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
Form and substance, recommendations, and price fixing
Judgement of the Court of Justice of 29 June 2023 in case C-211/22 Super Bock
Capsulas Nº 245
Background Super Bock, a Portuguese beer manufacturer, provided a list of the minimum resale prices to its distributors, either orally or by email. This list was generally followed by the distributors, and compliance with it was monitored and incentivised with discounts. The Portuguese Competition Authority found this conduct to be a restriction of competition by... Read More
La investigación clínica en Atención Primaria
El Global
La Atención Primaria (AP) en España es un pilar fundamental en nuestro sistema sanitario. La labor que desempeñan las y los profesionales sanitarios en este ámbito es encomiable. Como muestra, el papel que han jugado en la reciente pandemia. No es mi intención aquí entrar en el debate sobre las cuestiones que seguro necesitan mejorarse en la... Read More
Cuenta atrás para disponer de un canal de denuncias
El Global
Los canales internos de denuncias, también conocidos como “sistemas internos de información” o “whistleblowing channels”, tienen un papel cada vez más relevante, especialmente en el compliance penal. Ya desde 2010 nuestro Código Penal (art. 31 bis) prevé que las compañías puedan quedar exentas de responsabilidad, a al menos atenuarla, por determinados delitos cometidos por sus... Read More