1. The Global Drug Gap: Access Inequities and Policy Implications Michael R. Reich Harvard School of Public Health International Conference on Pharmacoepidemiology Barcelona

2. ICPE-Barcelona Main Point #1 Serious global inequities in access to pharmaceutical products exist between rich and poor countries. The Global Drug Gap

3. ICPE-Barcelona Main Point #2 Strategies are needed for three categories: ESSENTIAL DRUGS NEW DRUGS YET-TO-BE-DEVELOPED DRUGS

4. ICPE-Barcelona Main Point #3 Policies need to include: PUSH approaches (subsidies) PULL approaches (incentives) PROCESS approaches (organizational strengthening)

5. ICPE-Barcelona Moses hands down easy to swallow tablets...

6. ICPE-Barcelona Access to pharmaceuticals Access is not just a technical issue Access is connected to: –social values –economic interests –political processes Access is on the international agenda

7. ICPE-Barcelona Too often, ‘access’ means Finding empty shelves in government health facilities Purchasing drugs from private drug stores Obtaining poor-quality drugs Receiving little information about dispensed products

8. ICPE-Barcelona ‘Access’ can also mean Too many drugs: Case of young girl in Bangladesh with bloody dysentary Prescribed 16 different medications, mostly inappropriate Family sold some land in order to purchase the medicines

9. ICPE-Barcelona Factors that affect access Is the product available in the national market? Is the product distributed within the country? How does the prescription process function? How does payment work?

10. ICPE-Barcelona  ESSENTIAL DRUGS According to the World Health Organization, one-third of the world’s population does not have access to essential drugs and vaccines.

11. ICPE-Barcelona Essential drugs are: “those that satisfy the health care needs of the majority of the population … [and that] should therefore be available at all times in adequate amounts and in appropriate dosage forms.” –source: WHO

12. ICPE-Barcelona WHO Model List of EDs: 302 drugs in 27 therapeutic categories in 1999 list 90% of the products are off-patent adopted by nearly 150 countries embodies principles of both efficiency and equity

13. ICPE-Barcelona Access to essential drugs What can be done to improve access to essential drugs in poor countries?

14. ICPE-Barcelona Strategy #1: INTERNATIONAL MARKET Strengthen state’s capacity to use the international market, for efficient procurement Related example: UNICEF’s global procurement service Strategies for essential drugs

15. ICPE-Barcelona Strategy #2: MANAGEMENT CAPACITY Improve state’s capacity to manage the national pharmaceutical system Example: improved warehousing and distribution Example: better control of corruption Strategies for essential drugs

16. ICPE-Barcelona Strategy #3: MAINTAIN SUPPLIES Focus on financial mechanisms to maintain supplies Example: community-managed funds for drug purchasing Example: international loans to support procurement Strategies for essential drugs

17. ICPE-Barcelona Strategies for essential drugs Strategy #4: RATIONAL USE Improve rational use of essential drugs Example: public detailing directed at health workers Example: social marketing directed at consumers

18. ICPE-Barcelona  NEW DRUGS What can be done to improve access to new drugs in poor countries?

19. ICPE-Barcelona *Preliminary data Trends in Rates of Death Men 25-44 Years Old, USA, 1982-1997 From national vital statistics, Centers for Disease Control & Prevention 0 10 20 30 40 50 60 70 Year Deaths per 100,000 Population Unintentional injury Heart disease Cancer Suicide HIV infection Homicide Liver disease Stroke Diabetes 8385878991939597*8486889092949682

20. ICPE-Barcelona Source: AIDS Epidemic Update: December 1998 (Geneva: UNAIDS and World Health Organization, 1999, p. 4). HIV and AIDS Estimates, Global and Sub-Saharan Africa

21. ICPE-Barcelona Gap between rich and poor “With each passing date, the gap between rich and poor countries in caring for people with HIV is becoming morally more reprehensible.” – Peter Piot, Executive Director, UNAIDS, Sept 1999, Lusaka

22. ICPE-Barcelona An ethical dimension Need to consider the fairness of the international distribution of research benefits

23. ICPE-Barcelona Not just HIV/AIDS drugs Other examples: Praziquantel for schistosomiasis Asthma treatments Tuberculosis treatments

24. ICPE-Barcelona Strategies for new drugs Strategy #1: MARKET Use the Market Example: Purchase new drugs, as Brazilian government has done for antiretrovirals, spending $230 M in 1998 Related example: Develop market for patents

25. ICPE-Barcelona Strategies for new drugs Strategy #2: MANDATES Legal mandates for access Example: Use compulsory licensing by non-patent holders But: Limited number of countries with manufacturing capability; and political controversy

26. ICPE-Barcelona Strategies for new drugs Strategy #3: MUNIFICENCE Expand donation programs from pharmaceutical manufacturers Example: Merck’s donation program of ivermectin Source: Suzanne Whitfield, International Eye Foundation

27. ICPE-Barcelona Strategies for new drugs Public and private actors must resolve conflicting interests and establish partnerships and principles for access to new drugs. Important implications for R&D system for generating new products.

28. ICPE-Barcelona  YET-TO-BE DEVELOPED DRUGS What can be done to improve access to yet-to- be developed drugs in poor countries?

29. ICPE-Barcelona Global population and drug sales (by value), 1997 Source: IMS Health, 1999, at www.phrma.org

30. ICPE-Barcelona Strategies for yet-to-be- developed drugs Strategy #1: PUBLIC SUBSIDIES R&D Public subsidies for R&D on new products Example: NIH Example: TDR for tropical diseases

31. ICPE-Barcelona Strategy #2: PARTNERSHIPS Construct new public-private partnerships on specific diseases or for specific products Example: Medicines for Malaria Venture Strategies for yet-to-be- developed drugs

32. ICPE-Barcelona Strategy #3: PRODUCT PATENTS Protect product patents in developing countries, to create incentives Example: TRIPS Agreement (Trade Related Aspects of Intellectual Property Rights) Strategies for yet-to-be- developed drugs

33. ICPE-Barcelona Strategy #4: FINANCIAL INCENTIVES Create purchase funds or guaranteed markets, for private corporate research Example: Proposal for vaccine development Strategies for yet-to-be- developed drugs

34. ICPE-Barcelona Conclusion #1: Issues of access to pharmaceuticals need to be addressed through multiple policies.

35. ICPE-Barcelona Conclusion #2: Solutions are needed that both protect incentives for R&D and reduce inequities of access.

36. ICPE-Barcelona Conclusion #3: Strategies for Access Involve: Technical dimensions Ethical dimensions Political dimensions