Does the political will exist to bring quality-assured and affordable drugs to low- and middle-income countries?

References

• UNAIDS. Fast-Track strategy to end the AIDS epidemic by 2030. Geneva: UNAIDS; 2014 [cited 2019 Feb 11]. Available from: http://www.unaids.org/en/resources/campaigns/World-AIDS-Day-Report-2014
   Google Scholar
• UNAIDS. 90-90-90 an ambitious treatment target to help end the HIV epidemic. Geneva: UNAIDS; 2014 [cited 2019 Feb 11]. Available from: http://www.unaids.org/en/resources/documents/2017/90-90-90
   Google Scholar
• Marcus JL, Chao CR, Leyden WA, et al. Narrowing the gap in life expectancy between HIV-infected and HIV-uninfected individuals with access to care. J Acquir Immune Defic Syndr. 2016;73:39–12.
   PubMed Web of Science ®Google Scholar
• Hammer SM. Antiretroviral treatment as prevention. N Engl J Med. 2011;365:561–562.
   Web of Science ®Google Scholar
• World Health Organization. Guideline on when to start antiretroviral therapy and on pre-exposure prophylaxis for HIV. Geneva: World Health Organization; 2015 [cited 2019 Feb 11]. Available from: http://apps.who.int/iris/bitstream/10665/186275/1/9789241509565_eng.pdf?ua=1
   Google Scholar
• Althoff KN, Smit M, Reissc P, et al. HIV and ageing: improving quantity and quality of life. Curr Opin HIV AIDS. 2016;11:527–536.
   PubMed Web of Science ®Google Scholar
• Mahy M, Autenrieth CS, Stanecki K, et al. Increasing trends in HIV prevalence among people aged 50 years and older: evidence from estimates and survey data. AIDS. 2014;28(Suppl 4):S453–S459. [cited 2019 Feb 11]. Available from: https://journals.lww.com/aidsonline/Fulltext/2014/11004/Increasing_trends_in_HIV_prevalence_among_people.6.aspx
   PubMed Web of Science ®Google Scholar
• World Health Organization. Global price reporting mechanism for HIV, tuberculosis and malaria. Geneva, Switzerland: World Health Organization. [cited 2019 Feb 11]. Available from: http://www.who.int/hiv/amds/gprm/en/
   Google Scholar
• UNAIDS. Fast-Track and human rights advancing human rights in efforts to accelerate the response to HIV. Geneva, Switzerland: UNAIDS; 2017 [cited 2019 Feb 11]. Available from: http://www.aidsdatahub.org/sites/default/files/publication/UNAIDS_Fast-Track_and_human_rights_2017.pdf
   Google Scholar
• Kates J, Waxler A, Lief E. Donor government funding for HIV in low- and middle-income countries in 2016. California: Kaiser Family Foundation & Geneva: UNAIDS; 2017 [cited 2019 Feb 11]. Available from: http://files.kff.org/attachment/Report-Donor-Government-Funding-for-HIV-in-Low-and-Middle-Income-Countries-in-2016
   Google Scholar
• Kaiser Family Foundation. The global HIV/AIDS epidemic. California: Kaiser Family Foundation; 2017 Nov 29 [cited 2019 Feb 11]. Available from: http://files.kff.org/attachment/Fact-Sheet-The-Global-HIV-AIDS-Epidemic
   Google Scholar
• Pascual F. Intellectual property rights, market competition and access to affordable antiretrovirals. Antivir Ther. 2014;19:57–67.
   Web of Science ®Google Scholar
• UNAIDS. Miles to go: closing gaps, breaking barriers, righting injustices. Geneva: UNAIDS; 2018. p. 111. [cited 2019 Feb 11]. Available from: http://www.unaids.org/en/resources/documents/2018/global-aids-update
   Google Scholar
• AIDS Medicines and Diagnostics Service. Combined global demand forecasts for antiretroviral medicines and HIV diagnostics in low- and middle-income countries from 2015 to 2020. Geneva: World Health Organization; 2016 September [cited 2019 Feb 11]. Available from: http://apps.who.int/iris/bitstream/handle/10665/250088/9789241511322-eng.pdf;sequence=1
   Google Scholar
• Gupta A, Juneja S, Vitoria M, et al. Projected uptake of new Antiretroviral (ARV) medicines in adults in low- and middle-income countries: a forecast analysis 2015–2025. PLoS One. 2016;11(10):e0164619.
   PubMed Web of Science ®Google Scholar
• Habiyambere V, Dongmo Nguimfack B, Vojnov L, et al. Forecasting the global demand for HIV monitoring and diagnostic tests: A 2016–2021 analysis. PLoS One. 2018;13(9):e0201341.
   Web of Science ®Google Scholar
• Habiyambere V, Ford N, Low-Beer D, et al. Availability and use of HIV monitoring and early infant diagnosis technologies in WHO member states in 2011–2013: analysis of annual surveys at the facility level. PLoS Med. 2016;13(8):e1002088.
   PubMed Web of Science ®Google Scholar
• WHO. Access to anti-retroviral and direct-acting antiviral medicines, and HIV diagnostics. 2016 update. Geneva: WHO; 2018.
   Google Scholar
• AIDS-Info. [cited 2019 Feb 11]. Available from: http://aidsinfo.unaids.org/
   Google Scholar
• Stover J, Bollinger L, Izazola JA, et al. What is required to end the AIDS epidemic as a public health threat by 2030? The cost and impact of the Fast-Track approach. PLoS One. 2016;11(5):e0154893.
   PubMed Web of Science ®Google Scholar
• UNAIDS. Miles to go, closing gaps, breaking barriers righting injustices. Geneva: UNAIDS; 2018. p. 66. [cited 2019 Feb 11]. Available from: http://www.unaids.org/sites/default/files/media_asset/miles-to-go_en.pdf
   Google Scholar
• Fortunak JM, de Souza R, Kulkarni AA, et al. Active pharmaceutical ingredients for antiretroviral treatment in low- and middle-income countries: a survey. Antivir Ther. 2014;19(3):15–29. [cited 2019 Feb 11]. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4318528/
   Web of Science ®Google Scholar
• Pinheiro E, Vasan A, Kim JY, et al. Examining the production costs of antiretroviral drugs. Aids. 2006;20:1745–1752. [cited 2019 Feb 11]. Available from: https://journals.lww.com/aidsonline/Fulltext/2006/08220/Examining_the_production_costs_of_antiretroviral.8.aspx
   Web of Science ®Google Scholar
• Wikipedia Good Manufacturing Practice (GMP). [cited 2019 Feb 11] Available from: https://en.wikipedia.org/wiki/Good_manufacturing_practice
   Google Scholar
• Laird T. Cost estimates for new molecules. Org Process Res Dev. 2005;9:125–126.
   Web of Science ®Google Scholar
• Medicin Sans Frontieres. Untangling the web of antiretroviral price reductions. 18th ed. Medicin Sans Frontieres; 2016 [cited 2019 Feb 11]. Available from: https://msfaccess.org/sites/default/files/HIV_report_Untangling-the-web-18thed_ENG_2016.pdf
   Google Scholar
• Pharmacompass. [cited 2019 Feb 11]. Available from: https://www.pharmacompass.com/price/Pharmacompass
   Google Scholar
• Pinheiro E, Brüning K, Macedo MF, et al. Production of antiretrovirals in low and middle income countries. Antivir Ther. 2014;19(6):49–55. [cited 2019 Feb 11]. Available from: http://apps.who.int/medicinedocs/documents/s21615en/s21615en.pdf
   Web of Science ®Google Scholar
• Field R. How the government created and sustains the private pharmaceutical industry. J Health Law Policy. 2012;6(1).
   Google Scholar
• Celia F. Pharma ups the ante on DTC advertising. Pharmaceutical Commerce; 2017 [cited 2019 Feb 11]. Available from: http://pharmaceuticalcommerce.com/brand-marketing-communications/pharma-ups-ante-dtc-advertising/
   Google Scholar
• Pollack A. Drug goes from $13.50 a tablet to $750, overnight. New York Times. 2015 Sep 20 [cited 2019 Feb 11]. Available from: https://www.nytimes.com/2015/09/21/business/a-huge-overnight-increase-in-a-drugs-price-raises-protests.html
   Google Scholar
• Rushton C. Company hikes price 5,000% for drug that fights complication of AIDS, cancer. USA Today. 2015 Sep 18 [cited 2019 Feb 11]. Available from: https://www.usatoday.com/story/news/health/2015/09/18/company-hikes-price-5000-drug-fights-complication-aids-cancer-daraprim/32563749/
   Google Scholar
• Silverman E. Martin Shkreli was hardly an outlier when it came to jacking up prices on older drugs. Pharmalot. 2018 May 2 [cited 2019 Feb 11]. Available from: https://www.statnews.com/pharmalot/2018/05/02/shkreli-drug-prices-generics/
   Google Scholar
• Pinheiro E, Brum-Soares L, Reis R, et al. Chagas disease: review of needs, neglect, and obstacles to treatment access in Latin America. Rev Soc Bras Med Trop. 2017;50(3):296–300. [cited 2019 Feb 11]. Available from: http://www.scielo.br/pdf/rsbmt/v50n3/0037-8682-rsbmt-50-03-00296.pdf
   PubMed Web of Science ®Google Scholar
• Pan American Health Organization. Strategic fund: access to quality medicines and health supplies for all in the Americas. Regional Office for the Americas of the World Health Organization. [cited 2019 Feb 11]. Available from: http://www.paho.org/hq/index.php?option=com_content&view=article&id=12163%3Apaho-strategic-fund&catid=8775%3Aabout&Itemid=42005&lang=en
   Google Scholar
• Association for Accessible Medicines. 2018 Generic drug access & savings in the U.S. access in Jeopardy. Association for Accessible Medicines; 2018 [cited 2019 Feb 11]. https://accessiblemeds.org/sites/default/files/2018_aam_generic_drug_access_and_savings_report.pdf
   Google Scholar
• QuintilesIMS Holding. Prescription drug market to touch $610 billion in 2021; 2017 May 4 [cited 2019 Feb 11]. Available from: https://manageria.biz/2017/05/04/prescription-drug-market-to-touch-610-billion-in-2021/
   Google Scholar
• Dave CV, Kesselheim AS, Fox ER, et al. High generic drug prices and market competition: a retrospective cohort study. Ann Intern Med. 2017;167(3):145–151. [cited 2019 Feb 11]. Available from: http://annals.org/aim/article-abstract/2636750/high-generic-drug-prices-market-competition-retrospective-cohort-study
   PubMed Web of Science ®Google Scholar
• Dave CV, Hartzema A, Kesselheim AS. Prices of generic drugs associated with numbers of manufacturers. N Engl J Med. 2017;377:2597–2598.
   PubMed Web of Science ®Google Scholar
• Gupta R, Kesselheim AS, Ross JS. Prioritization of generic drug review—reply. JAMA Intern Med. 2017;177(1):141–142. [cited 2019 Feb 11]. Available from: https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2594766
   Web of Science ®Google Scholar
• US Food and Drug Administration. FDA tackles drug competition to improve patient access. US Department of Health and Human Services; 2017 June 27 [cited 2019 Feb 11]. Available from: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm564725.htm
   Google Scholar
• US Food and Drug Administration. Statement from FDA commissioner Scott Gottlieb, M.D. on new steps to facilitate efficient generic drug review to enhance competition, promote access and lower drug prices. US Department of Health and Human Services; 2018 Jan 3 [cited 2019 Feb 11]. Available from: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm591184.htm
   Google Scholar
• US Food and Drug Administration News Release. FDA approves first generic drug under new pathway aimed at enhancing market competition for sole source drugs. US Department of Health and Human Services; 2018 Aug 8 [cited 2019 Feb 11]. Available from: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm616167.htm
   Google Scholar
• Medicines Law & Policy. The TRIPS Flexibilities Database. [cited 2019 Feb 11]. Available from: http://tripsflexibilities.medicineslawandpolicy.org/
   Google Scholar
• Boseley S. Calls for action on patients denied £100,000 cystic fibrosis drug. The Guardian. 2019 Feb 3. [cited 2019 Feb 11]. Available from: https://www.theguardian.com/science/2019/feb/03/nhs-cystic-fibrosis-drug-orkambi-vertex?CMP=Share_iOSApp_Other
   Google Scholar
• ‘t Hoen E The Italian exception – a personalised approach to accessing high-priced patented medicines. Medicines law and policy; 2007 May 5 [cited 2019 Feb 11]. Available from: https://medicineslawandpolicy.org/2017/05/the-italian-exception-a-personalised-approach-to-access-to-high-priced-patented-medicines/
   Google Scholar
• Tribune de Geneve. L’Inde au secours de la Suisse contre l’hépatite C. Geneva, Switzerland; 2017 May 3 [cited 2019 Feb 11]. Available from: https://www.tdg.ch/suisse/inde-secours-malades-lhepatite-c/story/22799116
   Google Scholar
• ‘t Hoen EFM, Veraldi J, Toebesc B, et al. HV medicine procurement and the use of flexibilities in the agreement on trade-related aspects of intellectual property rights, 2001–2016. Bull World Health Organ. 2018;96:185–193. [cited 2019 Feb 11]. Available from: https://www.who.int/bulletin/volumes/96/3/17-199364.pdf
   Web of Science ®Google Scholar
• World intellectual property organization intellectual property handbook: policy, law and use. Geneva: World Intellectual Property Organization; 2008. p. 17–21. [cited 2019 Feb 11]. Available from: http://www.wipo.int/export/sites/www/about-ip/en/iprm/pdf/ch2.pdf
   Google Scholar
• Intellectual Property India. The patents act, 1970. Ministry of Commerce and Industry, Government of India; [cited 2019 Feb 11]. Available from: http://www.ipindia.nic.in/writereaddata/Portal/IPOAct/1_113_1_The_Patents_Act_1970_-_Updated_till_23_June_2017.pdf
   Google Scholar
• ‘t Hoen E. The global politics of pharmaceutical monopoly power. Diemen AMB Publishers; 2009 [cited 2019 Feb 11]. Available from: https://www.opensocietyfoundations.org/sites/default/files/politics_20090312.pdf
   Google Scholar
• Sidley P. Silent trump card gives state winning hand. Business Day (South Africa). 2001 Apr 20.
   Google Scholar
• Zimmerman R, Pesta J. Drug industry, AIDS community is jolted by cipla AIDS-drug offer. Wall Street J. 2001 February 8. [cited 2019 Feb 11]. Available from: https://www.wsj.com/articles/SB981583719750566041
   Google Scholar
• ‘t Hoen E, Berger J, Calmy A, et al. Driving a decade of change: HIV/AIDS, patents and access to medicines for all. J Int AIDS Soc. 2011;14(1):15.
   Web of Science ®Google Scholar
• ‘t Hoen E, Hogerzeil HV, Quick JD, et al. A quiet revolution in global public health: the world health organization’s prequalification of medicines programme. J Public Health Policy. 2014;35(2):137–161.
   Web of Science ®Google Scholar
• World Trade Organization. Declaration on the TRIPS agreement and public health. DOHA WTO Ministerial. Geneva: World Trade Organization; 2001 Nov 14 [cited 2019 Feb 11]. Available from: https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm
   Google Scholar
• World Health Organization. WTO decision on the implementation of paragraph 6 of the DOHA declaration on the trips agreement and public health. Geneva: World Health Organization; [cited 2019 Feb 11]. Available from: http://www.who.int/medicines/areas/policy/wto_impl_para6/en/
   Google Scholar
• de Voogd. Letter to Ambassador Ahsa. Amsterdam, The Netherlands: International Development Association. 2015 Mar 6.
   Google Scholar
• Boulet P, ‘t Hoen E. Procurement of patented medicines by SADC member states. A report for SADC Member States and the future SADC Pharmaceutical Procurement Services (SPPS) based on the lessons learned during the Trade, TRIPS and Access to Medicines project 2012–2014. [cited 2019 Feb 11]. Available from: http://ttatm.sarpam.net/wp-content/uploads/Procurement-of-patented-medicines-by-SADC-MS-English-v5-final.pdf
   Google Scholar
• Ford N, Wilson D, Chaves GC, et al. Sustaining access to antiretroviral therapy in the less-developed world: lessons from Brazil and Thailand. Aids. 2007;21:S21–9. [cited 2019 Feb 11]. Available from: https://journals.lww.com/aidsonline/Pages/ArticleViewer.aspx?year=2007&issue=07004&article=00004&type=Fulltext
   PubMed Web of Science ®Google Scholar
• Médecins sans Frontières. Access Campaign. Persistent US attacks on India’s patent law & generic competition. Médecins sans Frontières; 2015 [cited 2019 Feb 11]. Available from: https://www.msfaccess.org/sites/default/files/IP_US-India_Briefing%20Doc_final_2%20pager.pdf
   Google Scholar
• Silverman E. El Salvador is the latest Latin American country to worry pharma over compulsory licensing. Phamalot. 2018 Dec 24 [cited 2019 Feb 11]. Available from: https://www.statnews.com/pharmalot/2018/12/24/el-salvador-compulsory-licensing-pharma/
   Google Scholar
• Medicines Patent Pool. MPP in numbers, annual report 2016. Geneva: Medicines Patent Pool; 2016 [cited 2019 Feb 11]. Available from: https://medicinespatentpool.org/uploads/2017/06/MPP_Annual-report-2016_LQ.pdf
   Google Scholar
• ‘t Hoen E. Indian hepatitis C drug patent decision shakes public health community. Lancet. 2016 May 26:1–2. [cited 2019 Feb 11]. Available from: http://www.thelancet.com/pb/assets/raw/Lancet/pdfs/S0140673616306560.pdf
   Web of Science ®Google Scholar
• Vial L. Opposition against patent EP 2 203 462, filed on 26 March 2008 In the name of Gilead Pharmasset LLC for “nucleoside phosphoramidate prodrugs”. Munich, Germany: European Patent Office; 2015 Feb 10 [cited 2019 Feb 11]. Available from: https://cdn.patentoppositions.org/uploads/patent_opposition/user_uploaded_file/58d66b6efb1640213c000000/pdf_e777e650-f389-0134-14a0-50e549351d0c.pdf
   Google Scholar
• I-MAK. First-ever U.S. patent challenges dispute Gilead’s monopoly on hepatitis C drugs that blocks millions from treatment. New York: I-Mak Press Release; 2017 Oct 25 [cited 2019 Feb 11]. Available from: http://www.i-mak.org/2017/10/25/first-ever-us-patent-challenges-gilead-hepatitis-c/
   Google Scholar
• ‘t Hoen E, Boulet P, Baker BK. Data exclusivity exceptions and compulsory licensing to promote generic medicines in the European Union: A proposal for greater coherence in European pharmaceutical legislation. J Pharm Policy Pract. 2017;10(1):19.
   Google Scholar
• Shah ASV, Stelzle D, K K L, et al. Global burden of atherosclerotic cardiovascular disease in people living with HIV: systematic review and meta-analysis. Circulation. 2018;138:1100–1112.
   PubMed Web of Science ®Google Scholar
• World Health Organization. Non-communicable diseases: the slow motion disaster, in ten years in public health 2007–2017. Geneva, Switzerland: World Health Organization; 2017 [cited 2019 Feb 11]. Available from: http://www.who.int/publications/10-year-review/ncd/en/
   Google Scholar
• World Health Organization and International Bank for Reconstruction and Development/The World Bank. Tracking universal health coverage: 2017 global monitoring report. World Health Organization and the International Bank for Reconstruction and Development/The World Bank; [cited 2019 Feb 11]. Available from: http://pubdocs.worldbank.org/en/193371513169798347/2017-global-monitoring-report.pdf
   Google Scholar
• Bollyky TJ. Access to drugs for treatment of noncommunicable diseases. PLoS Med. 2013;10(7):e1001485.
   Web of Science ®Google Scholar
• Dyer O. Pfizer and Cipla plan to make cancer drugs affordable in Africa. Br Med J. 2017;359:j4848. [cited 2019 Feb 11]. Available from: https://www.bmj.com/content/359/bmj.j4848
   Web of Science ®Google Scholar
• Emanuel E. We can’t afford the drugs that could cure cancer. Wall Street J. 2018 Sep 20. [cited 2019 Feb 11]. Available from: https://www.wsj.com/articles/we-cant-afford-the-drugs-that-could-cure-cancer-1537457740
   Google Scholar
• High Level Panel on Access to Health Technologies. A report of the United Nations secretary-general’s high level panel on access to medicines: promoting innovation and access to health technologies. New York: High Level Panel on Access to Health Technologies; 2016 [cited 2019 Feb 11]. Available from: https://static1.squarespace.com/static/562094dee4b0d00c1a3ef761/t/57d9c6ebf5e231b2f02cd3d4/1473890031320/UNSG+HLP+Report+FINAL+12+Sept+2016.pdf
   Google Scholar
• Ripin DJ, Jamieson D, Waning B, et al. ARV procurement and supply chain management. Antivir Ther. 2014;19 Suppl 3:79–89. [cited 2019 Feb 11]. Available from: https://www.researchgate.net/publication/266947772_Antiretroviral_procurement_and_supply_chain_management
   Web of Science ®Google Scholar