La gran cita del derecho farmacéutico
El Global
La última semana de mayo fue la elegida para celebrar una de las grandes citas de los que nos dedicamos al derecho farmacéutico. Me refiero al XVI Curso de Derecho Farmacéutico que tuvo lugar en Madrid los días 28 y 29 de mayo organizado por la Fundación CEFI. La calidad de los ponentes y la... Read More
Evolución de los canales de denuncias de compliance
El Global
La evolución normativa habida en los últimos años en el entorno del compliance se ha traducido en que cada vez esté más extendido el convencimiento entre nuestras compañías de la necesidad de contar con un sistema de compliance adecuado. Aun así, parece que esa evolución no se detiene y en la actualidad se está tramitando... Read More
International Comparative Legal Guide to Product Liability 2019: Chapter 25 – Spain
A practical cross-border insight into product liability work
INTERNATIONAL COMPARATIVE LEGAL GUIDE
Recently the 2019 issue of The International Comparative Legal Guide to Product Liability was published. This Guide offers a practical insight into product liability issues across the world, and includes both general articles on novelties in the field of product liability and country specific Q&A chapters. This year Xavier Moliner has been once more in... Read More
Jordi Faus participates at the XVI Course on Pharmaceutical Law organized by CEFI
Jordi Faus makes a presentation on the regulatory uncertainties between marketing authorization and reimbursement decisions
In the last years, the Course on Pharmaceutical Law organized by Fundación CEFI has become a reference forum for the legal analysis of issues that affect the life of a medicinal product. At the first session held on 28 May, Faus & Moliner participated with a presentation by Jordi Faus. Jordi Faus participated at the... Read More
The Ministry of Health seeks to ban hospitals from buying medicinal products that have received an express resolution of no reimbursement
The General Directorate publishes a “Report” about the rules applicable to medicinal products that have been expressly denied reimbursement
Capsulas Nº 201
Background One of the hot topics in Spanish pharmaceutical law is knowing how to act from the moment when a product is authorized by the EU until a resolution of its inclusion (or not inclusion) in the pharmaceutical provision is adopted. Spanish law provides that before marketing a medicinal product in Spain it is compulsory... Read More
Keys of the Stability Programme submitted by the Spanish Government to the European Commission and the EU Council of Ministers
The Stability Programme 2019-2022 submitted by the Spanish Government includes some of the measures recommended by the Spanish Independent Fiscal Responsibility Authority (AiReF)
Capsulas Nº 201
At the end of April, the Spanish Government made public the Stability Programme which, jointly with the National Reform Program, was submitted to the EU. Both the Stability Programme and the National Reform Program contain a set of proposals made by the AiReF (a Spanish body that, since 2017, has carried out a detailed evaluation... Read More
El informe de los “expresamente no incluidos”
El Global
Una de las cuestiones candentes en el derecho farmacéutico en España es cómo actuar desde que un producto es autorizado por la UE (y que por tanto ya podría comercializarse) hasta que se decide sobre su inclusión o no en la prestación farmacéutica pública. La Ley dice que para la comercialización de un medicamento en... Read More
When deciding about medicines, the impartiality of the institutions of the EU is out of discussion
Judgement of the Court of Justice of the European Union (CJEU) of 27 March 2019, Dr. August Wolf v the European Commission, Case C-680/16 P
Capsulas Nº 201
Principle of impartiality According to the Charter of Fundamental Rights of the EU, every person has the right to have his or her own affairs handled impartially by the institutions and bodies of the EU. This implies that members of the institutions of the EU shall not show bias or personal prejudice (subjective impartiality); and... Read More
No tenemos remedio
El Global
Apenas ha transcurrido poco mas de un año desde la entrada en vigor de la nueva Ley de Contratos del Sector Público (LCSP) que apostaba por impulsar la calidad en la contratación pública y volvemos a las andadas. Me refiero al anuncio sobre las recomendaciones de la AIReF en gasto farmacéutico no hospitalario, de las... Read More
Sobre Valtermed
El Global
El 16 de enero, en respuesta a un tuit de la SEFH, Patricia Lacruz hizo público, también en Twitter, que el Ministerio y las CCAA habían empezado a trabajar en Valtermed, un sistema de información “para medir el valor terapéutico en la práctica clínica real de los medicamentos de alto impacto sanitario”. Ya se sabe... Read More