1 Essential Medicines for HIV/AIDS: an Update Overview of the Satellite Selection and safety n Hans Hogerzeil (WHO/EM): Health systems, PHC, human rights n Siobhan Crowley (WHO/HIV): Treatment of children with HIV Panel: Helene Moller (WHO/EM), James Fitzgerald (PAHO), Atieno Ojoo (UNICEF) Quality and pricing n Atieno Ojoo (UNICEF): Access to quality medicines for children n Joelle Daviaud (GFATM): Quality of medicines from global funds n Jorge Bermudez (UNITAID): Investing in quality of medicines n Jos Perriens (WHO/HIV): Price trends of HIV/AIDS medicines Panel: David Jamieson (SCMS), Dai Ellis (Clinton Foundation)

2 Available at the front: n Copies of abstracts n Sample copies of 15 key WHO documents on medicines, with order forms for free copies to be sent home, eg: ä WHO Model Formulary ä WHO Bookshelf (240 publications on CD-ROM) ä WHO Model List of Essential Medicines for Children ä WHO Model Quality Assurance System for Procurement Agencies ä Measuring medicine prices and availability (WHO/HAI standard protocol) ä Various interagency guidelines (drug donations, good procurement, etc) ä Etc…

3 Essential Medicines as part of Health Systems, PHC and Human Rights Hans V. Hogerzeil, MD, PhD, FRCP Edin Director, Essential Medicines and Pharmaceutical Policies World Health Organization, Geneva

4 Global Distribution of Child Deaths (each dot = 5000 deaths; about 30,000 deaths per day) Source: Black et al., Lancet 2003; 361:

5 Essential Medicines are part of Health Systems n Health Systems are based on six pillars: ä Health information ä Good governance ä Health care financing ä Human resources ä Service delivery ä Essential Medical Products and Technologies n The new single WHO Department of Essential Medicines and Pharmaceutical Policies is now part of the WHO Cluster of Health Systems and Services n The best way to promote universal access is through health systems based on Primary Health Care (Dr Margaret Chan, WHO Director-General)

6 Renewed Primary Health Care (from the medicines point of view) n 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. n Health services (including PHC) are delivered through three different channels: ä Public facilities ä Private not-for-profit facilities (NGO, faith-based) ä Private for-profit services

7 Is the concept of Essential Medicines still able to support PHC? n The selection of EMs remains a corner stone for PHC ä Selection has become more systematic and evidence-based n The quality of medicines and quality of services must be regulated ä Regulation of medical products is largely insufficient, but slowly improving ä Regulation of quality of service (e.g. distribution) is a new concept in many countries n Universal access to PHC depends on the quality of care ä Much better information on availability, price, convenience and rational use of medicines ä Essential medicines may be cheap, but are often not available in public sector ä Consumer prices of EMs are too high (public and private sector) ä Need for convenient dosage forms (children, heat stable) and convenient clinic access ä Rational use: good science on best interventions, but low implementation in countries n The concept of Essential Medicines supports social justice ä Availability, quality and rational use of a basic range of essential medicines for all

8 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 107%, and dissolution <80% in 45 minutes. * Samples were judged to have “failed” if content was 110%, and dissolution <65% in 30 minutes.

9 Example of better price information (Peru): Public dispensing is more cost-effective than private dispensing Brand – Private pharmacy Generic – Private pharmacy Generic – Public sector One month’s therapy – glibenclamide* 4.4 days2.1days0.9 days One month’s therapy – ranitidine** 7.9 days2.2 days1.3 days *for oral treatment of type-2 diabetes; ** for treatment of peptic ulcer Days' minimum wages needed to pay for treatment, Peru

10 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) StateMedian % availabilityMedian price ratio Chennai TN30%0.27 Haryana10%0.33 Karnataka12.5%0.48 Maharashtra (2) %0.41 West Bengal0%0.75 Source: Kotwani et al Ind J Med Res May 2007

11 Essential Medicines support social justice n Justice as a right, not as a charity ä The WHO Constitution, the Universal Declaration of Human Rights, the International Covenant on Social, Economic and Cultural Rights and General Comment 14 (2000) support the fundamental right to the highest attainable level of health; this includes access to essential medicines n Emphasis on human rights strengthens the case for universal access ä Human Rights Checklist for national essential medicine programmes: n Access to EMs as indicator for government commitment 1. Which essential medicines are covered by the right to health? 2. Have all beneficiaries of the medicine programme be consulted? 3. Are there mechanisms for transparency and accountability? 4. Do all vulnerable groups have equal access to EMs? How do you know? 5. Are there redress mechanisms in case human rights are violated?

12 Access to Essential Medicines: Classical framework (WHO, ) Rational Selection Affordable prices Sustainable financing Reliable Systems Classical indicator for access: 30% of world population has no regular access to essential medicines; 50% in some areas of Africa and Asia; 15% of those without access live in Africa, 38% live in India Four components of access:

13 Access to Essential Medicines: Update on framework (WHO, 2008) Rational Selection Affordable prices Sustainable financing Reliable Systems Access to essential medicines as part of the progressive fulfilment of the Right to Health: Government commitment to social justice Specific Access Indicators covering the separate determinants of access, for use by WHO/MTSP , UNDP/MDGs and the UN/Special Rapporteur on the Right to Health Access to EMs for Special Groups: children controlled EMs therapeutic sera New methods: Selection Medicine prices Prequalification PHC systems

14 New standard set of indicators for measuring access, for WHO/MTSP, UNDP/MDG Gap Analysis and Lancet assessment Government commitment: n Access to essential medicines/technologies as part of the fulfillment of the right to health, recognized in the constitution or national legislation (S) n Existence and year of a published national medicines policy (S) Rational selection: n Existence and year of a published national list of essential medicines (S) Affordable prices: n Legal provisions to allow/encourage generic substitution in private sector (S) n Median consumer price ratio of 30 selected EMs in pub/private facilities (P) n Percentage mark-up between manufacturers' and consumer price (P) Sustainable financing: n Public and private per capita expenditure on medicines (P) n % of population covered by national health service or health insurance (P) Reliable systems: n Average availability of 30 selected EMs in public/private health facilities (O)

15 Thank you! The Essential Medicines family