1. La recherche avance, la vie progresse. MEDICINE AND HEALTH IN THE TROPICS Plenary Session 3 « The Pharmaceutical Industry’s R&D Drive and the issue of Tropical diseases » 13 of September 2005 Dr Pierre Le Sourd Leem President Dr Pierre Le Sourd Leem President

2. La recherche avance, la vie progresse. 2 The issue of Tropical Diseases  Definition –« Neglected infectious diseases that disproportionately affect poor and marginalized populations » (TDR – Special Program for Research and Training in Tropical Diseases)  Current disease portfolio Source: World Health Report, 2004World Health Report, 2004 * DALYs - Disability Adjusted Life Years (the number of healthy years of life lost due to premature death and disability) TDR Disease Category: 1 – « Emerging or uncontrolled disease » 2 – « Control strategy available, but disease burden persists » 3 – « Control strategy effective / Elimination planned »

3. La recherche avance, la vie progresse. What is the Pharmaceutical Industry doing about it ?  Drug Companies part of the solution instead of the issue

4. La recherche avance, la vie progresse. 4 Medicines exist but don’t reach the patients in need Source: IFPMA, Septembre 2004 Most essential medicines are off-patent and inexpensive; however over 50 % of populations in Least Developed Countries lack regular access to these products

5. La recherche avance, la vie progresse. 5 What are the real barriers ?  Poverty  Lack of public health infrastructure  Lack of human resources  Lack of manufacturing capability  High tariffs on medicines  Political denial

6. La recherche avance, la vie progresse. 6 Successful interventions supported by Drug Companies (1)  In last decade, global companies have become critical contributors to numerous programs and initiatives targeting health needs of the poor  In 2003, the value of donations by major companies matched the US AID Global Budget for Health –3,7$ billion over last 5 years

7. La recherche avance, la vie progresse. 7 Successful interventions supported by Drug Companies (2)  Examples of concrete actions –Malaria  In 2001, Novartis formed a partnership with WHO to provide Coartem at no profit in developing countries  Sanofi-Aventis launched a Specific Program: « Impact Malaria » to develop new treatments, new therapeutic strategies, educational campaign and to provide drugs at price, « not loss, not profit »  Achievements: Pilot projects in South Africa resulted with outstanding health outcomes:  Malaria cases reduced by 86%  Hospital admissions for malaria reduced by 82%  Malaria deaths decreased by 87% –Tuberculosis  In South Africa, a huge involvement of Sanofi-Aventis Rifafour – a combination of 4 medicines –commercialized to enable better compliance A specific training program of 15$ million developed – DOT Supporters (DOT: Directly Observed Treatment) for Health agents  Ambitions:  Building of 9 Training centers  100,000 Health agents trained

8. La recherche avance, la vie progresse. 8 Successful interventions supported by Drug Companies (3)  Examples of concrete actions –Leishmaniasis  Ampules of Glucantime (Sanofi-Aventis) provided at no profit –Onchocerciasis  40 million doses of Mectizan (Merck) donated annually in 34 countries –Trachoma  16 million treatments donated in 11 countries  More than 80$ million of Zithromax (Pfizer) donated –Leprosy  35$ million donated in multi-drug treatment (Novartis)  Achievements: About 13 million people cured over the past 15 years, while some 2-3 million people have been protected from developing deformities –Lymphatic Filariasis  6 billion treatments of albendazole (GSK) planned to be donated  20 million treatments of Mectizan (Merck) donated  Achievements: 80 million people have received treatment

9. La recherche avance, la vie progresse. 9 Successful interventions supported by Drug Companies (4)  HIV/AIDS reference –To increase access to ARVs in developing countries, a huge involvement of the Pharmaceutical Industry  564$ million in 2002  Involvement in International Programs  ONUSIDA  ACCESS: thanks to significant price discounts, more than 330,000 patients in developing countries received ARVs by the end of September 2004  Pharmaceutical Initiatives  Determine Donation Program (Abott), Secure the Future (BMS), African Comprehensive HIV/Aids Partnership (Merck&Co), International HIV/Aids Health Literacy Grants Program (Pfizer)…  Health agents Training, equipments supply, prevention technical aids, health education

10. La recherche avance, la vie progresse. 10 New or improved treatments needed Source: IFPMA, Septembre 2004

11. La recherche avance, la vie progresse. 11 Drug resistance is widespread: the example of Malaria

12. La recherche avance, la vie progresse. 12 What about new drugs and vaccines ? (1)  Quantum leap in Research is coming –R&D is at a crossroad –Development of Biotech Products…  2003: 40% of New Molecular Entities  2010: around 100 New Molecular Entities expected –… could deliver major breakthroughs… –… leading to new hope for Tropical Diseases

13. La recherche avance, la vie progresse. 13 What about new drugs and vaccines ? (2)  New dynamics in R&D for Neglected Diseases –Establishment of dedicated research centers by major companies and increasing not-for-profit approach to R&D for neglected diseases –Creation of a R&D efforts database of IFPMA members –Growing number of product development public private partnerships (PPPs) –Proliferation of R&D players, including public research institutes, academia, major pharma companies, small specialized biopharmaceutical companies from developed and developing countries, etc.

14. La recherche avance, la vie progresse. 14 Establishment of Dedicated Research Centers Source: IFPMA, Septembre 2004

15. La recherche avance, la vie progresse. 15 Creation of a R&D efforts database  In September 2005, launch of a database collecting all the health initiatives involving the pharmaceutical industry to benefit the Developing countries –A comprehensive list of both R&D and Access Initiatives –Accessible on the Internet (via the IFPMA website) by the general public –Create an overall vision for industry activities in addressing developing countries needs –Build a central depositary used to create new collaborations and partnerships

16. La recherche avance, la vie progresse. 16 Public-Private Partnerships development (1)  TDR – The Special Program for Research and Training in Tropical Diseases - and its Industry Partner: a long and fruitful collaboration

17. La recherche avance, la vie progresse. 17 Public-Private Partnerships development (2)  Examples of Product Development PPPs for Neglected diseases Source: IFPMA, Septembre 2004

18. La recherche avance, la vie progresse. 18

19. La recherche avance, la vie progresse. 19 FAC Project: an innovative partnership against Malaria  For Malaria, new medicine needed to adress drug resistance –WHO recommands the development of 4 Artemisine Combination Therapies (ACT) : –But, 2 combinations needed a new fixed-dose combination  FAC Project: –A scientific partnership, coordinated by DNDi, to develop fixed- dose combination of Artesunate/Amodiaquine (AS/AQ) and Artesunate/Mefloquine (AS/MQ) –A public-private Innovative partnership: Sanofi-Aventis & DNDi  In 2006, a new medicine available Easy to use for adults and children Less expensive: Target price 1$ Off patent  WHO estimations: 50 to 100 million of people could received this treatement

20. La recherche avance, la vie progresse. 20 Results: a growing R&D pipeline Source: IFPMA, Septembre 2004

21. La recherche avance, la vie progresse. 21 Conclusions  Public-private partnerships prove to offer the most effective solution  Pharmaceutical companies increasing its commitment in: –Developing dedicated R&D projects –Establishing many health partnerships –Bringing critical resources (products, money, people) –Contributing in valuable cross-country experience and expertise in health care delivery –Introducing a private sector management philosophy that helps achieve needed results  Significant and promising global awareness

22. La recherche avance, la vie progresse. 22 Conclusions  Therefore, any successful initiatives must include: –Political will –Partners –Infrastructure to get the medicines to patients –Physicians training and patient education –Proper diagnosis & dispensing –Quality control –Proper dispensing –Monitoring of outcomes