Research and Development: Alternatives to Patent Monopolies

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Research and Development Alternatives to Patent
Monopolies

• Amy Kapczynski
• UC Berkeley Law
• May 14, 2009

From MSF Campaign for Access to Essential
Medicines, AccessNews (No. 18, Jan 2009)
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Program

• What is the research and development (RD)
  crisis?
• Why do we have an RD crisis?
• What can governments (especially in the SADC
  region) do to encourage relevant RD?

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New Chemical Entities Approved,1975-1999
Troullier et al, Drug Development for Neglected
Diseases, 359 Lancet 2188 (2002)
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Worldwide Pharmaceutical Market by Region, 2005
CIPIH Report, data provided by IMS Health
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From Nwaka Hudson, Innovative Lead Discovery
Strategies for Tropical Diseases, Nature Reviews
Drug Discovery 5, 941-955 (November 2006)
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Type I, II and III Diseases

• Type I large burdens of disease in rich and poor
  countries
• Hepatitis B, measles
• Cardiovascular diseases, tobacco-related
  illnesses
• Type II majority of disease burden in poor
  countries
• HIV/AIDS, TB
• Type III overwhelmingly / exclusively in poor
  countries
• Sleeping sickness, river blindness, buruli ulcer,
  Chagas, leprosy, dengue, leishmaniasis, guinea
  worm

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Adult mortality rates by major cause group and
region, 2004
Slide taken from http//www.who.int/entity/healthi
nfo/global_burden_disease/GBD2004ReportFigures.ppt
, data from WHO Global Burden of Disease Report
2004
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Projected deaths by cause and income, 2004 to
2030
Intentional injuries
Other unintentional
Road traffic accidents
Other NCD
Cancers
Cardiovascular disease
Maternal/perinatal/nutritional
Other infectious
HIV, TB, malaria
Slide taken from http//www.who.int/entity/healthi
nfo/global_burden_disease/GBD2004ReportFigures.ppt
, data from WHO Global Burden of Disease Report
2004
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Alternative Strategies for RD

• Government grants, for example
• to universities or other public sector
  researchers
• to non-profit drug companies (product
  development partnerships or PDPs)

• Prizes, for example
• Broad prizes funded at the multilateral level
• Narrow prizes, e.g. Barbados and Bolivia proposal
  and XPrize proposal for TB Diagnostic

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Importance of the Public Sector (including
universities) to Drug Development

• Jonathan J. Jensen et al., The Contribution of
  Public Sector Research to the Discovery of New
  Drugs (Poster delivered at March 2007 AUTM
  Conference) (Preliminary Results)

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Percentage of ALL Drugs Developed by the Public
Sector (1988 2005)

• All drugs 8
• Priority review drugs 19
• HIV drugs 25

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Product Development Partnerships
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2007 Funding Levels for PDPs

• DNDi - 29 million
• Institute for One World Health - 27 million
• TB Alliance - 40 million
• Medicines for Malaria Venture - 76 million
• International AIDS Vaccine Initiative - 81
  million

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Inducement Prizes

• Definition financial reward but no product
  monopoly
• Broad multilateral prize proposals rewards for
  improving health, measured by DALYs
• see S. 2210 your materials
• Narrow prize proposals Bolivia / Barbados
  proposal on TB diagnostic, XPrize for TB
  diagnostic

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What can governments do?

• Support new mechanisms for RD at multilateral
  level (and regional level)
• e.g. Inter-governmental Working Group at WHO
• Directly support RD with grants, for example to
• own public sector and universities
• PDPs like DNDi
• to fund focused prizes (e.g. Xprize for TB
  Diagnostic)