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Tag: PTA operator

  • Which LATAM countries mandate post-trial access for medical devices?

    Four Latin American jurisdictions textually mandate post-trial access (PTA) for medical devices: Costa Rica (Ley 9234 Art. 53(k)), Brazil (Lei 14.874/2024 Art. 37), Chile (Código Sanitario Art. 111 A → 111 C), and Peru (DS 021-2017-SA Art. 2.1.36). Ecuador’s AM 00069-2024 does not. Argentina’s Disp. 12792/2016 is inferential.

    Most LATAM PTA statutes were drafted for medicines. Device sponsors who assume drug rules apply without reading product-class language understate exposure in four countries and overstate it in others.

    Short answer: which countries mandate device PTA?

    Express textual reach (4): Costa Rica, Brazil, Chile, Peru.

    Inferential / confirm-with-regulator: Argentina (productos y materiales; no dispositivo médico); Panama (Art. 68 “el producto” — confirm import pathway with DNFD).

    Medicines-only among binding PTA countries: Ecuador.

    Ten-country PTA mandate list: Argentina, Brazil, Panama, Chile, Peru, Ecuador, Costa Rica, Guatemala, Honduras, and Nicaragua (LATAM PTA operator map).

    Colombia disclaimer: Colombia does not currently mandate post-trial access by statute. When post-trial supply is required, bioaccess® can operate voluntary continuity programs on sponsor request. PTA statutory mandates in LATAM currently apply to Argentina, Brazil, Panama, Chile, Peru, Ecuador, Costa Rica, Guatemala, Honduras, and Nicaragua.

    Which jurisdictions expressly cover medical devices?

    Costa Rica — strongest express device language. Ley 9234 Art. 53(k) obliges free post-study provision of “el medicamento, dispositivo o procedimiento que ha sido objeto de investigación,” with enumerated exits. Art. 28 sets duration at “mientras lo requieran.” No other LATAM PTA instrument states device and procedure coverage this plainly (Map hub).

    Brazil — Chapter VI extends to devices and ATMPs. Lei 14.874/2024 Art. 37 applies the post-trial chapter to “produtos e dispositivos médicos” and experimental advanced therapies “no que couber.” Decreto 12.651/2025 Art. 31 speaks of produto sob investigação. Full analysis: Brazil PTA pillar.

    Chile — Art. 111 A pulls devices into Art. 111 C. Código Sanitario Art. 111 A requires the provisional-use authorization for “todo producto farmacéutico o dispositivo médico.” Art. 111 C then binds that authorization holder — and later the sanitary-registration holder — to free continuity “por todo el tiempo que persista su utilidad terapéutica” (Chile PTA pillar). ISP’s April 2026 device GCP guide (Res. Ex. N° 341 / 2.050) cites Art. 111 A but is silent on Art. 111 C; guidance silence does not erase the statute.

    Peru — definitional inclusion. DS 021-2017-SA Art. 2.1.36 defines producto en investigación as “un producto farmacéutico o dispositivo médico.” Título X (Arts. 115–118) operates on that term with no device carve-out (Peru PTA pillar).

    Which mandate countries are silent, inferential, or medicines-only?

    Ecuador — medicines-only. AM 00069-2024 Arts. 80–81 create a sponsor free-supply duty inside a medicines / natural-medicinal-products reglamento. Device exposure there runs through ethics-committee expectations and informed consent, not those articles (Map hub).

    Argentina — inferential. Disp. 12792/2016 Art. 3(f) covers products and “los materiales” that must match the approved study. Dispositivo médico does not appear. Confirm with ANMAT before assuming the cohort import route applies (Argentina PTA pillar).

    Panama — product language; confirm pathway. Decreto Ejecutivo 21/2026 Art. 68 refers to “el producto”; Chapter XIII covers medicines and other products for human health. Device studies fit a fair reading, but sponsors should confirm the import-permit-extension pathway with DNFD. Primary-source verification required for any device-class DNFD circular not already cited on the Panama pillar.

    Guatemala, Honduras, and Nicaragua sit in the ten-country PTA mandate set (Map hub); device-specific textual reach is thinner than the four express jurisdictions and should be verified before protocol lock. Guatemala AM 82-2019 vs AM 206-2021 supersession status remains primary-source verification required.

    What operational gaps remain after a device duty attaches?

    Obligation is not pathway. Costa Rica Art. 53(k) mandates free device provision, but Art. 55 addresses importation only before an approved study begins — no post-trial import route is identified in the statute (Map hub). Brazil Art. 37 is clear, yet RDC 38/2013 speaks of medicamento; build post-close import from the trial’s own authorizations (Brazil pillar).

    Chile’s open-ended “utilidad terapéutica” raises replacement, consumable, explant, and end-of-life questions the statute does not answer — close them in the protocol (Chile pillar). Peru’s duty can mean continued consumables or support for an implanted system with no device-specific carve-out (Peru pillar).

    Before first site activation: classify each country as express / inferential / medicines-only / no PTA statute; quote the device-scope article; name the post-close import mechanism or document that none exists; define device-system continuity in the protocol; appoint an importer of record after trial authorizations lapse.

    Working on a LATAM device PTA program? bioaccess® is a US-headquartered, LATAM-native operator for regulatory, importadora, and 2–8 °C GDP cold-chain functions. Contact Julio Martinez-Clark, Co-Founder & CEO, at jmclark@bioaccessla.com or +1 (954) 903-7210. More at bioaccessla.com/roadmap.

    Related pillar

    For the full 20-country mandate matrix, cost allocation, and duration comparative — including the ten binding-statute countries and Colombia’s no-PTA framing — read Post-trial access in Latin America: the operator’s map.

    Sources

    • Costa Rica — Ley N.º 9234 (Arts. 28, 53(k), 55): https://documentos.una.ac.cr/bitstream/handle/unadocs/5670/Texto%20Completo%20Norma%209234.pdf?sequence=1&isAllowed=y
    • Brazil — Lei nº 14.874/2024 Art. 37: https://www.planalto.gov.br/ccivil_03/_ato2023-2026/2024/lei/l14874.htm
    • Brazil — Decreto nº 12.651/2025 Art. 31: https://www2.camara.leg.br/legin/fed/decret/2025/decreto-12651-7-outubro-2025-798105-publicacaooriginal-176652-pe.html
    • Brazil — ANVISA RDC nº 38/2013: https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&tipo=RDC&numeroAto=00000038&seqAto=000&valorAno=2013&orgao=RDC/DC/ANVISA/MS&codTipo=&desItem=&desItemFim=&cod_menu=1696&cod_modulo=134&pesquisa=true
    • Chile — Código Sanitario Arts. 111 A, 111 C: https://www.bcn.cl/leychile/navegar?idNorma=5595
    • Chile — Ley 20.850: https://www.bcn.cl/leychile/navegar?idNorma=1078148
    • Chile — ISP Res. Ex. N° 341 / Res. Ex. 2.050: https://www.bcn.cl/leychile/navegar?idNorma=1223885
    • Peru — DS 021-2017-SA Arts. 2.1.36, 115–118: https://ensayosclinicos-repec.ins.gob.pe/images/Reglamento_de_EC.pdf
    • Ecuador — AM 00069-2024 Arts. 80–81, 95(c): https://www.espoch.edu.ec/wp-content/uploads/2025/10/ac-00069-2024_dic_31_compressed_1-1.pdf
    • Argentina — ANMAT Disposición 12792/2016 Art. 3(f): https://www.boletinoficial.gob.ar/detalleAviso/primera/154162/20161117
    • Colombia — Resolución 2378 de 2008: https://www.ins.gov.co/Normatividad/Resoluciones/RESOLUCION%202378%20DE%202008.pdf
    • LATAM PTA Operator Map: https://bioaccessla.com/blog/latam-post-trial-access-operator-map
    • Brazil PTA pillar: https://bioaccessla.com/blog/brazil-post-trial-access-lei-14874
    • Chile PTA pillar: https://bioaccessla.com/blog/chile-post-trial-access-ley-20850
    • Peru PTA pillar: https://bioaccessla.com/blog/peru-post-trial-access-ds-021-2017-sa
    • Argentina PTA pillar: https://bioaccessla.com/blog/argentina-post-trial-access-anmat-disposicion-12792
    • Panama PTA pillar: https://bioaccessla.com/blog/panama-post-trial-access-decreto-ejecutivo-21-2026

  • Who pays for post-trial access under Brazil Lei 14.874?

    The sponsor pays. Under Lei nº 14.874/2024 Article 31 §4, free post-trial supply of the experimental medicine is the sponsor’s responsibility; Decreto nº 12.651/2025 Article 31 restates that duty as fornecimento gratuito.

    Brazil is the only Latin American country where free post-trial supply is an explicit, sponsor-funded statutory duty that reaches drugs, medical devices, and advanced therapies. Brazil’s Ministry of Health puts it plainly: continued treatment after the study “não é uma expectativa, mas um dever legal” — not an expectation, but a legal duty (INAEP FAQ). Sponsors budgeting a Brazilian trial in 2026 budget the product, the cold chain, pharmacovigilance, and the ANVISA import trail against that duty — not against an ethics-committee expectation.

    Who pays for post-trial access under Brazil Lei 14.874?

    The sponsor, exclusively, and free of charge to the participant.

    Three instruments say the same thing in slightly different words:

    • Lei 14.874/2024 Article 31 §4 — where continued treatment with the experimental medicine is necessary after trial end, “o fornecimento do medicamento será de responsabilidade do patrocinador.”
    • Lei 14.874/2024 Article 34 §1 — the sponsor guarantees free post-trial supply whenever the investigator considers the product the best therapy for that participant’s condition and the risk-benefit ratio is more favorable than available alternatives.
    • Decreto 12.651/2025 Article 31 — the sponsor “deverá garantir aos participantes da pesquisa o fornecimento gratuito do produto sob investigação” whenever the responsible investigator reaches that same clinical judgment.

    ANVISA’s RDC nº 38/2013 Article 18 adds operational content to the same rule for medicines assistance programs: the sponsor funds complete free treatment (inciso I), keeps custody and storage of the product (II), may not commercialize it under the program (III), and funds integral assistance for complications arising from its use (VI). Separately, Lei 14.874/2024 Article 35 §2 makes the sponsor responsible for care needed because of study-caused reactions.

    Neither the participant, the treating institution, nor the public health network is the primary payer for investigational-product supply under Chapter VI. Availability of the product in the public network is an interruption ground under Article 33 VII, not a cost-shift rule during the program.

    How does the statute allocate cost before the trial even starts?

    Cost allocation is planned before first patient in. Lei 14.874/2024 Article 30 requires the sponsor and the investigator to submit a plano de acesso pós-estudo to the research ethics committee (CEP) before the trial starts, justifying whether free post-trial supply will be needed. If it will, Article 30 §1 requires a programa de fornecimento pós-estudo, and §2 requires that program to guarantee continued safety follow-up and receipt of the experimental treatment “por prazo determinado.” Article 30 §3 adds a scheduling constraint sponsors routinely miss: the program may only begin after regulatory approval, and the request must be filed early enough for participants to transition without a treatment gap.

    At trial end, Article 31 requires an individual assessment for each participant, performed by the investigator with the sponsor and the participant heard. Under Article 31 §2, free supply is triggered whenever the investigational product is the best therapy for that participant’s condition and shows a more favorable risk-benefit ratio than available alternatives. Article 32 sets the four evaluation criteria: disease severity, availability of satisfactory alternatives in the participant’s locality, whether the product addresses an unmet clinical need, and whether evidence of benefit exceeds evidence of risk. Article 31 §3 and Article 34 §2 both provide that the participant “deverá migrar automaticamente” into the post-study program — migration is automatic, not opt-in.

    Article 37 is why MedTech and cell-and-gene sponsors cannot treat cost allocation as a pharma-only issue: “Aplicar-se-ão aos produtos e dispositivos médicos e aos produtos de terapias avançadas experimentais, objeto de ensaio clínico, as disposições deste Capítulo, no que couber.” The whole post-trial chapter — including who pays — applies to medical devices and experimental advanced therapy products, insofar as applicable. Decreto 12.651/2025 Article 31 reinforces the point by using produto sob investigação rather than medicamento.

    How long must the sponsor fund free supply?

    There is no fixed end date measured from trial close. Lei 14.874/2024 Article 33 permits interruption only on seven grounds, each requiring a justification submitted to the CEP:

    1. participant decision;
    2. cure or introduction of a satisfactory alternative;
    3. absence of continued benefit;
    4. a disqualifying adverse reaction;
    5. technical or safety impossibility of manufacture (provided the sponsor supplies an equivalent or better marketed alternative);
    6. inciso VI — “transcurso do prazo de 5 (cinco) anos, contado da disponibilidade comercial do medicamento experimental no País”;
    7. availability in the public health network.

    Inciso VI carries visible veto history on the Planalto text: the original statute showed “VI – (VETADO),” then the five-year text was marked “(Promulgação partes vetadas)” and promulgated on 1 July 2025 (DOU 2 July 2025). The five-year cap is in force after that promulgation.

    The practical effect is that the five-year clock only starts when the product becomes commercially available in Brazil. A sponsor that never commercializes there, or commercializes late, has no five-year backstop running in its favor. The exposure terminates on clinical or supply events under the other six grounds, or on the commercial-availability clock once it has started — not on a date fixed at trial close. That is why Brazil’s Ministry of Health describes the duty as running “desde o planejamento da pesquisa até o período pós-estudo.”

    What roles do the CEP and ANVISA play in who pays?

    The CEP and ANVISA do not pay. They gate the program that the sponsor funds.

    • CEP — approves the pre-trial plan (Art. 30), the post-study program (Decreto Art. 31 §1), and any interruption justification (Art. 33). The INAEP FAQ states that the program must be submitted for CEP evaluation — “Não basta notificar” — and that the competent CEP is, as a rule, the coordinating centre’s CEP. Decreto Article 31 §2 reserves detailed guidelines to a future INAEP norm.
    • ANVISA — Article 34 §3 requires that importation and dispensing during the post-study program be previously authorized by the competent sanitary authority. For medicines, RDC 38/2013 remains the operative assistance-program instrument: the sponsor or a contracted organização representativa do patrocinador files the anuência; for post-study supply ANVISA issues “um ofício autorizando o fornecimento” (Art. 3 §2), not a comunicado especial.
    • INAEP — the Instância Nacional de Ética em Pesquisa issues ethics norms and acts as appellate instance over CEP decisions (Lei Art. 8). It does not fund supply.

    The cost driver for a sponsor is therefore not a regulator invoice. It is the tail: free product, GDP distribution, pharmacovigilance, ANVISA reporting, and CEP maintenance running until one of the seven Article 33 events occurs, with the five-year clock not starting until Brazilian commercial availability. Price that tail in the Article 30 pre-trial plan. For devices and advanced therapies, also decide in the protocol how the product will physically be imported and dispensed after close — RDC 38/2013 speaks of medicamento, while Article 37 of the statute already attaches the duty.

    Related pillar

    For the full Brazil framework — Chapter VI Arts. 30–37, Decreto 12.651/2025 Art. 31, the RDC 38/2013 import sequence, INAEP’s role, and device/ATMP scope — read Post-trial access in Brazil under Lei 14.874/2024 and Decreto 12.651/2025.

    Working on a LATAM post-trial 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’re evaluating PTA feasibility in Brazil or elsewhere in Latin America, contact Julio Martinez-Clark, Co-Founder & CEO, at jmclark@bioaccessla.com or +1 (954) 903-7210. More at bioaccessla.com/roadmap.

    Sources

    • Lei nº 14.874, de 28 de maio de 2024 (Marco Legal de Pesquisa Clínica), Arts. 30–37, 65; promulgação das partes vetadas (Art. 33 VI), DOU 2.7.2025 — https://www.planalto.gov.br/ccivil_03/_ato2023-2026/2024/lei/l14874.htm
    • Decreto nº 12.651, de 7 de outubro de 2025, Art. 31 — https://www2.camara.leg.br/legin/fed/decret/2025/decreto-12651-7-outubro-2025-798105-publicacaooriginal-176652-pe.html
    • ANVISA RDC nº 38, de 12 de agosto de 2013, Arts. 3, 18 — https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&tipo=RDC&numeroAto=00000038&seqAto=000&valorAno=2013&orgao=RDC/DC/ANVISA/MS&codTipo=&desItem=&desItemFim=&cod_menu=1696&cod_modulo=134&pesquisa=true
    • Ministério da Saúde / INAEP FAQ, “O acesso (fornecimento) pós-estudo é opcional? Como a regra funciona?” (20 Feb 2026) — https://www.gov.br/saude/pt-br/composicao/orgaos-colegiados/inaep/faq/faq/acesso-pos-estudo/o-acesso-fornecimento-pos-estudo-e
    • bioaccess® Brazil PTA pillar — https://bioaccessla.com/blog/brazil-post-trial-access-lei-14874

  • Does Panama require post-trial access?

    Yes. Since 23 April 2026, Panama requires investigators and sponsors to ensure post-trial access under Artículo 68 of Decreto Ejecutivo No. 21 de 23 de abril de 2026, published in Gaceta Oficial Digital No. 30510-C. The duty runs until the product is commercialized in Panama.

    Sponsors closing Panamanian sites in 2026 and 2027 are exposed to a binding obligation that many secondary summaries still miss. The decree implements Titles III and IV of Ley 84 de 14 de mayo de 2019 on health research, entered into force on promulgation under Article 105, and is listed on the MINSA research-regulation hub and the CNBI normativa local page.

    What does Article 68 require?

    Article 68 is titled “Acceso a productos por parte de los participantes.” Its first paragraph uses the mandatory verb deben asegurar: investigators and sponsors must ensure that every participant who demonstrated clinical or public-health benefit during the study keeps access to the product until commercialization in the country, in line with import rules. For that purpose they must request from the competent authority an extension of the research import permit for the exclusive use of that study’s participants through the post-research phase. The full text is in the MINSA copy of Decreto 21/2026 (Gaceta 30510-C).

    Three operational points follow from the article and Chapter XIII:

    1. Co-obligors. The subject is plural — los investigadores y patrocinadores. Panama makes the local principal investigator jointly responsible with the sponsor, which is unusual in the region.
    2. Mechanism. The filing is an extension of the existing research import permit for a closed cohort, not a compassionate-use application. Article 99 ties importation of investigational products to an active RESEGIS project record, ethical approval, and authorization by the Dirección Nacional de Farmacia y Drogas (DNFD).
    3. Agreements. The third paragraph requires acuerdos, convenios u otras figuras documenting the sponsor’s commercialization intent in Panama, modelled on CIOMS, so access can be offered once study participation ends.

    Exceptional cases go to the accredited Comité de Bioética de la Investigación (CBI) that approved the protocol, which decides the applicable mechanisms against previously defined criteria (Article 68 paragraph 2).

    Who pays, and for how long?

    Duration. Article 68 ends the duty at hasta su comercialización en el país — until commercialization in Panama. There is no fixed month count and no statutory cap. Where the sponsor does not plan to register and commercialize in Panama, the obligation is open-ended on its face, and the exit must be negotiated with the CBI under the exceptional-cases paragraph. CIOMS Guideline 6 states that continued access to interventions that have demonstrated significant benefit “may end as soon as the study intervention is made available through the local public health-care system or after a predetermined period of time that the sponsors, researchers and community members have agreed before the start of a trial.” That is why the PTA exit belongs in the protocol and informed consent, not at close-out.

    Cost. Article 68 does not use the word gratuito, so cost allocation is not stated verbatim there. It is reached through linked provisions in the same decree: Article 61 states that participants “no deben incurrir en ningún gasto por participar en un estudio de investigación”; Article 71 num. 2 makes the CIOMS international ethical guidelines a fundamental document for approval, execution and follow-up; and CIOMS Guideline 6 places the obligation to care for participants’ health needs on the researcher and the sponsor, including plans for continued access to interventions that have demonstrated significant benefit. In practice, sponsors should budget product, importation, labelling, cold-chain and local filing costs for the post-research phase.

    What misconceptions should sponsors drop?

    “Panama has a mechanism but no mandate.” Accurate before 23 April 2026; wrong now. Article 68 uses deben asegurar and names both investigators and sponsors. The decree entered into force on promulgation under Article 105.

    “Ley 419/2023 is the Panamanian PTA law.” The year is wrong and the statute is the wrong one. It is Ley 419 of 1 February 2024 (Gaceta 29962-A), a commercial-medicines and public-procurement statute. The health-research statute is Ley 84 de 14 de mayo de 2019. Post-trial access as a binding obligation flows from Ley 84/2019 through Decreto 21/2026 Article 68.

    “Decreto Ejecutivo 27/2024 is the operative PTA instrument.” Decreto Ejecutivo No. 27 de 10 de mayo de 2024 (Gaceta 30028-C) remains in force as the implementing regulation for Ley 419/2024. Its Article 2 num. 3 still defines acceso a medicamento post-estudio clínico as a pharmaceutical product used in a clinical study in Panama, supplied on the treating investigator’s justification of continued benefit until the product is commercially available in the country or as the CBI determines. What Article 104 of Decreto 21/2026 repealed is only Decreto Ejecutivo No. 1843 de 16 de diciembre de 2014, Decreto Ejecutivo No. 6 de 3 de febrero de 2015, and Resolución No. 390 de 6 de noviembre de 2003 — not Decreto 27/2024. Decreto 27/2024 describes an available medicines-regime route; Article 68 imposes a must.

    “PTA in Panama is a compassionate-use filing.” Article 68 routes it through an extension of the research import permit for a defined cohort, evidenced in RESEGIS under Articles 99 and 100, with DNFD authorization.

    What should sponsors do before database lock?

    Define the PTA exit in the protocol and informed consent while the study is open. Obtain CBI approval of the arrangement and the acuerdos o convenios required by Article 68 paragraph 3 before close-out. Keep the RESEGIS record live through the post-research phase. Treat the import-permit extension, DNFD interaction and Spanish labelling (Article 97) as a workstream distinct from the trial, with a named local filer able to act as tramitante where the sponsor has no Panamanian entity. Confirm which accredited CBI holds the file — that committee, not MINSA centrally, decides exceptional-case mechanisms.

    bioaccess® operates regulatory, importadora and 2–8 °C GDP cold-chain functions for LATAM post-trial access programs. For Panama PTA feasibility against the current instrument, contact Julio Martinez-Clark, Co-Founder & CEO, at jmclark@bioaccessla.com or +1 (954) 903-7210. More at bioaccessla.com/roadmap.

    Related pillar

    For the full Article 68 analysis — verbatim text, co-obligor structure, RESEGIS/DNFD/CBI sequence, and device-scope reading — see Post-trial access in Panama under Decreto Ejecutivo 21/2026 Article 68.

    Sources

    • Decreto Ejecutivo No. 21 de 23 de abril de 2026 (MINSA CDN copy of Gaceta 30510-C text): https://minsa.b-cdn.net/sites/default/files/publicacion-general/decreto_ejecutivo_no_21_de_23_de_abril_de_2026_-_reglamenta_titulos_iii_y_iv_ley_84_de_14-5-2019_investigacion_en_salud.pdf
    • Gaceta Oficial Digital No. 30510-C, 23 April 2026: https://www.gacetaoficial.gob.pa/storage/gacetas/2026/04/30510_C/GacetaNo_30510c_20260423.pdf (automated fetch of gacetaoficial.gob.pa returned an Incapsula challenge; instrument text verified against the MINSA CDN PDF above, whose pages carry the Gaceta 30510-C headers)
    • MINSA — Regulación de Investigación para la Salud: https://www.minsa.gob.pa/informacion-salud/regulacion-de-investigacion-para-la-salud
    • CNBI — Normativa local (lists Decreto Ejecutivo N° 21 del 23 de abril de 2026): https://cnbi.senacyt.gob.pa/normativa-local/
    • Ley 84 de 14 de mayo de 2019: http://www.minsa.gob.pa/sites/default/files/general/ley_84_de_14_de_mayo_de_2019_regulaips.pdf
    • Ley 419 de 1 de febrero de 2024 (Gaceta 29962-A): https://www.minsa.gob.pa/sites/default/files/normatividad/ley-419-de-2024-ley-de-medicamentos.pdf
    • Decreto Ejecutivo No. 27 de 10 de mayo de 2024 (Gaceta 30028-C), Art. 2 num. 3: https://www.minsa.gob.pa/sites/default/files/general/decreto_ejecutivo_27_de_10_de_mayo_de_2024.pdf
    • CIOMS International Ethical Guidelines for Health-related Research Involving Humans (2016), Guideline 6: https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf
    • Panama PTA pillar: https://bioaccessla.com/blog/panama-post-trial-access-decreto-ejecutivo-21-2026

  • The legal architecture of Latin American post-trial access: SDEA, DPA, product liability, sponsor accession

    A Latin American post-trial access (PTA) program is a regulatory filing wrapped in four contracts. The filing is the visible part — an ANMAT import expediente, an ANVISA ofício, a DIGEMID authorization. The four contracts are what determine who answers to a regulator, who answers to a patient, and who answers to a plaintiff’s lawyer three years after the last shipment.

    Those four instruments are a Safety Data Exchange Agreement, a country-specific Data Processing Agreement, a product-liability allocation, and — the one most often missing — a sponsor accession mechanism that binds the marketing-authorization holder to the same schedules the operator signed. This piece sets out how we paper each of them and the five architectural mistakes that recur in draft PTA agreements we review.

    Why the paperwork carries more weight than the filing

    In nine Latin American jurisdictions the continued-supply duty is statutory and sits on the sponsor. Brazil’s Lei nº 14.874/2024 Art. 31 §4 states that “o fornecimento do medicamento será de responsabilidade do patrocinador,” and Art. 33 inciso VI releases the sponsor only five years after commercial availability in Brazil. Chile’s Código Sanitario Art. 111 C, inserted by Art. 34 of Ley 20.850, attaches the free-supply duty to the holder of the provisional-use authorization and then to the sanitary-registration holder — including a successor that acquired the registration later. Peru’s DS 021-2017-SA Art. 40(p) and Art. 89 put both the access duty and the funding on the sponsor. Panama’s Decreto Ejecutivo 21/2026 Art. 68 (Gaceta Oficial Digital 30510-C, 23 April 2026, which reglamentates Titles III and IV of Ley 84 de 14 de mayo de 2019) names investigadores y patrocinadores as co-obligors.

    None of those statutes names an operator, an importadora, or a managed-access vendor. The obligation is the sponsor’s by law. Everything the operator does — the import authorization under Disposición ANMAT 12792/2016 Art. 4, the cold-chain leg, the pharmacovigilance intake — is performed on behalf of an obligor that remains the obligor. If the contract does not say so with precision, the operator has effectively assumed a statutory duty it has no legal standing to discharge.

    Pillar 1: the Safety Data Exchange Agreement

    The SDEA is the instrument that connects local adverse-event intake to the sponsor’s global pharmacovigilance system. It should be executed within 30 days of the Work Order, not left to a later “PV annex to follow.”

    Three ICH guidelines set the substance. ICH E2A fixes the expedited-reporting clock: fatal or life-threatening unexpected adverse drug reactions require notification “as soon as possible but no later than 7 calendar days after first knowledge by the sponsor,” followed by a fuller report “within 8 additional calendar days” (§III.B.1), while all other serious unexpected ADRs run on a 15-calendar-day clock (§III.B.2). Because the clock starts on sponsor knowledge, the SDEA must set an internal onward-transmission deadline for the local operator that is materially shorter — otherwise the sponsor’s regulatory clock is being consumed by the operator’s intake queue. ICH E2F governs periodic reporting: the DSUR is an annual report with a data lock point on “the last day of the one-year reporting period” and submission “no later than 60 calendar days after the DSUR data lock point” (§2.2), so the SDEA must specify who supplies PTA-cohort line listings into that cycle and by when. ICH E3 §12 sets the safety-evaluation structure the underlying trial report already follows, which is the format PTA safety data should feed into rather than a parallel one.

    Practical drafting points: name the sponsor’s global PV mailbox and the operator’s PV contact by role, define the reconciliation cadence, and state expressly that regulatory reporting to the local authority is the sponsor’s obligation performed through the operator as agent, with the operator’s duty limited to timely, accurate onward transmission.

    Pillar 2: the Data Processing Agreement — country by country

    There is no single Latin American data-protection instrument, so there is no single DPA. The controlling article set changes by jurisdiction:

    Jurisdiction Instrument Transfer article Notes for PTA drafting
    Argentina Ley 25.326 Art. 12(1)–(2) Transfer to countries without adequate protection is prohibited; Art. 12(2)(b) carves out medical-data exchange where the affected person’s treatment requires it. Art. 11(4) makes the transferee subject to the transferor’s obligations and imposes joint liability.
    Argentina (clauses) AAIP Resolución 198/2023 Anexo I Approves two model clause sets: responsable–responsable and responsable–encargado. Use the latter where the operator processes only on sponsor instruction (Cláusula 6.1).
    Brazil Lei nº 13.709/2018 (LGPD) Arts. 33–36 Art. 33 II(a)–(b) permits transfer on specific or standard contractual clauses; Art. 33 VIII permits it on specific, highlighted consent distinguished from other purposes.
    Mexico LFPDPPP (DOF 20 March 2025) Arts. 35–36 Health data is sensitive (Art. 2 fr. VI) and requires express written consent (Art. 8). Art. 36 fr. II exempts transfers necessary for medical treatment or health-service management.
    Chile Ley 19.628 → Ley 21.719 Art. 10 → Arts. 27–29 Ley 21.719 was published 13 December 2024 and enters into force 1 December 2026. Any Chilean PTA DPA signed now should be drafted to the Arts. 27–29 transfer regime, not only to Ley 19.628 Art. 10.
    Peru DS 016-2024-JUS (Reglamento, Ley 29733) Arts. 18–20 In force 120 calendar days after publication (31 March 2025). Art. 20.1 permits model contractual clauses imposing “cuando menos las mismas obligaciones” on the importer.
    Colombia Ley Estatutaria 1581 de 2012 Art. 26 Health data is sensitive (Art. 5); Art. 26(b) carves out medical-data exchange required by the data subject’s treatment. Otherwise the SIC issues a declaración de conformidad (Art. 26, par. 1).

    The operator-side drafting position is the same everywhere: the sponsor is responsable/controller, the operator is encargado/operator, processing is limited to documented instructions, sub-processing requires prior written consent, and the operator returns or deletes on termination subject to statutory retention. Where the destination country has no adequacy finding, attach the applicable model clauses as a schedule rather than describing them in the body.

    The Argentina adequacy mistake

    The most common error in Argentine PTA drafting is treating Commission Decision 2003/490/EC as if it authorised outbound transfers from Argentina. Article 1 reads: “Argentina is regarded as providing an adequate level of protection for personal data transferred from the Community.” Article 2 confines the decision to adequacy in Argentina “with a view to meeting the requirements of Article 25(1) of Directive 95/46/EC.” The instrument is unidirectional — EU to Argentina.

    A PTA data flow from Argentine sites to a sponsor in the United States, or to an access vendor in the Netherlands, is an Argentine outbound transfer governed by Ley 25.326 Art. 12, and the correct instrument is the AAIP responsable–encargado model agreement under Resolución 198/2023, not a citation to the 2003 decision. Treating the adequacy finding as reciprocal is a defect that survives review because it looks like a considered legal position.

    Pillar 3: product liability sits with the sponsor

    The operator is not the manufacturer, does not hold the marketing authorization, and cannot practically bear product-liability risk for the product itself. A managed-access or expanded-access vendor is in the same position. Neither controls design, manufacture, batch release, labelling content, or the safety profile — so neither can defend a product claim on the merits or insure it economically.

    Our drafting position, and the position we recommend to any operator in this role:

    • The sponsor or titular defends and indemnifies the operator against third-party claims arising from the product itself, including design, manufacture, and labelling defects.
    • The sponsor maintains product-liability insurance covering the PTA territories for the duration of the program plus a tail, and provides certificates on request.
    • The operator’s liability cap covers operator services only. Product liability sits outside the cap.
    • Carve-outs outside the cap in both directions: gross negligence, wilful misconduct, breach of confidentiality, intellectual-property infringement, and breach of data-protection obligations.

    The cap itself is negotiable, usually expressed against fees paid under the Work Order over a defined lookback. Its composition is not: a cap that silently absorbs product liability converts a services agreement into an uninsured product warranty.

    Pillar 4: sponsor accession as a condition precedent

    Because the sponsor holds the statutory supply duty, the product liability, the marketing authorization, and the primary pharmacovigilance obligation, an operator’s Work Order should be conditioned on sponsor accession. Two mechanisms work:

    1. Direct accession — the sponsor executes a short accession instrument to the schedules that allocate safety data exchange, data processing, and liability (in our template set, schedules C, E and F).
    2. Tripartite side letter — the sponsor, the access vendor or intermediary, and the operator sign a single side letter confirming the sponsor’s indemnity, insurance, PV ownership, and patient-continuity funding, with the underlying Work Order otherwise unchanged.

    Either way the Work Order should not become effective until accession is signed. Without it, the operator holds a services contract with a counterparty that cannot deliver the indemnity the contract assumes, and the patient-continuity commitment has no funded obligor behind it.

    Five architectural mistakes we see repeatedly

    1. No sponsor accession condition. The operator signs with an intermediary and inherits an unfunded, uninsurable duty.
    2. Product liability inside the operator’s cap. Structurally wrong for a non-manufacturer.
    3. The reciprocal-adequacy error. Argentina→US or Argentina→NL flows papered as if Decision 2003/490/EC covered them.
    4. No patient-continuity run-off. Termination should trigger a defined run-off — our default is 90 days — during which supply, PV intake, and cold-chain continue at the sponsor’s cost.
    5. No sponsor-funded continuity trigger. If the sponsor terminates the program or the access vendor disengages, the continuity obligation must be expressly sponsor-funded, or patients absorb the commercial dispute.

    Governing law, dispute resolution, and pre-send gates

    For cross-border PTA services agreements with a US-headquartered operator, Delaware law with AAA-ICDR arbitration seated in New York is a sensible default: neutral to the LATAM performance jurisdictions, familiar to sponsor counsel, and enforceable across the region under the New York Convention. Local-law carve-outs remain necessary for the statutory duties themselves, which are not contractible away.

    Before any PTA agreement leaves our desk it passes four gates: (1) a counsel memo verifying the regulatory framework and article citations for each performance jurisdiction; (2) named performing entities, including the habilitada local entity and the importadora of record; (3) sponsor accession path agreed in principle, in writing, before signature; and (4) harmonized statutory-obligation language, so that the same duty is not described one way in the recitals and another way in the schedules.

    Frequently asked questions

    What legal architecture does a LATAM post-trial access program require?
    Four instruments beyond the services agreement itself: a Safety Data Exchange Agreement connecting local adverse-event intake to the sponsor’s global pharmacovigilance system; a country-specific Data Processing Agreement built on the applicable transfer article (Argentina Ley 25.326 Art. 12, Brazil LGPD Arts. 33–36, Colombia Ley 1581 Art. 26, and so on); a product-liability allocation placing defence, indemnity, and insurance on the sponsor or titular; and a sponsor accession mechanism binding the marketing-authorization holder to those schedules. The regulatory filing — import authorization, ethics submission — is separate and downstream.

    What is a Safety Data Exchange Agreement (SDEA) in PTA?
    An SDEA is the bilateral agreement that defines how safety information moves from the PTA site and local operator into the sponsor’s global pharmacovigilance system. It should be executed within 30 days of the Work Order and built on ICH principles: ICH E2A §III.B for the 7-day and 15-calendar-day expedited-reporting clocks, ICH E2F §2.2 for annual DSUR periodicity and the 60-day post-data-lock-point submission window, and ICH E3 §12 for the safety-evaluation structure the data must fit. It names PV contacts, sets onward-transmission deadlines shorter than the sponsor’s regulatory clock, and fixes a reconciliation cadence.

    What is a Data Processing Agreement (DPA) in Argentine PTA?
    It is the instrument that makes an Argentine PTA data flow lawful under Ley 25.326. Art. 12(1) prohibits transfer to countries or organisations that do not provide adequate protection levels, and Art. 11(4) makes the transferee subject to the transferor’s obligations with joint liability. Where the sponsor sits in a country without an Argentine adequacy finding, the practical route is the responsable–encargado model agreement approved by AAIP Resolución 198/2023, attached as a schedule. Cláusula 6.1 limits the importer to the exporter’s documented instructions, with no decision-making power over scope or content.

    Does EU Commission Decision 2003/490/EC cover Argentina→US or Argentina→EU data flows?
    No. Article 1 of Decision 2003/490/EC regards Argentina as adequate for “personal data transferred from the Community,” and Article 2 limits the decision to adequacy in Argentina for the purposes of Article 25(1) of Directive 95/46/EC. The decision is unidirectional: EU to Argentina. An outbound transfer from Argentine sites to a US sponsor or a Dutch access vendor is governed by Ley 25.326 Art. 12 and requires its own adequacy basis, statutory exception, or model clauses. Article 3 of the decision, in fact, gives EU authorities power to suspend flows to recipients in Argentina — the opposite of a reciprocal permission.

    Who bears product liability in a PTA program — the sponsor, the manufacturer, or the operator?
    The sponsor or the titular of the marketing authorization. The operator is not the manufacturer, does not hold the authorization, and does not control design, manufacture, batch release, or labelling — so it cannot defend a product claim on the merits or insure it at a rational price. The correct architecture has the sponsor defend and indemnify the operator for product-related third-party claims, maintain product-liability insurance covering the PTA territories for the program term plus a tail, and accept that product liability sits outside the operator’s services liability cap.

    Why should PTA operators condition the Work Order on sponsor accession?
    Because the sponsor holds every obligation the Work Order depends on: the statutory continued-supply duty, the marketing authorization, primary pharmacovigilance responsibility, product liability, and the funding for patient continuity. An operator that contracts only with an intermediary holds an indemnity from a party that does not control the product and a continuity commitment with no funded obligor. Making accession a condition precedent — rather than a post-signature action item — is the only reliable way to ensure the risk allocation in the schedules is enforceable against the party that can actually perform it.

    What is a tripartite side letter in LATAM PTA?
    A single short instrument signed by the sponsor, the access vendor or intermediary, and the local operator, used where the sponsor will not accede directly to the operator’s schedules. It confirms four things: the sponsor’s defence and indemnity for product-related claims; the sponsor’s product-liability insurance covering the PTA territories; sponsor ownership of primary pharmacovigilance and regulatory reporting; and sponsor funding of patient continuity, including any run-off period. It leaves the underlying Work Order commercial terms untouched, which is usually why it is the faster path to signature.

    What is the standard liability cap in a LATAM PTA Work Order?
    There is no single market standard, and any figure quoted as one should be treated with suspicion. Caps are typically expressed as a ceiling tied to fees paid under the Work Order over a defined lookback period. The more consequential negotiation is not the number but the composition — what the cap covers and what sits outside it. A cap that quietly includes product liability turns a services agreement into an uninsured product warranty, which is a worse outcome for the operator than a low number with clean carve-outs.

    What carve-outs should sit outside the liability cap?
    Five, in both directions: gross negligence, wilful misconduct, breach of confidentiality, intellectual-property infringement, and breach of data-protection obligations. Product liability should also sit outside the operator’s cap, because the operator is not the manufacturer. Data-protection breach deserves particular attention in Latin America: Argentina’s Ley 25.326 Art. 11(4) imposes joint liability between transferor and transferee, and Mexico’s LFPDPPP Art. 59 fr. IV allows sanctions for sensitive-data infractions to be increased up to twofold, so capped data-protection exposure can be materially lower than actual statutory exposure.

    What is the standard patient-continuity run-off period?
    Our default drafting position is 90 days from the effective date of termination. During that window, product supply, pharmacovigilance intake, and cold-chain and importation services continue at the sponsor’s cost while the sponsor arranges an alternative route — a successor operator, an extension study, or transition into commercial or public-system supply. The reason to fix a defined period rather than “a reasonable transition” is that the statutory obligations do not pause: Brazil’s Lei 14.874/2024 Art. 33 lists exhaustive interruption grounds, and contract termination between a sponsor and its operator is not one of them.

    Should managed-access-program specialists require sponsor accession too?
    Yes, and for the same structural reason. A managed-access or expanded-access specialist occupies the same position as a regional operator: it is not the manufacturer, does not hold the marketing authorization, and cannot bear product-liability risk for the product. Whether the intermediary is a global access platform, a specialty distributor, or a regional CRO, the party with the statutory supply duty and the insurable product risk is the sponsor. Any access architecture that leaves the sponsor outside the contractual chain has a gap at exactly the point where a patient-harm claim would land.

    Working on a LATAM post-trial 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’re evaluating PTA feasibility in Argentina, Brazil, Chile, Peru, Panama, Mexico or Colombia, contact Julio Martinez-Clark, Co-Founder & CEO, at jmclark@bioaccessla.com or +1 (954) 903-7210. More at bioaccessla.com/roadmap.

    Sources

    • ICH E2A, Clinical Safety Data Management: Definitions and Standards for Expedited Reporting — https://database.ich.org/sites/default/files/E2A_Guideline.pdf
    • ICH E2F, Development Safety Update Report — https://database.ich.org/sites/default/files/E2F_Guideline.pdf
    • ICH E3, Structure and Content of Clinical Study Reports — https://database.ich.org/sites/default/files/E3_Guideline.pdf
    • Commission Decision 2003/490/EC of 30 June 2003 (Argentina adequacy) — https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32003D0490
    • Argentina, Ley 25.326 (Protección de los Datos Personales) — https://servicios.infoleg.gob.ar/infolegInternet/anexos/60000-64999/64790/texact.htm
    • Argentina, AAIP Resolución 198/2023 (RESOL-2023-198-APN-AAIP, BO 18/10/2023), model international-transfer clauses — https://servicios.infoleg.gob.ar/infolegInternet/anexos/390000-394999/391538/norma.htm
    • Argentina, AAIP Resolución 198/2023 Anexo I (IF-2023-108581614-APN-DNPDP#AAIP) — https://servicios.infoleg.gob.ar/infolegInternet/anexos/390000-394999/391538/res198.pdf
    • Argentina, Disposición ANMAT 12792/2016 (post-study import procedure) — https://www.boletinoficial.gob.ar/detalleAviso/primera/154162/20161117
    • Argentina, Disposición ANMAT 7516/2025 (GCP, in force 1 December 2025) — https://www.boletinoficial.gob.ar/detalleAviso/primera/332695/20251009
    • Brazil, Lei nº 13.709/2018 (LGPD) — https://www.planalto.gov.br/ccivil_03/_ato2015-2018/2018/lei/l13709.htm
    • Brazil, Lei nº 14.874/2024, Arts. 30–37 — https://www.planalto.gov.br/ccivil_03/_ato2023-2026/2024/lei/l14874.htm
    • Brazil, Decreto nº 12.651/2025, Art. 31 — https://www2.camara.leg.br/legin/fed/decret/2025/decreto-12651-7-outubro-2025-798105-publicacaooriginal-176652-pe.html
    • Mexico, Ley Federal de Protección de Datos Personales en Posesión de los Particulares (DOF 20 March 2025; last reform DOF 14 November 2025) — https://www.diputados.gob.mx/LeyesBiblio/pdf/LFPDPPP.pdf
    • Chile, Ley 19.628 sobre Protección de la Vida Privada — https://www.bcn.cl/leychile/navegar?idNorma=141599
    • Chile, Ley 21.719 (published 13 December 2024; in force 1 December 2026) — https://www.bcn.cl/leychile/navegar?idNorma=1209272
    • Chile, Ley 20.850 and Código Sanitario Art. 111 C — https://www.bcn.cl/leychile/navegar?idNorma=1078148
    • Peru, Decreto Supremo N° 016-2024-JUS (Reglamento de la Ley 29733) — https://www.gob.pe/institucion/anpd/normas-legales/6554453-16-2024-jus
    • Peru, Reglamento de Ensayos Clínicos, DS 021-2017-SA, Arts. 115–118 — https://ensayosclinicos-repec.ins.gob.pe/images/Reglamento_de_EC.pdf
    • Colombia, Ley Estatutaria 1581 de 2012 — https://www.funcionpublica.gov.co/eva/gestornormativo/norma.php?i=49981
    • Panama, Decreto Ejecutivo No. 21 de 23 de abril de 2026, Art. 68, Gaceta Oficial Digital No. 30510-C (primary-source Gaceta PDF, read 6 September 2026)

  • Post-trial access in Peru under DS 021-2017-SA

    Peru obliges sponsors to keep supplying the investigational product, free of charge, to participants who are still benefiting after a trial ends. The duty lives in Título X (Arts. 115–118) of the Reglamento de Ensayos Clínicos approved by Decreto Supremo N.° 021-2017-SA, and it covers medical devices as well as drugs.

    What makes Peru different from the rest of Latin America is not the strength of the obligation but its drafting. Most regional PTA mandates state a duty and stop. Peru states the duty, names two authorization routes, lists the exact documents required for one of them, and assigns the post-access safety reporting. That specificity is why Peru is the most operationally tractable post-trial access market in the region.

    The obligation: Article 115 and Article 40(p)

    Article 115 defines post-study access as the free availability, to the research subject, of the investigational product studied in the trial — expressly including products that already hold a Peruvian sanitary registration — after the study closes or after that subject’s participation ends. It also requires that post-study access be anticipated before the study begins and disclosed during the informed consent process (DS 021-2017-SA, Art. 115).

    The same instrument places the duty on the sponsor directly. Article 40(p) makes the sponsor responsible for “asegurar el acceso de los sujetos de investigación, después de la culminación del ensayo clínico al producto de investigación” under the terms of Título X, and adds that this must be specified in the informed consent form. Article 40(s) separately requires free access to the investigational product, complementary products and trial procedures during participation — so the Peruvian scheme is continuous rather than a distinct post-close programme bolted on later.

    Article 115 sets conditions for when the duty is enforceable: the seriousness of the medical condition, the effect of withdrawing or modifying treatment, the absence of satisfactory therapeutic alternatives in Peru for that subject’s condition, sufficient efficacy and safety information, and a positive benefit-risk balance. The product must have proved beneficial to the subject in the principal investigator’s judgment, and “su uso se mantendrá en cuanto hubiere beneficio” — supply continues as long as benefit continues. There is no fixed end date.

    One clause matters in feasibility modelling. Where the pathology falls under the management of a MINSA General Directorate, the sponsor must maintain access “hasta que le sea accesible a través de dichas direcciones” — until the patient can obtain the product through the public system. For conditions inside a national programme, that converts an open-ended commitment into a handoff with a definable end state. For conditions outside one, it does not.

    Who pays

    The sponsor. Article 89 states that investigational products for use in clinical trials “serán financiados por el patrocinador y proporcionados gratuitamente al sujeto de investigación.” Read with Article 115’s “disponibilidad gratuita” and Article 40(p), there is no cost-sharing construct available in Peru — not co-payment, not reimbursement, not a named-patient sale. Budget the cost of goods, import, storage, dispensing and destruction as sponsor expense for the full benefit period.

    Devices are in scope

    Article 2, numeral 2.1, item 36 defines “producto en investigación” as “un producto farmacéutico o dispositivo médico” investigated or used as a comparator in a clinical trial, referring both terms back to Ley N.° 29459. Título X operates on “producto en investigación,” so the post-trial access duty applies textually to device trials, not only pharmaceutical ones.

    A device PTA commitment can mean continued supply of consumables, continued availability of an implanted system’s disposables, or continued technical support — and the Reglamento gives no device-specific carve-out. We treat device PTA exposure in Peru as live from protocol design onward.

    Two authorization routes under Article 116

    Article 116 provides that post-study access may be authorized through either of two mechanisms:

    Route 1 — an extension clinical trial authorized by OGITT. The Oficina General de Investigación y Transferencia Tecnológica of the Instituto Nacional de Salud grants authorization for a trial that constitutes an extension study, following the ordinary trial-authorization requirements in Article 67. Under Article 7, the INS is the national authority responsible for enforcing the Reglamento and for authorizing and overseeing clinical trials.

    Route 2 — case-by-case authorization by the ANM. The Reglamento’s abbreviation table defines ANM as the Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios. In practice that authority is DIGEMID, which describes itself as “la Autoridad Nacional responsable de garantizar la eficacia, seguridad y calidad de los productos farmacéuticos, dispositivos médicos y productos sanitarios” and lists among its functions to “emitir opinión técnica vinculante y supervisar la autorización de los productos y dispositivos en investigación en el marco de lo dispuesto en el Reglamento de Ensayos Clínicos en el Perú” (DIGEMID, Institución).

    Article 116 also fixes the trigger sequence: the principal investigator who considers post-study access appropriate for a subject communicates that to the sponsor, and the sponsor — not the investigator, not the site — files the application with the ANM.

    The routes are not interchangeable. An extension trial suits a defined cohort continuing on protocol with a data objective, and carries full trial-authorization machinery: ethics committee approval, insurance, reporting. The ANM route suits individual patients continuing after close, with no research objective. Choosing between them is the first decision in a Peru PTA plan.

    Article 117: the seven-document set

    The reason Peru is productizable is Article 117. For the ANM route, authorization is granted “para cada caso concreto,” on application by the sponsor that ran the trial, and the requirements are enumerated:

    # Article 117 requirement
    a Application for authorization addressed to the ANM
    b Written informed consent of the subject or legal representative, signed by the subject and the principal investigator
    c Clinical report in which the principal investigator justifies the need for the treatment
    d Duly completed official medical prescription (receta médica oficial)
    e Agreement of the person responsible for the institution or establishment where the treatment will be applied
    f Updated investigator’s brochure, as applicable
    g Copy of the resolución directoral authorizing the clinical trial from which the case derives

    Two of the seven are not sponsor-controlled — item (d) requires a Peruvian official prescription and item (e) requires institutional sign-off from the treating site. Those are the items that slip. Item (g) is why trial-close document retention matters: sponsors that archive the resolución directoral badly discover it when a case is already pending. Because the list is closed and enumerated, the scope of work is definable in advance: one dossier per patient, seven artifacts, two requiring site coordination. That is a service specification, not an open-ended regulatory exercise.

    Import, dispensing and product handling

    PTA supply still has to physically enter Peru and reach the patient under the Reglamento’s product rules. Article 94 provides that the ANM authorizes importation of the investigational product and complementary products by resolución directoral specifying the authorization’s validity period, and must issue it within three business days of application, against four documents: the import application, a copy of the OGITT trial authorization, a list of products and supplies, and proof of fee payment.

    Downstream, Article 92 requires dispensing through a Unidad de Dispensación para Ensayos Clínicos within the pharmacy service of the research institution, under Good Storage and Good Dispensing Practices. Article 91 requires investigational-product labelling to carry “Solo para uso en investigación” and “Prohibida su venta.” Article 96 requires that unused or returned product be destroyed in the presence of a notary public, with the knowledge of the ANM and OGITT. A PTA programme inherits all of it.

    Timelines that are actually in the regulation

    The Reglamento states review periods for the trial-authorization route but not for the Article 117 case authorization.

    Step Statutory period Source
    ANM technical opinion on safety and quality of the investigational product 30 business days (45 for biologics) Art. 69
    OGITT resolution authorizing a clinical trial, including the ANM opinion 40 business days (60 for biologics or where technical commissions are convened) Art. 70
    ANM import authorization by resolución directoral 3 business days Art. 94
    ANM case-by-case post-study access authorization (Art. 116–117) No period stated in the Reglamento —

    Article 70 also suspends the clock when the authority requests supplementary information, so the 40-business-day figure is a floor on a clean file rather than a service level. Sponsors planning a Peru PTA bridge should build the Route 1 schedule from Article 70 and treat Route 2 duration as an assumption to be confirmed with the ANM for the specific case, not a published commitment.

    Pharmacovigilance after access begins

    Article 118 does not release the sponsor at authorization. The sponsor must report treatment results to the ANM within the established period, along with suspected adverse drug reactions, without prejudice to reporting to the corresponding territorial health authority. Peru PTA is therefore a supervised supply arrangement with a continuing safety-reporting duty — which belongs in the pharmacovigilance agreement and the vendor scope, since trial safety infrastructure is often being wound down at exactly the point PTA begins.

    Stability of the pathway

    Título X has not been amended. Decreto Supremo N.° 028-2023-SA of 17 October 2023 modified numeral 2.1 item 10 of Article 2, Article 34(b), Article 40(b), Article 52(e), the heading of Chapter III of Título V, Anexo 1 and Anexo 4, and incorporated items 2.1.48 and 2.1.49, a third paragraph to Article 6, Article 60(i), and new Articles 85-A and 85-B. Articles 115 through 118 are not among them. The pathway a sponsor plans against today is the pathway approved in DS 021-2017-SA of 28 June 2017.

    Working on a LATAM post-trial 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’re evaluating PTA feasibility in Peru, contact Julio Martinez-Clark, Co-Founder & CEO, at jmclark@bioaccessla.com or +1 (954) 903-7210. More at bioaccessla.com/roadmap.

    Frequently asked questions

    Does Peru require post-trial access?
    Yes. Título X of the Reglamento de Ensayos Clínicos, approved by Decreto Supremo N.° 021-2017-SA, creates a binding post-study access duty. Article 115 defines it as free availability of the investigational product to the research subject after the study closes or after that subject’s participation ends, and Article 40(p) assigns the duty to the sponsor. The obligation is conditional rather than automatic: Article 115 requires the principal investigator to find the product beneficial for that subject, and weighs the seriousness of the condition, the effect of withdrawal, the absence of satisfactory alternatives in Peru, the available efficacy and safety data, and the benefit-risk balance.

    What is Decreto Supremo 021-2017-SA?
    It is the Peruvian Reglamento de Ensayos Clínicos, dated 28 June 2017, the decree that governs authorization and conduct of clinical trials in Peru. It sets sponsor and investigator responsibilities, ethics committee accreditation, OGITT trial authorization, investigational product controls, import, pharmacovigilance and supervision. Título X (Articles 115–118) is its post-study access chapter. It was amended by Decreto Supremo N.° 028-2023-SA of 17 October 2023, which did not touch Articles 115–118.

    Who pays for post-trial supply in Peru?
    The sponsor, entirely. Article 89 requires that investigational products be financed by the sponsor and provided free of charge to the research subject, and Article 115 describes post-study access itself as “disponibilidad gratuita.” Article 40(p) puts the access obligation on the sponsor and requires that it be disclosed in the informed consent form. There is no cost-sharing, reimbursement or named-patient sale construct available. Sponsors should budget product cost, import, storage, dispensing and destruction for the entire period the principal investigator finds benefit continuing.

    What are the two authorization routes for PTA in Peru?
    Article 116 names them. The first is authorization of a clinical trial constituting an extension study, granted by OGITT at the Instituto Nacional de Salud under the ordinary trial-authorization requirements of Article 67. The second is a case-by-case authorization from the Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios (ANM) for an investigational product that the principal investigator judges beneficial to the subject. Under Article 116, the investigator notifies the sponsor and the sponsor files the ANM application.

    What is the 7-document checklist under Article 117?
    For the ANM route, Article 117 requires: (a) an application addressed to the ANM; (b) written informed consent signed by the subject or legal representative and the principal investigator; (c) a clinical report in which the principal investigator justifies the need for treatment; (d) a duly completed official medical prescription; (e) agreement from the person responsible for the institution where treatment will be applied; (f) an updated investigator’s brochure as applicable; and (g) a copy of the resolución directoral authorizing the trial from which the case derives. Authorization is granted case by case.

    Does Peru PTA apply to medical devices?
    Yes, textually. Article 2, numeral 2.1, item 36 defines “producto en investigación” as a pharmaceutical product or medical device investigated or used as a comparator in a clinical trial, referencing Ley N.° 29459 for both terms. Título X operates on that same defined term, so the post-study access duty reaches device trials. The Reglamento contains no device-specific exemption from Articles 115–118, which means MedTech sponsors should model continued availability of the device system and its consumables in the same way drug sponsors model continued dosing.

    How long does OGITT authorization take?
    Article 70 gives OGITT a maximum of 40 business days to issue the resolution authorizing a clinical trial, inclusive of the 30 business days Article 69 allows the ANM for its binding technical opinion on the investigational product’s safety and quality. For biologic investigational products, or where the INS convenes technical commissions for controversial matters, the maximum is 60 business days, inclusive of a 45-business-day ANM opinion. The clock is suspended while the applicant responds to a request for supplementary information, so these are clean-file maxima rather than expected durations.

    How long does DIGEMID/ANM case-by-case authorization take?
    The Reglamento does not state a review period for the Article 116–117 case-by-case authorization. It does set an adjacent deadline that is often confused with it: under Article 94, the ANM must issue the investigational product import authorization by resolución directoral within three business days of application. Sponsors should confirm the expected case-review duration with the ANM for the specific product and patient rather than planning against a published figure, and should not assume the three-day import period applies to the Article 117 dossier.

    What is the difference between OGITT and DIGEMID in Peru PTA?
    OGITT — the Oficina General de Investigación y Transferencia Tecnológica of the Instituto Nacional de Salud — authorizes and supervises clinical trials, including the extension trial that constitutes Route 1 under Article 116. DIGEMID acts as the ANM: it issues binding technical opinions on investigational product safety and quality (Article 69), authorizes importation (Article 94), grants the case-by-case post-study access authorization (Articles 116–117), and receives the post-access safety reports (Article 118). Route 1 is an INS filing; Route 2 is a MINSA medicines-authority filing.

    What are the pharmacovigilance obligations during Peru PTA?
    Article 118 requires the sponsor to communicate the results of the treatment to the ANM within the established period, together with suspected adverse drug reactions attributable to the product, without prejudice to reporting adverse reactions to the corresponding territorial health authority. This duty runs for the life of the post-study access arrangement, which under Article 115 continues as long as the principal investigator finds benefit. Sponsors should ensure safety case processing, medical monitoring and the local reporting channel survive database lock rather than being decommissioned with the trial.

    Sources

  • Post-trial access in Latin America: the operator’s map

    Ten Latin American countries legally require a trial sponsor to keep supplying the investigational product after the study closes. Three more address post-trial continuation in binding instruments with weak or unassigned duties. Seven impose nothing. If your Phase 3 has LATAM sites, that distinction is a line item, not an ethics footnote.

    We built this map because the region is now diverging fast. Brazil enacted a statute in 2024 and its regulation in 2025. Honduras went from zero to a mandate in February 2026. Panama replaced its research decree in April 2026. Meanwhile most global vendor and law-firm summaries still cite instruments that have been repealed, and several repeat citation errors that a regulator would catch on the first review cycle.

    Where the mandates actually are

    Across 20 jurisdictions, the classification breaks down as follows.

    Binding statutory mandate (10): Argentina, Brazil, Chile, Peru, Ecuador, Costa Rica, Guatemala, Honduras, Nicaragua, Panama. Each has a law, decree, resolution or ministerial normativa that obliges continued provision of the investigational product after the trial ends.

    Binding instrument, weak or unassigned duty (3): Uruguay, Bolivia, Venezuela. Venezuela’s Buenas Prácticas Clínicas §6.12.1 requires the sponsor only to “procurar… la provisión del tratamiento” after the trial — endeavour, not provide (INHRR). Uruguay’s Decreto 158/019 Anexo numeral 24 says participants “deben tener la certeza de que contarán con los beneficios demostrados” but names no obligor at all (IMPO). Bolivia’s Art. 99 routes continuation entirely into the compassionate-use chapter, requiring per-patient DINAMED authorization (AGEMED).

    No mandate (7): Mexico, Colombia, Paraguay, El Salvador, Dominican Republic, Cuba, Puerto Rico. In each case we read the operative clinical-trial instrument and it contains no post-trial supply obligation.

    The comparative matrix

    Country Mandate status Primary instrument Cost allocation Import mechanism
    Argentina Binding statute Disp. ANMAT 12792/2016; GCP base reset by Disp. 7516/2025 Sponsor, free to participant, site and payer (Art. 3(g)) Dedicated PTA import expediente to ANMAT–DERM, valid 12 months (Art. 4); physical import via INAME (Art. 5)
    Brazil Binding statute Lei 14.874/2024 Arts. 30–37 + Decreto 12.651/2025 Art. 31 Sponsor (Lei Art. 31 §4); free supply (Decreto Art. 31) ANVISA authorization + import licence under RDC 38/2013
    Chile Binding statute Ley 20.850 Art. 17; Cód. Sanitario Art. 111 C “Sin costo para el paciente”; duty on provisional-authorization holder, then registration holder ISP special provisional-use authorization (Art. 111 A); CENABAST exceptional import
    Peru Binding statute DS 021-2017-SA Arts. 115–118 Sponsor-funded, provided free (Arts. 40(p), 89) OGITT extension trial or case-by-case ANM/DIGEMID authorization (Art. 116) with a seven-document set (Art. 117)
    Panama Binding statute Decreto Ejecutivo 21/2026 Art. 68, Gaceta Oficial 30510-C, 23 Apr 2026 Investigators and sponsors co-obligated to ensure access; cost not stated verbatim Extension of the trial import permit for exclusive participant use (Art. 68); RESEGIS registration + DNFD authorization (Art. 99)
    Ecuador Binding statute AM 00069-2024 Arts. 80–81, 95(c) Sponsor or legal representative, “entrega gratuita” (Art. 80) No PTA-specific route; general ARCSA import authorization
    Costa Rica Binding statute Ley 9234 Arts. 28, 53(k) Sponsor, free, “mientras lo requieran” None identified in the statute for post-trial product
    Guatemala Binding statute (instrument version unconfirmed) AM 82-2019 Art. 64; MSPAS index lists AM 206-2021 Supply “podrá ser solicitada al patrocinador” — request-driven, not automatic Compassionate-use authorization by the DRCPFA (Art. 65)
    Honduras Binding statute (new) Acuerdo 0256-ARSA-2025 Art. 63 Sponsor or legal representative, “sin costo” (Art. 63) Extension trial or compassionate use (Art. 63); special ARSA import authorization (Art. 86)
    Nicaragua Binding statute Normativa-166 Cap. VI num. 16 Sponsor obliged; free-of-charge stated for the trial phase only General trial import rules; no PTA route
    Uruguay Binding guidance Decreto 158/019 Anexo num. 24 No obligor named n.a.
    Bolivia Binding guidance Norma para Estudios Clínicos Art. 99 → Arts. 74–76 Not allocated post-trial Per-patient DINAMED compassionate-use authorization
    Venezuela Binding guidance Normas de BPC §§5.4.5, 6.12.1 Free during trial only; post-trial duty is “procurar” None described
    Mexico No mandate for product supply NOM-012-SSA3-2012 §11.2.2 Investigator must arrange continued “tratamiento y cuidados” — not IP supply n.a.
    Colombia No mandate Res. 2378/2008 n.a. n.a.
    Paraguay No mandate Resol. DINAVISA 238/2024 n.a. n.a.
    El Salvador No mandate Lineamientos Técnicos, Ac. Ejec. 1530 (2025) n.a. n.a.
    Dominican Republic No mandate Manual CONABIOS, 2ª ed. n.a. — §7.1 gives an information right only n.a.
    Cuba No mandate BPC en Cuba (CECMED) n.a. — §4.3.2 covers adverse-event medical care only n.a.
    Puerto Rico (US) No mandate 21 CFR 312 Subpart I n.a. — permissive expanded-access framework n.a. (US customs territory)

    Why this is a closing cost, not an ethics footnote

    A sponsor that runs sites in Brazil, Chile, Peru, Panama and Argentina and then closes the study has, in five jurisdictions, a legally enforceable duty to keep shipping product to responders — free of charge, under separate authorizations, for a period the sponsor does not control.

    Brazil’s Ministry of Health states the position without hedging: continued post-study treatment “não é uma expectativa, mas um dever legal, aplicável desde o planejamento da pesquisa até o período pós-estudo” (INAEP FAQ). That duty is priced nowhere in a standard Phase 3 budget. It requires a cohort-scale filing distinct from the trial dossier, an import authorization with its own clock, GDP-compliant cold chain for as long as the cohort persists, and pharmacovigilance reporting after database lock.

    The obligation also survives corporate events. Chile’s Código Sanitario Art. 111 C states the duty “afectará al titular del registro sanitario, aun cuando no haya sido el titular de la autorización provisional o haya adquirido con posterioridad el registro sanitario” (BCN). Buy a Chilean registration and you buy the free-supply obligation attached to it. That belongs in diligence, not in a site-activation checklist.

    The five strongest sponsor obligations

    Brazil. Lei 14.874/2024 Art. 30 requires the sponsor and investigator to file a post-study access plan with the CEP before the trial starts. Art. 31 §4 puts the cost on the sponsor. Art. 33 permits interruption only on listed grounds, including the “transcurso do prazo de 5 (cinco) anos, contado da disponibilidade comercial do medicamento experimental no País.” Decreto 12.651/2025 Art. 31 restates the free-supply duty whenever the investigator judges the product the best therapeutic alternative. Full detail in our Brazil post-trial access pillar.

    Chile. Art. 111 C obliges continuity “sin costo para el paciente… por todo el tiempo que persista su utilidad terapéutica” — no commercialization endpoint, no five-year cap. See the Chile Ley 20.850 analysis.

    Panama. Article 68 of Decreto Ejecutivo 21/2026 (Gaceta Oficial 30510-C, 23 April 2026) reads: “Los investigadores y patrocinadores deben asegurar a todos los participantes el acceso al producto, siempre que se haya comprobado el beneficio clínico o de salud pública de la intervención durante el estudio; hasta su comercialización en el país.” It then requires the sponsor to apply for “una extensión del permiso de importación del producto utilizado durante la investigación para uso exclusivo de los participantes.” The decree entered into force on promulgation under Art. 105. Detail in the Panama Decreto 21/2026 pillar.

    Argentina. Disposición ANMAT 12792/2016 is the only instrument in the region that is purely a post-trial access import procedure. Art. 3(g) requires a sworn sponsor declaration that supply will be “sin costo alguno para el participante, el establecimiento asistencial o su cobertura de salud” — note that the site and the payer are named, not just the patient. Art. 4 gives the DERM authorization a 12-month validity. Art. 2 excludes authorized extension studies, which run on a different track. See the Argentina Disposición 12792 pillar.

    Peru. DS 021-2017-SA is the best-drafted operational regime in the region: Art. 115 defines the obligation and its trigger conditions, Art. 116 names two authorization routes (OGITT extension trial or case-by-case ANM/DIGEMID authorization), Art. 117 lists the documents, Art. 118 assigns post-access pharmacovigilance. Art. 40(p) makes it a sponsor duty. See the Peru DS 021-2017-SA pillar.

    Where the duty reaches devices

    Most LATAM post-trial provisions were drafted for medicines. Four jurisdictions reach hardware textually.

    Costa Rica is the clearest. Ley 9234 Art. 53(k) obliges the sponsor to provide, free of charge and after the study concludes, “el medicamento, dispositivo o procedimiento que ha sido objeto de investigación,” with four exhaustive exits — including a reasoned treating-physician resolution filed in the record and communicated to the CEC within three working days. Art. 28 sets the duration at “mientras lo requieran.”

    Brazil reaches devices through Lei 14.874/2024 Art. 37: “Aplicar-se-ão aos produtos e dispositivos médicos e aos produtos de terapias avançadas experimentais… as disposições deste Capítulo, no que couber.” Chile reaches them through Código Sanitario Art. 111 A, which covers “los productos farmacéuticos y los elementos de uso médico.” Peru reaches them through the definition of producto en investigación in Art. 2.1.36.

    Ecuador does not. AM 00069-2024 is a reglamento for medicines and processed natural medicinal products, so a device sponsor’s Ecuadorian exposure runs through ethics-committee expectations and the informed consent, not through Arts. 80–81.

    What changed between 2024 and 2026

    Honduras added a mandate. Acuerdo 0256-ARSA-2025 Art. 63 defines post-trial access as “la entrega sin costo por parte del patrocinador o su representante legal,” even where the product has no Honduran sanitary registration, subject to three cumulative conditions. Published in La Gaceta on 28 January 2026, in force 30 days later. The predecessor Acuerdo 041-2020 had no post-trial provision at all. Read Art. 63 alongside Art. 18 numeral 5, which softens the duty to facilitating access “cuando el patrocinador lo considere” — a real internal tension, and a reason not to treat Honduras as equivalent to Brazil.

    Panama replaced its research decree. Decreto Ejecutivo 21/2026 reglamenta Titles III and IV of Ley 84 de 14 de mayo de 2019 and entered into force on promulgation, 23 April 2026. Its Art. 104 repeals Decreto Ejecutivo 1843 of 2014, Decreto Ejecutivo 6 of 2015 and Resolución 390 of 2003.

    Ecuador deleted its endpoint. AM 00069-2024 Art. 80 states the free-supply duty with no termination point. The repealed AM 0075-2017 had capped it: Art. 39(w) ran only “hasta que el producto se comercialice en el país” (MSP Ecuador). Art. 81 narrowed the trigger to three cumulative conditions while the duration became open-ended. Almost nobody has flagged that trade.

    Brazil completed a two-step build. Statute in 2024, regulation in 2025, with further INAEP guidance promised by Decreto 12.651/2025 Art. 31 §2.

    Argentina reset its GCP base. Disposición 7516/2025 took effect 1 December 2025 (Art. 8). Its Art. 7 repealed Disposiciones 6677/10, 4008/17, 9929/19 and 2172/25 plus Circulares 0001/11 and 004/18. Disp. 12792/2016 is absent from that repeal list, so the post-trial import procedure stands — but the substantive continuity duty moved into the new GCP annex, and sponsors are filing against instruments that no longer exist. The legal architecture of LATAM PTA piece works through how the obligation layer and the import layer interact.

    Colombia: no binding post-trial access statute

    We read Resolución 2378 de 2008 and Resolución 8430 de 1993 in full, checking expressly for post-trial supply language. Neither contains any. Res. 8430/1993 allocates only harm-related costs — Art. 13 medical care for research-related injury, Art. 15(j) treatment availability and indemnification, Art. 15(k) additional costs against the research budget.

    That makes Colombia a cost-certainty jurisdiction: no statutory tail obligation, no separate post-trial filing, no open-ended supply exposure. It does not make post-trial access impossible. A sponsor that wants to continue supplying responders in Colombia can run a voluntary continuity program on its own initiative, handled through the ethics committee, the informed consent and the general product import rules. The exposure is contractual and reputational rather than statutory, which means it has to be allocated in the CRO and site agreements rather than assumed away.

    Mexico sits in an adjacent position and is routinely misdescribed. NOM-012-SSA3-2012 §11.2.2 obliges “el investigador principal” to arrange continuation of “el tratamiento y cuidados” to prevent withdrawal effects. That is an investigator duty about care, not a sponsor duty to supply the investigational product.

    What sponsors get wrong

    Citing repealed instruments. Argentina’s Disp. 6677/2010, which historically carried the continuity obligation, is repealed. Ecuador’s AM 0075-2017 is repealed. Honduras’s Acuerdo 041-2020 is revoked in its entirety. Panama’s Decreto Ejecutivo 1843/2014 and 6/2015 are repealed. Filings and legal memos still quote all of them.

    The “Ley 419/2023” error. Panama’s medicines statute is Ley 419 of 1 February 2024, not 2023 — and it is a commercial-medicines law, not the post-trial access instrument. The binding post-trial duty sits in Decreto Ejecutivo 21/2026 Art. 68, under Ley 84 of 2019. Getting this wrong signals to a Panamanian reviewer that the filer has not read the current framework.

    Treating Argentina’s RAEM as post-trial access. Disposición 4616/2019 approves the Régimen de Accesibilidad de Excepción a Medicamentos: an individual-patient exceptional import route with 90-day, 180-day and one-year quantity windows (Boletín Oficial). It contains no reference to clinical trials or post-trial access. Filing a trial cohort through RAEM means one expediente per patient, per renewal, on the wrong legal basis. Cohort post-trial access in Argentina runs on Disp. 12792/2016.

    Assuming an obligation implies a pathway. Costa Rica mandates continued free provision of the device or medicine under Art. 53(k), but Art. 55 addresses importation only before an approved study begins. No post-trial import route is identified in the statute. Ecuador and Nicaragua have the same shape. The obligation is real; the mechanism has to be constructed.

    The fastest route to compliance

    For a sponsor closing a multi-country LATAM Phase 3, the sequence that works is: classify each participating country into mandate / soft / none using the operative current instrument; identify which mandate countries require a filing distinct from the trial dossier (Argentina, Brazil, Panama, Peru at minimum); confirm whether your product class is textually in scope, which matters most for devices; establish who the legal importer of record will be in each country, since the trial import authorization frequently expires with the trial; and only then estimate cohort size, duration and cold-chain cost. Countries with no mandate still need a documented position, because the ethics committee and the informed consent will ask.

    Working on a LATAM post-trial 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’re evaluating PTA feasibility in Argentina, Brazil, Chile, Peru, Panama, Costa Rica or elsewhere in Latin America, contact Julio Martinez-Clark, Co-Founder & CEO, at jmclark@bioaccessla.com or +1 (954) 903-7210. More at bioaccessla.com/roadmap.

    Frequently Asked Questions

    Which Latin American countries require post-trial access?
    Ten jurisdictions impose a binding statutory duty: Argentina, Brazil, Chile, Peru, Ecuador, Costa Rica, Guatemala, Honduras, Nicaragua and Panama. Three more — Uruguay, Bolivia and Venezuela — address post-trial continuation in binding instruments but with weak verbs, no named obligor, or routing into per-patient compassionate use. Seven impose nothing: Mexico, Colombia, Paraguay, El Salvador, the Dominican Republic, Cuba and Puerto Rico. The classification depends on reading the operative current instrument, not a secondary summary, because five of these countries changed their framework between 2024 and 2026.

    Which LATAM country has the strongest post-trial access mandate?
    Brazil. Lei 14.874/2024 Art. 30 requires a post-study access plan to be filed with the ethics committee before the trial begins, Art. 31 §4 assigns the cost to the sponsor, and Art. 33 permits interruption only on listed grounds — one of which is the passage of five years from the product’s commercial availability in Brazil. Decreto 12.651/2025 Art. 31 restates the free-supply duty. Brazil’s Ministry of Health describes this as a legal duty rather than an expectation. Chile is the closest runner-up because Art. 111 C has no endpoint at all and the obligation follows the sanitary registration to any subsequent holder.

    Does post-trial access in LATAM apply to medical devices or only drugs?
    Both, in four jurisdictions. Costa Rica’s Ley 9234 Art. 53(k) is the most explicit, obliging free post-study provision of “el medicamento, dispositivo o procedimiento.” Brazil extends its post-trial chapter to devices and advanced therapies through Lei 14.874/2024 Art. 37. Chile’s Código Sanitario Art. 111 A covers “elementos de uso médico.” Peru’s definition of producto en investigación in DS 021-2017-SA Art. 2.1.36 includes devices. Ecuador’s AM 00069-2024 does not cover devices. Argentina’s Disp. 12792/2016 covers products and “materiales” without using the word dispositivo médico, so device coverage there is inferential.

    Which LATAM countries do NOT require post-trial access?
    Mexico, Colombia, Paraguay, El Salvador, the Dominican Republic, Cuba and Puerto Rico. Colombia’s Resoluciones 2378/2008 and 8430/1993 contain no post-trial supply obligation; Res. 8430/1993 allocates only harm-related costs. Mexico’s NOM-012-SSA3-2012 §11.2.2 imposes a continuity duty on the principal investigator covering treatment and care, not on the sponsor to supply the investigational product. Notably, both Paraguay (2024) and El Salvador (2025) rewrote their research frameworks in this window and declined to add a post-trial provision, which cuts against the assumption that the whole region is converging on mandatory access.

    What changed in LATAM post-trial access regulation in 2024-2026?
    Five substantive moves. Brazil completed a two-step build with Lei 14.874/2024 and Decreto 12.651/2025. Ecuador’s AM 00069-2024 repealed AM 0075-2017 and deleted the “until commercialized in the country” endpoint, converting a bounded duty into an open-ended one. Argentina’s Disposición 7516/2025 took effect 1 December 2025 and repealed Disp. 6677/10 among others, resetting the GCP base while leaving the 2016 post-trial import procedure standing. Honduras moved from no mandate to a binding mandate via Acuerdo 0256-ARSA-2025 Art. 63, in force from late February 2026. Panama’s Decreto Ejecutivo 21/2026 entered into force 23 April 2026 with a binding post-trial duty in Art. 68.

    What is the difference between cohort PTA (Argentina) and individual expanded access (RAEM)?
    They are separate legal regimes with separate instruments. Post-trial access under Disposición ANMAT 12792/2016 is a cohort-level procedure: one expediente covering the named participants from an ANMAT-authorized trial, approved by the ethics committee, filed with the Dirección de Evaluación y Registro de Medicamentos, with a 12-month import authorization under Art. 4. The Régimen de Accesibilidad de Excepción a Medicamentos under Disposición 4616/2019 is an individual-patient exceptional import route with 90-day, 180-day and one-year quantity limits, and it makes no reference to clinical trials. Using RAEM for a trial cohort produces per-patient filings on the wrong basis.

    Who pays for post-trial access in Latin America?
    The sponsor, in every country where the duty is clearly allocated. Brazil’s Lei 14.874/2024 Art. 31 §4 puts the supply on the sponsor. Peru’s DS 021-2017-SA Art. 89 requires products to be sponsor-financed and provided free. Costa Rica’s Ley 9234 Art. 53(k) and Ecuador’s AM 00069-2024 Art. 80 both name the sponsor. Chile’s Art. 111 C places the duty on the provisional-authorization holder and then the registration holder. Argentina goes furthest: Disp. 12792/2016 Art. 3(g) requires a sworn declaration that supply carries no cost to the participant, the treating institution or the health coverage. Uruguay, Bolivia, Nicaragua and Honduras leave the cost-bearer partly or wholly unstated.

    How does a sponsor find a qualified PTA operator in Latin America?
    Test three capabilities separately. First, regulatory: can the operator file the country-specific post-trial authorization itself, naming the correct current instrument and article, rather than subcontracting it blind. Second, importation: can it act as legal importer of record after the trial import authorization lapses, which it does in several countries. Third, distribution: can it hold and ship the product under 2–8 °C GDP conditions for the life of the cohort, with pharmacovigilance reporting after database lock. Global post-trial supply vendors market the service regionally without naming Latin American countries or local filing capability on their public pages, so ask for the specific article and the specific authorizing office.

    What is the fastest route to compliance for a sponsor closing a multi-country LATAM Phase 3?
    Start from the operative instrument in each participating country, not from a regional summary. Classify each country as binding mandate, weak instrument or no mandate; determine which mandate countries require a filing distinct from the trial dossier — Argentina, Brazil, Panama and Peru at minimum; confirm your product class is textually in scope, which is the decisive question for devices; appoint a legal importer of record in each country because trial import authorizations frequently expire with the trial; then size the cohort, the duration and the cold chain. Countries with no mandate still need a documented, defensible position for the ethics committee.

    Sources

    • Argentina — Disposición ANMAT 12792/2016: https://www.boletinoficial.gob.ar/detalleAviso/primera/154162/20161117
    • Argentina — Disposición ANMAT 7516/2025: https://www.boletinoficial.gob.ar/detalleAviso/primera/332695/20251009
    • Argentina — Disposición ANMAT 4616/2019 (RAEM): https://www.boletinoficial.gob.ar/detalleAviso/primera/208794/20190604
    • Brazil — Lei nº 14.874/2024: https://www.planalto.gov.br/ccivil_03/_ato2023-2026/2024/lei/l14874.htm
    • Brazil — Decreto nº 12.651/2025: https://www2.camara.leg.br/legin/fed/decret/2025/decreto-12651-7-outubro-2025-798105-publicacaooriginal-176652-pe.html
    • Brazil — ANVISA RDC nº 38/2013: https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&tipo=RDC&numeroAto=00000038&seqAto=000&valorAno=2013&orgao=RDC/DC/ANVISA/MS&codTipo=&desItem=&desItemFim=&cod_menu=1696&cod_modulo=134&pesquisa=true
    • Brazil — Ministério da Saúde / INAEP FAQ on acesso pós-estudo: https://www.gov.br/saude/pt-br/composicao/orgaos-colegiados/inaep/faq/faq/acesso-pos-estudo/o-acesso-fornecimento-pos-estudo-e
    • Chile — Ley 20.850 and Código Sanitario Arts. 111 A–111 C: https://www.bcn.cl/leychile/navegar?idNorma=1078148
    • Peru — Reglamento de Ensayos Clínicos, DS 021-2017-SA: https://ensayosclinicos-repec.ins.gob.pe/images/Reglamento_de_EC.pdf
    • Panama — Decreto Ejecutivo No. 21 de 23 de abril de 2026, Gaceta Oficial Digital No. 30510-C (Arts. 68, 99, 104, 105); primary text read from the Gaceta Oficial PDF
    • Panama — Ley 419 de 1 de febrero de 2024 (medicamentos): https://www.minsa.gob.pa/sites/default/files/normatividad/ley-419-de-2024-ley-de-medicamentos.pdf
    • Ecuador — Acuerdo Ministerial 00069-2024: https://www.espoch.edu.ec/wp-content/uploads/2025/10/ac-00069-2024_dic_31_compressed_1-1.pdf
    • Ecuador — Acuerdo Ministerial 0075-2017 (repealed): https://www.salud.gob.ec/wp-content/uploads/2022/09/A.M.-0075-REGLAMENTO-ENSAYOS-CLINICOS-1.pdf
    • Costa Rica — Ley N.º 9234, Ley Reguladora de Investigación Biomédica: https://documentos.una.ac.cr/bitstream/handle/unadocs/5670/Texto%20Completo%20Norma%209234.pdf?sequence=1&isAllowed=y
    • Guatemala — Acuerdo Ministerial 82-2019: https://medicamentos.mspas.gob.gt/phocadownload/Acuerdo%20Ministerial%2082-2019.pdf
    • Guatemala — MSPAS legislación vigente index (AM 206-2021): https://medicamentos.mspas.gob.gt/index.php/legislacion-vigente/acuerdos
    • Honduras — Acuerdo No. 0256-ARSA-2025: https://www.tsc.gob.hn/web/leyes/Acuerdo-0256-ARSA-2025.pdf
    • Nicaragua — Normativa-166, Norma para la Regulación de Ensayos Clínicos: https://www.minsa.gob.ni/sites/default/files/2022-10/Norma%20de%20Ensayos%20Clinicos.11833.pdf
    • Uruguay — Decreto N° 158/019, Anexo: https://www.impo.com.uy/bases/decretos-originales/158-2019/8
    • Bolivia — Norma para Estudios Clínicos (AGEMED): https://www.agemed.gob.bo/archivos_agemed/ensayosclinicos/001-2021.pdf
    • Venezuela — Normas de Buena Práctica Clínica (INHRR): https://inhrr.gob.ve/pdf/pdf_jr/JR-1311-2013.pdf
    • Mexico — NOM-012-SSA3-2012: https://sidof.segob.gob.mx/notas/docFuente/5284148
    • Colombia — Resolución 2378 de 2008: https://www.ins.gov.co/Normatividad/Resoluciones/RESOLUCION%202378%20DE%202008.pdf
    • Colombia — Resolución 8430 de 1993: https://www.minsalud.gov.co/sites/rid/Lists/BibliotecaDigital/RIDE/de/dij/resolucion-8430-DE-1993.PDF
    • Paraguay — Resolución DINAVISA 238/2024: https://dinavisa.gov.py/wp-content/uploads/2024/10/2.-Requisitos-de-Ensayos-Clinicos.-Resol.-238_2024.pdf
    • El Salvador — Lineamientos Técnicos para la Investigación en Salud, Acuerdo Ejecutivo 1530 (2025): https://asp.salud.gob.sv/regulacion/pdf/lineamientos/lineamientostecnicosparalainvestigacionensalud-Acuerdo-Ejecutivo-1530-29052025_v1.pdf
    • Dominican Republic — Manual de Normas y Procedimientos Operativos, CONABIOS: https://conabios.gob.do/wp-content/uploads/2025/02/1.Manual-de-Normas-y-Procedimientos-Operativos-V2-13-02.pdf
    • Cuba — Buenas Prácticas Clínicas en Cuba (CECMED): https://www.cecmed.cu/sites/default/files/adjuntos/Reglamentacion/Dir_BPC.pdf
    • United States / Puerto Rico — 21 CFR 312.310 (Expanded Access, Subpart I): https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-312/subpart-I/section-312.310
    • FDA — Expanded Access training materials: https://www.fda.gov/media/193381/download