A new method for submitting proposals in public tenders: the “inclusive offer”
Report 11/2013, of 22 of May, of the Consultancy Board for Public Procurement of the Autonomous Region of Aragon
CAPSULAS Nº 144
Background The General Technical Secretary of the Department of Health, Social Welfare and Family of the Autonomous Region of Aragon raised the following issue before the Consultancy Board for Public Procurement of such Region: if in a bid the object of the contract is divided into various lots, is it possible to include in the... Read More
Nociones de Derecho para Departamentos Técnicos de la Industria
Juan Suarez speaks about Spanish Administrative Law at a course aimed to persons working in the pharmaceutical industry
The University of Barcelona, conscious of the importance that regulations have in the pharmaceutical sector, has decided to organize a course to deal with some general aspects of Spanish administrative law. Faus & Moliner partner Juan Suarez, whose professional career includes several years at the legal department of the Ministry of Health and of the... Read More
The direct effect of the European Union law celebrates its 50th anniversary
Regarding the judgment of the European Court of Justice in the Case Van Gend & Loos of 5 February 1963
CAPSULAS Nº 143
50 years have passed since the delivery of the Van Gend & Loos judgment, the first one in which the European Court of Justice established the doctrine known as the principle of direct effect. The creation of the EEC in 1957, a few years after the end of the Second World War, marked an authentic... Read More
Hot topics that economic efficiency assessments raise in daily legal practice
Jordi Faus speaks about "Hot topics that economic efficiency assessments raise in daily legal practice"
Defining the criteria for economic efficiency assessment of medicines is essential. This is one of the conclusions of the Conference held on 8 May 2013 in Madrid, where various experts have discussed about these matters. The Conference has been organized by the Department of Economy of Medicines of the University Carlos III in Madrid, in... Read More
El nuevo sistema de financiación, artículo 85 Ter. 1 de la Ley 29/2006
Faus & Moliner partner Juan Suárez speaks about pricing and reimbursement of medicines in Spain and about therapeutic equivalence
Faus & Moliner has been present, once more, at the Pharmaceutical Law course organized by CEFI, the Spanish Centro de Estudios para el Fomento de la Investigación. The objective of the CEFI courses has always been to analyse, from a legal but also practical perspective, the main issues that affect the life of a medicinal... Read More
Administrative liability if European rules are infringed
The judgment of the National High Court of 6 March 2013 limits the right to claim liabilities to those who invoked European rules
CAPSULAS Nº 143
Background Some years ago, in Spain it was almost impossible to market food supplements and similar plant based products unless they were included in the Annex of the Order of 3 October 1973. The administrative practice consisted of systematically withdrawing these products from the market, without considering if the products were legally marketed in other... Read More
The strategies in view of the approval of generics and the rules of competition defense
Decision 13-D-11 of the French Competition Authority in the case Sanofi-Aventis (Plavix®)
CAPSULAS Nº 143
Background The generic clopido grel based medicinal products that were approved starting from July 2008, when the basic patents of this product expired, showed two diffe rences with respect to Plavix® that was the reference medicinal product: the generics contained a clopidro gel salt different from the one used for Pla vix® and could not include, among their approved... Read More
Some essential premises regarding the evidence to prove solvency in public procurement procedures
Resolution of the Central Administrative Court of Public Procurement Appeals of 18 April 2013, resolution No 152/2013
CAPSULAS Nº 143
The resolution of the Central Administrative Court of Public Procurement Appeals at issue had to resolve on a decision that excluded a company from a tender for not having submitted sufficient documentation to prove that it met the economic solvency requirements demanded in the tender conditions. Basic premises to prove solvency From this resolution we... Read More
The interest of the administration is not the only public interest that deserves to be protected
Resolution of the Central Administrative Court of Public Procurement Appeals of 27 of March of 2013 in the case of the central purchasing body for medicinal products
CAPSULAS Nº 142
At the end of March, the Central Administrative Court of Public Procurement Appeals issued its resolution regarding the Specifications approved by INGESA for the Framework Agreement for the selection of suppliers of medicinal products for various Autonomous Communities and State Organizations, which is known as the central purchasing body for medicinal products. It is a... Read More
The fact that an association provides paid services to the pharmaceutical industry is not enough to revoke its declaration of public interest
Judgment of the National High Court, of 6 of March of 2013, which annuls the decision of the Ministry of Health to revoke the declaration of public interest of a scientific association
CAPSULAS Nº 142
The “Spanish Breast Cancer Research Group” (GEICAM) was formed in April 2002. According to its bylaws, such association had the purpose to perform scientific research in oncology, and breast cancer in particular. For the implementation of such objective it organized, among other activities, courses, conferences, publications, prizes and scholarships among its associates, physicians dedicated to... Read More