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

EDMA

EDMAStrategic Plan 2003-2004

27 November 2002

John Place

EDMA

Contents

Section

1. Summary and Overview

2. Mission and Priorities

3. Strategy framework

4. Objectives and Deliverables 2003-4

5. Key Issues

Page3456

19

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

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

EDMA

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

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 Committee4.2 Regulation: IVD Directive Committee4.3 Awareness: Public Relations Committee

EDMA

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

EDMA

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 …)

EDMA

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

EDMA

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.)

EDMA

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

EDMA

4.2: IVD Directive Committee Objectives and Action Plan 2003-4


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

EDMA

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.

EDMA

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

EDMA

4.2.1: Regulatory Working PartiesObjectives and Action Plan 2003-4


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

EDMA

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.

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

EDMA

4.3: Public Relations CommitteeObjectives and Action Plan 2003-4


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

EDMA

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

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

EDMA

• 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

EDMA

• 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

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

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