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
Parallel import of in vitro diagnostic medical devices
Judgment of the Court of Justice of the European Union (CJEU), of 13 October 2016, (Case C-277/15, Roche Diagnostics Deutschland GmbH vs Servoprax GmbH)
CAPSULAS Nº 175
Background Roche Diagnostics markets in vitro diagnostic medical devices in Germany. Servoprax purchased said devices in the United Kingdom, where they were also marketed, and then added a label and instructions in German and sold them in Germany. The product’s label in Germany made reference to two units of measurement (“mmol/l” and “mg/dl”), whilst in... Read More
Los tribunales acotan las injerencias en la libertad de prescripción
EL GLOBAL
Nuestro ordenamiento jurídico consagra la libertad de prescripción del facultativo a través de la Ley de garantías y uso racional de los medicamentos y productos sanitarios, cuyo artículo 79 dispone que médicos, odontólogos y podólogos son los únicos profesionales facultados para instaurar un tratamiento con medicamentos de prescripción. Conviene matizar, no obstante, que dicha libertad... Read More
Competencia, OPEP y medicamentos
EL GLOBAL
Al regresar de sus vacaciones de verano, una de las primeras sentencias que dictó el Tribunal General de la Unión Europea tuvo por objeto el recurso presentado por Lundbeck contra la decisión de la Comisión de 19 de junio de 2013, que la declaraba culpable de infringir las normas sobre libre competencia y le imponía... Read More
Risks in the agreements between patent holders and generic medicinal product companies
Judgment of the General Court of the European Union of 8 September 2016, Case T-472/13, Lundbeck
CAPSULAS Nº 174
Background This extensive judgment (+120 pages) addresses the ruling adopted by the European Commission in June 2013, which declared that Lundbeck, Merck, Arrow, Alpharma and Ranbaxy had infringed European rules on competition when agreeing that Lundbeck would provide economic compensation to the manufacturers of generic medicinal products for not marketing Citalopram in certain territories during... Read More
Significant recent developments in terms of administrative procedure
Law No. 39/2015, of 1 October, on the Common Administrative Procedure of Public Authorities comes into force
CAPSULAS Nº 174
On 2 October, Law No. 39/2015, which regulates the common administrative procedure of Public Authorities (LPAC) comes into force. This Law revokes various other laws and regulations. Amongst the foregoing, the most relevant is Law No. 30/1992, on the Legal System applicable to Public Authorities and Common Administrative Procedure. The legislator, on this occasion, has... Read More