Abstract
The lack of treatments during the recent Ebola and Zika outbreaks dramatically exposed the vulnerability of the global health system and the dire consequences of that vulnerability. But even where therapies against infectious diseases had been available, an additional threat has gained world-wide attention: antimicrobial resistance (AMR). A growing number of microbial organisms are becoming resistant to available drugs with increasingly diverse risks for a rapid global spreading of infections. Unfortunately, the traditional intellectual property (IP)-based innovation system and regulatory frameworks do not provide sufficient incentives to invest in the development of new antimicrobials. Hence, there are few new treatments in the pipeline to replace a growing number of ineffective drugs or problematic drug combinations. Repairing these broken economic incentives, improving access to and sustaining the effectiveness of antimicrobials is among the most important challenges in the health and life sciences. In this paper we emphasise that this goal can only be achieved through integrated strategies and a better global coordination of interdisciplinary multi-sector responses.
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Notes
- 1.
See e.g. the summary of different EMA initiatives and actions on “Public Health Threats”, available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/general/general_content_000788.jsp&mid=WC0b01ac05809db683 (accessed 10 August 2017). Cf. the FDA Medical Countermeasures Initiative with a summary of special initiatives and actions, available at: https://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/AboutMCMi/ucm262925.htm (accessed 10 August 2017).
- 2.
See e.g. the EMA’s overview on “Marketing authorisation and market exclusivity”, available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000392.jsp&; as for the U.S. cf. FDA, Economic Assistance and Incentives for Drug Development, available at: https://www.fda.gov/drugs/developmentapprovalprocess/smallbusinessassistance/ucm069929.htm (both accessed 10 August 2017).
- 3.
Ibid.
- 4.
Article 3(1) (a), Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (Orphan Drugs Regulation).
- 5.
EURORDIS. What is a rare disease?, available at http://www.eurordis.org/about-rare-diseases (accessed 29 June 2017); However, the European portal Orphanet lists 21,503 entries. Source: http://www.orpha.net/consor/cgi-bin/Disease_Search_List.php?lng=EN&TAG=S (accessed 29 June 2017).
- 6.
WHO Fact Sheet on AMR, available at: http://www.who.int/mediacentre/factsheets/fs194/en/ (accessed 10 July 2017).
- 7.
WHO update, United Nations high-level meeting on AMR, available at: http://www.who.int/antimicrobial-resistance/events/UNGA-meeting-amr-sept2016/en/ (accessed 20 August 2017).
- 8.
WHO Fact Sheet on Global infectious disease surveillance, available at: http://www.who.int/mediacentre/factsheets/fs200/en/ (accessed 10 July 2017).
- 9.
Sun and Dennis (2016).
- 10.
- 11.
European Commission (2017).
- 12.
WHO Fact Sheet on AMR, available at: http://www.who.int/mediacentre/factsheets/fs194/en/ (accessed 10 July 2017).
- 13.
Ibid.
- 14.
Holmes et al. (2016).
- 15.
- 16.
Silver (2011b).
- 17.
- 18.
Dr. Margaret Chan, Director-General of the World Health Organisation, Address to the UN General Assembly on AMR, New York, USA, 21 September 2016. http://www.who.int/dg/speeches/2016/unga-antimicrobial-resistance/en/ (accessed 09 June 2017).
- 19.
See Ban Ki-moon, Secretary-General's remarks to High-Level Meeting on AMR (as delivered on 21 September 2016), available at: https://www.un.org/sg/en/content/sg/statement/2016-09-21/secretary-generals-remarks-high-level-meeting-antimicrobial (accessed 16 June 2017).
- 20.
WHO fact sheet on Anitimicrobial resistance, available at http://www.who.int/mediacentre/factsheets/fs194/en/ (accessed 20 August 2018).
- 21.
EMA Annual Report 2015, available at http://www.ema.europa.eu/docs/en_GB/document_library/Annual_report/2016/05/WC500206482.pdf, at 20 (accessed 18 August 2017).
- 22.
O’Neill et al. (2016).
- 23.
Ibid.
- 24.
Technical report by the ECDC/EMEA Joint Working Group, available at https://ecdc.europa.eu/sites/portal/files/media/en/publications/Publications/0909_TER_The_Bacterial_Challenge_Time_to_React.pdf (accessed 10 August 2017).
- 25.
World Bank (2016).
- 26.
Dr. Margaret Chan, Director-General of the World Health Organisation interviewed by UN News Centre, https://www.youtube.com/watch?v=_SmkvAeq1R4 (accessed 10 June 2017).
- 27.
On Sept. 25th 2015, countries adopted a set of goals to end poverty, protect the planet, and ensure prosperity for all as part of a new sustainable development agenda. Each goal has specific targets to be achieved over the next 15 years, see: United Nations Sustainable Development Goals, available at: http://www.un.org/sustainabledevelopment/sustainable-development-goals (accessed 09 June 2017).
- 28.
See e.g. the WHO News Release: WHO updates Essential Medicines List with new advice on use of antibiotics, and adds medicines for hepatitis C, HIV, tuberculosis and cancer, available at: http://www.who.int/mediacentre/news/releases/2017/essential-medicines-list/en/ (accessed 10 August 2017).
- 29.
Ibid.
- 30.
Renwick et al. (2016a).
- 31.
- 32.
- 33.
Hay et al. (2014).
- 34.
The PEW Charitable Foundation (2016).
- 35.
The Pew Charitable Foundation report, ‘A Scientific Roadmap for Antibiotic Discovery: A sustained and robust pipeline of new antibacterial drugs and therapies is critical to preserve public health’ 2016, available at http://www.pewtrusts.org/en/research-and-analysis/reports/2016/05/a-scientific-roadmap-for-antibiotic-discovery (accessed 10 June 2017).
- 36.
Roin (2009).
- 37.
WIPO Committee, Study on Alternatives to the Patent System that are Used to Support R&D Efforts, Including both Push and Pull Mechanisms, Special Focus on Innovation-Inducement Prizes and Open Source Development Models, Fourteenth Session Geneva, November 2014, available at: http://www.wipo.int/edocs/mdocs/mdocs/en/cdip_14/cdip_14_inf_12.pdf (accessed 10 June 2017).
- 38.
Kesselheim and Outterson (2011).
- 39.
- 40.
Kesselheim, A. S. & Outterson, K., supra n. 39.
- 41.
- 42.
- 43.
Outterson et al. (2016).
- 44.
See for example https://www.keionline.org/delinkage (accessed 10 September 2017) and https://keionline.org/endorsedelinkage (accessed 10 September 2017). Generally see: Love and Hubbard (2007) and Love (2014, 2016).
- 45.
See World Health Organisation, the World Intellectual Property Organisation and the World Trade Organisation (2013); See World Health Organisation Assembly resolution WHA69.23 on ‘Follow-up of the report of the Consultative Expert Working Group on Research and Development: Financing and Coordination’ at para 9 to 11, available at: http://apps.who.int/gb/ebwha/pdf_files/WHA69/A69_R23-en.pdf (accessed 10 May 2017).
- 46.
See: Dreifuss and Mogae (2016).
- 47.
Stevens (2017).
- 48.
See European Parliament resolution of 19 May 2015 on safer healthcare in Europe: improving patient safety and fighting AMR (2014/2207(INI)), Article 62 ‘Calls on the Member States and the Commission to start a reflection process to develop a new economic model, that de-links the volume of sales from the reward paid for a new antibiotic, which would reflect the societal value of a new antibiotic and allow for sufficient return on investment for the company, while the purchaser would gain the right to use the product and have full control over volumes’.
- 49.
O’Neill (2015).
- 50.
Ibid.
- 51.
Ibid., p. 67.
- 52.
Ibid.
- 53.
Ibid., p. 68.
- 54.
Ibid., p. 63.
- 55.
Pages 54–58; see also O’Neil (2015), supra n. 56.
- 56.
- 57.
Title XI, Food and Drug Administration (FDA) Amendments Act of 2007.
- 58.
Kades (2005).
- 59.
See Kesselheim objections to FDA review vouchers, in Kesselheim (2008).
- 60.
Outterson et al. (2007).
- 61.
Outterson (2009a).
- 62.
Kesselheim and Outterson (2011).
- 63.
The characterisation of an incentive mechanism as either push or pull mechanism may be uncertain at times and should be understood as indicative of the intended objectives of the measure in concrete circumstances. Meaning that the same mechanism, depending on the optic of analysis, may be at times considered a pull or a push mechanism or even both.
- 64.
Renwich et al., above at n 33, p. 2.
- 65.
- 66.
Renwich et al., above at n 33, p. 3.
- 67.
Spellberg et al. (2012).
- 68.
Morel and Mossialos (2010).
- 69.
Gould and Lawes (2016).
- 70.
Mossialos et al., above at n. 74, p. 100 et seq.
- 71.
Finch and Hunter (2006).
- 72.
Mossialos et al., above at n. 74, p. 101.
- 73.
See. H.R. 6, 21ST CENTURY CURES ACT, available at: http://docs.house.gov/billsthisweek/20150706/CPRT-114-HPRT-RU00-HR6.pdf (accessed 10 October 2017).
- 74.
United States Government Accountability Office (GAO) (2017).
- 75.
United States Government Accountability Office (GAO) (2017).
- 76.
Ibid.
- 77.
For further information, see the webpage of the European Innovative Medicine Initiative, available at: http://www.imi.europa.eu/about-imi/how-imi-works (accessed 17 October 2017).
- 78.
EU’s 2nd Innovative Medicine Initiative (IMI 2), available at: http://www.imi.europa.eu/content/imi-2 (accessed 10 October 2017).
- 79.
The right prevention and treatment for the right patient at the right time Strategic Research Agenda for Innovative Medicines Initiative 2, available at http://www.imi.europa.eu/sites/default/files/uploads/documents/About-IMI/research-agenda/IMI2_SRA_March2014.pdf (accessed 17 October 2017).
- 80.
Guideline on the scientific application and the practical arrangements necessary to implement the procedure for accelerated assessment pursuant to Article 14(9) of Regulation (EC) No. 726/2004, available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001788.jsp&mid= (accessed 17 October 2017).
- 81.
See: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000955.jsp&mid=WC0b01ac05809f843a (accessed 16 October 2017).
- 82.
See: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000660.jsp&mid=WC0b01ac05809f8439 (accessed 17 October 2017).
- 83.
European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance, 30 June 2017 EMA/4260/2001 Rev. 9, available at: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004089.pdf (accessed 17 October 2017).
- 84.
Cf. Kesselheim, A. S. & Outterson, K., supra n. 39; Outterson (2014).
- 85.
- 86.
Cf. Millman (2014).
- 87.
Roin (2013).
- 88.
- 89.
Cf. Price (2014).
- 90.
- 91.
Merrett et al. (2016).
- 92.
Outterson (2014).
- 93.
Such as Regulation (EC) No 141/2000 of the European Parliament and the Council on orphan medical products, OJ L 18/2000, pp. 1–5; the US-Orphan Drug Act of 1983 and US-Orphan Drug Regulations (21 CFR 316) (recently revised). Cf. the EU’s 2nd Innovative Medicine Initiative (IMI 2), available at: http://www.imi.europa.eu/content/imi-2 (accessed 10 June 2017), or the US Generating Antibiotics Incentives Now (GAIN) ACT. See. H.R. 6, 21ST CENTURY CURES ACT, available at: http://docs.house.gov/billsthisweek/20150706/CPRT-114-HPRT-RU00-HR6.pdf (accessed 10 June 2017).
- 94.
Grootendorst et al. (2011).
- 95.
Merrett et al. (2016).
- 96.
Ibid.
- 97.
Årdal et al. (2016).
- 98.
Ibid.
- 99.
See homepage of the Boston University School of Law, CARB-X GLOBAL PARTNERSHIP, available at: https://www.bu.edu/law/faculty-scholarship/carb-x/). For further information see also the CARB-X webpage, which is available at http://www.carb-x.org/ (both accessed 10 September 2017).
- 100.
Ibid.
- 101.
Ibid. (adding more information on the funding: “The Biomedical Advanced Research Authority (BARDA), within HHS’ Office of the Assistant Secretary for Preparedness and Response, will provide $30 million in research and development funding through CARB-X during the first year and up to $250 million over five years. The AMR Centre, a public-private initiative formed in 2016 to drive the development of new antibiotics and diagnostics, aims to provide $14 million to support CARB-X projects in year one and up to $100 million over five years. The Wellcome Trust, a global charitable foundation focused on biomedical research, will contribute further funding and its expertise in overseeing projects of this kind.”).
- 102.
Christine Årdal, Kevin Outterson, Steven J Hoffman et al. supra n. 97.
- 103.
Ibid.
- 104.
See Ban Ki-moon, Secretary-General's remarks to High-Level Meeting on AMR (as delivered on 21 September 2016), available at: https://www.un.org/sg/en/content/sg/statement/2016-09-21/secretary-generals-remarks-high-level-meeting-antimicrobial (accessed 16 June 2017).
- 105.
At UN, global leaders commit to act on AMR’, 21 September 2016, United Nation News Centre, http://www.un.org/apps/news/story.asp?NewsID=55011#.WVjUyYiGM2w (accessed 18 July 2016).
- 106.
ibid.
- 107.
- 108.
Cf. Årdal et al. (2016).
- 109.
Ibid.
- 110.
Ibid.
References
Årdal C, Outterson K, Hoffman SJ et al (2016) International cooperation to improve access to and sustain effectiveness of antimicrobials. Lancet 387:296–307. https://doi.org/10.1016/S0140-6736(15)00470-5
Boucher HW, Talbot GH, Bradley JS et al (2009) Bad bugs, no drugs: no ESKAPE! An update from the Infectious Diseases Society of America. Clin Infect Dis 48:1–12
Dreifuss R, Mogae FG (co-chairs) (2016) The United Nations Secretary-General’s high level panel on access to medicines report promoting innovation and access to health technologies, pp 31–32. Available at: https://static1.squarespace.com/static/562094dee4b0d00c1a3ef761/t/57d9c6ebf5e231b2f02cd3d4/1473890031320/UNSG+HLP+Report+FINAL+12+Sept+2016.pdf. Accessed 10 Jun 2017
Echols RM (2011) Understanding the regulatory hurdles for antibacterial drug development in the post-Ketek world. Ann N Y Acad Sci 1241:153–161
Eichberg MJ (2015) Public funding of clinical-stage antibiotic development in the United States and European Union. Health Secur 13(3):156–165. https://doi.org/10.1089/hs.2014.0081. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4486734/
E Budish, Roin BN, William H (2015) Do firms underinvest in long-term research? Evidence from cancer clinical trials. Am Econ Rev 105(7):2044–2085
European Commission (2017) European one health action plan against AMR. Available at: https://ec.europa.eu/health/amr/sites/amr/files/amr_action_plan_2017_en.pdf. Accessed 10 Jul 2017
Finch R, Hunter P (2006) Antibiotic resistance—action to promote new technologies: report of an EU Intergovernmental Conference held in Birmingham, UK, 12–13 Dec 2005. J Antimicrob Chemother 58:3–22
Goldman M, Compton C, Mittleman BB (2013) Public-private partnerships as driving forces in the quest for innovative medicines. Clin Transl Med 2:2. https://doi.org/10.1186/2001-1326-2-2. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3564715/. Accessed 18 Sept 2017
Gould IM, Lawes T (2016) Antibiotic stewardship: prescribing social norms. Lancet 387:1699
Grootendorst P et al (2011) New approaches to rewarding pharmaceutical innovation. CMAJ 6:183
Hay M et al (2014) Clinical development success rates for investigational drugs. Nat Biotechnol 32(1):40–51. https://doi.org/10.1038/nbt.2786. Accessed 10 Jul 2017
Holmes AH, Moore LS, Sundsfjord A et al (2016) Understanding the mechanisms and drivers of AMR. Lancet 387(10014):176–187
Infectious Diseases Society of America (2011) Combating AMR: policy recommendations to save lives. Clin Infect Dis 52(Suppl 5):S397–S428
Kades E (2005) Preserving a precious resource: rationalizing the use of antibiotics. NW Univ Law Rev 99:611
Kesselheim AS (2008) Drug development for neglected diseases—the trouble with FDA review vouchers. N Engl J Med 359:1981. Available at: http://dx.doi.org/10.1056/NEJMp0806684. Accessed 10 Jun 2017
Kesselheim AS (2010) Using market-exclusivity incentives to promote pharmaceutical innovation. N Engl J Med 363:1855. Available at: http://www.nejm.org/doi/abs/10.1056/NEJMhle1002961. Accessed 15 Aug 2017
Kesselheim AS, Outterson K (2011) Improving antibiotic markets for long-term sustainability. Yale J Health Policy Law Ethics 11:101
Kremer M, Williams H (2010) Incentivizing innovation: adding to the tool kit. In: Lerner J, Stern S (eds) Innovation policy and the economy, vol 10. University of Chicago Press, Chicago, IL, pp 1–17
Laxminarayan R (2014) Antibiotic effectiveness: balancing conservation against innovation. Science 345(6202):1299–1301
Love J (2014) Alternatives to the patent system that are used to support R&D efforts, including both push and pull mechanisms, with a special focus on innovation-inducement prizes and open source development models. World Intellectual Property Organisation, CDIP/14/INF/12
Love J (2016) Discussion paper: an economic perspective on delinking the cost of R&D from the price of medicines. UNITAID
Love J, Hubbard T (2007) The big idea: prizes to stimulate R&D for new medicines. Chic-Kent Law Rev 82(3)
Merrett et al (2016) Towards the just and sustainable use of antibiotics. J Pharm Policy Pract 9:31. https://doi.org/10.1186/s40545-016-0083-5
Millman J (2014) Why the drug industry hasn’t come up with an Ebola cure. The Washington Post, 13 Aug 2014. Available at: http://www.washingtonpost.com/blogs/wonkblog/wp/2014/08/13/why-the-drug-industry-hasnt-come-up-with-an-ebola-cure/. Accessed 10 May 2017
Minssen T (2012) Assessing the inventiveness of biopharmaceutical under EU & US patent law. INEKO, Lund
Minssen T (2014) European responses to the Ebola crisis. Part I: Initiatives at the European Medicines Agency. Available at: http://blogs.law.harvard.edu/billofhealth/2014/11/12/european-responses-to-the-ebola-crisis-part-i-initiatives-at-the-european-medicines-agency-ema/. Accessed 13 Jul 2017
Minssen T, Nilsson David (2012) The US Supreme Court in Mayo v Prometheus—taking the fire from or to biotechnology and personalized medicine? QMJIP 376:383
Morel C, Mossialos E (2010) Stoking the antibiotic pipeline. BMJ 340:c2115. https://doi.org/10.1136/bmj.c2115
Mossialos EM et al (2010) Policies and incentives for promoting innovation in antibiotic research. European Observatory on Health Systems and Policies. http://www.euro.who.int/__data/assets/pdf_file/0011/120143/E94241.pdf. Accessed 3 Oct 2017
Mossialos E, Morel C, Edwards S, Berenson J, Gemmill-Toyama M, Brogan D (2009) Policies and incentives for promoting innovation in antibiotic research. European Observatory on Health Systems and Policies. Available at: http://www.euro.who.int/__data/assets/pdf_file/0011/120143/E94241.pdf. Accessed 6 Dec 2012
O’Neill J (2015) Securing new drugs for future generations: the pipeline of antibiotics. Review on AMR, Wellcome Trust and UK Government, p 23. Available at: https://amr-review.org/sites/default/files/160525_Final%20paper_with%20cover.pdf. Accessed 10 Jun 2017
O’Neill J et al (2016) The review on AMR: final report and recommendations, at 1. Available at: https://amr-review.org/sites/default/files/160525_Final%20paper_with%20cover.pdf. Accessed 10 Sept 2017
Outterson K (2009a) Legal ecology of resistance: the role of antibiotic resistance in pharmaceutical innovation. Cardozo Rev 31:613
Outterson K (2009b) The legal ecology of resistance: the role of antibiotic resistance in pharmaceutical innovation. Cardozo Rev 31:1
Outterson K (2014) New business models for sustainable antibiotics. Center on Global Health Security Working Group Papers, Chatham House (The Royal Institute of International Affairs), Working Groups on AMR, Paper 1
Outterson K, Samora B, Keller-Cuda K (2007) Will longer antimicrobial patents improve global public health? Lancet Infect Dis 7:559
Outterson K, Gopinathan U, Clift C, So AD, Morel CM, Røttingen J-A (2016) Delinking investment in antibiotic research and development from sales revenues: the challenges of transforming a promising idea into reality. PLoS Med 13(6):e1002043. https://doi.org/10.1371/journal.pmed.1002043 Accessed 10 May 2017
Payne DJ, Gwynn MN, Holmes DJ, Pompliano DL (2007) Drugs for bad bugs: confronting the challenges of antibacterial discovery. Nat Rev Drug Discov 6:29–40
Pogge T (2012) The health impact fund: enhancing justice and efficiency in global health. J Hum Dev Capab 13(4):537–559
Power E (2006) Impact of antibiotic restrictions: the pharmaceutical perspective. Clin Microbiol Infect 12:25. Available at http://dx.doi.org/10.1111/j.1469-0691.2006.01528.x. Accessed 10 Sept 2017
Price WN (2014) Making do in making drugs: innovation policy and pharmaceutical manufacturing. BCL Rev 55:491
Price WN (2015) Black-box medicine. HARV J Law Technol 28:419
Projan SJ (2003) Why big pharma getting out of antibacterial drug discovery? Curr Opin Microbiol 6:427–430
Rai AK, Reichman JH, Uhlir PF, Crossman C (2008) Pathways across the valley of death: novel intellectual property strategies for accelerated drug discovery. Yale J Health Policy Law Ethics 8:1–36
Renwick MJ, Brogan DM, Mossialos E (2016a) A systematic review and critical assessment of incentive strategies for discovery and development of novel antibiotics. J Anthibiotics 69(2):73. Available at: http://dx.doi.org/10.1038/ja.2015.98. Accessed 10 Sept 2017
Renwick MJ, Brogan DM, Mossialos E (2016b) A systematic review and critical assessment of incentive strategies for discovery and development of novel antibiotics. J Anthibiotics 69(2):73–88 at p. 73. Available at: http://dx.doi.org/10.1038/ja.2015.98. Accessed 10 Jun 17
Rex JH et al (2013) A comprehensive regulatory framework to address the unmet need for new antibacterial treatments. Lancet Infect Dis 13(3):269–275
Roin BN (2009) Unpatentable drugs and the standards of patentability. Texas Law Rev 87:503–570. Available at SSRN: http://ssrn.com/abstract=1127742. Accessed 10 Sept 2017
Roin BN (2013) Solving the problem of new uses. Available at SSRN: http://ssrn.com/abstract=2337821 or http://dx.doi.org/10.2139/ssrn.2337821. Accessed 10 Jun 2017
Sachs R (2016) Preserving the future of personalized medicine. UC Davis L Rev 49
Saez C (2016) AMR, regulatory systems high on pharma industry 2016 agenda. IP Watch. Available at: http://www.ip-watch.org/2016/02/17/ifpma-interview-antimicrobial-resistance-regulatory-systems-high-on-pharma-industry-2016-agenda/. Accessed 10 May 2017
Sharma P, Towse A (2011) New drugs to tackle AMR: analysis of EU policy options. Office of Health Economics. https://www.ohe.org/publications/newdrugstackleantimicrobialresistanceanalysiseupolicyoptions. Accessed 17 Oct 2017
Silver LL (2011a) Challenges of antibacterial discovery. Clin Microbiol Rev 24(1):71–109
Silver LL (2011b) Challenges of antibacterial discovery. Clin Microbiol Rev 24(1):71–109. http://doi.org/10.1128/CMR.00030-10. Accessed 10 Jun 2017
Spellberg B, Sharma P, Rex JH (2012) The critical impact of time discounting on economic incentives to overcome the antibiotic market failure. Nat Rev Drug Discov 11(2). https://doi.org/10.1038/nrd3560-c1
Stevens P (2017) Delinkage: can prizes replace patents for medicine innovation? Available at: https://geneva-network.com/article/delinkage-2-2/. Accessed 20 Dec 2017
Stiglitz JE, Jayadev A (2010) Medicine for tomorrow: some alternative proposals to promote socially beneficial research and development in pharmaceuticals. J Generic Med 7:217–226. https://doi.org/10.1057/jgm.2010.21
Sun LH, Dennis B (2016) The superbug that doctors have been dreading just reached the U.S. The Washington Post. Available at: https://www.washingtonpost.com/news/to-your-health/wp/2016/05/26/the-superbug-that-doctors-have-been-dreading-just-reached-the-u-s/?utm_term=.8158c3d51b54. Accessed 13 Jul 2017
The PEW Charitable Foundation (2016) Antibiotics currently in clinical development, May 2016. http://www.pewtrusts.org/~/media/assets/2016/05/antibiotics-currently-in-clinical-development.pdf?la=en. Accessed 16 Sept 2017
Thomas JR (2014) Toward a theory of regulatory exclusivities. In: Okediji RL, Bagley MA (eds) Patent law in global perspective. Oxford University Press, New York, pp 345–376
United States Government Accountability Office (GAO) (2017) Report to congressional requesters: antibiotics. Available at: http://www.gao.gov/products/GAO-17-189. Accessed 17 Oct 2017
WHO (2012) The evolving threat of AMR. Options for action. World Health Organisation, Geneva. Available at: http://apps.who.int/iris/bitstream/10665/44812/1/9789241503181_eng.pdf. Accessed 10 Jun 2017
World Bank (2016) Drug-resistant infections: a threat to our economic future. Washington, DC
World Health Organisation, the World Intellectual Property Organisation, the World Trade Organisation (2013) Promoting access to medical technologies and innovation intersections between public health, intellectual property and trade. Available at: https://www.wto.org/english/res_e/publications_e/who-wipo-wto_2013_e.htm
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Denmark. CeBIL’s research is supported by a Novo Nordisk Foundation grant for a Collaborative Research Programme (grant agreement number NNF17SA0027784).
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Minssen, T., Nordberg, A. (2020). Rules and Tools in the Battle Against Superbugs—A Call for Integrated Strategies and Enhanced International Collaboration to Promote Antimicrobial Drug Development. In: Eccleston-Turner, M., Brassington, I. (eds) Infectious Diseases in the New Millennium. International Library of Ethics, Law, and the New Medicine, vol 82. Springer, Cham. https://doi.org/10.1007/978-3-030-39819-4_6
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