Adverse effects of drugs and vaccines in Norway

1.1 Which are the main kinds of responsibility (contractual, in tort, criminal) of the following subjects with respect to adverse drugs reactions?

1. Manufacturers

It is mandatory for manufacturers of pharmaceuticals distributed in Norway to be member of the Drug Liability Association and hence contribute to the Drug Liability insurance scheme. The Product Liability Act Chapter 3 provides a special regulation of claims related to adverse reactions of drugs, pursuant to which the patient can claim damages from the Drug Liability Association’s insurance scheme without having to prove fault or defect (strict liability). Members of the Drug Liability Association are, as a main rule, liable only for the amount which the insurance scheme is obliged to pay pursuant to the Product Liability Act Chapter 3, and recourse is as a main rule limited to cases where the member has caused the damage intentionally. The insurance scheme has the right to seek recourse from non-members irrespective of fault or defect.

The manufacturer may also be liable in tort pursuant to the regular rules on product liability (the Product Liability Act Chapter 2) or non-statutory culpa liability, although this is less relevant in practice.

The manufacturer can be subject to criminal charges in case the drug is not in compliance with the Medicines Act.

2. Healthcare professionals

Healthcare professionals may be subject to non-statutory culpa liability for medical malpractice or damages for non-economic loss. However, due to the compensation schemes set out in the Patient Injury Act and the Product Liability Act, it is not normal practice to raise the claim against the healthcare professional as such.

3. State

A patient may be entitled to compensation for personal injury from the Norwegian state pursuant to the Patient Injury Act where the injury is caused by ‘treatment failure’.

Which are the conditions for claiming compensation (including the burden of proof)?

2.1 In order to be able to claim compensation under the Civil liability regime, the following conditions must be met

The Product Liability Act

Claims seeking compensation for personal injury caused by a drug fall within the remit of the Product Liability Act Chapter 3, which applies irrespective of fault and irrespective of whether the injury is caused by a defect of the drug. The compensation is payable by the Drug Liability Association’s insurance scheme which is mandatory to all manufacturers of pharmaceuticals distributed in Norway (or in some cases the importer). There are three conditions for compensation: First, the injury must have occurred as a result of adverse reactions, which it is unreasonable to expect the patient to deal with. The patient’s medical condition pre-drug administration, the nature and scope of the injury, how the drug impacted one’s illness, as well as the assumed and actual adverse reactions to the drug are taken into account. Known adverse reactions are usually accepted as these risks can be outweighed by the drug’s positive effects. Second, the patient must have experienced financial loss, such as loss of earnings, increased medical expenses and the like. Compensation for permanent or substantial injury (‘menerstatning’) may be granted without financial loss in order to compensate for reduced quality of life and personal fulfilment, provided that the medical disability is 15% or higher.  Third, the claim must be timely submitted, cf. item 2.3 below. The drug must also have been administered after 1 July 1989. (If it concerns a drug administered before this date the patient may submit a claim to the pharmaceutical company directly). No compensation shall be granted when the injury (a) is a consequence of an incorrect dispatch or confusion of medicinal product or other negligence in a pharmacy, doctor, hospital or other relevant part of the supply chain; (b) has been committed in a way that goes against what would constitute foreseeable use of the medicinal product, including use contravening what it is justifiable and which breaches a specified warning, or if the incorrect use is due to negligence on the part of the doctor by incorrect prescription or inadequate guidance, (c) is a consequence of the drug not working or not working effectively enough, or (d) is due to a side effect which, in the situation of the injured party, it is reasonable for them to bear the consequences of. In this assessment, emphasis is placed on their state of health before use, the significance of the medicinal product for their illness, the presumed and actual effects of the medicinal product, the nature and extent of the damage and the conditions otherwise. In the case of experimental injuries, the exceptions set out in (a) and (b) are not applicable.

The Patient Injury Act

If the injury occurs as a result of a healthcare professional committing a ‘treatment failure’, such administering an incorrect dosage, then it is considered a patient injury under the Patient Injury Act. Three requirements must be satisfied in order to obtain compensation under the Patients Injury Act. First, the patient must have suffered a temporary or permanent injury due to treatment, examination or follow-up. Moreover, the injury must be due to a treatment failure, i.e. a treatment error or omission, though compensation may, in certain cases, be offered without such a failure, including when the damage is severe or unexpected. Finally, the patient injury must, as a general rule, have led to a financial loss exceeding what they would otherwise have incurred. This is because the aim of compensation is to cover extra expenses attributable to the patient injury. Said loss cannot be lower than NOK 10,000. If the cause of a patient’s injury cannot be ascertained, and the injury is probably due to external influences during treatment, it should normally be assumed that the injury is due to errors or failure in the provision of health care.

2.2 Which are the grounds for exclusion of liability?

A. Manufacturers

The Product Liability Act ascertains that a manufacturer is not liable if the manufacturer can prove (a) that it has not put the product for sale as part of its business, or (b) that the defect did not exist when the product was put on the market, nor should the defect or damage have been averted or remedied afterwards, or (c) the lack of safety is due to the fact that the product complies with rules issued by public authorities, and which are in all respects mandatory. Additional exclusions for liability for pharmaceuticals are outlined under § 3-3 of said Act, which provides that no compensation shall be granted – even if the damage is due to a lack of safety of the medicinal product which entails liability pursuant to Chapter 2 above – when the damage:

1. is a consequence of an incorrect dispatch or confusion of medicinal product or other negligence in a pharmacy, doctor, hospital or other relevant link of the supply chain,
2. has been committed in a way that goes against what would constitute foreseeable use of the medicinal product, including use contravening what it is justifiable, and which breaches a specified warning, or if the incorrect use is due to negligence on the part of the doctor by incorrect prescription or inadequate guidance,
3. is a consequence of the drug not working or not working effectively enough, or
4. is due to a side effect which, in the situation of the injured party, it is reasonable for them to bear the consequences of. In this assessment, emphasis is placed on their state of health before use, the significance of the medicinal product for their illness, the presumed and actual effects of the medicinal product, the nature and extent of the damage and the conditions otherwise.

However, in the case of experimental injuries, the exceptions under (a) or (b) do not apply.

Exceptions may also apply due to use outside the country.

B. and C. Healthcare professionals & State

Healthcare professionals and the State are not liable under the Patient Injury Act if the patient injury is due to external influences. For vaccines, the burden falls on the State to prove that additional causes may have resulted in the injury.

2.2 Which are the grounds for exclusion of liability?

A.    Manufacturers

The Product Liability Act ascertains that a manufacturer is not liable if the manufacturer can prove (a) that it has not put the product for sale as part of its business, or (b) that the defect did not exist when the product was put on the market, nor should the defect or damage have been averted or remedied afterwards, or (c) the lack of safety is due to the fact that the product complies with rules issued by public authorities, and which are in all respects mandatory. Additional exclusions for liability for pharmaceuticals are outlined under § 3-3 of said Act, which provides that no compensation shall be granted – even if the damage is due to a lack of safety of the medicinal product which entails liability pursuant to Chapter 2 above – when the damage: 

1. is a consequence of an incorrect dispatch or confusion of medicinal product or other negligence in a pharmacy, doctor, hospital or other relevant link of the supply chain,
2. has been committed in a way that goes against what would constitute foreseeable use of the medicinal product, including use contravening what it is justifiable, and which breaches a specified warning, or if the incorrect use is due to negligence on the part of the doctor by incorrect prescription or inadequate guidance,
3. is a consequence of the drug not working or not working effectively enough, or
4. is due to a side effect which, in the situation of the injured party, it is reasonable for them to bear the consequences of. In this assessment, emphasis is placed on their state of health before use, the significance of the medicinal product for their illness, the presumed and actual effects of the medicinal product, the nature and extent of the damage and the conditions otherwise.

However, in the case of experimental injuries, the exceptions under (a) or (b) do not apply.

Exceptions may also apply due to use outside the country.

B. and C. Healthcare professionals & State

Healthcare professionals and the State are not liable under the Patient Injury Act if the patient injury is due to external influences. For vaccines, the burden falls on the State to prove that additional causes may have resulted in the injury. 

2.3 Which are the time limits for submitting a claim for compensation?

Product Liability Act

Compensation claims must be set forth no later than three years after the patient became aware or should have become aware that the injury was caused by the drug, and in any case within 20 years from the date of circulation of the drug.

Patient Injury Act

Compensation must be sought no later than three years after the patient became aware or should have become aware that the treatment (or lack therof) led to the injury.

2.4 Which damages can be compensated?

Product Liability Act

Compensation under the Product Liability Act covers ‘personal injury’ caused by a drug (‘drug injury’) or during testing of a drug (‘experimental injury’) insofar as Norwegian law applies (cf. § 1-4). 1 Experimental injury includes any damage caused by the experiment, e.g. of the medicinal product itself (drug damage), the experimental procedure, special sampling, special use of technical equipment or special treatment in connection with the experiment.

If the harmful drug was not given for consumption in Norway, the provisions only apply if the direct injured party was a resident in Norway and the same drug, manufactured by the same manufacturer at the time of the injury, was also sold or approved for registration in Norway. Adverse reactions as a result of a clinical trial are also covered by the drug insurance scheme.  

Patient Injury Act

The damages that can be compensated under the Patient Injury Act includes injuries due to: 

1. failure in the provision of health care, even if no one can be blamed;
2. technical failure of apparatus, tools or other equipment used in the provision of health care;
3. infection, where this is not mainly due to the patient's condition or illness;
4. vaccination, or
5. matters that entail responsibility for the health and care service or health professional in accordance with general compensation rules.

However, even if there is no statutory basis for liability, compensation may still, in exceptional cases, be granted when a patient injury that is particularly large or particularly unexpected has occurred, and which cannot be regarded as a result of a risk that the patient must accept.  Whether sufficient information was provided in advance is considered important for such cases.

Compensation under the Patient Injury Act mainly covers economic damages such as expenses for medical treatment, medication, transport, legal costs, loss of income and the like. If the injury results in the death of the patient, compensation may also be granted for the loss of a provider and funeral expenses, as well as other ‘reasonable expenses in connection with the death’. In certain cases, individuals may receive compensation for non-financial losses, including for permanent or significant patient injuries. A patient injury must last for at least 10 years to be considered permanent. The patient injury must lead to a medical disability of at least 15% to constitute significant.

2.5 Is it possible to claim compensation directly to the insurance company of the damaging party?

Claims for compensation under the Product Liability Act and the Patient Injury Act should both be submitted to Norsk Pasientskadeerstatning (NPE). For drug injuries, NPE calculates the compensation for approved claims on behalf of Norwegian Drug Liability Insurance and the Drug Insurance Pool, the two private companies responsible for drug injury compensation. 

If the claim concerns a drug administered before the 1st July 1989 the patient must submit a claim to the pharmaceutical company directly.

3.1 How would the answers above change if adverse drugs reactions occur within a compassionate use program?

As the pharmaceutical companies are listed as the responsible party for drugs approved in a compassionate use program (CUP), and as drug injuries caused as a result of a clinical trial are also covered by the drug insurance scheme, it is likely that the answers above do not change.

The Norwegian Medicines Agency may allow for drugs which do not have a market authorization to be marketed if (1) it has a market authorization in the EEA in accordance with the rules in Directive 2001/83 / EC as amended by Directive 2003/63 / EC, Directive 2004/24 / EC and Directive 2004/27 / EC, and (2) it can be justified on the basis of protecting public health. In special cases, the Norwegian Medicines Agency may make other exceptions to the requirement for a marketing authorization other than those listed above. 

The CUP in Norway is based on EU rules, though the Norwegian Medicines Agency has published its own guidelines. According to these guidelines, the pharmaceutical company is responsible for submitting an application for a pharmaceutical product to be approved in a CUP. For an application to be approved the following conditions must be met:

1. The use of the drug in the program only applies to patients with chronic, life-threatening, long-term or severe disabling diseases.
2. The use of the drug in the program only applies to patients who cannot be included in any ongoing studies and who do not benefit from treatment with drugs that have a marketing authorization.
3. There is sufficient evidence that the drug's efficacy and safety is predominantly positive for the relevant patient group in terms of a benefit-risk assessment. 
4. The applicant must have submitted an application for a marketing authorization and / or have ongoing clinical studies on the product in question.

4.1 How would the answers above change if the adverse drugs reactions occur as part of an off-label use?

The Product Liability Act does not lay down specific rules for off-label use. As the rules for liability do not specify that the drug must be administered for an authorized indication, it is highly likely that the liability rules remain the same. However, the exclusions for liability under § 3-3 may be particularly relevant for off-label use, including where the drug injury is caused by damage that has been committed in way going against what constitutes as foreseeable use of the medicinal product, including use contravening what it is justifiable and which breaches a specified warning, or if the incorrect use is due to negligence on the part of the doctor by incorrect prescription or inadequate guidance. Conversely, many off-label uses, such as for cancer, are standard practice and often prescribed for economic reasons so for these cases it might be difficult to argue that an off-label prescription was not justifiable or not foreseeable.

5.1 How would the answers above change if the adverse drugs reactions concern a vaccine?

This depends on whether the vaccine is part of the national vaccine programme. If so, then the Patient Injury Act applies wherein claims are directed against the State. The burden of proof for compensation claims under The Patient Injury Act is notably lower for vaccines (reversed burden of proof). The general rule is that persons are entitled to compensation ‘when the vaccine could have been the cause of your injury, and there are no other more likely causes’. The burden then falls on the State to show what those other causes would be.

If the vaccine is not part of the national vaccine program, the Product Liability Act Chapter 3 applies, and compensation may be sought under the Drug Injury insurance scheme. Both types of claims are submitted to NPE. 

5.2 Is any public indemnity/compensation provided in the case of both compulsory and not compulsory vaccination?

The State is responsible for paying the compensation for the pharmaceutical products which are part of the national vaccination programme. A claim may also be pursued against one of the pharmaceutical companies who developed or manufactured the vaccine. Who is liable to pay the compensation in this case depends on the contract between the State and the private party involved.

6.1 Which liabilities can be insured? Is there any compulsory insurance?

The pharmaceutical insurance covers damages falling within the ambit of the Product Liability Act irrespective of whether the producer, importer or other insured party is to blame for the damage or the safety deficiencies. Pharmaceutical manufacturers are required, through their membership in the Norwegian Medicines Agency, to have insurance for medical product liability pursuant to §3-4 of the Product Liability Act. This also applies to parties importing medicines from a manufacturer who does not have such insurance. Actors developing medicines must also have such insurance. Said insurance is for the benefit of the injured party and may also cover damage caused by anonymous or uninsured medicines. 

The Norwegian Medicines Liability Association is responsible for the compulsory pharmaceutical insurance scheme.

The King may allow only limited insurance to be taken out against a full guarantee that the manufacturer will cover excess liability costs.

7.1 Are there particular procedural issues to be highlighted in relation to ADR claims?

Individuals cannot appeal a NPE decision relating to drug injury. They must turn to the courts if they wish to pursue the case further.