The importance of defining the relevant product market
Judgement of the General Court of the European Union of 12 of December of 2018, Case T-691/14 Servier and Others v European Commission
Capsulas Nº 197
Introduction The General Court of the European Union partially annuls the Decision of the European Commission (EC) of 9 of July of 2014, which sanctioned Servier and certain generic companies for entering into agreements that restricted competition and which also sanctioned Servier for abusing its dominant position. According to these agreements, the generic companies agreed... Read More
New Spanish Data Protection Law: the latest features on the processing of personal and health data
Law 3/2018, on Data Protection and Digital Rights, complementing the EU General Data Protection Regulation (GDPR), comes into force.
Capsulas Nº 197
Information and consent Law 3/2018 simplifies the duty of the data controller to provide information to the data subject as regards his/her personal data. The controller is no longer required to provide at first instance all the information set forth in the GDPR. According to this Law, the controller can provide the data subject with... Read More
An arbitral award cannot be annulled in the enforcement proceeding of such award
Decision of the Court of Appeals of Barcelona, of 19 December 2018
Capsulas Nº197
Introduction The efficacy of arbitration as an alternative dispute resolution mechanism is based, inter alia, on the fact that arbitral awards are binding on the parties. In this regard, one can compare an arbitral award to a court judgement. From the moment in which such award is final, the parties must comply with it. In... Read More
El blockchain ha venido para quedarse
El Global
La incorporación de nuevas tecnologías en la Administración Pública suele ser un proceso complicado y lento. Veamos sino como está costando incorporar a las distintas fases de los procedimientos de contratación el uso de los medios electrónicos. Un ejemplo de las dificultades para introducirlos en los procesos de contratación es que tras la entrada en... Read More
Ensayos clínicos, datos de salud y la nueva LOPD
El Global
El pasado 6 de diciembre (Día de la Constitución) se publicó por fin en el BOE la Ley Orgánica de Protección de Datos Personales y Garantía de los Derechos Digitales (LOPD-GDD). Esta nueva ley viene a complementar determinadas cuestiones que el Reglamento General de Protección de Datos (RGPD), aprobado por el Parlamento Europeo, dejaba a... Read More
Los retos alfa y los retos beta
El Global
La semana pasada tuve el placer de participar en la 5ª Jornada Hacia un sistema sanitario basado en la creación de valor de la Fundación Instituto Roche. Presenté una breve ponencia sobre el “Marco legal y nuevos modelos de financiación en terapias innovadoras”, que cerré con una reflexión que he venido repitiendo al menos en los últimos cinco... Read More
Update of the Spanish rules in connection with the so-called ‘prescription by nurses’ of medicines and medical devices
Royal Decree 1302/2018, amending Royal Decree 954/2015 on the indication, use and dispensation authorization of medicinal products and medical devices by nurses
Capsulas Nº196
Background On 24 October 2015, Royal Decree 954/2015, regulating the indication, use and authorization for dispensation of medicinal products and medical devices by nurses, came into force. Three years later, on 24 October 2018, this new Royal Decree 1302/2018 came into force to modify the previous one. The modification was aimed to solve certain difficulties... Read More
Is it possible for a substance evaluated under the medical devices’ rules to benefit from a SPC?
Judgement of the Court of Justice of the European Union (CJEU), of 25 October 2018, in the Case C-527/17 Boston Scientific v Deutsches Patent
Capsulas Nº196
When it comes to medicinal products, the 20-year period of market exclusivity granted to the patent holder is not entirety enjoyed by such holder. This is because of the time existing between the patent application for a particular molecule (moment from which the patent period starts to run) and the grant of the marketing authorization... Read More
The CJEU states that the technical requirements should not refer to the key features of a company’s products or services
Judgment of the Court of Justice of the European Union (CJEU), 25 October 2018, in the Case C-413/17 Roche v Polyclinic Dainava Kaunas
Capsulas Nº196
Background In this judgment, the CJEU resolves a preliminary ruling raised in a dispute against the specifications of a public contract for renting laboratory diagnostic material called by Polyclinic Dainava Kaunas, in Lithuania. One of the tenderers, Roche, appealed against the tender specifications due to considering that the technical requirements of the tender contained restrictions... Read More
The Supreme Court recognizes locus standi to appeal against the granting of a marketing authorization of a competing product
Judgement of the Supreme Court, Contentious-Administrative Chamber, of 8 October 2018
Capsulas Nº196
Introduction As in the Judgement of the Spanish Contentious-Administrative Central Court No. I, of 2 July 2018, commented in our Capsulas Nº 192, in this Judgement it is once again confirmed -now by the Supreme Court- the possibility of challenging the grant of a marketing authorization (“MA”) of a competing product, thus changing with the... Read More