Transcript Access to Essential Medicines: Global Overview and the Case of

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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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:
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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 R&D
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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 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
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Markets do not reflect health needs
Drug R&D outcome
1975-1999: 13+3 / 1393 NCE’s
Tropical diseases: 13
Tuberculosis: 3
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Most Neglected Patients with
Most Neglected Diseases
Market Failure
Public Policy Failure
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Survey on company R&D spending
R&D
on ID&NDs
Disease
spending
Top 20 PI by sales
Other ID’s
11 responded (117 of 406 B) Malaria
9
2
7- on M & TB
TB
5
7- less than 1% on ND
A S Sickness
0
8- 0$ on MND
Chagas D
1
Leishmaniasis
1
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 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
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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 R&D for new drugs
least of all for diseases for which there is
market.
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no
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
R&D for ND of the Developing
World
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“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
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In practice, TRIPS consolidates
monopolies for maximum ROI
Does not ensure Southern access to
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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 R&D 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 R&D for ND
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TDR, Pasteur, India, Brazil, Malaysia, Africa WG, Patient
Representative, MSF
MSF : Feasibility Study /30 M USD / 5 yrs
Pilot projects
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R&D Treaty / convention
1. Ends / Means / Strategy
2. ENDS:
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Equity Based approach to
redress fatal imbalance in
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focus of R&D
distribution of R&D benefits
Washington Nov 1, 2002
R&D Treaty / convention: MEANS
Where is the scientific capacity?
Where does it need to be enhanced/motiv.?
Financing:
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Knowledge:Public domain vs private property
IP can leverage access by financing production
Funding though Global Health Security Measures
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R&D Treaty / convention:
Means
Global Health Security Measures
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modified “pull” mechanisms?
tax credits & deductions
 guaranteed purchasing
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Modified “Pull” Mechanisms?
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“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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R&D Treaty / convention: Strategy
Political Focus:
Trade and Health at
 G/8 / WTO / WHO / National/ Bilaterals?
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Must be Concrete
Advocacy - TACD, others?
Public awareness
 government responsibility
 partnership with scientific community/
enlightened industry
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R&D Treaty / convention
ENDS / Means / Strategy
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clear focus on most neglected diseases of
the most neglected patients
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