9 September 2016

Delinkage Bibliography

Congressional Testimony/Legislation

Lessig, Lawrence. Testimony at hearing before the United States Senate, Committee on Health, Education, Labor and Pensions, Subcommittee on Primary Health and Agency on The High Cost of High Prices for HIV/AIDS Drugs and the Prize Fund Alternative. May 15, 2012. Washington, DC.

Stiglitz, Joseph. Testimony at hearing before the United States Senate, Committee on Health, Education, Labor and Pensions, Subcommittee on Primary Health and Agency on The High Cost of High Prices for HIV/AIDS Drugs and the Prize Fund Alternative. May 15, 2012. Washington, DC.

Moon, Suerie. Testimony at hearing before the United States Senate, Committee on Health, Education, Labor and Pensions, Subcommittee on Primary Health and Agency on The High Cost of High Prices for HIV/AIDS Drugs and the Prize Fund Alternative. May 15, 2012. Washington, DC.

Oldham, Frank. Testimony at hearing before the United States Senate, Committee on Health, Education, Labor and Pensions, Subcommittee on Primary Health and Agency on The High Cost of High Prices for HIV/AIDS Drugs and the Prize Fund Alternative. May 15, 2012. Washington, DC.

Akhter, Mohammad N. “The Cost of HIV/AIDS Treatment in the United States.” Hearing before the United States Senate, Committee on Health, Education, Labor and Pensions, Subcommittee on Primary Health and Agency on The High Cost of High Prices for HIV/AIDS Drugs and the Prize Fund Alternative. May 15, 2012. Washington, DC.

Love, James. “The de-linkage of R&D costs and drug prices through the Prize Fund for HIV/AIDS will cost less, expand access, accelerate and improve innovation, and replace an incentive system that is expensive, inefficient and unsustainable.” Hearing before the United States Senate, Committee on Health, Education, Labor and Pensions, Subcommittee on Primary Health and Agency on The High Cost of High Prices for HIV/AIDS Drugs and the Prize Fund Alternative. May 15, 2012. Washington, DC.

Prize Fund for HIV/AIDS Act, S. 1138, 112th Cong. (2011).

Medical Innovation Prize Fund Act, S. 1138, 112th Cong. (2011).

Think Tanks/Policy Papers/Independent Academics

Clift, Charles et al., eds. Towards a New Global Business Model for Antibiotics: Delinking Revenues from Sales. London: Chatham House, 2015. https://www.chathamhouse.org/sites/files/chathamhouse/field/field_document/20151009NewBusinessModelAntibioticsCliftGopinathanMorelOuttersonRottingenSo.pdf

Jaczynska, Ella, Kevin Outterson, and Jorge Mestre-Ferrandiz. Business Model Options for Antibiotics: Learning from Other Industries. London: Chatham House and Big Innovation Centre, 2015.

Kieny, Marie-Paule. “Creating an Intergovernmental Consortium for New Antibiotics: A New Development Model.” In AMR Control 2015: Overcoming Global Antimicrobial Resistance, edited by Global Health Dynamics, 26-32. Woodbridge, Suffolk, UK: Global Health Dynamics Limited, 2015. http://www.finddx.org/wp-content/uploads/2016/03/WAAR-2015_AMR-Control-2015_Overcoming-Global-AMR.pdf#page=28

Rubio, Joaquim Campoy. “Ebola, R&D on Neglected Diseases and the Health Impact Fund.” SSRN (2015). http://ssrn.com/abstract=2663616

Outterson, Kevin. “New Business Models for Sustainable Antibiotics.” Working Groups on Antimicrobial Resistance, paper 1 (February 2014). Chatham House. https://www.chathamhouse.org/sites/files/chathamhouse/public/Research/Global%20Health/0214SustainableAntibiotics.pdf

Hoetz, Peter et al. Strengthening Mechanisms to Prioritize, Coordinate, Finance, and Execute R&D to Meet Health Needs in Developing Countries. Washington, DC: Institute of Medicine, 2013. https://nam.edu/wp-content/uploads/2015/06/GlobalHealthRD.pdf

Pugatch, Meir Perez, Rachel Chu, and David Torstensson. Assembling the Pharmaceutical R&d Puzzle for Needs in the Developing World: An Assessment of New and Proposed Delinking Initiatives Aimed at Encouraging R&D Into Neglected and Tropical Diseases and Specific Type II Diseases. Washington: Pugatch Consilium, 2012. https://www.apifarma.pt/salaimprensa/noticias/Documents/Assembling%20the%20RD%20puzzle_FINAL.PDF

MSF Access Campaign. How a Global R&D Convention Could Fill The Gaps Left By Today’s Medical Innovation System. Geneva: Médecins Sans Frontières, 2012. http://www.ghd-net.org/sites/default/files/MedInno_Briefing_GlobalConventionRD_ENG_2012Update.pdf

Government/Intergovernmental Documents

Love, James. An Economic Perspective on Delinking the Cost of R&D from the Price of Medicines. Geneva: UNITAID (WHO), 2016. http://unitaid.org/en/statements/1518-unitaid-study-looks-at-delinking-cost-of-r-d-from-price-of-medicines

Love, James. 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. CDIP/14/INF/12. Geneva: WIPO, 2014. http://www.wipo.int/meetings/en/doc_details.jsp?doc_id=287218

Media

Mullard, Asher. “Momentum Builds Around New Antibiotic Business Models.” Nature Reviews Drug Discovery 13 (October 1, 2014): 711-3. http://dx.doi.org/10.1038/nrd4455

Mackenzie, Debora. “Affordable Drugs for All.” New Scientist 201, no. 2697 (February 27, 2009): 22-3. http://dx.doi.org/10.1016/S0262-4079(09)60569-8

Multinational Monitor. “Eyes on the Prize: Incentivizing Drug Innovation without Monopolies.” May/June 2009. http://www.multinationalmonitor.org/mm2009/052009/interview-love.html

Love, James. “Would Cash Prizes Promote Cheap Drugs?” New Scientist (November 7, 2007). https://www.newscientist.com/article/mg19626296.100-would-cash-prizes-promote-cheap-drugs/

Academic Articles

Mishra, Shiva Raj et al. “Young People Have a New Vision for Essential Medicines.” Lancet Diabetes & Endocrinology (July 2016). http://dx.doi.org/10.1016/S2213-8587(16)30153-X

Hollis, Aidan. “Sustainable Financing of Innovative Therapies: A Review of Approaches.” PharmacoEconomics (June 2016). http://dx.doi.org/10.1007/s40273-016-0416-x

Outterson, Kevin et al. “Delinking Investment in Antibiotic Research and Development from Sales Revenues: The Challenges of Transforming a Promising Idea into Reality.” PLOS Medicine 13, no. 6 (June 2016): e1002043. http://dx.doi.org/10.1371/journal.pmed.1002043

Rex, John H. and Kevin Outterson. “Antibiotic Reimbursement in a Model Delinked from Sales: A Benchmark-based Worldwide Approach.” Lancet Infectious Diseases 16, no. 4 (April 2016): 500-5. https://www.bu.edu/law/files/2016/05/Antibiotic-reimbursement-in-a-model-delinked-from-sales-a-benchmark-based-worldwide-approach.pdf

Renwick, Matthew J., David M. Brogan, and Elias Mossialos. “A Systematic Review and Critical Assessment of Incentive Strategies for Discovery and Development of Novel Antibiotics.” Journal of Antibiotics 69, no. 2 (February 2016): 73-88. http://dx.doi.org/10.1038/ja.2015.98

Brogan, David M. and Elias Mossialos. “Systems, Not Pills: The Options Market for Antibiotics Seeks to Rejuvenate the Antibiotic Pipeline.” Social Science & Medicine 151 (February 2016): 167-72. http://dx.doi.org/10.1016/j.socscimed.2016.01.005

Mendelson, Marc et al. “Maximising Access to Achieve Appropriate Human Antimicrobial Use in Low-income and Middle-income Countries.” Lancet 387 (January 2016): 188-98. http://dx.doi.org/10.1016/S0140-6736(15)00547-4

Love, James. “Drug Pricing is out of control, what should be done?” PLOS BLOGS. October 19, 2015. http://blogs.plos.org/yoursay/2015/10/19/talking-drug-prices-pt-4-drug-pricing-is-out-of-control-what-should-be-done-by-james-love/

Hollis, Aidan and Peter Maybarduk. “Antibiotic Resistance Is a Tragedy of the Commons That Necessitates Global Cooperation.” Journal of Law, Medicine & Ethics 43, no. 2 S3 (Summer 2015): 33-7.

Balaseagram, Manica, Charles Clift, and John-Arne Røttingen. “A Pathway towards an Alternative Business Model for Antibiotic Innovation: A Framework, Fund and Institutional Mechanism.” Journal of Law, Medicine & Ethics 43, no. 2 S3 (Summer 2015): 22-6.

Balasegaram, Manica et al. “A Global Biomedical R&D Fund and Mechanism for Innovations of Public Health Importance.” PLOS Medicine 12, no. 5 (May 2015): e1001831. http://dx.doi.org/10.1371/journal.pmed.1001831

Bors, Cindy et al. “Improving Access to Medicines in Low-Income Countries: A Review of Mechanisms.” Journal of World Intellectual Property 18, no. 1-2 (March 2015): 1-28. http://dx.doi.org/10.1111/jwip.12032

Laxminarayan, Ramanan. “Antibiotic Effectiveness: Balancing Conservation Against Innovation.” Science 345, no. 6202 (September 2014): 1299-1301. http://www.sciencemag.org/content/345/6202/1299.full.html

Hill, Julia E. “Changes to Intellectual Property Policy in South Africa: Putting a Stop to Evergreening?” Expert Opinion on Therapeutic Patents 24, no. 8 (August 2014): 839-43. http://dx.doi.org/10.1517/13543776.2014.931376

Kameda, Koichi. “Needs-Driven Versus Market-Driven Pharmaceutical Innovation: The Consortium for the Development of a New Medicine against Malaria in Brazil.” Developing World Bioethics 14, no. 2 (August 2014): 101-8. http://dx.doi.org/10.1111/dewb.12056

Moon, Suerie. “WHO’s Role in the Global Health System: What Can Be Learned from Global R&d Debates?” Public Health 128, no. 2 (February 2014): 167-72. http://dx.doi.org/10.1016/j.puhe.2013.08.014

So, Anthony D. and Tejen A. Shah. “New Business Models for Antibiotic Innovation.” Upsala Journal of Medical Sciences 119, no. 2 (2014): 176-80. http://dx.doi.org/10.3109/03009734.2014.898717

Haider, Narmeen, Aidan Hollis, and James Love. “Delinkage Proposals and the Measurement of Health Benefits.” Whittier Law Review 35, no. 3 (2014): 349-62.

Agitha, T.G. “Global Governance for Facilitating Access to Medicines: Role of World Health Organization.” Journal of Intellectual Property Rights 18, no. 6 (November 2013): 589-95. https://www.researchgate.net/profile/Agitha_Tg2/publication/260598457_JIPR_18(6)_589-595/links/0c960531c0001f00dc000000.pdf

Agitha, T. G. “Alternative Incentive Models Delinking R&D Costs from Pharmaceutical Product Price.” Journal of Intellectual Property Rights 18, no. 5 (October 2013): 491-8. http://14.139.47.15/bitstream/123456789/21532/1/JIPR%2018(5)%20491-498.pdf

Freeman, Phyllis and Anthony Robbins. “How can the public health community help to invigorate a ‘health first’ perspective in global drug development debates?” Journal of Public Health Policy 34, no. 3 (August 2013): 361-9. http://dx.doi.org/10.1057/jphp.2013.31

Outterson, Kevin, Thomas Pogge, and Aidan Hollis. “Combating Antibiotic Resistance through the Health Impact Fund.” In The Globalization of Health Care: Legal and Ethical Issues, edited by I. Glenn Cohen, 318-38. New York: Oxford University Press, 2013.

Ho, Cynthia M. “Beyond Patents: Global Challenges to Affordable Medicines” In The Globalization of Health Care: Legal and Ethical Issues, edited by I. Glenn Cohen, 302-17. New York: Oxford University Press, 2013.

Love, James. “Balancing Options for Health Research and Development.” Bulletin of the World Health Organization 90, no. 11 (November 2012): 796-6A. http://www.who.int/bulletin/volumes/90/11/12-113886/en/

Moon, Suerie, Jorge Bermudez, and Ellen ’t Hoen. “Innovation and Access to Medicines for Neglected Populations: Could a Treaty Address a Broken Pharmaceutical R&D System?” PLOS Medicine 9, no. 5 (May 2012): e1001218. http://dx.doi.org/10.1371/journal.pmed.1001218

Musselwhite, Laura W. et al. “First Universities Allied for Essential Medicines (UAEM) Neglected Diseases and Innovation Symposium.” American Journal of Tropical Medicine and Hygiene 68, no. 1 (January 2012): 65-74. http://dx.doi.org/10.4269/ajtmh.2012.11-0608

So, A. D. et al. “Towards New Business Models for R&D for Novel Antibiotics.” Drug Resistance Updates 14, no. 2 (April 2011): 88-94. http://dx.doi.org/10.1016/j.drup.2011.01.006

Lemaire, Jean-François and Martina Casenghi. “New Diagnostics for Tuberculosis: Fulfilling Patient Needs First.” Journal of the International AIDS Society 13 (October 2010): 40. http://old.biomedcentral.com/1758-2652/13/40/

Kesselheim, Aaron S. and Kevin Outterson. “Fighting Antibiotic Resistance: Marrying New Financial Incentives To Meeting Public Health Goals.” Health Affairs 29, no. 9 (September 2010): 1689-96. http://dx.doi.org/10.1377/hlthaff.2009.0439

Gombe, Spring and James Love. “New Medicines and Vaccines: Access, Incentives to Investment, and Freedom to Innovate.” In Access to Knowledge in the Age of Intellectual Property, edited by Gaëlle Krikorian and Amy Kapczynski, 531-46. New York: Zone Books, 2010.

Fisher, William W. and Talha Syed. “A Prize System as a Partial Solution to the Health Crisis in the Developing World.” In Incentives for Global Public Health: Patent Law and Access to Essential Medicines, edited by Thomas Pogge, Matthew Rimmer, and Kim Rubenstein, 181-208. New York: Cambridge University Press, 2010.

Liddell, Kathleen. “The Health Impact Fund: A Critique.” In Incentives for Global Public Health: Patent Law and Access to Essential Medicines, edited by Thomas Pogge, Matthew Rimmer, and Kim Rubenstein, 155-80. New York: Cambridge University Press, 2010.

Pogge, Thomas. “The Health Impact Fund: Better Pharmaceutical Innovations at Much Lower Prices.” In Incentives for Global Public Health: Patent Law and Access to Essential Medicines, edited by Thomas Pogge, Matthew Rimmer, and Kim Rubenstein, 135-54. New York: Cambridge University Press, 2010.

Crager, Sara E. and Matt Price. “Prizes and Parasites: Incentive Models for Addressing Chagas Disease.” Journal of Law, Medicine & Ethics 37, no. 2 (Summer 2009): 292-304. http://dx.doi.org/10.1111/j.1748-720X.2009.00373.x

Weilbaecher, Ann. “Diseases Endemic in Developing Countries: How to Incentivize Innovation.” Annals of Health Law 18, no. 2 (Summer 2009): 281-309. http://lawecommons.luc.edu/cgi/viewcontent.cgi?article=1115&context=annals

Love, James and Tim Hubbard. “Prizes for Innovation of New Medicines and Vaccines.” Annals of Health Law 18, no. 12 (Summer 2009): 155-86. http://keionline.org/sites/default/files/prizes_new_medicines_annals_healthlaw.pdf

Love, James and Tim Hubbard. “The Big Idea: Prizes to Stimulate R&D for New Medicines.” Chicago-Kent Law Review 82, no. 3 (October 2007): 1519-54. http://studentorgs.kentlaw.iit.edu/cklawreview/wp-content/uploads/sites/3/vol82no3/Love.pdf

Love, James. “Measures to Enhance Access to Medical Technologies, and New Methods of Stimulating Medical R & D.” UC Davis Law Review 40, no. 3 (March 2007): 679-715. http://lawreview.law.ucdavis.edu/issues/40/3/developing-drugs-for-developing-word/DavisVol40No3_Love.pdf

Love, James. “Drug Development Incentives to Improve Access to Essential Medicines.” Bulletin of the World Health Organization 84, no. 5 (May 2006): 408. http://www.cptech.org/ip/health/rnd/love-who052006.pdf

Love, James and Tim Hubbard. “Paying for Public Goods.” In CODE: Collaborative Ownership and the Digital Economy, edited by Rishab Ghosh, 207-29. Cambridge, MA: MIT Press, 2005. http://keionline.org/sites/default/files/lovehubbard-code.pdf

Love, James. “Pharmaceutical Research and Development and the Patent System.” International Journal of Health Services 5, no. 2 (April 2005): 257-263. http://dx.doi.org/10.2190/PXBW-TRDR-XAC0-2THW

Love, James and Tim Hubbard. “A New Trade Framework for Global Healthcare R&D.” PLoS Biology 2, no. 2 (February 2004): 147-50. http://dx.doi.org/10.1371/journal.pbio.0020052