Royal Decree Law 16/2012, dated 20th April, published in the Official State Gazette on the 24th of April (hereinafter, Royal Decree Law), constitutes a bona fide Omnibus Act which encompasses healthcare services, pharmaceutical benefits and human resources within the National Healthcare System (Servicio Nacional de Salud, hereinafter “ NHS”). The recourse to regulate by means of a Royal Decree Law is warranted by the urgent need to adopt measures which would reduce the public healthcare deficit, with these measures the Government aims to save an estimated 7 billion Euros.
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The Royal Decree Law introduces a vast assortment of measures and introduces modifications in several legal regulations, emphasizing those reforms carried out in Act 16/2003, for the cohesion and quality of the National Healthcare System, Act 29/2006, on guarantees and the rational use of prescription drugs, and Act 44/2003, for the classification of healthcare professions. Following is a summary of the novelties introduced by the Royal Decree Law which are most likely to affect the pharmaceutical sector.
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