El pacto
EL GLOBAL
Sin duda una de las noticias que ha acaparado la atención mediática en los últimos días ha sido el pacto por la sostenibilidad del Sistema Nacional de Salud, recientemente suscrito entre el Ministerio de Sanidad, Servicios Sociales e Igualdad y Farmaindustria. El acuerdo alcanzado ha levantado una expectación perfectamente legítima, pero para los que llevamos... Read More
Important fine to an investigator that promoted a clinical trial without administrative approval
The Judgment of the Superior Court of Justice of 19 December 2013 confirms a fine of 120.000 Euros imposed by the Autonomous Region of Madrid
CAPSULAS Nº 150
Background As a result of an anonymous complaint made before the Spanish Agency of Medicinal Products and Medical Devices (AEMPS in Spanish), an infringement procedure was initiated against a physician claiming that he had carried out a clinical trial, acting as sponsor and principal investigator, without obtaining prior approval, without having received a favorable ruling... Read More
A company bidding for the supply of consumable products may be obliged to offer measuring devices free of charge
Resolution No 88/2014, of 5 February 2014, of the Central Administrative Court of Public Procurement Appeals
CAPSULAS Nº 150
Background In a public tender procedure for the award of a supply agreement of test strips to measure parameters or indicators for the diagnosis, it is frequent that the winner be also obliged to supply, free of charge, measuring devices as well as any other equipment necessary for their use. This obligation was provided for... Read More
Biological medicinal products must be identified by their trademark in medical prescriptions
Royal Decree 81/2014, of 7 February, modifies Royal Decree 1718/2010, of 17 December, on medical prescription and dispensation orders
CAPSULAS Nº 150
Background Royal Decree 81/2014, of 7 of February, which establishes the rules to ensure cross-border healthcare assistance, and which modifies Royal Decree 1718/2010, of 17 of December, on medical prescription and dispensation orders came into force on 8 of February. The amendment of Royal Decree 1718/2010 is the result of incorporating Directive 2011/24/EU to our... Read More
Liability of the owner of a website for the comments published by users in its forums
Judgment of the Supreme Court, Civil Chamber, of 7 January 2014
CAPSULAS Nº 150
Background and legal framework The owner of a computer store called “Aiguamolls” brought a claim against Meristation Magazine, S.L. for the degrading expressions published in the forums of its website that were addressed to both Aiguamolls and its owner. The plaintiff considered to have suffered a violation to his right to honour and requested that... Read More
Continúa la inseguridad jurídica
EL GLOBAL
El pasado mes tuve el placer de participar en la mesa organizada por el periódico EG para debatir el futuro de las licitaciones de medicamentos emprendidas en Andalucía. La organización logró sentar a la mesa a una notable representación del sector, y se esperaba asimismo la participación de un alto representante del SAS que, finalmente,... Read More
El uso ‘off label’ necesita autorización
EL GLOBAL
Esta semana las bases de datos jurídicas de los abogados han publicado una sentencia del Tribunal Superior de Justicia de Madrid de 19 de diciembre de 2013 en el relación a la sanción que impuso la Comunidad de Madrid a Vicente Soriano por infringir la Ley 29/2006. La sentencia expone que a raíz de una... Read More
Administración de medicamentos en dosis o pautas de administración diferentes a las estipuladas en su ficha técnica
Cuadernos de Derecho Farmacéutico, issue 48, January-March 2014
The prescription, manipulation or administration of medicinal products in doses or administration forms different than the ones stipulated in the SMPC is a practice which is increasing nowadays in several Spanish hospitals. However, said practice, to be legal, has to meet the following requirements: (i) it has to be exceptional, (ii) it requires a specific and justified... Read More
El calado de las normas y la trascendencia de la imagen
EL GLOBAL
Hace dos semanas les hablaba de la imagen de la administración y de algunos gestos que me suscitaban algunas dudas. Poco después de escribir esa columna completé un trabajo que me pidió una editorial de Londres explicando las novedades más significativas que se habían producido en España, en el ámbito del derecho farmacéutico, en el... Read More
The new Code of Practice for the Pharmaceutical Industry 2014 comes into force
Farmaindustria publishes the new ethical rules on interaction of the industry with healthcare professionals and patient organisations
CAPSULAS Nº 149
The new Code of Practice for the Pharmaceutical Industry came into force on the 1st of January 2014. This Code updates and consolidates in a single text the previous code of interaction with healthcare professionals (October 2010), the code of interaction with patient organisations (January of 2012), their implementation guides, as well as the Rules... Read More