Post-trial access in Panama under Decreto Ejecutivo 21/2026 Article 68

Panama made post-trial access binding on 23 April 2026. Decreto Ejecutivo 21/2026 Article 68 obliges investigators and sponsors to supply until commercialization.

Panama now imposes a binding post-trial access obligation. Article 68 of Decreto Ejecutivo No. 21 de 23 de abril de 2026 requires investigators and sponsors to ensure that every participant who demonstrated clinical or public-health benefit keeps access to the investigational product until that product is commercialized in Panama.

The instrument is four months old. It was published in Gaceta Oficial Digital No. 30510-C on 23 April 2026 and entered into force on promulgation under Article 105. Most post-trial access (PTA) guidance in circulation still describes Panama as having an import mechanism but no obligation, or cites instruments that no longer govern health research. Sponsors closing studies in Panama in 2026 and 2027 are exposed to a requirement their vendors have not read.

What Decreto Ejecutivo 21/2026 actually is

Decreto 21/2026 is the implementing regulation for Titles III and IV of Ley 84 de 14 de mayo de 2019, the statute that regulates and promotes health research in Panama and establishes its governance. Per the Infojurídica record for the decree, Title III of Ley 84/2019 covers the Comité Nacional de Bioética de la Investigación (CNBI) and Title IV covers the management of health research projects. Ley 84/2019 was published in Gaceta Oficial 28775-A on 16 May 2019.

The decree runs 105 articles across fifteen chapters, is signed by President José Raúl Mulino Quintero and Minister of Health Fernando Boyd Galindo, and rests on the Constitution, Ley 66 de 10 de noviembre de 1947 (Código Sanitario) and Ley 84 de 2019. The CNBI hosts its own copy, a practical signal that the bioethics system treats it as the operative reference.

Article 68 verbatim

Article 68 is titled “Acceso a productos por parte de los participantes.” The operative first paragraph 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, de conformidad con criterios especificados en la reglamentación y en cumplimiento de la normativa correspondiente a la importación de estos productos. Para tales efectos, solicitará ante la autoridad competente, una extensión del permiso de importación del producto utilizado durante la investigación para uso exclusivo de los participantes de dicho estudio hasta cumplir la fase post investigación.”

Our English translation: “Investigators and sponsors must ensure access to the product for all participants, provided the clinical or public-health benefit of the intervention was demonstrated during the study; until its commercialization in the country, in accordance with criteria specified in the regulations and in compliance with the rules governing importation of these products. For such purposes, they shall request from the competent authority an extension of the import permit for the product used during the research, for the exclusive use of the participants in that study, until the post-research phase is complete.”

The second paragraph assigns exceptional cases to the research bioethics committee. The third requires “acuerdos, convenios u otras figuras” reflecting the sponsor’s intent to commercialize the product in Panama, modelled on the CIOMS guidelines, so the sponsor can offer access once study participation ends — expressly “a fin de evitar que la descontinuación de una intervención prive a los participantes de la investigación de capacidades básicas o reduzca considerablemente la calidad de vida que habían logrado durante el estudio.”

Investigators and sponsors are co-obligated

The subject of Article 68 is plural: “los investigadores y patrocinadores.” That is unusual in the region, where most PTA provisions name the sponsor alone. Panama makes the local principal investigator jointly responsible.

The investigator therefore carries a personal regulatory duty to escalate if the sponsor does not fund continued supply, and Article 69 requires the sponsor to secure at least one principal investigator resident in Panama answering scientific, ethical and legal questions — so there is always an identifiable domestic co-obligor the CNBI and the accredited Comité de Bioética de la Investigación (CBI) can hold to account.

Article 68 does not use the word gratuito, so cost allocation is not stated verbatim. It is reached indirectly: Article 71 num. 2 makes the CIOMS international ethical guidelines for health-related research involving humans a fundamental document governing approval, execution and follow-up of research, and Article 66 requires the CBI to apply CIOMS in vulnerability analysis. CIOMS Guideline 6 states that “the obligation to care for participants’ health needs rests with the researcher and the sponsor” and requires plans for “providing continued access to study interventions that have demonstrated significant benefit.” Read with Article 61, under which participants “no deben incurrir en ningún gasto por participar en un estudio de investigación,” the practical outcome is sponsor-funded supply — inferred from Articles 61, 66 and 71, not quoted from Article 68.

Duration: until commercialization in Panama

The end point in Article 68 is “hasta su comercialización en el país” — until the product is commercialized in Panama. There is no fixed month count and no cap. For a device or drug with no Panamanian registration plan that phrasing is open-ended, which is why the third paragraph of Article 68 demands agreements documenting the sponsor’s commercialization intent. A sponsor not planning to commercialize must either negotiate a defined exit with the CBI under the exceptional-cases paragraph or plan for a long tail.

CIOMS supplies the standard the CBI will most likely apply: provision “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.” A sponsor that has not defined the PTA exit at protocol stage has weaker footing at study close.

The extension of the import permit

Article 68 names a specific filing: an extensión del permiso de importación covering the investigational product for the exclusive use of that study’s participants, through the post-research phase. It is not a compassionate-use application — it is an extension of the existing research import permit, scoped to a closed cohort.

The surrounding machinery sits in Chapter XIII. Under Article 95, where a high-risk study uses medicines or products for human health, product evaluation before the trial starts belongs to the Dirección Nacional de Farmacia y Drogas (DNFD), filed through the RESEGIS platform of the Dirección General de Salud Pública with GMP certification, certificate of analysis, investigator’s brochure and product manuals; the DNFD answers within fifteen working days. Article 99 states plainly that “la importación de los productos de investigación se hará en base al registro del proyecto de investigación en la plataforma RESEGIS, la aprobación ética y su autorización por la Dirección Nacional de Farmacia y Drogas.” Article 100 makes the investigator or tramitante responsible for evidencing all approval and importation documentation in RESEGIS.

Three approvals therefore gate every post-trial shipment: an active RESEGIS project record, CBI ethical approval covering the post-trial phase, and DNFD authorization. Article 97 adds labelling minimums — identification or code, lot, expiry, storage conditions, special warnings — with Spanish required except where the DNFD accepts English on prior justification. For a 2–8 °C product that chain must hold through a supply period that may run years past the last patient visit.

RESEGIS, the DNFD and the CBI

RESEGIS is the Registro y Seguimiento de la Investigación para la Salud, established under Article 79 in the Dirección General de Salud Pública. The MINSA introductory guide confirms that the principal investigator registers the project and that a third party or tramitante may file on the investigator’s behalf provided the investigator is already enrolled. That tramitante route is how a sponsor without a Panamanian legal entity gets filings made locally.

The CBI’s role in PTA is decision-making, not advisory. Article 68 paragraph 2 gives the accredited committee authority over exceptional cases and requires it to determine the applicable mechanisms against previously defined criteria; Article 66 requires the CNBI and accredited CBIs to hold a standard operating procedure for these situations. The CBI that approved the protocol is the body that will approve, condition or reject a proposed PTA arrangement, and Article 91 requires the investigator to load approval certifications into RESEGIS.

What Article 104 repealed — and what it did not

Article 104 repeals Decreto Ejecutivo No. 1843 de 16 de diciembre de 2014, Decreto Ejecutivo No. 6 de 3 de febrero de 2015 (the prior bioethics regulation) and Resolución No. 390 de 6 de noviembre de 2003. Any PTA position built on the pre-2026 bioethics-committee framework rests on repealed instruments.

Article 104 does not repeal Decreto Ejecutivo No. 27 de 10 de mayo de 2024, published in Gaceta 30028-C. That decree implements Ley 419 de 1 de febrero de 2024, the commercial medicines and public-procurement statute, and defines “acceso a medicamento post-estudio clínico” in Article 2 num. 3 as a pharmaceutical product used in a clinical study in Panama, supplied on the treating investigator’s justification of continued benefit “hasta que este esté comercialmente disponible en el país o según lo determine el Comité de Bioética en Investigación.” It stays part of the medicines regime. What changed on 23 April 2026 is that the obligation now lives in Article 68 of the health-research decree. Decreto 27/2024 describes an available route; Article 68 imposes a must.

Misconceptions worth correcting

“Panama has a mechanism but no mandate.” Accurate before 23 April 2026, wrong now. Article 68 uses deben asegurar.

“Ley 419/2023 is the Panamanian PTA law.” The number is right, the year is wrong, and the statute is the wrong one. It is Ley 419 of 1 February 2024, and it regulates commercial medicines and public procurement, not health research. The health-research statute is Ley 84 de 14 de mayo de 2019.

“Decreto Ejecutivo 27/2024 is the operative PTA instrument.” It is the operative instrument for the medicines regime and it still contains the definition, but the binding continued-supply obligation for study participants now sits in Decreto 21/2026 Article 68.

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

What sponsors should do before database lock

Define the PTA exit in the protocol and informed consent, not at close-out. Get the CBI to approve the arrangement and the acuerdos o convenios required by Article 68 paragraph 3 while the study is still open. Keep the RESEGIS record live through the post-research phase. Budget the import-permit extension, DNFD interaction and Spanish labelling as a workstream distinct from the trial, with a named local filer able to act as tramitante. And confirm which accredited CBI holds the file — that committee, not MINSA centrally, decides the exceptional-case mechanism.

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 Panama 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

What does Panama require for post-trial access?
Panama requires investigators and sponsors to ensure that every trial participant who demonstrated clinical or public-health benefit continues to receive the investigational product until it is commercialized in Panama. The requirement is Article 68 of Decreto Ejecutivo No. 21 de 23 de abril de 2026. Operationally the sponsor must request an extension of the research import permit covering only that study’s participants, keep the project record active in the RESEGIS platform, obtain Dirección Nacional de Farmacia y Drogas authorization for importation under Article 99, and document the arrangement with the accredited research bioethics committee that approved the protocol.

Is post-trial access mandatory in Panama?
Yes, since 23 April 2026. Article 68 of Decreto Ejecutivo 21/2026 uses the mandatory verb deben asegurar (“must ensure”) and names both investigators and sponsors as obligors. The decree entered into force on promulgation under Article 105 and was published in Gaceta Oficial Digital No. 30510-C. Before that date, Panama had a definitional and import route for post-study medicine access under Decreto Ejecutivo 27/2024 but no clearly worded affirmative duty on the sponsor. Guidance describing Panama as a mechanism-only jurisdiction is out of date.

Who pays for post-trial access in Panama?
In practice the sponsor. Article 68 does not use the word gratuito, so cost allocation is not stated verbatim in that article. It arrives through three linked provisions: Article 61 states that participants must not incur any expense for participating in a research study; Article 71 num. 2 makes the CIOMS international ethical guidelines a fundamental governing document; and CIOMS Guideline 6 places the obligation to meet participants’ health needs on the researcher and the sponsor. Sponsors should budget product, importation, labelling, cold-chain and local filing costs.

How long must sponsors provide post-trial access in Panama?
Until the product is commercialized in Panama — “hasta su comercialización en el país” in Article 68. There is no fixed duration and no statutory cap. Where the sponsor does not intend to register and commercialize in Panama, the obligation is open-ended on its face, and the exit must be negotiated with the research bioethics committee under the exceptional-cases paragraph of Article 68. CIOMS Guideline 6 supports ending provision once the intervention is available through the local public health system or after a period agreed before the trial started, which is why the exit should be defined in the protocol.

What is Decreto Ejecutivo 21/2026?
Decreto Ejecutivo No. 21 de 23 de abril de 2026 is the Panamanian regulation implementing Titles III and IV of Ley 84 de 14 de mayo de 2019 on health research. It has 105 articles across fifteen chapters covering the CNBI, accredited bioethics committees, participant rights, the RESEGIS registration platform, the administrative review procedure, and Chapter XIII on research using medicines and other products for human health. It was published in Gaceta Oficial Digital No. 30510-C and entered into force on promulgation.

What happened to Decreto Ejecutivo 27/2024?
It is still in force as the implementing regulation for Ley 419 de 1 de febrero de 2024, the commercial medicines and public-procurement statute, and it still defines acceso a medicamento post-estudio clínico in Article 2 num. 3. Article 104 of Decreto 21/2026 repeals Decreto Ejecutivo 1843/2014, Decreto Ejecutivo 6/2015 and Resolución 390/2003 — not Decreto 27/2024. What changed is authority: the binding post-trial obligation on investigators and sponsors now comes from Article 68 of Decreto 21/2026, so citing Decreto 27/2024 as the whole picture understates the duty.

Does Panama post-trial access apply to medical devices?
Article 68 refers to “el producto” without limiting it to medicines, and Chapter XIII is titled “De la investigación para la salud donde se utilizan medicamentos y otros productos para la salud humana.” Article 95 covers “medicamentos o productos para la salud humana,” and the glossary in Article 2 num. 8 defines high-risk intervention technology as a medical or health technology used to intervene in diagnosis, treatment, prevention or rehabilitation. On that reading device studies are within scope. Sponsors of device trials should confirm the specific import pathway with the Dirección Nacional de Farmacia y Drogas rather than assume the medicine route applies unchanged.

What is the difference between Ley 84/2019 and Ley 419/2024?
Ley 84 de 14 de mayo de 2019 regulates and promotes health research and establishes its governance; its Title III creates the Comité Nacional de Bioética de la Investigación and its Title IV governs management of health research projects. Ley 419 de 1 de febrero de 2024 regulates medicines and other products for human health and their public procurement. Post-trial access as an obligation flows from Ley 84/2019 through Decreto 21/2026 Article 68. Note also that the frequently seen citation “Ley 419/2023” is wrong on the year.

Who reviews and approves post-trial access requests in Panama?
Three bodies, in sequence. The accredited Comité de Bioética de la Investigación that approved the protocol reviews the post-trial arrangement and, under Article 68 paragraph 2, decides exceptional cases against previously defined criteria. The Dirección Nacional de Farmacia y Drogas evaluates the product and authorizes importation under Articles 95 and 99. The Dirección General de Salud Pública operates the RESEGIS platform under Article 79, where the investigator or tramitante must evidence all approval and importation documentation under Article 100.

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