1. EDMA Page 1 EDMA Strategic Plan 2003-2004 27 November 2002 John Place

2. EDMA Page 2 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

3. EDMA Page 3 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

4. EDMA Page 4 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

5. EDMA Page 5 3. Strategy Framework EDMA 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 TF Reimbursement 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 WP Standardn WP Qual Man WP EU legisln WP Market Res. Committee IVD Directive Committee

6. EDMA Page 6 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

7. EDMA Page 7 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.

8. EDMA Page 8 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 …)

9. EDMA Page 9 4.1: Market Research Committee Objectives and Action Plan 2003-4

10. EDMA Page 10 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 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. SE 14 Dec 99 ARRIVAL Due date : 7 Dec 99 FI 7 Apr 00 19 May 00 28 Sep 00 DK 15 Feb 00 AT 22 Jul 99 5 Dec 00 5 Jan 01 GB 7 Jun 00 PT 12 Aug 00 ES 30 Sep 00 IT 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.)

11. EDMA Page 11 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

12. EDMA Page 12 4.2: IVD Directive Committee Objectives and Action Plan 2003-4

13. EDMA Page 13 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.

14. EDMA Page 14 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

15. EDMA Page 15 4.2.1: Regulatory Working Parties Objectives and Action Plan 2003-4

16. EDMA Page 16 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:  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 Committee Background 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.

17. EDMA Page 17 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

18. EDMA Page 18 4.3: Public Relations Committee Objectives and Action Plan 2003-4

19. EDMA Page 19 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 Issues Continuation of funding for PR activities

20. EDMA Page 20 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

21. EDMA Page 21 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

22. EDMA Page 22 How to co-ordinate industry activities globally, for example  global activities promotion of IVDs  regional activitiesregulation of IVDs  national activitiesreimbursement / 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

23. EDMA EDMA represents the in vitro diagnostics industry active in Europe EDMA Office Place St Lambert 14 Woluwe St Lambert 1200 Brussels, Belgium Tel +32 2 772 2225 Fax +32 2 772 2329 Email edma@edma-ivd.be Web site www.edma-ivd.be For better decisions in health care