Fostering R&D and Promoting Access to Medicines (for all)

From Alma Ata, via Doha to Geneva(in 10 minutes)

Bellagio, Italy 22-26 October 2007

Ellen ‘t Hoen

Quick History

• 1975 WHO 1st Essential Medicines List(E. Lauridsen: “a peaceful revolution in international

public health”. Pharma: “.. a threat to investment in drug research”

• 1986 WHO Revised Drug Strategy (RDS)• (1986 Intellectual Property Committee (IPC)

steps up lobby to include IP in GATT)• 1996 IP concerns raised 1st time at WHA - RDS

resolution WHA49.14

WHA49.14

• WHO DG: “to report on the impact of the work of the World Trade Organization (WTO) with respect to national drug policies and essential drugs and make recommendations for collaboration between WTO and WHO, as appropriate.”

Quick History II• 1999 WHA52.38 WHO to provide support on patent

issues and update WHO’s RDS to reflect concerns with regard to new trade rules.

• 1999 Amsterdam Conference on Access• 1999 WTO Seattle - Access to Medicines on WTO

agenda– e.g. EC proposes CL for drugs on the WHO EDL

• 2001 Doha Declaration on TRIPS and Public Health (2003 August 30 decision)

• 2002 cost no longer a barrier to entry in WHO EML• 2002 UK CIPR report==> focus on access side of the debate, less on

innovation

1999 WHA52.38URGES Member States:

(1) to reaffirm their commitment to developing, implementing and monitoring national drug policies and to taking all necessary concrete measures in order to ensure equitable access to essential drugs;

(2) to ensure that public health interests are paramount in pharmaceutical and health policies;

(3) to explore and review their options under relevant international agreements, including trade agreements, to safeguard access to essential drugs;

Requests the Director-General:…(5) to strengthen and expand the provision of independent

information on market prices of startingmaterials of assured quality for production of essential drugs;…(7) to cooperate with Member States, at their request, and with

international organizations in monitoring and analysing the pharmaceutical and public health implications of relevant international agreements, including trade agreements, so that Member States can effectively assess and subsequently develop pharmaceutical and health policies and regulatory measures that address their concerns and priorities, and are able to maximize the positive and mitigate the negative impact of those agreements;

(8) to review and update the revised drug strategy to reflect current and continued challenges in the pharmaceutical sector and the principles articulated in the renewed health-for-all policy;

… this is so harmful for innovation - there will be no new drugs

Quick History III• April 2003 NGOs organise 1st International

meeting on a global framework for supporting health research and development (R&D) in areas of market and public policy failure.

• May 2003 WHA (56.27) establishes CIPIH• April 2006 CIPIH publishes its report.

– Well researched, result of a commission with wide variety of views, evidence based conclusions, linking access to innovation, and 60 specific recommendations.

==>

• “There is no evidence that the implementation of TRIPS agreement in developing countries will significantly boost R&D in pharmaceuticals on Type II and particularly Type III diseases. Insufficient market incentives are the decisive factor.”

WHO Commission on Intellectual Property, Innovation and Public Health, April 2006

Quick History IV

• 2006 (WHA 59.24) establishes Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG)

• IGWG I Dec. 2006• IGWG II Nov. 2007• IGWG to present its final report 2008 to WHA.

WHA resolution 59.24- 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;

WHA 60.30 - to encourage the development of proposals for

health-needs driven research and development for discussion at the Intergovernmental Working Group that includes a range of incentive mechanisms including also addressing the linkage between the cost of research and development and the price of medicines, vaccines, diagnostic kits and other health-care products and a method for tailoring the optimal mix of incentives to a particular condition or product, with the objective of addressing diseases that disproportionately affect developing countries;

(Global consensus minus one)

To answer the questions

1. A lot2. Current draft backtracks from CIPIH

recommendations, is weak on access issues, risks endorsing financing mechanisms simply because they exist e.g. AMC … but is open to new proposals

3. Those that de-link paying for the cost of R&D from the price of the product

4. Those that support the status quo