# Vaccine injury insurance in Estonia: why a public no-fault scheme URL: https://insurancelawestonia.ee/blog/2026-11-01-vaccine-injury-insurance-estonia/ Author: Dr Olavi-Jüri Luik, Partner, Head of Insurance Law, attorney at law (Advokaadibüroo WIDEN OÜ) Published: 2026-11-01 Last updated: 2026-11-06 > How Estonia compensates vaccine injuries: product liability vs liability insurance vs public no-fault insurance. Medicinal Products Act Chapter 5¹ in 2026. Vaccination is one of the most effective public health measures and overwhelmingly safe. In rare cases, however, serious adverse effects occur. If a vaccine causes permanent injury, who should compensate the loss, and through what mechanism? In 2022 Estonia introduced vaccine injury insurance, governed by Chapter 5¹ of the Medicinal Products Act (ravimiseadus, RavS).[^1] This post is based on an article by Olavi-Jüri Luik and Rauno Kinkar published in Juridica in 2022, which analysed the policy choices behind the scheme, and assesses how those choices have played out by 2026.[^2] ## Why product liability is not enough The injured person's first legal route is product liability: the manufacturer is liable without fault for damage caused by a defective product. In vaccine cases, however, the claimant faces several obstacles. **Development risk defence.** The manufacturer is not liable if it proves that the state of scientific and technical knowledge when the product was put on the market did not allow the defect to be discovered. For new vaccines, such as COVID-19 vaccines, this defence is particularly strong. **Proof of causation.** The claimant must prove that the vaccine caused the harm, which is often medically difficult because many conditions also occur independently of vaccination. **Inequality of arms.** A multinational pharmaceutical group and an individual are plainly unequal litigants. Proceedings are expensive and long. **Supply contract clauses.** Academic literature has noted that EU vaccine supply contracts may contain clauses under which Member States indemnify manufacturers for certain losses. This does not exclude the manufacturer's liability to the injured person, but shows that the state carries part of the risk anyway. ## Four possible models The article analysed four ways to organise compensation, in addition to existing product liability. **1. Compulsory liability insurance.** Manufacturers or distributors would have to insure their liability. The problem: a liability policy responds only where the insured is liable. If the manufacturer is not liable because of the development risk defence or evidential difficulties, the insurer need not pay either. Moreover, insurers operating in Estonia did not cover pharmaceutical liability because it was excluded in their reinsurance treaties. New vaccines were an emerging risk with unknown loss potential. **2. Voluntary liability insurance.** The same problem, with an even lower chance that cover would exist. **3. Public no-fault compulsory insurance.** The only condition is harm resulting from vaccination; the manufacturer's liability is irrelevant. Advantages: the claimant need not prove liability and the standard of proof can be lowered. The state or insurer can pool recourse claims against the manufacturer (in effect a collective action) and is a financially stronger litigant. Disadvantage: indirect pressure on taxation. **4. Social benefit.** A benefit is paid to help the injured person cope. This is not compensation and also burdens public finances. Internationally, various models exist: the Nordic patient and pharmaceutical injury schemes, the UK Vaccine Damage Payment with a high disability threshold, the US National Vaccine Injury Compensation Program, and dedicated schemes in Canada and Israel. Research suggests that the existence of a compensation scheme increases willingness to be vaccinated. ## Estonia's choice and the current rules The Government chose the third model: public compulsory insurance. The insurer is the Estonian Health Insurance Fund (Tervisekassa, formerly Haigekassa), and the policyholder is the holder of a manufacturing or wholesale licence who produces vaccines in Estonia or brings them in for distribution.[^1] The reason was practical: no human vaccines are produced in Estonia, and imposing compulsory insurance on foreign manufacturers would have been legally difficult. The main features of RavS Chapter 5¹ as of November 2026:[^1] - **Statutory insurance** (*sundkindlustus*, RavS § 99¹⁴): the obligation to compensate rests with Tervisekassa; the provision was amended in 2023 following the renaming of the Health Insurance Fund. - **Premium** (§ 99¹⁵) is paid by the distributor, that is, the holder of a wholesale or manufacturing authorisation for medicinal products or another person who manufactures vaccines in Estonia or imports them for distribution and use in Estonia (§ 99¹⁴(3)). - **Insured event** (§ 99¹⁶): serious damage to health resulting from a vaccination carried out in Estonia, lasting at least four months, or death. Causation must be at least probable, not certain, which is the lowered standard of proof recommended in the article. - **Compensation** (§ 99¹⁹): up to EUR 100,000, in bands (EUR 2,000, 10,000, 25,000, 50,000 and 100,000) according to severity; the amounts are indexed. - **Application** (§ 99²⁰) must be made within one year of the insured event; after that period Tervisekassa is released from the obligation to compensate. During drafting it was envisaged that Tervisekassa would ask the State Agency of Medicines, which had previously assessed links between vaccines and adverse events, to evaluate causation. In substance there are three possible outcomes: a link is unlikely, probable or certain. Under the act, a probable link already gives a right to compensation. ## Assessment as of 2026 **The scheme is simple and accessible.** The claimant need not go to court or prove manufacturer liability. The lowered standard of proof suits the nature of vaccine injury. **Compensation is banded, not full.** The scheme pays standardised amounts rather than full damages. In serious permanent injury cases actual loss (lost income, care needs) may be considerably higher. The claimant in principle retains a product liability claim for the excess, but that means returning to all the obstacles described above. **The time limit is short.** A one-year application period is short, given that the effects of vaccine injury and their permanence often emerge slowly. The period runs from the insured event (RavS § 99²⁰(1)), not from the date on which the claimant learned of the damage, and the time of the insured event has to be assessed on the facts of each case; the four-month duration requirement does not create an automatic additional period, so a 16-month window should not be assumed. Claimants should apply without delay and inform Tervisekassa of circumstances that become known later (RavS § 99²⁰(2)). **A model for other schemes.** Vaccine insurance is Estonia's first scheme compensating loss independently of fault and liability through public insurance. The contrast with patient insurance, in force since 2024, is instructive: patient insurance is liability insurance and requires the provider's liability (see [Patient insurance in Estonia: lessons from the first year](https://insurancelawestonia.ee/blog/2025-10-13-patient-insurance-estonia-first-year)). The vaccine scheme shows that a no-fault approach is possible in Estonian law where risks are specific and losses few. ## Frequently asked questions **Does the scheme cover voluntary vaccines (e.g. tick-borne encephalitis or travel vaccines)?** Cover is linked to distribution of the vaccine in Estonia, covers vaccinations carried out in Estonia, and the distributor pays the premium. Whether a particular vaccine is covered must be checked under the RavS and its implementing acts; in case of doubt, contact Tervisekassa. **Does receiving compensation exclude litigation against the manufacturer?** The scheme is not designed to exclude manufacturer liability. The claimant may in principle claim loss not covered by the payment under product liability, though in practice this is difficult and costly. **What does "at least probable" causation mean?** The claimant need not prove that the vaccine certainly caused the harm. In the author's view it suffices that, on medical assessment, a link is more likely than not. That is a considerably lower standard than the full conviction normally required in civil proceedings. **What if the application is rejected?** Tervisekassa's decision can be challenged; the procedure and time limits follow from the RavS and the rules of public law procedure. Time limits are short, so the decision should be assessed immediately on receipt. ## How it relates to other compulsory insurance The vaccine scheme differs from Estonia's other compulsory insurance. Motor and patient insurance are liability insurance: the insured event presupposes that someone is liable. Vaccine insurance is no-fault compulsory insurance with a public body as insurer. That is justified where the risk is a side effect of socially desirable activity (vaccination also protects others) and establishing individual liability is disproportionately difficult. For pharmaceutical manufacturers and their liability insurers, the scheme also shapes the residual exposure that remains under product liability. ## Conclusion For vaccine injuries, product liability is often illusory for the injured person. Public compulsory insurance with a lowered standard of proof was the right choice in Estonian conditions and is a functioning system by 2026. Its weaknesses are banded compensation and a short application period. Its purpose is not only to compensate but also to support trust in vaccination. *Based on: O.-J. Luik, R. Kinkar, "Vaktsiinikindlustuse süsteemi loomise valikukohad", Juridica 2022/1, pp. 53–64. Rewritten for the web and updated as of November 2026.* ## Related pages - [Product liability in Estonia](https://insurancelawestonia.ee/guides/product-liability-estonia) - [Patient insurance in Estonia](https://insurancelawestonia.ee/guides/patient-insurance-estonia) - [Research article: design choices for vaccine injury insurance](https://insurancelawestonia.ee/blog/2022-07-01-research-vaccine-injury-insurance) ## References [^1]: Medicinal Products Act (ravimiseadus, RavS) Chapter 5¹, §§ 99¹⁴–99²⁰ (RT I, 11.07.2026, 37; version in force 01.10.2026). . Vaccine injury insurance entered into force on 01.05.2022; § 99¹⁴(4) amended by RT I, 11.03.2023, 9. [^2]: O.-J. Luik, R. Kinkar, "Vaktsiinikindlustuse süsteemi loomise valikukohad", [Juridica](https://www.juridica.ee/article.php?uri=2022_1_vaktsiinikindlustuse_s_steemi_loomise_valikukohad) 2022/1, pp. 53–64.