edma page 1 edma strategic plan 2003-2004 27 november 2002 john place
TRANSCRIPT
Page 1EDMA
EDMAStrategic Plan 2003-2004
27 November 2002
John Place
Page 2EDMA
Contents
Section
1. Summary and Overview
2. Mission and Priorities
3. Strategy framework
4. Objectives and Deliverables 2003-4
5. Key Issues
Page3456
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Page 3EDMA
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 4EDMA
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 5EDMA
3. Strategy FrameworkEDMA Mission Scope of EDMA Activities
Priorities in red
Scope of EDMA Activities Priorities in red
Represent IVD industry in
Europe
Raise awareness & promote
better use of in vitro testing
Increase awareness of utility of IV testing among decision makers and the public
• Healthcare economics/cost utility• Funding and reimbursement
Be an effective voice in globalisdation
Be an effective voice in globalisdation
Work for a realistic
economic environmt for healthcare
Delivery Mechanism
Influence/inform about the implementation & interpretation of the IVD directive
Support an appropriate regulatory
system
IVD Directive Committee
Public Relations Committee
Health Econ TFReimbursement
TF
EDMA Office
• Coordinate with trade organisations globally• Support activities of GHTF
GHTF TF
Maintain and build market figures and classification system
• Be the face of the IVD industry in Europe• Coordinate IVD activities/NMAs in Europe
• 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
Central E WPStandardn WPQual Man WPEU legisln WP
Market Res. Committee
IVD DirectiveCommittee
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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 Committee4.2 Regulation: IVD Directive Committee4.3 Awareness: Public Relations Committee
Page 7EDMA
4.1: Market Research CommitteeBackground
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.
EDMA
Markets: European Economic Area
-1 %
0 %
1 %
2 %
3 %
4 %
5 %
6 %In Vitro Tests
Health Expenditure
GDP
Percentage increase on previous year
Health Expenditure, GDP and Sales of In Vitro tests
20011994 1995 1996 1997 1998 1999 2000
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4.1: Market Research CommitteeFocus
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 …)
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4.1: Market Research Committee Objectives and Action Plan 2003-4
Focus Key Objectives/ Deliverables Accountability
Product classification
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
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 PDB/MRWP PDB/JP MRWP MRWP NMAs/MRWP
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
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4.2: IVD Directive CommitteeBackground
In 1988, in response to increasing diversification of national regulations of key IVD products, EDMA reported to the Commission requesting a harmonizing directive for IVDs.
A first draft was published in 1992, the first EP reading was in March 1996 and the Directive was published on 7 December 1998.
SE14 Dec 99
ARRIVAL
Due date: 7 Dec 99
FI7 Apr 00 19 May 0028 Sep 00
DK15 Feb 00
AT22 Jul 995 Dec 005 Jan 01
GB7 Jun 00
PT12 Aug
00
ES30 Sep
00IT
17 Nov 00
FR Application Decrees?
EDMA is now heavily involved in providing information about the directive (implementation, interpretation) and follow on legislation (CTS, MEDDEV, NB Recommendations, Standards etc.)
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4.2: IVD Directive CommitteeFocus
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 12EDMA
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 13EDMA
4.2.1: Regulatory Working PartiesBackground
• 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 14EDMA
4.2.1: Regulatory Working PartiesFocus
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
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4.2.1: Regulatory Working PartiesObjectives 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 Promote use of symbols Promote harmonisation of labelling
Labelling TF
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
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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:
22
Fig 1: PRWP agreed approach Sept 2000
Patients
Health Payers
HealthcareManagers
LaboratoryScientists
Clinicians
Impr
ovin
g H
ealth
/ QoL
Cos
t Util
ity
Addressed by member companies
Addressed by IVD Image Campaign
Public field Business field
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
4.3: Public Relations CommitteeBackground to PR Strategy
Matched Funding - Maintain central fund to support local projects chosen from proposals submitted by NMAs. Monitor effectiveness of projects against their own objectives.
Page 17EDMA
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 18EDMA
4.3: Public Relations CommitteeObjectives 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 19EDMA
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
5: Key IssuesContinuation of funding for PR
activities
Page 20EDMA
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
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• 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
5: Key Issues Co-operation with Eucomed
Page 22EDMA
• 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
5: Key Issues Priorities of Trade Associations
EDMA
EDMA represents the in vitro diagnosticsindustry active in Europe
EDMA Office Place St Lambert 14Woluwe St Lambert1200 Brussels, Belgium
Tel +32 2 772 2225Fax +32 2 772 2329Email [email protected] site www.edma-ivd.be
For better decisions in health care