1. Alternative R&D Strategies for Drugs for Neglected Diseases: The Case & Possible Alternatives TACD IPR Meeting Washington Nov 1, 2002

2. J. Orbinski 1 -11-02 Washington Nov 1, 2002 Neglected Diseases Chronic Crisis Enduring medical need because of the limited availability of pharmaceuticals  14 million die of infectious diseases – 90% in the South  Infectious diseases: >50% mortality in ssAfrica and Asia  1 in 3 people World-wide: no access to essential Rx Neglected Diseases include: HIV/AIDS ( in the South), Malaria, Tuberculosis sleeping sickness, Chagas disease, leishmaniasis, filariasis, onchocerciasis, schistosomiasis, dengue, leprosy, Buruli ulcer, etc.

3. J. Orbinski 1 -11-02 Washington Nov 1, 2002 Lack of effective, affordable and easy-to-use medicines Existing or new drugs are too expensive Discontinued production of effective medicines Increasing resistance to older medicines Very few new drugs are developed to tackle high priority diseases lack of R&D

4. J. Orbinski 1 -11-02 Washington Nov 1, 2002 The Most Neglected Diseases Affect a large number of patients No purchasing power = no market No advocacy Group to plead for these patients No Strategic interests ( military or security) Less than 5% of 70 B R&D $ allocated to tropical diseases ( 10 / 90 Gap) R&D activity for Diseases of the South: Virtual Standstill ( 1 / 100 Gap) Virtually empty Rx Development pipeline

5. Markets do not reflect health needs

6. J. Orbinski 1 -11-02 Washington Nov 1, 2002 Drug R&D outcome 1975-1999: 13+3 / 1393 NCE’s Tropical diseases: 13 Tuberculosis: 3

7. J. Orbinski 1 -11-02 Washington Nov 1, 2002

8. J. Orbinski 1 -11-02 Washington Nov 1, 2002 Most Neglected Patients with Most Neglected Diseases Market Failure Public Policy Failure

9. J. Orbinski 1 -11-02 Washington Nov 1, 2002 Survey on company R&D spending on ID&NDs 2Malaria 5TB 9Other ID’s 1Leishmaniasis 1Chagas D 0A S Sickness R&D spending Disease Source: Fatal Imbalance report (MSF, 2001) – results from 11/20 top 20 pharma companies Top 20 PI by sales 11 responded (117 of 406 B) 7- on M & TB 7- less than 1% on ND 8- 0$ on MND

10. J. Orbinski 1 -11-02 Washington Nov 1, 2002 What does TRIPS do or not do for R&D for DNDs*? Conceptually: There is a clear overlap between TRIPS and the stimulation of R&D for drug development But which drugs for which diseases? *DND: Drugs for Neglected Diseases

11. J. Orbinski 1 -11-02 Washington Nov 1, 2002 In Principle, TRIPS does explicitly take the interests of developing nations into account: Preamble of TRIPS protection of IPR is not an end in itself, but has a functional role to play in relation to the priority objectives of public policy for which these rights were created. TRIPS should be harnessed to the service of development

12. J. Orbinski 1 -11-02 Washington Nov 1, 2002 Effect of TRIPS No + effect on RDND from Pharma but - effect in driving DW RD to N Markets Art 7/8/66: Attempt to balance the rights of patent holders and their obligations vis a vis society Safeguards ( Art 30/31) : have practical application for access to existing drugs, but

13. J. Orbinski 1 -11-02 Washington Nov 1, 2002 TRIPS safeguards do not accommodate a needs based stimulation of R&D for new drugs least of all for diseases for which there is no market.

14. J. Orbinski 1 -11-02 Washington Nov 1, 2002 Basic Problem: Private incentives to meet public ends is effective when a market exists. However, If no market, no means to meet public ends.

15. J. Orbinski 1 -11-02 Washington Nov 1, 2002 CIPR : UK Commission, Sept 2002 Focus: IPR and Health Findings (among others): Patent is a tool of Public Policy must operate to serve the greater public interest patents are failing to stimulate R&D for ND of the Developing World

16. J. Orbinski 1 -11-02 Washington Nov 1, 2002 “No Market, no Means” In South, a long-standing problem limited R&D capacity for needs-based DNDs Shrinking or non-existent R and D capacity TDR / PPPs are not sufficient responses TRIPS will exacerbate this problem of “no market no means” in the South

17. J. Orbinski 1 -11-02 Washington Nov 1, 2002 In practice, TRIPS consolidates monopolies for maximum ROI Does not ensure Southern access to new processes, products, knowledge, technology and capacity transfer. The net effect is to concentrate these in existing advanced market economies, with only secondary peripheral effects in the South.

18. J. Orbinski 1 -11-02 Washington Nov 1, 2002 Are patents alone sufficient to stimulate R&D for DNDs? Not yet!! What to do?

19. J. Orbinski 1 -11-02 Washington Nov 1, 2002 Alternatives Equity Focus: The Patient is the priority DNDi: Not-for- Profit- Initiative for RDNDs Treaty/Convention for R & D with a Global Health Security Measures

20. J. Orbinski 1 -11-02 Washington Nov 1, 2002 Drugs for Neglected Diseases Initiative Catalyzed by MSF Social Mission: MNDs of the most neglected patients Needs-driven, not for profit : Rx then Dx, Vx Not a PPP: a public response to crisis in R&D for ND TDR, Pasteur, India, Brazil, Malaysia, Africa WG, Patient Representative, MSF MSF : Feasibility Study /30 M USD / 5 yrs Pilot projects

21. J. Orbinski 1 -11-02 Washington Nov 1, 2002 R&D Treaty / convention 1. Ends / Means / Strategy 2. ENDS: Equity Based approach to redress fatal imbalance in focus of R&D distribution of R&D benefits

22. J. Orbinski 1 -11-02 Washington Nov 1, 2002 R&D Treaty / convention: MEANS Where is the scientific capacity? Where does it need to be enhanced/motiv.? Financing: Knowledge:Public domain vs private property IP can leverage access by financing production Funding though Global Health Security Measures

23. J. Orbinski 1 -11-02 Washington Nov 1, 2002 R&D Treaty / convention: Means Global Health Security Measures modified “pull” mechanisms? tax credits & deductions guaranteed purchasing Modified “Pull” Mechanisms? “orphan drug” legislation? Essential research obligations - with carrots ( 2 %) and sticks ( 4%)? International trust Fund: GFATM / GDF? Currency Transaction Tax ( Tobin)?

24. J. Orbinski 1 -11-02 Washington Nov 1, 2002 R&D Treaty / convention: Strategy Political Focus: Trade and Health at G/8 / WTO / WHO / National/ Bilaterals? Must be Concrete Advocacy - TACD, others? Public awareness government responsibility partnership with scientific community/ enlightened industry

25. J. Orbinski 1 -11-02 Washington Nov 1, 2002 R&D Treaty / convention ENDS / Means / Strategy clear focus on most neglected diseases of the most neglected patients