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:
- 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.
- 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).
- 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