Hong Kong Agreement on IPR and Access to Medicines: Public Health

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Hong Kong Agreement on IPR and Access to
Medicines Public Health Human Rights
Considerations

• J. Craig Phillips
• LLM, MSN, ARNP, BC, ACRN
• Florida International University

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Codification of Health as a Human Right

• International Human Rights Instruments
• Universal Declaration of Human Rights
• International Covenant on Economic, Social, and
  Cultural Rights
• International Covenant on Civil and Political
  Rights its Optional Protocols
• Constitution of the World Health Organization

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Codification of Health as a Human Right

• Inter-American System of Human Rights
• Additional Protocol of the American Convention on
  Human Rights in the Area of Economic, Social, and
  Cultural Rights (Protocol of San Salvador)
• American Declaration of the Rights and Duties of
  Man

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Public Health Goals Access to Medicines Human
Rights Context

• Rapid effective response to Public Health Needs
  Crises
• Quality meds at affordable prices
• Effective competition multiplicity of suppliers
• Wide range of Rx to meet basic health needs of
  the population
• Equality of opportunities for countries in need

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Where are the Worlds Medicines?
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Research Development

• Pharmaceutical R D the 50/50 split
• Public Funding
• High-income Transition countries 47
• Low- Middle-income countries 3
• Private Funding
• Pharmaceutical Industry 42
• Private not-for-profit funding 8

Source WHO (2004). The World Medicines Situation
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Why protect patents?

• Pros
• Innovation critical to new drugs development
• Allows prices to be set by what the market will
  bear

• Cons
• Actual cost of new drugs
• Neglect of diseases effecting worlds poor
• High-income countries, where access inhibited by
  high prices

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R D Spending 10 major pharmaceutical
companies, 2001
Source Moses, Z. (2002). The Pharmaceutical
Industry Paradox. Reuters Business Insight
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What medicines are being developed?

• Drugs development driven by market forces, not by
  health needs indicators
• 10-20 of pharmaceutical R D used for 90 of
  the worlds disease burden
• Examples
• Newest class of antimycobacterial (TB) medication
  is 20 years old
• Neglected Diseases Sleeping sickness,
  leishmaniasis, and Chagas disease

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Pharmaceutical Spending

• 1.4 World GDP Pharmaceuticals
• High-income countries spend 80
• Middle-income countries spend 19
• Low-income countries spend 2.4
• Highest expenditure increases occur in High-
  Middle-income countries

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Access to Essential Medicines

• 1.3 2.1 billion people without access
• Africa and India worst effected
• 10 of the Americas without access
• Factors that can increase affordability
• Generic competition
• Differential pricing
• Bulk purchasing
• Compulsory licensing

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The Access Framework
Source WHO (2000)
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Rational Use of Medicines

• Appropriate prescribing practices
• Avoid overuse of unnecessary meds
• Evidence-based diagnostic treatment guidelines
• Monitoring regulation of medicines

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Irrational medicines use

• Too many medicines prescribed per patient
  (polypharmacy)
• Injections used oral forms more appropriate
• Antimicrobial medicines prescribed in inadequate
  dose duration or antibiotics prescribed for
  non-bacterial infections, thereby contributing to
  the growing problem of antimicrobial resistance
• Prescriptions do not follow clinical guidelines
• Patients self-medicate inappropriately or do not
  adhere to prescribed treatment.

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Public Health Considerations

• What constitutes a national emergency?
• Botswana a case example
• Population 1,640,115
• Median age 29
• Life expectancy 33.87 years
• HIV/AIDS-adult prevalence 37.3
• People living with HIV disease 350,000
• GDP per capita - 10,100
• Nations response to HIV disease

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BotswanasAntiretroviral Program

• Collaborative effort between Ministry of Health,
  Merck, Gates Foundation
• Eligibility for ART program
• Batswana with current Omang card
• HIV antibody test positive
• CD4 cell count 200 or less (CDC defined AIDS)

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Conclusions

• International law holds Governments accountable
  for Human Rights
• Multinational Corporations are not governed by
  these international treaty agreements
• Public Health goals require commitment of
  multiple actors governments, corporations, and
  private citizens

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• One of the greatest diseases is to be nobody to
  anybody
• Mother Teresa