WHO Medicines Strategy Progress: 2000-2003 Priorities: 2004-2007

1. WHO Medicines Strategy Progress: 2000-2003 Priorities: 2004-2007 Dr Guitelle Baghdadi Essential Drugs and Medicines Policy World Health Organization November 2003

2. The access problem Health inequity - ensuring access to existing medicines and vaccines could save millions of lives each year Potential annual lives saved by 2015 with scaling up = 10.5 million Source: Commission on Macroeconomics and Health, WHO, 2001

3. 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 Policy 2. Access 3. Quality and safety 4. Rational use

4. WHO Medicines Strategy 2000-2003: some examples of progress 1. National Drug Policy • Operational package for monitoring policy impact – public sector, private sector, households • Traditional medicine strategy launched – bridging the gap between sceptics and enthusiasts 2. Access • Expanded 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

5. Promoting Rational Usein the Community WHO Medicines Strategy 2000-2003: some examples of progress 3. Quality and safety • Good manufacturing practices training (GMP) - 800+ participants from 50+ countries – 4 languages – 5,800+ copies CD-ROM/video • Quality assessment for priority products (“prequalification”) – now antiretroviral list includes 44 single-drug & 6 combination products 4. Rational use • Selection of essential medicines thoroughly revised – independent, open, evidence-based, expanded information • Comprehensive training programmes – use in community prescribing, drugs & therapeutics committees

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

7. WHO Medicines Strategy monitored through 26 country progress indicators (preliminary analysis of 2003 survey*) * Source: World Pharmaceutical Situation survey (« Level I » indicators). Raw frequencies without adjustment for reporting differences between the two surveys.

8. 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

9. Example 1: Access to essential medicines 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

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

11. Example 2: Medicine safety 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 death • Annually 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 medicines • Up 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

12. Member countries (68) Associate members (8) Example 2: Medicine safety 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

13. Health outcomes • HIV/AIDS • malaria - tuberculosis • childhood illnesses • reproductive health Health systems • delivery systems • financing • stewardship • creating resources 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 safety 4. Rational use

14. Saving lives with the right medicines www.who.int / medicines