ACCESS TO QUALITY AND AFFORDABLE ARVS IN EAST AFRICABYEMMANUEL KATONGOLEDIRECTOR /CHIEF EXECUTIVE OFFICER (CEO)QUALITY CHEMICAL INDUSTRIES LTDP.O.BOX 34871KAMPALA- UGANDA “Affordable access to Quality medicines”
BACKGROUND About 35 pharmaceutical manufacturers in East Africa but only 2 have WHO cGMP. Over 80% medicines for the region are imported. Current access to ARVs in the region is about 40% of those in need.o Resistance to the 1st line ARVs is beginning to be recorded hence the need for new ARVs.
UGANDA INTERVENTION: QCIL Burden of disease is predominantly African i.e. 63% of Global HIV/AIDS is home to Africa. To mitigate the adverse effects of the World Trade Organisation on Trade Related Aspects of Intellectural Property Rights (TRIPs)on access to affordable, newer and safer medicines for the poor. To take early and full advantage of the flexibilities and exemptions provided under the TRIPs agreement. d The Pharmaceutical plant is in line with Uganda Government’s Industrialisation policy with its numerous attendant benefits
PLANT CAPACITY 6,000,000 tablets per day in 3 shifts which is 1.6 billion tabletsa yearCurrent capacity utilization is 60% covering Uganda market.Signed 5 year MOU with Kenya.Advanced negotiations with RwandaMid this year we plan to a USD 50 million 2nd phase plantwhich will triple our capacity to 18 million tablets per day.
PRODUCTSCurrent products Anti-malarial products - Lumartem Tablets (Artemether and Lumefantrine) Anti-retroviral products - Duovir-N (Lamivudine, Nevirapine and Zidovudine fixed dose combination - Duovir ( Lamivudine and Zidovudine) - Effavir (Effavirenz)New products- Tenofovir- Emitricitabine- Lumartem Forte
ACHIEVEMENTS TODATEINTERNATIONAL CERTIFICATIONS: World Health Organization (WHO) Good Manufacturing Practices for plant and product attained. International Committee of Red Cross (ICRC) certification Drugs for Neglected Diseases Initiative (DNDI) certification National Drug Authority GMP and products marketing authorisation got from Kenya Pharmacy and Poisons Board GMP certification. Tanzania Food and Drugs Administration (TFDA) inspected the plant and await GMP certification
ACHIEVEMENTS TODATE CONT’DCompleted registration in Rwanda and Burundi.Participating under the Global fund –AMFm project as a mastersupplier of ACTs.Has helped curb shortages of ARVs and ACTs in the public sector.Over 200 jobs provided directly to Pharmacists, Biochemists,Chemical engineers, microbiologists, Civil, electrical, mechanicalengineers etc.90% employees are Locals. 1,000 indirect employments forsupport industries (51 suppliers)
CHALLENGES Dumping from overseas in a bid t buy markets: India and China subsidize finished pharmaceuticals exports by up to 30% thus making them artificially cheap. This is killing local capacity development.• Fragmented market Lack of skilled manpower Harmonization of medicines regulations in the region. Investment in research and development
CONCLUSIONPublic Private Partnerships in anintegrated East Africa common marketapproach will be key to sustainable accessof affordable medicines in the region.