“... now is the time to stop butting heads and start linking arms. It is not impossible to work out a united plan that will be acceptable for all, and in the end will benefit those who need it most.” E speranza I. C abral, MD S ecretary of H ealth Keynote Address at The 3rd MeTA Philippines Forum

Jacqueline Idusso Coordinator - National Secretariat UGANDA, QUALITY ISSUES – ENFORCEMENT OF GMP STANDARDS IN RESOURCE POOR SETTINGS MeTA23/10/20152

MeTA3 Introduction Uganda - least developed countries (LDCs) with over 88% of living in rural areas Gross National Income per capita was estimated to be $280 in 2005 (World Bank Data). Current population is 30 million and estimated to increase to 54 million by 2025 and to 103 million by 2050 (UNFPA) Over 70% of the population seek healthcare from the private sector thereby paying out of pocket Avoidable loss of life mainly due to limited access to efficacious, affordable essential medicines and health supplies

23/10/2015MeTA4 Background The major component for a sound health care delivery system is availability of quality medicines In 1993 a national drug policy and authority Act (NDP/A) was established to ensure the availability at all times of essential, efficacious and cost- effective drugs to the entire population of Uganda. Section 36 of the principal Act mentions drug quality but is not explicit on Good Manufacturing Practices (GMP) as a quality assurance measure

23/10/2015MeTA5 Lessons I For GMP to be enforced it must be legally binding Uganda adopted the WHO GMP and Pharmaceutical Inspection Cooperation Scheme (PIC/S) as part of the regulatory requirements NDA uses other sections within the law to enforce GMP through spelt-out regulations and working procedures (guidelines) GMP is implied where drug quality is mentioned in the principal Act and subsequent regulations

23/10/2015MeTA6 Lessons II Has been built over time through the initial WHO programs and eventually prequalification: by training and attachment Personnel trained are NDA product dossier evaluators, inspectors and local manufacturers The program often takes a regional approach which is thus a confidence-building and diffusion process Guidelines for GMP have been developed from the regulations and are made available to those regulated as are audit check lists

Lessons III Inspection process is largely dependent on skills and experience of the inspectors The inspections are site-specific and line-based (not product-based due to resource constraints) NDA enforces GMP by: – Making pre-registration inspection for GMP compliance a pre-requisite – Routine post marketing surveillance for in-country manufacturers – There are procedures to ensure that local manufacturers fall in line if found to be wanting at inspection 23/10/2015MeTA7

Example: Quality Chemicals Limited Local manufacturers seek expert advice on GMP from NDA inspectorate department Advice covers whole cycle: plant construction, upgrade, equipment installation and trial batch production NDA makes follow up visits to the plant to evaluate progress of plan in keeping with GMP License is granted once NDA is satisfied that processes and systems comply with GMP 23/10/2015MeTA8

WHO Prequalification Since Uganda is a LDC it is not bound by patents until 2016 and can thus produce generic drugs (ARVs of particular interest) QCL applied for WHO prequalification two months ago in order to remedy the negative effect of patent monopolies and enable generic competition Hopeful that WHO will respond to this request soon 23/10/2015MeTA9

23/10/2015MeTA10 Thank you! Jacqueline Idusso Coordinator in the National Secretariat

“... now is the time to stop butting heads and start linking arms. It is not impossible to work out a united plan that will be acceptable for all, and in the end will benefit those who need it most.” E speranza I. C abral, MD S ecretary of H ealth Keynote Address at The 3rd MeTA Philippines Forum