Belgische federatie van de industrie van de medische technologieën Richard Van den Broeck Directeur UNAMEC

Bedrijven in Europa ongeveer 25.000 Europe refers to EU + Norway, Switzerland. An enterprise is considered to be an SME if it employs fewer than 250 persons and has an annual turnover not exceeding €50 million. Source: Eucomed calculations based on the data obtained from National Associations of 15 countries for the latest year available. Countries with (partially) provided data: Belgium, Czech Republic, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, Poland, Portugal, Spain, Sweden, UK, Switzerland.

Europese MedTech markt Afgeronde evaluatie €100 billion Europe refers to EU + Norway, Switzerland. Source: WHO Global Health Expenditure Database, Eurostat, Eucomed calculations based on the data obtained from National Associations of 15 countries for the latest year available. Countries with (partially) provided data: Belgium, Czech Republic, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, Poland, Portugal, Spain, Sweden, UK, Switzerland.

Europese MedTech markt per land Note: Medical device market is estimated in manufacturers’ prices, and does not include margins, such as value added in the wholesaling and retailing, transportation costs, some taxes included in the final price, etc. NOT TO BE CONFUSED WITH EXPENDITURE ON MEDICAL DEVICES (which has to be represented in final purchasers’ prices) Source: World Medical Markets Fact Book 2013, Espicom Business Intelligence. Definition: Espicom uses a wide definition of medical equipment, similar to that used by the US FDA or EU regulatory authorities. In short, it is defined as any piece of equipment or apparatus used to treat or diagnose an illness, which comes into direct contact with the patient. Pharmaceuticals, IV diagnostics and laboratory equipment are not within the scope of this report. INCLUDES: CONSUMABLES Medical dressings (non-adhesive) Medical dressings (adhesive) Woundcare Products Sutures, sterile, surgical & dental goods Tubular metal needles/ needles for sutures Syringes (with/without needles) Syringes, Needles & Catheters Other needles, catheters, cannulae etc First-aid boxes & kits Blood-grouping reagents Others Ostomy appliances Electrodiagnostic Apparatus DIAGNOSTIC IMAGING Surgical gloves Electrocardiographs Scintigraphic apparatus Magnetic resonance imaging apparatus Ultrasonic scanning apparatus Other electro-diagnostic apparatus Other medical X-ray apparatus Computed tomography apparatus Radiation Apparatus Imaging Parts & Accessories Medical alpha beta, gamma ray apparatus Medical X-ray film (rolled) Medical X-ray film (flat) Contrast media X-ray tubes Dental Capital Equipment DENTAL PRODUCTS Parts & accessories for radiation apparatus Dental drill engines Dental Instruments & Supplies Dental & similar chairs (inc. parts & accessories) Dental X-ray apparatus Dental cements & other fillings Other dental fittings Artificial teeth Other instruments & appliances used in dentistry Splints & other fracture appliances ORTHOPAEDIC & PROSTHETIC DEVICES PATIENT AIDS Other artificial body parts Artificial joints Portable aids Other aids for the disabled Pacemakers, except parts & accessories Hearing aids, except parts & accessories Therapeutic appliances OTHERS Therapeutic respiration apparatus Mechano-therapy apparatus Wheelchairs, not mechanically propelled Medical, surgical sterilisers Other medical, surgical, dental furniture Wheelchairs, mechanically propelled Ophthalmic instruments & appliances Ultra-violet or infra-red ray apparatus Other instruments & appliances

Er bestaan meer dan 500,000 geregistreerde medische technologieën Source: Global Medical Devices Nomenclature (GMDN) Agency, 2010

Top technical fields in patent applications Number of patent applications filed, by field, 2012 Analysis based on European patent applications filed with the EPO in 2012 (Direct European applications filed in 2012 and international (PCT) applications entering the European phase in 2012), including divisional applications filed during the year. Based on the WIPO IPC-Technology concordance as revised in August 2012. Source: European Patent Office

4 hoofd segmenten MEDICAL EQUIPMENT IMPLANTS & SYSTEMS IN-VITRO DIAGNOSTIC MEDICAL CONSUMABLES

Sector medische technologieën in België Totale markt: € 3,4 billion Gemiddelde stijging van de markt: +- 4% 70% intramuraal - 30% extramuraal Aantal werknemers: +- 18.000 3 competent authorities: FAGG, WIV, FANC

Sector medische technologieën in België 3.4 billion € 100,0% Totaal 0.4 billion € 11,8% In-Vitro Diagnostics 1.2 billion € 35,3% M.E.S. 1.0 billion € 29,4% Verbruiksgoederen 0.8 billion € 23,5% Implantaten

Evolutie turnover Medical devices: +4% Implantaten: +7% In-Vitro Diagnostic: +5.5% Medical equipment: +4.5% Verbruiksgoederen: -1%

14,8% Productie 33,4% Multinational 64,3% Vlaanderen 77,4% Distributie 66,6% KMO 20,6% Brussel 7,8% Diensten 15,1% Wallonië

Onze vier prioriteiten Financiering Toegankelijkheid Kwaliteit / Meerwaarde Ethiek

Toekomst voor de medische technologieën Evolutie van de sector Globalisatie Grotere groepen Toename van automatisatie Meer systemen met ICT oplossingen

Toekomst voor de medische technologieën Evolutie van de gezondheidszorg Chronische aandoeningen en therapeutische monitoring Gepersonaliseerde gezondheidszorg Curatieve zorg → preventieve zorg Innovatie Translationele geneeskunde EBM & HTA

Toekomst voor de medische technologieën Hervorming van de gezondheidszorg Herziening nomenclatuur Ontkoppeling akte/product Financiering per DRG of zorgpad Besparingsmaatregelen Silostructuur → transversale structuur

Uitdagingen voor de medische technologieën in België Toepassing plan medische hulpmiddelen: traceerbaarheid, materiovigilantie, autocontrole, evaluatie, innovatie, publiciteit en informatie, ethiek Financiering nieuwe technologieën Nieuw wettelijk kader Namaak van medische technologieën Cyberaanval

DANK U