Compliance forever: actions for civil liability derived from a final criminal conviction never prescribe
Judgment of the Supreme Court, Criminal Chamber, of 13 November 2020
Capsulas Nº 214
Background In 2001, a citizen was sentenced to pay civil compensation as a result of the commission of a crime. After 15 years without such compensation being paid, the Court declared the civil liability claim barred by limitation. The public prosecutor did not agree with such decision and filed an appeal. The Court upheld such... Read More
#KeepCalm+Vaccinate
El Global
La semana pasada tuve el privilegio de participar en un Webinar organizado por la Fundación CEFI y dirigido por Victoria Fernández López (J&J) sobre las vacunas COVID-19. La jornada contó con la participación de destacados científicos, economistas y miembros de la administración; y compartí mesa virtual con dos grandes colegas como Kiko Carrion (Eversheds Sutherland)... Read More
Faus & Moliner participates in the CEFI Foundation Conference on COVID Vaccines
Jordi Faus intervenes with a presentation on marketing authorizations for vaccines
Since the first marketing authorisations for the COVID vaccines (Pfizer/BioNTech’s Cominraty®and Moderna’s vaccine) were granted in December 2020 and early January 2021, much has been said about the approval process for these products. In his presentation, Jordi Faus has set out the basic applicable principles to the process of approval of vaccines in accordance with... Read More
Interacción entre el derecho de acceso a la información pública y los derechos e intereses de terceros
CUADERNOS DE DERECHO FARMACÉUTICO, NÚM. 75, OCTUBRE-DESEMBRE 2020
The purpose of this article is to provide some insight on the interaction between the right to access public information and the protection of the rights and interests of third parties that may be affected when a request for access to information is made. This article has a critical view of how Law 19/2013 deals... Read More
New rules for conducting observational studies with medicines in Spain: less complexity and more transparency
Royal Decree 957/2020, of 3 November, which regulates observational studies with medicines for human use
Capsulas Especial
On 2 January 2021, Royal Decree 957/2020 (RD 957/2020) entered into force and replaced the Ministerial Order SAS/3470/2009 which had governed observational studies (OS) in Spain until then. After more than a decade with the 2009 Ministerial Order, it became clear that such Order was too complex, involved too much bureaucracy and needed and update... Read More
New version of the Code of Practice for the Pharmaceutical Industry of Farmaindustria
The new version of the Code of Practice has come into force on 1 January 2021
Capsulas Especial
Principles and values Since its first version, the Code of Practice has been based on a number of principles implicit in its provisions. The new version has the virtue of detailing them explicitly, in a format similar to the one used in the EFPIA Code. The 6 principles and values that must govern the activity... Read More
Approval process for COVID-19 vaccines
On the occasion of the grant of the marketing authorization to Comirnaty®, the vaccine developed by BioNTech and Pfizer
Capsulas Especial
Background On Monday, 21 December, the European Medicines Agency (EMA) issued its opinion in favour of granting a marketing authorization for the Covid-19 vaccine developed by BioNTech and Pfizer. In recent weeks, especially following the approvals by the Food & Drug Administration (FDA) in the United States and the Medicines & Healthcare Regulatory Agency (MHRA)... Read More
ModerNIZAr los procedimientos
El Global
El manifiesto de 300 profesionales de reconocido prestigio a favor de la creación de un HispaNICE es un documento muy relevante, con algunas ideas interesantes. Coincido con muchas de ellas y discrepo de alguna; pero lo que me anima a escribir esta columna es la necesidad de trasladarles que será imposible que el HispaNICE cumpla... Read More
Faus & Moliner has participated in the Life Sciences Commission of the Cercle d’Economia
Jordi Faus was part of the working group that has prepared the report "La recuperación post covid-19. Algunas reflexiones sobre el papel del sector de la salud"
Barcelona, 21 November 2020 – The Cercle d’Economia has presented the report “La recuperación post covid-19”. The Minister of Health, Salvador Illa, has participated in this important event. The report, prepared by its Commission of experts on life sciences, includes some reflections on the role of the health sector and its contribution to the post-Covid-19... Read More
Under the written laws of Spain …
El Global
A veces, a los abogados, nos piden que estudiemos un tema y preparemos un dictamen. En el mundo anglosajón, a este tipo de documentos los llaman una “Legal Opinion”. En España, tradicionalmente, los dictámenes concluyen con una frase del tipo “… esta es mi opinión que someto a cualquier otra mejor fundada en derecho”. No... Read More