Lessons from the regularisation procedure for homeopathic medicines
Judgments of the National High Court of 12 April, 16 May and 12 July 2024
Capsulas Nº 257
Background The three judgments were handed down in the context of proceedings brought by a pharmaceutical company against the refusal of the Spanish Agency for Medicines and Medical Devices (“AEMPS”) to grant marketing authorisations for homeopathic medicinal products. The requirement for marketing authorisation for homeopathic medicinal products was introduced by Royal Decree 2208/1994. However, this... Read More
Transfers of personal data to the US in research studies conducted in Spain
Frequently Asked Questions on the EU-US Data Privacy Framework document issued by the European Data Protection Board on 16 July 2024
Capsulas Nº 257
Background Clinical trials and other studies conducted in Spain are often sponsored by US entities. For this reason, patients’ health data and, in many cases, their biological samples collected in Spain are sent to the US. These health data and biological samples are personal data and their transfer to the US constitutes an international transfer... Read More
EU Ecolabel only if products comply with EU requirements
Judgment of the Court of 4 October 2024, Herbaria Kräuterparadies, C-240/23
Capsulas Nº 257
On 4 October 2024, the Court of Justice of the European Union (CJEU) issued an interesting ruling in the area of food supplements. This ruling clarifies the requirements of labelling of organic products in the European Union (EU). Background The main case concerned “Blutquick”, a food supplement marketed by a German company with the EU... Read More
Declaración de Helsinki
El Global
Hace sesenta años, en 1964, la Asociación Médica Mundial adoptó la primera versión de la “Declaración de Helsinki”. Fue el primer conjunto de principios éticos internacionales que orientan la investigación médica en seres humanos. Estas reglas éticas han influido enormemente en la formulación de normas y prácticas internacionales y nacionales en este ámbito: en las... Read More
Mirando al horizonte
El Global
Decía Woody Allen: “me interesa el futuro porque es el sitio donde voy a pasar el resto de mi vida”. La irónica cita de este maestro del cine me sirve para referirme a la importancia de interesarnos por nuestro futuro hoy, pues nos dará la oportunidad de poder llegar a él mucho más preparados. Esta... Read More
What news may we expect in Spain’s pharmaceutical policy in the next few months?
Some notes on the intervention of the Secretary of State for Health in Congress on October 14
Capsulas Nº 256
Last Monday, Javier Padilla appeared before the Health Commission of Congress to report on the general lines of action of the Ministry of Health. Among other functions, the Secretary of State for Health is responsible for developing and executing the national pharmaceutical policy, updating the National Health System’s common portfolio of services. The comnpetence of... Read More
Misión y Visión
El Global
El año 1999 fue uno lleno de hechos relevantes. El primero, y más obvio, ese año fue el último del siglo XX y del milenio. Ese año, por ejemplo, empezó el primer juicio político a un presidente de los EEUU en más de 130 años, y se injertó piel artificial a un bebé por primera... Read More
La fórmula magistral: la cobertura legal del cannabis medicinal
El Global
La legalización del cannabis medicinal en España está más cerca que nunca. En los últimos años, varios países europeos han avanzado en la regulación del uso terapéutico de esta planta, respondiendo a una demanda social creciente. El cannabis y sus derivados, como aceites de CBD y cremas, han sido empleados de manera extendida con fines... Read More
Faus Moliner participates in the Fifth Edition of the Summer Course NewsRARE
The event, organized by the Weber Foundation and co-sponsored by Aelmhu, took place on 26 September 2024
Lluís Alcover has participated in the round table discussion on “How does the Royal Decree on Health Technology Assessment affect orphan drugs?”, together with Max Brosa, Market Access advisor, Beatriz Perales, President of AELMHU, Pedro Gómes, Health Economist, former Secretary General of the ONT, former Deputy Director General of Pharmacy, civil servant of the Ministry... Read More
Faus Moliner participates in the Third Congress of Pharmaceutical Law organized by the Section of Pharmaceutical Law of ICAM
The Congress was held on September 19 and 20, 2024
Joan Carles Bailach has participated in the panel discussion on Transparency and confidentiality in drug pricing, together with RobertoGarcía, President and CEO of Meiji Pharma Spain, Arturo Lucas, Legal & Compliance director at Laboratorios Servier, AlbertoDorrego, Partner of the Public Law Department at Eversheds-Sutherland, with the moderation of JuanPablo Aros, Member of the Pharmaceutical Law... Read More