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The Global Drug Gap: Access Inequities and Policy Implications. International Conference on Pharmacoepidemiology Barcelona. Michael R. Reich Harvard School of Public Health. Main Point #1. Serious global inequities in access to pharmaceutical products exist between rich and poor countries.
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The Global Drug Gap:Access Inequities and Policy Implications International Conference on Pharmacoepidemiology Barcelona Michael R. Reich Harvard School of Public Health
Main Point #1 Serious global inequities in access to pharmaceutical products exist between rich and poor countries. The Global Drug Gap ICPE-Barcelona
Main Point #2 Strategies are needed for three categories: • ESSENTIAL DRUGS • NEW DRUGS • YET-TO-BE-DEVELOPED DRUGS ICPE-Barcelona
Main Point #3 Policies need to include: • PUSH approaches (subsidies) • PULL approaches (incentives) • PROCESS approaches (organizational strengthening) ICPE-Barcelona
Moses hands down easy to swallow tablets... 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 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 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 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? 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. 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 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 ICPE-Barcelona
Access to essential drugs What can be done to improve access to essential drugs in poor countries? ICPE-Barcelona
Strategies for essential drugs Strategy #1: INTERNATIONAL MARKET • Strengthen state’s capacity to use the international market, for efficient procurement • Related example: UNICEF’s global procurement service ICPE-Barcelona
Strategies for essential drugs Strategy #2: MANAGEMENT CAPACITY • Improve state’s capacity to manage the national pharmaceutical system • Example: improved warehousing and distribution • Example: better control of corruption ICPE-Barcelona
Strategies for essential drugs Strategy #3: MAINTAIN SUPPLIES • Focus on financial mechanisms to maintain supplies • Example: community-managed funds for drug purchasing • Example: international loans to support procurement 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 ICPE-Barcelona
NEW DRUGS What can be done to improve access to new drugs in poor countries? ICPE-Barcelona
Trends in Rates of Death Men 25-44 Years Old, USA, 1982-1997 70 60 50 Unintentional injury 40 Deaths per 100,000 Population 30 Heart disease Suicide Cancer 20 HIV infection Homicide 10 Liver disease Stroke Diabetes 0 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97* From national vital statistics, Centers for Disease Control & Prevention Year *Preliminary data ICPE-Barcelona
HIV and AIDS Estimates, Global and Sub-Saharan Africa Source: AIDS Epidemic Update: December 1998 (Geneva: UNAIDS and World Health Organization, 1999, p. 4). 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 ICPE-Barcelona
An ethical dimension Need to consider the fairness of the international distribution of research benefits ICPE-Barcelona
Not just HIV/AIDS drugs Other examples: • Praziquantel for schistosomiasis • Asthma treatments • Tuberculosis treatments 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 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 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 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. ICPE-Barcelona
YET-TO-BE DEVELOPED DRUGS What can be done to improve access to yet-to-be developed drugs in poor countries? ICPE-Barcelona
Global population and drug sales (by value), 1997 Source: IMS Health, 1999, at www.phrma.org 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 ICPE-Barcelona
Strategies for yet-to-be-developed drugs Strategy #2: PARTNERSHIPS • Construct new public-private partnerships on specific diseases or for specific products • Example: Medicines for Malaria Venture ICPE-Barcelona
Strategies for yet-to-be-developed drugs Strategy #3: PRODUCT PATENTS • Protect product patents in developing countries, to create incentives • Example: TRIPS Agreement (Trade Related Aspects of Intellectual Property Rights) ICPE-Barcelona
Strategies for yet-to-be-developed drugs Strategy #4: FINANCIAL INCENTIVES • Create purchase funds or guaranteed markets, for private corporate research • Example: Proposal for vaccine development ICPE-Barcelona
Conclusion #1: Issues of access to pharmaceuticals need to be addressed through multiple policies. ICPE-Barcelona
Conclusion #2: Solutions are needed that both protect incentives for R&D and reduce inequities of access. ICPE-Barcelona
Conclusion #3: Strategies for Access Involve: • Technical dimensions • Ethical dimensions • Political dimensions ICPE-Barcelona