La modificación del régimen jurídico del medicamento a través de la Ley 10/2013 y la necesidad de un texto refundido de la Ley 29/2006

In July 2013, the Spanish Congress approved Law 10/2013. This Law implemented Directive 2010/84/EU on pharmacovigilance and 2011/62/EU on the the prevention of the entry into the legal supply chain of falsified medicinal products. Moreover, Law 10/2013 modified various aspects of Law 29/2006 on guarantees and rational use of medicinal products and medical devices.

The amendment of Law 29/2006 affected issues of great importance: among others, new rules were adopted on pricing and financing of medicines, on special products addressed to individual patients, on the therapeutic positioning of a product and its valid therapeutic alternatives; on substitution of medicines when dispensed at a pharmacy, reference pricing, legal regime of bio similar products, information systems and advertising.

In this work, the author goes through some of these novelties and analyzes them taking also into account the latest regulatory developments and the importance of working on and approving a consolidated version of Law 29/2006, as foreseen by the Fourth Final Provision of Law 10/2013.