WHO work on globalisation and access to medicines: an overview

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WHO work on globalisation and access to
medicines an overview

• Germán VelásquezDept. of Essential Drugs and
  Medicines PolicyWorld Health Organization
• Washington June, 2004

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• Access to essential medicines Background
  1997-2004

WHO technical cooperation
Future challenges
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WHO policy perspectives on access to medicines

• Access to medicines is part of the human right to
  health
• Essential medicines cannot be regarded as simply
  another commodity
• The affordability of essential medicines is a
  public health priority
• Adequate and appropriate incentives are needed to
  ensure RD for new medicines

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Access to essential medicines depends upon

• Affordable prices
• Rational selection and use
• Sustainable adequate financing
• Reliable health and supply systems

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Too many people still lack access to essential
medicines

• More than 1/3 of worlds population lack regular
  access
• In Africa less than 50 of the population have
  regular access

Percentage of populations and number of countries
with regular access to essential drugs
lt50
43
64
50-80
80-95
30
gt95
41
1
No data available
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Background 1997 2004

• Since 1999, three WHA resolutions have given WHO
  the mandate to
• Assist Member States to develop medicines and
  health policies related to international
  agreements
• 2. Monitor, analyse, study and report on health
  implications of international trade agreements
• 3. Produce an analysis of IPR, innovation, and
  public health, including appropriate funding and
  incentive mechanisms for the creation of new
  medicines

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• Access to essential medicines Background
  1997-2004

WHO technical cooperation
Future challenges
8
Policy guidance and information support

• DG's speeches
• WHO Medicines Strategy
• More than 20 WHO publications and related
  documents - available from WHO/EDM Documentation
  Centre (contact darec_at_who.int)

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WHO programme of work on pharmaceuticals and trade

• Guidance on cost-containment mechanisms for
  essential medicines, including ARVs
• Training and briefings on TRIPS safeguards
• Advice on the revision of national pharmaceutical
  legislation, e.g. in Brazil, Cambodia, P.R.
  China, Colombia, Indonesia, Kenya, Thailand
• Organization of inter-ministerial meetings
  (health, trade, patent office) on globalization,
  IPRs, and access to medicines, e.g. national
  meetings, ASEAN, SADC, and WHO regional meetings
• Others, e.g. Priority Medicines Project for EU
  and the world

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Cooperation with international organizations

• WTO
• WIPO
• UNCTAD
• UNDP

• UNAIDS
• UNICEF
• South Centre
• NGOs

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Monitoring the effects of globalization on access
to medicines

• 2003 World Medicines Survey includes section on
  IPR and marketing authorization responses from
  145 Member States received
• Network for monitoring the impact of
  globalization and TRIPS on access to medicines
• 4 WHO Collaborating Centres Brazil, Spain,
  Thailand and the UK
• Defining standard monitoring tools, methods, and
  selected indicators
• Data collection from 12 countries on the use of
  TRIPS safeguards

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WHO policy and technical support on TRIPS to over
70 countries

Meeting on TRIPS in OAPI countries (Yaoundé, May
2002)
Meetings on globalization, TRIPS access to
medicines (Jakarta, May 2000 and May 2003)

Briefing on TRIPS (SADC) South Africa, June 2000)
Workshop on TRIPS (Harare, August 2001)

Participants of both South Africa and Harare
meetings

Inter-country meeting on the TRIPS Agreement
(Warsaw, September 2001)

Country support guidance on cost containment
measures, advice on national medicines
legislation, and training briefings on TRIPS
safeguards

26 countries with WHO medicines advisors, based
in-country to facilitate collaboration between
WHO and national implementing agencies in
planning, implementation and monitoring of
medicines and related policies


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3x5 initiative

• WHO's work on IPRs and access to medicines is
  crucial for the success of 3x5 initiative and the
  new priorities of the Organization
• New joint publication "Determining the patent
  status of key essential drugs in developing
  countries" (WHO-UNAIDS MSF).

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• Access to essential medicines Background
  1997-2004

WHO technical cooperation
Future challenges
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Post-2005 scenario

• Transition period ends 1 January 2005 (Cuba,
  Egypt, India, Kuwait, Pakistan. Paraguay,
  Tunisia, United Arab Emirates and Uruguay)
• Opening of the "mailbox"
• patent applications as of 1 January 1995
• Exclusive marketing rights EMRs
• EMRs for up to 5 years may be applied

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Prospects for generic production post-2005

• Generic production of off-patent drugs not
  affected
• Mailbox provision and EMRs apply to products
  patented after January 1995
• Post 2005 availability of generic drugs will
  depend on
• Effective use of TRIPS-compliant public health
  safeguards
• Economic feasibility and incentives for generic
  producers
• Modification of nationals laws in the exporting
  and importing countries.

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New ways and incentives for RD of new medicines

• Resolution WHA56.27 expresses "concerns about
  the current patent protection system, especially
  as regards access to medicines in developing
  countries"
• Need to improve transparency and efficiency of
  the present patent system
• Public investment needed to develop new medicines
• Need to explore new alternatives to promote RD
  for new, needed medicines