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Meeting the Need for a Discussion of Unmet Medical Need.
Horgan, Denis; Borisch, Bettina; Eliasen, Bogi; Kapitein, Peter; Biankin, Andrew V; Gijssels, Stefan; Zaiac, Michael; Fandel, Marie-Helene; Lal, Jonathan A; Kozaric, Marta; Moss, Barbara; De Maria, Ruggero; Geanta, Marius; Nowak, Frédérique; Montserrat-Moliner, Antoni; Riess, Olaf.
  • Horgan D; European Alliance for Personalised Medicine, 1040 Brussels, Belgium.
  • Borisch B; Department of Molecular and Cellular Engineering, Jacob Institute of Biotechnology and Bioengineering, Faculty of Engineering and Technology, Sam Higginbottom University of Agriculture, Technology and Sciences, Prayagraj 211007, India.
  • Eliasen B; Institute of Global Health, Faculty of Medicine, University of Geneva, 1202 Geneva, Switzerland.
  • Kapitein P; Copenhagen Institute for Futures Studies, 1473 Copenhagen, Denmark.
  • Biankin AV; Inspire2Life, 3991 CD Houten, The Netherlands.
  • Gijssels S; Wolfson Wohl Cancer Research Centre, Institute of Cancer Sciences, University of Glasgow, Garscube Estate, Switchback Road, Bearsden, Glasgow G61 1QH, UK.
  • Zaiac M; Patient Expert Centre (PEC), 1930 Zaventem, Belgium.
  • Fandel MH; Novartis Pharma AG, 4056 Basel, Switzerland.
  • Lal JA; Sanofi, 1831 Diegem, Belgium.
  • Kozaric M; Department of Molecular and Cellular Engineering, Jacob Institute of Biotechnology and Bioengineering, Faculty of Engineering and Technology, Sam Higginbottom University of Agriculture, Technology and Sciences, Prayagraj 211007, India.
  • Moss B; Department of Genetics and Cell Biology, Institute for Public Health Genomics, GROW School of Oncology and Developmental Biology, Faculty of Health, Medicine and Life Sciences, Maastricht University, 6211 LK Maastricht, The Netherlands.
  • De Maria R; European Alliance for Personalised Medicine, 1040 Brussels, Belgium.
  • Geanta M; Bowel Cancer UK, London SE11 5DP, UK.
  • Nowak F; Alleanza Contro il Cancro, 00161 Rome, Italy.
  • Montserrat-Moliner A; Faculty of Medicine, University of Medicine and Pharmacy "Carol Davila", 050474 Bucharest, Romania.
  • Riess O; Coordination du Plan France Médecine Génomique 2025, Inserm, 75013 Paris, France.
Healthcare (Basel) ; 10(8)2022 Aug 19.
Article in English | MEDLINE | ID: covidwho-1997563
ABSTRACT
As Europe and the world continue to battle against COVID, the customary complacency of society over future threats is clearly on display. Just 30 months ago, such a massive disruption to global lives, livelihoods and quality of life seemed unimaginable. Some remedial European Union action is now emerging, and more is proposed, including in relation to tackling "unmet medical need" (UMN). This initiative-directing attention to the future of treating disease and contemplating incentives to stimulate research and development-is welcome in principle. But the current approach being considered by EU officials merits further discussion, because it may prove counter-productive, impeding rather than promoting innovation. This paper aims to feed into these ongoing policy discussions, and rather than presenting research in the classical sense, it discusses the key elements from a multistakeholder perspective. Its central concern is over the risk that the envisaged support will fail to generate valuable new treatments if the legislation is phrased in a rigidly linear manner that does not reflect the serpentine realities of the innovation process, or if the definition placed on unmet medical need is too restrictive. It cautions that such an approach presumes that "unmet need" can be precisely and comprehensively defined in advance on the basis of the past. It cautions that such an approach can reinforce the comfortable delusion that the future is totally predictable-the delusion that left the world as easy prey to COVID. Instead, the paper urges reflection on how the legislation that will shortly enter the pipeline can be phrased so as to allow for the flourishing of a culture capable of rapid adaptation to the unexpected.
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Full text: Available Collection: International databases Database: MEDLINE Type of study: Prognostic study Language: English Year: 2022 Document Type: Article Affiliation country: Healthcare10081578

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Prognostic study Language: English Year: 2022 Document Type: Article Affiliation country: Healthcare10081578