Pharmaceutical insurance compensation may be claimed for harm caused by a COVID-19 vaccine administered in Finland.
Compensation claims are made by submitting a completed claim notification form to the Finnish Mutual Insurance Company for Pharmaceutical Injury Indemnities. The relevant medical records of the injured party will be required for assessing any pharmaceutical product damage. There is no need for the injured party to obtain these records, as the insurance company will do so when it needs them for processing the claim. To expedite the process, the claim should specify the care institution where the vaccine-related harm was treated.
No compensation is payable for minor loss or damage. Pharmaceutical insurance covers non-trivial vaccine damage that has caused personal injury to the vaccine recipient. Compensation may be claimed if the harm caused by the vaccine has not passed in 14 days, or if this harm has resulted in medical expenses or loss of earnings exceeding EUR 85.
The following questions and answers concern compensation for loss or damage caused by COVID-19 vaccines.
Are coronavirus vaccines insured?
Three coronavirus vaccines are currently administered in Finland: the Pfizer-BioNTech Comirnaty vaccine, the AstraZeneca COVID-19 Vaccine and the Moderna COVID-19 Vaccine. Pharmaceutical insurance covers coronavirus vaccines that have been procured in Finland via the EU common procurement mechanism. All of the coronavirus vaccines currently administered in Finland meet this condition and are covered by insurance.
How many claim notifications have been submitted and compensation payments made for coronavirus vaccines?
331 claim notifications have so far been submitted for coronavirus vaccines, with compensation awarded in 73 decisions and denied in 73 decisions. 185 cases are pending.
The adverse reactions reported have been transient and typical of vaccines. Compensation has been paid for temporary inconvenience and the costs of treating illness, and also for lost earnings. The grounds for compensation paid so far include allergic reactions to the vaccine and various forms of pain, such as pain in the vaccination arm and muscle and joint pain. Compensation has been declined in cases where the injury was minor, meaning that the symptoms caused by the vaccine did not last for 14 days, and in cases where there was no probable causal link between the vaccine and the reported symptom.
This information is updated at intervals of approximately two weeks. Further details, for example of the type of cases in which compensation has been paid, will be published when the number of cases is sufficient to ensure that data protection will not be compromised.
I have been harmed by a coronavirus vaccine. Where can I get compensation?
Coronavirus vaccines administered in Finland are covered by pharmaceutical insurance (see previous question for further details). Pharmaceutical insurance compensation may be paid for harm caused by any vaccine that probably caused personal injury, meaning physical illness or injury, or mental illness.
The compensation may be claimed by completing a claim notification form.
Are all harmful effects of coronavirus vaccines eligible for compensation?
Pharmaceutical insurance does not cover mild or minor vaccine damage. Personal injury caused by a vaccine is eligible for compensation when, due to the injury, the injured party has
- suffered an incapacity to work or otherwise impaired bodily functions for not less than 14 consecutive days, or
- sustained a permanent physical injury or illness, or
Even if the conditions set out in points 1-3 are not satisfied, an injured party may be reimbursed for unavoidable and necessary medical expenses and loss of earnings sustained in treating vaccine damage and totalling not less than EUR 85.
I reported the harm caused by a coronavirus vaccine to Fimea. Am I eligible for pharmaceutical insurance compensation?
An adverse reaction to a medicine is not the same as pharmaceutical product damage. The latter is defined more narrowly than the former, meaning that the mere report of an adverse reaction does not immediately imply that pharmaceutical product damage has occurred under the terms and conditions of pharmaceutical insurance.
An adverse reaction means a harmful and unintended effect of a medicine or vaccine. Fimea maintains a register of adverse reactions to coronavirus vaccines reported in Finland. Details from these reports are also forwarded to the Finnish Institute for Health and Welfare (THL) and the Eudra Vigilance database of the European Medicines Agency (EMA).
The Finnish Medicines Agency (Fimea) is a national executive bureau of the Ministry of Social Affairs and Health that exercises regulatory control over medicines and blood and tissue products, and develops the pharmaceutical industry. Fimea maintains a register of adverse reactions to pharmaceutical products and vaccines. Healthcare professionals and users of pharmaceutical products may report suspected or verified adverse reactions to this register. The main purpose of the reporting system is to detect previously unrecognised and rare adverse reactions.
You should submit a claim notification to the Finnish Mutual Insurance Company for Pharmaceutical Injury Indemnities if you suspect any vaccine damage.
What does the insurance cover?
The insurance covers personal injuries caused by a vaccine. There must be a probable causal link between use of the vaccine and the damaging consequences. Pharmaceutical product or vaccine damage refers to a physical illness or injury that was probably caused by a drug or vaccine. A probable causal link means that the damaging consequences were either the certain or probable outcome of taking the vaccine.
Pharmaceutical insurance does not cover consequential pharmaceutical product damage.
An illness or injury caused by the failure of a vaccine to have the intended effect is not regarded as pharmaceutical product damage.
What kind of compensation is available?
The most common compensation for vaccine damage covers the costs of necessary and unavoidable medical care, together with earnings lost during periods of incapacity for work.
The compensation payable varies according to the details of the individual case. The nature and scope of insurance coverage depends on the kind of damage that was caused by taking the vaccine. These forms of damage vary widely, so the compensation also varies in nature and size.
Assessments of compensation apply the provisions of the Finnish Tort Liability Act (vahingonkorvauslaki, no. 412 of 1974) and any applicable norms and guidelines of the Traffic Accident Board.
Other compensation may be paid in rare, more serious cases. For further details, see
How much compensation is available?
The compensation depends on the damage suffered.
The costs incurred through pharmaceutical product damage will be reimbursed in full against receipts or other supporting documents.
The compensation payable for temporary incapacity (pain and suffering) depends on the degree of incapacity involved, which is assessed on medical grounds with the compensation determined according to the norms and guidelines of the Traffic Accident Board. Incapacity due to pharmaceutical product damage is generally not especially great, with most assessed to fall into incapacity categories between 1 and 3.
Any permanent functional incapacity is defined in accordance either with the Decree (1649/2009) or the Decision of the Ministry of Social Affairs and Health, depending on the time of receiving the injury, and the norms and guidelines of the Traffic Accident Board. Pharmaceutical product damage seldom causes permanent injury.
The size of compensation for lost earnings will be determined according to the income of the injured party.
Pharmaceutical insurance is a secondary compensation system, meaning that any statutory compensation for which the injured party is eligible will be deducted from the insurance compensation payable.
What information is required for processing an insurance claim?
The injured party must complete a claim notification and send it to the Finnish Mutual Insurance Company For Pharmaceutical Injury Indemnities.
The medical records of the injured party related to the injury will be required for assessing any pharmaceutical product and vaccine damage. The claim notification form includes an authorisation from the injured party enabling the insurance company to obtain any documents that are required for processing the claim. There is no need for the injured party to obtain these documents, as the insurance company will do so when they are required for processing the claim. This generally expedites processing of the claim.
How do I submit a claim for compensation?
You should complete and sign the accident report carefully and send it to the Finnish Mutual Insurance Company for Pharmaceutical Injury Indemnities, PO Box 115, FI-00181 Helsinki.
You may also send the claim notification by Encrypted Email using the link provided on the Home Page of this website.
Where can I get advice on completing a notice of injury?
Every health services unit has a patient ombudsman who can provide assistance when completing an accident report.
I took a coronavirus vaccine while travelling abroad and then suffered symptoms from the vaccine. Am I eligible for pharmaceutical insurance compensation?
The pharmaceutical product insurance is only valid within the territory of Finland. Vaccines administered abroad are not covered by pharmaceutical product insurance, nor can the associated compensation be paid for any loss or damage that they cause.
What is the State guarantee? Will the government pay compensation?
An insurance company must always be sufficiently solvent. The COVID-19 pandemic is such a new and unknown risk that no insurance company can bear it alone. It is very common for insurance companies to share particularly large risks through reinsurance arrangements, but these are not yet available for coronavirus vaccines. Some other arrangement was required instead of reinsurance to enable pharmaceutical product insurance for coronavirus vaccines.
The Finnish government has accordingly granted an insurance guarantee to the Finnish Mutual Insurance Company for Pharmaceutical Injury Indemnities. A charge will be levied for this guarantee in the same way as for reinsurance. The guarantee applies to coronavirus vaccines that are procured in Finland through the EU procurement mechanism. The pharmaceutical product insurance accordingly only covers coronavirus vaccines administered in Finland that were procured through the EU procurement mechanism. All coronavirus vaccines administered in Finland are currently covered by insurance.
The insurance company will pay pharmaceutical product damage insurance compensation to injured parties if any reimbursable losses or damage are suffered due to coronavirus vaccines. The government will only contribute to compensation payments exceeding a total of EUR 3 million annually.