Vaccine compensation regimes in France

  1. Are COVID-19 vaccinations obligatory in your jurisdiction? Are you expecting any legislative changes to enable mandatory vaccines for all or certain people (e.g. healthcare professionals, public servants, school children, the elderly, frequent travellers)?
  2. How would any COVID-19 vaccine be paid for in your jurisdiction (is it reimbursed from the public health system)?
  3. What legal regime(s) and regulations govern vaccine compensation in your jurisdiction? Is there specific legislation enacted or anticipated in relation to a COVID-19 vaccine or will it be covered under existing legislation?
  4. Who is covered/eligible for compensation (please cover compulsory and non-compulsory vaccination)?
  5. What damages are compensated, e.g. death, injury, disability, pain, mental suffering of a close person, economic damage (please cover compulsory and non-compulsory vaccination)?
  6. What are the necessary conditions for a person to make a claim for compensation, including burden of proof (please cover compulsory and non-compulsory vaccination)?
  7.  Who would be liable to pay the compensation, e.g. the state, the manufacturer of the vaccine (please cover compulsory and non-compulsory vaccination)?
  8. Is there a de minimis threshold or a cap on compensation?
  9.  Is compensation based on tariffs or individual assessment?
  10.  Can a claimant obtain additional compensation beyond payment made by the compensation system?
  11.  Are you aware of any future legal developments in your jurisdiction with regard to compensation of COVID-19 vaccines?

1. Are COVID-19 vaccinations obligatory in your jurisdiction? Are you expecting any legislative changes to enable mandatory vaccines for all or certain people (e.g. healthcare professionals, public servants, school children, the elderly, frequent travellers)?

In France, a COVID-19 vaccination is not obligatory (see the list of compulsory vaccinations in article L3111-2 of the French Public Health Code (PHC) and article 53-1 of the Decree No 2020-1310 of October 29th, 2020). The decision to vaccinate is shared between the patient and a healthcare professional. Thus, it is necessary to obtain the patient’s prior consent and to record it in the patient's medical file. 

However, the French government has recommended COVID-19 vaccinations for certain categories of individuals such as seniors in retirement homes, professionals working in these retirement homes at risk of developing a severe form of COVID-19, healthcare professionals aged 50 years or over, disabled people or persons affected by chronic illness. Since 18 January 2021, the government has recommended vaccinations for seniors aged 75 years or over and vulnerable patients with a high risk in case of contamination. (In accordance with the French Authority's advisories, see the following – 30 November 2020, 2 and 12 February 2021 and 2 March 2021). 

At this stage, we do not expect any legislative change to enable mandatory COVID-19 vaccines for all or certain individuals. Recently, the French government has been discussing the possibility of requiring COVID-19 vaccinations for healthcare professionals, but no concrete measure has been taken.

Finally, note that European discussions are currently being held to determine whether a “vaccination passport” system should be implemented.

2. How would any COVID-19 vaccine be paid for in your jurisdiction (is it reimbursed from the public health system)?

Covid-19 vaccines are purchased by the National Public Health Agency (ANSP) and made available free of charge to patients (see article 53-1 of the Decree No 2020-1310 of 29 October 2020). 

Decree No. 2020-1833 of 31 December 2020 provides full coverage of pre-vaccination and vaccination consultations and the costs of vaccinations for individuals. People who are not covered by social security are exempt from the advance payment of fees.

In France, regulations distinguish between compensation for compulsory and non-compulsory vaccines.

Concerning compulsory vaccination, the patient can expect full compensation for any damage and should claim compensation from the National Office for Compensation of Medical Accident (ONIAM) (see Article L3111-9 of the French PHC). If the offer proposed by the ONIAM is not satisfactory, the patient can refuse the offer and make an appeal to the administrative court.

There is no special procedure for compensation of damages resulting from recommended non-compulsory vaccinations. A vaccination is a medical act. Any harmful consequences can be compensated by different means such as:

  • Proceedings before the competent court; or
  • Proceedings before the Conciliation and Indemnity Commission (CCI) and, in case of rejection or disagreement with the proposed offer, a suit before the competent court.

By way of derogation, a specific compensation procedure is applicable in the context of the COVID-19 vaccination campaign. The patient can in principle lodge a claim directly with the ONIAM (and not the CCI) and will not have to prove a defect with the product or any fault by the healthcare professional to receive compensation (i.e. see question 6 below).

4. Who is covered/eligible for compensation (please cover compulsory and non-compulsory vaccination)?

Any person who has suffered a damage as a result of the COVID-19 vaccination programme defined by article 55-1 of Decree 2021-1262 of 16 October 2020 and article 53-1 of Decree 2020-1310 of 29 October 2020 is eligible for compensation pursuant to the general principles of French civil law since this vaccine is non-compulsory.

In case of a compulsory vaccination, compensation could be granted pursuant to the general provisions of the French PHC.

5. What damages are compensated, e.g. death, injury, disability, pain, mental suffering of a close person, economic damage (please cover compulsory and non-compulsory vaccination)?

Under French law, the principle is that of full compensation for any direct damage suffered by a direct or indirect victim. The court, the ONIAM and the CCI usually apply Dintilhac nomenclature to determine the damages to be compensated. This nomenclature lists all indemnifiable damages including functional deficit, loss of enjoyment (préjudice d’agrément), health expenses, aesthetic damage, and pain). In France, there is no separate regime, which governs vaccine compensation.

6. What are the necessary conditions for a person to make a claim for compensation, including burden of proof (please cover compulsory and non-compulsory vaccination)?

Generally speaking, the conditions for a person to make a claim for compensation are the same for compulsory vaccinations and non-compulsory vaccinations: the party claiming compensation must prove the damage suffered, the defect in the vaccine and the causal relationship between such damage and defect. However, in cases of lack of scientific consensus, the EUCJ has accepted that evidence of the causal link may be provided by the victim on the basis of serious, specific and consistent presumptions left to the discretion of the court ruling on the merits of the case (see EUCJ, 21 June 2017, Case C-621/15 N. W e.a./Sanofi Pasteur MSD e.a.). French courts have adopted a similarly reasoned ruling that the causal link between an injury and a health product (in these particular cases, the vaccine against Hepatitis B) may be evidenced by serious, specific and consistent presumptions (see Court of cassation, 18 October 2017, (n°15-20.791); Court of cassation, 14 November 2018, (n°17-27.980 ;17-28.529))

Under French law, claims for compensation in relation to a vaccine are often based on the liability for defective products, which is laid down by articles 1245 and seq. of the French Civil Code. However, note that in this case, the manufacturer of the vaccine may be exonerated from liability (in whole or part) in a few circumstances, such as:

  • He did not put the product into circulation; or
  • Having considered all circumstances, it is probable that the defect that caused the damage did not exist when the product was put into circulation or that this defect only became apparent afterwards; or
  • The state of scientific and technical knowledge at the time when the product was put into circulation did not allow for the detection of the defect; or
  • The defect is due to the compliance of the product with mandatory requirements issued by public authorities.

In the specific case of COVID-19 vaccinations, the party claiming compensation from the ONIAM will not have to prove the defect in the vaccine nor the health professional’s fault according to articles L3131-3 and L3131-4 of the French PHC since this vaccination was part of the management of a health-crisis situation (article L3131-1 of the French PHC).

7. Who would be liable to pay the compensation, e.g. the state, the manufacturer of the vaccine (please cover compulsory and non-compulsory vaccination)?

For compulsory vaccinations, compensation is usually paid by the national solidarity fund created for this purpose: the ONIAM (see Article L3111-9 of the French PHC).

For non-compulsory vaccination, French statutory law provides that compensation should be paid by the person/entity responsible for the damage and notably: 

  • the practitioner when responsible for the fault in the performance of the vaccination; and/or
  • the pharmacist/distributor if they committed a fault; and/or 
  • the manufacturer pursuant to articles 1245 and seq. of the French civil code as mentioned in Question 6; and/or
  • the Agence Nationale de Sécurité du Médicament (ANSM) if the ANSM failed to comply with its obligation to ensure the safety of marketed medicines (see Article L5322-2 of the French PHC).

An allocation of responsibility between two or more of these actors is possible.

For damages caused as part of the COVID-19 vaccination campaign, the French PHC provides the same protection to healthcare professional as it does for compulsory vaccinations (see article L3131-3 of the French PHC). In principle, the responsibility of the health professional may only be engaged in case of serious professional misconduct. Thus, the national solidarity, and more specifically the ONIAM (cf. article L3131-4 of the French PHC), will carry out full compensation for medical accidents attributable to care activities carried out as part of COVID-19 vaccination campaigns.

Finally, note that contractual arrangements between pharmaceutical laboratories and the EU may derogate to the above principle and result in the EU supporting such compensation.

8. Is there a de minimis threshold or a cap on compensation?

In the absence of specific rules governing vaccine compensation, general rules of French civil law apply. 

Thus, in accordance with the principle of full compensation, there is no minimum or maximum amount of compensation. The indemnification will be equal to the entire prejudice suffered by the victim.

9. Is compensation based on tariffs or individual assessment?

Compensation is determined based on an individual assessment and the specific circumstances of each case. However, informally and non-compulsorily, the courts usually apply Dintilhac nomenclature for the various items of prejudices. 

In addition, for the evaluation of damages and while taking into account the victim's personal situation, the courts may refer to the compensation scales established by the Court of Appeal of their district, the compensation scale published by the Gazette du Palais, the ONIAM’s compensation scale or the social security’s scale.

10. Can a claimant obtain additional compensation beyond payment made by the compensation system?

the patient accepts the offer of compensation from the ONIAM or the liable party (e.g. the manufacturer), this is considered as a settlement agreement within the meaning of Article 2044 of the French Civil Code. Therefore, no additional compensation will be granted. 

The same applies if a court has ruled upon a compensation amount. The claimant will not be able to obtain any further compensation. 

However, a claimant may ask a judge or the ONIAM for additional compensation if the claimant presents a further injury from the date of the settlement agreement provided that the concluded settlement did not exclude additional indemnification in case of aggravation of the damage.

Currently, there is no publicly available information on future legislative initiatives regarding compensation for COVID-19 vaccines.

Portrait of Jean-Baptiste Thiénot
Jean-Baptiste Thiénot
Counsel
Paris
Portrait of Aliénor  Fevre
Aliénor Fevre
Associate
Paris