1. WHO Model List of Essential Drugs/Programme – start and evolutionGlobal Perspective and Reflections Margaretha Helling Borda 21 October 2002, Cambodia M. Helling Borda October 2002 - 25 years anniversary

2. Overview of the presentation • Introduction and background • History and major events up to 1977 • After first EDL-what? (78-82) • Action and evolution (83-88) • Increased country impl.of EDC and NDP (89-96) • Expansion-new challenges (96-present) • Achievements today • Conclusion M. Helling Borda October 2002 - 25 years anniversary

3. Birth of Essential Drugs Concept (EDC) • Complaints in the early seventies: • No links between drugs and health needs • No access to most essential drugs • Rising costs of pharmaceuticals • Uneven rural-urban distribution • Protests against industry marketing practice • No comprehensive NDP to support PHC etc. • Against this background birth of EDC M. Helling Borda October 2002 - 25 years anniversary

4. Early years up to first WHO model EDL • 1975 –1976: • WHO era of essential drugs with WHA res. 28.66 • Informal WHO consultation on selection 1976 • Comments from countries and elsewhere stressing: • Any final list should be a local responsibility • Importance and need for well-established criiteria to guide in selection • Education of physicians and public through information system must accompany any essential drugs list M. Helling Borda October 2002 - 25 years anniversary

5. 1977 – WHO first model EDL • Comments from 1976 working paper and three other major working papers was background for the WHO first Expert Committee on Selection of Essential Drugs • WHO Expert Committee on the Selection of Essential Drugs held 17 –21 October 1977 • A little blue booklet of about 35 pages –TRS 615 became an instant WHO bestseller M. Helling Borda October 2002 - 25 years anniversary

6. The WHO first Expert Commite report TRS 615, the Selection of Essential Drugs • a model list of around 250 main and complementary drugs with criteria and guidelines for establishing the list • WHO had produced a vital tool for public health • According to Médecins sans Frontières (2000) « The first list was a major breakthrough in the history of medicine, pharmacy and public health ». M. Helling Borda October 2002 - 25 years anniversary

7. Not all « smooth sailing » in 1977 and after but… • Some complaints and objections • But… • TRS 615 started an evolution - became a central tool in the aim and process to assure regular access to essential drugs • the text in the first expert committee report has stood its test of time • Still is very much quoted and was used as basis for implementation of the essential drugs concept worldwide M. Helling Borda October 2002 - 25 years anniversary

8. After publication of first EDL – what? • 1978-82 • EDL became the technical tool and HFA/Primary Health Care the policy context • Provision of essential drugs one of the 8 key elements in the aims to attain Health For All by the year 2000 • Finding a way in a constrained, complex and confrontational atmosphere • Funds and human resources constraints • Searching for strategies • Lobbying for/against aWHO marketing code for pharm. • On the way to action –EDL must be part of NDP M. Helling Borda October 2002 - 25 years anniversary

9. Action and consolidation period • 1983 –1988: Milestones: • 1983: New DAP head -direct reporting to DG • 1984: WHA calls for meeting on RUD • 1985: Nairobi Conference of Experts on RUD • 1986: WHA adopts WHO Revised Drug Strategy • 1988: WHO publishes: Ethical Criteria for Medicinal Drug Promotion; Estimating Drug Requirements; World Drug situation; Guidelines for Developing National Drug Policies; and fifth WHO Model EDL « The Use of Essential Drugs « (title changed in third report 1982 to stress use) M. Helling Borda October 2002 - 25 years anniversary

10. Reflections on a very exciting action period • Countries started implementing ED programmes and NDPs • Close country and WHO collaboration– funds started coming • « Spirited marketing of the concept of essential drugs »: national and global advocacy • Nairobi conference – a mile stone for general acceptance of the EDC • Sharing of responsibilities outlined • Conference set the tone for years to come and reinforced WHO mandate as lead agency on pharmaceutical matters • Many lessons learnt from operationalizing the EDC concept M. Helling Borda October 2002 - 25 years anniversary

11. Increased country implementation of EDC and NDP: 1989 -1996 • EDC more widely known, accepted and implemented in developing countreis • Break up USSR created alarming shortage of essential medicines: adoption of EDL and NDP in the newly independant states (NIS) • WHO produced more « how to » methodologies and gudelines: e.g. NDP indicators; how to investigate drug use, good prescribing and teaching guides, regulatory and QA guides, donation guidelines etc., – all reported in the EDMonitor • First NDP Expert Commitee in 1995 to update 1988 guidelins M. Helling Borda October 2002 - 25 years anniversary

12. Expansion – new complex issues: 1996 –present • Catastrophic increases in HIV/AIDS, Malaria, TB • New expensive essential drugs – but advocacy, corporate responsiveness and competition have reduced antiretroviral prices 95% in 3 years • New partnerships • Much expanded mandates for WHO and department of Essential Drugs and Medicines Policy (EDM) • Comprehensive WHO/EDM documentation on websites and in publications (NDP, EDL, TRIP, Prices, QA, pharmaco-economics, WHO Formulary) M. Helling Borda October 2002 - 25 years anniversary

13. Summary of Achievements in 25 yearsUse of the WHO Model List of Essential Drugs • 156 countries have a national list of essential drugs, of which 81% have been updated in the last 5 years and one third within two years • Major international agencies (UNICEF, UNHCR, IDA) base their catalogue on the WHO Model List • Sub-sets: UN list of recommended essential drugs for emergency relief (85 drugs); interagency New Emergency Health Kit (55 drugs for 10,000 consultations) • Normative tools: WHO Model Formulary, International Pharmacopoea, Basic Quality Tests, and development of reference standards follow the WHO Model List • Source: WHO Department Essential Drugs and Medicines Policy 2002 M. Helling Borda October 2002 - 25 years anniversary

14. Achievements: Number of countries with a National Drug Policies1985 - 1999 • In 1999 one hundred and one (101) countries had a National Drug Policy • Among these about half (54) were low-income countries, 43 were middle – income countries and 4 were high-income countries • In 1995 there were fourty seven (47) countries with a NDP • In 1990 ten (10) countries had a NDP • In 1985 only five (five) countries had adopted a national drug policy • Source: WHO Department Essential Drugsand Medicines Policy 2002 M. Helling Borda October 2002 - 25 years anniversary

15. Achievements: Number of people with access to essential drugs: 1977 -1997 • In 20 years from 1977 to 1997, when world pop. went from around 4 to close to 6 billion people regular access to essential drugs nearly doubled; from around two to just under four billion people • In spite of this, as much as one-third of the world’s six billion people in 1997 lacked access and still lacks regular access • Worst situation in Africa where 320 million people have less than 50% access to essential medicines • Financing, delivery and other constraints limit access to essential drugs and these problems worsen with economic pressures and poverty • Source: WHO Department Essential Drugs and Medicines Policy 2002 M. Helling Borda October 2002 - 25 years anniversary

16. Conclusion • The content in TRS 615 of 1977 with the model essential drug list triggered of an evolution- a revolution- to increase access to essential drugs • The WHO Model list of Essential Medicines remains a powerful public health tool • Drug selection is a start – a core element in a succesful EDP and NDP implementation • The concept of essential medicines has global relevance for today’s challenges M. Helling Borda October 2002 - 25 years anniversary

17. Today – 25 th Anniversary of the first WHO Model list Essential Drug List- • Is a Tribute to the achievements of all countries with EDL, NDP and improvements in access to essential medicines • Thank you M. Helling Borda October 2002 - 25 years anniversary