1. Opening Address Paul Weinberger Chairman of the Executive Committee

2. BIVDA Strategy 2006 Headline Figures on IVDs Supply Chain Excellence Programme Carter Review Payment by Results Contents

3. 1.Procurement PASA & Collaborative Procurement Hubs SCEPSupply Chain Excellence Programme PBRPayment by Results CEPCentre for Evidence-based Procurement 2.External Affairs Public Relations Programme Independent Review of Pathology Services 3.Regulatory issues Local & Global MHRA Relationship 4.Market Audit BIVDA Strategy for 2006

4. Headline Figures for IVDs

5. Total UK Expenditure on Health £ billion Source: HM Treasury Spending Review 2002 Health expenditure as percentage of GDP 7.7 8.0 8.3 8.7 9.0 9.4

6. Total IVD Expenditure in Europe Source: EDMA IVD Market Estimates 2004

7. Total Lab Expenditure in Europe Source: EDMA IVD Market Estimates 2004

8. Total Self-test Expenditure in Europe Source: EDMA IVD Market Estimates 2004

9. Comparison of Lab sizes across Europe Source: Frost & Sullivan Market Report 2001

10. Supply Chain Excellence Programme

11. Source: PASA presentation to BIVDA 2005

12. BIVDA Response Formation of task force –Sub-group to Procurement working party Communication with stakeholders: –ACB / RCP / DOH –Briefing paper published Continued communication of key messages –Underinvestment in pathology –Lack of capital in NHS –Complexity of NHS deal requirements –In Vitro Diagnostic Directive Meeting with PASA, Commercial Directorate & DOH on 7 th October 2005

13. January 2006 Communication from PASA “We have concluded this intermediate assessment and in light of other developments it is clear that whilst there would be substantial benefit to the NHS in addressing lab pathology, far greater benefit can be achieved by aligning our strategic approach more closely with that of the wider Department of Health.” …..….but………..

14. Independent Review of Pathology Services

15. Review panel chaired by Lord Carter of Coles: –“70% of diagnoses based on pathology results” –“NHS spends £1.5Bn on pathology services” Panel also includes Prof Chris Price and Marcus Robinson Consulting widely with Stakeholders Expected to make recommendations to Ministers in Spring 2006

16. Review Panel’s Remit ‘to advise Ministers, in the context of current resource constraints, on the timeliness, reliability, capacity and efficiency of current pathology services in England, benchmarked against international standards and the feasibility of and benefits arising from wide-scale service reconfiguration, innovation and modernisation and involvement of the independent sector.’

17. BIVDA Response Submitted to review panel at end January –Reimbursement tariff –Reasonable expectations of evidence –Multiple models of service provision 1 st meeting with review panel 13 th Feb –Questions focussed on international pricing Followed up with further data 23 rd March –Comparative spending across Europe Next meeting 18 th April

18. Payment by Results

19. 2006/7 HRG Tariff published and withdrawn in March 2006 Revised Tariff published with amendments, including: –Removal of Chemical Pathology and Haematology indicative tariffs No BIVDA involvement up to this point Task force must be formed…………. ………..will look for volunteers?