Health and medical to Belgium
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Trends and opportunities

The market

Belgium is a member of the European Union (EU) and has a population of approximately 10 million people. Its gross domestic product (GDP) per capita is similar to Australia’s GDP per capita, which is approximately US$32,000 (calculated using purchasing power parity). Belgium's total annual healthcare expenditure is US$33.6 billion, which is approximately nine per cent of GDP.


The government is committed to restraining health expenditure growth to 4.5 per cent (in real terms) per year until 2009. From 2010, the real growth target for health expenditure is 2.8 per cent annually. The government is very aware of the effect on the Belgium economy between 2010 and 2040 of its aging population.


The government is very aware of the effect its aging population will have on the Belgium economy between 2010 and 2040. Social security policy and healthcare policy are driven by the preparation for the pressure that will be placed on government budgets during this period. It is estimated that in 2030, 30 per cent of the population will be aged over 60 years, up from the current figure of 22 per cent.


In Belgium, medical services are organised at three levels:


There is currently an oversupply of GPs and specialists. This has contributed to over-servicing and a lack of promotion of self-medication and over-the-counter medicines. House calls are very common in Belgium.


In Belgium, as in other European countries, around 90 per cent of the population is covered by a statutory health insurance system. The system of healthcare providers and insurance funds is administered at national level by the National Institute for Health and Disability Insurance – L'Institut national d'assurance maladie invalidité (INAMI) in French and het Rijksinstituut voor ziekte- en invaliditeitsverzekering (RIZIV) in Dutch.


The reimbursement process is subcontracted to health insurance mutuals.


Reimbursement is generally around 75 per cent of the total cost of doctors’ fees, medication and public and private sector hospital bills. With more serious conditions, such as heart problems or cancer, up to 100 per cent of the total medical bill may be reimbursed.

Medical services represented 85 per cent of overall expenditure. Pharmaceutical products, medical appliances, and equipment account for the remaining expenditure.


Government reforms within the past few years have targeted several areas, including:


Belgian governments have increased efforts to move patients out of hospitals and healthcare facilities and expand home healthcare. Home care services are provided by organisations such as the White-Yellow Cross – a private non-profit organisation that is the largest provider of nursing home services and home-nursing services in Belgium.
Opportunities

Despite being one of the smaller European countries, Belgium has a comparatively strong medical device market with a straightforward reimbursement system.

In Belgium, all medical procedures and devices are reimbursed on the basis of inclusion on a national list, the Nomenclatur.

INAMI/RIZIV, in conjunction with the Federal Ministry of Public Health, Food Chain Security and the Environment, decides which new procedures and devices are to be admitted for reimbursement and the level of that reimbursement. This makes Belgium one of the few European countries with a completely centralised reimbursement system leaving relatively little leeway for the individual medical practitioner.

Despite the introduction of these stricter controls, the pharmaceutical sector in Belgium is continuing to post healthy results. The Belgian Pharmaceutical Industry Association (AGIM-AVGI), reports that industry revenues have increased by over 6.5 per cent per annum in the past two years.

Competitive environment

Belgium produces less than 15 per cent of its overall demand for medical equipment. Most imports come from the USA and other European Union member states such as France, Germany, Great Britain and Sweden.


The Belgian Government supports the medical community in its procurement efforts by subsidising the purchase of medical equipment. Hospitals are entitled to subsidies from both the federal government and the regional governments of Wallonia, Flanders and Brussels. Subsidies are determined separately within each region, and the amount of the subsidy can vary from year to year depending on the budgetary situation of that particular region. For certain investments in medical equipment, subsidies cover 50–60 per cent of the investment.


The European single market has helped to strengthen the market share of European imports into Belgium by removing trade barriers and encouraging the free flow of goods and services between member nations. Also, timely after-sales service is key purchase-criteria for Belgian buyers, and the geographic proximity of European suppliers allows them to more easily service this demand.


In the pharmaceutical sector in Belgium, sales have become increasingly influenced and driven by international companies. All the large pharmaceutical multinationals have a presence in the Belgian market.
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Tariffs, regulations and customs

Australian companies looking to export healthcare supplies and equipment to Belgium should be aware that domestic prices for these products are determined by the Ministry of Social Affairs, Public Health and the Environment. Prices are based upon existing products and/or comparable products currently in the market. This fixed pricing can vary profitability on products when there are exchange rate fluctuations.


Australian companies wishing to distribute products that are implantable, sterile or destined for birth control must be licensed by the Belgian Ministry of Health. In addition, Belgium requires that all prices be registered with the Ministry of Economic Affairs.


On 1 January 1999, European Union (EU) authorities, along with the Australian Government, signed a Mutual Recognition Agreement (MRA). The effect of this agreement is a harmonised approach to testing and certification of medical equipment. In the case of Australian exporters, this means compliance with the requirements of the relevant European Commission (EC) Directives (or regulations) can be established in Australia and the CE marking applied to the product prior to export.


The CE mark, (although not officially, the CE letters come from the French for European Conformity) communicates that the product is certified as meeting designated EU standards.


After receiving the CE mark, a company exporting medical equipment to Belgium must select a local representative responsible for the handling of claims that may arise from the malfunctioning of the product. The representative can take any of the following three forms:


All of the above must have an official and effective address in Belgium.


Once the CE mark has been granted and a representative has been selected, the medical device can than be distributed throughout all 25 of the member states of the EU. The following non-EU countries also follow the EU regulations regarding the marketing of medical equipment: Iceland, Liechtenstein, Norway and Switzerland.


Belgium’s Federal Ministry of Social Affairs, Public Health and the Environment dictates that patients have access to medicinal products that are safe, efficient, correctly used and compliant with the regulations. Before being put on the market, medicines are subject to a marketing authorisation, granted either by:.




The standard rate of the value added tax (TVA/BTW) in Belgium is 21 per cent, with rates of 6 per cent and 12 per cent applied in some circumstances. TVA/BTW is applied to imported and domestically produced products. In contrast to other European countries, Belgian hospitals are obliged to pay TVA/BTW on all purchases.


Import duties and the TVA/BTW are applied to the cost, insurance, and freight (CIF) value of goods. Goods imported from EU-member states and the European Free Trade Association (EFTA) countries do not attract import duties, unlike goods imported from countries such as Australia.


As the health and medical sector covers a large range of products, import duties applicable for specific products need to be established on a case-by-case basis.


Austrade can assist Australian suppliers in understanding the application of tax and custom regimes to their activities.
Industry standards

As Belgium is a member state of the European Union (EU), products sold there must comply with EU regulations and standards.


The EU Medical Device Directive (MDD) refers to quality control procedures, which form the key components of the certification process. The specific reference is the EN 29000 series, which is the European transposition of ISO 9000. As of June 1998 all medical devices must conform to the MDD directive and display the CE mark.
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Marketing your products and services Market entry

When selecting a local representative (importer, distributor or servicing company), exporters should pay attention to the significant cultural differences which exist in Belgium. The local representative should prove their ability to operate nationally and in both Dutch and French, across the three regions of Belgium (Wallonia: French-speaking, Flanders: Dutch-speaking, and Brussels: officially bilingual).


There is no essential difference in marketing medical equipment to public or private hospitals. By law, public sector hospitals are required to issue tenders for equipment worth more than €15,000. Private hospitals enjoy more flexibility in their procurement practices; however, in general they follow the same rules as in the public sector.


In order to enter the medical equipment market in Belgium, Australian suppliers should be familiar with the European Union (EU) directives concerning the registration, marketing, and health/safety standards required throughout Europe, as well as regulations specific to Belgium.


With certain hospital and home healthcare equipment, Australian suppliers should note that European design aspects may be different to those in Australia. This is especially true in terms of visual design, including product shape, size, and colour. Market visits are strongly recommended to gain an appreciation of the competition.


Belgian hospitals are always seeking to acquire the latest medical technology, especially the university hospitals (managed by the medical schools). All graduating physicians, whether they are specialists or general practitioners, perform their internships in one (or several) of these hospitals. University hospitals are innovators and technology-leaders and should be considered as prime marketing targets by any supplier of innovative medical equipment or products.


The annual investment in new and replacement hospital equipment is estimated at over €200 million.


Most major companies have incorporated the Internet into their business strategy and have websites for marketing their products.


In Belgium, English is widely accepted in trade relations but it is still necessary to have the local importer/distributor ensure that all brochures, instructions and labels are translated into both Dutch and French. There may be a requirement for some medicines to include usage and care instructions in French, Dutch and German (the three official languages of the country).
Distribution channels

Belgium does not have Australian-style self-serve pharmacies and over-the-counter (OTC) medicines cannot be bought in the supermarket. As a result, pharmacists are the leading outlet for OTC and prescription medicinal products and sterile products. Larger pharmacies sell sterile and non-sterile products, including rehabilitation and patient mobility equipment.


Pharmacies are generally supplied by importers/distributors.


Supermarkets and hypermarkets have a significant market share in the sales of vitamins, dietary supplements and wound treatments.


Belgium also has a network of retail outlets called 'bandagists' that primarily service the home health market. Although there are only 120 bandagist stores compared to over 5200 pharmacies, bandagist stores account for 45 per cent of home health sales. These stores carry the entire range of (non-sterile) home health care products and sell both directly to outpatients and to hospitals. Originally developed for the purpose of measuring patients and providing customised medical supplies and equipment, bandagists are operated by specialists. Some import directly, but most purchase supplies and equipment from wholesalers.


Belgian law, not EU legislation, defines the relationship between an exporter and a Belgian distributor(s) including possible sub-distributors. Upon termination of a distribution agreement (either written or verbal) a Belgian distributor may have rights to compensation and damages. Belgian law will prevail even though a contract may specify otherwise.


Thus, in examining various distribution channels, it is important to note, while there is EU legislation that protects agents, there is Belgian legislation that protects distributors. Companies are strongly advised to seek competent local Belgian legal counsel in drawing up either an agency or distribution agreement.
Transport

Belgium has excellent transport infrastructure, systems and services and has traditionally served as a key transportation hub in Europe. Its ports, canals, railroads, airports and highways are integrated efficiently service public and commercial interests.


Antwerp is the second busiest port in Europe. Other major ports include: Port of Zeebrugge, Ghent and Ostend.


The main international airport is the Brussels National Airport. It is the hub airport for SN Brussels Airlines and its subsidiary, Virgin Express.


Belgium’s railway system provides passenger and freight services. Most commercial areas can be reached in under an hour from Brussels which is the centre of the country’s railway network. Most international lines servicing Europe (and beyond) pass through Brussels.


Belgium has over 1770 kilometres of highways.
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Links and industry contacts
Health and medical–related resources

Ministry of Public Health, Food Chain Safety and Environment – www.health.fgov.be
Cité Administrative de l'Etat - Rijksadministratief Centrum
Boulevard Pachéco Laan, 19 - B.5
Bruxelles - 1010 - Brussel
Belgique - België
Tel: +32 2 210 4767
Fax: +32 2 2 210 4771


Hospibel – www.hospibel.be
c/o Agoria
Diamant Building
Bd A. Reyers Laan 80
B-1030 Brussels
Belgium
Tel: +32 2 706 8001
Fax: +32 2 706 8009


Eucomed – www.eucomed.org
Place St Lambert 14
B-1200 Woluwe St Lambert
Brussels, Belgium
Tel: +32 2 772 2212
Fax: +32 2 771 3909


Union Group of Professional Belgian Medical Specialists (GBS) ­– www.gbs-vbs.org
Ave. de la Couronne 20
B-1050 Brussels
Belgium
Tel: +32 2 649 2147
Fax: +32 2 649 2690


UNAMEC – www.unamec.be
Leuvensestraat 29
B-1800 Vilvoorde
Belgium
Tel: +32 2 257 0590
Fax: +32 2 252 4398
Government, business and trade resources for Belgium

European Commission – http://europa.eu.int
Chamber of Commerce and Industry, Halle/Vilvoorde ­– www.kvkhv.voka.be
Federation of Chambers of Commerce and Industry of Belgium – www.cci.be
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Contact details

The Australian Trade Commission (Austrade) is the Federal Government agency that helps Australian companies win overseas business for their products and services by reducing the time, cost and risk involved in selecting, entering and developing international markets.

Austrade offers practical advice, market intelligence and ongoing support (including financial) to Australian businesses looking to develop international markets. Austrade also provides advice and guidance on overseas investment and joint venture opportunities, and helps put Australian businesses in contact with potential overseas investors.

A list of Austrade offices (in alphabetical order of country) is available.
More information

For further information please contact Austrade on 13 28 78 or email info@austrade.gov.au