La necesaria simplificación del nuevo Decreto de precios
EL GLOBAL
La semana pasada participé en un foro de debate sobre el próximo Real Decreto de financiación y precios de los medicamentos, una reunión organizada por Fuinsa en la que representantes de la administración y de la industria conversamos e intercambiamos puntos de vista sobre un tema de gran relevancia. De los temas que se trataron... Read More
“Alternativas Terapéuticas Equivalentes”, a conference organized by El Global and Gaceta Médica
Jordi Faus speaks about therapeutic equivalence and how this concept is being used by hospitals and regions in Spain
Therapeutic equivalence is becoming one of the hottest topics in Spanish pharmaceutical law and practice. On 27 March 2013, the Central Court for Administrative Contractual Appeals ruled that when approving an invitation to tender dividing the object of the contract in various lots, different active ingredients should not be included in the same group because... Read More
Alternativas Terapéuticas Equivalentes
Presentation at the El Global Conference "Alternativas Terapéuticas Equivalentes: ¿Indicaciones en entredicho?"
Therapeutic equivalence is becoming of the hottest topics in Spanish pharmaceutical law and practice. On 27 March 2013, the Central Court for Administrative Contractual Appeals ruled that when approving an invitation to tender dividing the object of the contract in various lots, different active ingredients should not be included in the same group because therapeutic... Read More
Fuinsa organizes a forum to debate about the new rules on pricing and reimbursement in Spain
Jordi Faus participates at an event where officials from the Ministry of Health have been able to listen to suggestions from the industry in connection with the upcoming rules
The rules which govern pricing and reimbursement of medicines in Spain go back to 1990, when Royal Decree 271/1990 was approved implementing the provisions contained in the first EU Transparency Directive. Since then, major changes have occurred in the legal and economic environment in Spain and also in the EU. At the same time that... Read More
Un impulso a la investigación clínica en España
AMIFE
Desde hace ya un tiempo el mundo sanitario y farmacéutico está siendo objeto de numerosas y profundas reformas normativas, lamentablemente no siempre positivas para estos sectores. Dentro de estas pocas reformas que nos atrevemos a calificar de positivas está la modificacion de la normativa que regula la investigación clínica con medicamentos de uso humano en... Read More
The novelties introduced in Law 29/2006 on Guarantees and Rational Use of Medicinal Products and Medical Devices come into force
Law 10/2013 which incorporates Directives 2010/84/EU and 2011/62/EU, and modifies Law 29/2006 (Official Journal No 177, 25 July 2013)
CAPSULAS Nº 145
Introduction After its parliamentary procedure was finished, on 25 July Law 10/2013, which amends Law 29/2006 on Guarantees and rational use of medicinal products and medical devices, was published in the Official Journal. The provisions of Law 10/2013 came into force immediately, the next day after its publication. The initial objective of the project, as... Read More
Más sobre alternativas terapéuticas equivalentes
EL GLOBAL
En España, donde somos proclives a las definiciones y a las siglas, sería bueno poner pausa en el debate sobre las alternativas terapéuticas equivalentes (ATEs). De otro modo nos arriesgamos a que cuaje la idea de que existen productos que son ATEs, que nos inventemos algún símbolo para ellos o alguna campaña de comunicación, y... Read More
Alternativas Terapéuticas Equivalentes
Juan Suarez speaks about the legal framework for declaring that two medicines are therapeutically equivalent
In recent times, the debate about when and how two or even more medicines may be declared therapeutically equivalent has become more and more important in Spain. Many Spanish regions and hospitals are taking the view that they may rule that some products are equivalent and then direct prescribers to use the one with the... Read More
Faus & Moliner participates at the XLIX Fuinsa Meeting on Therapeutic Equivalence
Juan Suarez speaks about the legal framework for declaring that two medicines are therapeutically equivalent
In recent times, the debate about when and how two or even more medicines may be declared therapeutically equivalent has become more and more important in Spain. Many Spanish regions and hospitals are taking the view that they may rule that some products are equivalent and then direct prescribers to use the one with the... Read More
Liability for defective product: the importance to inform about the identity of the manufacturer or importer
Judgment of the Provincial Court of Santa Cruz de Tenerife, of 18 March 2013, which dismisses the claim by a consumer against the suppliers of the product
CAPSULAS Nº 144
Background A consumer, keen on practicing frontenis, went to the famous sports store “Decathlon” to purchase some glasses from the brand called “Ikus”, made from polycarbonate highly resistant to the impacts generally received by those who practice this sport. For some reason, the consumer suffered a damage, according to him produced by such defective glasses,... Read More