a view from europe
DESCRIPTION
A view from Europe. 5 May 2009 John Wilkinson Chief Executive. Contents. Some facts about the sector in Europe How Europe works The financial crisis – How will it affect us in Europe What is going on in Europe Trends Regulation Politics. Some facts. Nearly 11.000 manufacturers - PowerPoint PPT PresentationTRANSCRIPT
A view from EuropeA view from Europe
5 May 2009
John Wilkinson
Chief Executive
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ContentsContents
► Some facts about the sector in Europe
► How Europe works
► The financial crisis – How will it affect us in Europe
► What is going on in Europe– Trends– Regulation– Politics
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Some factsSome facts
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The European medical technology industryThe European medical technology industry
► Nearly 11.000 manufacturers► 80% are SMEs► Annual growth rate of ca 6%► 8% of total sales reinvested in R&D
(= EUR 5.8 billion) ► Average life cycle of 18 months► 529,000 employees (EU+EFTA)► 6.8% of total healthcare expenditure ► (= 0.55% of GDP)
► Total sales EUR 72.6 billion
= nearly 33% of world market share (EUR 219
billion)
► Trade– Germany (€14.0 bn), Ireland (€6.6 bn), France (€6.1
bn), and the UK (€5.6 bn) are major exporters of medical technology
– Germany, Ireland, the UK, Denmark, Sweden and Finland have trade surpluses in medical technology
► As a comparison (in billion EUR):
– USA = 98.0 (45%)
– Japan = 23.1 (11%)
– China = 3.7 (2%)
– Brazil = 3.0 (1%)
Source: Eucomed
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Germany27,8%
New EU Member States**
5%
Other European Countries*
18,4%
Switzerland2,3%
Spain8,3%
United Kingdom16,2%
France13,8%
Italy8,5%
The European medical technology industry 2007The European medical technology industry 2007
Percent of Total European Medical Technology Sales (€72.6 bn)
* Finland, Sweden, Denmark, Norway, Netherlands, Belgium, Luxembourg, Portugal, Austria, Greece, Ireland
** Estonia, Latvia, Lithuania, Poland, Czech Republic, Slovakia, Hungary, Slovenia, Malta, Cyprus, Bulgaria, Romania
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European Medical Technology Imports & ExportsEuropean Medical Technology Imports & Exports
€0 €2,000 €4,000 €6,000 €8,000 €10,000 €12,000 €14,000 €16,000
SlovakiaFinland
Czech RepublicNorway
PortugalPoland
DenmarkSwedenAustriaIreland
SpainUnited Kingdom
ItalyFrance
Germany
Millions
Total ExportsTotal Imports
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Source: OECD Health data 2006
6,98,2
7,08,2
6,55,7 6,4 6,4 6,4
2,0 2,81,2
4,83,0
1,1
2,3
2,22,4
2,31,5
3,1
3,6 2,8
3,6
4,0
3,5
8,5
2,4
USA Germany UK France Italy Spain Averageother EU
Japan Australia China Rep ofKorea
India Brazil Mexico
Public expenditure % of GDP Private expenditure % of GDP
15,4
10,6
8,1
10,5
8,7 8,18,7
7,9
9,5
5,6 5,6 4,8
8,8
6,5
Ration of GDP SpendingRation of GDP Spending
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8.60% 8.0%6.50% 6.37% 6.10% 5.50% 5.3% 4.80%
Germany Japan France NorthEuropeanaverage
Spain USA Portugal UK
Source: OECD Health data 2006
Percentage of total healthcare spending Percentage of total healthcare spending allocated to medical technologiesallocated to medical technologies
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Health Spending in Europe in 2005: Percent of Health Spending in Europe in 2005: Percent of GDPGDP
Percent of GDP Spent on Healthcare
0%
2%
4%
6%
8%
10%
12%
14%
Slovak
iaLa
tvia
Estonia
Cyprus
Lithu
ania
Roman
ia
Czech
Rep
ublic
Poland
Irelan
d
Finlan
d
Hunga
rySpa
in
Bulgari
a
Luxe
mbourg
United
King
dom
Slovenia
Denmark Ita
ly
Netherl
ands
Sweden
Malta
Austria
Norway
Belgium
Greece
Portug
al
German
y
France
Switzerl
and
Europe Average = 8.7%
Source: Eucomed Medical Technology Brief, May 2007
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Per Capita Health Spending
0
1,000
2,000
3,000
4,000
5,000
6,000
Bulgari
a
Roman
iaLa
tvia
Slovak
ia
Poland
Lithu
ania
Estonia
Czech
Rep
ublic
Hunga
ry
Cyprus
Malta
Portug
al
Greec
eSpa
in
Sloven
ia
Finlan
dIta
ly
United
King
domIre
land
Belgium
Netherl
ands
Austria
German
y
Sweden
France
Denmar
k
Switzerl
and
Luxe
mbour
g
Norway
Euro
Health Spending in Europe in 2005: Per CapitaHealth Spending in Europe in 2005: Per Capita
Europe Average = €2,073
Source: Eucomed Medical Technology Brief, May 2007
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How Europe worksHow Europe works
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SubsidiaritySubsidiarity
► The “subsidiarity principle” means that EU decisions must be taken as closely as possible to the citizen. i.e. the Union does not take action (except on matters for which it alone is responsible) unless EU action is more effective than action taken at national, regional or local level.
► The concept of subsidiarity has both a legal (EU Treaty) and a political dimension.
As a result, there are varying views as to its legal and political consequences.
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Subsidiarity and HealthSubsidiarity and Health
► Article 152(5) of the EC Treaty states that the Community has to respect the ‘responsibilities of the Member States for the organisation and delivery of health services and medical care’.
► In combination with Article 152(4)(c) of the EC Treaty, action in the field of public health is not allowed under the EC Treaty.
► On the other hand, where the Commission has the competence to regulate, it should strive for a high level of public health protection according to Article 152(1) of the EC Treaty (e.g. in the Medical Device Directives and Cross Border Healthcare).
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EU CommissionEU CommissionP O L I C I E S E X T E R N A L R E L A T I O N S
Agriculture and Rural Development
Competition
Economic and Financial Affairs (ECFIN)
Education and Culture
Employment, Social Affairs and Equal Opportunities
Energy and Transport
Enterprise and Industry (ENTR)
Environment (ENVI)
Executive Agencies
Maritime Affairs and Fisheries
Health and Consumers (SANCO)
Information Society and Media
Internal Market and Services (MARKT)
Joint Research Centre
Justice, Freedom and Security
Regional Policy
Research (RTD)
Taxation and Customs Union
Development
Enlargement
EuropeAid - Co-operation Office
External Relations
Humanitarian Aid
Trade (TRADE)
G E N E R A L S E R V I C E S
Communication
European Anti-Fraud Office
Eurostat
Publications Office
Secretariat General
I N T E R N A L S E R V I C E S
Bureau of European Policy Advisers
Informatics
European Commission Data Protection Officer
Infrastructures and Logistics - Brussels
Infrastructures and Logistics - Luxembourg
Internal Audit Service
Interpretation
Legal Service
Office For Administration And Payment Of Individual Entitlements
Personnel and Administration
Translation
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New technologies – a cost driver?New technologies – a cost driver?
“We all know that new technologies save lives, increase patient safety and greatly improve
healthcare.
But they can be very costly. We must therefore ensure that technology and medical devices are properly evaluated and used in the most effective way.“
Androulla Vassiliou, EU Health Commissioner12 February 2009 Speech at European Policy Centre, Brussels
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So what is stopping us?So what is stopping us?
► Barriers to information: Reliable and transparent information on available healthcare facilities and treatments should be made accessible to patients
► Barriers of access & procurement: Silo budgeting and cost containment still main drivers for decision-making
► Barriers of structure: One size fits all for >100,000 products?
► Barriers of human resource: Most European countries have a shortage in healthcare personnel (quality and quantity)
► However industry needs to improve communication of ‘value’
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How will financial crisis affect business in How will financial crisis affect business in Europe?Europe?
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FT 9FT 9thth April 2009 April 2009
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Economic downturn is accentuating changes in Economic downturn is accentuating changes in treatmenttreatmentpractices and reduction in healthcare practices and reduction in healthcare consumptionconsumption► Percent who say they or family member have done the following in the past
year because of cost
Source:Kaiser Family Foundation Kaiser Health Tracking Poll – Election 2008 (10/8-13 | 4/3-13); McKinsey CF/PMP joint venture
SIMILAR TRENDS SHOWING IN EUROPE
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Mixed impactMixed impact
Short-term impact limited:
- High public sector provision- Capital spending hit first
Debt Mountain will mean:
► Public spending under pressure
► Years of cost cutting exercises
► Danger that crude cost saving exercises will prevail
► Innovation constrained or seen as answer?
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What is going on in EuropeWhat is going on in Europe
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What is going on in Europe?What is going on in Europe?
► Erosion of ‘Subsidiarity’ of Health
► Cross-Border healthcare (patients rights) directive
► Patient safety initiative
► Late payments directive
► Free movement of labour
► Steady increase in regulation
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RegulationRegulation
Medical Devices Directives► Recast Consultation► Suspended but not gone away► Over-reaction to needed modifications of the management of the system
Pthalates/PVC► Directive 2007/47/EC Annex I, Essential Requirement 7.5 related to phthalates
classified as CMR 1 & 2 (comes into force March 2010)► Risk assessment, labelling, justification
ReachDEHP, DBP and BBP on priority list of substances for Authorization
– Use in medical devices would need special approval– ECHA consultation on this list was open until April 14– Our focus: exempt DEHP from the need for authorization
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Does the patients‘ rights directive have the Does the patients‘ rights directive have the answer?answer?
► Legal certainty on patients‘ mobility, effective liability and insurance, simple redress
► Equal access to high quality and cost-effective health technology innovation
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BUTBUT
► Still huge variation in resources across EU– Absolute
and
– Distribution of those resources (x2 number of MD’s in Italy versus UK)
► Huge variation in reimbursement systems
► Varying mix of public/private sector involvement
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New Parliament/New Commission 2010New Parliament/New Commission 2010
Unknown new priorities but likely to include:
► Security (includes energy)
► Environment
► Financial stability
► ? Health
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What role for the EU going forward?What role for the EU going forward?
► Reduce barriers and red tape for patients and industry alike
► Invest commitment, time and leadership in the medical innovation sector -innovations are critical to sustain Europe's economic and social systems and to remain competitive
► Promote long-term investment that will lead to considerable savings for national health security systems as well as strong EU exports
► Safeguard incentives for industry to invest in R&D
Industry perspective but what will happen?
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Uncertainty
But opportunity for those aligned with system needs…
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More information?More information?
Visit www.eucomed.org