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
The public audience and information period for the draft of Royal Decree on the funding and pricing of medical devices is open
Draft of Royal Decree regulating the public funding of medical devices for non-hospitalized patients and setting the commercialization margins
Capsulas Nº 193
Introduction The future Royal Decree comes to implement the provisions on these matters contained in the Consolidated Text of the Law on Guarantees and Rational Use of Medicinal Products and Medical Devices and, therefore, it will regulate the procedure for the inclusion, review and exclusion of medical devices from the pharmaceutical provision of the National... Read More
For the first time, a holder of a reference medicinal product is allowed to challenge a generic approval in Court in Spain
The Judgement of the Contentious-Administrative Central Court No. I, of July 2, 2018 recognizes locus standi to defend the data exclusivity of the registration dossier
Capsulas Nº 192
Background Can holders of reference medicinal products appeal against the approval of generics? Can such holders ask the Spanish Medicines Agency (AEMPS) or a Court in Spain to review the grant of a marketing authorization if they consider that there has been any violation of any regulation? This has been one of the most troublesome... Read More
The e-Administration: an unfinished business
Draft of Royal Decree implementing Law 39/2015 and Law 40/2015 regarding performance and functioning of the public sector by electronic means
Capsulas Nº 192
Introduction Law 39/2015, on the common administrative procedure of public administrations and Law 40/2015, on the legal regime of the public sector were aimed to transform the public administration into a digital one. Both laws implied an unprecedented change in the relationships with and between public Administrations. Law 39/2015 states that companies having to interact... Read More
La publicidad de los medicamentos o la eterna asignatura pendiente
El Global
La intervención de las nuevas responsables de Sanidad y de Hacienda en las comisiones correspondientes del Congreso, hace escasas fechas, ha abordado buena parte de los asuntos candentes en los que esperábamos conocer la postura del nuevo Gobierno. A las políticas de recuperación de la sanidad universal y de eliminación de copagos, ya conocidas, se... Read More