El impacto de los canales digitales y redes sociales en la promoción de medicamentos. Panorama normativo y nuevas herramientas de Control
CUADERNOS DE DERECHO FARMACÉUTICO, NUM. 83, OCTOBER-DECEMBER 2022
Social media and digital channels have established themselves as a regular means of information dissemination for the industry. This scenario creates new challenges for companies’ compliance with the regime for promotion of medicinal products, such as the difficulty of controlling the final recipient of the information or the possibility for individual internet users to generate... Read More
Encaje de la Compra Pública de Valor
CUADERNOS DE DERECHO FARMACÉUTICO, NUM. 83, OCTOBER-DECEMBER 2022
The purpose of this article is to provide a practical overview of the legal tools offered by the regulations on public procurement to develop value-based public procurement projects. It provides several initial guidelines to be followed so that companies that want to build their value-based propositions and contracting bodies that wish to engage in this... Read More
Women´s Life Science Network
El Global
El pasado 1 de diciembre las abogadas de Faus Moliner tuvimos el privilegio de asistir en Zurich a unas sesiones sobre “Digital Health and Artificial Intelligence: Drivers in Transforming the Life Sciences Industry”, organizadas por la Women’s Life Sciences Network. Esta red tiene entre sus objetivos fomentar el intercambio de conocimientos y experiencias entre las... Read More
Datos de Salud: compartir sí, con garantías
El Global
El pasado martes tuve ocasión de participar en un interesante webinar sobre el impacto de la protección de datos personales en el ámbito de las ciencias de la salud, a raíz de la propuesta de reglamento sobre el Espacio Europeo de Datos Sanitarios (EEDS). Lo organizaba el “Life Sciences Practice Group”, grupo de abogados europeos especializados en el sector life... Read More
Updates in compliance programmes
Organic Law no. 10/2022, of 6 September, on the comprehensive guarantees of sexual freedom broadens the scope of situations in which companies can be criminally liable
Capsulas Nº 232
Exemption via compliance programmes The Spanish Criminal Code (article 31 bis) establishes that companies may be criminally liable for certain offences committed by their employees or managers. However, it also provides that such liability can be avoided or mitigated if the company has an adequate compliance programme in force. To this end, compliance programmes must... Read More
Exclusion of the purchase of medicinal products from the Law on Public procurement
Appeal of unconstitutionality against Foral Law no. 17/2021, of 21 October, which amends Foral Law no. 2/2018, of 13 April, on public procurement of Navarra
Capsulas Nº 232
Background The Spanish Government lodged an appeal of unconstitutionality against Foral Law no. 17/2021, of 21 October, which regulates certain aspects of public procurement in Navarra, as per the Official State Gazette of 21 September 2022. This Law modifies the traditional system for the purchase of medicinal products for hospital use with the aim of... Read More
What point in time must be considered when defining the reference group?
The Administrative Chamber of the National High Court provides an answer in an interesting judgment
Capsulas Nº 232
Timings in the processing of OPRs On 6 September, the Ministry of Health published the 2022 update of the reference price system order for medicinal products covered by the NHS, which, in turn, opened the period for allegations. This Draft Order is based on the information available in the official Nomenclator of the NHS dated... Read More
Reducing penalties by up to 40% without waiving the right to judicial appeal
The judgement of the Administrative Chamber of the Supreme Court of 6 October 2022 provides additional insights to those presented in 2021
Capsulas Nº 232
Mechanisms of reduction of administrative penalties Reducing pecuniary penalties in the event of recognition of responsibility and/or prompt payment is now a possibility in all sanctioning procedures, pursuant to article 85 of Law no. 39/2015. This decision follows from the successful implementation of this mechanism in specific areas, namely traffic and tax penalties. There are... Read More
¿Vamos por el buen camino?
EL GLOBAL
Recientemente EFPIA y EUCOPE han emitido un comunicado mostrando su preocupación sobre la dirección que están tomando las actividades de implementación del Reglamento (UE) 2021/2282 sobre evaluación de tecnologías sanitarias. Del comunicado se desprenden algunas ideas que merecen reflexión. Primera. ¿La nueva regulación simplificará y homogeneizará la evaluación de tecnologías sanitarias (ETS) o acabará... Read More
Los efectos de la inflación en la compra pública en el ámbito sanitario
El Global
El contexto socioeconómico actual, enmarcado en el conflicto bélico entre Rusia y Ucrania, en el que se utiliza el precio del combustible y la energía como un arma más en la contienda, está tensionando la economía como pocas veces se había visto antes. El encarecimiento de productos energéticos y determinadas materias primas conduce a una... Read More