WHO Essential Drugs Strategy

1
Ensuring access to essential medicines in
developing and least developed countries framework
for action
Jonathan D. Quick, MD, MPH Essential Drugs and
Medicines Policy (EDM) World Health Organization
(WHO) March 2002
2
People are needlessly suffering and dying -
medicines unavailable, unaffordable, unsafe, or
wrongly used
The challenge

• In Africa and S.E.Asia
• 1/2 of deaths among children, young adults due to
  6 diseases
• prompt diagnosis and treatment could save over3
  million lives per year

3
In poorer countries drugs are largest household
and second largest public expenditure for health
The challenge
Pharmaceutical spending, as of total health
spending
Greece
Germany
Italy
France
Spain
Denmark
UK
United States
Netherlands
Norway
Bulgaria
Czech Rep.
Hungary
Croatia
Poland
Estonia
Slovenia
Lithuania
Mali
Egypt
China
Indonesia
Thailand
Tunisia
Jordan
Argentina
South Africa
0
10
20
30
40
50
60
70
4
Access to essential drugs has increased from 2
to4 billion people in 20 years - but a huge gap
remains
The challenge
Percentage of population with regular access to
essential drugs (1997)
Source WHO/DAP (1998)
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Ensuring access to essential drugs -
framework for collective action
Access framework
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Modernizing the essential drugs concept
-Creating a WHO Essential Drugs Library
1. Rational selection

• WHO Model List of Essential Drugs
• 11th model list
• 306 drugs

7
Many factors contribute to the final price of a
drug
2. Affordable prices
Margins may be 20 to 80 of final price
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Affordable prices - promote competition reduce
costs
2. Affordable prices

• price information
• price competition - generic drugs of assured
  quality
• price control - producer, distributor, retailer
• reduce duties, taxes, markups
• differential pricing of newer essential drugs
• apply WTO/TRIPS safeguards as appropriate

9
WHO indicative price information
2. Affordable prices

• MSH-WHO essential drugs price indicator
• 499 products

10
Competition is highly effective in reducing
prices - the example of antiretrovirals
2. Affordable prices
Source UNAIDS, B. Samb, 2000
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Building a large generic market takes time- and
requires a combination of strategies
2. Affordable prices
National strategies for generics 1. Supportive
legislation regulation 2. Reliable quality
assurance 3. Professional, public acceptance 4.
Economic incentives
Percent of new prescriptions, U.S.
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Declaration on the trips agreement and public
health -WTO Ministerial Conference, Doha,
November 2001
2. Affordable prices

• Gravity of public health problems in developing
  countries
• HIV/AIDS, tuberculosis, malaria, other epidemics
• Intellectual property protection important for
  new medicines
• Recognize concerns about effect on prices
• TRIPS to be implemented in a manner, to protect
  public health and to promote access to medicines
  for all.
• WTO Members have rights to use flexibilities
• Provisions to be read in the light of TRIPS
  objectives and principles
• Compulsory licences and right to determine the
  grounds
• (solution to be found for non-producing
  countries)
• Regime of exhaustion without challenge
  (parallel imports)

WT/MIN(01)/DEC/W/2 , 14 November 2001, World
Trade Organization, MINISTERIAL CONFERENCE, Doha,
9 - 14 November 2001
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Checklist for policy-makers Globalization,TRIPS
and access to pharmaceuticals

• Government process and resources
• Identify focal point within Ministry of Health
• Establish contacts, working group, with trade and
  other ministries
• Develop mechanism to monitor the health impact of
  agreements
• National patent and related legislation should
• Promote standards of patentability that take
  health into account
• Permit compulsory licensing, parallel importation
  and other measures to promote availability and
  ensure fair competition
• Permit requests for extension of transitional
  period for TRIPS implementation, if needed and if
  eligible
• Consider national public health interests before
  TRIPS-plus

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WHO policy and technical support on TRIPS to over
60 countries - health, trade and patent officials
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WHO policy and technical guidance for
countries- collaborative work with international
organizations

• Perspectives on the WTO/TRIPS agreement
• TRIPS and pharmaceuticals
• Traditional medicines and intellectual property
• Public health and patent legislation
• Network for monitoring impact
• Annotated bibliography

Globalization, TRIPS and access to
pharmaceuticals. WHO Policy Perspectives on
Medicines No. 3 March 2001
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Advocacy, corporate responsiveness, competition
have reduced antiretroviral prices 95 in 3 years
2. Affordable prices
??
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Differential pricing - adaptation of prices to
purchasing power of governments and households
2. Affordable prices

• Already practiced with reductions over 90 - Key
  factors
• bulk purchasing - competition - skillful
  negotiation
• Feasibility has been demonstrated
• economically feasible
• compatible with WTO TRIPS agreement
• Key factors for wider use include
• preventing leakage of products to unintended
  markets
• preventing leakage of prices into developed
  market decisions
• Sustainable mechanisms for single-source products
  
• bilateral agreements ? voluntary licensing
• compulsory licensing ? patent waivers

Prices do matter -- especially for low-income
countries poor households
Source Report of WHO-WTO Workshop on
Differential Pricing and Financing of Essential
Drugs, April 2001
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Public financing - in 38 countries public drug
expenditure is lt US 2.00 / capita
3. Sustainable financing
Public drug expenditure per capita(US) (n
193)
US 51-gt100
(7)
US 11-50
(26)
US 3-10
(22)
US lt1-2
(38)
No data
(100)
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Drug benefits in public health insurance -
insurance coverage rising in most regions
3. Sustainable financing
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The new Global Fund to Fight AIDS, TB, Malaria
-international solidarity for prevention and
treatment
3. Sustainable financing
Pledges May-August 2001 US millions By March
2002 1,900 million
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Drug financing - develop all viable funding
sources within overall health care financing
policy
3. Sustainable financing

• Expand external funding - grants, donations
• interim measure which should not undermine
  national policy
• Appropriate government funding
• public sector user charges are a transitional
  measure
• Expand health insurance coverage drug benefits
• Extend employer role in health and drug financing
• Support NGOs, other community and local financing
• Better use out-of-pocket spending

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Reliable health and supply systems - successful
examples exist in all regions
4. Reliable supply systems
23
Substandard drugs often have no active ingredient
- antibiotics, anti-malarials, anti-tuberculars
included
4. Reliable supply systems
Percentage breakdown of data on 325 cases of
substandard drugs
Source reported from around the world to WHO
database
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Key actions - ensure availability and quality
4. Reliable supply systems

• integrate drug management in health systems
  development
• create an efficient mix of public, private,
  not-for-profit services
• assure drug quality through production
  distribution chain
• promote rational prescribing, dispensing, use by
  patients

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Ensuring access to essential medicines in
developingand least developed countries -
framework for action
Conclusion

Medicines for all?s for all? - inequities -
opportunities - unanswered questions
Essential medicines have a huge impact - too
often unavailable, unaffordable, unsafe, wrongly
used
Access depends on - rational selection,
affordable prices, sustainable financing,
reliable systems
Globalization has a significant influence -
international agreements, funding, innovation
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Questions for consideration

• What percent of the population in this region -
  in your country - has regular access to the
  medicines they need?
• What are the biggest barriers to access?
  Availability? Price? Financing? Quality?
  Supply systems?
• Which of these barriers are related to
  globalization? Which barriers are local?

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