticas Públicas y Gobierno de la Universidad de Alcalá, que dirige Carmen Mateo. El Foro, celebrado en las instalaciones del Parlamento Vasco en Vitoria, se convocaba con un título que no podía... Read More
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