The marketing authorization holder of a reference product has the right to appeal against the approval of the generic in court
Judgment of the Court of Justice of the European Union of 23 October 2014, Case C-104/13, Olainfarm
CAPSULAS Nº 156
Background This case began when Olainfarm filed a case in the Latvian courts against the granting of a marketing authorization of a generic of its product Neiromidin in favour of Grindeks. The Latvian judges, when analyzing the appeal, understood that it was convenient to raise two issues to the European Court of Justice. The first... Read More
The Spanish Competition Authority monitors the health sector closely and reinforces its intervention mechanisms
A new procedure is triggered in the sector of test strips for blood sugar control; and the Collaboration Procedure is reinforced
CAPSULAS Nº 156
Utmost stringency Spanish authorities in charge of the defense of competition continue to act firmly against activities which may restrict or prevent competition in any manner. The preamble of Law 15/2007 is very clear to this regard: the existence of effective competition between companies constitutes one of the elements that define market economy and the... Read More
The 7.5% deduction resulting from RD-Law 8/2010 does not apply in sales when a higher discount was already included in the invoice
Judgment of the Administrative Chamber of the High Court of Andalusia, First section, of 11 September 2014
Capsulas Nº 156
Background In our Capsulas of September 2012 we referred to the judgment passed by the Administrative Court 8 of Sevilla, in a case where a hospital had applied a 7.5% deduction on the supply of medicinal products made after 1 June 2010. The hospital was applying this deduction pursuant to Royal Decree-Law 8/2010. In its... Read More
Traders must ensure that their advertising is properly released when third parties intervene
Ruling of the Advertising Jury of Autocontrol of 11 September 2014 (Individual vs. Reckitt Benckiser España, “Durex”)
CAPSULAS Nº 156
Background This ruling was given as a result of a claim filed by an individual against and advertisement of Durex personal lubricants. The advertisement was being shown at a pharmacy office through a screen facing the street. The claimant considered that the content of the video was not appropriate for minors and that, therefore, it... Read More
La entrada en vigor de la Ley de Transparencia
EL GLOBAL
Dentro de dos meses entrará en vigor el grueso de la Ley de Transparencia, Acceso a la Información Pública y Buen Gobierno, que debe permitir a cualquier persona acceder a cualquier documento que obre en poder de cualquier administración pública y que haya sido elaborado o adquirido en el ejercicio de sus funciones. La ley... Read More
Chambers Global Practice Guides – Life Sciences 2015
CHAMBERS AND PARTNERS - GLOBAL PRACTICE GUIDES
For more than 20 years Chambers Guides have ranked lawyers and law firms across the world. Chambers now offers clients a new series of Global Practice Guides, which contain practical guidance on doing legal business in key jurisdictions. Chambers selects leading law firms in each jurisdiction to write the “Law & Practice” sections. The “Law... Read More
Medicamentos falsificados y Código Penal
EL GLOBAL
La semana pasada la Agencia Española de Medicamentos y Productos Sanitarios (Aemps) prohibió la comercialización y ordenó la retirada del mercado de los productos Megas X comprimidos y Megas X Gold comprimidos, que se presentaban como complementos alimenticios cuando en realidad contenían sildenafilo en cantidad suficiente para ejercer una acción farmacológica. Se trata de una... Read More
Technology transfer in the pharmaceutical sector: experiences after 25 years negotiating and drafting agreements
Faus & Moliner participated in "Monday's Patent Meeting" at the Patent Center of the University of Barcelona
The “Monday’s Patent Meetings” are a discussion and learning forum that the Patent Center of the University of Barcelona has been organizing since 2001. During this meeting, held on 29 September in Barcelona, Jordi Faus made a presentation about technology transfer in the pharmaceutical sector. In his speech, Jordi Faus shared with the audience his... Read More
The rules on misleading advertising help to overcome the difficulties to criminally prosecute falsified medicines
Judgment of the Criminal Court of Madrid of 4 July 2014
CAPSULAS Nº 155
Background In this case, the court analyzes whether the commercialization and advertising of Bio-Bac, which started in Spain in the 90s could be criminally prosecuted. Bio-Bac was a compound of proteins and amino-acids which was marketed at the offices of some doctors and also directly to consumers through internet. The information which was given to... Read More
The re-evaluation of medicines by the regions conflicts with the current legislation
Judgment of the Administrative Court of Castilla y Leon of 21 July 2014
Capsulas Nº 155
Background In recent times, it is frequent that committees and evaluation groups formed within the regional administrations in Spain or in scientific societies reassess the efficacy of medicines which have been accepted for reimbursement within the National Health System. Frequently, the conclusions of these pseudo-evaluations are used to give instructions on prescription. Sometimes, doctors who... Read More