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3 min read
The third and final entry of the Freyr 3D Series | Orphan Drugs in LATAM explores the landscape in Colombia. After reviewing the experiences of Mexico and Brazil, we close this trilogy with a country that built an early and solid legal framework, yet still faces the challenge of maintaining long-term access to these high-cost therapies.
Regulatory Framework in Colombia
- Decree 481 of 2004, with which Colombia took its first steps in recognizing medicines with low commercial availability. This decree regulated so-called Medicamentos Vitales No Disponibles (MVND) —indispensable life-saving products that, due to low profitability, are not found in the local market or are not available in sufficient quantities. Although this figure does not correspond normatively to orphan drugs, it set a precedent by establishing differentiated access mechanisms for hard-to-procure cases.
- The true turning point came with Law 1392 of 2010, which expressly recognized orphan diseases in Colombia, declared them a matter of national interest, and established the State’s obligation to ensure diagnosis, treatment, and patient registry.
- Two years later, Law 1438 of 2011 reinforced this vision by explicitly including orphan drugs within health benefits plans.
This framework made Colombia an early reference point in the region, although legal strength alone does not remove the economic and operational challenges that condition real patient access.
Access Mechanisms and Requirements
- MVND (Decree 481 of 2004): allows importation under a simplified pathway, without ordinary marketing authorization, the country’s main exceptional access route.
- Full marketing authorization (Decree 677 of 1995): orphan drugs in Colombia must follow the complete registration route, with the option of prioritization when they have a high public-health impact.
- INVIMA technical requirements: dossier in CTD format, post-marketing pharmacovigilance plans, and labeling/information materials aligned with current regulations.
Technical Requirements
The process for orphan drugs in Colombia is demanding and is articulated through INVIMA:
- CTD dossier with quality, safety, and efficacy data.
- Clinical and preclinical evidence, often limited by low disease prevalence, is contextualized to the local setting.
- Post-marketing pharmacovigilance plans, mandatory to monitor safety and effectiveness in real-world practice.
- Traceability and patient registries, key to supporting regulatory and financing decisions.
- Labeling and information materials adapted to current standards.
Although there are differentiated mechanisms such as the MVND regime, the route for orphan drugs requires anticipatory preparation that combines international dossiers with local requirements and robust follow-up systems.
Challenges
The Colombian regulatory framework has been a pioneer in the region, but its implementation faces structural barriers:
- High therapy costs which strain the sustainability of the health system.
- Limited clinical evidence, which makes regulatory dossiers harder to substantiate.
- Dependence on imports exposes the country to logistical delays and supply issues.
- Reimbursement and coverage hurdles that can generate inequities in access.
- The need to strengthen traceability and patient registries, to generate local data that backs regulatory and public-health decisions.
In short, the challenge is no longer mainly normative, but economic and operational: ensuring that the legal framework translates into sustainable, continuous access.
In the regional context, Mexico has prioritized fast-track and reliance mechanisms; Brazil relies on incorporation into the SUS; while Colombia established a robust legal framework that recognizes orphan diseases as a national priority. The challenge now is to ensure that rights guarantee go hand in hand with a financing model.
Role of an Expert Partner
In an environment with so many opportunities and risks, having a specialized partner is decisive. Freyr LATAM supports companies in the adaptation of international dossiers to INVIMA, in anticipating regulatory risks, in the design of robust pharmacovigilance plans, and in building sustainable access strategies.
The combination of global expertise and local presence enables Freyr to shorten approval timelines and reduce risks, while helping companies position themselves as responsible actors in a highly sensitive market.
Explore how your company can turn regulatory complexity into a clear pathway to access in Colombia. Let’s discuss how to anticipate your strategy together.
