alternative r&d strategies for drugs for neglected diseases: the case & possible...

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