28 February 2020 | Country Update
The “New Methods” system for prioritising introduction of new health technologies has been described in legislationThe MOHCS has the main responsibility for health policy and for some aspects of social security policy. It fulfils this responsibility by means of legislation, annual budgetary allocations to the RHAs, a yearly letter of instruction to the RHAs, and through various governmental institutions. Whenever relevant, EU regulations are taken into account. Efforts to develop a systematic approach to setting policy priorities in health care have been long-standing and can be linked to the fundamental goals of ensuring equal access to health care services to the entire population, irrespective of their socioeconomic and other characteristics (Box2.1). The Public Health Act (2011) requires local authorities to have an overview of health conditions and influencing factors. The NIPH has developed “public health profiles” in order to help them identify and monitor areas for improvement in each region/municipality (see section 7.1).
Box2.1
The National Health Plans are the key strategic planning tools in the health care sector. Their planning horizon is normally four years, which is longer than the planning horizon of the annual health care budget. The latest plan was published in 2016 (see subsection “Stated objectives of the health system” below). They are developed by the MOHCS and present the current status of the health care system, including the key challenges, and suggest policy goals and measures aimed at meeting them (Ringard et al., 2013). As broad policy statements, these Plans are not formally evaluated.
The MOHCS is responsible for the planning of human resources for health (see section 4.2). In addition, hospital trusts and municipalities have a responsibility to plan, recruit and retain human resources. The MOHCS provides input regarding personnel and skill needs to the Ministry of Education, which is responsible for determining the educational capacity for different health personnel groups.
The overall responsibility for the planning of infrastructure and capital investment in public health care providers lies with the RHAs for specialist care and with the municipalities for primary care. Both the RHAs and the municipalities have a wide authority to plan their own infrastructure. RHAs have to consult the MOHCS for major investments in infrastructure (e.g. the building of new hospitals) (see section 4.1). In 2015 the RHAs established the Agency for Hospital Construction (Sykehusbygg HF) providing expertise for planning of hospital infrastructure to all hospital trusts.
The objectives of the Norwegian health care system are embedded in the national legislation and in various strategy documents. Health care coverage is universal, and health care services are expected to be of high quality and the same for all. The goal of ensuring “equal access to health care of good quality” is explicitly stated in the 1999 Patients’ Rights Act. Access to service should be according to health needs, with equal access for equal needs, regardless of gender, social and economic background, and geographical location. The principle of equality of access is supplemented by three other principles, giving priority to: (1) those in greater health need (i.e. according to the severity of medical condition); (2) interventions that are likely to lead to health improvement; and (3) interventions where the ratio between the expected benefit and cost is reasonable (i.e. the intervention is considered to be cost-effective) (Bringedal, 2005; Patients’ Rights Act 1999; Ringard et al., 2013).
The key policy documents for the period 2013–2018 are the National Health Plan for the period 2011–2015 and the current National Health and Hospital Plan for the period 2016–2019. The key goals of the National Health Plan 2011–2015 were to increase quality-adjusted life-years (QALYs) and reduce social inequalities in health. The National Health and Hospital Plan 2016–2019 has seven main goals, including strengthening mental health care, improving the skill-mix of health professionals and coordination of services (see Table6.1).
Table6.1
In 2013 the National System for the Managed Introduction of New Health Technologies, the so-called “New Methods” system, was established within the specialist health service to recommend and decide on the introduction of new health technologies in Norway.
From the 1 January 2020, the “New Methods” system has been described in legislation, through the amendments of the Specialist Care Act and the Patients’ Rights Act. The priority criteria for introduction of new health technologies are:
The key third-party payer in the Norwegian health care system is the NIS. The NIS is financed by contributions from employees, self-employed persons and other members, employers’ contributions and contributions from the state. As a general rule, all residents of Norway are members of the NIS. The NIS covers a wide range of social benefits and pensions, as well as health services (see section 3.2). Since 2009 the health care part of the NIS budget has been under the responsibility of the MOHCS. The NIS is regulated by the National Insurance Act (1997), and reimbursements for health services are managed by the Norwegian Health Economics Administration (Helfo) in the Directorate of Health (see Table2.1).
Table2.1
Other third-party payers are the providers of voluntary health insurance (VHI). The activity of private for-profit VHI providers is regulated in the general insurance legislation, with the current law dating from 2005. For more information on VHI, see section 3.5.
The Board of Health together with the County Governors are supervision authorities. They conduct surveillance, which provides a general picture of the quality of services, as well as system audits, and also react on information on possible deficiencies in services. The Board of Health can give warnings or withdrawal of authorization (if relevant) against health care personnel. All statutory services are subject to supervision (municipalities, private providers, publicly owned hospitals or health care personnel with private practice). In 2017 the parliament adopted a Supervision of Health Services Act, thus collecting all regulations on health supervision (at all levels, including municipal care) into one legislative act. The Act has partly been enacted as of July 2019.
The municipalities have a great deal of freedom in organizing health services without a direct command and control line from the central authorities (Norwegian Ministry of Health and Care Services, 2015b). However, this freedom has been challenged by an increasing amount of regulations on how these services should be delivered (see section 6.1). The main task of the central government is to ensure the high quality of services across the municipalities through funding arrangements and legislation, such as through the Municipal Health and Care Act (2011). Each municipality must ensure that services are provided in a coordinated manner and that health care personnel have the necessary competences.
Hospitals and specialist care, organized at the level of the RHAs, are regulated mainly by the Specialist Care Act (1999) and the Health Authorities and Health Trusts Act (2001). The MOHCS annually provides instructions to the four RHAs, containing RHA-specific tasks and requirements. For example, the 2018 annual letter of instruction to the South-Eastern RHA contains information on the total budget placed at its disposal and some notes on specific uses of this allocation, including comments on the areas of services the MOHCS would like the RHA to focus more on in the coming year (e.g. waiting times, mental health, substance abuse and quality and patient safety).
Certain areas of care that span across organizational levels are regulated by separate legislation, for example, the Mental Care Act (1999) and the Public Health Act (2011). Other key pieces of legislation are the Patients’ Rights Act (1999) and the National Insurance Act (1997). The latter regulates financing and entitlement to certain nonmedical benefits, such as rehabilitation, and benefits received in case of sickness, maternity, disability or occupational injury.
RHAs, hospitals, municipal providers and private practitioners are themselves responsible for ensuring the quality of their services. There is no requirement for provider accreditation or reaccreditation, although some hospitals or hospital departments are accredited (see below).
The Specialist Care Act (1999) states that every hospital must have a quality assurance commission as part of its mandated system of internal control. The Municipal Health and Care Act (2011) includes a similar requirement for primary health care providers. Systematic quality assurance is a legal requirement for all institutions providing health and care services in Norway (Norwegian Ministry of Health and Care Services, 2016a) and supervision of providers is increasingly targeted at establishing whether systems of internal control have been implemented and are functional. The Board of Health is responsible for the Reporting System for Serious Adverse Events, which previously applied only to the specialized health services, but since the enactment of the Supervision of Health Services Act in 2019 it also applies to municipal health care services, as well as to dental care and all privately provided health care services.
From 2012 to mid-2019 the Directorate of Health operated the National Reporting and Learning System (NRLS), which collected reports from hospitals and other providers of specialized care (private and public) on serious medical events (e.g. unexpected deaths), as well as events that could have resulted in patient harm (i.e. near misses) caused by the delivery of health care or where injury was inflicted on one patient by another. The NRLS was discontinued in May 2019 (see section 7.5). Since then, the Norwegian Health Care Investigation Board (UKOM) has been established to investigate adverse events (see Table.21).
Table.21
The Municipal Health and Care Act (2011) gave the Directorate of Health sole responsibility to develop, disseminate and maintain national clinical guidelines. These guidelines provide normative guidance but are not legally binding. There are currently 400 guidelines for GPs, local health centres, nursing homes, hospitals, etc. (for very specific interventions). These are distributed to health care personnel in print and are also available online via the Electronic Health Library. The RHAs, municipalities and managers of health care institutions are responsible for facilitating the implementation of national guidelines.
Table2.3 provides an overview of the regulation of providers.
Table2.3
In 2017 the Regulation on internal control in health services was replaced with the Regulation on leadership and quality improvement in the health services and obligated the Directorate of Health to “work systematically with quality-improvement and patient- and clients safety in all services”, and to ensure documentation of planning, implementation, evaluation and corrective measures taken to improve quality and patient safety. These changes are also reflected in the new Action Plan for Patient Safety and Quality Improvement 2019–2023 (Norwegian Directorate of Health, 2019a).
The scope of the statutory coverage is determined by parliament as part of the public budget approval process (see section 3.3). Municipal authorities are responsible for providing health care and social care services at the municipal level. They assess needs and determine access to services. All residents are entitled to essential medical and care services. This entitlement is included in the legislation of the Patients’ Rights Act of 1999, the Municipal Health and Care Act of 2011, and the Specialist Care Act of 1999, as well as the National Insurance Act of 1997. There is no positive list of services covered by the statutory system; access is based on need, according to the principles of prioritizing (see Box2.1). Decisions on public coverage of specialist services are informed by health technology assessment (see below).
Box2.1
A system for health technology assessment (HTA) was originally established in 1998 and NIPH has been responsible for it since 2016. Initially, the goal of HTA was to assess the clinical effectiveness of new medical technologies for clinicians. With rising health expenditure, the importance of cost–effectiveness analysis increased and the user base of HTAs has expanded from clinicians to managers. Evidence-based policy-making has also been embraced at national level and in 2013 the National System for the Managed Introduction of New Health Technologies, the so-called “New Methods” system,[1] was established within the specialist health service. It is based on a broad cooperation between multiple agencies: the four RHAs, the Procurement Services for the RHAs, the Directorate of Health, NIPH, the Norwegian Medicines Agency (NoMA) and the Norwegian Radiation and Nuclear Safety Authority. A broader stakeholder group was established to support further development of the system. The secretariat was initially based at the Directorate of Health to coordinate the cooperation internally and externally, to build a website with information on all commissions and deliveries from the system, to monitor the introduction of new technologies and to promote the development and consolidation of the system. In 2018 the ownership of the system was transferred from the MOHCS to the RHAs.
The “New Methods” system has two levels: a national level where decisions are made jointly by the RHAs based on single or full HTAs prepared by the NoMA and the NIPH, and a local (i.e. hospital) level, where decisions are made based on rapid/mini HTAs performed in a single hospital. The level of assessment depends on the type of technology and its intended authorized area of use. For example, certain technologies, such as medicines, are always assessed at the national level. Single HTAs focus on one health technology whereas full HTAs may be used to compare various technologies that have been used in clinical practice for some time. The aim of rapid/mini HTA reports is to ensure that patients have fast access to new and effective hospital treatments and that treatments that are ineffective or dangerous can be quickly discontinued. Since late 2015, in order to optimize the introduction of new technologies, single HTAs have been conducted for all new drugs and indications and HTA reports are thus available soon after a marketing authorization has been granted.
Proposals for assessments can be submitted by specialist health care providers, patients and patient organizations, industry, authorities and the general public. In addition, horizon scanning reports can identify new technologies for assessment. Submitted national-level HTA proposals are discussed and prioritized by a Commissioning Forum (Bestillerforum) consisting of the four medical directors (one from each RHA) and two delegates from the Directorate of Health, based on submitted proposals and horizon scanning reports. Further, each hospital has procedures for selecting technologies for rapid/mini HTAs; the HTA results are public and the RHAs jointly decide which technologies to introduce. After a single HTA has been completed, the Procurement Services health trust (Sykehusinnkjøp HF) conducts negotiations. Subsequently, a Decision Forum comprised of the four CEOs (one from each RHA) makes decisions in consensus whether to introduce the technology or not. If the technology is of relevance for the national clinical guidelines developed by the Directorate of Health, the guidelines will have to be updated.
From the system’s introduction in 2014 to May 2019, 166 decisions on pharmaceutical and 30 decisions on other medical technologies have been made (Fig2.2). Even though there is no formal cost/effectiveness threshold, there is a de facto upper limit of cost/quality assessment that is used.[2]
Fig2.2
Between 2003 and 2016 the Health Agency Procurement Service (Helseforetakenes Innkjøpsservice, HINAS) established by the RHAs coordinated procurement of medical equipment among public hospital trusts. In 2016 HINAS became part of the Agency for Hospital Procurement Services, which took over this coordinating function. The rationale behind having a single agency in charge of all procurement agreements was that, through concentrated purchasing power, it would be able to achieve savings through better contractual terms. The common procurement policy is not applied to all purchases, but only to those that are large enough, in both monetary value and volume, to represent a possible gain if conducted on a national scale. The common procurement policy has since expanded beyond Norway, as part of cooperation with other Nordic countries.
The introduction of new medical technologies, including medical devices and aids, is evidence-based. This is ensured by the “New Methods” system (see subsection Health technology assessment above). Since 2018 the manufacturing and distribution of medical devices and aids have been supervised by NoMA (previously, the Directorate of Health had legislative responsibility in this area).
The MOHCS is responsible for the management and supervision of the production, import and distribution of medicines, with a particular emphasis on legislative and financial measures, including the reimbursement scheme for patients with medical expenses above a certain limit (see section 3.4).
NoMA is in charge of marketing authorization, classification, pharmacovigilance, pricing, reimbursement and providing information on medicines to prescribers and the public (see section 5.6). Since Norway is a member of the EEA, the regulation of pharmaceuticals is harmonized with the relevant EU regulations.
Pharmaceutical companies must apply for a marketing authorization in order to sell their products on the Norwegian market, and the system is aligned with the European Medicines Agency’s process. There are four procedures that may be used when applying for a marketing authorization: the national procedure; mutual recognition procedure; decentralized procedure; or centralized procedure. Within the national procedure, the application is filed with the NoMA and must contain information on the quality, safety and (medical) efficacy of the product. A marketing authorization will not be issued if the potential risks associated with using a product outweigh its potential benefits. Since 2012 the total time schedule for the national procedure has been harmonized with the decentralized procedure and is set at 210 calendar days (excluding “clock stops”). Authorization is valid for five years.
After market access has been granted within the national procedure, the applicant may apply, through the mutual recognition procedure, for the national authorization to be recognized in other EEA member states. The applicant may choose to seek authorization separately from all member states (decentralized procedure) or apply directly to the European Medicines Agency (centralized procedure).
The NoMA is responsible for the monitoring of adverse reactions of all medicinal products used in Norway. It also contributes to the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC). A pharmaceutical company that markets medicines in Norway (i.e. the marketing authorization holder, MAH) has the primary responsibility over the efficacy and safety of their medicinal products, and must ensure that it has an appropriate system of pharmacovigilance and risk management in place for those products. In order to fulfil these requirements, the MAH must ensure that all information relevant to assessing the potential risks and benefits of their products is periodically reported to the authorities through periodic safety update reports (PSURs) and continuously through expedited reporting of individual case safety reports (ICSRs). According to the 1992 Medicinal Products Act, physicians and dentists must also report adverse drug reactions to the NoMA. In 2017 the NoMA established a new national pharmacovigilance database, VigiNor. This database is compatible with the EudraVigilance system of the European Medicines Agency.
Norway is a signatory of the 1994 Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which regulates pharmaceutical patent protection between signatory countries. Patent protection is normally granted for 20 years in Norway, which is the same as in the EU. Patents can cover: the active substance; how the active substance is produced; medical preparation (when the active substance is not new but the application is); and new medical uses (i.e. new indications) for existing drugs and formulations (e.g. tablets). A generic product cannot be put on the market if the patent has not expired (even if the market authorization period has expired).
The advertising of pharmaceuticals is regulated by the Medicinal Products Act (1992) and is monitored by the NoMA. Direct advertising to patients, including advertising on the Internet, is only allowed for over-the-counter (OTC) pharmaceuticals. Promotion of OTC drugs within and outside pharmacies is restricted and staff handling these medicines are prohibited from marketing the products and giving any recommendations (except for generic substitutes). Advertising to health care professionals is allowed, but cannot be combined with handing out objects, gifts, services, awards or other items of economic value. Any supply of free medicine samples to doctors is strictly regulated.
The activities of pharmacies are regulated by the Pharmacy Act and related regulations. The Act liberalized the pharmaceutical market in 2001 by removing some of the limitations on the ownership of pharmacies, but the requirement that pharmacies must be run by a pharmacist was retained. Manufacturers of medicinal products and persons with the right to prescribe medicinal products cannot be granted a pharmacy licence. In addition, the limitations on establishing new pharmacies were removed. Since then pharmaceutical wholesalers have taken over the majority of private pharmacies – 84% in 2017 (Norwegian Pharmacy Association, 2018). Pharmacy chains are allowed.
Each pharmacy must have two separate licences: one licence to own the pharmacy (the proprietor’s licence) and the other to run the pharmacy (the operating licence). Only pharmacies or medicinal outlets (controlled by pharmacies) may carry out the retail sale of pharmaceutical products requiring prescription. The first online pharmacies selling prescription drugs were established in 2016, after a change in regulation, and the NoMA publishes a list of approved online pharmacies on its website. Online pharmacies must offer all medicines approved in Norway, with the exemption of pharmaceutical products with specific requirements for storage and delivery (such as temperature). Online pharmacies must meet the same safety regulations as traditional pharmacies, and must be registered with the NoMA.
Generic substitution has been allowed in Norway since 2001. Pharmacies are not allowed to substitute therapeutically (i.e. to dispense a medicine with equal therapeutic benefits, but with a different active ingredient) nor to substitute biological medicinal products with biosimilar products. The NoMA evaluates new medicines on the Norwegian market in terms of their interchangeability and publishes a “substitution list”, which is updated monthly. In recent years there has been an increase in the use of biosimilar medicinal products in Norway. For example, biosimilars such as Epoetin and Anti-Tumour Necrosis Factor (Anti-TNF) had more than 80% of the market share (in terms of volume) in 2015 (OECD, 2017).
The EU Falsified Pharmaceuticals Directive 2011 / 62 / EU was adopted into Norwegian legislation and became effective in October 2015. While importing pharmaceutical products from the EU or the EEA for private use was previously permitted, all personal imports of prescription pharmaceuticals are now prohibited, except for special cases where an import permit has been granted (e.g. for people who come to Norway for a temporary stay). The purpose of the strict regulation is to prevent incorrect use and to protect consumers from illegal products. Private import of OTC products authorized in Norway is still permitted, subject to certain rules (for example, the imported quantity must not exceed three months’ personal use). Private import of homoeopathic medicines from the EU is permitted. Counterfeit pharmaceuticals rarely appear on the Norwegian market (Weltzien, Kjendlie & Gaarder-Olsen, 2017).
Manufacturers’ prices are not regulated and wholesalers are free to negotiate mark-ups with the manufacturers. The NoMA is responsible for setting maximum pharmacy purchase prices. Suppliers of prescription medicines must apply for a maximum retail price, whether or not they are seeking reimbursement for the product. Medicines can only be sold at or below the maximum retail price level. An international price referencing system has been used since July 2002 to set maximum prices for both new and existing medicines. Prices are based on the average of the three lowest pharmacy purchase prices in Austria, Belgium, Denmark, Finland, Germany, Ireland, the Netherlands, Sweden and the United Kingdom. If a medicine is marketed in fewer than three of the reference countries, the mean price is taken of the countries where a market price exists.
Pharmacy mark-ups for prescription products (both reimbursed and non-reimbursed) are fixed at 2.0% for all medicines. There is also a flat rate add-on of NKr 29 (€3) per pack, plus value added tax (VAT) of 25%. An additional add-on of 0.5% is applied to products which require refrigeration.
Generic prices cannot exceed the maximum market price of the original branded product. In 2005 a stepped price model was implemented in order to reduce public expenditure on generic drugs covered by Helfo. Under this scheme, a maximum reimbursement price is set for both branded and generic pharmaceuticals included in the scheme. The maximum reimbursement price level is automatically reduced (in steps) following patent expiry. The size of these reductions depends on annual sales prior to the establishment of generic competition and time since competition was established. There is no regulation of pharmacy mark-ups within this stepwise price system. Pharmacies therefore have a financial incentive to carry out generic substitution and to dispense the cheaper product. Since 1995 prices of OTC medicines have not been regulated.
Reimbursement decisions for medicines used outside hospitals are made by the NoMA. When applying for reimbursement, pharmaceutical companies need to follow the guidelines for the submission of documentation for single technology assessment of pharmaceuticals. Cost–effectiveness analysis is well established in Norway and the use of QALYs as a parameter has been increasing. No maximum payment threshold per QALY has been defined. For products associated with a substantial cost to the public budget, decisions on reimbursement are taken by the MOHCS. Helfo decides on reimbursement for individual patients for pharmaceuticals without general reimbursement or indications not covered by general reimbursement (Schedule 3 in Table2.4).
Table2.4
There are three reimbursement categories for pharmaceuticals (see Table2.4). Schedule 2 (the so-called “blue list”) is de facto a “positive list” which lists medicines that may be publicly reimbursed for specified diagnoses (see also section 3.3.1).
In 2006 the H-prescription scheme was established for medicinal products that can be administered by the patients themselves (medicines prescribed in the hospital but for outpatient use), but where the expenses are covered by the RHAs. The scheme builds on a solution involving direct payment between a pharmacy and a health trust (hospital). The patient receives the H-prescription and can pick up the medicinal product from the pharmacy of his/her choice. From 2014 cancer medicines have been included in the H-prescription scheme. Effective from 2018, medicines for treatment of HIV and hepatitis B and C have also been transferred from the blue list to the H-prescription scheme. In 2019 a number of orphan drugs were included.