No olvidemos la importancia y los beneficios del ‘compliance’
EL GLOBAL
A estas alturas ya son pocas las compañías farmacéuticas o del sector de los productos sanitarios que no tienen asumida la importancia de contar con un sistema de complianceadecuado. Aun así, cada vez es mayor la frecuencia de noticias que, siendo más o menos cercanas, nos recuerdan que no podemos olvidarnos del compliance. De hecho, últimamente hemos... Read More
Cosméticos más seguros
EL GLOBAL
El pasado 28 de febrero entró en vigor el nuevo Real Decreto 85/2018 por el que se regulan los productos cosméticos. Esta norma viene a sustituir al Real Decreto 1599/1997 sobre cosméticos y, juntamente con el Reglamento (UE) 1223/2009, en vigor desde 2013, conforma el actual marco normativo de referencia en España en lo que... Read More
Piden acceso a las Actas de la Comisión de Precios de 2007 a 2017: transparencia y finura
EL GLOBAL
La Ley 19/2013, de transparencia y acceso a la información pública entró en vigor hace cuatro años, y desde finales de 2014 se aplica a la Administración General del Estado. Es una ley compleja, pero que parte de un principio muy sencillo: todas las personas tienen derecho a acceder a la información pública. Todas quiere... Read More
A final “No” to tenders for “Therapeutically equivalent alternatives”
The Supreme Court, in a judgement of 29 January, rules in favour of an appeal prepared by Faus & Moliner representing one of our clients
CAPSULAS Nº 188
Background In July 2013, the Healthcare Service of Andalucia (SAS) opened a tender for a framework agreement with the intent of selecting certain active ingredients to treat specific diseases. The purpose of the contracting authority was to select, for certain therapeutic indications, one single company who would supply a given drug among those which could... Read More
Final countdown for the implementation of the European Regulation of Data Protection
Regulation (EU) 2016/679, of 27 of April of 2016, on the protection of natural persons with regard to the processing of personal data and the free movement of such data
CAPSULAS Nº 188
On 25 of May the General Data Protection Regulation (GDPR) will be implemented. From then onwards, the GDPR will be the reference standard, and the current regulations of each Member State will be repealed. Therefore, in Spain, Organic Law 15/1999, on Data Protection will be repealed. Many of the concepts and mechanisms contained in the... Read More
Transparency wins: third parties can access the documents of a marketing authorization application file
Judgements of the General Court of the European Union, of 5 February 2018, in the Cases T-235/15, T-718/15 and T‑729/15
CAPSULAS Nº 188
Background In these three Judgements, the General Court analyzed the decisions of the European Medicines Agency (EMA) to grant access to a third party to the documents submitted in the context of applications for marketing authorizations (MA). The pharmaceutical companies who provided such documents to the EMA and then became MA holders, separately brought actions... Read More
The European Commission publishes the opinion of its experts on financing models for innovative medicines
Report of the “Expert Panel on effective ways of investing in Health” on financing models of innovative medicines published on 9 February 2018
CAPSULAS Nº 188
Background The Expert Panel on effective ways of investing in Health was created with the purpose of providing non-binding advice to the Commission on matters related to the efficacy, access and resilience of the healthcare systems. The report that we refer to, called “Innovative payment models for high-cost innovative medicines”, is interesting as it provides... Read More
Presente y futuro del medicamento biosimilar
EL GLOBAL
Hace escasas fechas tuve el placer de asistir a la II Jornada Nacional de Biosimilares, magníficamente organizada como siempre por la Asociación Española de Biosimilares (BioSim). El evento fue un éxito indiscutible, con gran afluencia de público que abarrotaba el salón de actos del Ministerio de Sanidad Servicios Sociales e Igualdad, y ponentes de enorme... Read More
Faus & Moliner participates in the “Chambers Global Practices Guides – Pharmaceutical Advertising 2018”
Jordi Faus, Juan Suárez and Francisco Aránega 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.
Mayor transparencia y mejor competencia
El Global
Faltan dos semanas escasas para que entre en vigor la nueva Ley de Contratos del Sector Público. La nueva ley persigue diversos objetivos, todos ellos relevantes, como son implementar definitivamente la contratación íntegramente electrónica, facilitar el acceso de las Pymes a la contratación, favorecer la calidad de las obras, bienes o servicios a contratar, etc.... Read More