The safety of COVID-19 vaccines is very high – serious injuries are rare. For example, as of the morning of 22 November, more than 1.6 million doses of vaccine had been administered in Estonia, of which only 0.37% of doses (5950 notifications) were reported to the State Agency of Medicines regarding all possible side effects and vaccine ineffectiveness. There are even fewer reports – 237 – describing at least one serious suspected adverse reaction with a temporal relationship. The most common side effects are pain at the injection site, tiredness, and fever, which go away on their own within a few days.
- But how is compensation done in these rare unfortunate cases?
- Who is responsible for vaccine damage?
- Why do we need a vaccine damage system to be created through insurance?
In the case of possible vaccine damage, two situations must be distinguished: (i) the damage is due to the vaccine being properly administered and/or (ii) the damage is due to the provision of healthcare (vaccination) (e.g., failure by the provider to provide care, harm to the patient, etc.). The latter is, in essence, in extremely rare cases where the healthcare provider (doctor or nurse) is responsible. Rather, in the case of vaccines, the responsibility can theoretically be discussed in the case of a properly administered vaccine. According to Estonian law, this is a so-called producer responsibility.
- 1064 (4) of the LOA expressly provides that the deficiency is caused by the compliance of the product with the mandatory requirements as at the time of placing the product on the market unless otherwise provided by law. Pursuant to § 9 (1) of the Medicinal Products Act, Immunological medicinal products are any medicinal product consisting of vaccines, antibodies, toxins, serums, or allergen products. Thus, damage caused by a vaccine is covered by the producer’s liability regulation.
The following are considered to be producers (§ 1062 (1) of the LOA):
– a person who manufactures a finished product, raw material, or part of a product;
– a person who claims to be the manufacturer of a product and indicates the person’s name, trademark, or another distinctive mark on the product;
– a person who brings a product into Estonia or into a member state of the European Union in the course of the person’s economic activities with the objective of selling, leasing, or marketing of the product in any other manner.
Thus, the content of the liability of the manufacturer is the liability of the person who manufactured the particular vaccine or the person who identifies himself/herself as the manufacturer of the vaccine or who placed the vaccine on the market for the victim. It is, in essence, liability for a product in connection with its manufacture or placing on the market.
The vaccine is placed on the market primarily through its supply or transfer to resellers, wholesalers, or retailers.
According to the regulation of producer responsibility, victims can file claims against persons who have brought vaccines to Estonia for marketing purposes in addition to producers (the latter are equated with producers). In this case, the producer and distributor are jointly and severally liable to the injured party. It is, therefore, the choice of the injured party to bring an action for damages against the manufacturer or the importer or against both at the same time.
As an additional unresolved issue in the Estonian judicial system, the undersigned points to the so-called development risk, which in certain cases relieves producers of producer responsibility.
Namely, § 1064 (1) 5) of the LOA stipulates that the producer shall not be liable for damage arising from a product if the producer proves that due to the level of scientific and technical knowledge at the time of placing the product on the market, the deficiency could not have been detected.
The legal literature suggests that pressure from pharmaceutical companies on the need to increase public welfare has also been cited as one of the reasons for including the Development Risk Directive. Namely, it would encourage drug developers, and proponents of risk-taking have shown that it protects incentives for innovation, encourages companies to use the latest knowledge, and ensures the stability of product liability insurance costs in Europe. Thus, the rationale for the concept of developmental risk is to provide protection for drug developers to innovate. Although this issue has not been debated in court in Estonia, there is a risk that in certain cases, producers may thus be released from liability based on development risk.
In the light of the above, the wish of the Republic of Estonia to regulate possible compensation for vaccine injury through the insurance system is very welcome.
At least 27 countries are using a no-fault program to compensate for vaccine injury – various scientific articles and websites show that at least 27 countries around the world use the no fault program to compensate for vaccine injury compensation program. In most cases, with the exception of Finland and Sweden, these programs are public systems. The scientific journal The Lancet points out that no-fault compensation schemes can help boost confidence in the marketing of vaccines. Of the 194 WHO member states, 25 have implemented guilt-free vaccine injury compensation programs.
Estonia joining the vaccine injury compensation system as the 28th country is, in my opinion, very welcome. Thereby, the Estonian state shows that it also cares about those very rare cases where a person is harmed by vaccination.