Preclinical & Clinical Trial Requirements
Preclinical & clinical trial requirements in Spain – a comprehensive legal overview. Prepared in association with Faus & Moliner Abogados, a leading law firm in Spain, this is an extract from The Pharma Legal Handbook: Spain, available to purchase here for USD 99.
1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?
No, clinical trial may be conducted abroad. For those cases whenever clinical trials are conducted outside the European Union, the applicant of the marketing authorization shall submit a declaration stating that the clinical trials carried out outside the European Union meet the ethical requirements set forth in the Spanish legislation.
2. How are clinical trials funded?
Most of clinical trials conducted in Spain are sponsored by the pharmaceutical industry, being funded by the sponsoring companies. Clinical trials in Spain might be sponsored also by individuals, institutions or organizations, either private or public.
3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?
The clinical trials protocols shall describe the reasons, objectives, design, methodology, statistical considerations and organization of a clinical trial. The authorizing of clinical trials in Spain by the AEMPS requires prior assessment of the protocol, done jointly, by the AEMPS and the Ethics Committee for research with medicinal products.
4. What are the requirements for consent by participants in clinical trials?
Trial participants must freely give their consent before being included in a clinical trial. Consent must be given after having been informed of all aspects of the clinical trial that are relevant to the participant’s decision to participate. Minors or incapacitated persons’ consent must be given through their legal representatives. Consent must be given in writing. The principal investigator is normally in charge for obtaining informed consent from trial subjects.
The Ethics Committee shall approve the process for obtaining consent from trial subjects and the patient information sheet / informed consent form. Such documents must be at least in Spanish.
5. May participants in clinical trials be compensated?
According to Spanish law participants may only be reimbursed for any expenses or losses related to their participation in trials. However, in special situations, the Ethics Committee may report favorably the compensation to participants for the inconveniences derived from their participation in the clinical trial, provided that said compensation does not influence the decision of the participant to participate in the clinical trial.
6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?
Participants will be compensated against any personal damage caused as a result of their participation in the clinical trial, as well as the economic damages that derived from said personal damage, provided that this damage is not inherent either: (i) to the pathology under study or (ii) to the natarual course of the disease of the participant as a result of the ineffectiveness of the treatment.
Under Spanish law, one of the conditions for conducting a clinical trial is the contracting, by the sponsor, of a civil liability insurance covering the civil liability the sponsor, the principal investigator and the investigator’s team, and the site against any claim brought by participants for damages suffered due to the clinical trial. The minimum guaranteed amount shall be EUR 250,000 per trial subject. A maximum insured capital per trial and per year of EUR 2,500,000 may be established.