Access to Antimalarial Medicines Dr Clive O Ondari Essential Drugs and Medicines Policy Dept & Roll Back Malaria Department World Health Organization October 2003

WHO - EDM 2 Malaria as cause of death of children under 5 yrs, by WHO region, 2000 % of all deaths Rank AFRO120.3 EMRO132.5 SEARO230.2 WPRO–0.0 AMRO–0.0 EURO–0.0

WHO - EDM 3 % of all deaths Rank Malaria Respiratory inf Diarrhoea HIV/AIDS4 9.0 Measles5 8.4 Low birth weight6 5.8 Leading causes of death for children under 5 yrs, in the WHO African Region, 2000

WHO - EDM 4 Current Situation: n Quality of antimalarial drugs has been declining. n The efficacy of (affordable) antimalarial drugs has been declining and high cost of replacement options. n Over 50% of the population does not have regular access to most vital essential drugs. n 60-90% of the population seek initial treatment from unqualified sources, i.e. street vendors, kiosks. n Supply of drugs is often inefficient and unreliable. n Use of ineffective drugs leads to inadequate treatment and leads to drug resistance.

WHO - EDM 5 WestCentralEast SP Therapeutic Failures ( ) ALERT PHASE ACTION PHASE

WHO - EDM 6 Problems of resistance to antimalarial drugs n Era of availability of cheap and effective drugs has come to an end n Both CQ & SP cost <US$0.2/adult treatment course, but resistance to CQ widespread, and to SP increasing n Alternatives for multi-drug resistant falciparum malaria are x10 expensive

WHO - EDM 7 Factors leading to development of resistance n Lack of guidelines/poor drug treatment policies n Irrational prescribing n Irrational drug use n Drug concentration “tail” n Liberalized, uncontrolled drug market leading to poor quality products circulating in international and domestic markets

WHO - EDM 8 The Abuja Declaration, African Summit on Roll Back Malaria (Abuja, Nigeria), April 2000 Call upon all member states to: 1.“Make treatment of malaria available as peripherally as possible including home treatment” 2.“Make appropriate treatment available and accessible to the poorest groups in the community” Pledge to: 1.“Reduce or waive taxes and tariffs for …antimalarial drugs” 2.“Explore and develop traditional medicine in the area of malaria control”

WHO - EDM 9 Developing and promoting interventions to improve access to good quality antimalarial drugs  Rational selection and use WHO will continue to work with member states to ensure that: 1)Evidence that is accumulated in the clinical practice is used to develop and update malaria treatment guidelines, 2)Treatment guidelines form the basis for the development of essential drugs list 3)Essential drugs list guide the procurement, distribution and use of antimalarial drugs 4)New antimalarial drugs, including novel combinations, are evaluated adequately and registered in a timely manner.

WHO - EDM 10 Rational Antimalarial Drug Selection

WHO - EDM 11 Recommended combination antimalarials: n Artesunate + amodiaquine n Artesunate + sulfadoxine-pyrimethamine n Artesunate + mefloquine n Artemether + lumefantrine

WHO - EDM 12 Cost implications of combination therapy Average cost per adult treatment (US$)

WHO - EDM 13 Global negotiation to reduce price of new antimalarials n Expert consensus that co-formulated artemisinin combination best option for use where multi-resistant malaria n Artemether/lumefantrine (Coartem) is only medicine of this type currently licensed n Novartis has agreed to provide drug at cost through WHO for 10 years – US$ 2.40 for adult treatment n Countries to request, direct or through NGOs

WHO - EDM 14 Developing and promoting interventions to improve access to good quality antimalarial drugs  Sustainable financing Efforts are directed towards: 1)Developing guidelines on sustainable financing 2)Dissemination and promotion of interagency guidelines on drug donation 3)Advocacy for increased budget allocation for essential drugs

WHO - EDM 15 Pilot Project on Quality of Antimalarial Products n Project Design : ä Country selection criteria: “spot light countries” in AFRO and EMRO ä Evaluation of the most widely used antimalarials products in the regions ä Sampling from various levels of the distribution chain (household, private sector pharmacy, peripheral health units, district hospital, teaching/referral hospital and district and/or central medical store ä Evaluation of samples on a rapid assessment kit (Mini-lab) and central laboratory (pharmacopeal tests) in CENQAM, South Africa

WHO - EDM 16 Failure rates (%) - Content

WHO - EDM 17 Failure Rates (%) - Dissolution

WHO - EDM 18 Pre-qualification of ACT Manufacturers and Products n Objectives: ä To accelerate sustained access to, and use of, good quality ACTs ä To ensure that adequate and effective treatment reaches significantly greater numbers of people in need ä To assist/support the implementation of ACTs in ways that respond to the specific needs and requests of individual countries ä To support drug regulatory agencies in regulating ACTs

WHO - EDM 19 RBM/EDM Planned Activities - Biennium n Rational Selection and Use ä Collect and collate efficacy and safety data on new AM ä Develop training materials for new AM ä Assist in the dissemination of training materials ä Provide assistance in training activities n Affordable Prices for Antimalarial Drugs ä Collect information on pricing/prices of antimalarials ä Assist countries in the procurement of antimalarials ä Collect data on domestic manufacturing - capacity etc

WHO - EDM 20 RBM/EDM Planned Activities - Biennium n Providing assistance in ensuring sustainable financing ä Develop a database on national budgets/expenditures on AM ä Develop a database on the availability of AM (esp. ACTs) n Strengthening drug supply, quality assurance and regulatory systems ä Develop guidelines for registration of new antimalarials ä Assist countries to evaluate quality and monitor inspection activities (including pre-qualification of sources of products) ä Provide support to training in the areas of pharmaceutical inspection (GMP) - manufacturing and distribution channels ä Initiate the development of monographs for new AM