Argentina’s national blood system is undergoing a sweeping transformation following the publication of Resolution No. 536/2026 by the Ministry of Health, introducing the most significant update to the country’s blood donation and transfusion regulations in more than a decade.
The new framework modernizes the nation’s blood services by prioritizing safety, quality, and traceability, while aligning regulations with the latest scientific and technological advances. According to the Ministry of Health, the reform aims to ensure safe and sufficient blood access for all residents across the country through updated standards that strengthen donation and transfusion processes, improve patient and donor protection, and reflect current medical evidence.
Shift to 100% Voluntary Blood Donation
One of the most notable changes under Resolution 536/2026 is the elimination of Argentina’s longstanding replacement donation model, under which patients or their families were often required to provide blood donors before surgeries or medical procedures.
The new regulation replaces that system with a 100% voluntary and regular donation model, meaning patients will no longer need to present donors to access surgeries or treatments, except in cases where donations for a specific patient are therapeutically justified.
Health officials say the reform will improve transfusion safety because voluntary and repeat donors typically show lower rates of transfusion-transmissible infections. Authorities also stressed that the responsibility for securing blood should not fall on patients or their families, adding that voluntary donation systems generate better outcomes in both blood safety and availability.
Updated Donor Eligibility Criteria
The new rules also revise donor selection criteria, eliminating restrictions the government considers outdated or discriminatory.
Under the updated framework, donor assessments will focus exclusively on the individual behaviors and medical history of prospective donors, including specific sexual practices, drug use, and other evidence-based risk factors, rather than broader categorical exclusions.
Another notable change removes the requirement for fasting before donation. Instead, donors are now advised to consume at least 500 milliliters of water or electrolyte beverages approximately 30 minutes before giving blood.
New Waiting Periods for Donors
Resolution 536/2026 also updates deferral periods for blood donation in certain situations. Individuals must now wait six months before donating if they have:
- Had a new sexual partner, or more than one sexual partner in the previous three months involving anal intercourse
- Used HIV preventive medications such as PrEP
- Received tattoos, piercings, or invasive cosmetic procedures
- Been incarcerated in a penal institution for more than 72 hours
The Ministry stated that these waiting periods reflect advances in blood testing technology and are designed to minimize the risk of transmitting infections through transfusions.
Hospital Blood Banks to Be Phased Out
A major structural component of the reform is the gradual closure of hospital-based blood banks in favor of a more centralized national network.
Regional Hemotherapy Centers will take over responsibility for organizing, processing, and distributing blood supplies across the country. Officials believe this model will create a more efficient, safer, and lower-cost blood management system.
The integrated network will allow authorities to monitor and track each unit of blood from donation through transfusion, improving oversight and accountability nationwide.
Mandatory Digital Traceability Systems
To strengthen transparency and control, all hemotherapy centers, blood banks, and transfusion services will be required to implement digital record-keeping systems.
These computerized systems must document every stage of the blood supply chain—from donor recruitment and blood collection to processing and transfusion—ensuring full traceability of every blood unit.
The Ministry of Health said the digitalization of records will help identify errors more quickly, prevent incidents, and improve emergency response capabilities.
Regulation of Advanced Blood-Based Therapies
The new resolution also establishes updated rules for advanced treatments involving blood-derived products and cellular therapies, including:
- Platelet-Rich Plasma (PRP)
- Autologous Ophthalmic Serum (AOS)
Only facilities authorized under Argentina’s Blood Law will be permitted to produce these products, placing their manufacture and use under direct state supervision.
Officials said this move is intended to strengthen oversight of regenerative medicine and specialized therapies increasingly used in ophthalmology and other medical fields.
Two-Year Transition Period for Compliance
Hospitals, blood banks, and hemotherapy centers will have up to two years to adapt their facilities, systems, and procedures to comply with the new standards.
The Ministry noted that implementation of the reform will not require additional budget allocations, as the changes will be carried out within the ministry’s existing legal and operational framework.
Toward a Modernized National Blood System
By replacing outdated regulations and introducing comprehensive administrative and technical standards for hemotherapy, immunohematology, and cellular therapy, Argentina is seeking to build a modern blood services system aligned with the most advanced healthcare models in the region.
Health authorities emphasized that periodic regulatory updates are essential as medical science and technology continue to evolve, ensuring Argentina’s blood system remains safe, efficient, and responsive to future healthcare needs.