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Covid-19 vaccines: compensation issues for Covid-19 vaccine injuries in Sweden
Mannheimer Swartling Advokatbyrå, Stockholm
Mannheimer Swartling Advokatbyrå, Stockholm
Over the past year, several Covid-19 vaccines have been put on the market worldwide and as vaccine production and administration proceed, we all hope to see the end of the pandemic in the near future. However, reports suggest that not all people are inclined to get the vaccine. Concern over both known and unknown side effects and their consequences may be contributing to such doubts. Many countries therefore seem to face a complex task in carrying out effective vaccination campaigns.
In Sweden, participation in national vaccination programmes has historically been very high and recent polls show that a majority of the population is willing to get the Covid-19 vaccine. However, the negative experiences with the mass vaccination during the H1N1 influenza pandemic, where hundreds of children suffered Pandemrix-induced narcolepsy in Sweden, have contributed to some scepticism also in relation to the Covid-19 vaccines. For example, potential side effects, liability for vaccine injuries and the possibilities to obtain compensation for such injuries have been discussed. In order to address some of these uncertainties, the Swedish Government has submitted a proposal on a new law on state compensation for personal injuries caused by Covid-19 vaccines as a complement to the financial protection offered by the Swedish Pharmaceutical Insurance. This article aims to provide an overview of the compensation system available through the Swedish Pharmaceutical Insurance and the legislative proposal in relation to potential Covid-19 vaccine injuries.
The Swedish Pharmaceutical Insurance
The Swedish Pharmaceutical Insurance (the ‘Insurance’) enables individuals who suffer from adverse effects of pharmaceutical treatments (including vaccines) to receive compensation without having to undergo legal proceedings. The Insurance, which is a no-fault insurance, is usually a more favourable, simpler and less expensive way for an individual to receive compensation than going to court. The Insurance is based on a voluntary agreement between companies working with pharmaceuticals in Sweden and is financed by the shareholders through an annual service fee and premium. Owning a share in the Insurance gives patients using the shareholder’s pharmaceuticals (including vaccines) the right to have their injuries investigated and, if applicable, receive compensation from the Insurance.
However, the Insurance has certain financial limitations, for example in relation to so-called serial injuries. A serial injury is defined as a pharmaceutical injury that has afflicted several persons as a result of the same kind of damaging characteristic of one or more pharmaceutical products within the same therapeutic field of application, provided that the product has been deregistered or its use restricted as a result of the effects of the injury, or the effects of the injury were caused by a manufacturing defect. For such injuries, liability under the Insurance is generally limited to a maximum of SEK 150 million for all injuries attributable to one and the same calendar year. However, for any serial injuries caused by Covid-19 vaccines, the liability under the Insurance has recently been further limited to a maximum of SEK 20 million for all injuries attributable to one and the same calendar year. According to LFF Service AB (which owns the Insurance) the limitation is due to international reinsurance companies not being willing to take the risks associated with the comprehensive Covid-19 vaccination campaign.
The proposal for a new law on state compensation for Covid-19 vaccine injuries
After the H1N1 influenza pandemic, several claims for compensation have been reported to the Insurance by people that have developed narcolepsy following the Pandemrix mass vaccination. These vaccine injuries have been classified as serial injuries, hence the liability under the Insurance has been limited to SEK 150 million. People suffering from narcolepsy due to the Pandemrix vaccination are therefore at risk of being refused compensation from the Insurance. Because of this, a law on state compensation was adopted in order to enable these individuals to receive state compensation when the Insurance has reached its financial limits.
With regard to potential serial injuries caused by Covid-19 vaccinations, there is an even greater risk that the limitation for serial injuries under the Insurance will become applicable. Consequently, the level of protection under the Insurance for individuals suffering from Covid-19 vaccine injuries will not be equivalent to the level of protection offered for those suffering injuries caused by other pharmaceuticals. With this in mind, and in light of the events following the mass vaccination during the H1N1 influenza pandemic, the Swedish government has submitted a proposal for a law on state compensation for personal injuries that may arise as a result of Covid-19 vaccination. The new law shall be complementary to the Insurance and is intended to enable persons who have suffered personal injury due to a Covid-19 vaccine to receive state compensation in situations where the Insurance has reached its financial limits. According to the proposal, state compensation shall also be paid for personal injuries caused by a Covid-19 vaccine manufactured by a pharmaceutical company that is not a shareholder in the Insurance. The new law is proposed to enter into force on 1 December 2021 and shall also apply to Covid-19 vaccine injuries that may have occurred before that date. Pending the entering into force of the proposed law, the Swedish Legal, Financial and Administrative Services Agency (Sw. Kammarkollegiet) has signed an agreement with LFF Service AB on settlement of claims and compensation for vaccine injuries caused by Covid-19 vaccines that are not included in the Insurance.
As has been described in this article, the compensation system for vaccine injuries available through the Insurance enables individuals to obtain compensation in a simpler and less expensive way than to bring an action for damages against the vaccine manufacturer in court. However, as the amount of compensation payable under the Insurance has been significantly limited in relation to serial injuries caused by Covid-19 vaccines, the protection offered through the Insurance might be inadequate in relation to such injuries. There is a risk that the financial limitation may negatively affect people’s propensity to take the vaccine. The Swedish Government’s legislative proposal might therefore constitute an important measure to strengthen the people’s trust in the compensation system for vaccine-related injuries and thereby the vaccination campaign as a whole. As the rollout of the Covid-19 vaccines in Sweden proceeds, it remains to be seen if the proposed law will help increase the willingness to accept the vaccine while also ensuring that anyone who suffers a personal injury due to Covid-19 vaccination receives adequate compensation.
 https://www.regeringskansliet.se/49547d/contentassets/75e443620d114663ab7400837ab5ab7d/statlig-ersattning-till-personer-som-insjuknat-i-narkolepsi-efter-pandemivaccinering-prop-201516137.pdf, p. 17.