En funciones… y todo funciona
EL GLOBAL
Ya se ha cumplido más de un mes desde que España está dirigida por un gobierno en funciones. En este periodo, sin perjuicio de los vaivenes que se produjeron en algunas cabalgatas, los Reyes Magos llegaron a las casas de los españoles el 6 de Enero. A futuro, las fiestas de los carnavales no corren... Read More
España, pionera en regulación de la investigación clínica
EL GLOBAL
He tenido el privilegio de asistir a la jornada de presentación del nuevo Real Decreto de ensayos clínicos con medicamentos (RD1090/2015, de 4 de diciembre), organizada por la Agencia Española de Medicamentos y Productos Sanitarios (Aemps).Y digo el privilegio porque dicha jornada, que tuvo lugar en el Ministerio de Sanidad agotó su aforo el mismo... Read More
El fácil encaje de la salud como derecho fundamental
EL GLOBAL
La semana pasada, EG publicaba una reseña con un título opuesto al que he escogido para esta columna: “El difícil encaje de la salud como derecho fundamental”. El autor se refería, con razón, a las dificultades a las que se enfrentará cualquier grupo parlamentario que quiera reformarla Constitución e incluir el derecho a la protección... Read More
New rules for carrying out clinical trials in Spain: in a faster, safer and more transparent way
Royal Decree No. 1090/2015, of 4 December on clinical trials involving medicinal products, Research Ethics Committees and the Spanish Clinical Trials Register
CAPSULAS Nº 167
Following a lengthy process going back over two years, on 24 December 2015, Royal Decree No. 1090/2015, regulating clinical trials involving medicinal products was published in the Spanish Official Journal. Said Royal Decree came into force on 13 January 2016 and replaces Royal Decree No. 223/2004 and Order SCO/256/2007. The new Royal Decree seeks, on... Read More
The Supreme Court rejects the arguments of the distribution sector on the “right to be supplied”
Judgment of 15 December 2015 in the appeal of FEDIFAR appeal against Royal Decree 782/2013 on the distribution of medicinal products for human use
CAPSULAS Nº 167
Background In 2013, the Spanish Federation of Wholesalers (FEDIFAR) appealed against Royal Decree 782/2013, requesting its annulment as it was subject of an “unlawful regulatory omission”. According to FEDIFAR, the Law on Guarantees and Rational Use of Medicinal Products and Medical Devices recognises wholesalers’ unconditional right to be supplied by the manufacturers of medicinal products.... Read More
Pharmaceutical companies are now free to promote their products directly to nurses
Royal Decree No. 954/2015 on prescription, use and authorisation for dispensing medicinal products and medical devices for human use by nurses
Capsulas Nº 167
Background Royal Decree No. 954/2015 came into force on 24 December 2015. The possibility that nurses may prescribe the use of certain medicinal products was introduced in 2009 as part of the Law on Guarantees and the Rational Use of Medicinal Products and Medical Devices. The aim of the legislator was to provide legal coverage... Read More
Los enfermeros y la promoción de medicamentos
El Global
Hace unos cuantos años, la Comisión Europea inició una revisión de las normas relativas a la promoción e información de medicamentos de prescripción. El objetivo era explorarla posibilidad de que las compañías farmacéuticas ofrecieran, directamente a los pacientes, información sobre medicamentos de prescripción. En aquella época, el comisario Liikanen lideró el llamado G10, un grupo... Read More
Collecting debt principal through the Plan of Payments to Suppliers does not impede the claiming of late payment interest
The voluntary or involuntary waiving of late payment interest is contrary to EU regulations and therefore null
CAPSULAS Nº 166
In recent years various so-called “Plans of Payments to Suppliers” (PPP, as abbreviated in Spanish) have been approved in Spain. The PPP are financing mechanisms for payment to suppliers of Public Authorities, intended to offset the non-payments suffered by said suppliers as a consequence of the economic crisis. However the regulations controlling the PPP also... Read More
The existence of similar contractual conditions may imply a restriction on competition
Judgment of the Supreme Court, Contentious-Administrative Chamber, of 13 November 2015
CAPSULAS Nº 166
Background The judgment we discuss is the result of a sanctioning procedure brought by the Spanish Competition Authority (CNMC) against several cinema distributors. The CNMC, in a ruling of 10 May 2006, and the Spanish National High Court, in a judgment of 5 June 2013, declared that there had been a breach of competition law... Read More
Making a mistake does not necessarily mean automatic exclusion from a tender
Decision by the Central Administrative Court for Contractual Appeals of 4 December 2015, number 1108/2015
CAPSULAS Nº 166
Background When a dossier is prepared for taking part in a public tender, it is common for many documents to be handled. Furthermore, each one must be placed in its corresponding envelope in accordance with a large number of instructions described in the specifications. This all means that on more than one occasion, involuntary mistakes... Read More