Alternative%20R

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Alternative RD Strategies for Drugs for
Neglected Diseases The Case Possible
Alternatives
TACD IPR Meeting Washington Nov 1 , 2002
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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 gt50 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.

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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 RD

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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 RD allocated to tropical
  diseases ( 10 / 90 Gap)
• RD activity for Diseases of the South Virtual
  Standstill ( 1 / 100 Gap)
• Virtually empty Rx Development pipeline

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Markets do not reflect health needs
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Drug RD outcome

• 1975-1999 133 / 1393 NCEs

Tropical diseases 13
Tuberculosis 3
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(No Transcript)
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Most Neglected Patients with Most Neglected
Diseases

• Market Failure
• Public Policy Failure

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Survey on company RD spending on IDNDs
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
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What does TRIPS do or not do for RD for DNDs?

•  Conceptually
•  
• There is a clear overlap between TRIPS and the
  stimulation of RD for drug development
• But which drugs for which diseases?

DND Drugs for Neglected Diseases
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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

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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  

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TRIPS safeguards

• do not accommodate a needs based stimulation of
  RD for new drugs
• least of all for diseases for which there is no
  market.

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Basic Problem

• Private incentives to meet public ends is
  effective when a market exists.  However,
• If no market, no means to meet public ends.

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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 RD for ND of
  the Developing World

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No Market, no Means

• In South, a long-standing problem
• limited RD 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

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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.

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Are patents alone sufficient to stimulate RD for
DNDs?

• Not yet!!
• What to do?

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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

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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 RD for
  ND
• TDR, Pasteur, India, Brazil, Malaysia, Africa WG,
  Patient Representative, MSF
• MSF Feasibility Study /30 M USD / 5 yrs
• Pilot projects

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RD Treaty / convention

• Ends / Means / Strategy
• ENDS
• Equity Based approach to
• redress fatal imbalance in
• focus of RD
• distribution of RD benefits

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RD Treaty / convention MEANS

• Where is the scientific capacity?
• Where does it need to be enhanced/motiv.?
• Financing
• KnowledgePublic domain vs private property
• IP can leverage access by financing production
• Funding though Global Health Security Measures

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RD 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)?

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RD 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

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RD Treaty / convention

• ENDS / Means / Strategy
• clear focus on most neglected diseases of the
  most neglected patients