General information, not legal or insurance advice. Rules change. Confirm the current requirement with the reviewing ethics committee, the health authority and a broker licensed in each country before you rely on it. bioaccess® is a CRO. We don’t sell, underwrite or bind insurance.
If you’re a US, European or other foreign sponsor planning a study in Latin America, insurance will come up early. It also tends to come up in the wrong order. Sponsors often try to buy a policy before they have a protocol, or assume the US product-liability policy they already hold will satisfy an ethics committee in Lima or San José.
This guide covers what the law actually says in the main Latin American markets. For each country we answer five questions: is insurance mandatory, which rule requires it, does the policy have to sit with a local insurer, what term or minimum applies, and when in the submission you need it. Every requirement links to the primary text we read. Where we couldn’t verify something, we say so.
Key takeaways
- Most of the region requires it, but not in the same way. Peru, Costa Rica, Argentina (drug trials), Chile, Guatemala and Mexico have written requirements. Colombia, the Dominican Republic and El Salvador put the policy on the ethics or submission checklist. Brazil’s 2024 law imposes an indemnity duty on the sponsor but doesn’t require a policy in the statute. Panama’s 2026 decree requires financial provisions for compensation.
- “Local” matters. Argentina requires a policy “constituted in the country”. Peru requires coverage in Peru, and a foreign insurer must have a legal representative there. Costa Rica requires a policy that is “valid and enforceable” in Costa Rica from an insurer with a branch or service center in the country. A worldwide master certificate on its own often won’t satisfy the reviewer.
- The policy follows the protocol, not the other way around. Insurers price a specific study: its design, risk, number of participants, countries, sites and duration. Certificates in several countries must show the protocol number and title. Without a protocol there’s nothing to underwrite.
- Tail periods are written into law in some countries. Costa Rica requires at least two years after the study ends, and three years after each participant’s participation. Peru requires the policy to run until the National Final Report and to be renewed while late damages are possible.
- Mexico changed the sequence in 2025. COFEPRIS now authorizes the protocol first. The sponsor then has 15 business days to file the policy or a financial fund, or the authorization can be revoked.
Why Latin American rules differ from what US sponsors expect
In the United States no federal rule requires clinical trial insurance. Coverage is usually driven by site and CRO contracts. Much of Latin America works differently: participant-injury protection is written into health regulation, ethics committees check the policy as part of approval, and several countries’ general insurance laws limit cover placed with insurers that aren’t authorized locally.
There’s also a liability point. Several countries make the sponsor responsible for trial-related injury whether or not anyone was at fault, and regardless of what the policy pays:
- Chile: the holder of the investigational-use authorization is liable even for damage that couldn’t have been foreseen. Once damage is shown, causation by the trial is presumed, and the limitation period is ten years from when the damage appears (Código Sanitario art. 111 E).
- Guatemala: if the policy doesn’t cover the full damage, the sponsor is liable for the rest without any need to show fault (Acuerdo Ministerial 82-2019, §11.4).
- Peru: the sponsor’s duty to compensate is independent of the policy’s validity or limits (DS 021-2017-SA, art. 29).
So the policy is how the sponsor proves it can pay for that duty. It doesn’t replace the duty.
Country comparison table
| Country | Insurance mandatory? | Legal basis | Local insurer or local policy? | Term or minimum in the rule | When it’s needed |
|---|---|---|---|---|---|
| Brazil | Sponsor must indemnify; the statute has no insurance mandate | Lei 14.874/2024, arts. 23, 26 XV | Brazilian brokers say local admitted cover is expected (confirm) | None in the statute | Set by contracts and ethics review |
| Mexico | Yes: insurance or a financial fund | COFEPRIS Acuerdo of 24 Apr 2025, art. 5; NOM-012-SSA3-2012 §5.14 | Not specified in the rules reviewed | None | Within 15 business days after protocol authorization |
| Colombia | On the GCP ethics and sponsor checklists (drug trials) | Res. 2378/2008, Technical Annex | Not verified | Value “according to international standards” | In the ethics file before approval |
| Argentina | Yes (drug trials for registration) | ANMAT Disp. 7516/2025, Annex II §3.14 | Yes: “seguro constituido en el país” | None | Before the study starts; insurer named in the consent form |
| Chile | Yes | Código Sanitario art. 111 F | Not verified | Through study closure (CEC practice) | With the ISP and ethics package |
| Peru | Yes, plus a financial fund | DS 021-2017-SA, art. 28 | Coverage in Peru; foreign insurer needs a legal representative in Peru | Until the National Final Report, then renewed while late damage is possible | Before authorization; details in the consent form |
| Costa Rica | Yes | Ley 9234, art. 31; Reglamento 39061-S, art. 14 | Enforceable in Costa Rica; insurer with a branch or service center in the country | At least 2 years after the study ends; 3 years after each participant’s participation | Ethics review before start; each participant gets proof of the policy |
| Panama | Sponsor “financial provisions” required | Decreto Ejecutivo 21/2026, art. 67(2) | Not specified | None | Attached to the bioethics submission |
| Dominican Republic | Yes (submission requirement) | CONABIOS requirements (2025) and Manual | Not verified | None | At submission to CONABIOS |
| Guatemala | Yes (drug trials) | Acuerdo Ministerial 82-2019, §11 | Insurer established in the country or working with a national insurer | Payouts equal to the sponsor’s home-country standard | Before the trial starts |
| El Salvador | Yes in practice | CNEIS SOP manual; SRS GCP inspection guide (2025) | Policy must show how it applies in El Salvador | None | With the CNEIS submission; checked at inspection |
None of the rules above sets a minimum dollar limit. Limits come from ethics committees, site and CRO contracts, and the insurer’s underwriting.
Country by country
Brazil
Legal basis: Lei 14.874/2024, the national law on research with human beings. Art. 23 says participants will be indemnified for damage arising from their participation and will receive related health care, and that the sponsor is responsible for both. Art. 26 XV repeats this among the sponsor’s duties. Art. 26 §3 makes the participating institutions jointly responsible for full care of participants. Art. 18 §3 bars any consent-form language suggesting the participant waives rights or that the sponsor is exempt from liability. ANVISA’s drug-trial rule, RDC 945/2024, also places the costs of resolving trial-related adverse events on the sponsor, according to NIH ClinRegs.
Is a policy mandatory? The statute doesn’t require an insurance policy. It requires the sponsor to pay. In practice, sites, contracts and some ethics committees expect that duty to be insured. Brazilian brokers report that a risk located in Brazil generally has to be placed with an insurer authorized by SUSEP, the federal insurance regulator, which means a local Portuguese-language policy issued in reais (NeuCorr, GVM). Confirm this with a SUSEP-registered broker for your structure.
For device sponsors: the law applies to medical devices “no que couber” (where applicable) (art. 62). ANVISA’s device-trial rule is RDC 837/2023.
Mexico
Deep dive: Mexico’s 15-business-day insurance rule.
Legal basis:
– NOM-012-SSA3-2012 §5.14: the research budget must include a financial fund and mechanisms to guarantee continued treatment and the compensation a participant is legally owed for directly related damage. That fund “may be covered with the study insurance”.
– §7.2: the institution, the committees, the PI and, where applicable, the sponsor are responsible for health damage caused by the research.
– §10.6: the consent form must state the participant’s right to compensation and to free treatment.
What changed in 2025: COFEPRIS’s simplification Acuerdo (signed 24 April 2025, published in the DOF on 28 April 2025) removed the study insurance from the initial protocol application. Article 5 now requires the applicant to file three things within 15 business days after the protocol is authorized:
– the ethics-approved consent form
– the “Seguro del estudio (Póliza/Certificado) o fondo financiero vigente” that covers the participants
– the emergency-care form and agreement
Authorizations without this complete information may be revoked. No-risk observational studies are exempt from the insurance and emergency-care items. The sponsor also signs a sworn statement in the new single sponsor form (Formato Único del Patrocinador) committing to file these documents. Changing sponsor (amendment J) requires the policy or fund again.
Policy content: according to ClinRegs, earlier COFEPRIS guidance said the policy or certificate must be in the name of the license holder and the sponsor, cover all local participants, and show the number of participants, the study title and the protocol number.
Local insurer: we found no COFEPRIS rule requiring a Mexican-admitted insurer. Ask your broker how Mexico’s insurance law treats your structure.
Colombia
Legal basis: Resolución 2378 de 2008 adopts Good Clinical Practice for institutions running research with medicines. Its Technical Annex lists “Póliza de seguro para los participantes” among the documents the ethics committee reviews and files. The sponsor checklist asks whether the sponsor provides a “póliza contractual y extracontractual para eventos adversos asociados y atribuibles al producto de investigación, cuyo valor estará de acuerdo con estándares internacionales”. In plain terms: contractual and non-contractual liability cover for adverse events attributable to the investigational product, sized to international standards.
Who and when: the sponsor, before ethics approval.
Not verified: whether a Colombian-licensed insurer is required, and how this applies to medical-device studies. Res. 2378 is written for medicines.
Argentina
Legal basis: ANMAT Disposición 7516/2025. It was published on 9 October 2025, took effect on 1 December 2025, and replaced the 6677/2010 regime. Annex II covers local GCP requirements for clinical pharmacology studies for registration:
– §3.14.1: the sponsor must ensure medical care and contract insurance “en el país” for harm the study causes to participants. Approval doesn’t exempt the sponsor from legal liability.
– §3.14.2: a study may only be carried out once the sponsor has contracted a “seguro constituido en el país” to cover the risks or potential damage to participants.
– §1.2.2(t): the study insurance policy is part of the ethics committee file.
– Appendix D (consent form): the consent form must name the insurance company and its address. It may not include limiting phrases such as “damages will be covered if you followed the study doctor’s instructions” or “reasonable costs will be covered”.
Not verified: the equivalent rule for medical-device trials, and provincial rules (for example Buenos Aires province).
Chile
Legal basis: Código Sanitario art. 111 F, added by Ley 20.850. Holders of the special provisional-use authorization for research with pharmaceuticals or medical devices must hold civil liability insurance, under a Ministry of Health regulation. A supreme decree is to set which classes of medical devices require the policy. Art. 111 E makes the holder liable even for unforeseeable damage, presumes causation once damage is shown, and sets a ten-year limitation period.
What ethics committees ask for: the Health Sciences Ethics Committee of the Pontificia Universidad Católica (CEC Salud UC) issued a statement in March 2025 setting its minimums. The insured must be the authorization holder, the policy must identify the study, it must cover all civil damages related to the research, and it must stay in force until formal closure, including the last follow-up visit.
Not verified: whether the implementing regulation and the device-class decree have been issued, and whether a Chilean insurer is required.
Peru
Legal basis: DS 021-2017-SA, the Clinical Trials Regulation.
– Art. 27: the PI and sponsor provide free care for trial-related injury, and the sponsor must indemnify.
– Art. 28: the sponsor must contract a policy covering damages to participants. Until the policy pays out, the sponsor must keep a financial fund for immediate free treatment. The policy must have coverage in Peru, and if the insurer is foreign it must have a legal representative in Peru. This information must appear in the consent form. The policy must stay in force until the National Final Report is submitted, and then be renewed while late damage is possible, up to the end of any lawsuit.
– Art. 29: defines what is compensable, including pregnancy-related damage, and says the sponsor’s duty doesn’t depend on the policy.
ClinRegs also notes a sponsor or CRO affidavit confirming the policy and the fund (Res. 0423-2019).
Costa Rica
Deep dive: Costa Rica insurance under Ley 9234.
Legal basis: Ley 9234, the Biomedical Research Law.
– Art. 31: clinical research must be covered by a civil liability policy, from the start of the research until at least two years after the participant’s participation ends. The policy must be enforceable in Costa Rica, and the scientific ethics committees (CEC) set its term starting from that minimum.
– Art. 32: each participant receives proof or a copy of the policy showing its number, issuer, term, conditions and claim procedure.
Regulation: Decreto 39061-S, art. 14:
– the sponsor’s policy runs from the start of the study until at least two years after the final report is delivered to the CEC
– each participant is covered from the signing of the consent form until three years after their participation ends
– the sponsor must also cover the investigator and team, except for negligence or protocol violations
– the PI must carry their own civil liability policy
– insurers must have branches or service centers in Costa Rica
Under art. 15, insurers must pay within 30 days of receiving complete documentation, and CONIS refers non-compliance to SUGESE, the insurance regulator.
Panama
More on the decree: Panama Decreto 21 of 2026: what sponsors need to know.
Legal basis: Ley 84 de 2019 and Decreto Ejecutivo 21 of 23 April 2026. Art. 61 gives participants the right to the compensation they need for research-related adverse events, “según los estándares del país”. Art. 67(2) requires the investigator to obtain from the sponsor “las previsiones financieras para la compensación efectiva de los posibles daños” and attach that agreement to the CNBI or accredited bioethics committee submission.
Our reading: the decree requires a documented financial provision. We didn’t find an explicit insurance-policy mandate in its text. A certificate of insurance is the usual way to document that provision, and committees may ask for one.
Dominican Republic
Basis: the submission checklist of CONABIOS, the national bioethics council, lists “Póliza de seguro para participantes“. Its Manual describes this as a civil liability, health or research policy for participants, “as the Council considers appropriate”. The Council also checks the insurance or indemnity that covers the sponsor’s and investigator’s liability.
Guatemala
Basis: Acuerdo Ministerial 82-2019 (MSPAS):
– §11.1–11.2: a trial of an investigational product, a new indication, or one without therapeutic interest for the participant may begin only after insurance covering all resulting damage is in place. Every participant must be covered for injury, disability and death.
– §10.2: the policy covers the civil liability of the sponsor, investigators, collaborators and site, and must be documented before the trial starts.
– §11.3: insurers must be recognized nationally or internationally and either established in Guatemala or working with Guatemalan insurers. Payouts must equal what the sponsor would pay in the trial’s country of origin for the same damage.
El Salvador
Basis: the CNEIS submission checklist asks for information on the sponsor’s participant policy, “specifying how it applies in El Salvador”. The regulator SRS’s 2025 GCP inspection guide checks whether trials hold policies “under current regulation”.
What every LATAM policy needs to show
Across these countries, reviewers check the same handful of things:
- The study: protocol number and title, and in Mexico the number of participants. A policy can’t be issued for a study that hasn’t been defined.
- The insured parties: the sponsor or authorization holder, and often the PI, team and site. Costa Rica and Guatemala write this into the rule.
- Territory and enforceability: in-country coverage (Peru), “constituted in the country” (Argentina), or enforceable with a local service presence (Costa Rica).
- Period: through the final report and beyond (Costa Rica and Peru), and in Chile at least through closure.
- Consent-form alignment: insurer name and policy details in the consent form (Peru, Costa Rica, Argentina). The policy has to exist before the consent form is final.
- No limiting language: Argentina bans specific phrases, and Brazil bars any waiver of rights.
How to sequence insurance with your submission
- Pick the countries first. Local-insurer and term rules differ, and a policy built for one country doesn’t automatically travel.
- Get the protocol to near-final. Insurers underwrite a specific study. Some brokers will quote from a solid draft, but they still need the design, risk level, enrollment, sites and duration. See our companion guide, What insurers need before they’ll quote a clinical trial policy.
- Request quotes for both a master policy and local policies at the same time. Ask the broker to confirm in writing which countries need admitted local paper.
- Draft the consent form injury section with the policy details in hand.
- Bind and issue certificates before the ethics submission in countries that require the policy upfront. In Mexico, have it ready to file within 15 business days of COFEPRIS authorization.
- Diarize the tail. Costa Rica and Peru set minimum periods after the study ends.
Related guides
- What insurers need before they’ll quote a clinical trial policy
- Mexico: the COFEPRIS 15-business-day insurance rule
- Costa Rica: Ley 9234 insurance requirements
- Runoff and tail coverage after LPLV
- Admitted local paper vs freedom-of-services certificates
- The EC/IRB insurance certificate that starts a LATAM device FIH
How bioaccess® helps
We build insurance into the submission plan from the first country decision. We line up the protocol, consent forms and site list the insurer needs, coordinate certificates and named-insured endorsements with your broker, and check the paperwork against each ethics committee’s checklist. We’re not an insurer, and we don’t sell or bind policies.
Talk to bioaccess® about your country plan
FAQ
Is clinical trial insurance legally required in Latin America?
In most of the main markets, yes. It’s required by statute or regulation in Peru, Costa Rica, Argentina (drug trials), Chile, Guatemala and Mexico, where a financial fund is the alternative. Colombia, the Dominican Republic and El Salvador list it in ethics or submission requirements. Brazil requires the sponsor to indemnify but doesn’t require a policy in its 2024 law. Panama requires documented financial provisions.
Can I use my US product liability or global master policy?
Sometimes, as part of the program, but often not by itself. Argentina requires insurance constituted in Argentina. Peru requires coverage in Peru with a local legal representative for foreign insurers. Costa Rica requires a policy enforceable in Costa Rica from an insurer with a local service presence.
Can I get a quote before I have a protocol?
Not a meaningful one. Insurers price the specific study: its design, risk, enrollment, countries, sites and duration. Certificates in several countries must show the protocol number and title. A near-final draft is the practical minimum.
Is there a minimum coverage amount?
None of the national rules we reviewed sets a dollar minimum. Colombia’s GCP resolution refers to “international standards”, and Guatemala ties payouts to the sponsor’s home-country standard. Limits are set by ethics committees, contracts and underwriting.
How long must the policy last?
It depends on the country. In Costa Rica, at least two years after the study ends and three years after each participant’s participation. In Peru, until the National Final Report and longer while late damage is possible. Chilean committees ask for coverage through formal closure.
Who must hold the policy, the sponsor or the CRO?
The sponsor, or the authorization holder in Chile. According to ClinRegs, Peru accepts a policy held by the sponsor or the CRO, but under art. 29 the sponsor’s duty to compensate stays in place. Costa Rica also requires the sponsor to cover the investigator and team, and the PI to hold their own policy.
Does Mexico still require the policy before approval?
Not since COFEPRIS’s April 2025 simplification Acuerdo. The policy or fund is filed within 15 business days after protocol authorization, and missing it can lead to revocation.
Are medical-device trials treated the same as drug trials?
Not always. Argentina’s 2025 rule, Colombia’s GCP resolution and Guatemala’s Acuerdo are written for medicines. Chile delegates device classes to a decree. Confirm the device pathway country by country.
Sources
Primary texts were read on 28 October 2026. See the inline links above. Secondary: NIH ClinRegs country profiles for Brazil, Mexico and Peru; CEC Salud UC (2025); NeuCorr and GVM (Brazil brokers).
Last verified: 28 October 2026. Written by Julio G. Martinez-Clark, CEO of bioaccess®.