TRIPs and Public Health: The Unresolved Debate Tenu Avafia tralac tralac

1. TRIPs and Public Health: The Unresolved DebateTenu Avafiatralacwww.tralac.org

2. “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

3. 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

4. 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

5. 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: • 3 year waiting period for new drugs before compulsory licenses can be issued; • Ambiguous provision around compulsory licensing which could result in lengthy litigation • 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

6. 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

7. 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