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Executive Summary
Sweden’s healthcare system is one of the best and most well-developed in the world. The population of 10 million enjoys very good health overall. Sweden spends about 11% of its Gross Domestic Product (GDP) on health and medical services, which is on par with most other European countries. The infant mortality rate is less than 2.6 deaths per 1,000 in the first year of life and the average life expectancy is 80 years for men and 84 years for women. As Sweden has a population that is one of the oldest in the world (20.37% are 65 years or older), there will be an increasing demand for medical equipment and supplies, as well longer-term medical treatments, to meet the health needs of an aging population.
The responsibility for health and medical care in Sweden is shared by the central government, the regions, and the municipalities. Sweden is divided into 290 municipalities and 21 regions. The regions have the primary responsibility for providing health and medical services. They decide on the allocation of resources to health services and are responsible for the overall planning of the services offered. It is also the regions that own and run the hospitals, health centers, and other institutions. Regions are responsible for dental care for residents up to the age of 23. The 290 municipalities are responsible for the disabled, home healthcare of the elderly, and nursing homes. They are also responsible for providing care for people with psychological disorders, support and services for people released from hospital care, and school healthcare. Private healthcare, accounting for 12% of total healthcare costs, mainly offers primary care, such as healthcare centers or homes for the elderly.
There are 100 hospitals in Sweden, of which about 85 are run by regional governments; the remainder are private. Seven of these 85 are regional university hospitals offering highly specialized care and where teaching and research is based. There are about 46,000 licensed physicians and 106,000 registered nurses in Sweden, most are employed in the healthcare sector. Outpatient care is organized into primary care districts, each with 5,000 to 50,000 inhabitants.
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Market Entry
To successfully enter the Swedish market, it is recommended that firms from the United States (U.S.) establish a local presence, either through local agents, distributors, or sales subsidiaries. All products sold in Sweden must carry the CE mark. In addition, all labeling and instruction manuals must be translated into Swedish.
Sweden’s customs laws and regulations follow those of the European Union (EU). As such, Sweden applies external EU tariffs to imports from the U.S. and other non-EU countries. Goods imported to Sweden are also subject to a value added tax (VAT) of 25%. Sweden uses the metric system and products sold in Sweden should be adapted for use with the metric system whenever possible. Electric current in Sweden is 50 Hz, AC 230V single-phase and 230/240V three-phase.
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Current Market Trends
The two main factors that are expected to have strong effects on the Swedish healthcare system in the future are:
- An aging population, which is likely to lead to increased demand for healthcare products as well as healthcare related services such as equipment and supplies for the home healthcare sector.
- Lifestyle related diseases and conditions such as diabetes, being overweight, etc.
Of the predominant diseases, the main causes of death are cardiovascular conditions including strokes (35%) and cancer (26%). Chronic diseases that require monitoring and treatment, and often life-long medication, place significant demands on the system.
The incidence of smoking, however, has been falling in Sweden since the mid-1980s. According to a European Union survey, only 9% of people smoke daily, the lowest proportion among all EU member states.
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Best Prospects
Best prospects and current demand for U.S. exporters include:
- e-health and other areas of healthcare-ICT interaction such as telemedicine and m-health; and
- medical equipment.
e-Health
The Swedish government launched a national strategy for e-health in 2006, updated in 2010, which emphasizes that information and communication technology will be used as a strategic tool at all levels in the healthcare sector. It also states that “citizens must also be able to contact care services via the internet for assistance, advice or help with self-treatment.” In 2017, for continued development work in the field of e-health, the Swedish government and the Swedish Association of Local Authorities and Regions endorsed a common vision for e-health by 2025. The vision replaced the latest strategy from 2010 and will continue to build on the ideas and approaches to make use of the opportunities of digitization in social services and health care. The vision states that “in 2025, Sweden will be best in the world at using the opportunities offered by digitization and eHealth to make it easier for people to achieve good and equal health and welfare, and to develop and strengthen their own resources for increased independence and participation in the life of society.”
Today, e-health is an integrated part of the healthcare sector. Swedish County Councils spend about SEK 10.6 billion ($1.2 billion) annually in healthcare IT, of which SEK 8 billion ($0.9 billion) is used for the procurement of services, software, equipment, and supplies. It is estimated that 95% of all documentation in primary care is made in electronic healthcare records (EHRs), while the corresponding figure for specialized hospital care is estimated at 69%. E-prescriptions have become very popular, and it is estimated that 99% of all pharmaceutical prescriptions in Sweden are issued electronically.
Medical equipment
According to Business Monitor, the Swedish market for medical equipment is estimated at $2.6 billion in 2019, and Sweden ranks as the third most attractive market in Western Europe in which to commercialize a medical device. For the coming years, the market is expected to show a moderate growth, around 4.8% per annum. Domestic production is strong in areas such as wheelchairs, hospital furniture, sterilizers, and blood pressure monitors, and Swedish innovations such as the pacemaker, hemodialysis, and the gamma knife have gained international recognition. As most of the domestic manufacture is for export, the medical equipment market is dependent on imports. In 2017, imports were estimated at $1.7 billion. The best sales potential for U.S. manufactured medical equipment is expected to be in the following areas:
- Non-invasive surgical equipment
- Orthopedic and prosthetic equipment
- Home healthcare – equipment and supplies
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Market Size
Hospitals, Procedures, Healthcare Professionals
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Number of hospitals
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100
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2017
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…Public
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85
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2017
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…Private
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15
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2017
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Number of hospital beds
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23,207
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2016
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… available beds per capita
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2.32 per 1,000 people
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2016
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…of which in general hospitals
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N/A
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|
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…of which in specialized clinics and rehabilitation centers
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N/A
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|
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Number of surgical procedures
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2,882,104
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2015
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…of which minor surgical procedures
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532,136 (18.5%)
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2015
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…of which transluminal endoscopic surgery
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456,869 (15.9%)
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2015
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Physicians
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46,295
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2015
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…of which surgeons
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2,005
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2015
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…of which internists
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4,168
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2015
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…of which pediatricians
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1,701
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2017
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Dentists
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5,150
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2017
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Note: The number of physicians and dentists refer to the total number licensed practitioners not older than 65.
Sources:
Hospitals and beds: Swedish Association of Local Authorities and Regions (SKL). https://vardenisiffror.se/hospitals. https://skl.se/ekonomijuridikstatistik/statistik/ekonomiochverksamhetsstatistik/landstingekonomiochverksamhet.1342.html.
Procedures and professionals: The National Board of Health and Welfare. http://www.socialstyrelsen.se/publikationer2016/2016-10-15. http://www.socialstyrelsen.se/statistik/statistikdatabas.
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Demographics
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Main Competitors
In the e-health sector, there are few service providers that dominate the market. Five suppliers (Cerner, Evry, Cambio, CombuGroup, and Norbotten County Council) have a 97% share of all users among their eight systems.
For medical equipment, domestic production is strong (wheelchairs, hospital furniture, sterilizers, and blood pressure monitors) and the medical device sector is one of the leading export sectors in Sweden. Some of the internationally known Swedish medtech companies include Getinge (medical systems, extended care, and infection control), Molnlycke Healthcare (single-use surgical and wound care), and Elekta (the Leksell Gamma Knife). Major global companies with a strong presence in Sweden include GE Healthcare, Baxter, Fresenius, Philips, Abbott, Thermo Fisher, Johnson & Johnson, Siemens, and Nobel Biocare.
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Registration Process
The Medical Products Agency (MPA) is the Swedish national authority responsible for regulation and surveillance of the development, manufacturing and marketing of medical devices, drugs and other medicinal products. The Medical Products Agency can be reached at www.lakemedelsverket.se.
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Reimbursement
Capitation is a reimbursement form that is applied to a large portion of the primary care activities in Sweden. This entails a fixed capitation for the healthcare provider, received per patient registered at the primary care center, regardless of whether the patient seeks treatment or not.
Outpatient specialist care providers are reimbursed through payment per treatment (tariffs). The tariffs can be either fee-for-service, i.e. the provider receives remuneration whenever the patient seeks treatment, or bundled payments whereby the provider is reimbursed for a full care episode independently of the number of care contacts.
Global budgets or a mix of global budgets, diagnosis-related groups (DRG), and performance-based methods are used to reimburse hospitals. Two-thirds or more of total payment is usually in the form of budgets, and about 30% is based on DRGs.
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Barriers
There are no significant trade barriers to U.S. medical devices.
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Procurement and Tenders
Public tenders above specific contract values are published in the EU database TED
https://simap.ted.europa.eu/web/simap/european-public-procurement.
Sweden has no public database listing contracts with lower values. Instead, listings of procurements are provided via private sector databases. The major firms providing these are listed on the National Agency for Public Procurement webpage
http://www.upphandlingsmyndigheten.se/leverantor/forbereda/hitta-affarsmojligheterna/.
All public tenders regarding provision of private healthcare services are published at
https://www.valfrihetswebben.se.
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Government and Association Links
Web Resources
Government health plans
Government agencies and regulators, trade associations:
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FAQs
1. Do Medical products exported to Sweden need to be authorized/registered before being marketed and sold?
Medical devices on the Swedish market need to be registered with the Medical Products Agency.
For manufacturers of medical devices, it is also important to note that that labelling and instructions (user’s manual, display, voice etc.) must be written in Swedish. This applies both when the device is being used by a patient or by trained staff and if the device is used in a hospital or in private. For certain devices it is also necessary that an assessment is carried out by a third party called a Notified Body to demonstrate that the device complies with the requirements.
Medicinal products can also be sold in Sweden only after being authorized/registered by the Swedish Medical Products Agency. This applies to products exported from the USA, but also to medicinal products that may already be on the market in other EU countries. All medicinal products need authorization from the Swedish Medical Products Agency. Furthermore, a product being sold as a food supplement elsewhere may be classified as a medical product in Sweden.
2. What are some specific market access issues to think about regarding Sweden?
With Sweden’s healthcare system being very decentralized with 21 county councils in charge both of primary and specialized care, it can be difficult to find and keep track of all ongoing procurements. Much of the information in the tenders is often also communicated only in Swedish. The best approach for companies new to the Swedish market is to work with suitable local distributors. It is also recommended to visit and attend trade shows to get acquainted with the market.
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U.S. Commerial Service Contact Information
Name: Johan Bjorkman
Position: Commercial Spercialist
Email: Johan.Bjorkman@trade.gov
Phone: +46 (0) 8-783-5356
