Is it possible to challenge no reimbursement decisions?
Judgment of the High Court of Justice of Madrid of 11 February 2022, and Judgment of the Supreme Court of 17 February 2022
Capsulas Nº 225
Background The Directorate-General of Pharmacy (DGP) is the competent body to rule on the reimbursement of medicinal products. Reimbursement decisions must be based on the “general, objective and published” criteria listed in article 92 of Royal Legislative Decree 1/2015. Among such criteria, the incremental clinical benefit of the new product, cost-effectiveness factors, and the existence... Read More
Liability for damages in corporate groups
The Supreme Court (Judgment of 24 January 2022) confirms its case law as regards which company is liable for damages caused by defective products
Capsulas Nº 225
Background In today’s globalised world, it is increasingly common to see claims for damages allegedly caused by defective products being filed with little precision. In many cases, the corporate group to which the manufacturing company belongs is sued as a diffuse entity. In other cases, a specific company of the group is sued, despite not... Read More
Algo se mueve
El Global
El proceso de compra pública de medicamentos, por la singularidad de estos productos, ha tenido un difícil encaje con las normas de contratación pública que han sido promulgadas en las últimas décadas. Reforma tras reforma, en las conferencias que se organizaron para explicar las sucesivas novedades legislativas, siempre escuché reputadas voces que reclamaban la necesidad... Read More
Share your colors, share your story
El Global
El 28 de febrero fue el Día Mundial de las enfermedades raras. Bajo el lema “share your colors, share your story” se organizaron numerosos eventos alrededor del mundo con un objetivo claro: generar awareness e impulsar cambios para las personas que viven con una enfermedad rara, así como su familiares y cuidadores. Al respecto, me gustaría compartir... Read More
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