How to evaluate a LATAM post-trial access operator: 10 questions to ask

Most “who does post-trial access in Latin America” shortlists are vendor decks. The diligence question is whether the operator can still import, cold-chain, report safety, and keep patients on product years after database lock — under the instrument that is actually in force in that country.

I am Julio Martinez-Clark, CEO of bioaccess®. Use these ten questions before you sign a PTA work order. They map to our published LATAM post-trial access operator map and legal architecture pillars. This is not a quote and not legal advice.

Regulatory questions

1. Which current instrument and article create the duty? Ask for the citation they will put in the work order: Panama Decreto Ejecutivo 21/2026 Art. 68, Brazil Lei 14.874/2024 Arts. 30–37 and Decreto 12.651/2025, Chile Código Sanitario Art. 111 C (Ley 20.850), Argentina ANMAT Disposición 12792/2016, Peru DS 021-2017-SA Arts. 115–118, Costa Rica Ley 9234 Art. 53(k). If the proposal still cites a repealed Panama Decreto 27/2024 path or treats Argentina Disposición 6677/2010 as if Disp. 7516/2025 erased 12792, stop.
2. Which office authorizes the continued-supply file? Name the authorizing desk — not “the agency.” Argentina’s post-study import is a Disposición 12792 filing before study end; Brazil’s CEP/ANVISA stack and RDC 38/2013 framing are not interchangeable with Argentina’s cohort route. Wrong office is a multi-month miss.
3. Does the country mandate PTA for devices at all? Our operator map is explicit: Colombia does not currently mandate post-trial access by statute. Ecuador stays off the “express device mandate” column unless a primary instrument says otherwise. Do not buy a Colombia PTA program that invents a duty the map does not list.

Import and supply questions

4. Who is importer of record after the trial import permit lapses? PTA fails when the trial-only import story dies at LPLV. Ask who holds the extension, special-import, or successor authorization, and whether that role is the same entity named as registration holder later.
5. Can they keep 2–8 °C (or the protocol’s real band) for years past database lock? Multi-year cohort supply is a GDP problem, not a courier problem. Ask for the named depot, excursion SOP, and who owns product that is still on patients after the CRO’s “study close” invoice.
6. What are the pharmacovigilance onward-transmission clocks? PTA is still a safety file. Ask who receives SAEs from sites, who files to the national authority, and who keeps the SDEA alive when the original CRO work order ends.

Contract and liability questions

7. Is there a signed SDEA within a defined window? Our legal-architecture pillar treats ICH E2A/E2F-style safety exchange as part of the PTA stack, not an afterthought. “We will paper PV later” is a red flag.
8. Which country DPA model is on the table? Argentina Ley 25.326 / AAIP tooling, Brazil LGPD, Chile Ley 21.719 (in force 1 December 2026), Peru DS 016-2024-JUS, and Mexico’s LFPDPPP stack are not one regional template. Ask for the controller/processor labels in local terms.
9. Is sponsor accession a condition of signature? Product-liability and patient-continuity risk should not sit only on a local operator while the US sponsor stays off the accession page. If the work order is silent, assume the gap is intentional.
10. What is the patient-continuity run-off if the operator exits? Ask for the written handoff: who imports next, who holds temperature-controlled stock, who tells the investigator and the patient, and which instrument keeps the file open. A PTA proposal without a run-off clause is a brochure.

Red flags in proposals

• Reliance on repealed or misnamed instruments (wrong Panama decreto; “Ley 419/2023” folklore; Argentina RAEM sold as the trial-cohort PTA route).
• Mixing commercial registro / IOR sales with PTA duty as if they were the same file.
• No named authorizing office, no cold-chain owner, no PV clock, no DPA country, no accession language.
• A single “LATAM PTA” price that pretends Brazil Art. 37, Chile Art. 111 C, and Panama Art. 68 are one operating system.

What “operator” has to mean for multi-year PTA

A LATAM PTA operator is not a one-time importer who can forward a carton. The map pillar’s job is country×instrument clarity; the operator’s job is to keep that instrument executable after the CRO’s study budget ends. That usually means one accountable party for continued import authorization, GDP storage, PV exchange, and patient-facing continuity — not a chain of layered subcontracts that each expire at database lock.

Compare that to commercial market access. The LATAM registration holder / IOR line and the public LATAM Launch Subscription card answer who holds registro for already FDA-cleared or CE-marked devices. PTA answers who keeps beneficial investigational (or successor) supply moving under a trial-era duty. Mixing the two in one proposal is how diligence fails.

How to use the answers

Score each question pass/fail against the country you actually need. Then open the country pillar: Panama Decreto 21/2026 Art. 68, Brazil Lei 14.874, Argentina Disp. 12792/2016, Chile Ley 20.850 / Art. 111 C, Peru DS 021-2017-SA. Market-access registro questions stay on LATAM market access — they do not replace the PTA diligence file.

If you want bioaccess® to run the diligence against a live protocol country list, send the protocol stage, device risk class, and which countries already have patients on treatment. We will map the instrument, authorizing office, and contract gaps — without inventing a duty the statute does not create.