Ensayos clínicos en la UE: better together
El Global
Este año 2022 que recién empezamos se inicia con muy importantes novedades en el ámbito de los ensayos clínicos con medicamentos. Como estaba previsto, este próximo 31 de enero entrarán en funcionamiento el portal del Sistema de Información de Ensayos Clínicos (“CTIS”, por sus siglas en inglés) y la base de datos de ensayos de... Read More
Orphan medicinal products should not be subject to reference pricing
Judgment of the National High Court of 2 December 2021
Capsulas Especial
Background This judgment, which is of utmost importance, was issued following an appeal lodged by Farmaindustria against the 2019 Reference Price Order. Farmaindustria argued that the price reduction resulting from the inclusion of orphan medicinal products in the reference price system prevents such products from benefiting from the incentives set out in Regulation 141/2000. Such... Read More
Novedades en relación con la transparencia del precio de los medicamentos
CUADERNOS DE DERECHO FARMACÉUTICO, NUM. 79, OCTOBER-DECEMBER 2021
The purpose of this article is to provide some analysis on the latest developments in the area of price transparency of medicines for human use. This article analyses a report issued by the Ministry of Health that defends maintaining a certain degree of confidentiality in the price of medicines, as well as the European Commission’s... Read More
Dispensing vs. delivery of medicines
Judgment of the Supreme Court of 2 November 2021
Capsulas Nº 222
Our CAPSULES of 23 June reported on the admission of a cassation appeal that granted the Supreme Court the opportunity to interpret the terms “dispensing” and “delivery” of medicines, which are hugely relevant to new business models and emerging platforms. The Judgment of 2 November 2021 resolves the appeal and offers interesting arguments as to... Read More
When is an administrative decision deemed notified?
Judgement of the Supreme Court of 10 November 2021
Capsulas Nº 222
Background This case is about whether the beneficiary of a subsidy must return the subsidy to the Administration that granted it or not. The Administration considered that the subsidy must be returned because the beneficiary had not complied with its terms. The matter was brought before the Spanish Audiencia Nacional which ruled that the beneficiary... Read More
Further clarity on the term of the statute of limitations for agency fees
Judgment of the Supreme Court of 23 November 2021
Capsulas Nº 222
Background In the case of agency contracts, the agent promotes commercial transactions on behalf of the principal in exchange for a commission. Unless a more beneficial contractual provision for the agent exists, the commission accrues upon execution of the commercial transaction promoted by the agent (art. 14 of Law 12/1992). Payment must be made before... Read More
Amendments to the Law of Unfair Competition: greater control of the online marketplace
Royal Decree-Law 24/2021 qualifies new practices in the area of imitations, searches and online reviews as unfair
Capsulas Nº 222
Background Royal Decree-Law 24/2021, of 2 November, transposed several European directives into Spanish law, with a particular impact on consumer and commercial practices. This regulation makes various amendments to our legislation, including to the Retail Trade Law and the General Consumer and User Protection Act. In this article, we highlight the amendments made to Law... Read More
Más medios para una mejor transparencia
El Global
El Consejo de Transparencia y Buen Gobierno (CTBG) publicó, el pasado 30 de noviembre, su Plan Estratégico 2022-2025 donde se detallan, entre otras, sus principales líneas, objetivos y ejes de actuación para los próximos 4 años. Entre los objetivos estratégicos fijados destacan los siguientes: por un lado, adecuar y mejorar los recursos económicos y la estructura del CTBG a sus competencias y funciones;... Read More
PSPs: luz al final del túnel
El Global
Los programas de soporte a pacientes (PSPs), entendidos de manera amplia como cualquier programa que persigue atender necesidades de los pacientes y dotarles de herramientas que les permitan entender mejor su patología y/o su tratamiento así como mejorar sus resultados en salud, son una práctica cada vez más extendida en España. El cambio de paradigma... Read More
The European Council approves the final version of the Regulation on Health Technology Assessment
European assessment processes will be created to support budgetary decision-marking in healthcare
Capsulas Nº 221
Background and scope On 9 November, the European Council gave its final go-ahead to the proposal for a Regulation on Health Technology Assessment (HTA), which the European Commission presented in January 2018 and was particularly promoted during the Portuguese Presidency in the first semester of 2021. The Regulation still needs to be adopted by the... Read More