A unique type of insurance
There is a unique type of insurance available in Sweden for those who suffer from the adverse effects of pharmaceutical treatment. The Swedish Pharmaceutical Insurance covers anyone who is treated with prescribed medication or medication purchased from a legitimate dealer in Sweden. It also includes patients who receive medication at a hospital, or who suffer adverse reactions or side effects due to participation in clinical trials that are covered by the insurance.
The quickest and simplest way to receive compensation in the event of medication-related injury is to present your case to the Swedish Pharmaceutical Insurer. You can also take your case to court, but the burden of proof may be greater.
Information for patients
How is a medication-related injury evaluated?
Once you have submitted your claim, it is processed by a claims adjuster. You will receive confirmation from the insurance company that your claim is being processed. The claims adjuster will often request medical records, invalidity certificates and other statements from medical specialists. The assessment and evaluation process is conducted in consultation with experts in medical science.
When the evaluation is complete, you will be notified of whether or not you are entitled to compensation. Following this decision, the compensation amount is then calculated. This is carried out in accordance with the general principles governing the Tort Liability Act. The intention is that you should be in the same financial position as you would otherwise have been if the injury had not occurred.
How long does the process take?
On average the process takes about four months from the date on which you submit your claim to the date on which you receive a decision regarding your entitlement to compensation. Cases can vary depending on the degree of complexity.
The time required to assess the amount of the compensation may vary depending on whether the injury can be regulated directly or whether a decision has to be delayed until matters such as possible invalidity settlement or sickness benefits are addressed.
Is it possible to appeal?
If you are not satisfied and would like to dispute the decision made by the Swedish Pharmaceutical Insurer, you may appeal to the Pharmaceutical Injury Panel, an independent panel comprised of experts in medical science, laymen and representatives of the legal profession, appointed by the government. The opinion of the panel is advisory, however the Swedish Pharmaceutical Insurer usually follows its recommendation.
If you are dissatisfied with the insurer’s final decision following the Pharmaceutical Injury Panel, you may initiate general proceedings against the insurer at a general court to appeal against the decision. For claims filed before January 1, 2007 any dispute will be settled by arbitration.
What is covered by the insurance?
There are three relevant types of insurance that go hand in hand, the Pharmaceutical Insurance, the Patient Insurance and the Road Traffic Insurance. They provide compensation for injuries not normally covered by ordinary healthcare insurances. When a decision has been made in favour of paying compensation, the amount is determined in accordance with the principles of the Tort Liability Act – the tables are adjusted on an annual basis.
If your injury requires medical attention or hospitalisation, this is covered by your normal health insurance. However, you may be entitled to compensation for pain and suffering from the Swedish Pharmaceutical Insurer.
You may also be entitled to receive compensation for additional expenses incurred as a consequence of the injury. Receipts must be presented.
The insurance may also compensate for loss of income during the period of illness. Should you have permanent injury, you may be entitled to compensation for bodily defect or permanent harm. The degree of invalidity is evaluated based on special norms.
If your injury results in permanent additional expenses or inconvenience, you may be entitled to compensation for these. You may also be entitled to receive compensation for loss of income over an extended period of time. This may be in the form of an amount to cover loss of income or an annuity. It is sometimes not certain that an individual will be able to resume work, and in such cases the insurance company will monitor the individual’s state of health until this has been determined.
Who provides this insurance?
The Swedish Pharmaceutical Insurance is financed by the shareholders of LFF Service AB, the Swedish Pharmaceutical Insurance Service, which is comprised of pharmaceutical companies, R&D companies, CROs, KD, Tamro and medical universities.
Which injuries will the insurance indemnify?
If you have suffered a personal injury that with preponderant probability has been caused by a pharmaceutical product and which could not reasonably have been predicted by the doctor, then indemnity will be disbursed. Personal injury covers both physical injury and mental illness, but psychological complaints must have a medically demonstrable effect in order to be considered a personal injury. The injury must be more severe than the primary complaint from which you suffer.
The insurance does not cover injury caused by naturopathic products or homeopathic remedies. If you are uncertain as to whether the insurance applies to your injury, you can submit a claim report to have your case tested.
The limit for submission is 10 years after the patient stopped taking the medication.
What are the advantages of reporting to the insurer compared to presenting a case in court?
Submitting a claim to the insurer means the case will be handled in an easier manner and more quickly and the burden of proof is not as great as is usually the case via legal proceedings. It is sufficient that there is preponderant probability that the injury was caused by a pharmaceutical product. Furthermore, it may be possible to be compensated for injuries caused by known side effects and for which the company may not be legally liable to indemnify.
Information for companies
Who are the shareholders?
LFF Service AB was created for companies and organisations that work with pharmaceuticals in Sweden. Owning a share in the company ensures patients using any shareholder’s pharmaceutical product the right to have his/her injury investigated by the Swedish Pharmaceutical Insurance Service and if relevant, receive compensation from the insurance.
Ninety-eight per cent of companies that manufacture and market pharmaceutical products in Sweden are shareholders. However, LFF shareholders also include universities that carry out research into medical drugs, biotechnology companies, companies involved in clinical trials and distributors of medicines.
Why become a shareholder?
The industry takes joint responsibility if a patient suffers a medication-related illness or injury that requires financial compensation. The insurance policy also covers people participating in clinical trials. LFF handles the financing, investigation and administrative processes pertaining to those pharmaceutically induced complications that do arise on the Swedish market despite meticulous testing.
How can we become a shareholder?
Any company wishing to become a shareholder can apply by completing the Application for participation and sending it to LFF, Box 176 08, S-118 92 Stockholm, Sweden.
What are the fees and premium?
LFF’s shareholders pay the association and its insurance company Svenska Läkemedelsförsäkringen AB an annual service fee and premium directly related to the size of their operations. The fee and premium is set every year by the association’s annual general meeting.