Procurement of COVID-19 medicinal products outside public procurement rules
Royal Decree-Law 3/2022, of 1 March, published in the Official State Gazette of 2 March 2022
Capsulas Especial
Background On 2 March 2022, Royal Decree-Law 3/2022 on measures to enhance sustainability in road freight transport and on the functioning of the logistics chain was published in the Official Journal. This legal instrument includes an interesting Additional Provision on medicinal products against COVID-19. According to this Additional Provision, certain medicinal products may be supplied... Read More
Faus & Moliner participates in the “Chambers Global Practices Guides – Pharmaceutical Advertising 2022″
Jordi Faus, Laura Márques y Verónica Carías write the chapter about Law and Practice in Spain
CHAMBERS GLOBAL PRACTICES GUIDE
The ‘Law & Practice’ section provides easily accessible information on navigating the legal system when conducting business in the jurisdiction. Leading lawyers explain local law and practice at key transactional stages and for crucial aspects of doing business. The “Trends and Developments” section analizes the latest trends and developments in connection with pharmaceutical advertising in... Read More
Investigación “Made in Spain”
El Global
Hace pocos días el Consejo de Ministros ha aprobado el anteproyecto de ley por el que se modifica la Ley 14/2011, de la Ciencia, la Tecnología y la Innovación. De una primera lectura de esta propuesta, que ahora iniciará su tramitación parlamentaria como proyecto de ley, extraigo algunas reflexiones que creo oportuno destacar. En primer... Read More
Fabricación y suministro de proximidad
El Global
La Comisión Europea acaba de publicar su Informe sobre las respuestas recibidas en la fase de consulta sobre la revisión de la legislación farmacéutica europea. Se recibieron casi 500 contribuciones, y los temas que se han identificado como críticos son diversos, destacando la simplificación del sistema regulatorio, el acceso a los medicamentos, el papel de... Read More
Are orphan drugs subject to reference pricing?
Judgment of the Supreme Court of 3 February 2022
Capsulas Nº 224
Background On 3 March 2020, a Resolution of the Council of Ministers excluded orphan medicinal products from the reference price system under two conditions: that no “therapeutic alternative” exists or, otherwise, that the relevant orphan medicinal product provides a “significant clinical benefit”. According to this Resolution, the Permanent Pharmacy Commission (PPC) is the body in... Read More
When does an enforceable agreement exist?
Judgment of the Supreme Court of 23 December 2021
Capsulas Nº 224
In the pharmaceutical sector, it is common for companies to agree and sign preliminary docu ments containing all or some of the provisions of future contracts (e.g., term-sheets, letters of intent, memoranda of understanding, etc.) prior to executing the final agreements (e.g., licensing and supply, manufacturing, co-development, co-marketing or co-promotion agreements, etc.). Given that there is... Read More
Construction of the principle of mutual recognition in the marketing of food supplements
Judgment of the National High Court of 22 November 2021
Capsulas Nº 224
Background This judgement was published on 26 January. It resolves an appeal lodged against a decision of the Spanish Medicines Agency (AEMPS) that declared, in June 2019, that a product being marketed as a food supplement in Spain should be classified as a medicinal product. The appellant relied on the principle of mutual recognition. The... Read More
Jordi Faus appointed Secretary of the International Bar Association (IBA)’s Healthcare & Science Committee
Our founding partner, Jordi Faus, has been appointed Secretary of the International Bar Association (IBA)’s Healthcare & Life Sciences Law Committee
The Healthcare and Life Sciences Law Committee is a fast-growing committee with a dynamic and diverse membership across the world, which provides a forum of discussion among health and life Science lawyers. It aims to provide regular updates of important changes in all aspects of healthcare law, pharmaceutical, biotech and medical devices regulatory law, intellectual... Read More
Lecciones del Covid
El Global
“For me, it is crystal clear – we need to build a stronger European Health Union”. Este fue el mensaje de Ursula von der Leyen, Presidenta de la Comisión, en su discurso sobre el Estado de la Unión de 2020. Es necesario extraer lecciones de la actual crisis y construir una Unión Europea de la... Read More
Huérfanos protegidos
El Global
La sentencia de la Audiencia Nacional de 2 de diciembre es conocida. Incluir los medicamentos huérfanos en los conjuntos de referencia impide que estos productos se beneficien de los incentivos previstos en el Reglamento (UE) 141/2000 para fomentar su investigación, desarrollo y comercialización. Por tanto, la normal legal española que podría obligar a incluirlos en... Read More