The public audience and information period for the draft of Royal Decree on the funding and pricing of medical devices is open
Draft of Royal Decree regulating the public funding of medical devices for non-hospitalized patients and setting the commercialization margins
Capsulas Nº 193
Introduction The future Royal Decree comes to implement the provisions on these matters contained in the Consolidated Text of the Law on Guarantees and Rational Use of Medicinal Products and Medical Devices and, therefore, it will regulate the procedure for the inclusion, review and exclusion of medical devices from the pharmaceutical provision of the National... Read More
For the first time, a holder of a reference medicinal product is allowed to challenge a generic approval in Court in Spain
The Judgement of the Contentious-Administrative Central Court No. I, of July 2, 2018 recognizes locus standi to defend the data exclusivity of the registration dossier
Capsulas Nº 192
Background Can holders of reference medicinal products appeal against the approval of generics? Can such holders ask the Spanish Medicines Agency (AEMPS) or a Court in Spain to review the grant of a marketing authorization if they consider that there has been any violation of any regulation? This has been one of the most troublesome... Read More
The e-Administration: an unfinished business
Draft of Royal Decree implementing Law 39/2015 and Law 40/2015 regarding performance and functioning of the public sector by electronic means
Capsulas Nº 192
Introduction Law 39/2015, on the common administrative procedure of public administrations and Law 40/2015, on the legal regime of the public sector were aimed to transform the public administration into a digital one. Both laws implied an unprecedented change in the relationships with and between public Administrations. Law 39/2015 states that companies having to interact... Read More
La publicidad de los medicamentos o la eterna asignatura pendiente
El Global
La intervención de las nuevas responsables de Sanidad y de Hacienda en las comisiones correspondientes del Congreso, hace escasas fechas, ha abordado buena parte de los asuntos candentes en los que esperábamos conocer la postura del nuevo Gobierno. A las políticas de recuperación de la sanidad universal y de eliminación de copagos, ya conocidas, se... Read More
Compliance penal, no sólo evitar la responsabilidad penal de la compañía
El Global
Aunque a los que nos dedicamos al asesoramiento a compañías en el ámbito del compliance nos interesa cualquier nueva resolución de los tribunales en esa materia, en estos días me ha llamado especialmente la atención una sentencia del Tribunal Supremo del pasado 28 de junio. Lo interesante de esa sentencia es que señala que sería... Read More
Real World Data o la importancia de los datos en el sector farmacéutico
El Global
Este pasado junio tuvo lugar en Bruselas una nueva reunión del Grupo de Expertos de la Comisión Europea en el marco del foro “STAMP” (Safe and Timely Access to Medicines for Patients). Dicho foro congrega a expertos de la Agencia Europea del Medicamento (EMA) y de diferentes agencias nacionales (HMA) de los Estados Miembros (EEMM), entre ellos España. Su... Read More
No todo vale
El Global
Recientemente, el Tribunal Administrativo de Recursos Contractuales de la Junta de Andalucía (TARCJA) dictó la resolución nº 108/2018, de 10 de mayo de 2018, por la que anuló los pliegos de una licitación convocada para la adjudicación de un contrato para el suministro de medicamentos de fluidoterapia. Los pliegos en cuestión establecían como criterio de... Read More
The European Commission presents its proposal for SPC Manufacturing Waiver proposal limited to exports
Proposal 2018/0161 (COD) for an amendment of Regulation (EC) 469/2009 concerning the supplementary protection certificate for medicinal products
CAPSULAS Nº 191
An interesting proposal The proposal of the so-called SPC Manufacturing Waiver presented by the European Commission will permit that while a Supplementary Protection Certificate (SPC) is in force, generics or biosimilars may be manufactured in the EU in order to be exported to countries where they can be marketed without breaching valid patents. According to... Read More
One more judgement against therapeutic equivalent alternatives (ATEs), this time in Andalusia
The High Court of Justice of Andalusia, in a Judgement dated 18 May 2018, embraces the doctrine of the Supreme Court that upheld an appeal prepared by Faus & Moliner
CAPSULAS Nº 191
Background In 2014, Farmaindustria filed an appeal against the Framework Agreement called by the Andalusian Health Service (SAS) for the selection of active ingredients for certain indications. Farmaindustria based among other reasons, on the idea that grouping active ingredients in the same lot, defined by therapeutic indications, violates public procurement rules. The Court of First... Read More
Changes on European regulations on orphan drugs
Commission Regulation (EU) 2018/781 amending Regulation (EC) 847/2000 as regards the definition of the term “similar medicinal product”
CAPSULAS Nº 191
Introduction The precise and unambiguous definitions of “active substance” and “similar active substance” is essential in the field of medicinal products for rare diseases: the so-called “orphan medicinal products”. Regulation (EC) 847/2000, where the definitions of “active substance” and “similar active substance” are contemplated, was recently amended by Regulation (EU) 2018/781, effective as of 19... Read More