The World Health Organization Negotiation on Public Health, Innovation, and Intellectual Property

In April 2006, WHO released a report by the Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH Report).

The WHO Intergovernmental Working Group (IGWG) on Public Health, Innovation and Intellectual Property was established in 2006 by WHA Resolution 59.24 and tasked with producing a "global strategy and plan of action" with the goal of "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." 

A Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property was adopted in May 2008 by WHA resolution 61.21

In November 2008, a results-oriented and time-limited Expert Working Group (EWG ) on R&D Financing was established. The group has the mandate to examine current financing and coordination of research and development, as well as proposals for new and innovative sources of funding to stimulate research and development related to Type II and Type III diseases and the specific R&D needs of developing countries in relation to Type I diseases.

The B&B&B&S proposals , Important Dates,  KEI Documents, Member State Submissions, Non-government interventions, News reports

BANGLADESH, BARBADOS, BOLIVIA AND SURINAME SUBMISSIONS TO THE WHO

April 2009 the governments of Bangladesh, Barbados, Bolivia and Suriname (B&B&B&S) presented 5 proposals to the Expert Working Group (EWG ) on R&D Financing =  

Bangladesh, Barbados, Bolivia, and Suriname Proposal 1: Chagas Disease Prize Fund for the Development of New Treatments, Diagnostics and Vaccines

Bangladesh, Barbados, Bolivia, and Suriname Proposal 2 : A Prize Fund to Support Innovation and Access for Donor Supported Markets: Linking Rewards for Innovation to the Competitive Supply of Products for HIV-AIDS, TB, Malaria and Other Diseases for Humanitarian Uses.

Bangladesh, Barbados, Bolivia, and Suriname Proposal 3 : Proposal for WHO Discussions on a Biomedical R&D Treaty.

Bangladesh, Barbados, Bolivia, and Suriname Proposal 4 : Prize Fund for Development of Low-Cost Rapid Diagnostic Test for Tuberculosis.

Bangladesh, Bolivia, and Suriname Proposal . Prizes as a Reward Mechanism for New Cancer Treatments and Vaccines in Developing Countries.

BACKGROUND: These proposals are based in part in 6 proposals that the governments of Barbados and Bolivia submitted to the IGWG negotiation on April 2008 in response to resolution WHA 60.30

Maryam Karga-Hinds, Director of the Barbados Drug Service. "The 2Bs Proposal (Barbados & Bolivia)" (pdf , ppt ). April 2008 Presentation at the KEI Consultation on the WHO IGWG II bis negotiations.

Original BARBADOS & BOLIVIA SUBMISSIONS TO THE WHO/IGWG

2008 April.  Working Document Proposed by Bardados and Bolivia

Proposal 1: Prize Fund for Development of Low-Cost Rapid Diagnostic Test for Tuberculosis 

Proposal 2: Prize Fund for the Development of New Treatments for Chagas Disease

Proposal 3: Priority Medicines and Vaccines Prize Fund (PMV/pf)

Proposal 4: Prizes as a Reward Mechanism for New Cancer Treatments

Proposal 5: A Licensed Products Prize Fund (LP/pf) for Donors 

Proposal 6: Clinical Trials on Medicines as Global Public Goods

IMPORTANT DATES :

2008 November: Expert Working Group (EWG ) on R&D Financing Established

2008 May 24: Global strategy and plan of action approved by the 61st  World Health Assembly.

WHA 61.21 with Global Strategy and Plan of Action (in Spanish ) 

Comments at the conclusion of the WHA/IGWG

IGWG bracketed text that was negotiated at the 61st WHA

2008 April 28/ May 3: Continuation of IGWG Second meeting

2008 May 3. White Paper. IGWG Draft Plan of Action 

2008 May 3. White Paper. IGWG outcome document at 14.00 hours. Draft global strategy on public health, innovation and intellectual property

Comments of negotiators, NGOs and industry at the conclusion of IGWG II bis

2008 March 17-19: IGWG meeting on the Plan of Action. Link to documents.

2007 November 5-10: IGWG Second meeting in Geneva. Links to documents including Draft Global Strategy and Plan of Action. 

2007 August/September: Web Based Second Public Hearing. Many groups offer submissions for consideration, see KEI submissions below. IP watch article.

2007 May: 60th WHA passes Brazil proposed resolution on "Public health, innovation and intellectual property" WHA 60.30

2006 December 4-8:  IGWG First meeting in Geneva. Links to documents including Elements of a Global Strategy and Plan of Action.

2006  November 1-15: Web Based First Public Hearing. Many groups offer submissions for consideration, see KEI/CPTech submission below.

2006 May 2006: 59th WHA passes Kenya & Brazil resolution 59.24, calling for the establishment of an Intergovernmental Working Group to draw up a global strategy and plan of action based on the recommendations of the CIPIH, including researching a new framework to support sustainable, needs-driven, essential R&D work on diseases that disproportionately affect developing countries.

2006  April: The CIPIH issues its report. The final report includes many compromises, but reaches some important conclusions (highlights).

2006 January: Kenya submits a background document for its proposed resolution, and 285 scientists from 51 countries, including 5 Nobel Prize winners send a letter to the WHO Executive Board supporting the Kenyan resolution. On January 24, Brazil joins with Kenya in submitted a revised draft resolution proposed a WHO initiative to create a bold new global framework for essential health R&D.

2005 November: the Republic of Kenya submits a draft resolution to the 117th Session of the WHO Executive Board for the establishment of a working group to examine global health priorities for medical research and development. For more information, see CPTech website on 117th WHO Executive Board .

2004 February: A group of 162 scientists, economists, doctors, public health experts, members of parliament, and other experts sends a letter to the WHO Executive Board and to CIPIH requesting an evaluation of proposals for a medical R&D treaty.

2003 May: 56th WHA passes resolution 56.27, establishing the Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH). For more information, see CPTech website on the CIPIH Commission.

KEI DOCUMENTS :

KEI blog posts on the IGWG negotiation

2009 May. James Love. KEI conclusions to the 62nd World Health Assembly.

2009 April. James Love. KEI submission to the Expert Working Group on R&D Financing

2008 May. James Love. KEI Statement on WHA/IGWG resolution

2007 November. KEI Staff Statements on the IGWG II negotiation 

2007 November. Judit Rius Sanjuan. KEI summary of IGWG II (in Spanish )  

2007 November. KEI on US demarche IGWG 

2007 September. Jamie Love. KEI submission to Second Public Hearing: The role of prizes in stimulating R&D

2007 September. Manon Ress. KEI submission to Second Public Hearing: Collective Management of Intellectual Property -- The Use of Patent Pools to Expand Access to Needed Medical Technologies

2007 September. Spring Gombe. KEI submission to Second Public Hearing: Comments to the Draft Global Strategy and Plan of Action

2007 May. Thiru Balasubramaniam. KEI statement on adoption of WHA resolution "Public health, innovation and intellectual property"

2007 May. Judit Rius Sanjuan. WHO IGWG (in Spanish)

2006 December. James Love. Letter asking for reform of WHO's Essential Medicines List. IP Disputes in Medicine.

2006 November. Consumer Project on Technology. Submission to the IGWG Public Hearing (summary).

2006 May. James Love. "A new initiative at the WHO, Prizes rather than prices." Le Monde diplomatique.

2006 March. James Love. Real Health News no.4. WHO to Debate Global R&D "Framework."

2006 March. James Love. Working Agenda. At April 28 WHO EB meeting, Brazil proposes work on R&D Treaty.

2006 January. CPTech Statement on WHO EB Resolution on Global Framework for Essential Health R&D.

MEMBER STATES SUBMISSIONS :

2009 April: Member States proposals to the EWG

2008 April:  Working Document Proposed by Bardados and Bolivia.

2007 October:  Member States and Regional/Sub-regional positions and reports in preparation for the second meeting of the IGWG. Available here

2007 February: After the First IGWG meeting on december 2006, It was agreed that additional submissions on the plan of action and global strategy would be provided by Member States to the Secretariat by the end of February 2007. Member State submissions are available here
 

NON-GOVERMENT INTERVENTIONS AT IGWG Negotiation:

June 2009. Civil society Letter to the Members of the EWG

61st WHA
2008 May 24. James Love. KEI Statement on WHA/IGWG resolution (in Spanish ) 

2008 May 24. Clio Van Cauter. Medecins sans Frontieres Statement at the close of the 61st World Health Assembly

2008 May 24. Sarah Rimmington. Essential Action Comment Re Completion of IGWG (in Spanish)

IGWG II bis

2008 May 1. James Love. KEI statement to resumed IGWG II bis 

2008 May 1. James Arkinstall. Medecins Sans Frontieres intervention at IGWG 2.2 

2008 May 1. Sarah Rimmington. Statement of CMC - Churches' Action for Health at WHO IGWG II bis

2008 May 1. Christian Wagner. HAI statement on IGWG

IGWG II 

2007 November 8. James Love. KEI comments to IGWG 2

2007 November 8. Michel Lotrowska. MSF comments to IGWG 2

2007 November 8. Mogha Kamal Smith. Oxfam comments to IGWG 2 

60th WHA 

2007 May 21. Thiru Balasubramaniam. 60th WHA. Statement by Christian Medical Commission (CMC) Churches Action for Health and other organizations including Knowledge Ecology International (KEI), Health Action International and the Medecins sans Frontieres Access to Essential Medicines Campaign. 2006

IGWG I 

2006 December 8. IGWG Statement by Holy See Delegation.

2006 December 7. Michelle Childs. IGWG Statement by Consumers International.

2006 December 6. Dr. Bernard Pecoul. IGWG Statement by DNDi.

2006 December 5. IGWG Statement by Consumers International.

2006 December 5.  IGWG Submission by Churches' Action for Health.

2009 May 22. Malini Aisola for Indian Express. WHO gets what role

2008 July. Judit Rius Sanjuan for Puentes. Propiedad Intelectual y Salud: Un nuevo rol para la OMS? .

2008 May 29. IP Watch. WHO Adopts ‘Most Important Document Since Doha’ On IP And Public Health

2008 May 28. Bridges.  WHO adopts Strategy on Public Health, Innovation and Intellectual Property . 

2008 May 25. Sangeeta Shashikant for SUNS. WHA strengthens WHO's mandate on IP and Health

2008 May 24. IP Watch. Debate Surrounds Final WHO Global Strategy, Action Plan On IP And Health

2008 May 24. Reuters. WHO bridges rich-poor intellectual property split 

2008 May 6. IP watch. WHO IP And Health Group Concludes With Progress; Tough Issues Remain For Assembly  

2008 May 5. FT.com. WHO fails to strike drug deal  

2008 May 2. IP watch. WHO Members Inch Toward Consensus On IP, Innovation And Public Health

2007 November 14. Scripnews/ Informa UK. Talks on developing world diseases stall to 2008

2007 November 10. IP watch. WHO IP And Health Group Ends Meeting With Substantive Progress

2007 November 10. Reuters. Time runs out on talks on drugs for poor countries

2007 November 9. IP watch. WHO IP And Health Group Turns To IP; Meeting To Continue In 2008

2007 November 9. IP Watch. WHO Session On IP And Health Clashes On Vision, Practicalities

2007 November 8. Science Business. Patent pools: should pharma share IP with the developing world?

2007 November 8. IP Watch. Report Finds Significant Industry Affiliation in IGWG ‘NGO’ Comments

2007 November 7. Bridges Weekly. WHO committee on drug innovation and prices underway in Geneva 

2007 November 6. Agencia EFE. México modifica postura en acceso a medicinas y se alinea con EEUU, según ONG

2007 November 6. Financial Times. Drive to change patent regime for medicines

2007 November  6. WSJ Blog. Avery Johnson. WHO Mulls Patent Changes and Prizes for Needed Drugs

2007 November 5. AP. WHO Aims to Balance Drug Companies, Poor

2007 October 10. IP Watch. UN Talks On Public Health Access and Innovation Face Challenges (in spanish here and in French here )

2007 August 8. IP Watch. WHO Draft Negotiating Text On IP Cautiously Received

2007 August 1. Liberation. Le Kenya propose un fonds mondial pour faciliter l’accès des pays pauvres aux médicaments

2007 May 23. Bridges Weekly Trade News Digest. WHO Members Adopt Resolution On Pharmaceutical Innovation  

2007 May 23. IP Watch. World Health Assembly Agrees On IP And Innovation; US Abstains

2006  December 13. Bridges Weekly Trade News Digest. WHO Group on Health, Innovation, and Intellectual Property Holds First Meeting.

2006 December 11. Tove Iren S. Gerhardsen.US Advises Developing Country FTA Partners Not To Follow WHO IP Plan

2006 December 11. Tove Iren S. Gerhardsen.WHO Group Lays Foundation For Global Neglected Diseases R&D Plan.

2006 December 8. Lancet Editorial. Global strategies need truly global discussions. Lancet.

2006 December 5. Tove Iren S. Gerhardsen. Cautious Start For WHO IP Working Group As Members Feel Their Way. IP-Watch.

2006 December 5. Laura MacInnis. U.N. health agency launches pharmaceuticals review. Reuters.

2006 December 1. Martin Enserink. DRUG RESEARCH: WHO Panel Weighs Radical Ideas. Science. Vol. 314. no. 5804, p. 1373.

2006 November 16. Consultation On WHO IP Group Shows Polarised Debate; Challenge For Group.

2006 February 1. Bridges Weekly Trade News Digest. WHO Addresses Trade, Health, IP, and Innovation.

2006 January 30. Frances Williams for the Financial Times. WHO to decide on medical R&D.

2006 January 29. Sangeeta Shashikant for SUNS. R&D resolution, with brackets, to be transmitted to World Health Assembly.

2006 January 27. Tove Iren S. Gerhardsen for IP Watch. WHO Board Wrestles With IP And Public Health Report, R&D Proposal.

2006 January 27. Kaiser News Network. Scientists Call on WHO To Support Increased Funding for Neglected Diseases, Including HIV, TB, Malaria.

2006 January 26. Kanaga Raja for SUNS. Public support for Kenya-Brazil move at WHO on health R&D.

2006 January 25. Reuters. Scientists ask WHO to boost 'neglected' disease R&D.

2006 January 25. Kuwait News Agency. Doctors without Borders calls for support for research on neglected diseases.

2006 January 24. Tove Iren S. Gerhardsen for IP Watch. R&D Resolution Formally Submitted To WHO Board Meeting.