INNOVATION - A VALUE FOR HEALTH AND GROWTH, AN INTERNATIONAL STUDY ON MARKET ACCESS STAKES FOR THERAPEUTIC INNOVATION

Author(s)

Berard I1, Ginestet M2, Auvray F2, Sublet G1, Bouchara G1
1NEXTEP, PARIS, France, 2AGIPHARM, Paris, France

<span 'helvetica',sans-serif;="'Helvetica',sans-serif;" mso-fareast-language:="mso-fareast-language:" lang="EN-US" #333333;="#333333;" mso-ansi-language:="mso-ansi-language:" olor:="olor:" mso-fareast-'';="mso-fareast-'';" fr;="FR;" mso-bidi-font-weight:="mso-bidi-font-weight:" bold;"="bold;"" en-us;="EN-US;">Access to therapeutic innovation is a major issue, in terms of delay, equality and financing, addressed differently by each country. A study has been performed in order to investigate how the French regulatory framework benefit from the processes in place in other developed countries. OBJECTIVES:  Identify measures which can be organized at national level in France to favor the emergence and the access to therapeutic innovation. This study should highlight interesting mechanisms and evaluate their possible transposition in France. METHODS:   RESULTS:   Numerous countries recognize the strategic position of life sciences and the pharmaceutical sector, in particular with regard to capacities and potential of innovation, positive effects of which are medical as much as economic.Regarding accessibility: Access to the immediate market further to the MA approval (Germany, UK), For Orphan drug: flexibility of the assessment allowing an access more rapid (Sweden, Germany). Regarding financing: Specific financing (UK, Australia), follow real life evidence for a better use and set-up agreements (UK). Regarding attractiveness: politic consideration / dialogue possibility (UK), Collaborations between Researchers/pharmaceutical companies/university/public health authorities (Sweden, Denmark, UK) CONCLUSIONS:  Among the concrete and potentially interesting initiatives to resume other countries for France: Reduce the deadlines of access and set up a fast-track: possibility of reducing significantly the deadlines after MA approval (Denmark), even of deleting them (Germany and UK) and develop follow-up of real life evidence (following the example of Denmark, Sweden and UK).

Conference/Value in Health Info

2016-10, ISPOR Europe 2016, Vienna, Austria

Value in Health, Vol. 19, No. 7 (November 2016)

Code

PHP29

Topic

Health Policy & Regulatory

Topic Subcategory

Pricing Policy & Schemes

Disease

Multiple Diseases

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