Delinking Investment in Antibiotic Research and Development from Sales Revenues: The Challenges of Transforming a Promising Idea into Reality

PLoS Medicine

Volumn 13, Issue 6, 2016, Pages

  Outterson, Kevin ^a,b,c   Gopinathan, Unni ^d,e   Clift, Charles ^b,c   So, Anthony D ^f,g   Morel, Chantal M ^c,h   Røttingen, John Arne ^b,c,e,i,j  

^a BOSTON UNIVERSITY   (United States)

^b ROYAL INSTITUTE OF INTERNATIONAL AFFAIRS   (United Kingdom)

^c DRIVE AB   (Switzerland)

^d OSLO UNIVERSITY HOSPITAL   (Norway)

^e NORWEGIAN INSTITUTE OF PUBLIC HEALTH   (Norway)

^f JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

^g Box 256   (Sweden)

^h LONDON SCHOOL OF ECONOMICS   (United Kingdom)

ⁱ UNIVERSITY OF OSLO   (Norway)

^j HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBIOTIC AGENT; ANTIINFECTIVE AGENT;

ANTIBIOTIC RESISTANCE; ARTICLE; CONCEPTUAL FRAMEWORK; DRUG INDUSTRY; FINANCIAL MANAGEMENT; GROSS NATIONAL PRODUCT; HUMAN; REALITY THERAPY; RESEARCH; WORLD HEALTH ORGANIZATION; COMMERCIAL PHENOMENA; DRUG RESEARCH; ECONOMICS; INVESTMENT; THEORETICAL MODEL;

ANTI-BACTERIAL AGENTS; COMMERCE; DRUG INDUSTRY; INVESTMENTS; MODELS, THEORETICAL; PHARMACEUTICAL RESEARCH;

EID: 84978032252     PISSN: 15491277     EISSN: 15491676     Source Type: Journal    
DOI: 10.1371/journal.pmed.1002043     Document Type: Article

References (24)

1. The White House. Executive Order—Combating Antibiotic-Resistant Bacteria [Internet]. 2014 [cited 2015 Sep 1]. https://www.whitehouse.gov/the-press-office/2014/09/18/executive-order-combating-antibiotic-resistant-bacteria
2. The White House. National Action Plan for Combating Antibiotic-Resistant Bacteria [Internet]. 2015 Mar [cited 2015 Sep 1]. https://www.whitehouse.gov/sites/default/files/docs/national_action_plan_for_combating_antibotic-resistant_bacteria.pdf
3. WHO. Global action plan on antimicrobial resistance. 68th World Health Assembly. [Internet]. Geneva, Switzerland; 2015 [cited 2015 Oct 9]. http://apps.who.int/gb/ebwha/pdf_files/WHA68/A68_R7-en.pdf
4. The Review on Antimicrobial Resistance, chaired by Jim O’Neill. Antimicrobial Resistance: Tackling a crisis for the health and wealth of nations [Internet]. 2014; [cited 2015 Sep 10]. http://www.jpiamr.eu/wp-content/uploads/2014/12/AMR-Review-Paper-Tackling-a-crisis-for-the-health-and-wealth-of-nations_1-2.pdf
5. Silver LL, Challenges of antibacterial discovery. Clin Microbiol Rev. 2011Jan;24(1):71–109. doi: 10.1128/CMR.00030-1021233508
6. Coates ARM, Halls G, Hu Y, Novel classes of antibiotics or more of the same?Br J Pharmacol. 2011May;163(1):184–94. doi: 10.1111/j.1476-5381.2011.01250.x21323894
7. The Review on Antimicrobial Resistance, chaired by Jim O’Neill. Securing new drugs for future generations: The pipeline for antibiotics [Internet]. 2015 [cited 2015 Sep 1]. http://amr-review.org/sites/default/files/SECURING%20NEW%20DRUGS%20FOR%20FUTURE%20GENERATIONS%20FINAL%20WEB_0.pdf
8. WHO. WHO’s first global report on antibiotic resistance reveals serious, worldwide threat to public health [Internet]. News release; 2014 [cited 2015 Oct 9]. http://www.who.int/mediacentre/news/releases/2014/amr-report/en/
9. Outterson K, New business models for sustainable antibiotics [Internet]. London: Royal Institute of International Affairs; 2014 [cited 2014 Oct 18]. http://www.chathamhouse.org/sites/default/files/public/Research/Global%20Health/0214SustainableAntibiotics.pdf
10. So AD, Gupta N, Brahmachari SK, Chopra I, Munos B, Nathan C, et al. Towards new business models for R&D for novel antibiotics. Drug Resist Updat. 2011Apr;14(2):88–94. doi: 10.1016/j.drup.2011.01.00621439891
11. Clift C, Gopinathan U, Morel C, Outterson K, Røttingen J-A, So A, Towards a New Global Business Model for Antibiotics. Delinking Revenues from Sales. Report from the Chatham House Working Group on New Antibiotic Business Models. London: The Royal Institute of International Affairs; 2015. https://www.chathamhouse.org/sites/files/chathamhouse/field/field_document/20151009NewBusinessModelAntibioticsCliftGopinathanMorelOuttersonRottingenSo.pdf
12. Hoffman SJ, Outterson K, Røttingen J-A, Cars O, Clift C, Rizvi Z, et al. An international legal framework to address antimicrobial resistance. Bull World Health Organ. 2015Feb1;93(2):66. doi: 10.2471/BLT.15.15271025883395
13. Consultative Expert Working Group on Research and DevelopmentResearch and development to meet health needs in developing countries: Strengthening global financing and coordination. Geneva, Switzerland: World Health Organization; 2012.
14. Van Boeckel TP, Gandra S, Ashok A, Caudron Q, Grenfell BT, Levin SA, et al. Global antibiotic consumption 2000 to 2010: an analysis of national pharmaceutical sales data. Lancet Infect Dis. 2014Aug;14(8):742–50. doi: 10.1016/S1473-3099(14)70780-725022435
15. Projan SJ, Why is big Pharma getting out of antibacterial drug discovery?Curr Opin Microbiol. 2003Oct;6(5):427–30. 14572532
16. Rex JH, Outterson K, Antibiotic reimbursement in a model delinked from sales: a benchmark-based worldwide approach. Lancet Infect Dis. 2016April;16(4):500–505. doi: 10.1016/S1473-3099(15)00500-927036356
17. Goossens H, Ferech M, Vander Stichele R, Elseviers M, ESAC Project GroupOutpatient antibiotic use in Europe and association with resistance: a cross-national database study. Lancet. 2005Feb12;365(9459):579–87. 15708101
18. Love J, Hubbard T, Prizes for innovation of new medicines and vaccines. Ann Health Law. 2009;18(2):155–86, 8 p. preceding i. 21950238
19. Hoen E ‘t, Berger J, Calmy A, Moon S, Driving a decade of change: HIV/AIDS, patents and access to medicines for all. J Int AIDS Soc. 2011;14:15. doi: 10.1186/1758-2652-14-1521439089
20. Megget K., Fixing the broken antibiotics business model [Internet]. Royal Society of Chemistry; 2016 [cited 2016 Feb 26]. http://www.rsc.org/chemistryworld/2016/01/antibiotics-resistance-business-model-commercial-strategies
21. Cecchini M, Langer J, Slawomirski L, Antimicrobial resistance in G7 countries and beyond: Economic Issues, Policies and Options for Action [Internet]. Organisation for Economic Co-operation and Development; 2015Sep [cited 2016 Feb 26]. http://www.oecd.org/els/health-systems/Antimicrobial-Resistance-in-G7-Countries-and-Beyond.pdf
22. Hoffman SJ, Outterson K, What Will It Take to Address the Global Threat of Antibiotic Resistance?J Law Med Ethics. 2015;43(2):363–8. doi: 10.1111/jlme.1225326242959
23. Hoffman SJ, Caleo GM, Daulaire N, Elbe S, Matsoso P, Mossialos E, et al. Strategies for achieving global collective action on antimicrobial resistance. Bull World Health Organ. 2015Dec1;93(12):867–76. doi: 10.2471/BLT.15.15317126668439
24. Årdal C, Outterson K, Hoffman SJ, Ghafur A, Sharland M, Ranganathan N, et al. International cooperation to improve access to and sustain effectiveness of antimicrobials. Lancet. 2016Jan16;387(10015):296–307. doi: 10.1016/S0140-6736(15)00470-526603920