The protection of health does not justify restricting discounts on the sale of medicinal products on the Internet
Judgment of the Court of Justice of the European Union (CJEU) of 19 October 2016, Case C-148/15, Deutsche Parkinson Vereinigung eV
CAPSULAS Nº 176
A very important judgment In the context of pharmaceutical law, business initiatives often run into barriers that are raised under the generic argument of public health protection. Invoking the argument of health protection has often been an easy solution to restrict private initiatives, used by those who are unable to support their positions using more... Read More
The CJEU provides additional context regarding what should be considered as an industrially manufactured medicinal product according to Directive 2001/83/EC
Judgment of the Court of Justice of the European Union (CJEU) of 26 October 2016 (Case C-276/15), Hecht-Pharma
CAPSULAS Nº 176
Background Hohenzollern Apotheke (HA), a German pharmacy, produces medicinal products without having a marketing authorisation (MA) under the German law, which excludes medicinal products frequently prescribed by doctors and dentists from requiring said authorisation, when the essential manufacturing steps for such products are carried out in a pharmacy and are to be dispensed to the... Read More
Is it possible to challenge social clauses in public contracts?
Resolution No. 600/2016 of the Central Administrative Court of Contractual Appeals (TACRC) of 22 July 2016
CAPSULAS Nº 176
Recently, different administrations have taken measures to promote the inclusion of social aspects (“social clauses”) amongst the criteria for awarding public contracts and the trend in favour of their acceptance has grown. However, it must be noted that not all social clauses are valid. By means of this Resolution, the TACRC rejected a social clause... Read More
Leyes, reglamentos y una muerte por incendio
EL GLOBAL
La semana pasada, en la ciudad de Reus, falleció una persona de más de 80 años a causa de un incendio en su domicilio. La vela con la que a duras penas iluminaba su habitación debió de caerse incendiando el colchón de su cama. Hacia dos meses que le habían cortado la luz por no... Read More
Los efectos deseables de los tratados de libre comercio
EL GLOBAL
El pasado 30 de octubre se producía la firma de un importante tratado económico y comercial (conocido como el “CETA” por sus siglas en inglés) entre la Unión Europea y Canadá, cuyo principal objetivo es establecer mecanismos que eliminen barreras al comercio entre ambos territorios. El camino hasta la firma del CETA (cuya entrada en... Read More
Internet, precios y protección de la salud
EL GLOBAL
Que internet ha cambiado diversos aspectos de nuestras vidas es innegable. Estos cambios se están produciendo de forma significativa en el o de la economía colaborativa y del comercio electrónico. La sentencia que les comentaré esta semana revela cómo el mundo del medicamento y de la farmacia no son una excepción; y a la vez... Read More
Importaciones paralelas y libertad de circulación
EL GLOBAL
La comercialización de productos farmacéuticos en la Unión Europea está sujeta a controles estrictos que tienen por objeto garantizar la calidad, la seguridad y la eficacia de dichos bienes. El control administrativo de estas actividades es sin duda conveniente, dado su impacto potencial en la salud, pero resulta imperativo dotar al sistema de un cierto... Read More
Publishing the data generated by off-label use does not imply that an unauthorised clinical trial is being carried out
Judgement of 20 July 2016 of the Supreme Court of Justice of Galicia
CAPSULAS Nº 175
Background The Department of Health of Galicia imposed a fine of €120,000 on a medical practitioner in such region of Spain for having prescribed growth hormones to several patients in order to treat specific neurological pathologies for which said medicinal product had not been evaluated or authorised. The decision of the regional administration was supported... Read More
Access to public information and personal data protection
Guidelines of the Spanish Data Protection Agency on the reuse of public sector information and on anonymising procedures
CAPSULAS Nº 175
Introduction Law No 19/2013 on transparency, access to public information and good governance, as is well known, sets out that requests for access to information possessed by Public Administrations may be denied when said information contains personal data. In order to ensure consistency between the principles of transparency and access to public information and the... Read More
How to avoid the obligation of having to purchase surplus stock under just in time manufacturing agreements
Supreme Court Judgment of 5 October 2016
CAPSULAS Nº 175
Background In 1990, two Spanish companies verbally entered into a just in time supply agreement, under which the manufacturer was bound to continuously deliver, in very short turnaround times, product orders placed by its client. Twenty-five years later, the client unilaterally terminated the agreement. The manufacturer brought suit, asking for the client to be held... Read More