Diez años de transparencia en España; ¿qué retos nos deparan los próximos años?
COMUNICACIONES EN PROPIEDAD INDUSTRIAL Y DERECHO DE LA COMPETENCIA, NÚM. 100 SEPTEMBER-DECEMBER 2023
This article addresses the implications for the pharmaceutical sector of the application in Spain of Law 19/2013, of 9 December 2013, on transparency, access to public information and good governance, 10 years after its entry into force. In addition, the implications of the entry into force of the Tromsø Convention are analyzed. Finally, the challenges... Read More
Poniendo a prueba el principio de tipicidad
El Global
Recientemente se ha publicado una sentencia del Tribunal Supremo, de fecha 11 de diciembre de 2023, que, cuanto menos, podríamos calificar de controvertida. En ella se confirma la sanción impuesta a una oficina de farmacia por vender medicamentos directamente a las clínicas sin las preceptivas autorizaciones. Controvertida por “estirar” el principio de tipicidad hasta límites... Read More
La unión hace la fuerza
El Global
Como se desprende de su nombre la Unión Temporal de Empresas (UTE) es una fórmula de colaboración transitoria entre empresas para un fin concreto. Si bien una UTE puede formarse con varios objetivos, el principal motivo de ser de esta figura es facilitar e incentivar el acceso a contratos públicos a empresas que, por sí... Read More
More requirements for conducting prospective observational studies with medicinal products at regional level
Autonomous Communities' regulations establishing additional requirements for conducting prospective observational studies in their territories
Capsulas Nº 248
On 2 January 2021, Royal Decree 957/2020 regulating observational studies with medicinal products for human use (EOMs) came into force. This regulation meant the simplification of the requirements, as well as a reduction of bureaucratic burdens, for conducting EOMs in Spain. EOMs provide essential data on the conditions of use, safety and effectiveness of medicinal... Read More
Ten contributions to an efficient framework for regulating the use of artificial intelligence in the medicinal product lifecycle
Contributions by Faus Moliner to the EMA’s Reflection Paper on the use of AI in the lifecycle of medicines
Capsulas Nº 247
The European Medicines Agency (EMA) opened for public consultation a “reflection paper” on the use of artificial intelligence (AI) in the development and regulation of human and veterinary medicines. Our feedback is as follows: General considerations: transparency When it comes to AI and machine learning (ML), it is essential to ensure transparency and intelligibility of... Read More
El renacimiento del mecenazgo
El Global
Con gran suspense hasta el último momento, como si de una película de Hitchcock se tratara, finalmente el pasado miércoles se convalidó el Real Decreto-ley 6/2023, también conocido como “decreto ómnibus”. De hecho, la convalidación ha tenido lugar por un voto de diferencia, 172 a favor y 171 en contra. Así se aprueba (afortunadamente) la... Read More
Updates in the Patronage Law and the eternal question: are we dealing with a donation, sponsorship or collaboration?
Royal Decree-Law 6/2023 of 19 December which amends the Tax Scheme for Non-profit Organisations and Tax Incentives for Patronage Law 49/2002
Capsulas Nº 246
Introduction Pharmaceutical sector’s collaboration is crucial for advancing and promoting clinical research, as well as other activities contributing to the benefit of the health sector and patients. This includes aspects like training, education, and the provision of healthcare services. Typically, healthcare (such as hospitals, foundations, universities and other academic bodies and scientific societies) and patient... Read More
Acuerdo político en el reglamento de IA: un mapa de navegación
El Global
36 horas. Ese es el tiempo que estuvieron reunidos, a lo largo de tres intensos días, los representantes de las instituciones de la Unión Europea (UE) antes de conseguir alcanzar un acuerdo político sobre el futuro reglamento de Inteligencia Artificial (IA). Si bien se trata de una norma horizontal y no sectorial, algunos de los... Read More
The proposed revision of the European pharmaceutical legislation in detail (I): changes to the regulatory protection periods, goodbye to the one-size-fits-all model?
About regulatory protection in the revision of the pharmaceutical legislation of the EU
Capsulas Nº 245
1. Introduction One of the objectives of pharmaceutical regulations is to manage the coexistence of innovative medicines and generics or biosimilars. Regulatory protection, including data and market protection periods, plays a key role in maintaining this balance. Despite having been in place for a long time, we are facing a new round in the debate... Read More
As patients, we have the right to obtain, free of charge, a copy of all our medical records
Judgment of the Court of Justice of the European Union of 26 October 2023, C‑307/22
Capsulas Nº 245
A German citizen asked his dentist for a copy of his medical records free of charge. He was dissatisfied with the treatment he had received and was considering lodging a complaint. There was no agreement as to whether the patient was entitled to be provided with a copy of his medical records free of charge.... Read More