The Global Drug Gap:Access Inequities and Policy Implications
Michael R. ReichHarvard School of Public Health
International Conference on PharmacoepidemiologyBarcelona
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Main Point #1
Serious global inequities in access to
pharmaceutical products exist between rich and poor countries.
The Global Drug Gap
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Main Point #2
Strategies are needed for three categories:
•ESSENTIAL DRUGS •NEW DRUGS•YET-TO-BE-DEVELOPED
DRUGS
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Main Point #3
Policies need to include: •PUSH approaches (subsidies)•PULL approaches (incentives)•PROCESS approaches
(organizational strengthening)
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Moses hands down easy to swallow tablets...
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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
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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
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‘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
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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?
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ESSENTIAL DRUGS
According to the World Health Organization, one-third of the world’s population does not have access to essential drugs and vaccines.
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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
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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
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Access to essential drugs
What can be done to improve access to essential drugs in poor countries?
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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
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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
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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
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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
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NEW DRUGS
What can be done to improve access to new drugs in poor countries?
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*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
Death
s per
10
0,0
00
Popula
tion
Unintentional injury
Heart disease
CancerSuicide
HIV infectionHomicide
Liver diseaseStrokeDiabetes
83 85 87 89 91 93 95 97*84 86 88 90 92 94 9682
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Source: AIDS Epidemic Update: December 1998 (Geneva: UNAIDS and World Health Organization, 1999, p. 4).
HIV and AIDS Estimates, Global and Sub-Saharan
Africa0 10 20 30 40 50
New AIDS deaths, 1998
Child Infections, 1998
New HIV Infections, 1998
People living with HIV, end 1998
Child AIDS deaths to date
Child infections to date
AIDS deaths to date
HIV infections to date
Infections and deaths, in millions
Sub-Saharan Africa
Global
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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
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An ethical dimension
Need to consider the fairness of the international distribution of research benefits
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Not just HIV/AIDS drugs
Other examples:•Praziquantel for schistosomiasis
•Asthma treatments•Tuberculosis treatments
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Strategies for new drugsStrategy #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
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Strategies for new drugsStrategy #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
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Strategies for new drugsStrategy #3: MUNIFICENCE• Expand donation programs
from pharmaceutical manufacturers
• Example: Merck’s donation program of ivermectin
Source: Suzanne Whitfield, International Eye Foundation
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Strategies for new drugsPublic 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.
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YET-TO-BE DEVELOPED DRUGS
What can be done to improve access to yet-to-be developed drugs in poor countries?
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Global population and drug sales (by value),
19970% 10% 20% 30% 40% 50% 60%
North America
Europe
Japan
Asia
Latin America & Caribbean
Near East
Africa
Oceania% Global Population% Global Pharmaceutical Sales
Source: IMS Health, 1999, at www.phrma.org
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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
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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
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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
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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
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Conclusion #1:
Issues of access to pharmaceuticals need to be addressed through multiple policies.
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Conclusion #2:
Solutions are needed that both protect incentives for R&D and reduce inequities of access.
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Conclusion #3:
Strategies for Access Involve:
•Technical dimensions•Ethical dimensions•Political dimensions