Lawyer: compensation for vaccine damage does not observe the principles of good faith or there is no real understanding of actual situations

Riina Kütt before the sleep study, which was just one study among many that the woman had to undergo within four and a half months after the side effects of the corona vaccine appeared. Photo: Erakogu

• Linking health damage to vaccine might prove difficult.
• Using only the digital medical record does not qualify as justified evidence.
• On arrival of the vaccines, the gathering of data on side effect was limited.

People whose severe health damage gas gone uncompensated, whose illness is not associated with the corona vaccine and who consider the interpretation of the law, the content of the evidence used and their collection to be sometimes skewed, are considering contesting the Health Insurance Fund's negative decision in court and do not rule out asking for compensation directly from the drug manufacturer.

«Personal experience and finding fellow victims led us to the idea of ​​joining together,» said Riina Kütt from the non-profit organization Ikkagi Inimesed. «It is clear by now that the vaccine also causes rare and severe side effects, but it is almost impossible to get fair compensation for long-term suffering as long as the nature of the disease and its consequences are not understood.»

Riina Kütt, who changed her career from defense forces member to a leading trainer for adults, was healthy until she received a Pfizer vaccine injection last July. The night after the injection, she felt a stabbing-burning pain in her left hand, from where it radiated to other limbs within a week. In addition, swallowing, breathing, the functioning of the heart were disturbed – functions which are not subject to a person’s will.

At first, the doctors did not see a disorder of the immune system behind the health problems. «They were attending me but ignored that the problems had started immediately after the vaccination. They investigated the wrong things which could not bring results,» said Kütt.

Finally, Kütt reached the West Tallinn Central Hospital. «The doctor listened to me carefully and immediately said that he would not look at the digital medical record because it could contain all kinds of misleading information.» After thorough research, it became clear what was wrong with Kütt. By that time, four and a half months had passed since the vaccination.

«Unfortunately, not everyone has that much luck and perseverance to find a doctor who would help and prepare a proper medical history of all activities,» said Kütt. Life also shows that even this is not always enough to get compensation.

Negative decisions

«People are still sick and some are completely unable to work,» describes the lawyer Jaanika Reilik-Bakhoff those left without compensation by the Health Insurance Fund, who have turned to the Pallo&Partnerid law firm for help. «They mostly were vaccinated last year, so imagine how long they have had to live with the troubles in the meantime.»

According to Reilik-Bakhoff, the arguments used in refusing compensation cannot be accepted; they are based on general statistics, but the health damage of a specific patient should be analyzed instead. «For example, the Health Insurance Fund has justified the negative decision by stating that this is not a known side effect of the vaccine. But the safety studies of the vaccines will not be completed until 2023 or 2024, which means that the information sheet cannot yet list all the side effects.»

According to Maia Uusküla, head of the safety supervision office of the Agency of Medicines, data on side effects are collected to detect new danger signals. However, the majority of side effect reports concern mild, short-term and known disorders. Serious reactions are described in about five percent of cases, of which a quarter may be related to a vaccine. «Even if the same health problem has been reported 20 times, it does not automatically mean that there is a causal relationship with the vaccine,» she said. One should view the broader picture: who gets sick and when. The big drawback is that the notifications contain only the information that the person wants to release.

However, Kütt believes that the Agency of Medicines has also prevented data gathering about the side effects by its own actions. Namely, the agency arbitrarily narrowed the collection of information when it obliged doctors to report at the end of 2020 only those deviations in which case the doctors considered a connection between the vaccine and the health problem possible. The World Health Organization (WHO) and the European Medicines Agency, on the other hand, say that any reaction with a temporal relationship to vaccination must be reported.

At that time, the vaccines had just received a temporary marketing license and information was scarce. Yet the doctors were given an overwhelming task: to act as a detective without any evidence. «The result is that the patient's complaints are often recorded biased or left unrecorded at all. Also, the number of the international classification of diseases, which is extremely necessary for big data analysis, is not included in the medical record. However, based on these data, it is now decided whether to pay compensation or not,» she said.

Legal failure as well?

Unlike Finland, vaccine compensation in Estonia is only available for severe health damage. «Of course, the state could also compensate for lighter cases, but there is nothing directly wrong with the law itself. Mistakes arise from how the law is implemented,» Reilik-Bakhoff believes.

Before deciding on the amount, it is first necessary to first assess whether it is a case of insurance at all. According to the lawyer, the law precisely provides these terms. Unfortunately, the Health Insurance Fund has arbitrarily added another condition to the legal provision: the damage to health must be documented by a physician. This is where the health insurance fund makes a mistake. «I have repeatedly read this article of four and a half lines – there is no such requirement in the definition of an insurance case,» emphasized Reilik-Bakhoff.

The Ministry of Social Affairs has its own explanation for the matter. According to Heli Paluste, the head of the healthcare network, compensation can be refused if a person has not seen a doctor. «According to the Law of Obligations Act and the Act on the Organization of Healthcare Services, the doctor has a legal obligation to record. Without documents it is not possible to prove that health damage has occurred.»

It sounds like a play on words, but Reilik-Bakhoff does not agree with Paluste's interpretation either. «The payment of compensation can be refused if the patient does not comply with the treatment or does not show up for the appointment, but the problem is that the doctors have not even made an appointment or prescribed any treatment.»

In the lawyer's opinion, these interpretations also clearly show that it is not possible to distinguish between two separate stages which follow each other: one is the determination of an insurance case and the other is the payment of compensation. The minister's regulation, which also includes the documentation requirement imposed on the doctor, will be involved only when it is decided how much compensation a person will receive.

«During the preparation of the bill these provisions were discussed by a group of experts, which included not only state representatives and lawyers but also doctors; it was a consensus proposal,» Paluste said. The experts did not consider it necessary to start listing groups of diseases in the law or to duplicate the international classification of diseases.

In Reilik-Bakhoff's opinion, however, the regulation is not built on the principle of good faith, or otherwise there is no real understanding of what situations people actually find themselves in.

Only the digital record is not enough

According to Uusküla, when evaluating the application, the Agency of Medicines sees all medical records going back several years in the digital record – this provides an overview which places health disorders in the right context. For example, which diseases a person has suffered from in the past.

However, it does not depend on the patient whether or not the doctors send any information about them to the national system. «As far as the evidence necessary for decision-making is concerned, it cannot be based only on the entries in the digital record. If necessary, evidence must also be collected from other sources, and this tends to be ignored,» said Reilik-Bakhoff.

The lawyer recently had a case where the insurance stopped paying compensation to a patient with a broken rib because the doctor coded his condition differently than previously in the digital record. Two court levels found upon the complaint that the compensation must in any case be paid according to a medical certificate submitted later, which confirmed that the individual had not yet recovered. «However, not a single clarifying question had been asked of the people whose stories I know and who were paid no compensation,» Reilik-Bakhoff stated.

In Finland, an individual is paid compensation if the harm to damage occurring after a corona vaccine injection lasts at least two weeks; in Estonia this time is eight times longer, or four months. What is perhaps less known is that the patient need not be on sick leave for all these four months. «If a person barely staggers to workplace and cannot pick up things; it does not mean that he is healthy, even though he is not on sick leave,» said Reilik-Bakhoff.

«It must be understood that the vaccine insurance fund is not for improving the standard of living, but for compensating the serious harm to health caused by the vaccine,» Uusküla emphasized. «The evaluation of the applications shows that there are few serious health problems which are likely to be related to the vaccine, and this is fully consistent with the known safety profile of vaccines.»

«My advice to those who have vaccine damage and who do not accept a negative answer: stand up for your rights,» said Reilik-Bakhoff. If the state refuses to compensate the damage, a claim against the drug manufacturer can be considered.

The manufacturers have received state guarantee for dozens of compensation claims

Because of the strict requirements of the Vaccine Insurance Act which came in force in May, patients can still approach drug manufacturers for compensation, which are likely to meet claims more kindly, but on the other hand, dealing with a large corporation tends to be more complicated and expensive.

Last November, Estonia joined the pre-purchase agreements of the seven vaccine manufacturers participating in the joint procurement of the European Union. Contracts with five manufacturers are still valid: AstraZeneca, Pfizer, Moderna, Novavax and Janssen.

Reuters wrote in July 2020 that most of the countries with which AstraZeneca had concluded supply contracts gave the manufacturer protection against future claims related to the corona vaccine. Ruud Dobber, a member of the management, explained at that time that the manufacturer cannot take the risk if the vaccine displays side effects within four years. Reaching an agreement on this matter is primarily in the national interests of the states.

Heli Paluste, head of the health care network of the Ministry of Social Affairs, assured Postimees that the state has an obligation to fully compensate all manufacturers for the costs related to vaccine damages claims if Estonian residents appeal to the manufacturer for compensation.

But how many damage claims has the state received from drug manufacturers so far? According to Paluste, the Ministry of Social Affairs is not allowed to release the details of the vaccine pre-purchase agreements concluded on behalf of the European Union member states, which is why it is not disclosed how many damage claims Estonia has been informed of, what is the maximum amount being discussed and which manufacturers these claims concern.

The veil of secrecy was slightly lifted by responses sent by Minister of Health and Labor Peep Peterson to three vaccine manufacturers in August.

For example, Pfizer was assured that the ministry would guarantee payment for 40 claims submitted between March 22 and May 24, 2022, which includes both benefits to the patient and all costs associated with handling these claims, including legal fees.

The same promise is repeated in the letter sent to AstraZeneca and Moderna, from which it appears that the country has not received information about any claim from either manufacturer after March 25, 2022. AstraZeneca is also reminded that if the manufacturer has received any claims, they must be reported immediately. This suggests that there might have been such requirements in the past.

According to Paluste, no decision has been reached in any compensation dispute so far, so the money has not actually been transferred either.

Such processes do take time. However, the patient can demand a higher compensation from the manufacturer than the Estonian law provides. One just has to prove the damage. The manufacturer of pharmaceuticals may also be more generous than the state because its reputation is at stake in the dispute, but its financial risk is compensated. In the end, all vaccine damages are paid for by the taxpayer.

Compensation has been paid on seven occasions

866,000 individuals have been vaccinated against the corona virus at least once; a total of two million doses of vaccine have been administered.

The Health Insurance Fund has received more than a thousand applications for the compensation of vaccine damage; approximately half of them have been reviewed.

Until now, some 500 applications have been reviewed; compensation has been paid in seven cases, i.e. it has been allocated to 1.5 percent of applicants.

So far only the lowest-rate or 2,000 euro compensations have been paid (the possible rates of compensation are 2,000, 5,000, 10,000, 50,000 and 100,000 euros).

Up to one million euros have been allocated for the compensation of damage.