The Norwegian Drug Liability Association: Mandatory Insurance for Pharmaceutical Companies

In Norway, strict regulations govern the safety and responsibility associated with the manufacturing, import, and testing of medicinal products. To ensure that patients affected by drug-related injuries receive compensation, all stakeholders in this sector are required to obtain insurance through the Norwegian Drug Liability Association (DLA). This insurance is a legal requirement under Chapter 3 of the Norwegian Product Liability Act.

Who Should Obtain Insurance?

1. Manufacturers and Importers of Medicinal products

All companies that manufacture or import medicinal products into Norway are required to be members of the Norwegian Drug Liability Association and obtain drug liability insurance. This applies regardless of whether the medicinal product is commercially available or marketed under special conditions.

Wholesalers must ensure that the manufacturer or importer is a member of the DLA. If membership is missing, the wholesaler is obligated to pay the insurance premium that should have been paid.

2. Responsible Physicians and Dentists for Clinical Trials

Physicians and dentists conducting clinical drug trials are also required to obtain insurance. However, if the trial is organised by a manufacturer that is already a member of the DLA and the manufacturer’s medicinal products are marketed in Norway, the responsible physician or dentist does not need to obtain separate insurance.

Exception: In the case of large-scale trials involving more than 5,000 participants, the responsible investigator is required to obtain a separate membership in the DLA.

Only one investigator per clinical trial needs to be a member, even for multicentre studies, as long as the trial is coordinated under one protocol. Additional investigators may obtain membership if desired.

3. Compassionate use, named patient/Compassionate Use Program (unregistered medicinal products)

Medicinal products used under compassionate use, named patient/Compassionate Use Program (CUP), meaning medicinal products without market authorisation in Norway, prescribed to a specific patient/patient group, are also subject to insurance requirements. This means that the responsible physician or importer must ensure the correct insurance coverage is in place.

Why Is This Insurance Important?

Drug liability insurance ensures that patients who suffer harm due to use of a medicinal product or use during a clinical trial will receive compensation, regardless of fault. This contributes to a safer healthcare system, greater trust in the pharmaceutical industry, and fairer treatment of patients affected by unexpected side effects or injuries.

Compensation may cover:

Medical expenses
Lost income
Loss of provider (in case of death)
Non-economic damages (permanent medical injury), even if no financial loss occurred

How Are Claims Handled?

All claims related to injuries caused by medicinal products or clinical trials are handled by Norsk Pasientskadeerstatning (NPE) – the Norwegian System for Patient Injury Compensation. NPE is a public agency under the Ministry of Health and Care Services and administers both general patient injury cases and those under the drug liability insurance scheme. All application handling and investigation are free of charge for the claimant.

What Is Not Covered?

In general, the following are not eligible for compensation:

Errors in dispensing or product confusion at pharmacies, hospitals, or other healthcare providers
Incorrect use of the medicinal product
Lack of effect or insufficient effect of the medicinal product
Known and expected side effects, unless disproportionately severe

Note: Points 1 and 2 above do not apply to injuries occurring during clinical trials – these are covered under the insurance scheme.

How Can Mericon Help?

At Mericon, we have expertise in drug liability regulations and can guide you through the process of obtaining insurance and becoming a member of the Drug Liability Association. We assist with:

Registration and application process
Advice on premium calculation and reporting
Ensuring your business complies with legal requirements