Faus Moliner participates in the European Rare Disease Summit 2023 organized by Fundación Bamberg
Jordi Faus takes part in the panel on Innovation and Access to Orphan Drugs
During his intervention Jordi Faus stated that access to orphan drugs is a key issue in the upcoming review of EU pharmaceutical legislation and that now is the perfect time to exchange views and debate on this issue. Jordi Faus also explained how the jurisprudence of the courts, both national and European, is changing the... Read More
Afinando la frontera entre medicamentos y productos sanitarios
El Global
En septiembre de 2022 la Comisión publicó una nueva versión de su Manual para la clasificación de productos sanitarios y la distinción de otros productos frontera, adaptada a los Reglamentos 2017/745 y 2017/746 de productos sanitarios. El Manual da muestra de la necesidad de que los operadores cuenten con herramientas para delimitar la clasificación de... Read More
Confidencialidad del PVL de los medicamentos. Mayor acceso y más sostenible
Cuadernos de Derecho Farmacéutico, Monographic Edition: Propuestas para Innovar en el Acceso a los Medicamentos en el Sistema Nacional de Salud
In this article, Carles Bailach points out that maintaining the confidentiality of the price of medicines encourages Spain’s access to new treatments under better economic conditions, which contributes to maintaining the financial sustainability of the SNS. In addition, he presents his proposals to innovate in access to medicines.
Acceso a medicamentos no financiados
Cuadernos de Derecho Farmacéutico, Monographic Edition: Propuestas para Innovar en el Acceso a los Medicamentos en el Sistema Nacional de Salud
Lluís Alcover reflects on the conditions of access to non-financed medicinal products. He makes a brief analysis of the current situation and suggests two proposals to improve the access to non-financed medicinal products in Spain.
Más acceso y más sostenible
El GLobal
Sostenibilidad del Sistema Nacional de Salud (SNS) y acceso a medicamentos innovadores son dos caras de la misma moneda que, sin duda, serán el gran reto de las administraciones y la industria en los próximos años. Esta es una de las ideas que planteé en el marco de la jornada que organizó la Fundación CEFI,... Read More
The procedure to be followed when there is reasonable suspicion of collusive behaviour in public tenders
The Law on Public procurement amended by the General State Budget Law for 2023
Capsulas Nº 234
Introduction and background The General State Budget Law for 2023 includes a final provision that introduces a series of amendments to the Spanish Law on Public Procurement (LCSP, according to its Spanish acronym). One particular amendment stands out: for the first time, the law regulates the procedure to be followed in the event that the... Read More
New regulation for home delivery of medicines and other changes to the Madrid Pharmacy Law
On the approval of the new Law 13/2022, of 21 December, on Pharmaceutical Management and Care in the Community of Madrid
Capsulas Nº 234
Last Thursday, 22 December 2022, the new Madrid Pharmacy Law was published in the Official Gazette of the Community of Madrid, repealing the previous Law 19/1998, the main features of which are summarised below. Home delivery of medicinal products The regulation of home delivery was one of the novelties that has sparked the most debate... Read More
The starting date for the calculation of time-limits is the date of filing to the common electronic register, unless there is a specific electronic form or procedure
Judgment of the Chamber for Contentious-Administrative Proceedings of the Supreme Court (4th Section) of 25 October 2022
Capsulas Nº 234
Filing applications to the common electronic register The common electronic register (or general electronic register -art.16 of the Law no. 19/2015-, commonly known as RedSara) is a common point for submitting applications, documents and communications. It is a general register used for those applications that do not have an electronic procedure or a standardised form... Read More
Guidelines to facilitate the conduct of decentralised clinical trials of medicinal products in the European Union
European Commission, EMA and HMA recommendations on decentralised elements in clinical trials of 13 December 2022
Capsulas Nº 234
Decentralised clinical trials are those that are conducted largely outside the physical facilities of a healthcare centre, taking advantage of the use of technology. The increasing use of digital tools, and in particular the Covid-19 pandemic, has led to certain elements of clinical trials being conducted in a decentralised manner (e.g. informed consent management, investigational... Read More
A favor de un Real Decreto-ley
El Global
La normativa en materia de medicamentos está actualmente en proceso de evaluación y revisión tanto en Europa como en España. El proceso es complejo y requiere un debate sosegado entre todos los stakeholders del sector. Para ello se necesita tiempo; pero, ¿tenemos tiempo? Sin restar importancia ni urgencia a cualquiera de las propuestas que actualmente se están valorando; la realidad es... Read More