Incentivos, innovación y seguridad jurídica
El Global
La semana pasada empezó fuerte. El lunes, la Fundación CEFI organizó, con su habitual maestría, un seminario sobre los incentivos a la innovación en salud como ventaja competitiva de la UE. En la primera mesa, moderada por Silvia Martínez (BMS), se trataron cuestiones relacionadas con el marco actual y la importancia de los incentivos (Irene... Read More
Más certidumbre en la compra pública
El Global
Es frecuente leer o escuchar que la normativa de contratación pública es un corsé que no se ajusta como debería a la compra de medicamentos y productos sanitarios. Dicho desorden o desajuste va siendo moldeado mediante las interpretaciones razonadas y razonables que sobre la Ley de Contratos del Sector Público (LCSP) hacen los tribunales administrativos... Read More
Faus Moliner participa en «International Comparative Legal Guide to Product Liability 2024»
INTERNATIONAL COMPARATIVE LEGAL GUIDE
The 2024 edition of the magazine International Comparative Legal Guide to Product Liability is now available. The Guide offers a practical insight into product liability issues across the world, and includes general articles on novelties in the field of product liability and country specific Q&A chapters. Xavier Moliner and Juan Martínez were in charge of... Read More
Ensayos Fast Track
El Global
España es líder europeo en ensayos clínicos. Según los últimos datos publicados, de los 2.491 ensayos clínicos autorizados en la Unión Europea desde que está operativo el nuevo Sistema Europeo de Información (CTIS), los centros españoles participaron en 1.136 ensayos, casi la mitad del total. Según el Registro Español de Estudios Clínicos (REEC), el 58%... Read More
Faus Moliner participates in the “10th Annual World Life Sciences Conference” organized by the International Bar Association
Faus Moliner, together with Uría Menéndez, acted as co-chair of the local host committee of the "10th Annual World Life Sciences Conference" held in Madrid on May 30-31, 2024
With the participation of more than 200 lawyers and speakers from all over the world, the conference addressed the different challenges that the life-science sector faces, as well as the latest developments in this area. The conference was also attended by Blaz Visnar (Deputy to the Head of the Pharma Unit of the Directorate General... Read More
A propósito de la World Life Sciences Conference de la International Bar Association
El Global
La semana pasada tuvo lugar, en Madrid, la 10ª Annual World Life Sciences Conference de la International Bar Association. Beatriz Cocina (Uría) y yo actuamos como Local Host Committee Co-Chairs, y con la valiosa ayuda de Manuel Delgado (Lasker) logramos alojar este importante evento en el Círculo de Bellas Artes de Madrid, compitiendo con la... Read More
El medicamento en los tribunales en el año 2023
COMUNICACIONES EN PROPIEDAD INDUSTRIAL Y DERECHO DE LA COMPETENCIA, NÚM. 101 JANUARY-APRIL 2024
By means of this article we go through the most important decisions by Spanish andEuropean courts regarding medicinal products during the year 2023
How should the “benefit-risk” concept of a medicinal product be interpreted?
Judgment of the General Court of the European Union of 15 May 2024 (T-416/22)
Capsulas Nº 252
Background This judgment concerns an appeal against the European Commission’s Implementing Decision on marketing authorisations (“MAs”) for medicinal products containing the active substance hydroxyethyl starch (“HES”) indicated for the treatment of hypovolemia caused by sudden blood loss. All HES medicinal products had been authorised at national level by the Member States. In order to properly... Read More
Harmonisation of guidelines for the use of scientific data in advertising to healthcare professionals
New monograph of the Medicines Advertising Bulletin of Catalonia
Capsulas Nº 252
On 29 April 2024, the Medicines Advertising Bulletin of Catalonia issued a new notice outlining revised guidelines for using scientific publications and data into promotional materials for medicines. The document is based on Royal Decree 1416/1994 which regulates the advertising of medicinal products for human use, the Farmaindustria Code, the resolutions of the Jury of... Read More
Conformity with the SmPC is a “per se” rule in advertising of medicinal products
Decisions of the Jury of Advertising of Autocontrol of 29 February 2024 and 12 April 2024 in the Fasenra® case
Capsulas Nº 252
Background These decisions stem from a complaint by GSK against AstraZeneca for promotional materials related to the medicinal product Fasenra® that had been presented at several satellite symposia during national scientific congresses. AstraZeneca markets Fasenra® (benralizumab) which is indicated as an add-on maintenance treatment in adult patients with severe eosinophilic asthma (“AGE” by its Spanish... Read More