Technical Briefing Seminar for Consultants on Procurement and Supply Management

for HIV/AIDS, TB and Malaria

Copenhagen, Denmark

30 January-02 February 2005

Béchir N’Daw, UNAIDS Secretariat

Africa: disease versus health workforce

Africa's Burden of Diseases Africa's HIV Treatment Burden

Africa's Share of the World's Health Workforce

1.8 %

25% 69%

We are getting closer: The year 2000 price shift and beyond

Price reductions of a first line ARV regimen in Uganda

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Prices (US$/year)of a first-line antiretroviral regime in Uganda: 1998-2003

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Differential pricing

Generic competition

Voluntary licensing

Flexibilities in TRIPS

High volume purchases

Local production

Elimination of tariffs and taxes

… a combination of strategies to obtain affordable medicines:

Global Fund to Fight AIDS, Tuberculosis and Malaria

Report 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.

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

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)

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

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)

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

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

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

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".

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