Colombia’s Consejo de Estado Upholds Order for New National Drug Policy

PHARMA REGULATION · PRICE REGULATION · OCTOBER 22, 2026 · COLOMBIA

Judicial pressure is now shaping the timetable for pharmaceutical policy reform in Colombia. In a 17 September 2026 ruling, the First Section (Sección Primera) of the Consejo de Estado, Colombia’s highest administrative court, upheld with modifications and additions a 12 December 2024 decision of the Tribunal Administrativo de Cundinamarca ordering the government to lay the foundations of a new national pharmaceutical policy, according to the ruling and reporting by El Tiempo. The case is an acción popular, a constitutional action to protect collective rights, brought by the Procuraduría General de la Nación, Colombia’s inspector general’s office. The ruling keeps a working group led by three bodies: the Ministerio de Salud y Protección Social (Ministry of Health and Social Protection), which presides over its meetings and reports progress to the court; the Comisión Nacional de Precios de Medicamentos y Dispositivos Médicos (CNPMDM); and the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA), the country’s drug and food regulator. The group must be formed within one month of notification. The court modified the original order so that the new policy may be adopted through a new document of the Consejo Nacional de Política Económica y Social (CONPES), Colombia’s national economic and social policy council, or another suitable legal instrument, and added a compliance verification committee chaired by the Tribunal’s reporting judge (magistrado sustanciador).

The order lands on a regulatory architecture that has been built incrementally over more than a decade. The current pricing regime traces its delegated authority to Decree 705 of 2016, which assigned to the CNPMDM, the national drug and medical device price commission, the power to define pricing methodologies and regulate distribution margins. That commission updated its direct price-control methodology through Circular 18 of 2024, published in the Diario Oficial on 13 March 2024, and issued Circular 22 of 2026 on 19 June 2026 to incorporate, modify, and update maximum sale prices for medicines subject to direct price control. The court’s intervention suggests that this layered structure — functional as a technical instrument — has not satisfied the broader constitutional and statutory obligations that Colombian courts have been tracking since the Constitutional Court’s landmark ruling T-760 of 2008.

A court-enforced redesign, not a blank slate

The policy architecture the working group must navigate is dense. The foundational document is CONPES 155 of 2012, the council’s national pharmaceutical policy. Approved on 30 August 2012 with a ten-year horizon (2012–2021), it set out ten strategies covering information, pricing regulation, surveillance, access and rational use of medicines; the court noted that its validity ended in 2021 and that it has not been renewed. Circular 16 of 2023, published in the Diario Oficial on 9 August 2023, added a methodology specifically for pricing new medicines, drawing on therapeutic value assessments by the Instituto de Evaluación Tecnológica en Salud (IETS), the national health technology assessment body. Decree 433 of 2018 had earlier embedded IETS evaluations as a prerequisite for new-medicine price determination, with the supporting dossier filed with INVIMA together with the pharmacological evaluation request and forwarded to the IETS, though the decree states that the IETS evaluation cannot become a barrier to INVIMA’s granting of the sanitary registration.

A court-ordered redesign does not erase this infrastructure. It must instead identify where the existing framework falls short of the collective rights the courts found threatened and violated, including public health and safety, public assets, access to health services and consumer rights, and of the right to health as interpreted by the Constitutional Court. The Constitutional Court’s Auto 140 of 2019 — a follow-up order to T-760 of 2008 — had called for the removal of medicines from direct price control to be an objective process, a concern that Circular 18 of 2024 cites in its recitals. The new mandate appears to extend that scrutiny to the broader policy design, including pricing, supply, and local production. The Ministry argued on appeal that existing policies already addressed the problems at issue and that drafting of a new national pharmaceutical policy was under way; the court found that CONPES 155 expired in 2021 and that the record did not show that a new national pharmaceutical policy exists.

Industry exposure across three regulatory dimensions

For manufacturers and distributors operating in Colombia, the working-group process carries exposure across three dimensions. On pricing, the CNPMDM’s methodology for assigning medicines to ‘Group A’ markets subject to direct control — based on sales participation and market concentration scores, as set out in Circular 18 of 2024 — may be subject to revision if the new policy framework redefines the criteria for market relevance or concentration thresholds. On supply, any new framework that addresses availability obligations could impose distribution or stocking requirements beyond those currently in force. On local production, the mandate’s explicit inclusion of research, innovation and pharmaceutical production aimed at health autonomy as a policy dimension signals that the working group may examine incentive or requirement structures for domestic manufacturing — a thread already present in CONPES 155 of 2012.

The principal friction in translating a court order into an operative policy is institutional. Colombia’s pharmaceutical policy governance involves at minimum the Ministerio de Salud y Protección Social, the Ministerio de Comercio, Industria y Turismo, INVIMA, and the CNPMDM — each with distinct statutory mandates and, in the case of the two ministries, joint membership of the commission. Coordinating a redesign across these bodies under judicial supervision, while maintaining the continuity of the existing price-control regime, is an administrative sequencing challenge that the order itself does not resolve. The Statutory Health Law (Ley Estatutaria en Salud) 1751 of 2015 places drug price regulation and methodology with the national government, but the CNPMDM’s delegated authority under Decree 705 of 2016 means that, while that delegation stands, methodology changes run through the commission.

A further complication is the relationship between the new policy process and the existing regulatory calendar. Circular 22 of 2026, issued on 19 June 2026, has already updated maximum sale prices under the current methodology. If the working group’s output eventually modifies the methodology itself, manufacturers that have adjusted commercial strategies to the June 2026 price ceilings may face a second adjustment cycle.

The deeper structural signal is that Colombia’s pharmaceutical pricing system has now acquired two simultaneous oversight tracks — the technical-regulatory track of the CNPMDM and the judicial-constitutional track of the Consejo de Estado and Constitutional Court. For manufacturers, the operative risk is not the new policy itself, which remains to be designed, but the uncertainty interval between the court order and its eventual regulatory translation, during which the rules governing price ceilings, market classification, and supply obligations may be in contested flux.

Colombia Pharmaceutical Policy Framework Timeline

Why this is relevant

Sources: CNPMDM: Circular 22 de 2026 · INVIMA Normograma: Circular 18 de 2024 · INVIMA Normograma: Circular 16 de 2023 · Ministerio de Salud: Decreto 705 de 2016 · INVIMA: CONPES 155 de 2012 · El Tiempo: Consejo de Estado ordena avanzar en las bases de una nueva política farmacéutica nacional · Consejo de Estado, Sección Primera: sentencia de segunda instancia, rad. 25000-23-41-000-2019-00763-02 (17-09-2026, vía Consultorsalud) · Consultorsalud (30-09-2026) · El Universal: Consejo de Estado ordena nueva política farmacéutica en Colombia · Corte Constitucional: Auto 140 de 2019 · Ámbito Jurídico: Decreto 433 de 2018