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
Our proposals in relation to the amendment of the Law on Guarantees and Rational Use of Medicinal Products and Medical Devices
Executive summary of the intervention of Faus Moliner in the Public Consultation procedure organized by the Ministry of Health.
Capsulas Nº 231
At the end of July, the Ministry of Health invited all interested parties to make their proposals regarding the preparation of the draft bill amending the Law on Guarantees and Rational Use of Medicinal Products and Medical Devices. The proposals made by Faus Moliner included the following: 1. To amend the name of the Law... Read More
La frontera entre medicamentos y otros productos relacionados con la salud
El Global
“La belleza está en los ojos del que mira. En el caso de autos, literalmente”. Así empiezan las conclusiones la abogada general del Tribunal de Justicia de la Unión Europea (TJUE) en un caso en el que se examina si un producto destinado a favorecer el crecimiento de las pestañas -y comercializado como cosmético- puede... Read More
Pharma & Medical Device Regulation Spain 2023
LEXOLOGY PHARMA & MEDICAL DEVICE REGULATION SPAIN 2023
Lexology has recently published the guide “Pharma & Medical Device Regulation Spain 2023” with contributions from Eduard Rodellar, Lluís Alcover, Juan Martínez, Anna Gerboles and Santiago Tomás. This quick reference guide enables side-by-side comparison of local insights, including into the regulatory framework; clinical practice; marketing authorisation; amending authorisations; recall; promotion; enforcement of advertising rules; pricing... Read More
Legislar de forma valiente
El Global
El BOE de 21 de septiembre de 2022 publicaba la interposición por el Gobierno, de un recurso de inconstitucionalidad contra la Ley Foral 17/2021, de 21 de octubre, que modifica la Ley Foral 2/2018, de 13 de abril, de Contratos Públicos de Navarra. Dicha Ley introdujo una medida vanguardista, que modificaba el sistema tradicional de compra... Read More