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TACD IPR Meeting Washington Nov 1 , 2002

Alternative R&D Strategies for Drugs for Neglected Diseases: The Case & Possible Alternatives. TACD IPR Meeting Washington Nov 1 , 2002. Neglected Diseases. Chronic Crisis Enduring medical need because of the limited availability of pharmaceuticals

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TACD IPR Meeting Washington Nov 1 , 2002

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

  2. 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. Washington Nov 1, 2002

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

  4. 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 Washington Nov 1, 2002

  5. Markets do not reflect health needs

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

  7. Washington Nov 1, 2002

  8. Most Neglected Patients with Most Neglected Diseases • Market Failure • Public Policy Failure Washington Nov 1, 2002

  9. Disease R&D spending Other ID’s 9 Malaria 2 TB 5 A S Sickness 0 Chagas D 1 Leishmaniasis 1 Survey on company R&D spending on ID&NDs 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 Source: Fatal Imbalance report (MSF, 2001) – results from 11/20 top 20 pharma companies Washington Nov 1, 2002

  10. 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 Washington Nov 1, 2002

  11. In Principle, • TRIPS doesexplicitly 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 Washington Nov 1, 2002

  12. 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 Washington Nov 1, 2002

  13. 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. Washington Nov 1, 2002

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

  15. 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 Washington Nov 1, 2002

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

  17. 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. Washington Nov 1, 2002

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

  19. 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 Washington Nov 1, 2002

  20. 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 Washington Nov 1, 2002

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

  22. 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 Washington Nov 1, 2002

  23. 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)? Washington Nov 1, 2002

  24. 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 Washington Nov 1, 2002

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

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