Equivalencia terapéutica
Presentation at the CEFI Seminar on Public Procurement of Medicines in Spain
CEFI, Centro de Estudios para el Fomento de la Investigación organized this one day seminar to deal with the most relevant aspects affecting public procurement of medicinal products in Spain. The event was opened by Maria Alonso Burgaz, General Counsel for Lilly Spain and President of Fundacion CEFI; and by Jose Julian Diaz Melguizo, Director... Read More
Brotes verdes … en los juzgados
EL GLOBAL
Si recuerdan, hace unas semanas les hablaba de los cambios que se están produciendo en relación con la revisión judicial de los actos administrativos, de cómo la cultura jurídica de nuestros jueces está evolucionando hacia posiciones más críticas y exigentes. Algunas sentencias recientes ilustran esta tendencia. Esta semana, por ejemplo, la Audiencia Nacional ha hecho... Read More
Un nuevo marco para la distribución
EL GLOBAL
El Ministerio de Sanidad viene desarrollando tras la vuelta de vacaciones una frenética actividad normativa. Y a las novedades en materia de farmacovigilancia y registro, se ha venido a sumar ahora el largamente esperado real decreto sobre la distribución de los medicamentos de uso humano. Este nuevo marco legal llega cargado de importantes novedades, tales... Read More
XX Congress of the Asociación Española de Derecho Sanitario
Jordi Faus gives a presentation about "off-label" use of medicines
The Spanish Association of Health Law celebrated its annual Congress in Madrid on 17 October 2013. Among the various working sessions, one was dedicated to the legal regime under which medicines may be used “off label” in Spain. In recent times, in Spain, various regions have adopted formal or informal measures leading to “off label”... Read More
Límites legales al uso “off label” de medicamentos en derecho español y derecho comunitario
Presentation at the XX Congress of the Asociación Española de Derecho Sanitario
The Spanish Association of Health Law celebrated its annual Congress in Madrid on 17 October 2013. Among the various working sessions, one was dedicated to the legal regime under which medicines may be used “off label” in Spain. In recent times, in Spain, various regions have adopted formal or informal measures leading to “off label”... Read More
Seamos serios, por favor
EL GLOBAL
En las últimas semanas venimos asistiendo estupefactos al penúltimo sainete protagonizado por nuestras autoridades en torno al siempre polémico copago farmacéutico. El Gobierno que ya había anunciado en su día su intención de aplicar el sistema copago a los medicamentos que se dispensan de forma ambulatoria en los hospitales públicos, llevó finalmente esta medida a... Read More
Confidentiality of documents in public procurement procedures: scope, limits and application
Report 11/2013, of 26 of July, of the Consultancy Board for Public Procurement of the Generalitat of Catalunya (Permanent Commission)
CAPSULAS 146
The Consultancy Board for Public Procurement of the Generalitat of Catalunya (JCCA) has issued a report on confidentiality of documents in public procurement procedures. In its report, the JCCA admits that confidentiality is present “in all the phases of public sector procurement”, therefore it must not only be taken into consideration in the phases of... Read More
The new rules for pharmacovigilance of medicinal products for human use are already applicable
Royal Decree 577/2013 regulating pharmacovigilance of medicinal products for human use (Official Journal No 179, of 27 July 2013)
CAPSULAS 146
Royal Decree 577/2013, which regulates the pharmacovigilance of medicinal products for human use, was published last July in the Official Journal. The objective of this regulation, which replaces Royal Decree 1344/2007, is to adapt the Spanish System of Pharmacovigilance to the new rules introduced by the European Union. With this new Royal Decree our country... Read More
Guidelines on the leniency program in Spain: consolidation and update on administrative practice
Communication of 19 June 2013, issued by the Spanish National Competition Commission on the leniency program
CAPSULAS 146
The leniency program entitles the Spanish National Competition Commission (SNCC) to grant exemptions or reductions of the fines payable in cases of competition law infringement. Any company or natural person can request leniency (meaning the fine exemption or reduction) by reporting, revealing and proving to the SNCC the existence of a cartel as well as... Read More
Adaptarse y servir a los intereses generales o…
EL GLOBAL
Últimamente he leído y oído en diversos foros aquello de que para progresar no es tan importante ser fuerte como ser capaz de adaptarse al cambio. Lo dijo Charles Darwin como parte de su teoría de la evolución, y lo hizo en términos aún más radicales: en la naturaleza, las especies que no se adaptan... Read More