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Estonia · Law · SE

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The Law on Mandatory Liability Insurance of Health Care Service Providers

avaldatud riigiteatajasEstonia· Riigikogu· ET

Introduced

17 January 2022

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Status

AVALDATUD_RIIGITEATAJAS

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Discovery layer

Source updated

13 April 2022

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Summary

The bill establishes patient insurance and vaccine damage compensation systems. The bill establishes patient insurance, which is mandatory liability insurance for healthcare service providers (TTO). The draft stipulates the principles and organization of mandatory liability insurance of TTO, as well as the basis and extent of the damage to be compensated to the patient. The purpose of creating the new system is better patient protection and easier compensation than before application. In the event of a loss, where it would have been possible to avoid health damage by treating the patient, the insurance company will begin to evaluate the circumstances of the claim. The insurance amount per injured patient is up to 100,000 euros, 3 million euros for the entire one-year insurance period. Among other things, the draft establishes the minimum requirements for the organization of patient safety, including the creation of an information analysis system to prevent incidents of danger and damage. Plan the patient insurance system will be implemented from July 1, 2024 Secondly, the draft amends the Medicines Act and provides for compulsory vaccine damage insurance, or vaccine insurance. The purpose of vaccine insurance is to compensate people for severe health damage caused by vaccination in a simplified manner. This is the case if, probably as a result of the vaccination, the patient has suffered serious health damage that lasts at least four months. Compensation is also provided in the event that the person probably dies as a result of the vaccination. The regulation creates an opportunity for a person who has suffered serious health damage after vaccination to claim compensation at the rate established by law, depending on the severity of the damage. Vaccine insurance imposes an insurance premium obligation on the distributor of vaccines, the size of which depends on the number of doses marketed for use in Estonia and the government of the established payment rate. Insurance payments cover the costs of payment and processing of benefits by both the Health Insurance Fund and the Medicines Agency. The vaccine insurance rules are scheduled to take effect on May 1, 2022. In 2022, claims caused by COVID vaccines will be covered retroactively. From 2023, the system will also be extended to other vaccines, including immunization plan vaccines, flu, tick-borne encephalitis and so-called travel vaccines. Causal the connection between health damage and vaccination must start to be evaluated by the Medicines Agency, which has also done it now, but not with such a purpose and scope. It is difficult to predict the number of applications, but it is likely that the possibility of receiving compensation will increase the number of applications. The explanatory letter states that vaccination against Covid-19 started in Estonia on December 27, 2020. Since that date, 6405 possible side effects of vaccines have been reported to the Medicines Agency (as of 31.12.21) case. As of early December, there have been 237 cases of serious adverse events possibly related to the vaccination and four deaths. The cost of compensation for vaccine damage is estimated at 1 million euros in 2022, with system management and IT costs totaling 1.4 million euros. From 2023, the costs of the system will be covered by insurance premiums. Thirdly, the Health Insurance Act creates the possibility to add more to the list of diseases if there is a price agreement or limit price, also diseases for which the price of the drugs used to treat them is formed in the joint procurement of drugs by the European Commission. When reimbursing a person for medicines, the health insurance fund will have the opportunity to take into account the price of the medicine that was determined in the joint procurement of medicines by the European Commission. These are technical changes, but they are important to ensure legal clarity in the reimbursement of medicines. The change concerns the soon-to-be-marketed COVID-19 prescription drugs intended for use in home treatment. According to the draft, these changes will enter into force on May 1, 2022.

Machine translation from Estonian. The official text remains authoritative.

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