Faus & Moliner participates in the “Chambers Global Practices Guides – Pharmaceutical Advertising 2019”
Jordi Faus, Juan Suárez and Verónica Carías write the chapter about Law and Practice in Spain
CHAMBERS GLOBAL PRACTICES GUIDE
The ‘Law & Practice’ sections provide 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.
Enforcement of competition law in the pharmaceutical sector. Second generation issues
The Report of the European Commission COM(2019)17, of 28 January, and the Press Release of the Spanish Competition Authority talk much about access and little about parallel trade
Capsulas Nº 199
Access to medicinal products as primary concern The enforcement of competition law to companies operating in the pharmaceutical sector has gained great importance in recent years. We observe a shift in the traditional approach of the Commission and national authorities. In the 80’s, the time of the ‘blockbusters’, the main concern was assuring that companies... Read More
A new legal framework for the protection of trade secrets
Law I/2019, of 20 February, on Trade Secrets, came into force on 13 March 2019
Capsulas Nº 199
The new Trade Secrets Law (TSL) transposes Directive 2016/943 into Spanish law. The TSL defines ‘trade secret’ as any technological, scientific, industrial, commercial, organisational or financial information or knowledge meeting all the following conditions: (i) is secret (in the sense that it is not generally known or readily accessible to persons who normally deal with... Read More
Promotion of prescription glasses (considered as medical devices) and discriminatory advertising
Decisions of the Jury of Advertising of Autocontrol on prescription glasses (January 2019) and on discriminatory advertising (December 2018)
Capsulas Nº 199
Prescription glasses In January 2019, the Jury of Advertising – a specialized body within an association for self-regulation in advertising called Autocontrol, which is responsible for hearing cases relating to breaches of the provisions contained in self-regulatory advertising codes – issued a decision on a claim submitted by the Association of Media Users against Grupo... Read More
El historial médico europeo, una realidad cada vez más cercana
El Global
A inicios de febrero la Comisión Europea ha emitido una Recomendación en la que apunta diversas medidas para la creación de un sistema que permita a los ciudadanos de la UE acceder con más facilidad y de forma segura a sus historiales médicos, en formato electrónico, en todos los Estados Miembros. Sin duda un paso... Read More
El valor de una sociedad informada
El Global
La Aemps se ha hecho eco de la consulta pública lanzada recientemente por la Agencia Europea del Medicamento (EMA) respecto de los principios básicos a los que deberá ajustarse la información sobre los medicamentos de uso humano en formato electrónico (ePI) que ofrecerán en el futuro las agencias que evalúan estos productos en la Unión... Read More
Valtermed y otras ideas para los medicamentos de terapia avanzada
El Global
Los cambios que se están produciendo en el ámbito de las terapias farmacológicas son de una dimensión tal que exigen una reflexión calmada sobre su impacto y sobre cómo abordarlos. La innovación, esto me lo han oído decir a menudo, surge porque hay personas e instituciones (privadas y públicas) que se esfuerzan por resolver retos... Read More
El Brexit Farma
El Global
Por si alguien todavía tenía dudas, esta semana hemos tenido un par de ejemplos sobre la que se nos puede venir encima con esto del Brexit, especialmente si se produce sin acuerdo. Por una parte, hace pocos días la AEMPS emitió una nota informativa en la que indicaba que a partir del 30 de marzo... Read More
New requirements regarding non-financial information to be included in the annual accounts
Law 11/2018, amending the Code of Commerce, the Law on Companies and the Law on the Auditing of Accounts
Capsulas Nº198
Background Law 11/2018 substantially amends the obligations regarding non-financial information to be included in annual accounts. The objective of this new regulation, which transposes an EU Directive into Spanish law, is to improve the transparency of large companies and their corporate groups in order to provide investors and stakeholders with a better understanding of their... Read More
Clarification of the authorization process for the cultivation of cannabis for research, medical or scientific purposes
Information notes from the Division of Inspection and Control of Medicines of the Spanish Agency of Medicines and Medical Devices (AEMPS) published in the AEMPS’ website
Capsulas Nº 198
Cultivation of cannabis in Spain In Spain, the cultivation of Cannabis for research, medical and/or scientific purposes is totally forbidden unless an authorization from the AEMPS is obtained. The process to obtain such authorization, as well as the documentation and information to be provided during such process, is regulated with little accuracy in very old... Read More