New rules on fines for breaches of the Norwegian Medicines Act, Pharmacy Act and Medical Device Act enter into force on 1 January 2022

In 2018 and 2019, the government adopted new rules on fines for breaches in, inter alia, the Norwegian Medicines Act, Pharmacy Act and Medical Device Act. The rules have not yet entered into force, but it has now been decided that they will enter into force on 1 January 2022.

The new rules give the Norwegian Medicines Agency competence to impose fines in the following cases:

• Operating a pharmacy without license
• Illegal sales of medicines
• Illegal import of medicines
• Breach of conditions set out in a marketing authorization
• Breaches of the rules on labelling and advertising for medicines and medical equipment

The Norwegian Medicines Agency has not previously had the power to impose fines for breaches of these rules.

The preparatory work of the Act states that a decision to impose a fine will normally be regarded as a punishment under the European Convention on Human Rights ("ECHR"). The fine will therefore be subject to the stricter set of procedural rules in the Public Administration Act.

The preparatory work of the Act provides that violations will be assessed based on a standard of strict liability, which means that a fine can be imposed even if it cannot be demonstrated guilt by any physical person connected to the breach. In connection to this, it is worth noting that the Supreme Court as recently as April 2021 has stated that a strict criminal liability for enterprises will not be compatible with the ECHR, cf. HR-2021-797-A. According to this judgment, it must at least be proven that someone who acts on behalf of the company acts negligently. The same requirement will probably also apply to impositions of a fine from the Norwegian Medicines Agency.

A decision on a fine can be appealed to the Ministry of Health and Care Services. Cases can also be brought before ordinary courts. The Norwegian Medicines Agency may decide that a case cannot be brought before the courts before the administrative set of remedies are exhausted, cf. the Public Administration Act § 27b, but such a decision does not apply if the process lasts for more than six months and the company subject to the fine is not to blame (e.g. because necessary information is not provided in time).

Further criteria for determining the size of the fines are laid down in regulations. The Medicines regulation and the Pharmacy regulation will have provisions regulating this from 1 January 2022. In both cases, the maximum fine for breaches will be 15 times the National Insurance basic amount (NOK 1,595,985 in 2021, equivalent to about EUR 156 705), or 2 times the basic amount (NOK 212,798 in 2021, equivalent to about EUR 20 900) for breaches committed by persons. The regulation on sanctions for breaches of the Medical Devices Act, etc. § 2, which is in force, regulate when matters concerning illegal labelling or advertising can lead to fines or imprisonment, but does not contain separate provisions on fines for violations.

More information about the announcement can be found here (in Norwegian only).