WHO Medicines StrategyWHO Medicines StrategyProgress: 2000-2003Progress: 2000-2003Priorities: 2004-2007Priorities: 2004-2007

Dr Guitelle BaghdadiEssential Drugs and Medicines Policy

World Health OrganizationNovember 2003

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Health inequityHealth inequity - ensuring access to existing medicines and vaccines could save millions of lives each year

0.02.04.06.08.0

10.0

Infectious diseases

Maternal & perinatal

Respiratory infections

Cancers

Cardiovascular diseases

2015 without Scaling-Up 2015 with Scaling-Up

Potential annual lives saved

by 2015 with scaling up

= 10.5 million

Source: Commission on Macroeconomics and Health, WHO, 2001

The access problem

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WHO Medicines Strategy 2000-2003: 4 objectives guided country, regional and global work

WHO’s vision: people everywhere have access to the essential medicines they need; that the medicines are safe, effective, and of good quality; and that the medicines are prescribed and used rationally.

1. National Drug Policy1. National Drug Policy

2. Access2. Access

3. Quality and safety3. Quality and safety

4. Rational use4. Rational use

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WHO Medicines Strategy 2000-2003: some examples of progress

1. National Drug PolicyOperational package for monitoring policy impact – public

sector, private sector, households Traditional medicine strategy launched – bridging the gap

between sceptics and enthusiasts

2. AccessExpanded price information and new survey methodology

– helping health systems and consumers become informed buyers

Comprehensive guidance on international trade agreements – implications of WTO, Doha declaration

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WHO Medicines Strategy 2000-2003: some examples of progress

3. Quality and safetyGood manufacturing practices training (GMP) - 800+ participants

from 50+ countries – 4 languages – 5,800+ copies CD-ROM/videoQuality assessment for priority products (“prequalification”) – now

antiretroviral list includes 44 single-drug & 6 combination products

4. Rational useSelection of essential medicines thoroughly revised – independent,

open, evidence-based, expanded informationComprehensive training programmes – use in community

prescribing, drugs & therapeutics committees

Promoting Rational Usein the Community

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In each WHO region, support is tailored to country needs - 113 countries supported in 2002

Number of countries supported

0 10 20 30 40 50 60 70

Policy - implementation, monitoring

Access - public sector supply

Rational use - EML, guidelines

Quality - regulation, QA

AFRO AMRO EMRO EURO SEARO WPRO

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WHO Medicines Strategy monitored through 26 country progress indicators (preliminary analysis of 2003 survey*)

Percent of countries with: 1999 survey

2003 target

2003 survey

Policy1. National drug policy (NDP) 44% 55% 55%2. NDP implementation plan 36% 43% 46%

Access9. Countries with public health insurance covering drug costs 64% 70% 60%11. 75+% of public sector procurement by competitive tender 90% 95% 80%Quality and Safety14. Basic drug regulatory system 57% 75% 57%18. Adverse drug reaction reporting system 29% 35% 49%Rational Drug Use20. National information center 42% 50% 42%23. Current national essential medicines list 73% 75% 75%

* Source: World Pharmaceutical Situation survey (« Level I » indicators). Raw frequencies without adjustment for reporting differences between the two surveys.

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WHO Medicines Strategy 2004-2007: 5 prioritiesObjectives: policy, access, quality & safety, rational use

1. National medicines policies that focus on human rights, need for innovation, health-oriented approach to trade agreements, stronger ethical dimension

2. Access to traditional medicine by protecting knowledge and access, expanding evidence base, ensuring safety, informing consumers

3. Access to essential medicines, with emphasis on HIV medicines for 3-by-5, medicines for malaria, tuberculosis, childhood illness, reproductive health

4. Safer medicines through expanded safety monitoring and continued strengthening of quality assurance

5. Rational use through continuing education, initiatives linked to health insurance

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Two billion people still lack regular access to essential medicines

6 million people in developing income countries lack ARVs Medicines are the largest health expense for poorer

households and second largest public health expenditure Prices are high & vary greatly

Margins (taxes, duties, retail, distributor): 20-80% of final price Unreliable procurement and supply result in shortages

1/3 of poor households in some countries receive none of the prescribed medicines (low income, high prices, unavailable)

Poor quality is common and life-threatening 50 to 90% of “SP” anti-malaria combinations fail quality tests less than half of assessed ARVs meet international standards

Example 1: Access to essential medicines

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Improve access to medicines - MDG-8/Target 17. Support the 3-by-5 initiative – through assistance on:

Selection of core ARVs  Registration  Product specifications /

pharmacopoeial standards Prequalification of ARVs Market intelligence on sources,

prices, raw materials

 Procurement of core ARVs and diagnostics

 Supply management and monitoring  

Import taxes and margins Patent status and licensing  Quality assurance for local

production

Example 1: Access to essential medicines

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Medicines safety is a universal problem that will only intensify with increased access to newer medicines

Clinical trials show a medicine is effective and relatively safe – but interactions with medicines, pregnancy, other illnesses are only really known with large-scale use

In one major high-income country: Adverse reactions are among the top 10 causes of deathAnnually 106 000 deaths may be due to medicines effects

Over the next 3 years it is expected that:Over 3 million people may be on combination HIV/AIDS medicinesUp to 4 million malaria cases per year may be treated with new

arteminisin combinations Most of these treatments will occur in countries with limited

or no current capacity to monitor safety

Pomeranz et al., JAMA, 1998;279:1200-1205

Example 2: Medicine safety

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Member countries (68)Associate members (8)

Strengthened post-marketing safety monitoring, especially for new medicines

Maintain Programme for International Drug Monitoring – Uppsala Monitoring Centre Support national initiatives – eg, South Africa “Focused Surveillance on ARVs” Strengthen safety monitoring for new combinations for HIV/AIDS, tuberculosis, malaria, etc.Train regulators in safety monitoring and safety information for health care providers and patients

Example 2: Medicine safety

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WHO Medicines Strategy – vital for improved health outcomes, stronger health systems

WHO medicines strategy 1. National drug policy 2. Access to essential medicines 3. Quality and safety4. Rational use

Health systems • delivery systems• financing• stewardship• creating resources

Health outcomes• HIV/AIDS• malaria - tuberculosis• childhood illnesses• reproductive health

www.who.int / medicines

Saving lives with the right medicines