Guatemala Covid Vaccine NFCS

Introduction

Guatemala created a no-fault compensation for COVID-19 vaccines in 2021 through the passing of the Congress of the Republic of Guatemala Decree 8-2021 (‘Decree 8-2021’), which entered into force on 7 July 2021. The scheme is further regulated by the Acuerdo Ministerial 149-2021 of 23 July 2021 (‘Acuerdo Ministerial 149-2021’) and the Acuerdo Ministerial 150-2021 of 26 July 2021 (‘Acuerdo Ministerial 150-2021’).

The scheme is administered by the Ministry of Public Health and Social Assistance (Ministerio de Salud Publica y Asistencia Social). The Decree 8-2021 provides that a Comité de Evaluación de Reacciones Adversas Serias a la Vacunas (Committee for the Evaluation of Serious Adverse Reactions to Vaccines), a supporting expert body of the Ministry of Public Health and Social Assistance, is set up to assess compensation claims relating to COVID-19 injuries under the scheme (Decree 8-2021, Article 7, and also Acuerdo Ministerial 149-2021).

The funding for the scheme comes from central government (see Decree 8-2021, Article 10).

Vaccines Covered

This NFCS covers nationally approved vaccines purchased by or donated to the state within 24 months from the entry into force of the Decree No. 8-2021 (see Decree 8-2021, Article 2).

As the title of the Decree refers to emergency use vaccines and the scheme is operational only for 24 months from the entry into force of the Decree, it seems this NFCS might cover vaccines approved for emergency use only, although this is not specified in the Decree.

The scheme is not retroactive, therefore only vaccines administered before entry into force of the law are covered by this NFCS.

Injuries Covered

This NFCS covers both temporary and permanent injuries.

Under this NFCS only eligible injuries are covered. Eligible injuries are serious adverse reactions to a covered vaccine resulting in a significant impact on the injured person’s bodily functions. More specifically, these are injuries involving:

Hospitalisation or prolonging of hospitalisation of a vaccinated person;
Persistent or significant disability;
Death of the vaccinated person.

See Acuerdo Ministerial 150-2021, Article 2(g) and (h); see also Decree 8-2021, Article 3(e) and (f).

Charges for making a claim

It is not known whether there are any charges for making a claim under this scheme.

Claimants

Under this scheme the following categories of individuals are permitted to make a claim:

Vaccinated person who suffered a serious adverse reaction following a vaccine administered by the health sector of the State of Guatemala, or legal representative of the vaccinated person;
A family member within a legally recognised degree of kinship.

See Acuerdo Ministerial 150-2021, Article 2(h); see also Decree 8-2021, Article 3(f).

Under this scheme the claimant is allowed to nominate a legal representative to make a claim.

Funding for legal representation is not specifically provided by the scheme.

Losses covered

This scheme pays the following:

Live vaccine recipient

Dependants of vaccine recipient

Surviving family members of a deceased vaccine recipient

Compensation payments are for general categories and are not broken down into economic and non-economic losses.

No Compensation is specifically provided for dependants.

Compensation payments are for general categories and are not broken down into economic and non-economic losses.

Payments consist of a mixture of periodic payments and a lump sum payment.

Different types of compensation apply to those who are beneficiaries of social security and those who are not beneficiaries of social security (Decree 8-2021, Article 9).

If the vaccinated person whose claim for compensation is successful is a beneficiary of Guatemalan social security, the relevant social security legislation of the Guatemalan Institute of Social Security (Instituto Guatemalteco de Seguridad Social) will apply to their case.

If the claimant is not a beneficiary of Guatemalan social security, compensation consists of a lump sum payment equal to ten (in the event of serious or persistent disability) or fifteen (in the event of death) monthly minimum wages for non-agricultural activities.

Hospital treatment is also covered and compensation equal to the daily minimum wage for non-agricultural activities for each day of hospitalisation and subsequent rehabilitation for serious injuries is offered to those who are not beneficiary of social security.

Funeral expenses are not specifically available under this NFCS.

Loss of earnings are not paid under this scheme.

While there does not seem to be a general cap on compensation set out in statute, the Decree 8-2021 sets out at Article 9 a maximum quantum of fifteen monthly minimum wages for non-agricultural activities in the event of death of vaccinated people who are not social security beneficiaries.

There does not appear to be a minimum claim value under this NFCS.

Time limits for claims

The scheme does not set a time limit between vaccination and the adverse event occurring.

There is a time limit of 30 days from the date of vaccination for the vaccinated person to inform her Vaccination Centre or appropriate health institution that an adverse event allegedly attributable to vaccination has occurred (see Acuerdo Ministerial 150-2021, Article 4).

There is also a time limit of 30 days from the notification of the decision of the Expert Committee (the Comité de Evaluación de Reacciones Adversas Serias a la Vacunas) on whether a vaccine has caused a serious adverse event to file a claim for compensation with the competent 'Dirección de Área de Salud'.

It should be noted that a claim for compensation may only be filed with the Dirección de Área de Salud following a decision of the Committee finding a causal link between a covered vaccination and a serious adverse reaction (see Decree 8-2021, Article 8 and Acuerdo Ministerial 150-2021, Article 11).

Evaluating claims – standard of proof required

The standard of proof required by the scheme is Based on the Bradford Hill Criteria (see the Manual para la vigilancia de eventos supuestamente atribuibles a la vacunación o inmunización (ESAVI) Guatemala, here at Annex 7).

Appeals and the right to litigate

There seems to be a restricted right to litigate claims covered by this NFCS.

There is an exemption of liability for those involved in the development, manufacture, commercialization, acquisition, and distribution of an eligible COVID-19 vaccine, however this does not apply when fraudulent actions or omissions occur or when serious injury or death is caused and it can be demonstrated that this is the result of intentional or wilful misconduct (see Decree 8-2021, Articles 4 and 5).

Prior to receiving compensation, a statement from the claimant is required which declares acceptance of NFCS compensation and exempts the state of Guatemala and the Ministry of Public Health and Social Assistance from any responsibility in relation to the compensated adverse event (see Acuerdo Ministerial 150-2021, Article 16).

No information is available on an appeal processes.

Useful information and links

It is not known whether the scheme produces an annual report including data on claims & financial performance (claim numbers, payments, claim processing timeframes, administrative costs, etc).

Links to legislation:

Congress of the Republic of Guatemala Decree 8-2021: https://legal.dca.gob.gt/GestionDocumento/VisualizarDocumento?verDocumentoPrevia=True&versionImpresa=False&doc=106270

Acuerdo Ministerial 149-2021 of 23 July 2021: https://legal.dca.gob.gt/GestionDocumento/VisualizarDocumento?verDocumentoPrevia=True&versionImpresa=False&doc=109643

Acuerdo Ministerial 150-2021 of 26 July 2021: https://www.mspas.gob.gt/acuerdos-ministeriales-2021?task=download.send&id=2654&catid=274&m=0

Other resources:

Lexology press release: https://www.lexology.com/library/detail.aspx?g=372762fd-195c-404d-892b-48b0a2de9948

Manual para la vigilancia de eventos supuestamente atribuibles a la vacunación o inmunización (ESAVI) Guatemala: https://medicamentos.mspas.gob.gt/phocadownload/Farmacovigilancia/MANUAL%20ESAVI.pdf