El tratamiento de datos personales en el marco de los ensayos clínicos
El Global
En los ensayos clínicos se tratan, inevitablemente, datos personales de los participantes. A este respecto, tanto las normas que regulan los ensayos clínicos (Reglamento (UE) 2014/536 (RPD), y en España el Real Decreto 1090/2015), como las de protección de datos personales (Reglamento (UE) 2016/679 (RGPD), y en España la Ley Orgánica 3/2018), fijan reglas que... Read More
Competencia y mercado hospitalario
El Global
La Comisión Nacional de los Mercados y la Competencia (CNMC) ha anunciado el inicio de una investigación de posibles prácticas anticompetitivas en el mercado de inmunosupresores. De acuerdo con su nota de prensa, las actuaciones han incluido una inspección de dos días en la sede de un laboratorio farmacéutico titular de un fármaco destinado al... Read More
Un buen punto de partida para la modernización del sistema de financiación de medicamentos
El Global
Los cambios a los que venimos asistiendo en el ámbito de las terapias farmacológicas sitúan a nuestro sistema sanitario ante el gran reto de nuestra época: garantizar la sostenibilidad de un sistema sanitario tan ambicioso como el nuestro, en un escenario caracterizado por la irrupción continua de nuevas herramientas de alto valor terapéutico, pero de... Read More
The transparency of the prices of medicines
CUADERNOS DE DERECHO FARMACÉUTICO, NUMBER 68, JANUARY-MARCH 2019
The entry into force of Law 29/2017 on Public Procurement and the application of Law 19/2013 on transparency, access to public information and good government raises various questions in relation with the publicity that should be given to administrative decisions fixing the maximum ex-factory price for reimbursed medicines in Spain. The authors understand that the... Read More
Resueltas algunas dudas acerca de los contratos menores
El Global
El mes de marzo se publicó en el BOE la Instrucción 1/2019 de la Oficina Independiente de Regulación y Supervisión de la Contratación que pretende clarificar aspectos confusos del nuevo régimen del contrato menor tras la entrada en vigor de la LCSP. Uno de los aspectos más problemáticos del nuevo régimen del contrato menor reside... Read More
Faus & Moliner continues to lead the pharmaceutical law in Spain
Jordi Faus, the best lawyer for pharmaceutical law in Spain according to the Chambers & Partners Guide 2019
Chambers and Partners has published the 2019 edition of the Chambers Europe Guide, in which, based on opinions of clients and other lawyers, the leading lawyers and law firms in Europe are identified and classified and Faus & Moliner appears once again as the leading law firm in pharmaceutical law in Spain. Those consulted by... Read More
Pregabalin continues to generate debate about indirect patent infringements and the conduct of regulatory agencies
Judgement of the Court of Justice of the European Union (CJEU) of 14 February 2019, Staat der Nederlanden v Warner-Lambert Company LLC, Case C-423/17
Capsulas Nº 200
How to avoid indirect infringements In 2016, the judgment of the Court of Appeal of Barcelona about pregabalin was a major milestone in the doctrine of indirect patent infringement and its connection with the regulatory environment. Both Pfizer and the Court of Appeal understood that generic medicinal products that did not include pain treatment as... Read More
New crimes for which a company may be liable in Spain
Law 1/2019, of 20 February, amending Law 10/1995, on the Criminal Code, transposing several Directives of the European Union
Capsulas Nº 200
The amendment of the Spanish Criminal Code that we are referring to in this article entered into force on 13 March 2019 and has several implications for entities that operate in Spain. First, it increases the number of conducts that may be considered as a crime as well as the number of cases in which... Read More
Some tips in case of dawn raid by the Spanish Competition Authority
Judgements of the Supreme Court of 25 and 26 February 2019 regarding the “incidental finding” doctrine
Capsulas Nº 200
“Incidental finding” doctrine During dawn raids, the Spanish Competition Authority (CNMC) is entitled to investigate any document that is related to the object and purpose of the investigation. However, what happens if during a dawn raid the CNMC finds evidence regarding a potential anti-competitive practice different from the one that is being investigated? Is the... Read More
Which means are appropriate to send an out-of-court complaint: certified mail, certified fax or some other?
Judgement of the Supreme Court, Civil Chamber, of 5 February 2019
Capsulas Nº 200
Background Year after year since 2011, a real estate owner had been sending letters to the person in possession of such real estate, complaining about certain damages that the properties had suffered. The letters were sent by certified mail or certified fax, which are both services offered by Correos (Spanish public mailing service). The intention... Read More