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V3232-21 29 December 2021 · SG de Impuestos sobre el Consumo Criterion in force
IVA · ensayos clínicos

Clinical trials provided to non-EU entities may be subject to VAT if used in Spain

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.

The question raised

Whether the services for the organization and performance of the referred clinical trials provided by the applicant to an entity established outside the Community would be subject to Value Added Tax.

The DGT's ruling

Clinical trials are not exempt as healthcare services, since their primary purpose is research and not the health of the patient. If the recipient is an entity outside the EU, the service is generally not considered to be performed in Spain. However, pursuant to Article 70.Two of Law 37/1992, VAT shall be applicable if the services are effectively used or exploited in Spanish territory. This application must be analyzed on a case-by-case basis to determine whether such effective use exists.

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