Though a single sovereign state, the Kingdom of Spain is divided politically into regions known as Autonomous Communities, which enjoy significant legislative authority and political freedom within the scope of their devolved powers and territorial boundaries.
Directive 2010/84/EU on pharmacovigilance and Directive 2011/62/EU on the prevention of entry into the supply chain of falsified medicinal products were transposed in Spain by Law 10/2013, on 24 July, which also amended the Spanish Medical Products Act in order to guarantee the cohesion of the National Public Health System and equality of access to medicines by all citizens. This reform attributes sole competence to establish the scientific and technical conditions of therapeutic equivalence to national government via the Spanish Medicines and Health Products Agency (AEMPS in the Spanish acronym), as well as establishing the general procedural framework for the adoption of official decisions in this area.
Having clarified that the AEMPS has exclusive competence, as a national agency, to decide on the therapeutic equivalence of two or more drugs, let us now turn to consider the problems caused in Spain by the declarations of therapeutic equivalence made by agencies belonging to certain Autonomous Communities, a phenomenon that has engendered a tide of lawsuits and determined opposition from innovative drug companies.
In this context, the Murcia Health Service, the body responsible as a part of the national system for the provision of public health services in the Autonomous Community of Murcia, ordered the region’s physicians to substitute the AstraZeneca medicines Crestor® and Provisacor® for other, low-cost drugs using different active substances, based on the supposed therapeutic equivalence of the products in question.
AstraZeneca appealed against this decision on the grounds that the Murcia Health Service failed to follow due administrative procedure, and that it had acted ultra vires in ruling on the therapeutic equivalence of drugs, an area in which the Spanish Medicines and Health Products Agency has sole competence. This action ignored the constitutional right of all citizens to health care, clashed with the principle of the physician’s freedom to prescribe therapies, and breached AstraZeneca’s right to equal treatment of its products by health professionals prescribing and dispensing medicines throughout Spain.
The Spanish Court considered whether the Murcia Health Service’s action constituted a case of de facto regulation, defined as the use of powers by a government agency without regard for the procedures established by the pertinent legislation (manque de procédure), finding that it had indeed proceeded to make an evaluation of the drugs Crestor® and Provisacor®, despite its lack of competence in this area. The Court therefore found the regional health service guilty of de facto regulation, insofar as no decision had been issued in connection with the drugs by the competent agency, namely the AEMPS.
In this light, the Court ordered the Murcia Health Service to cease and desist, ruling that AstraZeneca should be compensated for the damages occasioned by the unlawful official action taken.