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Tag: acesso pós-estudo

  • 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