EDMA
Strategic Plan 2003-2004
27 November 2002
John Place
Page 1
EDMA
Contents
Section
1. Summary and Overview
2. Mission and Priorities
3. Strategy framework
4. Objectives and Deliverables 2003-4
5. Key Issues
Page
3
4
5
6
19
Page 2
EDMA
1: Summary and Overview
• This document sets out proposals for EDMA activities for 2003 - 2004,
building on the declared mission and priorities of EDMA listed in
section 2
• This Strategic Plan was introduced at the Kronberg Meeting in June
2002 and was discussed at meetings of the National Member
Associations and Corporate Associate Members of EDMA in October
2002. This final version of this Strategic Plan is expected to be
approved by the EDMA Executive in December 2002
• Section 3 sets out a strategy framework
• Section 4 sets out planned objectives and deliverables for 2003 - 2004
• Key issues are presented in Section 5
Page 3
EDMA
2: Mission and Priorities
The Mission of EDMA is:
• To represent the IVD industry in Europe
• To raise awareness and promote better use of laboratory testing
• To support an appropriate regulatory system
• To work towards a realistic economic environment for health care
• To be an effective voice in globalisation
In 1999 EDMA identified three priorities
• Raise awareness of the value of in vitro testing
• Ensure correct implementation and interpretation of the IVD Directive
• Provide European market figures
This document sets out a strategic framework for matching the mission (five
statements) with the identified priorities and the mechanisms for their delivery
The document then sets out programmes for 2003 to 2004 for each priority
Page 4
EDMA
3. Strategy Framework
Scope of EDMA Activities
Priorities in red
Delivery
Mechanism
• Be the face of the IVD industry in Europe
• Coordinate IVD activities/NMAs in Europe
IVD
Directive
EDMA
Office
Committee
EDMA Mission
Represent IVD
industry in Europe
Maintain and build market figures and classification
system
Support an
appropriate
regulatory system
Raise awareness &
promote better use
of in vitro testing
Market Res.
Committee
Influence/inform about the implementation &
interpretation of the IVD directive
IVD Directive
Committee
•
•
•
•
Central E WP
Standardn WP
Qual Man WP
EU legisln WP
Promote harmonised regulation in Eastern Europe
Monitor & influence ISO, CEN & NCCLS standardisation
Standardisation of Quality Management
Review EU documents in preparation with impact on IVDs
Increase awareness of utility of IV testing among
decision makers and the public
Work for a realistic
economic environmt
for healthcare
• Healthcare economics/cost utility
• Funding and reimbursement
Be an effective voice
in globalisdation
• Coordinate with trade organisations globally
• Support activities of GHTF
Public Relations
Committee
Health Econ TF
Reimbursement TF
GHTF TF
Page 5
EDMA
4: Objectives and Deliverables 2003-4
This section of paper sets out the programmes for 2003-2004 for each of
the three priorities EDMA has identified in the strategic framework, for
other Working Party activities and for the EDMA Office
4.1 Representation: Market Research Committee
4.2 Regulation: IVD Directive Committee
4.3 Awareness: Public Relations Committee
Page 6
EDMA
4.1: Market Research Committee
Background
EDMA’s Market Research
activity started as a
common interest group to
provide reliable market
estimates for the IVD
market. The first stage was
a large commitment of time
to the development of the
EDMA classification system
for IVDs, as pre-requisite
for reporting of sales data.
The reporting system is run by the NMAs themselves, who with few
exceptions have contracted with CIP in Paris as the independent auditor.
EDMA drives the product classification and organizes the annual
consolidation of European statistics.
Page 7
EDMA
4.1: Market Research Committee
Focus
 Provide an up-to-date, logical classification system for IVDs
 Version 5.0 end 2002
 Instrument classification 2003
 Provide annual IVD market estimate for Europe
 New format CIP
 European flash report
 Provide macroeconomic statistics as support for IVD industry
 Promote EDMA system globally (US, Japan …)
Page 8
EDMA
4.1: Market Research Committee
Objectives and Action Plan 2003-4
Focus
Key Objectives/Deliverables
Accountability
Product
classification




Classification TF
Classification TF
Classification TF
MRWP
Market estimate
 Encourage CAM reporting in all countries and NMA
participation in consolidation, esp. Scandinavia, UK,
Greece
 Arrange annual consolidation of European estimates
 Issue fast Press Release after consolidation
 Issue results and comments by September each year
 Hungary, Czechia, Poland included by 2003
 Review and propose improvements to reporting systems
CAMs/NMAs
Industry
statistics
 Update macroeconomic data from OECD annually
 Expand data to include central Europe by mid 2003
 Perform 2002 industry survey in 2003
JP
JP
JP
Other
 Negotiate with NMAs company HQ access to data
 Export audit system to Japan, USA
Flash Report TF
JP
Complete implementation of 5.0 revision by end 2002
Arrange for annual updates
Complete instrument classification. implementation 2003
Integrate with GMDN system if this becomes standard
PDB/MRWP
PDB/JP
MRWP
MRWP
NMAs/MRWP
Page 9
EDMA
4.2: IVD Directive Committee
Background
In 1988, in response to
increasing diversification of
national regulations of key
IVD products, EDMA
reported to the Commission
Due
date: 7
requesting a harmonizing
Dec 99
directive for IVDs.
FR
A first draft was published in Application
Decrees?
1992, the first EP reading
was in March 1996 and the
Directive was published on
7 December 1998.
IT
ES
GB
DK
AT
30 Sep
00
7 Jun 00
15 Feb 00
22 Jul 99
5 Dec 00
5 Jan 01
17 Nov
00
PT
FI
12 Aug
00
7 Apr 00
19 May 00
28 Sep 00
SE
14 Dec 99
EDMA is now heavily involved in providing information about the
directive (implementation, interpretation) and follow on legislation
(CTS, MEDDEV, NB Recommendations, Standards etc.)
Page 10
EDMA
4.2: IVD Directive Committee
Focus
 Provide information on transposition (now achieved in all countries)
 Provide information about implementation and interpretation of
the IVD Directive
 Monitor and respond to competent authority initiatives relative to
IVD Directive
 Participate in Commission meetings relative to medical devices
(MDEG, Annex II, Borderline, Vigilance EUDAMED)
 Co-ordinate global IVD industry positions
 Monitor MRA between EU and USA
 Support activities of GHTF
Page 11
EDMA
4.2: IVD Directive Committee
Objectives and Action Plan 2003-4
Focus
Key Objectives/Deliverables
Accountability
Transposition
 Issue regular updates by country of interpretation of
Directive and implementation of national regulations
(incl. Central Europe)
IVDWP/CEWP
Implementation
 Provide guidance on implementation of IVD Directive,
including Q&A cards
IVDWP/Edico
Competent
authorities
 Monitor and influence
Commission
 Participate and influence MDEG meetings
CT
Global
coordination
 Reach industry consensus on US/EU MRA by Dec 2002
 GHTF
CT/IVDWP
IVDWP
Page 12
EDMA
4.2.1: Regulatory Working Parties
Background
• EDMA is also a communication center for
other activities that support /follow on from
the main priorities.
• The Standardisation WP reviews, monitors
and influences the voluntary CEN ISO and
NCCLS standards supporting the IVD Directive
• Standards related to quality management are
reviewed, monitored and influenced by the
Quality Management WP and Risk
Management TF
• The Commission prepares many items of legislation that may have an
effect on IVD products, the health care environment and business and
trade issues in general. These documents are evaluated by the
European Legislation WP
• Finally, the Central Europe WP monitors regulatory and registration
requirements of the applicant countries and promotes adoption of
harmonizing regulations.
Page 13
EDMA
4.2.1: Regulatory Working Parties
Focus
 Standardization WP
 Labelling TF
 Self testing TF
 Traceability TF
 Quality Management WP
 ISO 9000 TF (with Eucomed)
 Risk management TF (with Eucomed)
 Laboratory accreditation TF
 European legislation WP
 Reimbursement TF (with Eucomed)
 Central Europe WP
Page 14
EDMA
4.2.1: Regulatory Working Parties
Objectives and Action Plan 2003-4
Focus
Key Objectives/Deliverables
Accountability
Standardisation








Monitor/influence standardisation activities
Develop position on analytical goals
Review/promote reference measurement systems
Develop guidance documents/position papers on standardisation
Work with partners to limit standards to the necessary/adequate
Improve relationship with NCCLS on a technical basis
Promote harmonisation of terminology
Establish platform with IFCC
Standardisation WP
Labelling



Promote acceptance supply of IFU by other means in EEA and CEE Labelling TF
Promote use of symbols
Promote harmonisation of labelling
Quality Management

Monitor/influence standardisation activities on quality & risk
management
Develop guidance & positions on quality & risk management
Work on accreditation with medical laboratories to prevent
unrealistic requirements
Quality Man. WP


European legislation


Promote reduction of VAT on IVDs
Avoid adverse effects on IVDs of tissue legislation
ELWP
ELWP
Central Europe



Hold a CE conference every two years
Promote adoption of IVD Directive in applicant countries
Promote development of NMAs in these countries
Central Europe WP
Page 15
EDMA
4.3: Public Relations Committee
Background to PR Strategy
Fig 1: PRWP agreed approach Sept 2000
Public field
Business field
Patients
Improving Health/ QoL
In September 2000, the PRWP
established a European consensus
on a preferred approach (fig 1)
In October 2000 the AGM approved
a four point priority action plan for
EDMA / PRWP:
Clinicians
Health
Payers
Laboratory
Scientists
Healthcare
Managers
Cost Utility
 Matched Funding - Maintain
central fund to support local projects
chosen from proposals submitted by
Addressed by member
Addressed by
companies
IVD Image Campaign
NMAs. Monitor effectiveness of
projects against their own objectives.
 Success stories - Provide success story packages to be modified by
other countries for local use.
 Supporting Evidence - Proactively develop and collate supporting
evidence for value of IVDs
 EU level stakeholders - Address IVD messages to EU level
organisations of patients, professionals, etc
22
Page 16
EDMA
4.3: Public Relations Committee
Focus
• Provide matched funding for selected awareness activities of
National Members Associations (NMAs)
• Prepare texts and materials for use in awareness campaigns
 Activate exchange of success stories among NMAs
 Update and expand supporting evidence (Benefits
presentation)
 Promote IFCC/EDMA Award and EDMA Symposium
 Co-operate with other EU level stakeholders to promote value
awareness
 Professional users associations
 Patients organizations
 Health economists
 Establish Labtestsonline in Europe
Page 17
EDMA
4.3: Public Relations Committee
Objectives and Action Plan 2003-4
Focus
Key Objectives/Deliverables
Accountability
Matched Funding
 Complete 2nd round funded initiatives in 1st Qtr 2003
PR Committee
Success Stories
 Arrange Workshop and recipes for success each year
 PR News 4 times per year
PR Committee
Supporting
Evidence
 Provide 6 examples with economic benefits every year
PR Committee
/CAM
Award & EDMA
symposium
 Organise 3rd Award in Barcelona 2003
 Organise 2nd Symposium in Barcelona 2003
Award TF
JP
EU Prof.
associations
 Get ELM to start actions in Europe by 2004, e.g. “HI-5”
 Joint awareness actions at Commission / Parliament
JP
JP
EU Patient
Associations
 Work towards a European patient forum EPPOSI / IAPO
 Publish two joint papers during 2002 – 4
 Joint awareness actions at Commission / Parliament
DB
DB/JP
DB
Health economists
 Develop a position on cost utilty of IVDs in 2003
Health Econ. TF
Labtestsonline
 Establish “Labtestsonline” in Europe by 2003
PR Committee
Page 18
EDMA
5: Key Issues
Continuation of funding for PR activities
Help with National Association projects
• EDMA and National associations have jointly funded successful PR activities
in 2001 and 2002. EDMA has approved Euro 230,000 of funding and
reduced its reserves to a minimum
• National Associations are planning further activities that will require
continuation of funding
Joint actions with European Laboratory Medicine
• EDMA is discussing with European the translation and adaptation of AACC
Labtestsonline for Europe
• EDMA has convinced ELM to actively promote laboratory medicine and will
follow up with concrete proposals - for example in the form of a “HI-5” like
activity - that will require funding
Joint actions with Patient Organisations
• Joint event with Intl Diabetes Federation at Parliament in Brussels and
Strasbourg November 2002
• Promotion of early diagnosis with EPPOSI
 CAMs to decide how to fund these activities: meeting 17 October 2002
Page 19
EDMA
5: Key Issues
IVD industry expertise in health economics
Mission: Working towards a realistic economic environment for health care
• EDMA has taken some initiatives
 Reimbursement Task Force (with Eucomed)
 Commissioned pilot study with LSE Health on the values patients
and family physicians place on in vitro tests
 Obtained Board position in ISPOR group on diagnostics
 Health Economic Task Force to develop a position on cost utility for
IVDs
• EDMA is weak in this area, with little support from members
 Reimbursement TF not functioning
 No flagship study to raise the special position of IVDs
 No support at health economic conferences
 There is a lack of expertise in the IVD industry
• How to discuss funding / reimbursement without needed expertise?
• An opportunity for EDMA to work closely with Eucomed
 Need to establish a new IVD industry and EDMA priority
Page 20
EDMA
5: Key Issues
Co-operation with Eucomed
•
•
•
Eucomed has new DG, Maurice Wagner
 opportunity to renew co-operation
 Eucomed applying pressure to merge
 Cooperation gives influence and authority
 IVD messages get more attention via EDMA
Eucomed can help EDMA:
 Commission and EP lobbying
 communications management (regular news, press releases)
 Eucomed Legal Interests Group
 reimbursement
EDMA can help Eucomed:
 Accounts
 Market audit and estimates
 EDMA Award and Symposium
 Meeting with Eucomed 23 July 2002
Page 21
EDMA
5: Key Issues
Priorities of Trade Associations
•
•
•
How to co-ordinate industry activities globally, for example
 global activities
promotion of IVDs
 regional activities regulation of IVDs
 national activities reimbursement / funding
AdvaMed activities in Europe
 How to co-ordinate activities with AdvaMed
 CAM help to channel activities via EDMA and NMAs and use
resources efficiently
EDMA National Member Association (NMA) meeting
 To debate / approve EDMA Strategic Plan 2002- 2004
 To discuss trade associations priorities
 To exchange information
 NMA meeting 18 October 2002
Page 22
EDMA
For better decisions in health care
EDMA represents the in vitro diagnostics
industry active in Europe
EDMA Office
Place St Lambert 14
Woluwe St Lambert
1200 Brussels, Belgium
Tel
Fax
Email
Web site
+32 2 772 2225
+32 2 772 2329
[email protected]
www.edma-ivd.be
EDMA