Copenhagen, Denmark 30 January-02 February 2005 Béchir N’Daw, UNAIDS Secretariat

1. Technical Briefing Seminar for Consultants on Procurement and Supply Managementfor HIV/AIDS, TB and Malaria Copenhagen, Denmark 30 January-02 February 2005 Béchir N’Daw, UNAIDS Secretariat

2. Africa: disease versus health workforce Africa's HIV Treatment Burden Africa's Burden of Diseases 25% 69% Africa's Share of the World's Health Workforce 1.8 %

3. We are getting closer: The year 2000 price shift and beyond Prices (US$/year)of a first-line antiretroviral regime in Uganda: 1998-2003 Launch of Accelerating Access Initiative (AAI) Negotiation with R&D Pharma within AAI Generic companies offer of price reduction to Uganda Negotiations with J. Clinton Foundation with 4 genetic companies Price US$ Further discussion with Generics Further price reductions by R&D Further discussion with Generics Oct-00 Nov-00 Sept-03 Jun-01 Oct-03 Feb-01 Dec-00 Apr-01 Mar-03 Jan-01 Mar-01 Jul-01 Jul-98 Sep 98 Aug-01 May-01 Aug-98 Jun-98 June 2000 Price reductions of a first line ARV regimen in Uganda

4. … a combination of strategies to obtain affordable medicines: • Differential pricing • Generic competition • Voluntary licensing • Flexibilities in TRIPS • High volume purchases • Local production • Elimination of tariffs and taxes

5. Global Fund to Fight AIDS, Tuberculosis and MalariaReport of the Third Board Meeting(10-11 October 2002) • C. PROCUREMENT AND PRICING • … • 10. Lowest possible price • … The Fund encourages Recipients to comply with national laws and applicable international obligations in the field of intellectual property including the flexibilities provided in the TRIPS agreement and referred to in the Doha Declaration in a manner that achieves the lowest possible price for products of assured quality.

6. The TRIPS Agreement • Granted for a minimum of 20 years • Compliance with required standards • Effective use of TRIPS flexibility depend upon national legislation • Authorization to produce, sale and import the patented product or process without the consent of the patent holder

7. Grounds for using Compulsory Licensing • Public non-commercial use/Government use • National emergency • Circumstances of extreme urgency • Voluntary license from the patent holder on reasonable commercial terms (Art. 31b) • Anti-competitive practices (Art. 8; 40)

8. Use of the TRIPS flexibilities Granting of Compulsory Licences - Article 31 • Indonesia (Oct 2004) for lamivudine (Glaxo) and nevirapine (BI) • Malaysia (Oct 2003) for didanosine (BMS), zidovudine (Glaxo) and lamivudine-zidovudine (Glaxo) • Mozambique for lamivudine (Glaxo), stavudine (BMS) and nevirapine (BI) • Zambia for lamivudine, stavudine and nevirapine • Zimbabwe – for ARVs in general

9. Parallel Imports • Purchasing drugs at a lower price • To promote pricing equity by authorizing importation of a patented product • Principle of international exhaustion of rights (Art. 6)

10. The Doha Declarationon the TRIPS Agreement and Public Health(Doha, Qatar - November 2001) • Primacy of public health in international trade • “… the Agreement can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all.” (Paragraph 4) • Reaffirmed WTO Members ability to use the flexibilities of the TRIPS Agreement

11. Doha - Importing under Compulsory Licensing • “Each Member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted”. (Paragraph 5 a.) • Paragraph 6 issue - “ … predominantly for the supply of the domestic market” - TRIPS Art. 31 (f) • Transition period for least developed country Members to provide patent protection for pharmaceutical products extended to 2016

12. WTO 30 August Decision of 2003 • “… allows any member country to import and export pharmaceutical products made under Compulsory Licences within the terms set out in the decision » • Amendment allowing export of generic pharmaceuticals under a Compulsory License • To help WTO Members with insufficient manufacturing capacity

13. World Health Assembly resolutions • Resolution WHA57.27 in May 2003 expressed "concerns about the current patent protection system, especially as regards access to medicines in developing countries", and urged Member states to "adapt national legislation in order to use to the full the flexibilities contained in the TRIPS Agreement" • Resolution WHA57.14 of 22 May 2004 urged Member States to "encourage that bilateral trade agreements take into account the flexibilities contained in the WTO TRIPS Agreement and recognized by the Doha Ministerial Declaration on the TRIPS Agreement and Public Health".

14. Intellectual Property Rights provisions in FTAs A TRIPS-plus world? • Adoption of more stringent IPR regime – beyond 20 years • Undermine the TRIPS flexibilities, Doha Declaration and the WTO 30 August Decision • Limit or delay access to affordable medicines • Data exclusivity for pharmaceutical test data • Drug Regulatory Authorities to enforce patents