Christoph Thalheim Secretary General European MS Platform

1. From Strasbourg 2003 to Bucharest 2009 – the impact of the MS Resolution of the European Parliament Christoph Thalheim Secretary General European MS Platform

2. Structure of this presentation • Introduction EMSP • Multiple Sclerosis – the disease & its therapies • EP Report & Resolution on MS • The “Code of Good Practice in MS” • …and its related “European Consensus Papers” • Costs of the disease versus budgetary issues • Summary

3. … is the umbrella organization of the predominant national MS-Societies in currently 33 European countries and represents almost half a million people affected by MS • and here are our members:

4. Sweden Iceland Finland Norway Russia Estonia Latvia Lithuania Netherlands Ireland UK Belarus Poland Germany Belgium Lux Czech R. Slovakia Austria Hungary Switzerland Slovenia France Romania Bosnia-Herzegovina Serbia Croatia Italy Spain Portugal Greece Malta

5. EMSP Members Sweden Iceland Finland Norway Russia Estonia Latvia Lithuania Netherlands Belarus Ireland UK Poland Germany Belgium Czech R. Lux Slovakia Austria Hungary Switzerland Slovenia Romania France Bosnia-Herzegovina Serbia Croatia Italy Portugal Spain Greece Malta

6. The burden of Multiple Sclerosis • Globally, at any point in time, around 30 people in 100,000 have been diagnosed with MS = 1.3 million * • MS symptoms mostly start between 25 and 31 years of age - Lost production due to decreased work capacity is one of the biggest cost driver of MS • Among chronic diseases, MS has one of the worst utility (quality of life) scores, similar to that of rheumatoid arthritis* * --------------------------------------------------------------------------* Atlas of MS – WHO / MSIF 2008 * * Dr. G. Kobelt ea, “The Burden of Rheumatoid Arthritis (RA) and Patient Access to Treatment”, 2007

7. List of currently approved DMTs for MS • beta interferon [IFN] 1b FDA:1993 EU: 1997 • beta IFN 1a-intramuscular [im] FDA: 1996 EU: 1997 • glatiramer acetate FDA:1996 EU: 2002 • mitoxantrone FDA: 2000 - not approved for MS in EU • beta IFN 1a-subcutaneous [sc] FDA: 2002 EU: 1998 • natalizumab FDA: 2004 FDA & EU:2006

8. CDP-323 Celltech Group MLN3697 Millennium/sanofi-aventis Dronabinol Unimed Pharma AVE 9897 sanofi-aventis Therapies in MS: the pipeline Laquinimod Teva Cladribine Merck Serono GSK-683699 GSK NBI-5788 Neurocrine BioSci Inc. BG-12 Fumapharm /Biogen ZK-117137 Schering AG IFN beta 1A Biopartners Cpn 10 Cbio Ltd Rituximab Biogen ATL-1102 Antisense Daclizumab, Biogen Idec ISIS-107248 Antisense Teriflunomide sanofi aventis Abatacept Bristol-Myers ABT-874 Abbots Lab IFN beta 1A Synovex IFN beta 1A Vakzine Phase III TV-5010 Teva MBP8298 Lilly/BioMS Phase II Interferon t, Pepgen C-6448 Merck & Co Fampridine Accorda/Elan BX-471 Berlex Biosciences/ Schering AG EMZ 701 Transition E-2007 Eisai Co. Ltd Fingolimod Novartis/ Mitsubishi CNTO1275 Centocor CCI-779 Wyeth Tovaxin, Opexa PharmaFrontiers Alemtuzumab ILEX Pharma Phase I Biosimilars Injectables Orals Other Courtesy Merck Serono

9. Key to successfull delay of disabling symptoms/ same for all existing and coming therapies • Early detection / confirmed diagnosis • Immediate start of appropriate treatment • Continued access & adherence to treatment

10. Presentation: Uma Aaltonen, MEP • Discussion with MEP‘s Official presentation of the “First EU Report on MS” 18th December 2003, EU Parliament Straßbourg Approval of the MS Report by 240 MEP‘s in the European Parliament (Petition 842/2001) concerning the effects of discriminatory treatment towards persons with MS, within the European Union (2003/2173 (INI)) …persons with Multiple Sclerosis, and many other chronic long-term illnesses, are subject to varying levels of medical and therapeutic care depending on their place of residence and …insufficient priority has been accorded by Member States of the Union…to remedying this fact;

11. The fight of a courageous British young lady with MS insisting on her right as European citizen for the best possible therapy, found strong support from the EMSP, the Petition Committee of the European Parliament and finally the European Parliament A CODE driven by a patient plightA true story of success • "There are hundreds of thousands of MS sufferers in the UK and across Europe who are finding life a lot harder than me but I am a strong person and fight hard to get what I should rightfully receive, while others are not in a position to be like this” Louise McVay before the Committee on Petitions, European Parliament July 2003

12. Structure of the “CODE of Good Practice” – requested by the European Parliament • A political statement reflecting “state of the art” practice outlined in the following European Guidelines: • Disease modifying therapies (e.g. Interferons) • Symptomatic treatments (e.g. against bladder problems) • Rehabilitation • Palliative Care • Principles of Quality of Life (developed by MSIF) • http://ec.europa.eu/health/ph_information/dissemination/diseases/neuro_en.htm#monitoring • Supported by epidemiology facts and figures available on an interactive internet database (www.europeanmapofms.org )

13. Small consensus group develops draft Repeated consultation with leading European experts Publication of the widely accepted findings Regular updates Acknowledgement on political level Implementation on the national working level Model character The method of development of The European Code of Good Practice could serve as a model for other chronic conditions

14. Purpose of the CODE • The European Code of Good Practice in Multiple Sclerosis is a political instrumentoffering help to national responsible authorities • Aiming to raise the standards in the five key areas critical for persons with MS up to the level of the current optimum • As practised in some EU member states and/or demanded by the leading experts in each field in European consensus

15. Major MS Conference held by EMSP 29- 30 May 2007 • Promoting European Code of Good Practice in MS • “Code” & related European Consensus Papers endorsed by: • President of the European Parliament, Prof. Dr. Gerd Pöttering, • the German Health Minister Chairwoman of the EU Health Council Ulla Schmidt • the European Commission (Commissioner Kyprianou), who confirmed his support again in the European Parliament on June 18, 2007 • http://www.ms-in-europe.org/ourevents/index.php?kategorie=events2007&cnr=58&anr=219

16. 40 000 35 000 30 000 25 000 20 000 Cost per patient (€ 2004) 15 000 10 000 5 000 0 stroke tumour trauma epilepsy migraine addiction dementia parkinson multiple sclerosis anxiety disorders affective disoders psychotic disorders Total Cost of MS in EuropeHigh cost compared to other disorders of the brain 1) J. Neurology (S) June 2005 (www.ebc-eurobrain.net) 2) Sobocki et al, Multiple Sclerosis (in press)

17. 45 40 35 30 25 Number of cases (million) 20 15 10 5 - Stroke Trauma Epilepsy Migraine Addiction Dementia Brain tumour Anxiety disorders Multiple Sclerosis Affective disorders Psychotic disorders Parkinson's disease Total Cost of MS in EuropeLow prevalence compared to other disorders of the brain • Prevalence 380’000 • Slightly over 2% of all brain disorders 1) J. Neurology (S) June 2005 (www.ebc-eurobrain.net) 2) Sobocki et al, Multiple Sclerosis (in press)

18. The need of “holistic budgeting” and higher priority of health in national budget decisions “The cost of diagnosis and treatment of MS at the earliest possible stage (but definitely within the window of the first five years of the disease) can be offset by the reduction of societal costs in the long term, with considerable gains in the quality of life for PwMS at the same time.” Dr. Gisela Kobelt at EMSP- MSID Conference Brussels, May 2007

19. Healthcare Expenditure as % of GDP Source: OECD figures for 2006

20. Summary • Aging society and the obvious increase of prevalence of chronic diseases require more “holistic budgeting” and higher priority for healthcare budgets, but this will not be enough: • Pharma industry and research bodies need to develop medicines which are more efficient & cheaper than what exists at the moment. • European Guidelines and consensus papers such as the “European Code of Good Practice in MS” – developed in close cooperation by medical experts and patients – are available and should be used on national level as tool to overcome existing inequities in healthcare.

21. Summary • Innovative medicines might be expensive, but they are a necessary investment into lower societal costs. • The proven considerable inequities in access to those innovative medicines are unacceptable (as pointed out by the European Parliament in 2003) and should be reduced, if not removed by the Member States of the European Union. • A positive development of patient empowerment and involvement in decision making processes over the past years is definitively true for the European Institutions, but not (yet?) for the - for health issues more important- national level

22. An appeal to all Health Policy Decision Makers An aging society and longer life expectancy are requiring wise decisions towards a future European Health Policy. Allow us patients as end users of new medicines and as experts in our chronic disease to make our contributions to those decisions, but also to take our reasonable share in the responsibility for those decisions. This is Your challenge, but also Your chance!

23. Thank you for your attention! Christoph ThalheimSecretary GeneralEuropean MS Platform christoph.thalheim@emsp.orgwww.ms-in-europe.org