A national patient federation has formally challenged Panama’s Social Security Fund over a major drug procurement process. The Federation of Associations of Patients with Critical, Chronic and Degenerative Diseases (Fenaeccd) raised alarms about potential safety gaps in the upcoming purchase of biotechnological drugs. The Ministry of Health has now confirmed it is reviewing national regulations governing these complex treatments.
The controversy centers on public tender LPU 05-2026, a $84.6 million acquisition of medications scheduled for December. Patient advocates argue the bidding documents lack specific requirements to guarantee the quality and efficacy of the biological products. These drugs are essential for managing serious conditions like cancer, rheumatoid arthritis, and other autoimmune diseases. The federation sent a detailed letter outlining its concerns to the National Directorate of Pharmacy and Drugs on October 28, 2025.
We have initiated a review of Executive Decree No. 27 to strengthen the registration and evaluation processes for biologics and biosimilars in the country, [Translated from Spanish]
Uriel Perez, the national director of Pharmacy and Drugs, provided this official response just one day later on October 29. His letter represents a significant institutional validation of the patient group’s worries. It explicitly acknowledges that the current regulatory framework may need strengthening, particularly concerning the classification of innovative biologics and the evaluation of biosimilars.
This regulatory review could force adjustments to the massive drug purchase before any contracts are awarded. The health ministry’s intervention introduces a new layer of scrutiny for a tender that patient groups say prioritizes cost savings over patient safety.
Patient Federation Identifies Critical Regulatory Gaps
Fenaeccd’s primary complaint focuses on the perceived lack of specialized regulation for biologics and their similar versions. These are not simple chemical compounds but large, complex molecules often derived from living cells. Even minor differences in their manufacturing can significantly impact their safety and effectiveness in patients. The federation’s letter pointed to the absence of mandatory requirements for solid evidence of clinical comparability.
It also highlighted a critical inconsistency in the tender’s eligibility criteria. Innovative biologic drugs are required to have at least two years of documented use within Panama. This same standard, however, is not uniformly applied to biosimilar products. Patient advocates contend this creates a dangerous double standard. Biosimilars are not identical copies and require their own rigorous evaluations to ensure they perform as safely and effectively as the original biologic.
Another major concern involves the potential for misleading product origins. The group warned that some drugs might be registered as coming from countries with high regulatory vigilance, like the United States or nations in the European Union. The actual manufacturing or final packaging, however, could occur in facilities located in regions with less stringent quality controls. This practice could ultimately compromise the final product’s quality without the knowledge of the purchasing agency or patients.
Prioritizing the lowest cost above all else poses a direct threat to therapeutic continuity. Patients relying on these treatments for stable management of their conditions could face clinical instability if a new, less rigorously vetted product proves ineffective or causes adverse reactions. The federation formally requested the health ministry to issue technical opinions and new guidelines that would fortify the supervision of these vital medications.
Health Ministry Acknowledges Flaws and Commits to Reform
The prompt reply from the National Directorate of Pharmacy and Drugs signals a receptive ear from health authorities. Director Uriel Perez confirmed that his agency is already examining Executive Decree No. 27, which was issued on May 10, 2024. This review will specifically target the rules for classifying innovative biologics and the requirements for registering biosimilars. The ministry insists it already demands information demonstrating quality, safety, and efficacy based on international standards.
The criterion of ‘at least two years of use in the country’ should apply to both innovative biologics and biosimilars, as in both cases evidence is needed to guarantee patient safety, [Translated from Spanish]
This statement from the health authority marks a pivotal alignment with the patient federation’s position. By agreeing that the two-year usage rule should be universal, the ministry acknowledges the unique complexities of all biologic medicines. This agreement opens the door for substantive changes before the Social Security Fund can proceed with the tender’s adjudication. For thousands of patients, a stronger regulatory framework is not a bureaucratic exercise but a fundamental safeguard for their health.
The ministry’s stance places the ball firmly in the court of the CSS. Any move to finalize the $84.6 million purchase may now require a pause pending the outcome of this regulatory review. The patient groups are watching closely, hoping the promised revision translates into concrete, enforceable rules that prioritize safety.
Social Security Fund Defends Procurement Process
Facing public criticism, the Social Security Fund has mounted a robust defense of its procurement strategy. The agency asserts that the entire tender process operates within a solid legal framework established by Law 419 of 2024 and reinforced by Executive Decrees 27 and 12. These laws, the CSS maintains, set forth strict procedures designed to ensure quality, safety, and transparency in all government acquisitions. The requirements are not arbitrary, officials explained.
According to the Fund, all participating medications must possess certifications from high-level regulatory agencies such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). Other mandated documents include the sanitary registration, clear identification of the manufacturer, and full product traceability. For innovative biological drugs, the CSS requires extensive documentation on safety and efficacy studies, a detailed description of the manufacturing process, and a formal commitment from the manufacturer to ensure a continuous supply.
The CSS also emphasized the collaborative nature of drafting the technical specifications. It stated that patient associations, technical guilds, and clinical specialists all participated in shaping the tender documents. This inclusive process, the Fund argues, allowed for the incorporation of criteria focused on traceability, therapeutic safety, and drug efficacy. The entire procurement remains under the supervision of the very same director nacional of Pharmacy and Drugs who is now reviewing the underlying regulations.
In public statements and social media posts, the CSS has repeatedly reaffirmed its commitment to quality and transparency. The agency seems determined to portray the tender as both legally sound and professionally managed. It insists that this oversight guarantees all purchased products will meet the nation’s legal and regulatory standards, providing a vital layer of pharmacovigilance.
Implications for Panama’s Public Health System
The outcome of this dispute carries significant weight for Panama’s public healthcare landscape. Biotechnological drugs represent a growing segment of essential treatments for complex conditions. Getting the procurement right affects not only patient health but also the long-term financial sustainability of the Social Security Fund. A misstep could lead to poorer health outcomes, increased costs from managing treatment failures, and a loss of public trust in the system.
The Fenaeccd views strict supervision of biologics and biosimilars as indispensable. Their members depend on these complex and continuous treatments to maintain their quality of life. For them, the ministry’s regulatory review is a welcome first step. The real test will be whether this process results in a more robust regulation and a public purchase that genuinely prioritizes quality and safety over the lowest possible cost.
All eyes are now on the health ministry as it conducts its review and on the Social Security Fund as it decides how to proceed with the tender. The resolution will set a critical precedent for how Panama manages the introduction of advanced, high-cost therapies into its public health system for years to come.