Alexandra Heumber

Médecins Sans Frontières

Access to Essential Medicines Campaign

Alexandra.heumber@msf.org

www.accessmed-msf.org

DEBRIEFING WHA May 2006

Essential Health R&D Access to medicines

July 6th, 2006

MSF Campaign Access to essential medicines in ’99 because:

• People do not have access because medicines that exist are priced out of reach

• Predominant paradigm Patent/High Price (TRIPs) driven

• Medicines that exist were not produced or production was threatened because of lack of viable market

• We cannot offer treatment because appropriate or adapted treatments do not exist. We call this the crisis on neglected disease research

Essential Health R&DAccess to medicines issue

The fatal imbalance - the situation in 1999 -

Tropical diseases: 13

Tuberculosis: 3

• 1975-1999: 1,393 new chemical entities marketed

• Only 1% of new drugs developed are for neglected diseases

Fatal Imbalance: any significant change since 1999?

• 1999-2004: 163 additional new chemical entities but only 3 new drugs for neglected diseases

• Expected PDP output: 8-9 drugs in 5 years -

no dramatic change to the fatal imbalance in 1999!

Tropical diseases: 16

Tuberculosis: 3

Trouiller et al., Lancet 2002, 359:2188-94; updated figures: Torreele, Chirac 2005

11.4% of total disease burden

1975 – 2004: 1556 new chemical entities marketed, of this

• Predominant paradigm: Patent (TRIps)/ High Price driven

• Neglected diseases Crisis: not only TB, Malaria, HIV/AIDS.

“Disease that disproportionately affect developing countries” Definition. Type I, II, III diseases. CIPIH report

• Innovation definition

“3D”: Discovery, Development, Delivery. CIPIH report

• Are the current initiatives are sufficient to bring the new drugs, vaccines , diagnostic tools that will respond to these critical health needs ?

Insufficient current initiatives : PPPs, Governments funding

Need to find additional mechanisms

The GAPs / The Question

WHA OutcomeOverview

WHO CIPIHReport Apr. 06 WHA Resolution May 27, 2006 A59/24

« Public Health, innovation, essential health research

and IPRs: towards a global strategy and plan of actionKenya-Brazil Proposal

Global Framework on Essential Health R&D. WHO EB Jan. 06

CIPIH Proposal EB Apr. 06 Intergovernmental Working Group- WHO leadership

To set up a Global Strategy and plan of action for improving access to medicines based on CIPIH report.Such a strategy and plan of action aims at:- Securing an enhanced and sustainable basis for: needs driven, essential health R&D relevant to diseases that disproportionately affect developing countries- Proposing clear objectives and priorities for R&D- Estimating funding needs in this area

IGW: ?• Who ?2 countries per

WHO Regions + EU+

Industry + NGOs

Chair ? WHO HTP Unit•When? 1st meeting

December ?

HOW to ensure an efficient process and outcome of this IGW to really address the access to medicines issue ?

The resolution

WHA resolution 59/24 § 3 (1):- to establish, in accordance with Rule 42 of the

Rules of Procedure of the World Health Assembly, an intergovernmental working group open to all interested Member States to draw up a global strategy and plan of action in order to provide a medium-term framework based on the recommendations of the Commission. Such a strategy and plan of action aims at, inter alia, securing an enhanced and sustainable basis for needs-driven, essential health research and development relevant to diseases that disproportionately affect developing countries, proposing clear objectives and priorities for research and development, and estimating funding needs in this area;

The key points: the framework ?

• Important of a GLOBAL plan of action: major international and collaboration.

• Need to be driven by real needs. Priority setting.

• Very strong role to the government and WHO. Political responsibilities

• Need to address the way essential R&D is financed: needs really deliver not only declaration of intention

The EC participation ?Before WHA

• 64 MEPs called on the Commission and the Council to support any initiative or resolution put forward at the WHA that defines government responsibility in setting health priorities and help achieve the goal of putting in practice a framework for ensuring sustainable health research and development that responds to, and is steered by, health needs, and results in affordable essential health products.

• Letter of Commissioner Kyprianou : welcomes the K-B initiative through his letter addressed to the MEPs on March 06

The EC participation ?Following the WHA- IGW

• Ensuring an efficient collaboration between the DGs involved (Sanco, Research, Development)

• Ensuring that Public Health concerns prevails over the others (Trade/IPRs)

• Identifying the gaps of the current EC initiatives (EDCTP restrictive mandate, Lack of EC funding for drug PPPs EC<1%) and elaborating plan to address them.

• Ensuring transparency of the EC’ participation to the IGW

• Ensuring Member States speak for themselves

The EC participation ?Following the WHA- IGW

DG Sanco

Official lead

DG Research

EDCTP: extend the mandate ?

IMI

FP7th / Budget Line Financial Perspective (INCO) ?

DG Dev• WHO-EC Strategy Partnership (pharmaceutical part) : to introduce the Health R&D issue ?

? Possible EC actions in order to ensure sustainable funding to neglected diseases in view of the participation to the IGW ?

EPe.g. Devpt

Committee’s

question to the EC

The IPRs /Access to medicines concerns

• Reference to the Free Trade Agreements Issue

• Global plan and strategy “based on the CIPIH recommendations”: which ones will be , apart the Health R&D issue ?

CONCLUSION

• Determination of the IGW’s composition and exact mandate in the coming months

• Importance of the NGOs’ participation to the process of the IGW, notably before the first meeting