May 12, 2026
10
min read
By
Dr. Luis Gustavo Celis Regalado — President, ALCEIC
On May 7, 2026, I attended — as president of the Latin American Association of Clinical Research Ethics Committees (ALCEIC) — the public hearing convened by the Seventh Permanent Constitutional Commission of the House of Representatives of the Congress of the Republic of Colombia, where discussion advanced on Bill 191 of 2025, an initiative that seeks to establish a comprehensive regulatory framework for clinical research involving human subjects in Colombia.
The short answer. Bill 191 of 2025 would establish a comprehensive regulatory framework for clinical research involving human subjects in Colombia. Discussion advanced at the May 7, 2026 public hearing — seven months after the first debate — with a more mature, concerted text shaped by the ecosystem's actors. Follow the bill's electoral context in Spanish and English.
Where does Bill 191 stand after seven months?
On October 20, in the framework of the first public hearing convened by the Seventh Commission of the House of Representatives, a first debate on Bill 191 of 2025 — which seeks to regulate clinical research in Colombia — took place. After an intense session in which differing viewpoints on the initiative were presented, one of the main conclusions was clear: this is a major opportunity for the country to have up-to-date legislation that responds to the needs of the health system and, in particular, to the needs of patients.
Seven months have passed since that first debate. During this period, the different actors in the ecosystem — each from their own mission and vision — have been reviewing the bill, updating its content, and adjusting it to the observations made at that first hearing. The text that arrived at the May 7 session is, therefore, a more mature, more concerted, and better-aligned-with-the-country's-realities text.
What would a clinical research law contribute to Colombia?
At this moment — when we find ourselves immersed in a globalized world and clinical research constitutes a strategic area for Colombia — it is legitimate to ask what a law of this type would contribute to the development and strengthening of our ecosystem. The principal contributions include:
- It facilitates innovation.
- It generates concrete benefits for patients, who would have earlier and more equitable access to innovative treatments.
- It is a source of job creation, especially for highly qualified personnel.
- It allows for improving the quality of the public and private institutions that participate in the ecosystem.
- It generates networking with developed countries, which favors competitiveness and allows Colombia to participate in late-phase and early-phase multicenter clinical studies, bringing us closer to the innovation frontier.
Argentina and Brazil understood this quickly and implemented a regulatory framework that allowed patient recruitment to begin swiftly. We cannot continue to wait.
What is the lesson from Mexico?
In the Mexican case, the country is advancing in this direction through the implementation of USMCA (T-MEC) and Plan México. The pharmaceutical sector saves the lives of thousands of Mexicans, and the protection of industrial property is the engine of that initiative, since it guarantees investment in biotechnology and medicine. The pharmaceutical industry has a large capacity to generate jobs and has set itself the goal of attracting USD 2 billion in sector investment. But to reach those goals, greater agility is required in the approval of clinical trials. That is why COFEPRIS, the Mexican regulatory agency, has set itself the goal of approving them in no more than 40 days, in addition to the expansion of infrastructure and tax incentives to encourage research.
The innovation generated in Mexico requires a legal framework centered on intellectual property. And Mexico presents several comparative advantages relative to other countries in the region:
- A large population with broad genetic diversity.
- An epidemiological profile similar to that of other countries in the northern hemisphere — cancer, cardiovascular diseases, obesity, and diabetes — which makes it a strategic site for developing clinical trials.
- A strategic geographic position as a natural bridge between the United States and Latin America, allowing them to focus and coordinate public policies that consolidate them as a region in a highly competitive environment.
- Human and physical capacity, with specialized research centers and hospitals.
- A constantly improving regulatory framework that provides the necessary guarantees for investment to be generated, especially through measures aimed at the protection of intellectual property: patent protection, extended protection, exclusivity, agile mechanisms for granting patents, and follow-up mechanisms.
In this sense, the State plays a fundamental role, since it is the guarantor that the legislation is fulfilled. This legislation must also be harmonized with international standards, generating trust and facilitating technology transfer. When clear mechanisms for the protection of intellectual assets exist, investment arrives. That is why I believe that the private sector and academia have the role of driving public policies that go beyond the government of the day and that place intellectual property at the center of economic development and investment across countries.
What should the Colombian law contain?
On the basis of the above, in Colombia's case, a Clinical Trials Law must be centered — in addition to patients — on innovation as an engine for generating capital in science, technology, and innovation, both locally and nationally or regionally. It must also be focused on resolving the felt needs of the population, especially of vulnerable populations, as is the case with rare diseases.
From an economic point of view, having a Clinical Trials Law will allow access to new treatments, will reduce the accessibility gap, and will enable greater equity and coverage for patient well-being. This translates into a high impact on the collective well-being of the Colombian population.
Epidemiologically, we have the population and we have the experience. What we need is a legal framework that allows us to accelerate processes so that Colombia is considered a country of first choice by the pharmaceutical industry. This process, in turn, drives the development of the national industry on the basis of the infrastructure that already exists. Innovation is a catalyst of economic and social development: in the USMCA review, intellectual property occupies a preponderant role, because it allows respect for data, its registration, and the use of tools such as artificial intelligence.
How would a regulatory framework generate trust?
Having a Clinical Research Law provides a regulatory and ethical framework that gives clarity to sponsors, to contract research organizations (CROs), to site management organizations (SMOs), to research centers, to investigators, and to clinical research ethics committees (CRECs). It defines the responsibilities of each ecosystem actor and, with that, generates a scenario of transparency and public trust.
When the ecosystem operates with trust — and very especially when it protects patients — clear ethical standards are defined, malpractice is delimited, patient participation is facilitated, and investment increases, because companies have clear rules on intellectual property and data protection. This has an impact on the quality of the evidence we generate, on higher-impact publications, and on the international recognition of Colombia as a country that has an instrument that protects patients.
The legal basis of the clinical research ecosystem, under a strict regulatory framework, provides security to research centers and investigators and allows the work to be carried out uniformly, without subjectivities and centered on participants. The State has the duty to safeguard the legal protection of both participants and their families because of clinical studies. The Law must contemplate clear rules for all actors, so that they are fully aware of the sanctions to which they are exposed when they do not comply with what is regulated. It must also establish that the rights of patients are crystal clear and that they adhere to universal principles, such as the Declaration of Helsinki and the ICH Guidelines.
What is the role of ethics committees (CRECs)?
In the case of CRECs, these constitute themselves as guarantors of the protection of subjects participating in a clinical trial. For that reason, their members must have solid training in:
- Bioethical principles and their practical application.
- Both local and international regulation.
- Clinical research methodology.
- Risk/benefit evaluation, especially in vulnerable populations.
- Informed consent.
- The handling of databases, including real-world data.
What regional efforts support the bill?
Finally, I want to highlight the work we have been carrying out at the National Table on Clinical Research led by INVIMA, in which, throughout these months, work has been done in a concerted manner on a new proposal for the bill, with notable participation by the different ecosystem actors and, very especially, by patient representatives.
In this same vein, I want to highlight the results of the CELAC–Africa High-Level Forum, held in Bogotá between March 18 and 21. There, it was proposed that the basis of cooperation between CELAC and the African Union should rest on three fundamental pillars: technical collaboration, political commitment, and the existence of solid legal frameworks. These three pillars enable the development of trust mechanisms as gradual processes that require the active participation of countries and an adequate adaptation to national realities. All of this will lead to processes of regulatory integration and convergence that will strengthen pharmaceutical markets, broaden access, consolidate local medicine production, make joint evaluations possible, and articulate the different actors of the health sector. Hence the importance for Colombia to have a solid Clinical Trials Law that constitutes one more pillar in the advance toward the signing of a Memorandum of Understanding between INVIMA and the African Union Development Agency (AUDA-NEPAD).
A final invitation
Colombia has the population, the experience, the GCP-certified centers, and proven human talent. What we need today is a modern, predictable legal framework harmonized with international standards. Bill 191 of 2025 represents a historic opportunity to respond to patients' needs, strengthen innovation, and position the country as a destination of first choice in clinical research in the region.
My invitation, as president of ALCEIC and as a bioethicist, is that we continue to work in a concerted manner, with patients at the center and with our sights set on a Colombia that produces, attracts, and protects clinical research of the highest quality.
Thank you very much.
Frequently asked questions
What is Bill 191 of 2025?
An initiative before Colombia's Congress that seeks to establish a comprehensive regulatory framework for clinical research involving human subjects in the country.
Where does the bill stand?
Discussion advanced at the public hearing of May 7, 2026, convened by the Seventh Permanent Constitutional Commission of the House of Representatives — seven months after the first debate of October 20. The text reaching that session is described as more mature and concerted, after review by the ecosystem's actors.
What would the law mean for sponsors and CROs?
It would provide a regulatory and ethical framework giving clarity to sponsors, contract research organizations (CROs), site management organizations (SMOs), research centers, investigators, and clinical research ethics committees (CRECs) — defining each actor's responsibilities and generating transparency and public trust.
Why does the article look to Mexico?
Mexico is advancing through USMCA implementation and Plan México, with COFEPRIS targeting clinical trial approvals in no more than 40 days. The article presents intellectual property protection — patents, exclusivity, and agile granting mechanisms — as the engine attracting investment in biotechnology and medicine.
About the author
Dr. Luis Gustavo Celis Regalado holds a Master's in Biology with emphasis in Human Genetics from the Universidad de los Andes and a specialization in Bioethics from the Universidad de La Sabana. He is a professor in the Faculty of Medicine at the Universidad de La Sabana, president of the Clinical Research Bioethics Committee of the same institution, and president of the Latin American Association of Clinical Research Ethics Committees (ALCEIC).
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