Sweden Covid Vaccine NFCS

Introduction

Sweden had an existing no-fault compensation scheme for vaccines created in 1978, and which incorporated covid-19 vaccines from 21 December 2020.

This scheme is a non-statutory scheme, it consists of insurance for members of the Swedish Pharmaceutical Insurance Scheme. Membership of the scheme is voluntary, but 98% of companies that manufacture and market pharmaceutical in Sweden are members.

The scheme is administered by the Swedish Pharmaceutical Insurer (Svenska Läkemedelsförsäkringen or LFF). Companies and organizations that take out pharmaceutical insurance become a partner in the jointly owned company LFF Service AB. Each policyholder owns a share each in LFF Service AB. This company in turn owns Svenska Läkemedelsförsäkringen AB or LFF, a captive insurance company that handles the damage. The Scheme rules are set out in an Undertaking.

In Sweden vaccines manufactured by Pfizer, AstraZeneca, Novavax and Moderna have been used. Pfizer, AstraZeneca, Novavax are members of Swedish Pharmaceutical Insurance scheme, so their vaccines are covered by the insurance.

Moderna has not taken out insurance from the scheme. Claims for damages form Moderna’s vaccines which were reported to the LFF before 1 December 2021 are regulated by LFF. All other claims for damages from Moderna vaccines are compensated by the state via Kammarkollegiet[1] under the same framework as in the Pharmaceutical Insurance NFCS. Claims arising from Moderna's Covid-19 vaccine must still be made to the Pharmaceutical Insurance NFCS, who then forward the claim to Kammarkollegiet.

The funding for the scheme comes from insurance contributions levied on members of LFF. There is a statutory top up provision 2020/21:221 passed on 10-Nov-2021 whereby the Swedish Government indemnified the scheme either when the vaccine manufacturer is not part of the Swedish Pharmaceutical Insurance (as was the case with Moderna) or when the 20 million SEK cap for covid injury compensation has been reached.

Vaccines Covered

This NFCS covers nationally approved vaccines from EU approved vaccines.

It includes vaccines approved for emergency use and standard approvals.

Injuries Covered

This NFCS covers both temporary and permanent injuries. To be eligible for compensation the vaccine recipient must have suffered an injury for not less than 30 days.

Under this NFCS any injury is potentially covered.

Charges for making a claim

There is no charge for making a claim under this scheme.

Claimants

The Undertaking states at Section 8 that compensation for drug damage is determined in accordance with Chapter 5 Sections 1 – 5 and Chapter 6 Section 3 of the Damages Act (Skadeståndslagen 1972:207)

Based on the Damages under this scheme the following categories of individuals are permitted to make a claim.

Vaccine recipient/their representative if the vaccine recipient is a child or incapacitated
A representative of the estate of a deceased vaccine recipient
Survivor of a deceased vaccine recipient

Under this scheme the claimant is allowed to nominate another person to make their claim. Funding for legal representation is not provided by the scheme as per section 8.3 of the Undertaking.

Losses covered

This scheme pays the following

Live Vaccine Recipient	Survivor of a Vaccine Recipient	Estate of a Deceased Vaccine Recipient
Both eligible economic and non-economic losses are compensated	Both eligible economic and non-economic losses are compensated	Both eligible economic and non-economic losses are compensated

The compensation follows Damages Act (Skadeståndslagen 1972:207) and the quantification is based on the Traffic Damage Board's tables. The following categories of payment are available.

Live Vaccine Recipients

Incurred Costs: medical expenses and other necessary and reasonable costs caused by the vaccine injury; The costs can be temporary or in some cases lifelong.
Temporary incapacity: Pain and suffering: Compensation for transient pain and suffering, this calculated from the point the injury occurred until the vaccine recipient’s condition has recovered. Based on a tables created by the Traffic Damage Board.
Permanent Harm: Compensation for lasting harm and inconvenience. The degree of disability is expressed as a percentage where 0% is completely undamaged and 100% is theoretically a condition when all bodily functions cease. This compensation also includes compensation for stress at work and inconvenience in general. The compensation is provided as a lump sum based on the Traffic Damage Board's tables
Scars or other changes in appearance: Based on the Traffic Damage Board's tables.
Loss of income: If an injury causes loss of income due to not being able to work or having a reduced capacity to work, compensation is provided for it. This is quantified as the actual loss that a person suffers taking into account sickness benefit and other benefits that have been paid. If the injury is so severe that the individual will never be able to work again compensation is provided until retirement age in the form of an annuity. Since the benefit is not pensionable, compensation for loss of pension is also provided in such cases.

Deceased Vaccine Recipients

The Damages Act (Skadeståndslagen 1972:207) specifies the following compensations are available if a vaccine has caused the recipient’s death.

Funeral expenses: Funeral expenses, to a reasonable extent, other costs resulting from the death
Loss of maintenance: Compensation for loss of maintenance shall be awarded to survivors who were legally entitled to the maintenance of the deceased or who were otherwise dependent on him, if maintenance was paid at the time of death or if it can be assumed that maintenance would have been paid in the near future thereafter. The loss is compensated to the extent that is reasonable in view of the survivor's ability and ability to contribute to his or her own livelihood through his own work or otherwise, other than through the compensation for the deceased’s loss of earning. The value of the deceased's housework in the home is incorporated into a maintenance payment.
personal injury caused by the death to someone who was particularly close to the deceased.

Payments consist of a mixture of periodic payments and a lump sum payment.

Funeral expenses are available under this NFCS.

Compensation under this scheme calculated on an individual basis using tariffs/guidelines to assist with quantification.

Loss of earnings are paid under this scheme. They are quantified on an individual basis.

Compensation under this scheme is capped, with a top value of 10 million SEK.

There is no minimum claim value under this NFCS.

Time limits for claims

The scheme does not set a time limit between vaccination and the adverse event occurring.

A claim under the scheme must be brought within 10 years of the vaccination.

Evaluating claims – standard of proof required

Claims are reported to the LFF on a standardised claim form. LFF then request Power of Attorney authorisation from the claimant to enable them to obtain medical records. A case officer compiles the records and sends them to a relevant medical specialist and in some instances the treating doctor. An administrator then determines the case. The standard of proof required by the scheme is the damage is predominantly caused by the vaccine and could not have been foreseen.

Appeals and the right to litigate

The right to litigate is not affected by use of the scheme - A claimant has a free choice to use the scheme or to litigate. However, if a claimant succeeds in their NFCS claim they sign over their rights to compensation from any other person who could be found liable for the damages to the NFCS, as specified in the Undertaking section 17.

There is an external review process where another organisation reviews the decision. The Pharmaceutical Injury Panel review the decision of the LFF. If a claimant disagrees with the decision of the Pharmaceutical Injury Panel they can take their case to court.