The “global marketing authorisation” covers all subsequent developments of the medicinal product
Judgement of the Court of Justice of the European Union of 28 June 2017, Joined Cases C-629/15 P and C-630/15 P, Novartis vs European Commission
CAPSULAS Nº 184
Background In 2001, Novartis obtained a marketing authorization under a centralised procedure for the medicinal product Zometa®, the active substance of which is zoledronic acid and which is indicated to treat certain bone complications in patients with cancer. In 2005, Novartis obtained another marketing authorization under a centralised procedure for the medicinal product Aclasta®, which... Read More
There is no need to panic: the burden of proof of the defect, the damage and the causal relationship continues to be for the plaintiff
Judgement of the contentious-administrative Chamber of the National High Court of 17 May 2017
CAPSULAS Nº 184
Background In our previous Capsulas we commented the judgement of the Court of Justice of the European Union of 21 of June and we warned about the uncertainty generated by the judgement as it included the possibility that a judge might consider that a vaccine is defective and that there is a causal link between... Read More
El paciente, agente activo del sistema sanitario
EL GLOBAL
El pasado mes de junio tuve el honor de participar en una mesa redonda sobre el derecho a la información de los pacientes, en el contexto del seminario sobre la colaboración entre industria farmacéutica y asociaciones de pacientes, magistralmente organizado como siempre por los responsables de la Fundación CEFI (Centro de Estudios para el Fomento... Read More
Vaccines and liability for defective products
Judgement of the European Court of Justice of 21 June, Case C-621/15, Sanofi Pasteur MSD
CAPSULAS Nº 183
Background The judgment of the European Court that we are discussing in this Capsulas is one example of the complexity of constructing European Community law. Given that accepting that a supranational organization approves and enforces common rules on some matters is very complicated, it is common that European Community law does not succeed in regulating... Read More
The Spanish law on agency agreements can be applicable to the distribution of medical devices having specific regulation
Judgement of the Supreme Court, of 19 May 2017
CAPSULAS Nº 183
Background In 1993, two companies entered into an oral contract regarding the distribution of medical devices, specifically maxillo-facial surgery related devices. The duration of the contract was indefinite and the parties did not agree on a termination notice period. In 2011, the manufacturer communicated his decision to unilaterally terminate the contract, by giving two months’... Read More
Claiming damages for competition law infringements has become easier
Royal Decree-Law 9/2017, of 26 of May, transposing some EU Directives in the financial, commercial and health sector
CAPSULAS Nº 183
Royal Decree-Law 9/2017, of 26 of May which transposes, among others, the Directive on actions for damages for competition law infringements was published last 26 of May with five months’ delay. The aim of the Directive is to ensure that anyone who has suffered harm caused by an infringement of competition law can obtain full... Read More
The Challenge of non qualified procedural acts is already a reality
Decision 64/2017, of 22 May 2017, of the Public Contracts Administrative Tribunal of Aragon
CAPSULAS Nº 183
Introduction As we anticipated in our Capsulas Newsletter No 181, April 2017, the regime of acts and resolutions from Public Contract Authorities that may be challenged has been altered by the Judgement of the European Court of Justice (ECJ), 5 of April of 2017 (Case C-391/2015). This TACPA´s Decision applies, for the first time in... Read More
#BCN4EMA, una opción verdaderamente ‘plug and play’
EL GLOBAL
El lunes pasado se celebró, en el Parc de Recerca Biomèdica de Barcelona, el acto de constitución del comité de apoyo a la candidatura de Barcelona como sede de la EMA. Un reto de este calado, lograr que Barcelona sea la nueva capital europea del medicamento, requiere no sólo del impulso conjunto y decidido de... Read More
Jordi Faus, member of the Support Committee for the candidacy of Barcelona to be the new home for the European Medicines Agency (EMA)
The Support Committe consists of eighty professionals with relevant careers and aims to involve the whole civil society to achieve the success of the candidacy
The creation of the Support Committee for the candidacy of Barcelona as seat of the EMA is part of the campaign #BCN4EMA, which is being jointly promoted by the Government of Spain, the Government of Catalonia and the Barcelona City Council to achieve that Barcelona becomes the new medicines capital of Europe. The creation of such Committe is intended to involve the whole civil society in... Read More
Los tribunales ponen orden en el sector
EL GLOBAL
El pasado jueves tuve el placer de asistir a una interesantísima jornada sobre nuevas propuestas en materia de financiación de fármacos y tecnologías sanitarias, organizada por la International Society for Pharmaeconomics Outcomes Research. Todos los ponentes, como era de esperar, rayaron a enorme altura -magistral, por citar tan sólo un ejemplo, el repaso del profesor Félix... Read More