Public health, innovation, and Intellectual Property Rights EU input to the global debate

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1 Public health, innovation, and Intellectual Property Rights EU input to the global debate Brussels, April 2, 2007 An Overview of Medical Needs Kees de Joncheere WHO/EURO 1

2 Leading Causes of Death 53.9 million from all causes, worldwide, 2002 data in WHR 2004 Injuries 11% Maternal 5% Respiratory & digestive 9% Other 6% Cancers 13% Cardiovascular 31% Infectious diseases 25% * 13.3 million *45% of all deaths in low-income countries are caused by 2 Infectious diseases

3 Tropical Disease Burden DISEASE INFECTED (MILLIONS) HEALTH BURDEN (DALY s) a VIRAL HIV / AIDS b million (2.7 million deaths / year) Dengue 0.8 million BACTERIAL Tuberculosis b 2, million (1.6 million deaths / year) PROTOZOAL Malaria million (1.1 million deaths / year) Sleeping sickness million Chagas disease million Leishmaniasis million HELMINTHIC Schistosomiasis million Onchocerciasis million Filariasis million a) Disability adjusted life years lost to the community by each patient with a disease b) 3 Impact mainly in developing countries. WHO estimates, 1999

4 Inter Governmental Working group on Public Health, Innovation and IPR Type of diseases Type 1 : prevalent in both rich and poor countries Type 2 : prevalent in both rich and poor countries, with high prevalence in poor countries Type 3 : largely or exclusively prevalent in poor countres 4

5 International organizations and other groups have developed methods for prioritizing health research Commission on Health Research for Development 1990 World Development Report 1993 Ad Hoc Committee on Health Research 1996 Global Forum for Health Research 2000 WHO-IFPMA Round Table UNDP/World Bank/WHO Special Programme for Research and Training in tropical Diseases (TDR) US National Institutes of Health (NIH) 1998 WHO report Priority Medicines for Europe and the world for EU presidency The Netherlands in 2004 Commission on Intellectual Property, Innovation and Health (WHO) Intergovernmental working Group on Innovation, Public Health and Intellectual Property (WHO)

6 Identifying gaps (unmet therapeutic needs): public health perspective 100% Untreatable with existing interventions including incurable chronic conditions 4 Combined efficacy of a mix of all available interventions 1 Treatable with current mix of interventions 2 Treatable with existing interventions but obstacles to access exist 3 Few treatments available, better formulations and delivery mechanisms needed 0% 6 0% Population coverage with current mix of interventions 100% Maximum achievable coverage

7 Why are there Pharmaceutical gaps? The science is not there High burden disease, but no market Low burden of disease and no market 7

8 R&D Spending Increases But New Molecular Entity Approvals Have Not No. of NMEs Approved Approvals R &D Spending $ Billions R&D Spend * 8 *NME (new molecular entity) total is through August 22, R&D spend for 2000 and 2001 are estimates. Source: Washington Analysis, LLC and PhRMA 1

9 Of the 1,393 new chemical entities that were registered by Western health authorities between , only 13 were specifically indicated for tropical diseases. Drug development for neglected diseases: a deficient market and a public-health policy failure, by Trouiller, P. et al., June 2002, The Lancet, 359:

10 Priority Medicines report : In-depth Reviews Size and nature of disease burden? Control strategy? Why does burden persist? What can be learnt from past/current research? Current pipeline of products to be used for this condition? Opportunities for research into new pharmaceutical interventions? Gaps between current research and potential research issues that are relevant and affordable, within a) five years or b) in the longer term? For which gaps are there opportunities for pharmaceutical research? 10

11 Priority Medicines report : Generating a Preliminary List of Diseases and Gaps Burden of disease ranking EU10, EU25 The world (including EU25) Cochrane database of systematic reviews Clinical efficacy Projections and trends PRELIMINARY LIST OF PRIORITY DISEASES AND GAPS Social solidarity IN DEPTH REVIEWS OF PRELIMINARY LIST OF DISEASES AND GAPS FINAL REPORT 11

12 "Commonality of interest" E U R O P E T H E W O R L D 1 0 % 8 % 6 % 4 % 2 % 0 2 % 4 % 6 % 8 % 1 0 %?? A n tim ic ro b ia l R e s is ta n c e???? Pandem ic Influenza?? Ischaem ic H eart D isease Diabetes M ellitus C a n c e r * A c u te S t r o k e * * H IV /A ID S Tuberculosis N eglected D iseases*** M a la r ia Alzheim er and other dem entias O s te o a r th r itis C O P D Alcohol use disorders U nipolar depression M a te r n a l h e m o r r h a g e 12 * Includes bladder, breast, cervical,colon, uterine, lung liver, m outh, oesophageal, ovarian, pancreatic, prostate, stom ach cancer and leukem ias, m elanom as, lym phatic cancers and m yelom as ** "C erebrovascular disease" *** C hagas disease, Dengue, Leishm aniasis, lym phatic filariasis, O nchocerciasis, Schistosom iasis, Trypanosom iasis

13 Preliminary List of Priority Diseases for which "priority medicines" are needed Infections due to antibacterial resistance Pandemic Influenza Smoking-related diseases/interventions Cardiovascular disease Diabetes Cancer Acute stroke HIV and AIDS Tuberculosis Neglected diseases Malaria Alzheimer disease Osteoarthritis Chronic obstructive pulmonary disease Alcohol dependency, alcohol liver disease Depression in Children and the Elderly Postpartum haemorrhage 13

14 "Neglected" diseases Malaria: Lack of cost efficient experimental models. Weak EU funding of new partnerships toward translational research Tuberculosis: More FDCs for second-line treatment of multidrug-resistant TB Weak EU funding of new partnerships toward translational research Leishmaniasis, trypanosomiasis, Buruli ulcer: Most medicines "old" and often dangerous Weak EU funding of new partnerships toward translational research Post-partum haemorrhage: Heat stable oxytocin would be a major advance in public health 14

15 High burden, preventable diseases with pharmaceutical gaps Smoking-related conditions: Public health, anti-smoking policies are the key interventions Pharmaceutical interventions to stop smoking may be useful adjuncts and better products are needed. For COPD, translational research to convert basic science advances into products that can be used in clinical trials. Secondary prevention of cardiovascular disease: The "polypill" concept using fixed dose combinations deserves further study. HIV/AIDS: There are particular "gaps" with regard to pediatric HIV formulations 15

16 High burden diseases where existing therapies could be improved Cancer : Capacity and coordination for comparative Phase II/III clinical trials Basic research into cancer biology Type 2 Diabetes: Heat stable insulin Increased infrastructure for clinical trials Type 1 diabetes: Gaps in basic biology, stem cell research, transplantation research Depression in children/elderly: Understanding biology of depression and its treatments 16

17 For further questions, please contact: Kees de Joncheere Elil Renganathan

18 This paper was produced for a meeting organized by Health & Consumer Protection DG and represents the views of its author on the subject. These views have not been adopted or in any way approved by the Commission and should not be relied upon as a statement of the Commission's or Health & Consumer Protection DG's views. The European Commission does not guarantee the accuracy of the data included in this paper, nor does it accept responsibility for any use made thereof.