Poland Covid Vaccine NFCS
Introduction
Poland created a no-fault compensation scheme for COVID-19 vaccines through the passing of the Act of 17 December 2021 Amending the Act on Preventing and Combating Infections and Infectious Diseases in Humans and Other Acts (OJ 2022 pos. 64). The amendment came into effect on 27th January 2022. The amended version of the Act of 5 December 2008 on Preventing and Combating Infections and Infectious Diseases in Humans (OJ 2008 No. 234 item 1570) is available here. The NFCS is regulated by Articles 17a to 17i of the Act.
It is administered by the Rzecznik Praw Pacjenta (Ombudsman for Patients' Rights), who are a public body.
The funding for the scheme comes from multiple sources – see Act of 5 December 2008 on Preventing and Combating Infections and Infectious Diseases in Humans (referred to below as ‘Infectious Diseases Act’), Articles 17b, 17c and 17e. These include suppliers’ payments on vaccine supply contracts (equal to 1.5% gross value of the contract), user fees, payments from the state budget, and private donations.
It should be noted, however, that the supplier contribution provision contained in Article 17c, sec. 1. does not apply to COVID-19 vaccines procured by agreement for early purchase of vaccines against COVID-19 disease caused by the SARS-CoV-2 virus stipulated by European Commission and EU Member States on 16 June 2020 (see Infectious Diseases Act, Article 17c, sec. 2).
Vaccines Covered
This NFCS covers EU-approved vaccines for specified diseases. Originally, the Compensation Fund only covered COVID-19 vaccinations. From January 2023, the scheme also covers serious adverse reactions occurring in connection to mandatory vaccinations provided for in the Preventive Vaccination Programme. It also covers anti-epidemic vaccinations (against measles, meningococcal infections, diphtheria, whooping cough, polio and hepatitis A), which are performed in persons at particular risk of infection or illness.
It is not specified in the statute whether the scheme includes vaccines approved for emergency use and standard approvals. However, as the scheme was introduced prior to covered COVID-19 vaccines receiving Standard marketing authorisation, it may be assumed this NFCS covers vaccines approved for both emergency use and standard approvals.
Injuries Covered
This NFCS covers both temporary and permanent injuries.
Under this NFCS only eligible injuries are covered. In order for an injury to be eligible for compensation, it has to be listed in the Summary of Product Characteristics (SmPC) of the relevant vaccine, and cause:
- anaphylactic shock necessitating observation in a hospital emergency department or emergency room or hospitalisation (for any period of time), or;
- hospitalisation for at least 14 days.
For more information on covered injuries, see the relevant Patients’ Rights Ombudsman section on the Polish government website here (in Polish).
Charges for making a claim
There is a charge for making a claim under this scheme of PLN 200 (which corresponds to about 37 GBP). The fee is reimbursed if a claim is successful or if the proceedings cannot be initiated, and it may also be waived by the Ombudsman in certain circumstances if the claimant is experiencing financial difficulties.
Claimants
Under this scheme the following categories of individuals are permitted to make a claim:
- Vaccine recipients and representatives of vaccine recipients (see Infectious Diseases Act, Article 17e, sec. 2).
Under this scheme the claimant is allowed to have a legal representative to make their claim.
Funding for legal representation is not specifically provided for by the 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 the dependants of a vaccine recipient. |
No Compensation is specifically provided for the estate of a vaccine recipient. |
Payments consist of a lump sum payment.
Funeral expenses are not available under this NFCS.
Compensation under this scheme calculated on an individual basis using tariffs/guidelines to assist with quantification. The specific amounts that can be awarded under this scheme are set out in Article 17a, and are the following:
In the event of anaphylaxis following a covered vaccination:
- PLN 3,000 in case of observation in a hospital emergency department or emergency room,
- PLN 10,000 in case of hospitalisation for up to 14 days.
In the event of hospitalisation of minimum 14 days following an adverse reaction to vaccination listed in the Summary of Product Characteristics (in proportion to the length of time spent in hospital):
|
Duration of hospitalisation |
Benefit amount |
|
14 - 30 days |
PLN 10,000 - PLN 20,000 |
|
31 - 50 days |
PLN 21,000 - PLN 35,000 |
|
51 - 70 days |
PLN 36,000 - PLN 50,000 |
|
71 - 90 days |
PLN 51,000 – PLN 65,000 |
|
91 - 120 days |
PLN 66,000 - PLN 89,000 |
|
>120 days |
PLN 100,000 |
In addition, a claimant may be entitled to further compensation if further treatment or hospitalisation in ICU is needed:
- surgery under general anesthesia - PLN 15,000;
- another surgical procedure or method of treatment or diagnostics posing an increased risk - PLN 5,000;
- hospitalization in an intensive care unit or intensive care unit lasting at least 7 days – PLN 10,000;
- hospitalization in an intensive care unit or intensive care unit lasting more than 30 days – PLN 20,000.
- The compensation benefit may also include reimbursement of the costs of further treatment or rehabilitation after the end of the observation or hospital stay, up to PLN 10,000 (in this case, a claimant should provide copies of the treatment or rehabilitation documentation together with documentation confirming the costs incurred).
Loss of earnings are not paid under this scheme.
Compensation under this scheme is capped, with a top value of PLN 100,000 (about 18,600 GBP).
There appears to be a minimum claim value under this NFCS of PLN 3,000 in case of observation in a hospital emergency department or emergency room following an adverse reaction to a covered vaccine.
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 one year from the last day of hospital stay or observation and no later than five years after vaccination. In the event the Summary of Product Characteristics of the relevant vaccine is updated to cover the claimant’s injury, the time limit will be one year from the SmPC update, but still no later than five years after vaccination.
Evaluating claims – standard of proof required
The decision on compensation is taken by the Ombudsman for Patients' Rights after obtaining an expert opinion from the Team for Benefits from the Protective Vaccination Compensation Fund. In order to be eligible for compensation an adverse event should be included in the Summary of Product Characteristics of the relevant vaccine. The standard of proof required by the scheme is not further specified.
Appeals and the right to litigate
There is a restricted right to litigate – NFCS proceedings shall not be initiated, and the initiated proceedings shall be discontinued if the applicant has been paid redress or damages on the basis of a final court decision issued in civil proceedings related to the occurrence of adverse reactions after the administered vaccine or vaccines, or if civil proceedings are pending (see Article 17f, sec. 17 and sec. 18).
If litigation is pursued after obtaining NFCS compensation, the compensation benefit granted by the NFCS is credited towards redress or damages in civil proceedings related to the occurrence of adverse reactions after the administration of a vaccine or vaccines.
There is an external review process - NFCS decisions can be appealed to the administrative court (Article 17g, sec. 3).
Useful information and links
The scheme produces a periodic report including data on claims (claim numbers, payments, etc) - The Ombudsman for Patients' Rights should submit a bi-annual report to the minister competent for health matters on vaccine compensation, in particular on the number of submitted applications and the amount of compensation benefits granted, taking into account the types of vaccines and their side effects (see Article 17i). It is not known whether this periodic report is published.
Links to Legislation:
Act of 17 December 2021 Amending the Act on Preventing and Combating Infections and Infectious Diseases in Humans and Other Acts (OJ 2022 pos. 64): https://isap.sejm.gov.pl/isap.nsf/DocDetails.xsp?id=WDU20220000064
Act of 5 December 2008 on Preventing and Combating Infections and Infectious Diseases in Humans (OJ 2008 No. 234 item 1570), as amended: https://isap.sejm.gov.pl/isap.nsf/download.xsp/WDU20082341570/U/D20081570Lj.pdf
Link of the scheme website:
Ombudsman for Patients' Rights website section on the Vaccine Compensation Fund:
https://www.gov.pl/web/rpp/fundusz-kompensacyjny-szczepien-ochronnych