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Regulatory Affairs
2026-03-11
15
min read
What Happens to Colombia's Clinical Research Bill 191 After the March 2026 Elections?
The two sponsors of Colombia's landmark clinical research legislation were not re-elected. Here's what this means for the future of clinical trial regulation in Latin America's fastest-growing research market — and what the industry must do next.
By
Julio G. Martinez-Clark
What Happened on March 9, 2026
On March 9, 2026, Colombians went to the polls to elect a new Congress for the 2026–2030 constitutional period. The results sent shockwaves through Colombia's clinical research community: Senator Fabián Díaz (Alianza Verde) and Representative Juan Daniel Peñuela — the two sponsors of Law Bill 191 (Proyecto de Ley 191 de 2025 Cámara) — were not re-elected.
Bill 191 is the first comprehensive clinical research law in Colombia's history. Its objective: to establish an integral regulatory framework for the approval, execution, monitoring, and promotion of clinical research with human subjects in Colombia, with special emphasis on radiopharmaceuticals and theranostic therapies.
**Why This Matters to MedTech, Biopharma, and Radiopharma Sponsors**
Colombia is one of the most active clinical trial markets in Latin America. Yet its clinical research regulatory framework is still governed by Resolución 8430 de 1993 — a regulation written over 30 years ago, before the modern era of medical devices, gene therapies, and radiopharmaceuticals. Bill 191 was the most significant legislative effort ever undertaken to modernize this framework.
Current Status of Bill 191
Bill 191 was filed on August 5, 2025 in the House of Representatives as an Ordinary Law. Representative Hugo Alfonso Archila Suárez was designated as coordinating rapporteur and convened a public hearing on October 21, 2025 before the Seventh Committee (Comisión Séptima) of the House.
More than 30 stakeholders from Colombia's clinical research ecosystem attended, including the Ministry of Health, INVIMA, the National Institute of Health, the National Cancer Institute, ACIC, Afidro (the Association of Pharmaceutical Research and Development Laboratories in Colombia, representing multinational pharma companies operating in the country), Avanzar, universities, and patient organizations.
As of today, the bill is in "Trámite en Comisión" (Committee Processing) status — it has not yet received approval in its first debate.
The Legal Framework: What Happens Now?
To understand the bill's future, it's essential to understand Colombia's constitutional rules governing legislative procedure.
The Two-Legislature Rule (Article 162)
Article 162 of Colombia's Constitution states that bills that have not completed their legislative process within one legislature but have received first debate in either chamber may continue in the next legislature. No bill may be considered in more than two legislatures. If a bill is not debated in Committee (first debate) during the legislature in which it was filed, it is automatically archived.
End of the Constitutional Period: Total Archive
There is an even more decisive factor: the 2022–2026 constitutional period ends on July 20, 2026, when the newly elected Congress takes office. At the end of the four-year constitutional period, all pending bills are archived — regardless of their state of progress. This includes Bill 191.
**Key Legal Clarification**
The departure of the bill's sponsors does not, by itself, cause the bill to be archived. A filed bill does not "belong" exclusively to its authors — the sponsors remain in office until July 20, 2026. However, politically, losing the two principal advocates significantly weakens the bill's chances during the approximately 3 months remaining in the current legislature.
Scenarios and Probabilities
Scenario
Description
Probability
Implication
What Key Institutions Said at the Public Hearing
The October 21, 2025 public hearing produced invaluable feedback. Government entities expressed a nuanced position: they support updating clinical research regulation but raised significant concerns with the bill's text:
Ministry of Health
Warned about the use of the term "competitiveness" due to bioethical implications. Raised concerns about compromising INVIMA's WHO reference agency certification. Noted an industry bias in the bill's bibliography. Announced it is developing a decree to update Resolución 8430 de 1993.
INVIMA (Dr. Francisco Rossi)
Welcomed the bill reaching Congress but insisted that clinical studies should not be viewed as a mechanism for economic competitiveness — rather as a tool for generating knowledge about the safety and efficacy of health interventions.
National Cancer Institute
Called for alignment with CONPES 4069 (the national science and innovation policy), inclusion of frameworks for biobanks and phytotherapeutics, and warned about the infeasibility of requiring GMP for magistrally produced radiopharmaceuticals.
ACIC, Avanzar & Research Centers
Expressed general support for the bill, requesting broader scope beyond radiopharmaceuticals and budgetary strengthening of INVIMA. ACIC (42 certified research centers) and Avanzar (130 members spanning academia, pharma, CROs — Contract Research Organizations, the specialized firms that manage clinical trials on behalf of sponsors — and research centers) both committed to supporting the legislative process.
Industry Action Plan: Two Phases
The most effective strategy to save Colombia's clinical research legislation operates on two parallel tracks.
Phase 1: March–July 2026 (Current Congress)
Objective: Maximize the bill's progress and build the political record for re-filing.
- Push for first-debate approval in the Seventh Committee — even if the bill ultimately gets archived, approval in first debate sends a powerful political signal and facilitates re-filing.
- Coordinate with Representative Hugo Alfonso Archila (coordinating rapporteur) to present a positive first-debate report.
- Request that Fabián Díaz and Juan Daniel Peñuela prioritize scheduling the bill in the Seventh Committee during their remaining months in office.
- Mobilize ACIC's 42 affiliated centers and Avanzar's 130 members to send formal communications to the Seventh Committee's leadership requesting scheduling.
- Incorporate technical observations from the Ministry of Health and INVIMA into the bill's text — this neutralizes government opposition and facilitates a positive report.
- Document the entire process (minutes, reports, presentations, technical opinions) as formal inputs for re-filing.
Phase 2: July 2026 and Beyond (New Congress 2026–2030)
Objective: Re-file an improved bill with new sponsors and a broad coalition from day one.
- Identify and cultivate new congressional sponsors — the most critical step.
- Build a multiparty coalition with co-sponsors from at least 3–4 different parties.
- Include sponsors in both the House and Senate to facilitate bicameral passage.
- Engage the Ministry of Science, Technology, and Innovation as a government ally.
- Present a technically strengthened bill incorporating all feedback from the public hearing.
- Re-file the bill in the first weeks of the new constitutional period (July–August 2026).
Key Allies in the New Congress
The strategy for the new Congress must focus on legislators with health policy expertise and existing engagement with the clinical research agenda:
Senator Norma Hurtado (Partido de la U)
Re-elected with 136,036 votes. Former president of the Seventh Committee of the Senate. Was designated as coordinating rapporteur for Bill 191 in the Senate. Has direct experience with clinical research issues. The natural strongest ally.
Senators from the Seventh Committee
Re-elected senators Honorio Henríquez Pinedo (Centro Democrático) and Esperanza Andrade — both were rapporteurs for health-related legislation and are familiar with the health policy landscape.
New Representatives from Valle del Cauca & Bogotá
New members of Congress with profiles aligned with health, science, and technology should be identified and engaged early in the new legislative period.
Building a Multiparty Coalition
One of the strategic weaknesses of the original bill was having only two sponsors from the same political tendency. The re-filed bill must correct this by building a cross-party coalition from the outset.
The coalition should be led by Avanzar — the Association for the Advancement of Clinical Research in Colombia — as the natural coordinating body. Founded in 1999 with over 25 years of history, Avanzar brings together 130 members spanning academia, the pharmaceutical industry, CROs, and research centers. Its seven specialized working commissions — including governmental affairs, regulatory affairs, and guild coordination — make it uniquely positioned to lead this effort.
ACIC (Colombian Association of Clinical Research Centers), with its 42 INVIMA-certified centers, provides additional institutional weight. Together with Afidro and individual CROs operating in Colombia, this coalition represents the full spectrum of clinical research stakeholders.
**The Improved Bill Must Incorporate**
- • Ministry of Health and INVIMA recommendations on protecting WHO certification
- • A balanced approach between economic competitiveness and participant protection
- • Alignment with CONPES 4069 (national science and innovation policy)
- • Regulatory frameworks for biobanks, gene therapies, cellular and immunological therapies
- • Budgetary strengthening of INVIMA as the regulatory authority
- • Broader scope beyond radiopharmaceuticals to cover all clinical research modalities
Should You Hire a Lobbyist?
Yes — but with strategic nuances. The recommendation is not to hire a generic lobbyist, but rather a specialized health legislative advisor who can serve as the operational arm of the broader coalition.
Lobbying (cabildeo) in Colombia is not illegal but has limited regulation. The only specific regulation is Resolution 2348 of 2011, which created a Public Registry of Lobbyists for the House of Representatives. The ideal advisor should have:
- Proven experience with health-related legislation before the Seventh Committee
- An active network of contacts with members of the new 2026–2030 Congress
- Deep knowledge of Colombia's health regulatory ecosystem (INVIMA, MinSalud, MinCiencias)
- Registration in the House of Representatives' lobbyist system
Function
Priority
Parliamentary management
Identify and cultivate relationships with new Seventh Committee members
High
Legislative drafting
Improve the bill's text based on technical observations received
Legislative monitoring
Track the bill's scheduling and legislative progress
Medium
Guild coordination
Coordinate voices across Avanzar, ACIC, Afidro, CROs, and sector stakeholders
Executive branch engagement
Coordinate with MinSalud, MinCiencias, and INVIMA on aligned technical positions
Medium–High
Suggested Action Timeline
bioaccess® and the Path Forward
bioaccess® has been deeply involved in Colombia's clinical research ecosystem for over 15 years. As the leading CRO for first-in-human clinical trials in Latin America, bioaccess® has a direct stake in the modernization of Colombia's regulatory framework.
bioaccess® CEO Julio G. Martinez-Clark has been an active voice in advocating for both Bill 191 and the modernization of Resolución 8430. bioaccess® will continue to work alongside Avanzar, ACIC, and the broader coalition to ensure that Colombia gets the world-class clinical research law it deserves.
The archival of Bill 191 is not a defeat — it is an opportunity to come back stronger. The bill generated an unprecedented consensus on the need to update clinical research regulation in Colombia, mobilized the entire sector ecosystem, and produced an invaluable body of technical inputs during the public hearing.
**The Realistic Objective**
Achieve approval of the clinical research law during the first legislature of the new period (July 2026–June 2027), leveraging the accumulated political and technical momentum. With the right coalition, the right sponsors, and a technically improved bill, Colombia can become the first country in Latin America with a comprehensive, modern clinical research law.
Related Reading
For a deeper dive into the substance of Bill 191 and why both the law and an updated Resolución 8430 are essential, read our comprehensive analysis:
Why Colombia's Clinical Research Revolution Needs Both Law Bill 191 And A Modern Resolution: A Call To Action
An in-depth analysis of why Colombia needs both legislative reform (Bill 191) and regulatory modernization (updating Resolución 8430 de 1993) to become a competitive global destination for clinical research.
🇨🇴 Versión en español: Por Qué la Revolución de la Investigación Clínica en Colombia Necesita Tanto el Proyecto de Ley 191 Como una Resolución Moderna
El mismo análisis detallado en español sobre por qué Colombia necesita tanto el Proyecto de Ley 191 como la actualización de la Resolución 8430 de 1993.
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