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Pharmaceutical Research in France Status and New Initiatives

"Drug Innovation" Workshop – Erice – May 24th-27th, 2007. Pharmaceutical Research in France Status and New Initiatives. Dr. Yves JUILLET. Innovation: a necessity. For medical , social and industry reasons Medical: Diseases still not cured :cancer, AIDS,

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Pharmaceutical Research in France Status and New Initiatives

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  1. "Drug Innovation" Workshop – Erice – May 24th-27th, 2007 Pharmaceutical Research in FranceStatus and New Initiatives Dr. Yves JUILLET

  2. Innovation: a necessity For medical, social and industry reasons • Medical: • Diseases still not cured :cancer, AIDS, • Moving diseases: AB resistance, Malaria… • New challenges: emerging diseases, ageing… • Social: a new paradigm - well being • Industry: only way of getting return on investment and challenging generic competition

  3. RECHERCHE REINVESTISSEMENT DECOUVERTE SELECTION PROFIT PROTECTION PAR BREVET Expiration du brevet SURVEILLANCE POST-COMMERCIALISATION DEVELOPPEMENT COMMERCIALISATION INTERNATIONALE Zone de risque financier maximum ESSAIS CLINIQUES ETC LANCEMENT Intervention maximale des Autorités ENREGISTREMENT FIXATION DU PRIX REMBOURSEMENT Heinz Redwood

  4. Companies' R&D in 2004 Source : Ministère de la Recherche

  5. Private R&D in France • More than 22.000 FTE in 2004 • Direct positive influence on public research: • National Research Centers and Institutes • Hospitals • Universities

  6. L’emploi du secteur se caractérise par des effectifs de R&D et de production importants Un poids de l’emploi en recherche au niveau le plus élevé par rapport aux autres industries et un emploi industriel important • La création d’emplois en 15 ans (1989 et 2004) a concerné toutes les familles professionnelles : R&D : x2 ; production : +22%; commercialisation: + 21%

  7. Pharmaceutical Industry Research is self-financed R&D Public Financing in France in 2003 … Source: Ministère de la Recherche

  8. Some other parameters • Research more and more complex • Genomic, proteomic • R&D success directly linked to health care system excellence and economic development • A world more and more competitive ↔ Country attractiveness

  9. Initiatives taken in France • Survey clinical research in France (2006) • "Leem Recherche" • CeNGEPS: National Center for Health Products Trials Facilitation • CSIS: Strategic Council for Health Industries (with Government)

  10. Clinical Research in FranceSurvey 2006 • Survey: 20 companies ≃ 62% turn over • Results: 258 studies, 74 countries, 17.000 centers, 138.000 patients ⇨ US 17%, Eastern Europe 15%, Germany 8% ⇨ France 8% (international studies including France) ⇨ / 2004 : ⇘ UK (5%vs 8%)

  11. 4. Analyses comparatives tous pays La France représente 8% des patients recrutés dans le monde • Bonne position de : • États-Unis • Pays de l'Est • Allemagne • Scandinavie • Baisse de la participation du Royaume Uni Mais par rapport à la population : France parmi les meilleurs * Autres pays Europe Ouest : Autriche, Belgique, Grèce, Irlande, Pays-Bas, Portugal, Suisse ** Pays de l'Est : Bulgarie, Croatie, Estonie, Hongrie, Lituanie, Pologne, Roumanie, Russie, Slovaquie, Slovénie, Tchéquie, Ukraine

  12. Touspays53 168 Etats-Unis Scandinavie 12,7 66 Allemagne Autres Eur. Ouest 6,4 65 Canada 4,3 Pays de l'Est 58 Asie France 4,1 Europe2.7 55 Moyen Or. Espagne 3,1 49 2,4 Australasie Australasie 48 2,4 Italie Allemagne 47 2,1 Espagne Italie Europe46 47 1,7 Royaume Uni Canada Tous pays0.5 46 1,1 Pays de l'Est France 0,5 45 Etats-Unis Roy. Uni 0,4 38 Am. Latine Am. Latine 0,3 33 Moyen Orient Scandinavie 0,0 30 Asie Autres Eur. Ouest 4. Analyses comparatives tous pays Nombre de patients recrutés :France dans la moyenne des pays européens Tauxde réponses100% Tauxde réponses100% Nombre moyen de patientsrecrutés parétude Nombre moyen de patientsrecrutés par étudepour 1 million d'habitants

  13. TousPays1,7 Par rapport à l’enquête 2004, les performances de l’Italie et de l’Espagne contrastent avec la situation de l’Allemagne et de l’UK. Vitesse de recrutement, la France se situe dans la moyenne inférieure des pays Vitesse moyenne de recrutement(nbr de patients recrutéspar centre par mois) Tauxde réponses : 69%soit 15 labos et 95 422 patientsconcernés 2,5 Pays de l'Est 2,2 Am. Latine 2,1 Asie 1,9 Moyen Or. 1,8 Scandinavie 1,8 Autres Eur. Ouest Europe1,7 1,8 Australasie 1,6 Espagne 1,4 France 1,4 Italie 1,3 Allemagne 1,2 Canada 1,0 Roy. Uni 0,8 Etats-Unis

  14. Perception par les fonctions internationales (score de 0 à 5) Qualité des Infrastructures** Importance des leaders d'opinion Importance des autorités d'enregistrement Etats-Unis 3,8 France 4,2 Etats-Unis 4,1 France 3,6 Etats-Unis 4,2 France 3,9 Allemagne 3,6 Roy. Uni 4,0 Roy. Uni 3,8 Canada 3,6 Allemagne 4,0 Allemagne 3,5 Scandinavie 3,4 Pays de l'Est 2,2 Pays de l'Est 2,0 Roy. Uni 3,4 Simplicité des autorisationsadministratives Qualité de la prise en chargemédicale Espagne 3,3 Italie 3,2 France 4,2 Etats-Unis 3,4 Australasie 3,1 Afrique du Allemagne 4,0 Allemagne 3,3 2,6 Sud Etats-Unis 3,8 France 2,8 Pologne 2,5 Roy. Uni 3,3 2,5 Pays de l'Est Hongrie 2,5 Pays de l'Est 2,4 Roy. Uni 2,5 Rep. 2,5 Tchèque Asie 2,3 Organisation en Recherche Clinique Amérique 2,2 Latine Russie 2,2 Etats-Unis 3,7 Roy. Uni 3,3 Allemagne 3,3 France 2,9 2,9 Pays de l'Est

  15. "Leem Recherche" Mission • To enhance, promote and make known therapeutic progress in France • Help all stakeholders to work together to reach this goal • Implement actions defined in the Leem Strategic Plan

  16. "Leem Recherche" Objectives • Make easier research and therapeutic progress in France and Europe • Initiatives and partnership involving public and private stakeholders • Education and training • Influencing positively public health and regulatory authorities

  17. « Leem Recherche »Organization Pharmaceutical Companies Leem Public and Private Stakeholders Leem Recherche Board Ex. Board Scientific Council Public and Regulatory Authorities Other Players, Global Public

  18. « Leem Recherche » Board • Company College (17 members): Company country managers, members of Leem Board, R&D Directors • Expert College (16 members): representing Public Research Institutes (including INSERM DG), University presidents, Ministries (Research, Economy), Hospitals… • Leem College: four members • President: P. Le Sourd, past-President Leem

  19. « Leem Recherche » Scientific Council • Public research College (18 members) including Pt Prof. P. Jaillon, Chair • Biotech Company reps (2 members) • Industry College: (18 members) including Council VP A. Bril (Servier)

  20. "Leem Recherche" Actions • Directory of R&D Centers of Pharmaceutical Companies in France • Opening of Leem Recherche Summer School (2nd,Sept 2007) • Post-doctoral fellowship organized by subject (6/year, 24.000 €) • Surveys i.e. cell therapies and tissue engineering, France competitiveness , mission in UK • Public Letter to Presidency candidates

  21. CeNGEPS National Center for Health Products Trials Facilitation • Launched 20 March 2007 • Objective: facilitate coordination and performance of private sponsored CT in hospitals and health networks

  22. CeNGEPSMissions • Improve CT quality • Make easier administrative and logistic aspects of industry CT • Keep and develop French territory attractiveness (performance speed) • Projects selected yearly with a more longer term strategy

  23. CeN GEPSBoard and Budget • Board: Leem 7 mbs, Regional clinical research Directors 6 mbs, INSERM 1 seat , partners 1 seat each(AFSSAPS, Hospital Federation, University…) • Budget: additional tax based on company turn over (9 M€/year) • Call for tender: 27 April 2007

  24. CeN GEPSPriority Actions • Development of inclusion capacity • Mapping of potential inclusion centers • Development of investigator networks • Granting of means to investigators and clinical research departments • Promoting actions with patient groups

  25. Strategic Council for Health Industries (CSIS) • Objective: High level dialogue between Government and Pharmaceutical Industry CEOs: how to develop or maintain attractiveness of France • Membership: • Government Prime Minister and Ministers of Finance, Health, Industry and Research • Industry: 7 CEOs of international and national Companies (i.e. J.F. DEHECQ Sanofi-Aventis, J.-P. GARNIER GSK, S. TAUREL Lilly, Fr.HUMER Roche..) • Three Meetings: 2004, 2006, 2007

  26. CSISLast Meeting Decisions • Joint Strategy (State/Industry) •  R&D budget + 10% / 3 years • Prevention and handling of health crisis (i.e. flu pandemia) • Social Security funding and expenditures: • Make policy better readible • Rapid access to innovations • Intellectual Property protection

  27. CSISLast Meeting Decisions (2) • Enhancement of Research policy • Increase research tax rebate • Promotion of European 7th PCRD • Protection against counterfeiting • Develop epidemiology tools • Allow quicker access to innovation including vaccines • Develop partnership to prevent and efficiently treat sanitary crises: how to anticipate best

  28. CSISPrevious Decisions • Develop Performance indicators for clinical research • Develop CEGEPS • Pragmatic Process for acceptance of CT • Training of clinical reasearchers (improve quality of studies) • Create bioproduction platform open to Industry. Specific interest for biotech products batch production for CT

  29. CSISPrevious Decisions (2) • Improve patents tax regime • Improve research tax rebate granting • Reduce assessment time by "Commission de la Transparence" • Publish quicker prices of innovative products

  30. Assessment by Transparency Committeea way of recognizing added therapeutic value of new products • European Marketing Authorization • Reimbursement , still at national level • Principles for France: Price of new products equal or higher than existing only if recognition of Improvement of Rendered Medical Services (ASMR) • Assessment by Transparency Committee after MA is granted

  31. SMR Basis • Improvement of efficacy and/or safety • Interest for Public Health • Improvement for the patient in comparison to existing products • Definition of specific population which will benefit from this innovation  Medical justified volumes • No health economic data assessment (only medical added value)

  32. ASMRImprovement of Rendered Medical Services:5 levels • ASMR I: major innovation, modifying deeply therapeutic strategy of specific diseases • ASMRS II: important innovation • ASMR III: minor innovation (efficacy, safety) • ASMR IV: minor improvement for the patient • ASMR V: no improvement

  33. Therapeutic improvement 2001-2006

  34. Conclusion I • Innovation a necessity • Pharmaceutical research strategic • Direct interlink between public and private research • Private research in France important even if having to face challenges(like in other European countries)

  35. Conclusion II • Innovation but: -- More and more sophisticated products • Specialists/Hospitals prescriptions • Research longer and more costly • Assessment shows good results even improvement these last 2-3 years

  36. Conclusion III • Some initiatives taken in France of major interest at short and long term • At Industry level: "Leem Recherche" • At Government level with industry : CSIS • Complementarity with decisions taken for public research i.e. « Competitivity Poles » • Success: • If Political will : new Governement to confirm/develop policies • If Industry confidence settled (long-term visibility, investment secured) • Public Research clearly playing the game (particularly in clinical research) • Great opportunities to take, even if sometimes late in our competition world

  37. Conclusion IV • New opportunities at European level: IMI (voted last week) • Will at the same time develop competitivity and partnership • We will win or loose together

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