As a result of the adoption of An Act amending the Act on Prevention and Control of Infections and Communicable Diseases The Immunization Compensation Fund has been launched, providing a fast-track compensation pathway for people who have experienced adverse reactions to vaccines. The establishment of the Fund was a much-anticipated step that will provide a quick and uncomplicated way to pay compensation.
When and what vaccinations?
According to the legislation passed, applications to the Patient Ombudsman for compensation benefits can be submitted from 12 February 2022. Applications submitted before this date will not be able to be considered. In its first year of operation, the Fund will only cover COVID-19 vaccinations performed from the start of the vaccination campaign in December 2020 (i.e. the law will be retroactive, meaning that it covers COVID-19 vaccinations performed from the start of the vaccination campaign in December 2020).
Importantly, the Act also covers the remaining immunizations, but those carried out only from 1 January 2023. - Ultimately, the benefit will cover adverse post-vaccination reactions (NOP) after routine mandatory vaccinations, primarily of children and adolescents up to 19 years of age, but also vaccinations that are carried out in an epidemic situation, organised by state authorities and financed from state budget funds (such as measles or meningococcal vaccinations), which may potentially be introduced in an epidemic state in the regulations issued pursuant to Article 46, paragraph 4, point 7 of the Act on preventing and combating infections and infectious diseases in humans. The compensation benefit will not cover cases of adverse reactions that occur after vaccination within the framework of recommended vaccination.
What are the award criteria?
According to the law, the compensation benefit will apply when, as a result of vaccination, adverse reactions listed in the summary of product characteristics occur that have necessitated hospitalisation for at least 14 days, or anaphylactic shock occurs, necessitating observation in a hospital emergency department, emergency room or hospitalisation. This criterion will not apply only in the case of anaphylactic shock, which, although a condition that resolves quickly under treatment, is a serious adverse reaction. The NOP reports show that by 31 January 2022, 17 989 NOPs had been registered out of 51 million Covid-19 vaccinations, or 0.05 per cent. Of these, several hundred people were hospitalised, but it is not known for how long, 2245 had serious and severe NOPs. In addition, as I have already mentioned, the compensation benefit will cover adverse reactions that occurred as a result of vaccination performed against COVID-19, carried out after 26 December 2020,
What amount of benefit?
The maximum amount of compensation under the Compensation Fund is PLN 100 000. Its final amount will depend on the number of days of hospitalisation, but also on the intensity of the symptoms. Thus, the benefit will amount to:
- £3,000 in the case of observation in a hospital emergency department or emergency room for anaphylactic shock;
- PLN 10,000 in the event of hospitalisation for anaphylactic shock lasting less than 14 days;
- from PLN 10,000 to PLN 20,000 in the case of hospitalisation lasting from 14 days to 30 days;
- From PLN 21,000 to PLN 35,000 in the case of hospitalisation lasting from 31 days to 50 days;
- From £36,000 to £50,000 of hospitalisation lasting from 51 days to 70 days;
- From £51,000 to £65,000 of hospitalisation lasting from 71 days to 90 days;
- From £66,000 to £89,000 of hospitalisation lasting from 91 days to 120 days.
In the above cases, the benefit will be paid in proportion to the period of hospitalisation. Hospitalization lasting more than 120 days will be entitled to PLN 100,000.
Except that the compensation benefit is further increased in the event of:
- surgery under general anaesthesia - by PLN 15,000;
- another surgical procedure or a method of treatment or diagnosis posing an increased risk - by PLN 5,000;
- hospitalisation in an intensive care or intensive care unit lasting at least 7 days - by PLN 10,000;
- hospitalisation in an intensive care or intensive care unit lasting longer than 30 days - by PLN 20,000.
According to the law, however, the total amount of the compensation benefit cannot exceed PLN 100,000.
Who will award them?
The benefit will be granted by an administrative decision of the Patient Ombudsman, following the opinion of the The Group on Benefits from the Immunization Compensation Fundwhich is chaired by Professor Tomasz Hryniewiecki - National Consultant in Cardiology, Chairman of the National Council for Cardiology and Plenipotentiary of the Minister of Health for the National Cardiovascular Programme. The team comprised six experienced medical specialists distinguished by their expertise in immunisation. The timeframe for processing the application will be two months, ensuring a quick determination and prompt payment of the Compensation Fund benefit.
The Patients' Ombudsman conducts inquiries, collecting the documentation necessary to handle requests. Cases are reviewed by the above-mentioned Ombudsman. Benefits team, whose task is to determine whether the patient has suffered an adverse reaction listed in the summary of product characteristics of the vaccine in question, which is one of the conditions for granting the benefit.
In the event that an application is incomplete or not properly paid, the Ombudsman will call upon the applicant to supplement the application within 30 days of receipt, indicating the deficiencies found. Also, if there is no basis for assessing the merits of the application, the Ombudsman will be able to issue a decision without the involvement of a panel. The decision issued by the Ombudsman will be subject to a complaint to the administrative court.
What fee?
The submission of an application for compensation is subject to a fee of PLN 200. If we do not present a confirmation of payment with the application, the Ombudsman will call us to supplement this deficiency within 30 days. Failure to pay the application within this period will result in the application not being considered. The application fee is refundable if a compensation payment is granted. If the Ombudsman leaves the application unprocessed or refuses to initiate proceedings, the fee will also be refunded. On the other hand, if a decision is made to refuse the benefit, the fee will not be refunded. If the applicant indicates that he or she is in a difficult financial situation and provides documents to prove it, the Ombudsman will waive the application fee.
Characteristics of applications
As of 12 February 2022, the Patient Ombudsman had received almost 700 claims for benefits from the Immunization Compensation Fund. Almost 20 per cent of the claims submitted were related to the occurrence of anaphylactic reactions immediately after vaccine administration. The remaining claims related to patients diagnosed with, for example, nervous system disorders or vascular, cardiac and blood disorders.
Such a high level of interest from patients, despite the short time since the new regulation came into force, proves that the creation of the fund was an expected and necessary solution. The administrative procedure is the best solution for providing financial support to patients who have suffered a vaccination-related injury.
The largest number of applications came from the Mazowieckie, Pomorskie and Małopolskie voivodeships, and the smallest from the Podlaskie voivodeship. People in the 61-70 age group apply most often for benefits from the Immunization Compensation Fund, and the fewest applications are for children.
All the applications reviewed by the Ombudsman so far relate to COVID-19 vaccination, which corresponds to the current scope of the Fund (as a reminder, from 01 January 2023, it will also cover mandatory vaccination). Of the applications submitted, 61.9 per cent relate to the vaccine Comirnaty (Pfizer-BioNTech), Vaxzevria (Astra Zeneca) 25.4 per cent, Spikevax (Moderna) 7 per cent and Janssen (Johnson & Johnson) 5.7 per cent.
When submitting an application, pay attention to
- if you send a paper application, remember to sign it in manuscript
- if the application is sent electronically, it must be signed electronically (so it cannot be a scan of a manually signed application)
- A certificate of vaccination (e.g. taken at the IKP or printed at the vaccination centre) must also be attached to the application.
- copies of medical records should also be attached
Let us also remember that if the COVID-19 vaccination and the associated hospital stay took place before the 27 January 2022, i.e. before the law comes into force, the deadline for applying for the benefit expires at the end of the current year, 2022.
There is the first compensation
Meanwhile, the first compensation for an adverse vaccination reaction has already been awarded. The Patient Ombudsman issued a decision concerning a patient from the Mazovia region who was diagnosed with Guillain-Barré syndrome. This is a very rare peripheral nerve disorder, leading to muscle weakness or paralysis, included in the Vaccine Janssen and Vaxzevria vaccine specifications. The medical opinion of the Ombudsman's Benefits Panel confirmed that the patient's 64-day hospital stay was due to an adverse reaction to the vaccine. With the Ombudsman's decision, the patient will therefore receive PLN 45,000 under the Immunization Compensation Fund.
Jakub Gołąb - Director of Social Dialogue and Communication Department of the Ombudsman for Patients' Rights
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