On November 15, 2024, the new Vaccination Law was approved by Decree Number 25-2024 by the Congress of the Republic of Guatemala. This legislation seeks to strengthen the immunization system and guarantee access to safe and effective vaccines for the entire population.
The most relevant aspects of the law are developed below:
The law seeks to guarantee protection against vaccine-preventable diseases through the universal administration of quality, safe and effective vaccines. To this end, the principles of equity, equality, availability, voluntariness, free of charge and universality are established.
The Immunization Program is created, which will be the technical regulatory entity in charge of advising the Ministry of Public Health and Social Assistance (MSPAS) regarding the guidelines for reception, cold chain, adequate storage, coordinating and monitoring compliance with all processes and protocols necessary to ensure vaccination and surveillance of vaccine-preventable diseases. Additionally, it will be the entity in charge of implementing the National Vaccination Schedule, which must be published at the beginning of each year, so that all people have access to the supply of vaccines. Said schedule will be reviewed by the National Council of Immunization Practices (CONAPI) annually in order to incorporate vaccines that are considered necessary and adequate according to the epidemiological profile of the country.
Likewise, the National Council of Immunization Practices (CONAPI) is created as the technical and scientific body in charge of advising the Ministry of Public Health and Social Assistance (MSPAS) regarding the use of vaccines, biological immunoglobulin preparations and specific antibodies for the prevention and effective control of immunopreventable diseases in the territory of Guatemala. It will be made up of a group of medical and public health experts from various health sectors.
As mentioned above, the Ministry of Public Health and Social Assistance (MSPAS), through the Immunization Program, must guarantee the sufficient and timely existence of the vaccines included in the National Vaccination Scheme, as well as the other required supplies. Therefore, the Ministry must strengthen health services, human resources, cold chain, and transportation to implement vaccination strategies, prioritizing health services that serve the neglected and vulnerable population.
To ensure safe and effective vaccination, they must be administered by health science professionals, or people who have been trained and accredited with the corresponding authorization, issued by the Ministry of Public Health and Social Assistance (MSPAS). In the case of minors and interdicted persons, they will be vaccinated in the presence or with the express authorization of one or both parents, guardians or legal representatives in charge of them.
In this sense, the obligation to create a Single Vaccination Registry in the health sector is established, as an instrument for recording the age and date of administration of each dose. The information contained in the registry will be exclusively accessible to the health sector.
Finally, the new Vaccination Law regulates that in situations that put the population at risk and that can be prevented by vaccination, the Ministry of Public Health and Social Assistance will develop and execute vaccination strategies and programs for the care and control of emergencies. In these cases, the acquisition made by the State may be carried out without the need for prior registration in the country, under the conditions established by the Department of Regulation and Control of Pharmaceutical and Related Products of the Ministry of Public Health and Social Assistance.
The information provided by ARIAS® is presented for informational purposes only. This information is not legal advice and is not intended to create, nor does it constitute, an attorney-client relationship. Readers should not act on the basis of this information without seeking advice from professionals in the field.
