1. 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

2. 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

3. 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

4. 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

5. Where are the Worlds Medicines?

6. Research & Development Pharmaceutical R & D – the 50/50 split Public Funding High-income & Transition countries47% Low- & Middle-income countries 3% Private Funding Pharmaceutical Industry42% Private not-for-profit funding 8% Source: WHO (2004). The World Medicines Situation

7. 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

8. R & D Spending – 10 major pharmaceutical companies, 2001 Source: Moses, Z. (2002). The Pharmaceutical Industry Paradox. Reuters Business Insight

9. 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 world’s disease burden Examples: Newest class of antimycobacterial (TB) medication is 20 years old Neglected Diseases – Sleeping sickness, leishmaniasis, and Chagas disease

10. 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

11. Access to Essential Medicines 1.3 – 2.1 billion people without access Africa and India worst effected 10% of the America’s without access Factors that can increase affordability Generic competition Differential pricing Bulk purchasing Compulsory licensing

12. The Access Framework Source: WHO (2000)

13. Rational Use of Medicines Appropriate prescribing practices Avoid overuse of unnecessary meds Evidence-based diagnostic & treatment guidelines Monitoring & regulation of medicines

14. 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.

15. 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

16. Botswana’s Antiretroviral 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)

17. 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

18. “One of the greatest diseases is to be nobody to anybody” – Mother Teresa –