Ministerial Agreement 40-2021 of the Ministry of Public Health and Social Assistance authorized the Norm of Exception of Liability and Compensation for Serious Adverse Reactions Attributable to Covid-19 Vaccines. This Agreement was published in the Official Journal this year, on February 18, and entered into force on this same day.
It is established that COVID-19 vaccination is voluntary, universal, and free. Persons who are vaccinated must sign a consent confirming that they have received information about the benefits and risks of vaccination, including possible known serious adverse reactions and that they voluntarily agree to this procedure.
Manufacturers of COVID-19 vaccines that are acquired and supplied by the State of Guatemala may only be responsible for intentional or severely blamed actions or omissions for non-compliance with their obligations of good manufacturing practices or any other obligation imposed on them in the process of registration and approval of vaccines. Such undertakings shall enjoy judicial immunity, with the sole exception of the death of the victim or a serious physical adverse reaction, which can be demonstrated by admissible evidence resulting from "intentional misconduct" by the pharmaceutical company. This liability and immunity exception regime shall apply only during the period in which the purchased COVID-19 vaccine is approved under the emergency use or transitional special approval regime.
The Committee on the Evaluation of Serious Adverse Reactions to Vaccines is established as part of the National Pharmacovigilance Program of the Department of Regulation and Control of Pharmaceuticals and Related Products of the General Directorate for Health Regulation, Surveillance and Control of the Ministry of Public Health and Social Assistance. The purpose of the Committee shall be to investigate and to issue an opinion whether a reaction or a serious adverse event (hospitalization, disability, life threat, congenital anomaly, or death) in the health of the person attributable to the COVID-19 vaccine is caused or not by such vaccines. The Committee will be composed of five (5) national experts with extensive experience in vaccination, who shall review the information of reports of serious adverse reactions attributable to COVID-19 vaccines and provide an opinion determining the severity, its causal association, and the determination of whether or not such reaction should be compensated by the State of Guatemala.
If the causality of a serious adverse event to the administration of the COVID-19 vaccine is established, a compensation system shall be determined through the care of the affected person, as needed, in the national health services network.
Compensation shall not apply if the event or serious physical adverse reaction is the result of the person’s intentional fraudulent conduct.