Compassionate use vs post-trial access in Latin America: do not file the wrong petition

U.S. teams often arrive in Latin America with one phrase — “compassionate use” or “expanded access” — and expect a single regional petition that keeps patients on product after a trial. That phrase does not map cleanly onto the instruments that actually govern continued supply in the region. Post-trial access (PTA) after an authorized study is usually a different legal object from named-patient / exceptional-import routes. Filing the wrong one produces per-patient dossiers, wrong desks, and gaps at last-patient-last-visit.

I am Julio Martinez-Clark, CEO of bioaccess®. This page separates those routes using instruments already published on bioaccessla.com — starting with the LATAM post-trial access operator map and the country pillars for Argentina, Brazil, Panama, Chile and Costa Rica. It is not a quote and not legal advice. For operator diligence questions, use how to evaluate a LATAM PTA operator.

Two problems that share vocabulary

Write the board question before you ask regulatory for a “compassionate use letter”:

• Post-trial access (cohort continuity). Identified participants who completed (or still sit in) an authorized clinical trial need continued investigational or successor product because benefit was shown or the statute / ethics framework requires free continuity. The filer is usually the sponsor. The cohort is defined by the trial.
• Named-patient / exceptional / RAEM-style access. An individual patient outside a trial dossier — or treated as if outside it — needs a medicine or device that is not locally registered, often on a treating physician’s request, with quantity and validity windows that look nothing like a trial extension. The filer is often the patient, family, or a physician — not the sponsor cohort manager.

U.S. FDA expanded access under 21 CFR 312 Subpart I is a permissive framework for use outside clinical trials. Puerto Rico sits in that U.S. customs picture on our operator map. Most LATAM countries either (a) impose a binding PTA duty after a trial, (b) offer a separate exceptional-import path, (c) soft-route continuation into “compassionate use” language, or (d) impose nothing. Mixing (a) with (b) is the filing error this page exists to prevent.

Where binding PTA actually sits

Across the twenty jurisdictions on the operator map:

• Binding statutory mandate (10): Argentina, Brazil, Chile, Peru, Ecuador, Costa Rica, Guatemala, Honduras, Nicaragua, Panama.
• Binding instrument, weak or unassigned duty (3): Uruguay, Bolivia, Venezuela — including Venezuela’s BPC “procurar” language and Bolivia’s routing of continuation into per-patient DINAMED compassionate-use authorization.
• No mandate (7): Mexico, Colombia, Paraguay, El Salvador, Dominican Republic, Cuba, Puerto Rico.

Colombia’s Resoluciones 2378/2008 and 8430/1993 contain no post-trial supply obligation; Res. 8430 allocates only harm-related costs. Mexico’s NOM-012-SSA3-2012 §11.2.2 is an investigator duty about continued treatment and care, not a sponsor duty to keep shipping investigational product. Do not invent a Colombian PTA petition because a U.S. template says “expanded access.”

Argentina: the cleanest PTA vs RAEM split

Argentina is the teaching case because both instruments exist in public text and sponsors still swap them.

Cohort PTA — Disposición ANMAT 12792/2016. This is the procedure for importing post-study medication, treatment and materials for participants in an ANMAT-authorized clinical pharmacology study. Article 3 requires the sponsor to file eight documents before the study ends. Article 4 gives DERM a twelve-month authorization per investigator and center. Article 3(g) requires a sworn declaration that supply is free to the participant, the treating institution, and the health coverage. Article 2 excludes authorized extension studies — those stay on the trial track. Detail: Argentina Disposición 12792 pillar.

Named-patient exceptional import — Disposición 4616/2019 (RAEM). The Régimen de Accesibilidad de Excepción a Medicamentos makes no reference to clinical trials. Article 2(a) aims at medicines not registered with ANMAT but registered in an Anexo I country under Decreto 150/92, “destinados a tratar un paciente en particular.” Article 4(a) makes the patient (or family / legal representative) the responsible filer on a treating physician’s prescription and prohibits any gestor or intermediary. Article 12 limits Customs validity to 90 days; quantity caps sit at 90 or 180 days depending on course. Using RAEM for a trial cohort produces one expediente per patient, per renewal, on the wrong legal basis.

If your Argentine continuation plan is “file RAEM for everyone who responded,” you do not have a PTA plan. You have a stack of individual exceptional imports that a sponsor is not even allowed to manage as gestor.

Brazil: PTA is statute; compassionate / expanded / post-estudo share a service channel

Brazil is the strongest PTA mandate in the region and still the easiest place to confuse vocabulary with ANVISA’s assistance-program menu.

• PTA duty: Lei 14.874/2024 Chapter VI (Arts. 30–37) and Decreto 12.651/2025 Art. 31. The sponsor must file a post-study access plan with the CEP before the trial starts, guarantee free supply when the investigator judges the product the best therapeutic alternative, and may interrupt only on listed Article 33 grounds — including five years counted from commercial availability in Brazil. Ministry of Health / INAEP language: continued treatment “não é uma expectativa, mas um dever legal.” Devices and advanced therapies are in scope through Art. 37. Detail: Brazil Lei 14.874 pillar.
• Import / assistance mechanics: For medicines, RDC 38/2013 still frames compassionate use, expanded access, and post-study supply as assistance programs. Post-study supply gets “um ofício autorizando o fornecimento,” not a comunicado especial (Art. 3 §2). ANVISA’s own public notice on Consulta Pública 1.210/2023 disclosed that between 2019 and 2023 it received 256 post-study supply requests alongside 558 compassionate use and 41 expanded access requests — three different request types on one service family, not one interchangeable petition.

Operational takeaway: the CEP-approved PTA program and the ANVISA anuência are not optional synonyms for “compassionate use.” A device sponsor also has a statutory duty under Art. 37 while RDC 38/2013 still speaks in medicamento terms — resolve the post-close import path in the protocol, not at close-out.

Panama, Chile, Costa Rica: PTA without a U.S.-style expanded-access label

• Panama — Decreto Ejecutivo 21/2026 Art. 68 (Gaceta Oficial 30510-C, 23 April 2026): investigators and sponsors must ensure participant access when clinical or public-health benefit was shown, until commercialization in the country, via extension of the trial import permit for exclusive participant use. This is not Ley 419 de 2024 (the commercial medicines statute) and not the repealed Decreto Ejecutivo 1843/2014 path. Detail: Panama Decreto 21/2026 pillar.
• Chile — Código Sanitario Art. 111 C (Ley 20.850): continuity “sin costo para el paciente… por todo el tiempo que persista su utilidad terapéutica,” with the duty following the sanitary-registration holder. That is an open-ended free-supply duty, not a 21 CFR Subpart I-style expanded-access grant. Detail: Chile Ley 20.850 pillar.
• Costa Rica — Ley 9234 Arts. 28 and 53(k): the clearest express device PTA duty in the region — free post-study provision of “el medicamento, dispositivo o procedimiento,” “mientras lo requieran,” with exhaustive exit conditions. The statute mandates supply; it does not hand you a post-trial import route in Art. 55 (which addresses importation before an approved study begins). Detail: Costa Rica Ley 9234 device PTA pillar. Do not republish a second Costa Rica PTA page under a synonym slug.

Where “compassionate use” language is doing different work

• Bolivia: the clinical-studies norm routes continuation into the compassionate-use chapter with per-patient DINAMED authorization — a soft/weak PTA posture that is not Brazil’s pre-trial CEP plan.
• Guatemala: AM 82-2019 Art. 64 is request-driven toward the sponsor; Art. 65 points at compassionate-use authorization by the DRCPFA. That is not automatic cohort PTA.
• Honduras: Acuerdo 0256-ARSA-2025 Art. 63 creates a new free-supply mandate and names extension trial or compassionate use as routes — read Art. 63 next to Art. 18 numeral 5’s softer “cuando el patrocinador lo considere” language before you equate Honduras with Brazil.
• United States / Puerto Rico: 21 CFR 312 Subpart I is permissive expanded access, not a LATAM-style sponsor PTA mandate. Do not paste Subpart I templates into an ANMAT 12792 or Panama Art. 68 file.

Filing mistakes that look like vocabulary errors

1. RAEM for an Argentine trial cohort. Wrong instrument, wrong filer, wrong quantity clock.
2. Calling Brazil PTA “compassionate use” in the CEP cover letter. Brazil already distinguishes post-estudo from uso compassivo and acesso expandido in ANVISA request counts and RDC 38/2013 framing.
3. Citing repealed PTA bases. Argentina Disp. 6677/2010 (repealed by Disp. 7516/2025), Ecuador AM 0075-2017, Honduras Acuerdo 041-2020, Panama Decretos 1843/2014 and 6/2015 — still appear in vendor decks.
4. Assuming obligation implies pathway. Costa Rica and Ecuador show mandate without a clean post-trial import article. Mechanism has to be constructed; it is not “file compassionate use.”
5. Inventing PTA where the map says none. Colombia and Mexico are the usual victims of template overreach.

Operator checklist before you pick a petition name

1. Classify the country: binding PTA / weak / none — using the current instrument on the operator map.
2. Decide whether the patients are trial participants (cohort PTA) or named patients outside that dossier (exceptional / RAEM-style).
3. Name the authorizing office and article you will put in the work order — not “the agency.”
4. Confirm whether devices are textually in scope (Costa Rica Art. 53(k), Brazil Art. 37, Chile Art. 111 A, Peru Art. 2.1.36; Ecuador AM 00069-2024 is medicines-oriented).
5. Appoint the importer of record for the period after the trial import permit lapses.
6. Size cold chain and pharmacovigilance for the real duration — Brazil’s five-year clock starts at Brazilian commercial availability; Chile’s Art. 111 C has no commercialization endpoint.

Working on a LATAM post-trial or exceptional-access program? bioaccess® is a US-headquartered, LATAM-native operator running regulatory, importadora, and 2–8 °C GDP cold-chain functions directly across the region. If you need the instrument, desk, and petition type mapped for a live protocol country list, contact Julio Martinez-Clark, Co-Founder & CEO, at jmclark@bioaccessla.com or +1 (954) 903-7210. More at bioaccessla.com/roadmap.

Frequently asked questions

Is compassionate use the same as post-trial access in Latin America?

Usually no. Post-trial access is continued supply to participants of an authorized trial under a country-specific duty or ethics framework. Compassionate use / exceptional / RAEM-style routes are typically individual-patient pathways that may have nothing to do with a closed or closing trial dossier. Argentina’s Disp. 12792/2016 versus Disp. 4616/2019 is the clearest split; Brazil’s ANVISA assistance channel literally counts compassionate use, expanded access, and post-study supply as separate request types.

Can I use Argentina’s RAEM for my trial cohort?

No. RAEM under Disposición 4616/2019 is an individual-patient exceptional import regime with no clinical-trial reference, patient-as-filer rules, and short quantity/validity windows. Cohort post-trial access runs on Disposición 12792/2016, filed by the sponsor before study end.

Does Brazil treat post-study supply as compassionate use?

No. Lei 14.874/2024 and Decreto 12.651/2025 create a sponsor PTA duty with a pre-trial CEP plan. RDC 38/2013 lists post-study supply alongside compassionate use and expanded access as assistance programs, but they are different request types. Ministry language calls post-study supply a legal duty, not an expectation.

Which LATAM countries require post-trial access?

Ten with binding statutory mandates: Argentina, Brazil, Chile, Peru, Ecuador, Costa Rica, Guatemala, Honduras, Nicaragua and Panama. Three with weak or unassigned duties: Uruguay, Bolivia, Venezuela. Seven with none, including Colombia and Mexico. Read the current instrument — five countries changed frameworks between 2024 and 2026.

Does Costa Rica’s Ley 9234 cover devices for PTA?

Yes. Art. 53(k) expressly includes dispositivo alongside medicamento and procedimiento. Duration is “mientras lo requieran” under Art. 28. That is PTA, not a U.S. expanded-access petition — and the statute still does not hand you a dedicated post-trial import article.

Does Colombia require compassionate use or PTA after a device trial?

Colombia does not currently mandate post-trial access by statute. Voluntary continuity can still be arranged through the ethics committee, informed consent and general import rules. Do not file a U.S.-style expanded-access template as if INVIMA had a PTA desk for closed studies.

How should a sponsor pick between PTA and named-patient filings?

Start from patient status and country instrument. Trial participants in a mandate country → country PTA filing (Argentina 12792, Brazil CEP/ANVISA post-estudo, Panama Art. 68 extension, and so on). Individual patients outside that cohort → the country’s exceptional / compassionate / RAEM-style path, if one exists. Then confirm importer of record, cold chain and PV clocks. Use the ten diligence questions on the PTA operator evaluation page before you sign a work order.