Essential Medicines – 35 years+ now Successes, Challenges and Outlook Pharmaceuticals and Global Health: Inequalities and Innovation in the 21st Century University of Sussex 19th July 2013 Krisantha Weerasuriya MD FRCP PhD Department of Essential Medicines and Health Products World Health Organization Essential Medicines and Health Products (EMP) Essential Medicines - History • Essential Medicines Concept – 1975 • First Expert Committee on Selection of Essential Medicines and First WHO Model List – 1977 • Second Committee – Selection and Use of Essential Medicines • List revised every 2 years by Expert Committee • Essential Medicines List for Children (EMLc) – 2007 • 18th List released in July 2013 after Expert Committee meeting in April 2013 Essential Medicines and Health Products (EMP) Essential Medicines are … The concept of essential medicines A limited range of carefully selected essential medicines leads to better health care, better drug management, and lower costs Definition of essential medicines Essential medicines are those that satisfy the priority health care needs of the population Selection of essential medicines Selected with due regard to disease prevalence, evidence on efficacy and safety, and comparative cost-effectiveness. Continuity, Sustainability From 1977 – Revised every 2 years, 18 Lists 374 medicines in 18th List (April 2013) The first list was a major breakthrough in the history of medicine, pharmacy and public health – Medicines sans Frontiers Essential Medicines and Health Products (EMP) The Essential Medicines Target National list of essential medicines Registered medicines All the drugs in the world Levels of use S CHW S dispensary Health center Hospital Referral hospital Private sector Department of Essential Medicines and Health Products Essential TBS 2012Medicines and Health Products (EMP) Supplementary specialist medicines Essential Medicines – in countries … • Over 100 countries have National Essential Medicines Lists based on WHO EML • When revising National Lists, medicines on WHO list will be taken into account • Multilateral agencies (World Bank, GFATM, Unicef, UNFPA) base their medicines procurement on WHO/National EML • Donations of medicines – is the medicine in the National List, if not in the WHO List Essential Medicines and Health Products (EMP) Essential Medicines – Successes • A universally accepted concept • Wide adoption in in low and middle income countries • Even wider implementation in High Income Countries – really ??!! • An official list for training, supply, reimbursement or related health objectives. They maybe state / provincial lists instead of or in addition to national lists. • Process has been robust – Declarations of Interests in the Technical Report itself • Is a strategy that has explicitly embedded health care needs and cost-effectivenes in health care system Essential Medicines and Health Products (EMP) Essential Medicines – Challenges • A concept and list ahead of necessary infrastructure in the LMICS and ahead of the political will necessary to implement it in HICs • Is a strategy that has explicitly embedded health care needs and cost-effectiveness in health care system • Quality of medicines • Once accepted, is it strong enough to withstand the influences? • Necessary expertise in countries to adapt the WHO List to a National List • Is it suitable for "forward guidance" to new medicines development for the pharmaceutical industry? Essential Medicines and Health Products (EMP) Health Technology Assessment (HTA) • Health technology assessment is a multi-disciplinary field of policy analysis that examines the medical, economic, social and ethical implications of the incremental value, diffusion and use of a medical technology in health care. (Does the medicine/ technology give value for money?) • Why now? • Governments facing funding problems in health care • National Institute of Clinical Excellence premier example (UK) –(NICE International) • CHOosing Interventions that are Cost Effective (WHOCHOICE) • HTA will be a partner in Selection of Essential Medicines Essential Medicines and Health Products (EMP) Essential Medicines – Outlook • Good – promising future! • HTA will be a strong partner in future but expertise ? • Universal Health Coverage – the major focus post 2015 Millennium Development Goals What will be the medicines delivered as part of UHC? • Defining what it useful for Health Care Systems – "Forward Guidance" – is it a better strategy than the "Market", for Medicines Development? • Not only new medicines but better formulations of existing ones – "heat stable oxytocin" • Serving health care needs rather than developing "Blockbusters"? Essential Medicines and Health Products (EMP) Essential Medicines – Conclusion • Discovery Science makes the Headlines Delivery Science saves the Lives Dr Margaret Chang, DG WHO • Essential Medicines has exploited existing medicines to deliver enormous improvements in the health • In the future, can the Essential Medicines Concept also guide to what the needed medicines are? • It would be advancing from influencing access, to improving innovation. Essential Medicines and Health Products (EMP)