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

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

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

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

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

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

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

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

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)

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

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

Shared Responsibilities