El medicamento en los Tribunales en el año 2017
Comunicaciones en Propiedad Industrial y Derecho de la Competencia de la Fundación CEFI, Number 83 January-April 2017
By means of this Article we go through the most importan decisions by Spanish and European courts regarding medicinal products during the year 2017.
El nuevo régimen de división en lotes
EL GLOBAL
La nueva Ley de Contratos del Sector Público (LCSP) ha traspuesto formalmente al ordenamiento jurídico una práctica que ya venía aplicándose por los tribunales administrativos desde que expiró el plazo para transponer las Directivas 2014/23/UE y 2014/24/UE. Nos referimos a la inversión del régimen general que recogía la normativa anterior (TRLCSP) que establecía la necesidad... Read More
Some medicines containing the same active substance may not be the same medicinal product (… in terms of reference price)
The General Court Judgement of 22 March, in Case T‑80/16 Shire, brings light into this delicate issue
CAPSULAS Nº 189
Background This case refers to the position taken by the European Medicines Agency (“EMA”) in relation to an application filed by Shire to obtain orphan designation for Idursulfase-IT. The EMA rejected to validate such application on the grounds that Idursulfase-IT contained the same active substance (“API”) as that of Elaprase®, another medicinal product for which... Read More
The rights of patients justify a final “No” to the ATE’s even under the new Spanish Law on Public Tenders
Decision No 31/2018, of 28 of February, of the Public Tender Court of Catalonia
CAPSULAS Nº 189
Background The Catalan Institute of Health and the Consortium for Health and Social Care of Catalonia called a tender for the award of a medicines supply framework agreement for the lipid lowering treatment with inhibitors of PCSK9. The tender was initially set as a single lot which would be awarded to a single supplier. After... Read More
The new rules on data protection facilitate biomedical research in Spain
The AEPD considers, in its Report 73667/2018, that the scope of the consent given in the field of biomedical research must not be interpreted in a restrictive way
CAPSULAS Nº 189
As a general rule, the current legislation establishes that in order to process personal data related to health for purposes of biomedical research it is necessary to have previously obtained the explicit consent of the patient, usually in writing. However, according to Law 14/2007 on Biomedical Research, such consent may not be required in certain... Read More
More possibilities in relation to the substances that can be used in the manufacturing of food supplements
Royal Decree 130/2018, of 16 March, amending the Royal Decree 1487/2009, of 26 September, regarding food supplements
CAPSULAS Nº 189
Background On 28 March 2018, the Royal Decree 130/2018, of 16 March, amending Royal Decree 1487/2009, of 26 September, regarding food supplements, came into force. The purpose of the new Royal Decree is to update and clarify the regulatory framework applicable to food supplements in Spain. The main aspects regulated by this new regulation are... Read More
Faus & Moliner participates at the Conference Impact of the new Law on Public Sector Contracts in the pharmaceutical sector organized by CEFI
Jordi Faus makes a presentation on Equivalent Therapeutic Alternatives
Jordi Faus makes a presentation in Madrid called ¿Are the lots by indication possible after the judgment of the Supreme Court on the Equivalent Therapeutic Alternatives (ETAs)?
No definitivo a las ATEs. Los medicamentos distintos no deben agruparse en un mismo lote
CUADERNOS DE DERECHO FARMACÉUTICO, NÚM. 64, ENERO-MARZO 2018
The new Spanish law on public tenders promotes the division of the contract into lots “as long as the nature or object of the contract allows such division”. The previous rule, which imposed that a justification was given when the contract was divided into lots, is reversed and replaced by the new rule, which only... Read More
Hay productos con el mismo API que no son el mismo medicamento
EL GLOBAL
Inmersos como estamos en los trabajos de modificación del sistema de precios de referencia, una reciente sentencia del Tribunal General de la UE aporta elementos de reflexión sumamente interesantes al debate en torno a cuándo dos productos deben considerarse el mismo medicamento. En el sistema actual, pueden incluirse en el mismo conjunto de referencia aquellos... Read More
Faus & Moliner maintains its leadership in pharmaceutical law in Spain
Jordi Faus is once more recognized as the best lawyer in Spain in pharmaceutical law by the Guide Chambers & Partners 2018
Chambers & Partners has published the edition 2018 of the Chambers Europe Guide, which, based on opinions of clients and other lawyers, identifies and classifies the main lawyers and firms in Europe and Faus & Moliner is once more considered as a leading firm in the area of pharmaceutical law in Spain. The clients consulted by the team of Chambers & Partners highlight the high degree of specialization... Read More