Transcript Revision of the Medical Devices Directive – An Industry

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
www.eucomed.org
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Some facts
www.eucomed.org
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The European medical technology industry
► Nearly 11.000 manufacturers
► Total sales EUR 72.6 billion
► 80% are SMEs
= nearly 33% of world market share (EUR 219
► Annual growth rate of ca 6%
billion)
► Trade
► 8% of total sales reinvested in R&D
–
(= EUR 5.8 billion)
Germany (€14.0 bn), Ireland (€6.6 bn), France
(€6.1 bn), and the UK (€5.6 bn) are major
exporters of medical technology
► Average life cycle of 18 months
–
► 529,000 employees (EU+EFTA)
Germany, Ireland, the UK, Denmark, Sweden and
Finland have trade surpluses in medical technology
► 6.8% of total healthcare expenditure
► (= 0.55% of GDP)
► As a comparison (in billion EUR):
–
USA = 98.0 (45%)
–
Japan = 23.1 (11%)
–
China = 3.7 (2%)
–
Brazil = 3.0 (1%)
Source: Eucomed
www.eucomed.org
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The European medical technology industry 2007
New EU Member
States**
5%
Other European
Countries*
18,4%
Germany
27,8%
Switzerland
2,3%
Spain
8,3%
France
13,8%
United Kingdom
16,2%
Italy
8,5%
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
www.eucomed.org
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European Medical Technology Imports & Exports
Total Exports
Total Imports
Germany
France
Italy
United Kingdom
Spain
Ireland
Austria
Sweden
Denmark
Poland
Portugal
Norway
Czech Republic
Finland
Slovakia
€0
€2,000
€4,000
€6,000
€8,000
€10,000 €12,000 €14,000 €16,000
Millions
www.eucomed.org
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Ration of GDP Spending
15,4
8,5
10,6
10,5
2,4
2,3
8,1
9,5
8,7
8,7
8,1
2,2
1,1
8,8
7,9
2,3
2,4
3,1
1,5
4,0
5,6
5,6
6,5
4,8
3,5
8,2
8,2
7,0
6,9
3,6
6,5
5,7
6,4
6,4
6,4
3,6
4,8
2,0
USA
Germany
UK
Source: OECD Health data 2006
France
Italy
Spain
2,8
Average
other EU
Public expenditure % of GDP
Japan
Australia
China
3,0
2,8
1,2
Rep of
Korea
India
Brazil
Mexico
Private expenditure % of GDP
www.eucomed.org
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Percentage of total healthcare spending allocated to
medical technologies
8.60%
8.0%
6.50%
Germany
Japan
France
6.37%
North
European
average
6.10%
Spain
Source: OECD Health data 2006
www.eucomed.org
5.50%
5.3%
USA
Portugal
4.80%
UK
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Health Spending in Europe in 2005: Percent of GDP
Percent of GDP Spent on Healthcare
14%
12%
Europe Average = 8.7%
10%
8%
6%
4%
2%
0%
Source: Eucomed Medical Technology Brief, May 2007
www.eucomed.org
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Euro
Health Spending in Europe in 2005: Per Capita
Per Capita Health Spending
6,000
5,000
4,000
Europe Average = €2,073
3,000
2,000
1,000
0
Source: Eucomed Medical Technology Brief, May 2007
www.eucomed.org
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How Europe works
www.eucomed.org
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Subsidiarity
► 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.
www.eucomed.org
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Subsidiarity 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).
www.eucomed.org
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EU Commission
POLICIES
EXTERNAL
Agriculture and Rural Development
Development
Competition
Enlargement
Economic and Financial Affairs (ECFIN)
EuropeAid - Co-operation Office
Education and Culture
External Relations
Employment, Social Affairs and Equal Opportunities
Humanitarian Aid
Energy and Transport
Trade (TRADE)
Enterprise and Industry (ENTR)
GENERAL
Environment (ENVI)
Communication
Executive Agencies
European Anti-Fraud Office
Maritime Affairs and Fisheries
Eurostat
Health and Consumers (SANCO)
Publications Office
Information Society and Media
Secretariat General
Internal Market and Services (MARKT)
Joint Research Centre
Justice, Freedom and Security
Regional Policy
Research (RTD)
Taxation and Customs Union
INTERNAL
RELATIONS
SERVICES
SERVICES
Bureau of European Policy Advisers
Informatics
European Commission Data Protection Officer
Infrastructures and Logistics - Brussels
Infrastructures and Logistics - Luxembourg
Internal Audit Service
Interpretation
www.eucomed.org
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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 Commissioner
12 February 2009 Speech at European Policy Centre,
Brussels
www.eucomed.org
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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’
www.eucomed.org
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How will financial crisis affect business in Europe?
www.eucomed.org
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FT 9th April 2009
www.eucomed.org
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Economic downturn is accentuating changes in treatment
practices and reduction in healthcare consumption
► Percent who say they or family member have done the following in the past
year because of cost
SIMILAR TRENDS SHOWING IN EUROPE
Source:Kaiser Family Foundation Kaiser Health Tracking Poll – Election 2008 (10/8-13 | 4/3-13);
McKinsey CF/PMP joint venture
www.eucomed.org
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Mixed 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?
www.eucomed.org
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What is going on in Europe
www.eucomed.org
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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
www.eucomed.org
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Regulation
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
Reach
DEHP, 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
www.eucomed.org
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Does the patients‘ rights directive have the answer?
► Legal certainty on patients‘ mobility,
effective liability and insurance, simple
► Equal access to high quality and costeffective health technology innovation
redress
www.eucomed.org
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BUT
► 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
www.eucomed.org
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New Parliament/New Commission 2010
Unknown new priorities but likely to include:
► Security (includes energy)
► Environment
► Financial stability
► ? Health
www.eucomed.org
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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?
www.eucomed.org
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Uncertainty
But opportunity for those aligned with system
needs…
www.eucomed.org
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More information?
Visit www.eucomed.org
www.eucomed.org
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