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A foundation sought clarification on whether organising clinical trials for pharmaceutical companies based outside the EU was subject to VAT. The DGT ruled that although the general rule of location places the service outside Spain, the criterion of effective use and enjoyment could apply if the services are utilised within Spanish territory.
Cuestión planteada Si los servicios de organización y realización de los referidos ensayos clínicos prestados por parte de la consultante a una entidad establecida fuera de la Comunidad se encontrarían sujetos al Impuesto sobre el Valor Añadido.
Los ensayos clínicos no están exentos por asistencia sanitaria, ya que su fin principal es la investigación y no la salud del paciente. Si el destinatario es una entidad fuera de la UE, el servicio no se considera realizado en España por regla general. Sin embargo, según el artículo 70.Dos de la Ley 37/1992, el IVA será aplicable si los servicios se utilizan o explotan efectivamente en territorio español. Esta aplicación debe analizarse caso por caso para determinar si existe tal uso efectivo.
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