Preclinical and Clinical Trial Requirements
Preclinical and clinical trials in Portugal – a legal guide. Prepared in association with Cuatrecasas, a leading law firm in Portugal, this is an extract from The Pharma Legal Handbook: Portugal, 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 trials may be conducted abroad. In those cases, and 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 Portuguese legislation.
2. How are clinical trials funded?
The majority of the clinical trials conducted in Portugal are sponsored by the pharmaceutical industry, being the trials funded by the sponsoring companies.
3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?
The consent of the participation in the clinical trials shall comply with the following requirements:The clinical trials protocols shall describe the reasons, objectives, design, methodology, statistical considerations and organization of a clinical trial. The conducting of clinical trials in Portugal requires prior authorization from Infarmed and favorable opinion of the National Ethics Committee for Clinical Research (CEIC).
4. What are the requirements for consent by participants in clinical trials?
- Participants should receive information, in a suitable language that they are able to understand, on the nature, scope, conditions and consequences and risks of the clinical trial;
- Participants should receive information on their rights to withdraw from the trial, at any moment, and without consequences, including any implications in the healthcare services provided to the participant;
- Consent should be obtained in writing.
5. May participants in clinical trials be compensated?
The Portuguese legislation on clinical trials prohibits the granting of financial incentives to trial participants. However, the participants may be reimbursed for any expenses or losses related to their participation in trials. The Portuguese Ethics Committee on Clinical Trials accepts the payment of lost wages as a result of their participation in the clinical trial, travelling and accommodation expenses, food, medical exams and any other expenses considered legitimate.
6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?
Under Portuguese law, one of the conditions for conducting a clinical trial is the contracting of a civil liability insurance covering the civil liability that may arise from the sponsor and the investigator for the damages caused to the participant. Moreover, the civil liability of the sponsor and of the investigator is joint and objective, which means that the sponsor and the investigator may be liable even though there may be no fault in their performance.