Is the concept of essential medicines still able to support the renewal of PHC?

1. Is the concept of essential medicines still able to support the renewal of PHC? Hans V. Hogerzeil MD, PhD, FRCP Edin Director, Medicines Policy and Standards A/Director, Technical Cooperation in Essential Medicines and Traditional Medicine

2. Renewed Primary Health Care (from the medicines point of view) • First-contact essential preventive and curative care, close to the people, specifically aimed at promoting equity, universal access and the fulfilment of the MDGs, and supported by essential referral systems where needed. • Health services (including PHC) are delivered through three different channels: • Public facilities • NP: Private not-for-profit facilities (NGO, faith-based) • PP: Private for-profit services

3. The essential medicines concept supports PHCOverview of the presentation The following aspects will be discussed: • Evidence-based selection of essential medicines • Quality of essential medicines • Quality of care: • Availability of essential medicines • Price of essential medicines • Rational use by prescribers and consumers • Essential medicines support social justice • Essential health technologies

4. The selection of essential medicines remains a corner stone for PHC • Rational selection guides prescribers and ensures cost-effective use of scarce resources (public sector, health insurance) • Selection of essential medicines has become much more systematic • Based on priority diseases and evidence-based treatment guidelines • Affordability changed from a condition into consequence of selection • WHO Model List of Essential Medicines now has three additional lists: • International Emergency Health Kit (inter-agency list) • Essential Medicines for Reproductive Health (inter-agency list) • Essential Medicines for Children • Challenge: The number of countries with an updated national EML seems to decline (public sector overtaken by donor supplies?)

5. Quality of essential medicines for PHC:Medicines and services must be regulated • Regulation of the quality of essential medicines is slowly improving; but many Low Income Countries still do not have functioning regulatory systems • Besides quality assurance of medicinal products, the systems should now also be regulated • The performance of the health system (rational use, availability, price) should be regulated and monitored • A licensing system must be started for the NP and PP sector, to qualify for receiving public subsidy for delivering essential services

6. Data from Africa (7 countries):Widespread quality problems with malaria medicines Content and dissolution are often insufficient * Samples were judged to have “failed” if content was <90% or >110%, and dissolution <65% in 30 minutes. * Samples were judged to have “failed” if content was <93% or >107%, and dissolution <80% in 45 minutes.

7. The new Essential Medicines concept:Quality of care • Universal access to PHC through the three channels also depends on the real and perceived quality of care. • Quality of prescribing • Availability and price • Many consultations are now related to chronic diseases (HIV/AIDS, NCDs). These are predictable, should be based on appointments, and be possible in evening hours to reduce loss of income The alternative:

8. Quality of care:Rational use of essential medicines for PHCGood science, low implementation • Large medical and economic losses through irrational use • Over half of prescriptions are incorrect or unnecessary • About half of patients never use the medicines as prescribed • Rational selection and good procurement save up to 70% of costs • Approaches to promoting rational use are now much better supported by scientific evidence than in 1978 • Few national RMU programmes exist; these should now start • Promoting rational use of medicines is part of procurement costs • Australia: National Prescribing Service saves >3x its costs • UNITAID dedicates 2.5% to quality. UNITAID and Global Fund should dedicate 5% to promoting rational use of the medicines they supply

9. Global example: public/private treatment of acute diarrhoea (50 studies)Treatment is better in the public sector More antibiotics, anti-diarrhoeals Less ORS Source: WHO/PSM database, 2004.

10. Global data from WHO pharmaceutical survey (140 countries)Many countries are not implementing evidence-based interventions to promote rational use of medicines % Countries implementing policies to promote rational use Source: WHO pharmaceutical database, 2003

11. Quality of care:Consumer prices of essential medicines are too high (especially in the private sector) • Access to essential medicines is measured as: • Availability in public, NP and PP facilities (basket of 30 EMs) • Consumer prices (generic, brand) in public, NP and PP facilities • Affordability (price related to lowest public sector salary) • Medicine price information is now of better quality than in 1978

12. Example of better price information (Peru):Public dispensing is more cost-effective than private dispensing Days' minimum wages needed to pay for treatment, Peru *for oral treatment of type-2 diabetes; ** for treatment of peptic ulcer

13. Example from 5 states in India (public sector):Medicines are cheap, but they are out of stock(Reference price: 1 = international generic non-profit wholesale price) Source: Kotwani et al Ind J Med Res May 2007

14. Data from Africa (11 countries):Average generic medicine prices in the public sector (Reference price: 1 = international generic non-profit wholesale price) Source: A.Desta,AFRO medicine price surveys Reasonable margin (+60%)

15. Data from Africa (11 countries):Private retail prices are 1- 4x public sector prices Ratio of average private/public prices (generic medicines) in 11 African countries Source: A.Desta,AFRO medicine price surveys

16. Example from one East African country:Essential medicines may be cheap in the public sector, but they are not available (private sector: 2.3x the price) Average availability of glibenclamide and metformin in country-wide samples of public and private facilities Source: A.Desta,AFRO medicine price surveys

17. Example from Africa:Medicines supply system in Kenya, April 2004

18. Essential Medicines support social justice • Justice as a right, not as a charity • The WHO Constitution, Universal Declaration of Human Rights, African Charter on Human rights and many other international treaties support the fundamental right to the highest attainable level of health. This includes access to essential medicines • Emphasis on human rights strengthens the case for universal access • Checklist for essential medicine programmes: • Which essential medicines are covered by the right to health? • Have all beneficiaries of the medicine programme be consulted? • Are there mechanisms for transparency and accountability? • Do all vulnerable groups have equal access to EMs? How do you know? • Are there redress mechanisms in case human rights are violated? Source: Hogerzeil HV. Human rights and essential medicines: What can they learn from each other? WHO Bull 2006; 84: 371-375

19. Essential Health Technologies: same story • PHC depends on basic technologies (stethoscope, simple diagnostic laboratory, blood pressure, ECG) • PHC also depends on essential referrals (hospital laboratories, diagnostic imaging, operation theatres, intensive care units) • WHO (EHT) is working towards • Assessing basic EHT needs for prevention and care • Norms and standards, evidence on appropriate technology • Vigilance and safety surveillance • Blood safety, reducing maternal deaths • Strengthening regional EHT support • Interdepartmental contacts / advice on EHT for priority diseases

20. Summary of main observations • The selection of essential medicines remains a corner stone for PHC, leading to better quality of care and cost-effective use of resources • The quality of medicines and of services must be regulated • Universal access to PHC depends on the real/perceived quality of care • Rational use, availability, price, convenience • Rational use: good science, low implementation; part of procurement • Consumer prices of essential medicines are too high • Essential medicines may be cheap, but not availablein public sector • The concept of Essential Medicines supports social justice

21. New approaches to WHO country support in essential medicines, in support of PHC: WHO will assist countries in: • setting priorities for public financing of a basic range of essential medicines for PHC and essential referrals, targeted at the poor • promoting the quality of medicines for PHC (prequalification) • regulating quality of PHC products, services and service providers • coordinating and integrating vertical medicine delivery systems • scaling up promotion of rational medicine use (proven interventions) • measuring government performance with regard to the price, quality, delivery and use of essential medicines as part of PHC • monitoring and promoting human rights and social justice

22. Conclusion The concept of essential medicines is as relevant and valid in 2008, as it was at its inception in 1977 "Essential Medicines" has remained a universal brand, associated with equity, social justice, common sense and good governance The concept has evolved with the times. It is now much more supported by scientific evidence, and has entered into new areas (e.g. prequalification, pricing, good governance, human rights) Most of these approaches can and should also be used for essential health technologies, within the overall support to health systems

23. www.who.int/medicines Thank you! The Essential Medicines family