La transparencia en los resultados de los ensayos clínicos
El Global
Hace pocos días la prestigiosa revista British Medical Journal (BMJ) hacía públicos los resultados de un estudio sobre el grado de cumplimiento de la obligación de publicar los resultados de los ensayos clínicos en el Registro Europeo de Ensayos Clínicos. La normativa europea sobre ensayos clínicos (Reglamento 536/2014) establece que el promotor de un ensayo realizado en... Read More
Nuevos espaldarazos a la transparencia en las decisiones de las autoridades sanitarias
El Global
La industria farmacéutica ha asistido en los últimos años a un cambio de paradigma en lo que se refiere a la transparencia y acceso a las decisiones de las autoridades sanitarias que afectan a los intereses públicos. El pasado mes de marzo, sin ir más lejos, nos hacíamos eco en la newsletter que edita mensualmente... Read More
No olviden registrarse
El Global
La Ley 9/2017, de 8 de noviembre, de Contratos del Sector Público (LCSP), estableció en su artículo 159.4.a) la obligación de que todos los licitadores que se presenten a licitaciones realizadas a través del procedimiento simplificado deben estar inscritos en el Registro Oficial de Licitadores y Empresas Clasificadas del Sector Público (ROLECSP) o en el... Read More
Substitution and selection of medicinal products in hospital pharmacies
The Spanish Medicines Agency modifies its website in connection with “non-substitutable medicinal products” stating that Order of 28 September 2008 does not apply to hospital pharmacies
Capsulas Nº 194
The Agency’s criteria Recently, the Spanish Medicines Agency (AEMPS) has updated its website including two surprising statements on its website in connection with the “non-substitutable medicinal products”. The first statement says that the Order of 28 September 2008, establishing medicinal products that cannot be substituted by the pharmacist “is applicable to the dispensing of medicinal... Read More
Transparency news regarding prices of medicinal products and marketing authorization applications
Resolutions 193, 194, 239, 257 and 266 of 2018 by the Council of Transparency and Good Governance
Capsulas Nº 194
Introduction This last summer the Council of Transparency and Good Governance (CTBG), an independent public body promoting transparency of public activities and ensuring compliance of the regulations on transparency and good governance, has settled various complaints bringing important updates in terms of access to public information concerning the prices of medicinal products and the applications... Read More
It is legitimate to limit the maximum authorized ex-factory price to the units of product dispensed in Spain and publicly funded
Decision of the Spanish Competition Authority of 30 August 2018, Case S/DC/0608/17, EAEPC vs laboratorios farmacéuticos
Capsulas Nº 194
Background On 30 August, the Spanish Competition Authority (CNMC) closed, hopefully for good, a procedure started more than 10 years ago against several companies that put into practice systems to ensure that the maximum ex-factory price authorized by the Ministry of Health would apply only to the units of product dispensed in Spain and publicly... Read More
Penalty clauses… Should they be applied literally, or can they be subject to moderation by a Judge?
Judgement of the Supreme Court, Civil Chamber, of 12 July 2018
Capsulas Nº 194
Penalty clauses In commercial agreements the parties usually include clauses to regulate the consequences of contractual breaches. When this kind of clauses foresee the payment of compensations and penalties by the breaching party, they are called “penalty clauses”. They have a twofold objective: to discourage the breach of the agreement and, in the event such... Read More
Sustitución y selección de medicamentos en los hospitales
El Global
Hace años, el entonces presidente de la SEFH José Luis Poveda hizo unas declaraciones señalando que las normas que regulan la sanidad pública española son demasiadas. En España, ciertamente, sobran muchos textos (circulares, instrucciones, guías, cartas…) que regulan cuestiones como si se tratase de normas, cuando su valor jurídico es más que dudoso. Esta semana,... Read More
Faus & Moliner participates at the Seminar on practical issues of competition Law in the pharmaceutical sector organized by CEFI
Jordi Faus makes a presentation about offers, discounts and other commercial practices in the retail and hospital market
The application of competition law to activities of the pharmaceutical sector raises specific challenges derived from special characteristics of this market. In this Seminar organized by CEFI, Jordi Faus has discussed about the impact of this regulation with regard to offers, discounts and other commercial practices in the retail and hospital market. In the retail... Read More
Medicinal product regulation and product liability in Spain: overview
Faus & Moliner collaborates with Practical Law in the Spanish Q&A section of the Life Sciences Global Guide
Practical Law - Thomson Reuters
Jordi Faus, Xavier Moliner, Francisco Aránega, Eduard Rodellar, Juan Suárez and Verónica Carías write the Q&A guide to medicinal product regulation and product liability law in Spain for the 2018/19 edition. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall... Read More