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
Transparencia y legitimidad
El Global
La sentencia que les comento esta semana, dictada el 5 de febrero por el Tribunal de Justicia de la UE, versa sobre el derecho de acceso a los documentos que manejan las administraciones públicas. El interés de la sentencia es doble. Por un lado, ilustra cómo en el entorno administrativo europeo conviven, con cierta naturalidad,... Read More
The future rules of the reference price system of medicines in the National Health System shall be submitted for consultation
The Ministry of Health, Social Services and Equality (MoH) launches a preliminary public consultation about the main features of its proposal for the amendment of the system
CAPSULAS Nº 187
The reference price system of medicines in the Spanish National Health System (NHS) is approaching its second decade of existence. The purpose of this system -created in order to control public expenditure- is to divide medicines which are funded by the NHS into groups following certain criteria. Each group has the same reference price, which... Read More
Companies hiring transportation services from a carrier can receive claims directly from another carrier outsourced by the former
Judgement of the Supreme Court of 24 of November of 2017
CAPSULAS Nº 187
Background When hiring transportation services, it is convenient to bear in mind if the carrier who has been hired (“hired carrier”) is the one who actually carries and delivers the goods to the recipient, or if the hired carrier has outsourced the provision of such transportation services to another carrier (“final carrier”). In case of... Read More
‘No’ definitivo a las ATE
El Global
¿Recuerdan la polémica de las Alternativas Terapéuticas Equivalentes (ATEs)? A finales de Julio de 2013, el Servicio Andaluz de Salud abrió la licitación de un llamado “Acuerdo Marco de homologación para la selección de principios activos para determinadas indicaciones”. El objeto del expediente era seleccionar, para cada lote licitado, un proveedor que suministraría uno de... Read More
El sistema de precios de referencia se somete a consulta pública
El Global
El actual sistema de precios de referencia de los medicamentos del Sistema Nacional de Salud, alcanzada su mayoría de edad, empieza a mostrar claros síntomas de agotamiento. Pese a los numerosos retoques de los que ha sido objeto en las dos décadas que han transcurrido desde su implantación en nuestro país, su arquitectura normativa no... Read More