Upload
egbert-mills
View
217
Download
0
Embed Size (px)
Citation preview
Alternative R&D Strategies for Drugs for Neglected
Diseases:
The Case & Possible Alternatives
TACD IPR Meeting
Washington Nov 1 , 2002
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.
J. Orbinski 1 -11-02 Washington Nov 1, 2002
Lack of effective, affordable and easy-to-use medicinesExisting 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
J. Orbinski 1 -11-02 Washington Nov 1, 2002
The Most Neglected Diseases
Affect a large number of patientsNo purchasing power = no marketNo advocacy Group to plead for these patientsNo 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
Markets do not reflect health needs
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
J. Orbinski 1 -11-02 Washington Nov 1, 2002
World pharmaceutical market> $406 bn in 2002
Neglected Diseases
Most Neglected DiseasesGlobal Diseases
For R&D, there are 3 typesof diseases
J. Orbinski 1 -11-02 Washington Nov 1, 2002
Most Neglected Patients with Most Neglected Diseases
Market Failure
Public Policy Failure
J. Orbinski 1 -11-02 Washington Nov 1, 2002
Survey on company R&D spending on ID&NDs
2Malaria
5TB
9Other ID’s
1Leishmaniasis
1Chagas D
0A S Sickness
R&D spending
Disease
Source: Fatal Imbalance report (MSF, 2001) – results from 11/20 top 20 pharma companies
Top 20 PI by sales
11 responded (117 of 406 B)
7- on M & TB
7- less than 1% on ND
8- 0$ on MND
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
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
J. Orbinski 1 -11-02 Washington Nov 1, 2002
Effect of TRIPSNo + effect on RDND from Pharma
but - effect in driving DW RD to N MarketsArt 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
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.
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.
J. Orbinski 1 -11-02 Washington Nov 1, 2002
CIPR : UK Commission, Sept 2002
Focus: IPR and HealthFindings (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
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
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.
J. Orbinski 1 -11-02 Washington Nov 1, 2002
Are patents alone sufficient to stimulate R&D for DNDs?
Not yet!!
What to do?
J. Orbinski 1 -11-02 Washington Nov 1, 2002
AlternativesEquity Focus: The Patient is the priority
DNDi: Not-for- Profit- Initiative for RDNDs
Treaty/Convention for R & D with a
Global Health Security Measures
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
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
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
J. Orbinski 1 -11-02 Washington Nov 1, 2002
R&D Treaty / convention: Means
Global Health Security Measuresmodified “pull” mechanisms?
tax credits & deductionsguaranteed 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)?
J. Orbinski 1 -11-02 Washington Nov 1, 2002
R&D Treaty / convention: StrategyPolitical Focus:
Trade and Health at G/8 / WTO / WHO / National/ Bilaterals?
Must be Concrete
Advocacy - TACD, others? Public awarenessgovernment responsibilitypartnership with scientific community/ enlightened
industry
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