Healthcare Resource Guide: Finland

 

Finland Statistics

http://www.mapsofworld.com/flags/finland-flag.html

Summary
Market Entry

Current Market Trends

Main Competitors

Current Demand

Registration Process

Reimbursement
Barriers

Trade Events

CS Contact

Best Prospects
Market Size

Capital: Helsinki

Population: 5.5 Million

GDP: $236.8 billion (2016)

Currency: Euro

Language: Finnish (92%), Swedish (5.5%), Others (2.5%)

Summary                              

In Finland in 2016, overall social protection expenditure amounted to 32% of GDP ($81.70 billion) while the sickness and health sector accounted for 22.40% ($18.30 billion) of GDP. Universal coverage is accessible for all citizens and permanent residents in the country, with a range of comprehensive health services delivered primarily by publicly owned and operated providers. In 2016, approximately 80% of services and programs within the system were funded through public expenditure. Private financing accounted for 20%.

Due to changing demographics in Finland and the globalization of the economy, the Finnish Government is preparing a Health, Social Services and Regional Government reform that is planned to be put into operation by 2019. The aim of the reform is to form larger units from the service providers, and to create full horizontal and vertical integration of primary and secondary levels of service and of health and social care. The reform is expected to change the traditional structure of primary healthcare significantly. The Ministry of Social Affairs and Health (STM) manages the preparation and implementation of Finland’s social welfare and healthcare policy. Additionally, STM mandates and organizes programs and reforms regarding healthcare provisions. The Finnish Office for Health Technology Assessment (FinOHTA), which operates under the National Institute for Health and Welfare (THL), is the agency responsible for providing assessments and analyses related to HealthIT. Finland’s 311 municipalities are legally obligated to provide healthcare services for their residents (i.e. primary, secondary and tertiary healthcare), as well as to collect taxes for the financing of services provided. They accomplish this through local municipal healthcare centers, or by regional healthcare districts, of which there are 20. Municipalities can purchase services from other hospital districts, the private sector or from abroad. These districts provide secondary care specialists, who are only available through a referral from a primary provider. The districts are also responsible for providing ambulance services. Hospital districts vary in size, with the smallest covering about 44,000 residents and the largest covering about 1,580,000 residents.

Municipalities contract a small proportion of primary care to private providers; however, that proportion is expected to increase. There are about 40 private hospitals which provide approximately 5% of hospital care in Finland. Private healthcare, excluding occupational services, accounts for about 6% of total healthcare expenditures. In these districts, university hospitals in the major cities of Finland form the basis of tertiary care and contain the most technologically advanced facilities and medical equipment in the nation. All levels of healthcare are funded by the municipalities, but the national government covers the cost of medical training and participates in financing by providing a general, non-earmarked, subsidy to the municipalities.

High-quality and technically sophisticated medical equipment has market potential in Finland, especially equipment that increases efficiency and reduces occupancy rates in hospitals. Finland also produces high-technology medical equipment. Increasing competition in the market is expected as local production expands. Direct imports from the United States accounted for 8% in 2017. However, local production and imports usually do not compete.

Market Entry

As a member of the European Union (EU), Finland’s local legislation concerning medical devices complies with EU directives. The National Supervisory Authority for Welfare and Health, Valvira, monitors the compliance of medical devices with legislation and regulations, monitors the marketing of medical devices and promotes their safe use. For more information, visit: www.valvira.fi/en/licensing/medical_devices.

See http://ec.europa.eu/growth/sectors/medical-devices/index_en.htm for further information from the European Commission, Enterprise and Industry, Medical Devices.

Medical trade is duty-free within the EU. Import duties are collected from production coming from non-EU countries. Duties assessed on medical equipment imported from the United States vary by product, ranging from 5-12%.

Current Market Trends

The operating budgets of Finnish public hospitals have been reduced, and major hospital procurement is focused primarily on replacing older equipment. In the private healthcare sector, investments in new medical equipment are expected to continue to increase.

In 2017 Finnish exports of health technologies increased by 5% to $2.22 billion. These numbers make Finland one of the few European countries that export more health technology than they import. Exports to the United States accounted for 39.9% of all health technology exports and remained essentially unchanged in comparison to 2016. Health technology is Finland’s largest tech sector representing nearly half of all high-tech exports and have increased at an average annual rate of 9% for the last two decades.

Medical equipment is Finland’s fastest-growing high-tech export sector. Over the last decades, the value of health technology exports has increased more than five-fold. In 2016 exports of medical equipment grew to over 11.8% to approximately $1.49 billion. In general, the market for health technology is expected to rise, but due to the upcoming healthcare reform and the prevailing uncertainties related to it expenditures are expected to slow down a little bit for the next couple of years.

Finnish medical personnel are very technology literate, and Finnish hospitals are very eager to try out the latest technology in the implementation of the most modern treatment methods. Local distributors provide the market with equipment packages and maintenance programs.

Finland is very advanced in its use of IT systems within the healthcare industry, relative to other European nations. According to the European Commission, Finland ranks 5th in terms of the deployment of Health IT within the EU. Individuals within the healthcare system have widespread, simple access to convenient ePrescription and eArchive services via KanTa (The Finnish Electronic Patient Record system). This allows citizens to access their medical records and to gain access to the Picture Archiving and Communications System (PACS), which allows them to see and send relevant information within the healthcare system. The use of electronic patient records among primary health centers and secondary care hospital districts is at 100% and mandatory for all public healthcare providers. Due to the continuous development of MyKanta pages, citizens’ use of e-health and e-welfare services is expected to rise rapidly in the future.

Finland’s capital Helsinki has launched a project in the social services and healthcare field, called Apotti, with the aim of building a regionally cohesive social services and healthcare system. The integration of information systems is unique and Apotti is serving as something of a pioneer on an international scale, as it provides information about the amount, quality, impact and cost/efficiency of treatment. The first deployment will be in the fall of 2018, in one of the big hospitals in the city of Vantaa.

Another prominent current project in the social services and healthcare field is the nationwide UNA project. Its goal is the renewal of social services and healthcare information systems implemented in stages. Together with the national Kanta services, UNA will form the core of the nationwide social services and healthcare information ecosystem. The project will be executed in a close co-operation with the actors of the Health, Social Services and Regional Government reform.

Main Competitors

Imports of health technology products rose 5.5% to $1.42 billion in 2017, the majority consisting of medical equipment. Over 80% of the medical equipment imported to Finland comes either from or through the EU. Direct imports from the United States account for 8%. Other important external supplier countries are Germany, the United Kingdom, Australia, Japan, and China.

Locally produced healthcare products (primarily medical equipment and pharmaceuticals) are well known for their quality and technological sophistication. In medical equipment, local Finnish companies are the biggest competitors for U.S. companies, with strength in dental equipment and specialized X-ray and IVD equipment. In pharmaceuticals, U.S. companies will find competition both from local Finnish companies like Orion, and from the Finnish production operations of global competitors like German Bayer, Japanese Santen, and even other U.S. firms like Pfizer.

Current Demand

High quality and technically sophisticated U.S. medical equipment has excellent market potential in Finland, especially equipment that increases efficiency and reduces occupancy rates in hospitals. Best prospects for U.S.-made medical equipment are in electronic medical records (EMR’s), X-ray equipment, patient monitoring systems, mini-invasive surgery, video endoscopes, digital image processing, and picture archiving. In regard to pharmaceutical products, Finland offers outstanding opportunities for drug target discovery, clinical research and Real-World evidence.

Another trend in the market is mobile health services (mHealth). As mHealth is a rather new phenomenon in the market, a common infrastructure software is currently missing. Finland offers the third best market prerequisites for the mHealth business among the EU countries. Telemedicine in Finland is expected to gain even more presence because of the continuous improvement of healthcare systems. And, as the population ages rapidly, demand for elderly care services and products is expected to grow.

Registration Process

Manufacturers must include contact details and information on the products they manufacture for the product register maintained by Valvira, the National Supervisory Authority of Welfare and Health registry, in the case the manufacturer:

  • Places medical devices on the market in its own name
  • Puts together systems and procedure packs to form medical devices for placing these on the market in its own name
  • Sterilizes systems, procedure packs or medical devices bearing a CE marking.

Representatives established in Finland must submit the same details.

Extra notification is necessary if the medical product is high-risk and includes IVDs intended for self-testing and if the device contains substance(s) of human origin.

To submit the notification, the party must be:

  • Entitled to represent the company
  • Authorized manufacturer’s representative
  • Or responsible for placing the product on the market

Notification of the cases mentioned above must be submitted within two weeks before placement on the market. This time limit applies also to the start of importing of self-testing devices.

Reimbursement

Products that are imported to the market need to fulfill the requirements set by legislation and controlled by Valvira. The manufacturer needs to give the declaration of conformity and make sure the imported products have a CE label. Valvira also requires the manufacturer to be able to present the necessary documents of the product and to prove that the usage complies with healthcare industry regulations. If these requirements are not met, the product cannot be imported to the Finnish market.

Barriers

There are no restrictions on imports in Finland, so long as they comply with EU requirements. Although marketing requires thorough knowledge of end user needs, the import climate is receptive to equipment that is new and of excellent quality. The market is very competitive.

Procurement & Tenders

Most purchasing of health technology and medical equipment is conducted by public procurement through national boards, agencies, centers, and offices executing charters from the central government. The government’s central procurement office, Hansel, Ltd, handles framework agreements. Finland is a party of the WTO Government Procurement Agreement, which means that U.S. companies can bid on goods to specified government entities on large contracts on an equal footing with Finnish firms. For more information: https://www.hansel.fi/en/

HILMA is a free electronic database, run by the Finnish Ministry of Economic Affairs and Employment, for actors to announce their upcoming procurements. The database also offers companies the possibility to get information of the ongoing tenders. All public companies, public authorities and the Lutheran and Orthodox Church are obligated to announce their tenders when the value exceeds a certain limit. For more information (only in Finnish and Swedish): https://www.hankintailmoitukset.fi/fi/docs/kynnysarvot/

When the tender exceeds the EU limit, it should also be announced at TED (Tenders Electronic Daily), the online version of the “Supplement to the Official Journal” of the EU, dedicated to European public procurement. Altogether some 460,000 calls for tenders are published per year via TED, for value of about 420 billion euro. Every day, approximately 1,700 public procurement notices are published on the database.

Trade Events

Finnish Dental Congress and Exhibition, November 22-24, 2018 (Finland’s largest event for dentistry professionals) http://www.hammaslaakaripaivat.fi/Apollonia/wwwhml.nsf/sp?open&cid=etusivu

The Finnish Medical Convention and Exhibition, January 9-11, 2019 (Finland’s largest medical exhibition) https://laakaripaivat.messukeskus.com/whats-on/?lang=en

FAQs

1. Is the CE mark enough to export a medical device to Finland?

No. Before placing a new product on the market, medical devices are required to have markings and instructions that ensure their safe use. The National Supervisory Authority for Welfare and Health Valvira monitors the compliance of medical devices with the legislations and regulations, monitors the marketing of medical devices and promotes their safe use. Till the end of October 2009 these tasks were carried out by the National Agency for Medicines. As a rule, the device must bear the CE marking that indicates conformity with the requirements.

2. What are the labeling/marking requirements on medical devices in Finland?

Mandatory information must be provided in Finnish, Swedish or English. Information intended for users or patients to safely operate a device must be in both Finnish and Swedish. Necessary information, such as name of the product and manufacturer, must be clearly marked on the retail packaging or marked on the product (a sticker, label, etc.). Labeling and marking requirements in Finland are based on the Act on Product Safety, which was enacted in accordance with the EU directive on general product safety. When applicable, information should be provided to secure safe use of a consumer product, such as instructions for use and storage and warning labels. CE marking is required across the European Union.

3. What are the major sales channels in Finland?

The principal sales channels for medical devices, served by diverse group of distributors, are for the private and public hospitals/clinics and for the pharmacies/orthopedic shops.

U.S. Commercial Service Contact Information

Name: Ms. Tiina Ketelä-Juvonen

Position: Commercial Specialist

Email: tiina.ketela@trade.gov

Phone: +358 9 6162 5278

Best Prospects

  • Electronic Medical Records (EMR)
  • Patient monitoring systems
  • Mini invasive surgery (MIS)
  • Magnetic resonance imaging (MRI) equipment
  • Video endoscopes
  • Digital image processing
  • Picture archiving
  • Drug target discovery

Market Size

Healthcare spending (including investment)

$22.9 billion (2015)

as percent of GDP

9.4% (2015)

of which spent on inpatient services (including long-term care)

$6.8 billion (2015)

of which spent on pharmaceuticals/consumables

$3.5 billion (2015)

of which spent on investments

$1.2 billion (2015)

of which spent on outpatient services

$6.8 billion (2015)

Hospitals, Procedures, Healthcare Professionals

Number of hospitals

212

Public

176

Private

36

Number of hospital beds

23,854 (2015)

…available beds per capita

435/100,000

…of which in general hospitals

20,033

…of which in specialized clinics and rehabilitation centers

3,821

Number of surgical procedures

8,850/100,000 (2014)

of which [Cataract surgery]

1,040.3/100,000 (2015)

of which [Transluminal coronary angioplasty]

218.5/100,000 (2015)

Physicians

20,970 (2016)

...of which surgeons

1,653 (2016)

...of which internists

1,159 (2016)

...of which pediatricians

513 (2016)

Dentists

4,500 (2017)

Demographics

Population

5.5 million

Life expectancy men/women

78/84.1 (2017)

Infant mortality

2.5/1000 live births (2017)

Percent of population older than 65

25.9% (2015)

…projection, 2030

31.1%

Annual deaths

54,000 (2017)

...caused by [circulatory system diseases]

37%

...caused by [neoplasms]

22%

Prevalence of [Alzheimer’s disease]

30.3% increase 2005-2015


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