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TRIPs and Public Health: The Unresolved Debate
Tenu Avafiatralac
www.tralac.org
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“We are simply asking for fair and equitable rules that would
take into account our development needs... But instead we risk
being pressured once again into accepting rules we don’t need
and can’t afford …”
Ambassador Nathan Irumba, Mission of Uganda and
Representative of Least Developed Countries at the WTO
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Public health situation in sub-Saharan Africa
Sub-Saharan Africa has 10% of world’s population but is home to 70% of all cases of HIV/AIDS
South Africa alone has 5.3 million people living with HIV/AIDS, more than North, South America, West-Indies, Western,& Central Europe, Australia combined
Swaziland went from 4% infection rate in 1992 to 38.8% in 2004
Life expectancy dropped in southern Africa by 29 years on average because of HIV/AIDS
Other pandemics e.g. malaria and tuberculosis still rampant
Of the estimated 1 000 000 malaria deaths that occur yearly in the world, 90% are in Africa, mostly children
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Impact of Doha Declaration and 30 August
Use of generics drugs is vital for the treatment of public health pandemics in Africa
Most sub-Saharan African countries have begun modest programmes treating PWAs using both patented and generic products
Levels of treatment still very low with less than 10% of PWAs needing ART Doha declaration on TRIPs and Public Health was a landmark moment for
developing countries with generic capacity 30 August WTO General Council Decision expressly allowed developing
countries without manufacturing capacity to import generics produced under compulsory license
WTO notification mechanism under 30 August has not been used to date for the possible reasons:
i) Mechanism deemed to be administratively burdensome ii) Fears of adverse impact on aid and FDI; and iii) lack of capacity to comply with Decision e.g. to prevent re-
exportation
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Implications of developments with India and escalation of bilaterals
India India has been the primary supplier of generics to African countries of essential
medicines Indian parliament passed patent Act in March 2005 to comply with TRIPs Full effect of Patents Act will only be known in due course, mailbox system and when
new drugs are required by ART patients Potentially problematic aspects of Act include:
i) 3 year waiting period for new drugs before compulsory licenses can be issued;
ii) Ambiguous provision around compulsory licensing which could result in lengthy litigation
iii) No provision on royalty rates to be paid to patent holders in the event of a compulsory license
Bilaterals
▪ African countries involved in bilateral discussions that might impact negatively on use of generic essential medicines
▪ SACU currently involved in negotiations with EFTA, and US, most countries involved in EPA negotiations
TRIPs plus provisions have been a feature of IP Chapters in FTAs
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TRIPs Council Negotiations and African countries
TRIPs and public health issues still on TRIPs Council agenda
Negotiations centering on finding a permanent solution to 30 August
Agreement
Deadline agreed set by Secretariat was 31 March 2005
Rwanda and Nigeria both made recent proposals at TRIPs Council
Luke warm reaction to African proposals by developed countries
Deadline missed after heated meeting, new deadline set for General
Council meeting
Concern has been expressed that failure to resolve the matter might
adversely impact on Hong Kong Ministerial in December
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Where to for African countries?
Work with pharmaceutical companies to devise ways to prevent re-
exportation of generics e.g. initiatives undertaken between GSK and
Kenya
Legislative amendments still need to occur in some countries to
make use of TRIPs flexibilities e.g. compulsory licensing
Investment in local capacity in countries where possible e.g. South
Africa
Some countries have issued compulsory licenses e.g. Mozambique,
Cameroon with government use
Permanent solution to Article 31 at TRIPs Council negotiations
Required vigilance before entering into ‘TRIPs plus’ commitments at
a bilateral level e.g. US-Morocco FTA provisions