The “new” Law on guarantees and rational use of medicinal products and medical devices
The Ministry presents a Draft Royal Legislative Decree which should be approved by the Government before the 25 of July
CAPSULAS Nº 159
Background In accordance with Article 82 of the Spanish Constitution, a Royal Legislative Decree is a rule that the Government can approve in order to consolidate into a single text certain rules, which have already been approved. Furthermore, the Government can take this opportunity to regulate, clarify and harmonise the rules that are to be consolidated; provided that this power has... Read More
Faus & Moliner participates at the Seminar on Risk Sharing Agreements organized by CEFI
Jordi Faus delivered a presentation on legal aspects of risk-sharing agreements
Since 2012, Spanish Law 29/2006 has included, as a criteria to consider when taking decissions on pricing and reimbursement of medicines, the so-called “return mechanisms” such as discounts or price reviews. On the other hand, it has been common, in recent times, to include mechanisms to reduce the uncertainty about the impact that the admission... Read More
Desafíos en terapias biológicas
El GLOBAL
Esta semana he tenido la ocasión de participar en una mesa redonda sobre terapias biológicas en el Congreso Nacional de Hospitales y Gestión Sanitaria celebrado en Alicante. La organización tuvo la gentileza de invitarme a participar junto con profesionales de reconocido prestigio en el ámbito de la farmacología, la clínica, y la gestión sanitaria. Cuando... Read More
Faus & Moliner participates at the 19th National Hospitals and Health Management Congress
Jordi Faus participates at a round table with a presentation on legal challenges of biological therapies
In recent times, the development of biological and biosimilar drugs has resulted in new legal challenges. Once the issues on the assessment and approval of these drugs were tackled at European level, rules at national level have had to deal with matters related to prescription, substitution and pharmacovigilance of these products. The relevance of these... Read More
¿Vamos a ir en contra de la OMS?
El GLOBAL
Disculpen que vuelva a comentar por tercera semana consecutiva en esta columna de opinión el proyecto de Real Decreto Legislativo mediante el cual el Ministerio de Sanidad pretende regularizar, aclarar y armonizar la Ley 29/2006; pero les aseguro que es realmente importante. En el artículo de la semana pasada les explicaba que en el proyecto... Read More
Contradicciones normativas
El GLOBAL
Estos días he seguido leyendo el proyecto de Real Decreto Legislativo mediante el cual el Ministerio de Sanidad pretende regularizar, aclarar y armonizar la Ley 29/2006. Los artículos de la Ley que regulan la financiación pública de medicamentos y sus precios son los más afectados. No es sorprendente que sea así, porque en los últimos... Read More
Incompatibilidades y seguridad jurídica
El GLOBAL
El Ministerio de Sanidad acaba de publicar su proyecto de Real Decreto Legislativo para aprobar el texto refundido de la Ley29/2006. Un Real Decreto Legislativo no es un Real Decreto-ley. De acuerdo con el artículo 82 de la Constitución, el Real Decreto Legislativo es una norma que puede aprobar el Gobierno para consolidar en un... Read More
Legislar es un reto, hacerlo bien es difícil
El GLOBAL
Llevo días pensando en la columna que escribió el director de El Global, Antonio Nieto, hace unas semanas en su columna semanal ‘El hashtag’ sobre el entorno legislativo de la sanidad (ver EG núm.685).Estoy de acuerdo con él que a veces la acumulación de normas hace que su cumplimiento sea farragoso y complicado. También estoy... Read More
In a commodatum agreement (loan for use), the return of the equipment can be requested at any time, as long as an express duration or a specific use have not been agreed on
Judgment of the Supreme Court of 3 of December of 2014
CAPSULAS Nº 158
Commodatum in healthcare environment In the judgment that we analyze the Supreme Court reminds us that the commodatum agreement is the one by virtue of which a party freely assigns an item to the other party, in order for such party to use it, during a certain time or for a specific use. Such relation... Read More
The practical implementation of the principle of equality in the field of pharmaceutical coverage
Judgment of the Superior Court of Justice of the Basque Country (Bilbao) of 2 of December of 2014
CAPSULAS Nº 158
Background The case that we refer to was originated when a patient suffering from a severe dry eye syndrome associated to Lyell’s Disease appealed against the resolution that denied her the visa and the financing of certain eye drops that are generally excluded from the pharmaceutical coverage because the Directorate General considers that this is... Read More