Law No. 9/2026 introduces a clearer legal framework for the authorisation, supervision and liability regime applicable to clinical trials, while simultaneously strengthening the protection of trial participants and the legal certainty of entities involved in clinical research activities.
The legislator’s objective is to enhance the safety of participants and to foster a more transparent and efficient environment for clinical research, while ensuring effective coordination between national authorities and the European system for the evaluation of clinical trials.
The law assigns a central role to two key authorities:
- INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde, I.P., the Portuguese National Authority of Medicines and Health Products, responsible for the application of the European Regulation and for the final decision regarding the authorisation of clinical trials;
- Comissão de Ética para a Investigação Clínica (CEIC), the national Ethics Committee for Clinical Research, responsible for the ethical evaluation of studies and for safeguarding the rights and interests of participants.
The decision to authorise a clinical trial is based on a combined scientific-technical and ethical assessment, with the CEIC’s opinion being binding in relation to ethical matters.
Applications for authorisation must be submitted through the European Clinical Trials Portal https://euclinicaltrials.eu/ and are subsequently evaluated by the competent national authorities.
Within this process, INFARMED verifies the compliance of the application and assesses its scientific and technical aspects, while the CEIC examines the ethical aspects and the documentation addressed to participants.
This system is intended to ensure greater uniformity, transparency and efficiency in authorisation procedures, in line with the European regulatory framework.
The new law further strengthens the legal safeguards afforded to participants in clinical trials, requiring clear and prior informed consent.
Specific rules are also established for:
- minors, whose assent must be obtained whenever possible;
- adults incapable of providing informed consent, whose participation requires the authorisation of their legally appointed representative;
- clinical emergency situations, in which consent may exceptionally be obtained at a later stage.
These provisions aim to ensure that clinical research is conducted in full compliance with fundamental ethical principles and with due respect for the rights, dignity and safety of participants.
The legislation further establishes that the sponsor and the investigator are jointly liable for any damage caused to trial participants, irrespective of fault.
To this end, the sponsor must take out civil liability insurance appropriate to the nature and risks of the clinical trial, ensuring compensation for any harm that may arise.
Moreover, any harm affecting a participant’s health during the trial and up to one year following the conclusion of their participation is presumed to have been caused by the clinical trial, unless proven otherwise.
Compliance with the law is supervised by INFARMED, which may carry out inspections at trial centres, laboratories, the sponsor’s premises, or any other location connected with the conduct of the clinical study.
Failure to comply with these obligations may constitute an administrative offence, subject to fines of up to:
- €50,000 for natural persons, and
- €750,000 for legal entities,
particularly in cases where clinical trials are conducted without authorisation or without the required civil liability insurance.
In conclusion
With the adoption of Law No. 9/2026, Portugal strengthens the legal framework governing clinical research, aligning it with the European regime and ensuring greater protection for participants, increased transparency in regulatory procedures, and enhanced accountability for the entities involved.
This new legal framework also aims to reinforce Portugal’s attractiveness and competitiveness as a destination for clinical trials, thereby supporting scientific research and the development of innovative medicinal products.
Belzuz Abogados, S.L.P. is an international law firm, headquartered in Madrid with offices in Lisbon and Porto, with extensive experience in providing legal advice in regulatory matters, healthcare law, clinical research and other highly regulated sectors.
Our team regularly advises pharmaceutical companies and healthcare sector entities, assisting with regulatory procedures, clinical trial agreements and compliance matters.