La evolución del sector de la biotecnología
El Global
En nuestro despacho llevamos años trabajando en el sector de la biotecnología. Desde esa posición hemos podido observar una gran evolución en el sector, que se basa en gran medida en la madurez y el nivel de colaboración que han alcanzado tres de sus actores principales. Por una parte, están los fundadores de las empresas.... Read More
The importance of participating in the parliamentary process of sectoral rules
Judgements of the Supreme Court of 10 and 28 of June 2019
Capsulas Nº 203
Background On June 10 June 2019, the Supreme Court issued a judgement which shows the importance of the parliamentary work for the proper interpretation of rules and the convenience for private companies to actively participate in such works, especially when they involve highly regulated sectors. Later, on 28 June 2019, the Supreme Court issued another... Read More
Home delivery of medicinal products and medical devices and the recently approved Pharmaceutical law of Galicia
Law 3/2019, of 2 July, on the organization of pharmaceutical services in Galicia
Capsulas Nº 203
Pharmaceutical home care Home delivery of medicinal products and medical devices has been a controversial subject in Spain, often because regulation is not clear in this respect. The new Pharmaceutical Law of Galicia suggests a regulatory solution for this issue and incorporates interesting provisions that are discussed in this article. Exceptional nature Article 7 of... Read More
The differences in the procedures for the authorisation of medicinal products are not sufficient to reject a parallel import
Judgement of the CJEU, of 3 July 2019, Case C-387/18, Delfarma sp. z o.o. v Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Capsulas Nº 203
Background This judgement is about a question referred for preliminary ruling by the Regional Administra tive Court of Warsaw (Poland) regarding the compatibility of the Polish legislation on parallel imports with EU law. Polish national law re quires imported medicinal products to: (i) have the same active substance, the same strength, the same route of administration, and... Read More
Prohibición de contratar por infracción en materia de competencia
El Global
Hoy les hablaré de una medida de lucha frente a las prácticas anticompetitivas que podríamos definir como tradicional por figurar desde hace bastantes años en las sucesivas leyes promulgadas para ordenar la contratación pública en este país. Me estoy refiriendo a la prohibición de contratar por infracción en materia de competencia. Ustedes se preguntarán, ¿qué... Read More
Una llamada a la mejora en la difusión de los resultados de la investigación clínica
El Global
Las normas sobre ensayos clínicos con medicamentos, desde hace ya bastantes años, obligan a los promotores a publicar los resultados, tanto positivos como negativos, que se obtengan de dichas investigaciones. En España, está obligación viene siendo cumplida principalmente al remitir dichos resultados a la base de datos de Ensayos Clínicos de la UE, la cual... Read More
Conocerse siempre ayuda
El Global
Les voy a pedir que esta semana acepten que me refiera al equipo de Faus & Moliner para ilustrar el mensaje que me gustaría trasladar. El martes pasado se hizo público que habíamos sido galardonados con el Premio Expansión como Mejor Despacho de Abogados en la categoría Ciencias de la Salud. Tras la lógica satisfacción... Read More
Strict interpretation of the “significant benefit” condition for the designation of an orphan medicinal product
Judgement of the General Court of 16 May 2019, Case T-733/17, GMP-Orphan v European Commission
Capsulas Nº 202
Background One of the available ways to obtain orphan drug designation for a medicinal product is to prove that such medicinal product will be of “significant benefit” to the patients. This “significant benefit” shall mean either (a) a clinically relevant advantage, or (b) a “major contribution” to patient care; and must be proved by means... Read More
The regional government of Galicia against the preparation of illegal magistral formulas
Judgment of the High Court of Justice of Galicia of 8 May 2019
Capsulas Nº 202
Background This judgment refers to a sanctioning proceeding against a healthcare center located in Galicia (a Spanish autonomous region) initiated by the Department of Health of such region. The healthcare center was charged with the commission of a serious infringement under the Spanish Legislative Decree 1/2015 consisting on the prescription and preparation of magistral formulas... Read More
The Ministry of Health updates the Guidelines for the advertising of medicinal products directed to the general public
Second edition of the “Guidelines for the advertising of medicinal products for human use directed to the general public" of the Ministry of Health, Consumption and Social Welfare
Capsulas Nº 202
In June, the Ministry of Health published the second edition of the “Guidelines for the advertising of medicinal products for human use directed to the general public”. For the drafting of this updated version of the Guidelines, the Ministry of Health has benefited from the collaboration of Autocontrol and Anefp, two Spanish associations for self-regulation... Read More