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