TRIPs and Public Health: The Unresolved Debate Tenu Avafia tralac www.tralac.org

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TRIPs and Public Health The Unresolved
DebateTenu Avafiatralacwww.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
  dont need and cant 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 worlds 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
• 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

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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