France Covid Vaccine NFCS

Introduction

France had an existing no-fault compensation scheme for vaccines created in 1964 (through the passing of the Law n°64-643 of 1 July 1964), which covered injuries resulting from compulsory vaccinations (see Borghetti 2016). The French vaccine NFCS is now regulated under the code de la santé publique (the Code of Public Health), L. 3111-9, and is part of a broader administrative no-fault system of compensation for medical accidents (see Looker and Kelly 2011). COVID-19 vaccinations administered in the course of the vaccination campaigns established by article 55-1 of decree 2021-1262 of 16 october 2020 and by the article 53-1 of decree 2020-1310 of 29 october 2020 were incorporated into the system in December 2020 (see here).

The scheme is administered by ONIAM (Office National d'Indemnisation des Accidents Médicaux), which is a public body under the authority of the Ministry of Health.

The scheme is funded through different sources, including:

A payment from the compulsory health insurance schemes, determined by decree and each year by the Social Security Financing Act;
The revenue from the reimbursement of expert assessment fees, provided for in Articles L. 1142-24-4, L. 1142-24-11, L. 1221-14, L. 1142-14 and L. 1142-15;
The revenue of penalties set out in articles L. 1142-14, L. 1142-15, L. 1142-24-6, L. 1142-24-7, L. 1142-24-16 and L. 1142-24-17 of the Code of Public Health;
The revenue of subrogation actions under articles L. 1221-14, L. 1142-15, L. 1142-17, L. 1142-24-7, L. 1142-24-16, L. 1142-24-17, L. 3131-4, L. 3111-9 and L. 3122-4 of the Code of Public Health;
Grants paid by the French State under articles L. 3111-9, L. 3131-4, L. 3135-1, and sections 4bis and 4ter of this chapter (Chapter II) of the Code of Public Health.

See Code of Public Health, L.1142-23.

Vaccines Covered

This NFCS covers mandatory vaccines and vaccines introduced as a health emergency measure (H1N1 and Covid-19 vaccines). The Covid-19 vaccines covered are those administered in the course of the vaccination campaigns established by article 55-1 of decree 2021-1262 of 16 October 2020 and by the article 53-1 of decree 2020-1310 of 29 October 2020 (see ONIAM website, here).

It is not specifically stated whether the scheme includes vaccines approved for emergency use and standard approvals. However, since COVID-19 vaccines started receiving standard marketing approvals by the EMA in 2022 it is assumed that both categories are covered.

Injuries Covered

This NFCS covers both temporary and permanent injuries.

Under this NFCS any injury is potentially covered.

Note that a threshold of disability is provided for medical accidents compensation under ONIAM, but this does not apply to compulsory vaccination or emergency health measures compensation.

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 or legal representative of the injured vaccinated person;
Close relatives of a vaccinated person (only if the injured vaccinated person or their legal representative is also filing a claim with ONIAM)
Legal heirs of a deceased vaccinated person or their legal representative.

See the compensation form available on ONIAM’s website (here).

Under this scheme the claimant is allowed to nominate a legal representative to make their claim. There appears to be some funding for legal counsel (as well as expert medical advice), with a maximum cap of 700€.

Losses covered

This scheme pays the following:

Live vaccine recipient

Dependants of vaccine recipient

Legal heirs of a deceased vaccine recipient

Both eligible economic and eligible non-economic losses are compensated.

No Compensation is specifically provided for dependants, however relatives of a vaccinated person can be eligible for compensation for economic and non-economic losses.

Both eligible economic and eligible non-economic losses are compensated.

It is not known whether payments consist of periodic payments, a lump sum, or a combination of the two.

Funeral expenses are available under this NFCS.

Compensation under this scheme is individualised, however there are non-binding compensation standards set out by ONIAM, which can be adapted by scheme assessors in individual cases (see ONIAM website here). The damages eligible for compensation are listed in a set of comprehensive guidelines known as DINTILHAC nomenclature (see here).

Compensation for loss of earnings is available under this scheme. It is quantified on an individual basis.

Compensation under this scheme is not capped and there is no 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. It also does not seem to specify any time limits on when a claim can be brought.

Evaluating claims – standard of proof required

The decision on causality is made by one or more appointed experts, with the burden of proving a causal link between vaccination and damage falling on the claimant.

Appeals and the right to litigate

There is a restricted right to litigate - if a compensation offer from ONIAM is accepted, no further recourse to the court system is available. If ONIAM's offer is refused by the claimant, it is possible to seek compensation in court. ONIAM has developed a preliminary offer system in which partial offers are made while a claimant’s case is still being investigated – courts have considered these acceptance of these partial offers as also barring further legal action.

There is also an external review process where an appeal against ONIAM’s decision may be filed with the Administrative Court (Tribunal Administratif).

Useful information and links

The scheme produces an annual report including data on claims & financial performance (claim numbers, payments, claim processing timeframes, administrative costs, etc) – for more information, see: https://www.oniam.fr/indemnisation-accidents-medicaux/rapport-d-activite

Link to the scheme website:

https://www.oniam.fr/accidents-medicaux-indemnis%C3%A9s/vaccination-contre-la-covid-19

Links to legislation:

Law n°64-643 of 1 July 1964: https://www.legifrance.gouv.fr/jorf/id/JORFTEXT000000684954/

Code de la santé publique (the Code of Public Health): https://www.legifrance.gouv.fr/codes/article_lc/LEGIARTI000036393284

Academic literature:

Looker, C. and Kelly, H. No-fault compensation following adverse events attributed to vaccination: a review of international programmes. Bull World Health Organ 89:371–378 (2011). doi:10.2471/BLT.10.081901. Available at: https://apps.who.int/iris/bitstream/handle/10665/270902/PMC3089384.pdf?sequence=1&isAllowed=y.

Borghetti, J. 2016. Causation in Hepatitis B. Vaccination Litigation in France: Breaking Through Scientic Uncertainty?, Chi.-Kent L. Rev. 91:543-566 (2016).

Available at: https://scholarship.kentlaw.iit.edu/cklawreview/vol91/iss2/7.

Additional resources:

ONIAM - Référentiel indicatif d’indemnisation: https://www.oniam.fr/procedure-indemnisation/bareme-indemnisation

Commission des Affaires Sociales - PROJET DE LOI DE FINANCES POUR 2023 MISSION «SANTÉ»: https://www.senat.fr/rap/a22-118-4/a22-118-4-syn.pdf