The National Federation of Associations of Critical, Chronic, and Degenerative Diseases (FENAECCD) has issued a serious alert regarding recent drug tenders (Single Price Tenders No. 05-2026 and 11-2026) being advanced by the Social Security Fund (CSS). The organization, which represents patients with highly complex diseases, expressed its deep concern over the lack of inclusion of crucial technical and clinical criteria to guarantee the safety, quality, and efficacy of the products to be acquired.
Ignored Contributions and Identified Risks
According to FENAECCD, despite presenting detailed technical comments and a supporting note from the Directorate of Pharmacies and Drugs of the Ministry of Health (MINSA) during harmonization meetings, their contributions were dismissed. The Federation highlighted the following key risks:
Lack of Evidence: Requirements for evidence of comparability and interchangeability of medications, especially biotechnological ones, are not being requested. Dubious Origin: There is a risk of admitting products from countries with weak regulatory norms, which could compromise their quality. History of Low Efficacy: FENAECCD recalled that there are previous cases where certain biosimilars have shown lower efficacy, causing relapses in chronic patients.
FENAECCD reiterated that it is not opposed to the purchase of biosimilars or generics, but emphasized that safety, efficacy, and quality must be proven to protect patients' health.
Lack of Regulatory Clarity
The organization also pointed out that while Law 419 of 2024 regulates biotechnological medicines for the first time, its regulation has not yet been published, adding uncertainty to the procurement processes.
In the specific case of Tender No. 11-2026, the Federation requested the inclusion of medicines that require interchangeability, as established by Resolution 985 of July 2025, and that the automatic substitution be prohibited in treatments essential for transplants and for the drug clozapine, due to the risk this poses for patient stability.
