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According to the preamble of Royal Decree-Law 16/2012, the Spanish national health system, regarded as one of the greatest achievements of the Spanish welfare state, is encountering serious economic difficulties, due mainly to less efficient management of its existing resources. There is also a considerable lack of coordination between autonomous community health services, resulting in differences in the level of services available to patients. On top of this, the system is facing new challenges that will have an adverse impact on public expenditure, such as an aging population, the need to include innovative therapy in clinical treatments or the development of new medicines.
 
The aim of Royal Decree-Law 16/2012 is to increase the sustainability of the system, improve efficiency in its management, encourage savings and economies of scale, introduce new tools through new technologies, bring about greater cohesion among regions, coordinate health and social services and, above all, ensure equal treatment throughout Spain with a basic portfolio of common services. Against this background, the government considered that the required conditions of extraordinary and urgent need set forth in article 86 of the Spanish Constitution had been fulfilled, permitting it to approve these measures by means of a Royal Decree-Law.

In this Newsletter we will take a look at the new elements introduced by Chapter IV of Royal Decree-Law 16/2012 amending Law 29/2006, of July 26, 2006, on the safeguards for and the rational use of medicinal products and medical devices (“Medicinal Product Law”). We will also summarize other key new legislation in Royal Decree-Law 16/2012-

1. INTRODUCTION
2. KEY NEW CHANGES INTRODUCED BY CHAPTER IV