Through Decree 8-2021 authorized by the Congress of the Republic and published on July 6 of this year in the official journal, the Law on Exemption from Liability and Creation of the Compensation Mechanism for the Use of Vaccines Against Covid-19 that Have Authorization of Emergency Use due to the SARS-CoV-2 Virus Pandemic was approved. This Decree will enter into force on July 7, 2021.
For a period of 24 months from the date of entry into force of the aforementioned Decree, the State of Guatemala will assume responsibility and apply the compensation mechanism stipulated in the new law to people affected by having been immunized with vaccines acquired by purchase or donation during this period of time. An affected person is an individual person who was administered, by the health sector of the State of Guatemala, the vaccine against Covid-19, and who by this circumstance rise to an event allegedly attributable to vaccination causing a serious adverse recession.
For this reason, this law regulates the exemption from civil liability of those who are considered as protected persons, being these involved in the development, manufacture, commercialization, acquisition, and distribution of vaccines against Covid-19. The exemption from civil liability for protected persons will depend on the terms in which the contract or acquisition agreement signed with the protected persons and the Ministry of Public Health and Social Assistance is established.
Decree 8-2021 establishes as cases of exception when intentional actions or omissions occur and in those cases in which the death of the vaccinated person has occurred or has suffered serious injury, and that in such cases it can be demonstrated that it is the result of intentional or malicious misconduct. Similarly, compensation will not be applicable in cases where the event is the result of the intentional fraudulent conduct of the affected person.
The Committee for the Evaluation of Serious Adverse Reactions to Vaccines is hereby set up to verify the serious adverse reactions attributed to the events allegedly attributable to vaccination, which shall carry out the investigation and determine whether such circumstances should be compensated through the compensation mechanism. The health authority shall be notified within 30 days of the adverse reaction in order to determine whether the adverse reaction is allegedly attributable to vaccination to the person concerned.
The Ministry of Public Health and Social Assistance is empowered to enter into contracts with the protected persons established in Decree8-2021 within the context of the respective emergency use authorizations, and may:
- Subscribe the contract in a language other than Spanish, having to be translated into Spanish by sworn translation after its subscription and prevailing the content of the contract in the language of subscription in case of discrepancy with the sworn translation.
- Submit such contracts to foreign legislation.
- Submit in the event of dispute concerning contractual non-compliance, interpretation, application, and effect to the international arbitral jurisdiction, in accordance with the relevant treaties and conventions ratified by Guatemala.
- Establish confidentiality clauses that safeguard the contracts and the information contained therein, in the context of article 22, paragraph 4 of the Law on Access to Public Information.
The provisions of Decree8-2021 will apply only to those cases in which the vaccine against Covid-19 is administered, after the entry into force.