Descuentos de fidelidad y abuso de posición de dominio
CUADERNOS DE DERECHO FARMACÉUTICO, NÚM. 62, JULIO-SEPTIEMBRE 2017
Loyalty rebates offered subject to the condition that the customer buys all or most of its needs of a given product from a supplier, are presumed to be illegal when granted by a dominant company. The judgement of the General Court in the Intel case seemed to qualify this presumption as a iuris et de... Read More
Barcelona ante la EMA
La Vanguardia
La labor que se ha realizado en los últimos meses en relación con la candidatura de Barcelona para acoger la Agencia Europea del Medicamento (EMA) ha sido de una potencia social y política indiscutible. La voluntad de aunar esfuerzos en torno a este proyecto que han mostrado las administraciones es muy destacable. Felicitaciones a la... Read More
The Administration cannot rely only on the ATC Classification to create the groups of the reference price system
Judgements of the Supreme Court 1217/2017, 1208/2017, and 1284/2017 of 11 of July, 10 of July and 18 of July of 2017
CAPSULAS Nº 184
Background These judgements are related to Order SSI/1225/2014, through which the Spanish Ministry of Health, Social Services and Equality (MOH) updated the reference prices for various medicinal products for 2015. Through this Order, the medicinal products Myfortic®, Reandron® and Kogenate® were included in groups C164 (mycophenolate), C410 (testosterone), and H84 (factor VIII of coagulation), respectively.... Read More
Access to the data regarding the cost of medicinal products and clinical trials data
Resolution No 149/2017 of 28 of June of 2017 of the Council for Transparency and Good Governance (CTBG)
CAPSULAS Nº 184
Background In March 2017, under Law 19/2013, on Transparency, Access to Public Information and Good Governance, an association of consumers and users requested the Spanish Ministry of Health, Social Services and Equality (MOH) to provide them with statistics of prescription and annual cost of certain medicinal products (price, number of prescriptions, total annual cost, financed... Read More
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