Norway is a party to the Agreement establishing the European Economic Area (the EEA Agreement), the purpose of which, essentially, is to enable the European Free Trade Association (EFTA) states – Norway, Iceland and Liechtenstein – to participate in the single market of the European Union. By implication, all EU legislation concerning the single market, in particular rules on free movement, competition law, state aid and relevant secondary legislation, including within the medical field, applies for all practical purposes as if Norway were an EU Member State.
The competent authority in Norway in relation to medicines is the Norwegian Medicines Agency (NoMA), which is subordinate to the Ministry of Health and Care Services. NoMA is entrusted with all tasks related to assessment of medicines, administration of the pharmaceutical distribution chain, pharmacoeconomics, supervision and provision of medical information to prescribers, the industry and the general public.
NoMA primarily derives its powers from the Act on Medicinal Products of 1992 and various regulations issued pursuant to it, most importantly the Regulation on Medicinal Products of 2009, and from the Pharmacies Act of 2000. The aforesaid legislation implements relevant secondary EU legislation, including Directive 2001/83/EC and Regulation (EC) No. 726/2004.
NoMA is also responsible as competent authority for medical devices. NoMA thus has administrative and advisory responsibilities related to the relevant medical devices legislation, in addition to supervisory authority over manufacturers, distributors and notified bodies. NoMA primarily derives its powers from the Act on Medical Devices of 1995 (the Medical Devices Act) and the Regulation on Medical Devices of 2005 (the Medical Devices Regulation), issued pursuant to the Medical Devices Act and implementing relevant secondary EU legislation, including Directive 90/385/EEC, Directive 93/42/EEC, Directive 98/79/EC, Regulation (EU) 2017/745 and Regulation (EU) 2017/746.
All major international pharmaceutical manufacturers are represented in Norway. At the distribution level, there are primarily three major wholesalers providing a full range of products to the market – each of them vertically integrated with its own pharmacy chain. There is a small number of independent wholesalers and pharmacies. In general, medicines are only dispensed by retail pharmacies and hospital pharmacies. Grocery stores, petrol stations, etc., are allowed to distribute a restricted list of over-the-counter (OTC) products.
Medical devices are sold in a variety of ways – to hospitals, private clinics, pharmacies, through pharmacies directly to patients, etc. – depending on the nature of the product. For the sale of medical devices, in particular to Norwegian hospitals, having a sales organisation in Norway, or cooperating with a local distributor or agent, is often necessary to provide customer service and know-how in relation to local public procurement procedures.
II THE REGULATORY REGIME
A substance, drug or preparation is classified as a medicine pursuant to the Act on Medicinal Products if it either (1) purports to be suitable to prevent, heal or alleviate disease, disease symptoms or pain, or modify physiological functions in human beings or animals; or (2) can be used or given to human beings or animals to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action, or to detect disease. The definition of medicines comprises prescription, OTC, herbal, plant-based and homeopathic medicines.
Notably, products may be included in the definition simply by being presented as having a certain effect (the first alternative), even if it is not a conventional medicine. In borderline cases, the assessment will normally take into account factors such as product name, packaging, administration mode, claims and end user. Similar products that are particularly susceptible to being covered by the definition include food supplements, cosmetics, feed, biocides and medical devices. Whether a product is included in the definition of medicines pursuant to the second alternative is normally based on an overall assessment of relevant factors, such as the product's composition, pharmacological characteristics, administration mode and the risk it poses in use.
Medical devices are defined as any equipment, apparatus, assistive device, material or any other object used alone or in combination, including with necessary software, on human beings to diagnose, prevent, monitor, treat or alleviate disease, injury or disability; examine, replace or amend anatomy or a physiological process; or prevent pregnancy. Borderline cases often concern the class of risk rather than how they are defined as medical devices. NoMA cooperates with relevant European authorities in borderline cases.
ii Non-clinical studies
Non-clinical studies are subject to the general requirements in relation to research as embodied in the Act on Medical and Health Scientific Research of 2008 and the Act on Research Ethics of 2017 – to the extent that they involve testing on human biological material, individuals' health information or in other ways involve human beings. If so, prior approval from the relevant regional health scientific research ethics committee (the Ethics Committee) is required. Research involving surplus embryos or cloning must further observe requirements and restrictions embodied in the Act on Biotechnology of 2003.
Non-clinical studies involving research on animals require prior approval from the Norwegian Food Safety Authority pursuant to the Regulation on the Use of Animals in Research of 2015. Research activities must comply with the requirements embodied in the regulation and must safeguard animal welfare.
iii Clinical trials
Clinical trials are also subject to the general requirements in relation to research, as mentioned in Section II.ii – in addition to specific requirements laid down in the Regulation on Clinical Trials of 2009 as regards medicines, and the Medical Devices Regulation as regards medical devices.
All clinical trials for medicines require additional prior approval from NoMA, whereas clinical trials for medical devices require additional prior approval from NoMA when the device is not already CE-marked or when it is to be used outside the scope for which it is CE-marked.
It is generally required that all clinical trials are conducted in accordance with good clinical practices and the Declaration of Helsinki – Ethical Principles for Medical Research involving Human Subjects 1964. This implies, inter alia, that clinical trials must be scientifically based and governed by ethical principles. Subjects may only be enrolled based on prior and informed written consent. Special provisions apply to minor subjects and subjects who do not have the ability to give consent, or whose ability to give consent is reduced.
Subjects must be insured in relation to all types of clinical trials. In many situations, this requirement may be met by way of mandatory insurance schemes, such as the Norwegian Drug Liability Insurance for medicines and the Norwegian System of Patient Injury Compensation (NPE) for medical devices (see Section VI). Adverse effects and incidents must be reported to NoMA.
It is a requirement that the sponsor of the clinical trial, or the producer of the medical device, is domiciled in the EEA or has an appointed representative in the EEA.
iv Named-patient and compassionate use procedures
Medicines without marketing authorisations (MAs) in Norway may, under certain circumstances and by way of exemption, be dispensed to patients.
Prescribers may apply to NoMA for an exemption of this kind for individual patients. A number of conditions must be fulfilled, in particular that use of the medicinal product in question is medically justifiable, for example, because no authorised medicine meets the individual's medical need.
NoMA may also approve use for a group of patients of non-authorised medicines in the context of compassionate use programmes, provided certain conditions are fulfilled, including that the programme only concerns patients with life-threatening, long-lasting, recurring or seriously disabling diseases, and that the relevant patients cannot be included in clinical trials and will not benefit from treatment with authorised medicines. It is for the manufacturer and the prescriber to decide on pricing. Medicines shall be dispensed to patients free of charge. Reporting obligations apply to, inter alia, adverse effects and amendments to the protocol for the programme.
v Pre-market clearance
Commercial distribution of medicines in Norway generally requires prior approval in the form of an MA from NoMA. Prescription medicines further need price approval from NoMA prior to being marketed.
There are four procedures available for obtaining an MA in Norway: centralised procedure; decentralised procedure; mutual recognition procedure; and national procedure. When an MA is first granted by another EEA Member State or the European Commission with effect also for Norway, a national MA issued by NoMA is nonetheless necessary. Special rules and procedures apply for herbal, plant-based and homeopathic medicines.
Generic products follow a somewhat simplified procedure in as much as they may rely on the toxicological, pharmacological and clinical documentation of a patented product – provided that patent protection, regulatory market protection and regulatory data protection periods have all expired. By contrast, it is necessary to document bioequivalence.
It is a requirement that the MA holder either resides within the EEA or has appointed a representative residing within the EEA.
The first MA is generally valid for a period of five years, after which it needs renewal. The second, renewed MA is normally perpetual.
For commercial distribution of medical devices in Norway, it is required that the manufacturer demonstrates compliance with all fundamental requirements applicable to the product in question, also known as 'declaration of conformity', and that the product bears a CE mark to evidence compliance. Applicable requirements depend on risk assessment and classification of the product in a certain risk class. Further, manufacturers or their representatives must, if they have a Norwegian business address, register themselves and the medical devices they market in the Norwegian Register for Medical Devices.
vi Regulatory incentives
Patents may be granted for medicines and medical devices for 20 years from the date of filing, as provided in the Patents Act.
Norwegian law concerning supplementary protection certificates (SPCs) is harmonised with EU directives. SPCs may be obtained for medicines in Norway. The duration of an SPC is limited to a maximum of five years without the possibility of extension.
Norway implemented Regulation (EC) No. 1901/2006 on medicinal products for paediatric use in 2017. Once paediatric studies have been performed according to an approved, implemented paediatric trial protocol, the holder may be given a six-month extension of the supplementary protection for the medicinal product.
An original medicine has automatic data and market exclusivity based on its MA for the first application in the EEA. This protection is a time-limited right to prevent others from basing its application for an MA on the original medicine producer's submitted documentation. If an MA was applied for the reference product in Norway after 1 November 2005 but before 12 January 2010, the document and market protection is 10 years. If an MA was applied for the reference product in Norway after 12 January 2010 or in the EEA after 1 November 2005, the reference product enjoys data protection for eight years, and market protection for 10 years. The protection may be extended by one year if an MA is applied for regarding a new indication of significant clinical importance during the document protection period (i.e., the first eight years).
It follows from Section 10 of the Act on Medicinal Products that, in special cases, exemptions to the requirement for an MA may be given. The exemption may be used for fast-track use of specific medicines (e.g., in situations of urgency), but the exemption is not much used in practice.
Medical devices may be protected through the Patent Act, but there is no SPC.
According to Section 47(1) of the Patent Act, a compulsory licence for exploitation of a patent may be obtained when it is deemed necessary for 'important public interests'. The provision applies in extraordinary situations, for example where there is the threat of an epidemic and the situation may only be prevented or improved through the exploitation of the invention.
vii Post-approval controls
Post-approval control requirements in Norway for medicines are largely harmonised with Directive 2001/83 and subsequent amendments thereto. The MA holder is obliged to implement and manage a pharmacovigilance system and to employ, at all times, a sufficiently qualified person who is responsible for system and risk management, as further specified in the Regulation on Medicinal Products. The qualified person must be domiciled and work within the EEA and must be reported to NoMA. All suspected adverse effects must be registered, and suspected serious adverse effects must be reported to the EudraVigilance database. Periodic safety reports must be submitted to the Periodic Safety Update Report repository at intervals stated in the MA, and NoMA must be notified of variations and amendments to the documentation or product information in accordance with Regulation (EC) No. 124/2008. Transfer of an MA from one legal entity to another must be reported to NoMA and must follow a certain procedure.
A medical device manufacturer domiciled outside the EEA is obliged to appoint a representative domiciled within the EEA. Any person who manufactures, distributes, owns or uses medical devices has an obligation to report deviations, errors and failures to NoMA, which also requires that a system for post-market surveillance is established.
viii Manufacturing controls
Manufacturing of medicines and any other activities involving packaging, repackaging, labelling, relabelling and release, generally require a manufacturing licence from NoMA. An exception is made, if certain conditions are met, for simple preparation or packaging of medicines in pharmacies, hospitals and other health institutions.
Manufacturing must take place in compliance with the EU Good Manufacturing Practice guidelines. Thus, certain requirements regarding, inter alia, having suitable production facilities, suitable production equipment and a sufficiently qualified person approved by NoMA, must be met. Requirements under the Regulation on Manufacturing and Import of Medicinal Products are harmonised with Directive 2003/94/EC.
ix Advertising and promotion
Advertising of medicines is regulated in the Act and Regulation on Medicinal Products and is permitted only for drugs that have been granted an MA. Advertising of medicinal products to the public is only allowed for OTC products and then only if examination or treatment by a doctor, dentist or veterinary surgeon is not a prerequisite. Prescription products may, therefore, only be advertised to healthcare professionals.
Information in the marketing material must be true, accurate, relevant and not misleading. Advertising or promoting a product that is not classified as a medicine but is recommended as a means of preventing, healing or alleviating illness, sickness symptoms or pain or affecting physiological functions, is prohibited. The purpose is to prevent undocumented claims about medical efficacy in advertising of products that are not medicines.
In addition, a Code of Conduct, compiled by the Norwegian Association of Pharmaceutical Manufacturers, applies to any kind of communication between manufacturers, suppliers and healthcare professionals or the public. It is based on the code adopted by the European Confederation of Pharmaceutical Industries and Associations (EFPIA).
The Medical Devices Act does not contain specific regulations on advertising and promotion but, as a general principle, all claims used in advertising and promotion should be true, accurate, relevant and not misleading, and the producers must be able to substantiate the claims.
x Distributors and wholesalers
The import, purchase, receipt, storage, delivery, distribution, sale and export of medicines are considered wholesale activities and require a wholesale licence issued by NoMA. Regular pharmacy activities are not defined as wholesale.
The Wholesaler Regulation of 1993 sets out the detailed requirements to be met by wholesalers. This includes requirements for good distribution practice (GDP), issued by the European Commission. In addition to suitable premises and equipment, there is a requirement of competence for the person who is responsible for the wholesale business of pharmaceuticals. Wholesalers must be able to deliver drugs within 24 or 48 hours anywhere in the country.
Wholesalers may sell medicines directly to nursing homes, professional end users of veterinary drugs and hospitals.
As a main rule, only pharmacies may sell medicines directly to consumers. A licence is required to own and run a pharmacy. Nonetheless, the Regulation on Sale etc. of Certain Non-Prescription Medicines Outside Pharmacies of 2003 (the LUA Regulation) allowed for the sale of OTC products from outlets other than pharmacies.
As of 1 January 2016, Norwegian pharmacies that are registered and approved by NoMA have been allowed to sell prescription and OTC products online.
xi Classification of products
To determine whether the Act on Medicinal Products applies to a given product or substance, it is necessary to classify it.
For medicines, there are strict requirements regarding quality, safety and efficacy. Moreover, special rules apply to import and sale. A number of products are similar to medicines and particularly susceptible to being defined as medicines, typically supplements, feed, cosmetics and medical devices. See Section II.x.
Norwegian legislation on classification of medicines is harmonised with EU legislation and implemented into the Regulation on Medicinal Products. NoMA has the authority to decide whether a substance is a medicine in borderline cases (see Section II.i). With legal basis in the LUA Regulation, NoMA has issued a list of OTC products that can be sold outside pharmacies, as addressed in Section II.x.
Pursuant to the Medical Devices Act and Regulation, medical devices are classified as active implantable medical devices, in vitro medical devices or other medical devices. In vitro medical devices are subclassified in List A, List B and self-test products. Other medical devices are subclassified in one of four risk classes (see Section II.x).
xii Imports and exports
The import and export of medicines generally require a licence issued by NoMA. Imports from the EEA to Norway and export activities are defined as wholesaler activities pursuant to the Wholesaler Regulation and will, in the first instance, require a wholesaler licence issued by NoMA (see Section II.xi). Some exceptions apply to holders of manufacturing licences. First, a manufacturing licence issued by NoMA includes the right to engage in, inter alia, import and export activities in relation to the medicines covered by the manufacturing licence. Second, holders of manufacturing licences issued in another EEA country may import medicines to Norway that are covered by the manufacturing licence, simply by notifying NoMA.
As of 1 October 2015, significant restrictions have applied to imports of medicines by private persons. Only OTC products may be imported and only from another EEA country for personal consumption and only on certain conditions, including that the medicine has a valid MA in Norway and that the imported quantity does not exceed three months' consumption. Whether conditions are fulfilled, for example, whether a medicine is an OTC product, depends on the assessment in Norway.
Imports to Norway directly from countries outside the EEA generally require a manufacturing licence, implying that medicines must be subjected to full inspection prior to release of the products for marketing in Norway. This again implies that the importer must engage a sufficiently qualified person to undertake necessary inspections and to release medicines for sale. Wholesalers with a wholesaler licence may escape the requirement for a manufacturing licence in the case of imports from a country outside the EEA, provided that the exporting country is a member of the Pharmaceutical Inspection Co-operation Scheme or has entered into a mutual recognition agreement with Norway. Medicines manufactured outside the EEA, but released in another EEA country, may be imported without new inspection and new release in Norway.
The Medical Devices Act and Regulation do not require specific import and export licences.
xiii Controlled substances
Manufacturers, wholesalers and others who handle medicines classified as narcotics or psychotropic substances need a manufacturing, import or wholesale licence (as the case may be) that specifically includes the substance in question. Further, imports or exports of a controlled substance require a special licence (drug certificate) for each shipment. The processing time for issuing a drug certificate is up to seven working days after NoMA receives the application.
Transport, storage and handling of controlled substances shall be conducted in a safe and secure manner and in compliance with the Wholesaler Regulation and the Regulation of Manufacture and Importation of Pharmaceuticals of 2004. Businesses that import or export controlled substances shall keep records of the last quarterly importation and exportation of the substances that require certificates, and of any certificates that are not used.
NoMA is the national administrative and supervisory body for medicines. It is responsible for monitoring and enforcing the Act on Medicinal Products. NoMA, inter alia, supervises clinical trials, manufacturers, importers, wholesalers and pharmacies, and the advertising of medicines. It also monitors controlled substances, including narcotics. NoMA may demand all information necessary for its supervision and decision-making.
The Council for Drug Information is a self-policing body established by the pharmaceutical industry. The Council shall ensure that all drug information and marketing to healthcare professionals and the public are in accordance with the Code of Conduct mentioned in Section II.ix. The Council acts on delegated authority from NoMA. Anyone who holds an MA is obliged to send a copy of all written advertising, regardless of the platform used, to the Council. The Council for Drug Information may issue coercive fines of up to 300,000 kroner for violations of the Code of Conduct.
In the case of repeated violations of advertising rules, NoMA may impose a ban on advertising for individual medicines.
At the outset, NoMA is responsible for the enforcement of the legislation relating to medical devices. For electromedical devices, the Directorate for Civil Protection is responsible for supervision and enforcement. Both supervisory authorities may obtain the information necessary and may require the person who produces, imports or markets a medical device to submit samples needed to carry out their investigations. If the medical devices potentially endanger public health, patients, users or any other persons' health or safety, or the necessary documentation is not obtainable, the supervisory authority shall take all necessary measures to withdraw the equipment from the market, prohibit or restrict the sales or use of it, and may also issue coercive fines.
III PRICING AND REIMBURSEMENT
The rules for determining, controlling and adjusting the prices of pharmaceuticals are found in Chapter 12 of the Regulation on Medicinal Products. NoMA provides detailed guidelines for pricing.
Non-prescription medicines and veterinary medicines are not subject to price regulations.
NoMA stipulates maximum sales prices to pharmacies (AIP) for prescription products for human use. AIP is set as the average of the three lowest market prices for the product in a variety of reference countries. Reference countries included in price comparison are Austria, Belgium, Great Britain, Denmark, Finland, Germany, Ireland, the Netherlands and Sweden. There are exceptions to the main rule, for example if the price turns out to be exceptionally low. AIP may be subject to adjustment in the case of changed circumstances or new information.
Maximum sales prices that the pharmacies may charge the patient equals AIP plus a certain maximum gross profit, which is also determined by NoMA.
A 'step price scheme' was introduced in 2005 to reduce governmental and patient medicine costs. In the step price system, the price of a medicine is reduced in stages, with fixed cut rates once the medicine's patent protection expires; it becomes subject to generic competition and is included in NoMA's list of interchangeable medicines. The starting point for calculating the step price is the maximum AIP for the original product the moment the first competing generic equivalent is launched.
The National Insurance Scheme reimburses costs for medicines and medical devices used outside institutions according to the National Insurance Act of 1997. The purpose is to ensure access to effective and essential medicines irrespective of users' financial situations. Reimbursements are either made through the general reimbursement scheme for pre-approved products or based on individual applications.
The holder of an MA may apply for pre-approved reimbursement, which means that the practitioner may prescribe medicines at reimbursed prices directly to the patient. Generally, this is considered favourable for distribution purposes. For medicines included in NoMA's list of interchangeable medicines, the National Insurance Scheme reimburses the maximum step price for medicines included in the substitution group. Reimbursement may be granted for an indication not covered by the MA, if at least one product within the substitution group has an MA for the indication in question. However, this does not apply if the indication in question is subject to patent or document protection.
If a patient needs a medicine or medical device that is not part of the reimbursement scheme, the patient, or the doctor on behalf of the patient, may apply for individual reimbursement.
IV ADMINISTRATIVE AND JUDICIAL REMEDIES
Generally, under Norwegian administrative law, a party may file a complaint if it believes that a decision by a relevant authority is wrong or may even make an appeal to its superior public authority. Decisions made by NoMA may thus be appealed to the Ministry of Health and Care Services. The deadline for a complaint is, as a general rule, three weeks. A negative decision from the Ministry of Health and Care Services may subsequently be tried by the courts, if challenged by a party with legal interest.
V FINANCIAL RELATIONSHIPS WITH PRESCRIBERS AND PAYERS
As mentioned in Section II.ix, a Code of Conduct, issued by the Norwegian Association of Pharmaceutical Manufacturers, based on the code adopted by EFPIA, applies to any kind of communication between manufacturers or suppliers and healthcare professionals or the public, including the requirement for information and documentation and rules on hidden marketing, promotion in hospitals, gifts, payment of expenses and use of health professionals as consultants. In addition, a number of bilateral agreements concerning interaction have been entered into between the Norwegian Association of Pharmaceutical Manufacturers and certain healthcare personnel organisations.
For medical devices, interaction between the industry and healthcare personnel is generally regulated by relevant organisations' ethical codes or guidelines and bilateral agreements.
In addition, the Act on Health Personnel generally prohibits healthcare professionals from receiving gifts in this capacity.
Although interaction is largely governed by soft law – with varying sanctions being relevant – deviations from the various rules could be relevant in relation to assessments pursuant to the general rules on anti-corruption, as set out in the Norwegian Penal Code of 2003.
VI SPECIAL LIABILITY OR COMPENSATION SYSTEMS
Liability for injuries caused by medicines is governed by the special liability regime embodied in Chapter 3 of the Product Liability Act, establishing the Drug Liability Insurance, which pays compensation to patients who have suffered injuries caused by medicines. To finance the Drug Liability Insurance, all manufacturers of medicines marketed or on clinical trial in Norway are mandatory members of, and must pay an insurance premium to, the Drug Liability Association. If a manufacturer is not a member itself, the relevant importer must be instead. Insurance premiums must be paid. Liability is not contingent upon fault being established, but a causal link between the injury and use of the medicine in question must be demonstrated. The right to compensation may, in certain cases, lapse, for example because of unforeseeable use contrary to given instructions. Claims must be submitted to the NPE, which investigates and assesses the claim on behalf of the Drug Liability Insurance and decides whether compensation should be paid and, if so, what the amount should be. If the NPE rejects the claim, the injured person may normally bring a civil action against the Drug Liability Insurance. Notably, the patient maintains the right to file a claim directly against the manufacturer or importer. If deemed liable, it is nonetheless the Drug Liability Insurance that pays compensation.
Liability for injuries caused by medical devices is governed by the general regime under the Product Liability Act, which essentially stipulates that the injury must have been caused by a product that has a safety defect and therefore does not comply with the safety standard that could reasonably be expected. Again, existence of a causal link is a prerequisite for liability; fault of the manufacturer is not.
Product liability for medicines and medical devices must be in conjunction with – and to some extent overlap – the scheme for compensation of patients who have suffered an injury while receiving healthcare services in public or private healthcare institutions. The system is embodied in the Patient Injury Act of 2001, which also establishes the NPE as being responsible for all case-handling in relation to such claims. The general condition for the right to compensation is that the injury has been caused by failures, for example malpractice or technical failures, in the course of the provision of healthcare, including participation in clinical trials. It is not a requirement that an error has been made. The NPE may, in principle, claim regress and invoke product liability against manufacturers, if the injury is caused by a medicine or a medical device rather than by the provision of healthcare as such. Rejection of claims may be appealed to the Patients' Injury Compensation Board. If also rejected there, the patient may bring a civil action against the Patients' Injury Compensation Board or, in principle, the manufacturer.
VII TRANSACTIONAL AND COMPETITION ISSUES
The Competition Act of 2004 is identical to the provisions of Articles 53 and 54 of the EEA Agreement and Articles 101 and 102 of the Treaty on the Functioning of the European Union. It thus prohibits agreements and cooperation distorting or restricting competition and abuse of a dominant position. The provisions of the Competition Act are enforced by the Norwegian Competition Authority, which may also enforce Articles 53 and 54 of the EEA Agreement in Norway. The latter is enforced in parallel by the EFTA Surveillance Authority (ESA) in Iceland, Norway and Liechtenstein.
To our knowledge, there have been no major cases in the life sciences sector concerning infringements of the aforesaid prohibitions on or involving the Norwegian market in recent years, but the Norwegian Competition Authority consistently supports political initiatives aimed at enhancing price competition on medicines.
Both the Norwegian Competition Act, through its regulations, and the EEA Agreement contain merger control regimes mirroring the merger control regime embodied in Regulation (EC) No. 139/2004, implying that above certain turnover thresholds, a mandatory pre-merger notification system applies. While the ESA and the EU Commission have exclusive competence over mergers with an EFTA or EU dimension respectively, it is, in practice, the EU Commission that handles all relevant cases, since mergers with only an EFTA dimension are very rare. The ESA and the Norwegian Competition Authority handle cases that concern the Norwegian market only. Whether it is one or the other depends on which turnover thresholds are fulfilled. The criterion for prohibiting mergers according to the Norwegian Competition Act is that the transaction constitutes 'a substantial impediment to effective competition'. We are not aware of transactions in the life sciences sector in recent years that have been prohibited, but some have only been approved subject to remedies.
VIII CURRENT DEVELOPMENTS
The Norwegian Ministry Health and Care Services has proposed to introduce administrative fines as an alternative sanction for infringements of certain key obligations in the Norwegian pharmacy and medicines regulations. An administrative fine is an administrative reaction to illegal conduct. It may be imposed even after the illegal conduct has been terminated. Existing sanctions include warnings, varying degrees of prohibition against certain activities, and punishment in the form of fines or imprisonment. Administrative fines may be contested before the ordinary courts. It is proposed that NoMA shall be able to issue administrative fines to legal entities for the following infringements, even if no physical person is identified as responsible for the infringement:
- non-fulfilment of requirements of certain necessary licences, such as ownership and operating licences for pharmacies, and wholesaler and import licences in the distribution chain;
- non-fulfilment of the requirement for a pharmaceutical manufacturer to ensure updated and correct information about marketed products; and
- non-fulfilment of the requirement for a manufacturer to report interruptions in supply.
Notably, in June 2018, NoMA was given powers to issue administrative fines for any infringement of the Norwegian rules on advertisement for medicinal products. This indicates a general trend to strengthen the enforcement of legislation related to medicines.
1 Kirti Mahajan Thomassen and Rune Nordengen are partners at Bull & Co Advokatfirma AS.