Brazil is the only Latin American country where free post-trial supply of an investigational product is an explicit, sponsor-funded statutory duty that reaches drugs, medical devices and advanced therapies alike. 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).
The duty has two layers. Lei nº 14.874, de 28 de maio de 2024 — the Marco Legal de Pesquisa Clínica — created it in Chapter VI, Articles 30 to 37, entering into force 90 days after its 29 May 2024 publication under Article 65. Decreto nº 12.651, de 7 de outubro de 2025 supplied the mechanics, taking effect on publication in the Diário Oficial da União of 8 October 2025 under Article 41. Sponsors budgeting a Brazilian trial in 2026 budget against both.
What the statute actually requires
Chapter VI of Lei 14.874/2024 is titled “Da continuidade do tratamento pós-ensaio clínico,” and it front-loads the work. Article 30 requires the sponsor and the investigator, before the trial starts, to submit a plano de acesso pós-estudo to the research ethics committee, 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 the end of the trial, 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 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 31 of the Decreto: the operative sentence
Decreto 12.651/2025 Article 31 states the duty in the language sponsors should quote in their own SOPs: the sponsor, after the trial ends, “deverá garantir aos participantes da pesquisa o fornecimento gratuito do produto sob investigação sempre que este for considerado pelo pesquisador responsável como a melhor alternativa terapêutica para a condição clínica do participante, com base em evidências disponíveis e em avaliação favorável da relação risco-benefício.”
Two details matter. First, the decree says produto sob investigação — investigational product — not medicamento. Second, Article 31 §1 requires the program to be drafted by the sponsor and submitted to the competent CEP, and to contain the supply strategy for the period after individual participation ends. Article 31 §2 reserves the detailed guidelines to a future norm from the Instância Nacional de Ética em Pesquisa.
Brazil’s Ministry of Health has already closed the obvious loophole. Asked whether the program can simply be notified, the INAEP FAQ answers: “Deve ser submetido para avaliação do CEP competente. Não basta notificar” (INAEP FAQ on submission). Pending the INAEP norm, the same page recommends a minimum submission package: program description, technical and risk-benefit justification, inclusion and maintenance criteria, a participant safety follow-up plan, expected supply duration and termination conditions under Article 33, allocation of sponsor, investigator and institution responsibilities, care-transition strategy, and whether ANVISA authorization is required.
Who pays, and for how long
Cost allocation is unambiguous. Lei 14.874/2024 Article 31 §4 states that where continued treatment with the experimental drug is necessary after trial end, “o fornecimento do medicamento será de responsabilidade do patrocinador.” Article 34 §1 repeats that the sponsor guarantees free post-trial supply, and Decreto 12.651/2025 Article 31 says fornecimento gratuito. ANVISA’s own RDC nº 38, de 12 de agosto de 2013 Article 18 assigns the sponsor complete free treatment (inciso I), product custody and storage (II), a bar on commercializing the product (III), and funding of integral assistance for complications arising from its use (VI). Article 35 §2 of the statute separately makes the sponsor responsible for care needed because of study-caused reactions.
Duration is where Brazil diverges from every other regime in the region. Article 33 permits interruption only on seven grounds, each requiring a justification submitted to the CEP: participant decision, cure or introduction of a satisfactory alternative, absence of continued benefit, a disqualifying adverse reaction, technical or safety impossibility of manufacture (provided the sponsor supplies an equivalent or better marketed alternative), inciso VI “transcurso do prazo de 5 (cinco) anos, contado da disponibilidade comercial do medicamento experimental no País,” and inciso VII availability in the public health network.
Inciso VI carries visible veto history: the Planalto text shows “VI – (VETADO)” immediately followed by the five-year text marked “(Promulgação partes vetadas)” — the vetoed passage was subsequently promulgated. 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, not on a date fixed at trial close.
Devices and advanced therapies are in scope
Article 37 of Lei 14.874/2024 is one sentence, and it is why MedTech and cell-and-gene sponsors cannot treat this 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 applies to medical devices and experimental advanced therapy products, insofar as applicable. Decreto 12.651/2025 Article 31 reinforces this by using produto sob investigação.
The caveat is operational, not legal: RDC 38/2013 was written in 2013 and speaks only of medicamento. ANVISA maintains a separate service channel for advanced-therapy product programs, but there is no equivalent device-specific post-study petition. For an implantable or an active device, the statutory duty exists while the import and dispensing pathway has to be built from the trial’s own authorization documents — a problem to solve in the protocol, not at trial close.
CEP, ANVISA and INAEP: three approvals, three functions
Lei 14.874/2024 Article 5 splits Brazil’s Sistema Nacional de Ética em Pesquisa into a national ethics instance and the CEPs. In post-trial access, the division of labor is:
- 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 this is, as a rule, the coordinating centre’s CEP.
- ANVISA — Article 34 §3 requires that importation and dispensing during the post-study program be previously authorized by the competent sanitary authority.
- INAEP — the Instância Nacional de Ética em Pesquisa issues ethics norms, credentials and accredits CEPs, and acts as appellate instance over CEP decisions (Art. 8). Decreto Article 31 §2 assigns it the post-study guidelines.
INAEP became operational during 2026. It adopted its internal regulation by Resolução nº 1 of 2 April 2026 and transitional CEP accreditation procedures by Resolução RCI nº 2 of 8 May 2026 (INAEP legislation index), and held its first ordinary meeting with full membership in Brasília on 14 August 2026, seating 15 titular and 15 alternate members from the scientific community alongside representatives of ANVISA, the Conselho Nacional de Saúde and three ministries (Ministério da Saúde). No post-study-specific INAEP norm appears in its legislation index yet. Two transitional rules still shape practice: Decreto Article 39 keeps Conselho Nacional de Saúde norms valid until INAEP replaces them, and Article 40 keeps CONEP as the appellate instance until INAEP’s members are seated.
The import mechanism
For medicines, RDC 38/2013 is still the operative instrument — ANVISA’s own programas assistenciais page lists post-study supply as one of three assistance programs under it. The sequence:
- The sponsor or a contracted organização representativa do patrocinador (ORP) files the anuência request with ANVISA (Art. 4).
- For post-study supply specifically, ANVISA does not issue a comunicado especial. Article 3 §2 provides that it issues “um ofício autorizando o fornecimento.”
- The import licence (LI) is filed on the RDC 39/2008 form and, per Article 16 parágrafo único, may be filed together with the anuência process.
- The dossier per Anexo I §IV is the Anexo IV petition form, the sponsor’s Anexo VI commitment declaration, the physician’s Anexo VII declaration, the physician’s CV, the Anexo VIII import quantity estimate, and the comunicado especial that authorized the trial.
- Post-anuência, imports follow the trial’s own comunicado especial or import document, and under Orientação de Serviço nº 01/2020 no pre-shipment authorization is required.
- Reporting continues: annual reports from the date of anuência, a final report within 90 days of program close, discontinuation notice within 60 days, and serious adverse event notification within 15 calendar days, or 7 in case of death (Arts. 17 and 18).
On timing, ANVISA’s service pages state an average of 20 calendar days for the medicines and biologics post-study petition service and 10 calendar days for advanced therapies. Those are service-level averages, not statutory deadlines — RDC 38/2013 sets no analysis period. Treat the CEP submission and the ANVISA filing as parallel critical-path items.
One watch item: ANVISA Consulta Pública nº 1.210/2023 proposed a risk-based revision of RDC 38/2013 allowing the post-study program to proceed by notification. Comments closed 2 January 2024 and the revision has not been finalized. The same notice disclosed that between 2019 and 2023 ANVISA received 256 post-study supply requests, alongside 558 compassionate use and 41 expanded access requests.
What this means for a sponsor’s budget
Brazil converts post-trial access from an ethics-committee expectation into a balance-sheet item with an indeterminate end date. The cost driver is not the product; it is the tail — free supply, cold-chain distribution, pharmacovigilance, ANVISA reporting and CEP maintenance running until one of 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, decide in the protocol how a device or advanced therapy will physically be imported and dispensed post-close, and treat the eventual INAEP norm under Decreto Article 31 §2 as a change-control trigger.
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Frequently asked questions
Does Brazil require post-trial access?
Yes, as a matter of statute. Lei 14.874/2024 Chapter VI (Arts. 30–37) and Decreto 12.651/2025 Article 31 require the sponsor to guarantee free continued supply of the investigational product to participants whenever the responsible investigator considers it the best therapeutic alternative for that participant’s clinical condition and the risk-benefit assessment is favorable. Brazil’s Ministry of Health describes this as “não é uma expectativa, mas um dever legal.” The obligation begins before the trial does: Article 30 requires a post-study access plan to be filed with the research ethics committee before enrollment starts.
What is Lei 14.874/2024?
Lei nº 14.874 of 28 May 2024 is Brazil’s Marco Legal de Pesquisa Clínica, the statute governing research with human subjects. It created the Sistema Nacional de Ética em Pesquisa com Seres Humanos, split into a national ethics instance and the CEPs, and devoted Chapter VI to continuity of treatment after the clinical trial. It entered into force 90 days after its 29 May 2024 official publication under Article 65. Its post-trial provisions replaced a regime that previously rested largely on Conselho Nacional de Saúde resolutions.
What is Decreto 12.651/2025?
Decreto nº 12.651 of 7 October 2025 is the implementing decree for Lei 14.874/2024. It took effect on publication in the Diário Oficial da União of 8 October 2025 under Article 41. Article 31 restates the sponsor’s free-supply duty using the broader phrase produto sob investigação, requires the sponsor to draft the post-study access program and submit it to the competent CEP with its supply strategy, and reserves detailed elaboration and review guidelines to a future INAEP norm. Articles 39 and 40 set transitional rules preserving CNS norms and CONEP’s appellate role.
Who pays for post-trial supply in Brazil?
The sponsor, exclusively and free of charge to the participant. Lei 14.874/2024 Article 31 §4 provides that supply of the medicine is the sponsor’s responsibility; Article 34 §1 requires the sponsor to guarantee free post-trial supply; and Decreto 12.651/2025 Article 31 uses fornecimento gratuito. RDC 38/2013 Article 18 adds that the sponsor must fund complete free treatment, keep the product properly stored, refrain from commercializing it, and fund integral assistance for complications arising from its use. Article 35 §2 of the statute separately covers care for study-caused reactions.
How long must sponsors provide post-trial access in Brazil?
There is no fixed end date. Lei 14.874/2024 Article 33 allows interruption only on seven grounds, each requiring justification submitted to the CEP: participant decision, cure or a satisfactory alternative, absence of continued benefit, a disqualifying adverse reaction, technical or safety impossibility of manufacture with an equivalent alternative supplied, five years counted from commercial availability in Brazil, or availability in the public health network. Because the five-year clock starts at Brazilian commercial availability rather than trial close, the practical tail is the longest in Latin America.
Does Brazil PTA apply to medical devices?
Yes. Article 37 of Lei 14.874/2024 extends the entire post-trial chapter to produtos e dispositivos médicos used in clinical trials, insofar as applicable, and Decreto 12.651/2025 Article 31 speaks of the investigational product rather than the medicine. The operational gap is that ANVISA’s RDC 38/2013 assistance-program framework addresses medicamento only, so device sponsors have a clear statutory duty but must build the post-close import and dispensing route from the trial’s own authorization documents. Resolve this in the protocol, not at close-out.
Does Brazil PTA apply to advanced therapy medicinal products (ATMPs)?
Yes. Article 37 names produtos de terapias avançadas experimentais alongside devices, so the post-trial chapter applies to cell, gene and tissue-engineered investigational products insofar as applicable. Unlike devices, ATMPs have a dedicated ANVISA service channel for compassionate use, expanded access and post-study supply of advanced therapy products, for which ANVISA states an average service time of 10 calendar days. Lei 14.874/2024 Article 28 §2 separately requires that import and export of experimental advanced therapies be authorized under specific regulation.
What is INAEP and what role does it play?
INAEP is the Instância Nacional de Ética em Pesquisa, the national ethics instance created by Lei 14.874/2024 Article 5 and structured by Decreto 12.651/2025. Under Article 8 of the statute it issues research ethics norms, credentials and accredits CEPs, monitors and inspects them, and serves as appellate instance over CEP decisions. For post-trial access specifically, Decreto Article 31 §2 assigns INAEP the complementary guidelines for preparing, presenting and ethically reviewing the post-study plan and program. INAEP adopted its internal regulation on 2 April 2026 and held its first full-membership ordinary meeting on 14 August 2026.
What is the import mechanism for post-trial supply in Brazil?
For medicines, ANVISA RDC 38/2013. The sponsor or a contracted ORP files an anuência request; for post-study supply ANVISA issues not a comunicado especial but “um ofício autorizando o fornecimento” (Art. 3 §2). The import licence is filed on the RDC 39/2008 form and may be submitted together with the anuência process (Art. 16). The Anexo I §IV dossier comprises the Anexo IV petition, the sponsor’s Anexo VI and physician’s Anexo VII declarations, the physician’s CV, the Anexo VIII quantity estimate, and the trial’s comunicado especial. Lei 14.874/2024 Article 34 §3 makes this prior authorization mandatory.
How does Brazil’s 5-year commercial-availability tail work in practice?
Article 33 inciso VI permits interruption after “transcurso do prazo de 5 (cinco) anos, contado da disponibilidade comercial do medicamento experimental no País.” The trigger is Brazilian commercial availability, not trial completion, marketing authorization elsewhere, or first commercial sale in another market. A sponsor that obtains ANVISA registration but delays Brazilian launch delays the start of its own five-year clock. Sponsors that never commercialize in Brazil cannot rely on inciso VI at all and must exit through one of the other six grounds, each of which requires a CEP-reviewed justification.
Sources
- Lei nº 14.874, de 28 de maio de 2024 (Marco Legal de Pesquisa Clínica), Arts. 5, 8, 28, 30–37, 65 — https://www.planalto.gov.br/ccivil_03/_ato2023-2026/2024/lei/l14874.htm
- Decreto nº 12.651, de 7 de outubro de 2025, Arts. 3, 30–31, 39–41 — 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. 1–4, 15–18, 26, Anexo I §IV — 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
- Ministério da Saúde / INAEP FAQ, “O programa de acesso pós-estudo deve ser submetido para aprovação ou basta notificar?” (20 Feb 2026) — https://www.gov.br/saude/pt-br/composicao/orgaos-colegiados/inaep/faq/faq/acesso-pos-estudo/o-programa-de-acesso-pos-estudo
- Ministério da Saúde / INAEP, Legislação (Resolução nº 1 of 2 Apr 2026; Resolução RCI nº 2 of 8 May 2026) — https://www.gov.br/saude/pt-br/composicao/orgaos-colegiados/inaep/legislacao
- Ministério da Saúde, “Inaep amplia colegiado com especialistas de diferentes regiões do Brasil” (18 Aug 2026) — https://www.gov.br/saude/pt-br/assuntos/noticias-ms/2026/agosto/inaep-amplia-colegiado-com-especialistas-de-diferentes-regioes-do-brasil
- ANVISA, Programas assistenciais (RDC 38/2013 programs; Orientação de Serviço nº 01/2020) — https://www.gov.br/anvisa/pt-br/assuntos/medicamentos/pesquisaclinica/programas-assistenciais
- gov.br service, “Solicitar autorização para uso compassivo, acesso expandido e fornecimento de medicamentos e produtos biológicos pós-estudo” — https://www.gov.br/pt-br/servicos/solicitar-autorizacao-para-uso-compassivo-acesso-expandido-e-fornecimento-de-medicamentos-e-produtos-biologicos-pos-estudo
- gov.br service, “Solicitar autorização para uso compassivo, acesso expandido e fornecimento de produtos de terapias avançadas” — https://www.gov.br/pt-br/servicos/solicitar-autorizacao-para-uso-compassivo-acesso-expandido-e-fornecimento-de-produtos-de-terapias-avancadas
- ANVISA, “Anvisa abre consulta pública sobre programas assistenciais” (Consulta Pública nº 1.210/2023) — https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2023/anvisa-abre-consulta-publica-sobre-programas-assistenciais