Latvia Covid Vaccine NFCS
Introduction
Latvia had an existing no-fault compensation scheme introduced in 2013 for damage caused to patients by health care practitioners (HCPs), which can be claimed from the Latvian ‘Medical Treatment Risk Fund’. This scheme appears to also cover cases of vaccine-related injury, but only in cases when this has been caused by an HCP (for example, if the injury has been caused by an injection mistake by the HCP administering the vaccine) -see CMS Guide 2021 (here) and also the website of the Latvian Health Inspectorate administering the Fund since 2019 (here).
In 2022, Latvia introduced a new NFCS for COVID-19 vaccines through Cabinet Regulation No. 272 Adopted on 3 May 2022 (‘Cabinet Regulation’), issued pursuant to Section 49.7 of the Law on the Management of the Spread of COVID-19 Infection.
This scheme was created under national legislation.
It is administered by the Zāļu valsts aģentūrā (ZVA) (State Medicines Agency), which is a public body.
The funding for the scheme comes from central government – see Cabinet Regulation, 1.2.
Vaccines Covered
This NFCS covers EU-approved COVID-19 vaccines administered in Latvia (namely the vaccines ‘Comirnaty’, ‘Spikevax’, ‘Vaxzevria’, ‘Jcovden’ or ‘Nuvaxovid’) – see ZVA website, here.
It includes vaccines approved for emergency use and standard approvals (see Cabinet Regulation, 3.2, stating the NFCS covers ‘[any] vaccine against COVID-19 which has been registered in a centralised registration procedure in conformity with Regulation (EC) No 726/2004...’).
Injuries Covered
This NFCS covers both temporary and permanent injuries.
Under this NFCS only eligible injuries are covered. Eligible injuries are those causing serious harm or moderately serious harm to a patient which are listed as adverse events in the product characteristics of the relevant COVID-19 vaccine. Additionally, the injury must have a long-lasting impact on the patient’s health, with the effects of the injury lasting for at least 26 weeks, or the injury resulting in the death of the patient. (see Cabinet Regulation, 3)
Charges for making a claim
There is no charge 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 an eligible injury or a legal representative of the vaccinated person;
- Legal heir of the vaccinated person in case of death due to vaccination.
(see ZVA website here)
Under this scheme the claimant is allowed to nominate a legal representative to make their claim.
Funding for legal representation is not specifically offered to claimants under this scheme.
Losses covered
This scheme pays the following:
|
Live vaccine recipient |
Dependants of vaccine recipient |
Estate 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 lump sum payment.
Funeral expenses are not specifically provided for under this NFCS.
Compensation under this scheme calculated on an individual basis using tariffs/guidelines to assist with quantification. The tariffs are included as Annex 1 to the Cabinet Regulation.
Loss of earnings are not paid under this scheme.
Compensation under this scheme has a top value of €142,290 (see Annex 1 to the Cabinet Regulation, and also to Section 49.7(1) of the Law on the Management of the Spread of COVID-19 Infection).
There is a minimum claim value under this NFCS of €5000 in the event the injured claimant is undergoing medical treatment of at least 26 weeks and/or has temporary incapacity for work for at least 26 weeks (if the person is employed) and she requires medical procedures, surgical interventions, and/or rehabilitation (see Annex 1 to the Cabinet Regulation).
Time limits for claims
The scheme does not set a time limit between vaccination and the adverse event occurring.
A claim under the scheme must be brought within two years from the date of discovery of the damage, but no later than three years from the date of vaccination.
Evaluating claims – standard of proof required
Under this scheme, there is a double assessment of causality, looking at:
- The potential causal link between the adverse effect caused to a patient and COVID-19 vaccination (see Cabinet Regulation, 9.2); and
- The potential causal link between the adverse effect caused by COVID-19 vaccination and the serious or moderately serious harm inflicted on the health or life of a patient (see Cabinet Regulation, 9.3).
If the ZVA finds that there is a possible causal relationship between a specific side effect and COVID-19 vaccination, it prepares all the necessary information and medical documentation within five working days and submits it to a specialist in the relevant field of the clinical university hospital or to a committee of specialist doctors to assess the possible causal relationship between the side effect caused by the vaccine against COVID-19 and the severe or moderate damage to the health or life of the patient (see Cabinet Regulation, 10).
Further information on the standard used by the ZVA to determine whether there is a causal relationship between a specific side effect and COVID-19 vaccination could not be found in the relevant statute or regulation.
A decision on compensation shall be taken by the ZVA within six months after receipt of the compensation claim. If additional information needs to be requested, collected, and evaluated, the period for examining the compensation claim and taking the decision may be extended for up to one year (see Section 49.7(2) of the Law on the Management of the Spread of COVID-19 Infection).
Appeals and the right to litigate
Use of the scheme and litigation are mutually exclusive and a claimant must choose which one they take (see Section 49.7(3) of the Law on the Management of the Spread of COVID-19 Infection).
There is an external review process of the ZVA’s decision. A decision of the Agency may be appealed with the Ministry of Health, whose decision may in turn be appealed in court in accordance with the the Latvian ‘Administrative Procedure Law’ (Cabinet Regulation, 20).
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:
Law on the Management of the Spread of COVID-19 Infection of 5 June 2020 (as amended), OP number 2020/110A.1: https://likumi.lv/ta/en/en/id/315278-law-on-the-management-of-the-spread-of-covid-19-infection
Cabinet Regulation No. 272 Adopted on 3 May 2022: https://likumi.lv/ta/en/en/id/332106-regulations-regarding-compensation-for-serious-or-moderately-serious-harm-to-the-health-or-life-of-a-patient-inflicted-due-to-adverse-effects-caused-by-vaccination-against-covid-19-infection
Link to the NFCS section on the ZVA website: