The National Federation of Associations of Critical, Chronic, and Degenerative Diseases (FENAECCD) has expressed concern over recent medicine tenders (Unique Price Tenders No. 05-2026 and 11-2026) conducted by the Social Security Fund (CSS).
The organization also pointed out that while Law 419 of 2024 regulates biotechnological medicines for the first time, its implementing regulations have not yet been published, adding uncertainty to procurement processes. According to the federation, one of the key risks is the lack of evidence, as requirements for evidence of comparability and interchangeability of medicines, especially biotechnological ones, are not being requested.
The organization, representing patients with high-complexity diseases, has expressed its position on the lack of inclusion of crucial technical and clinical criteria to ensure the safety, quality, and efficacy of the products to be acquired.
Furthermore, it indicates that there are previous cases where certain biosimilars have shown lower efficacy, causing relapses in chronic patients. It also states that there is a risk of accepting products from countries with weak regulatory norms, which could compromise their quality.
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.
