Confidentiality of documents in public procurement procedures: scope, limits and application
Report 11/2013, of 26 of July, of the Consultancy Board for Public Procurement of the Generalitat of Catalunya (Permanent Commission)
CAPSULAS 146
The Consultancy Board for Public Procurement of the Generalitat of Catalunya (JCCA) has issued a report on confidentiality of documents in public procurement procedures. In its report, the JCCA admits that confidentiality is present “in all the phases of public sector procurement”, therefore it must not only be taken into consideration in the phases of... Read More
The new rules for pharmacovigilance of medicinal products for human use are already applicable
Royal Decree 577/2013 regulating pharmacovigilance of medicinal products for human use (Official Journal No 179, of 27 July 2013)
CAPSULAS 146
Royal Decree 577/2013, which regulates the pharmacovigilance of medicinal products for human use, was published last July in the Official Journal. The objective of this regulation, which replaces Royal Decree 1344/2007, is to adapt the Spanish System of Pharmacovigilance to the new rules introduced by the European Union. With this new Royal Decree our country... Read More
Guidelines on the leniency program in Spain: consolidation and update on administrative practice
Communication of 19 June 2013, issued by the Spanish National Competition Commission on the leniency program
CAPSULAS 146
The leniency program entitles the Spanish National Competition Commission (SNCC) to grant exemptions or reductions of the fines payable in cases of competition law infringement. Any company or natural person can request leniency (meaning the fine exemption or reduction) by reporting, revealing and proving to the SNCC the existence of a cartel as well as... Read More
Adaptarse y servir a los intereses generales o…
EL GLOBAL
Últimamente he leído y oído en diversos foros aquello de que para progresar no es tan importante ser fuerte como ser capaz de adaptarse al cambio. Lo dijo Charles Darwin como parte de su teoría de la evolución, y lo hizo en términos aún más radicales: en la naturaleza, las especies que no se adaptan... Read More
Equivalencia terapéutica – Marco legal
Presentation at the Course on Therapeutic Equivalence and Biosimilars
Therapeutic equivalence is one of the hottest topics in Spanish pharmaceutical law and practice. In some regions, the purchasing authorities have decided to trigger public procurement procedures which may lead to the selection of one product and make it very difficult for prescribers to use a different one. In this event, the Spanish Rheumatology Society... Read More
Faus & Moliner speaks at a Course organized by the Spanish Rheumatology Society
Juan Suarez speaks about the legal framework for therapeutic equivalence in Spain
Therapeutic equivalence is one of the hottest topics in Spanish pharmaceutical law and practice. In some regions, the purchasing authorities have decided to trigger public procurement procedures which may lead to the selection of one product and make it very difficult for prescribers to use a different one. In this event, the Spanish Rheumatology Society... Read More
Análisis legal de las medidas relacionadas con la financiación, prescripción y dispensación de medicamentos
Presentation at the II Professional Meeting on Institutional Relations and Market Access
In Spain, regional governments are responsible for funding the cost of medicines, whilst the central government is the one who decides which products are reimbursed and at what price. This system has created some difficulties, because some regions have taken measures which make access to some medicines very difficult despite the fact that the central... Read More
II Professional Meeting on Market Access and Institutional Relations
Jordi Faus speaks about the measures taken by various regions in Spain regarding pricing and reimbursement of medicines
In Spain, regional governments are responsible for funding the cost of medicines, whilst the central government is the one who decides which products are reimbursed and at what price. This system has created some difficulties, because some regions have taken measures which make access to some medicines very difficult despite the fact that the central... Read More
Ahora toca cumplir con la industria
EL GLOBAL
Coincidiendo con el arranque del nuevo curso político comienzan a vislumbrarse algunos indicios en la evolución de nuestra economía que invitan a un moderado optimismo. Conjurado definitivamente el fantasma del rescate, gobierno y oposición, por una vez y sin que sirva de precedente, coinciden en aventurar que lo peor de la crisis parece haber pasado... Read More
La Aemps busca mantener el CPS en productos sanitarios
EL GLOBAL
Han leído la nota aclaratoria de la Agencia Española de Medicamentos y Productos Sanitarios sobre la publicidad de productos sanitarios tras la entrada en vigor de la Ley 10/2013 de 24 de julio? Si pretenden hacerlo, háganlo por la mañana, bien despiertos, y con un día liviano por delante. Se lo explico. La Ley 10/2013... Read More