The role of commercial enterprises in health

1. The role of commercial enterprises in health Dr. Petra Laux, GSK Brussels September 2001

2. Global Presence of GlaxoSmithKline • GSK is one of the industry leaders, with an estimated seven per cent of the world's pharmaceutical market. • GSK R&D has 24 sites in 7 countries and the budget is about £2.4bn/$4bn. • Global Manufacturing and Supply: GSK has 108 manufacturing sites in 41 countries • GSK has over 100,000 employees worldwide

3. Outline To bear witness of the views ofvarious GSK senior executives on • the challenge of improving healthcare • who can help • industry’s role and principles Peter

4. Our mission “Our global quest is to improve the quality of human life by enabling people to do more, feel better and live longer” But: Many people in developing countries do not have access to basic health care services, including safe and effective medicines

5. Our commitment addresses three critical areas: 1. Investment in research and development to the developing world 2. Sustainable preferential pricing 3. Community activities that promote effective healthcare

6. Sustainable Preferential Pricing Current scheme: • all Least Developed Countries and all countries in Sub-Saharan Africa • Governments, international agencies, NGOs, charities and international purchase funds; employers • all HIV, all anti-malarials • pilot for anti-infectives, de-worming agents and anti-diarrhoeals

7. Sustainability of preferential pricing • no prices below costs • no benchmarking of prices to developed world • no product diversion/parallel trade of preferential priced products • partnership • full IP Protection

8. Access to medicines is a complex and multifaceted issue, rooted in poverty • limited access to food and clean water • shortage of hospitals and clinics to administer medicines • poor distribution networks • high levels of illiteracy • low numbers of trained healthcare workers • lack of political will: health as a priority

9. A rich R & D pipeline for the developing world: 20 active projects hepatitis E vaccine, meningitis A and C combination vaccine, new diphtheria, tetanus, pertussis, hepatitis B vaccine, Malaria LAPDAP, for resistant infections, LAPDAP + artesunate (CDA), for acute, uncomplicated malaria; Malarone in the treatment of infants, children; Malarone in complicated, severe malaria; tafenoquine for the prevention of malaria; a tuberculosis vaccine (in collaboration with Corixa); tuberculosis chemotherapy (in partnership with the National Institutes of Health and St. Jude’s Children’s Research Hospital); Oxibendazole (for women of child-bearing age); sitamaquine for visceral leishmaniasis; a new combination product and a novel protease inhibitor for HIV/AIDS Photos (taken out to reduce data)

10. What about Intellectual Property? • Patent protection stimulates and fundamentally underpins continued research and development • Focus on IP and the TRIPs agreement in the access debate is misleading and counter-productive: • 95% of EDL medicines protected, 30% people no access • countries without IP have no better access: India • only 15% of ARVs are patent protected • TRIPS not implemented yet in many countries (50%) • preferential priced products are available

11. TRIPS and Doha • TRIPS contains inbuilt flexibilities to safeguard public health, eg Compulsory licensing, parallel trade • no reopening necessary • any clarification in line with existing agreement

12. Shared Responsibilities