Yes — in most cases a clinical trial in Brazil needs a locally admitted policy issued in Brazil, coordinated with your global master policy. No Brazilian rule requires clinical trial insurance as such, and insurance is not a requirement of the ethics review system — but local insurance regulation, sites and clinical trial agreements generally expect local cover, even for sponsors with robust global cover. This guide explains why, and how to set it up without delaying your study start.
The short answer: a local, admitted policy is usually expected
In practice, the insurance that funds the participant guarantee is generally expected to be a locally admitted policy — one issued by an insurer authorised to operate in Brazil — even when the sponsor already holds a global master policy abroad. The reasoning is practical: Brazilian insurance regulation generally requires risks located in Brazil to be placed with locally authorised insurers, and the participants, sites and courts operate under local law and in the local currency.
This does not make your global program irrelevant. Instead, the local and global policies are coordinated: limits, wordings and triggers are aligned so that participants are protected consistently and there is no gap — or unintended duplication — between the two layers.
Why the local policy matters for your study timeline
Under Brazil’s Law 14.874/2024 (art. 23), the sponsor must provide indemnification and health assistance to participants for harm arising from their participation. The law does not mention insurance, and insurance is not a requirement of the ethics review system (CONEP’s guidance says it does not require proof of insurance), but the committee assesses how participants will be cared for and compensated if an adverse event occurs and may ask for clarification — and the policy is usually how sponsors show it; the consent form cannot even limit indemnification or assistance to the policy or its sum insured. Insurance is the usual way to fund that duty, and sponsors, sites and clinical trial agreements commonly require it — which is why arranging the local policy early, not at the last minute, keeps your timeline on track.
How to set it up
- Start early. Share the protocol summary, phase, number of participants and sites, the investigational product and the required limits with your local broker as early as possible.
- Define the insured parties. Decide who is policyholder, who is insured (sponsor, CRO, site, investigator) and who benefits — CRO, site and investigator are not covered automatically, so name them expressly; this avoids gaps later.
- Check the claims-made terms. Brazilian clinical trial policies are civil liability, claims-made covers: confirm the retroactive date and keep cover running until the study closes, plus the extended reporting period.
- Coordinate with the global program. Align the local wording and limits with the master policy so the layers work together.
- Review conditions and exclusions. Check how the policy responds to study-related harm and what the wording excludes.
For the full picture of what this cover includes, see our pillar guide on clinical trial insurance in Brazil. When you are ready, NeuCorr can arrange the local policy and coordinate it with your global program — talk to our team.
This content is informational and does not replace specific legal, regulatory or insurance advice for your study.