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Access to medicines

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670:, the Kenya Coalition for Access to Essential Medicines (KCAEM), was formed in response to Kenya's Industrial Property Act 2001. The act outlined the rights of patent holders. Members of this coalition are local community-based and national NGOs, international NGOs, healthcare providers, journalists, lawyers and other individuals. The coalition works primarily with people living with HIV/AIDS and access to essential HIV/AIDS medications and treatments. It urges for flexibility in interpreting the TRIPS Agreement and efforts to implement production of generic antiretroviral drugs by local manufacturers and/or to import inexpensive drugs. It also calls for pharmaceutical companies to reduce the price of their medications. The coalition has garnered support from key government officials and organizations such as Kenyan Property Institute, Kenyan Ministry of Trade, and the Minister of Trade Mr. Nicholas Biwott MP. 535: 212: 352: 293:. The Doha Declaration responds to concerns of developing countries that patent protection rules and other IPRs were hindering access to affordable medicines for populations in those countries. The Doha Declaration emphasizes the flexibility of the TRIPS Agreement and highlights the right of respective government to interpret the TRIPS Agreement in terms of public health. It refers to specific parts of TRIPS, such as the use of compulsory licensing for 149: 619:. On June 20, 2024, MSF announced closing down its Access-to-medicines campaign focused on enabling access to medicines in resource limited settings. MSF plans to replace the campaign with a new effort that will focus on products, like medicines and vaccines, that MSF needs for its own relief efforts. Several advocates have criticized this move including the 326:(LMICs) is a voluntary license (VL). A VL is an agreement where an originator manufacturer allows a generic manufacturer to produce and sell a patented drug in specific countries under certain terms. These licences can be established directly between patent holders and generic manufacturers or through patent pooling mechanisms like the 1915: 252:. The TRIPS Agreement is argued to have the greatest effect on the pharmaceutical industry and access to medicines. It is argued that the TRIPS agreement negatively impacted generic drug industries in countries such as India. However, others argue that the agreement is open to interpretation. A clause in the TRIPS agreement allows 202:
Among populations that do not speak the main language in an area access to medicine can be hindered by language barriers as well as other cultural barriers. There is evidence that access is improved by having medical workers that speak the language of patients, as patients will be more likely to know
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to allow for generic brand production. In order the use of the medication to be effective, it must be manufactured in optimal laboratory conditions. Developing countries often lack air conditioning, stable electrical power, or refrigerators to store samples and chemicals. Also, quality generic brand
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is defined as the excessive increase in prices by sellers of essential goods to a level deemed higher than reasonable or fair. This sharp increase in prices may leave the buyer vulnerable. It also leads to inequitable access to essential goods among different socioeconomic groups. It is argued that
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for drugs in India, Indian drug companies were able to use alternative, legal processes to manufacture generic versions of drugs. These generic drug companies were able to produce low-priced drugs that were considered among the lowest in the world. This allowed India to provide free antiretroviral
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The declaration also allows for countries without manufacturing capabilities to turn to another country for the export of generic brands of patented medicines. This is known as the paragraph 6 system. As of 2010 it had only been called upon once, concerning the export of medicines from Canada to
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Many argue that generic brand production in developing countries increases competition and therefore is essential to bridge the global drug gap. As argued by various sources, the push for more measures such as market and data exclusivity, hinders low-income countries' ability to manufacture and
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In some countries pharmaceutical company have ultimate control of the pricing of their patented product. Therefore, the owner has control of the pricing of the medication, based on the price level the owner deems best to reflects their ability to manufacture and the level of profit desired.
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partnership, created in 2000, devoted to improving access to vaccines in low-income countries. The organization partners with several developing countries, donor governments, research agencies, and vaccines companies in both in industrialized and developing countries. It also partners with
1727: 522:. They argue that allowing generic competition is essential for making the long-acting drug affordable in middle-income countries. Lenacapavir, a twice-yearly injection, has shown strong potential for HIV prevention, offering hope for ending AIDS if widely accessible. The 236:(IPR), including those for patents and data protection. Under the TRIPS Agreement, WTO member nations, with a few exceptions, are required to adjust their laws to the minimum standards of IPR protection. Member nations are also obligated to follow specific 190:
production is limited by a government's ability to create effective spaces of market competition and to monitor the quality of generics brands; this ability has been found to be limited in certain developing countries. It also argued that
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and other private philanthropists. GAVI is noted as an important source of external funding for vaccines in low-income countries and played a crucial role in introducing the HPV vaccine and other new vaccines to developing countries.
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treatment to 340,000 HIV infected individuals in the country. Majority of adult antiretroviral drugs purchased for donor-funded programs in developing countries were supplied by Indian generic drug companies. In compliance to the
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allows developing countries to bring in medicines at lower cost. It specifically allows companies in Canada who may not own the right to make a medication to do so for export to certain countries in the developing world.
412:. However, Brazil is argued not to have restrictive patent laws. In the mid-1990s, Brazil began manufacturing generic versions of vital AIDS medication. Due to this, Brazil's AIDS mortality rate declined by almost 50%. 1785: 140:. Many argue that pharmaceutical companies push for data exclusivity—seeking to extend their monopolies by advocating for market exclusivity provided by patents and data exclusivity, or protection for new medicine. 334:
suggest that voluntary licensing was an effective tool in advancing access to Hepatitis C antiviral medicines. VL has also been effective in increasing access to HIV medicines in the development world via the
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and the inadequate access to essential AIDs medications constitute a national emergency. Therefore, the TRIPS Agreement can be interpreted to allow the manufacture of generic brands of patented HIV/AIDs drugs
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to a product or process for 20 years in a particular territory. The owner of the patent has the right to prevent the manufacture, use, sell, import, or distribution of the patented product. It is argued that
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Schaafsma, E. & Raynor, David & Berg, Lolkje. (2003). Accessing medication information by ethnic minorities: Barriers and possible solutions. Pharmacy world & science : PWS. 25. 185-90.
1843: 281:. Many argued that the TRIPS Agreement hindered developing countries from implementing measures to improve access to affordable medicines, especially for diseases of public health concern, such as 256:, which permits the manufacture of generic brands of patented drugs, at prices set in a competitive market in cases of national emergencies. For example, many believe that the HIV/AIDs crisis in 630:, the Ministry of Health and the Tanzania Food and Drugs Authority and the Strategies for Enhancing Access to Medicines Program introduced accredited drug dispensing outlets, with aid from 274: 1717:
Chequer, P., Sudo, E.C., & Vitfria, M.A.A. (2000). The impact of anti-retroviral therapy in Brazil. Paper presented at International AIDS Conference in Durban, paper no. MoPpE1066.
1916:"Johnson & Johnson Confirms Intent Not to Enforce Patents for SIRTURO® (bedaquiline) for the Treatment of Multidrug-Resistant Tuberculosis in 134 Low- and Middle-Income Countries" 277:
of 2001 worked to rectify the negative impact of the TRIPS Agreement. The Doha Declaration on the TRIPS Agreement and Public Health, effective November 2001, was adopted by
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SchĂĽklenk, Udo; Ashcroft, Richard E. (April 2002). "Affordable Access to Essential Medication in Developing Countries: ConflictsBetween Ethical and Economic Imperatives".
1995: 1955: 570:. At the time, no other generic versions of the drug was available. Turing dramatically raised the price of the drug from $ 13.50 a tablet to $ 750, a 5000% increase. 526:
will hear the Trust’s objections on September 19. The Trust claims that two of Gilead’s patent applications, concerning salt forms of the drug, lack true innovation.
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data and provides conductor of the trial temporary exclusive rights to the data. Many suggest that extending exclusivity periods can have consequences in delivering
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Godoy, Angelina Snodgrass (2015-06-01). "Market Myths and Assumptions: Examining the Transnational Politics of Access to Medicines Campaigning in Central America".
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Purchasers have little say over the price set. It is argued that competition is necessary to lower drug prices and improve access to affordable medications.
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Owoeye, Olasupo (2015). "International Patents Law and Public Health: Revisiting the TRIPS Compulsory Licensing Regime and the Doha Paragraph 6 System".
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only in the case of a national emergency and circumstances of extreme urgency and the right to determine what constitutes this—such as to address
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and/or a source of funding for drug donations to low-income countries. Others suggest that data exclusivity works to diminish the availability of
1458: 1204:"DELAURO HOLDS COMMITTEE HEARING ON PRESCRIPTION DRUGS UNCONSCIONABLE PRICE GOUGING IS IMPEDING CARE AND INCREASING OVERALL HEALTH CARE COSTS". 605: 679: 1382: 194:, state investment, and measures for infection prevention are necessary to allow for generic brand production in low-income countries. 2249: 659: 631: 278: 1296: 2166: 566:
drug, is considered an essential drug for HIV treatments. It is widely used to treat patients with AIDS-related and AIDs-unrelated
2050:"An Open Letter to Médecins Sans Frontières — Urgent Call to Reverse the Devastating Decision to Shutter the MSF Access Campaign" 736: 634:. It worked to create a nationwide chain of dispensers, which provide quality pharmaceutical drugs and services to its citizens. 586: 323: 534: 1818: 642: 471: 612: 340: 232:(WTO), effective January 1995. This agreement introduced global standards for enforcing and protecting nearly all forms of 164:
pharmaceutical companies have dramatically increased prices for treatments that are essential in treating diseases such as
2049: 593:´s Global Drug Facility`s a license that enabled the tender, procurement and supply of generic versions of bedaquiline. 511: 443: 249: 233: 1614:"Projected savings through public health voluntary licences of HIV drugs negotiated by the Medicines Patent Pool (MPP)" 1969:
Directorate, Government of Canada, Health Canada, Health Products and Food Branch, Therapeutic Products (2004-07-26).
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Directorate, Government of Canada, Health Canada, Health Products and Food Branch, Therapeutic Products (2004-07-26).
1569:"Effect of voluntary licences for hepatitis C medicines on access to treatment: a difference-in-differences analysis" 712: 601:
A number of countries and organizations have efforts to improve access to medicines in specific areas of the world.
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Many Indian families live below the poverty line due to healthcare expenses. From 1972 to 2005, due to a lack of
42: 879:"Raising the Barriers to Access to Medicines in the Developing World – The Relentless Push for Data Exclusivity" 684: 503:
in low- and middle- income countries (LMICs). Due to the introduction of generic brand competition, first-line
447: 229: 133: 98: 1122:"Improving Global Access to New Vaccines: Intellectual Property, Technology Transfer, and Regulatory Pathways" 1545: 49:
should be available, of good quality, and accessible. Reasonable access to medicines can be in conflict with
563: 384:, out of the estimated 820,000 infected individuals, only about 1.2% can afford essential AIDS medications. 380:, out of one million infected individuals, 30 have access to life-sustaining essential AIDS medications. In 620: 547: 507:
drugs' prices dropped by more than 99%, from $ 10,000/year per patient in 2000 to less than $ 70 in 2014.
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procedures. Before TRIPS, other international conventions and laws did not specify minimum standards for
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vaccine is considered the most expensive vaccine in history. However, the majority of those that have
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occur in low and middle income countries. In low-income countries, more than 90% of deaths are from
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Grover, Anand; Citro, Brian (2011). "India: access to affordable drugs and the right to health".
1047: 500: 253: 241: 129: 74: 847: 830: 351: 2172: 2162: 2080: 1989: 1949: 1793: 1760: 1661: 1643: 1590: 1481: 1459:"WTO "Paragraph 6" system for affordable access to medicines: Relief or regulatory ritualism?" 1353: 1345: 1236: 1186: 1151: 1085: 1039: 989: 908: 852: 811: 191: 94: 35: 152:
Martin Shkreli testifying before the House Committee on Oversight and Government Reform, 2016
2072: 1679: 1651: 1633: 1580: 1473: 1337: 1272: 1228: 1178: 1141: 1133: 1077: 1031: 979: 969: 898: 890: 842: 803: 113: 58: 1894:"Johnson & Johnson says it won't enforce secondary patents on tuberculosis med Sirturo" 1304: 330:. Such licences, are often non-exclusive and granted to multiple manufacturers. A study in 1728:"Civil Society Organisations oppose Gilead's patent applications for lenacapavir in India" 515: 475: 426: 373: 225: 89: 31: 1629: 1519: 1656: 1613: 1146: 1121: 984: 957: 903: 878: 744: 551: 504: 261: 186: 117: 2076: 1585: 1081: 791: 2243: 2130: 2063:
Mbwasi, Romuald; Mlaki, Wilson (2008). "Increasing access to medicines in Tanzania".
2035:"Doctors Without Borders is closing its widely regarded access-to-medicines campaign" 1248: 1097: 567: 559: 539: 397: 393: 298: 160: 125: 1365: 1051: 16:
The reasonable ability for people to get needed medicines required to achieve health
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There is estimated to be 1.8 million individuals HIV infected individuals in the
2009: 1609: 787: 582: 519: 467: 455: 421: 237: 169: 1035: 958:"Innovative Approaches to Increase Access to Medicines in Developing Countries" 1698: 1438:
Chung, Laura (Fall 2010). "Use of Paragraph 6 System for Access to Medicine".
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usage was at 90%. In Southeast Asia, where there is hepatitis B epidemic, the
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produce generic drugs. However, low-income countries often lack the essential
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Cohen-Kohler, J C (2007-11-01). "The Morally Uncomfortable Global Drug Gap".
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Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)
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Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)
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The appearance of generic manufacturers in low-income countries, such as
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There is estimated to be more than 4 million HIV infected individuals in
339:. On the hand there are groups critical of voluntary licensing including 282: 165: 102: 62: 1477: 1440:
North Carolina Journal of International Law & Commercial Regulation
1182: 894: 459: 290: 400:. There is also a high prevalence of HIV in smaller countries such as 2161:. Freeman, Michael D. A.,, Hawkes, Sarah,, Bennett, Belinda. Oxford. 2106: 651: 496: 409: 381: 377: 356: 257: 173: 85: 27: 1567:
Simmons, Bryony; Cooke, Graham S; Miraldo, Marisa (September 2019).
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Diependaele, Lisa; Cockbain, Julian; Sterckx, Sigrid (April 2017).
1786:"Activists sound alarm bells as Gilead seeks rights over HIV drug" 667: 533: 492: 350: 210: 147: 1699:"Price cuts have little impact on access to AIDS drugs in Uganda" 2205:"WTO | Managing the Challenges of WTO Participation: Case Study" 2157:
Freeman, Michael; Hawkes, Sarah; Bennett, Belinda (March 2014).
1844:"Daraprim price jump raises concerns among ID groups, providers" 638: 228:, is a multilateral agreement between all member nations of the 1383:"THE DOHA DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH" 396:
region. Brazil is argued to be one of the most affected by the
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Rwanda, with varying opinions about its results and potential.
1753:"Patent applications for HIV prevention drug opposed in India" 928:"Why Patent Protection In The Drug Industry Is Out Of Control" 737:"Access to essential medicines as part of the right to health" 458:. Although widely used by high-income countries, in 2006, Hib 581:
announced 2023 that it did not intend to enforce its patents
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Norviel, Vern; Hoffmeister, David M. (September 30, 2015).
1273:"WTO | intellectual property - overview of TRIPS Agreement" 831:"Intellectual Property and Access to Medicine for the Poor" 1169:
Weiss, Shira (2017-03-01). "The Ethics of Price Gouging".
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in 134 LMIC countries. Johnson & Johnson also granted
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refers to the reasonable ability for people to get needed
2228:"Lobby Petitions Government, Pharmaceutical Companies". 1819:"A Look At The Legality Behind Daraprim's Price Spike -" 132:. However, extending patent terms can be reinvested for 767:"Final Report High-Level Panel on Access to Medicines" 1971:"Introduction - Canada's Access to Medicines Regime" 429:, India reintroduced patent laws for drugs in 2015. 355:HIV/AIDS prevalence world map in 2009 according to 1457:Abbas, Muhammad Z.; Riaz, Shamreeza (2017-11-24). 1526:. Geneva Graduate Institute: Global Health Centre 510:Civil society organizations in India, led by the 61:people may not get treatment for conditions like 1546:"Voluntary licenses and non-assert declarations" 1221:Studies in Comparative International Development 615:has had such a campaign since 1999 known as the 792:"Powerful Ideas for Global Access to Medicines" 462:usage in Africa was about 24% In the Americas, 8: 2028: 2026: 1994:: CS1 maint: multiple names: authors list ( 1954:: CS1 maint: multiple names: authors list ( 1680:"Voluntary licenses and access to medicines" 116:is a regulatory measure limiting the use of 2189:: CS1 maint: location missing publisher ( 1466:The Journal of World Intellectual Property 1433: 1431: 848:10.1001/virtualmentor.2006.8.12.hlaw1-0612 617:Campaign for Access to Essential Medicines 215:Logo of the World Trade Organization (WTO) 30:. Such access is deemed to be part of the 1655: 1637: 1584: 1145: 983: 973: 902: 846: 731: 729: 641:vaccination alliance is an international 73:Most hindrances to access revolve around 1330:Clinical Pharmacology & Therapeutics 1751:Perappadan, Bindu Shajan (2024-09-17). 956:Stevens, Hilde; Huys, Isabelle (2017). 696: 518:' patent applications for the HIV drug 2182: 1987: 1947: 1115: 1113: 1111: 1109: 1107: 318:Another mechanism to enable access to 2152: 2150: 1931:"Canada's Access to Medicines Regime" 1501:European Intellectual Property Review 1412:"WTO | Glossary - Paragraph 6 system" 1377: 1375: 1323: 1321: 1063: 1061: 1017: 1015: 1013: 1011: 1009: 1007: 1005: 1003: 680:WHO Model List of Essential Medicines 7: 1024:Journal of Medicine & Philosophy 951: 949: 947: 872: 870: 868: 866: 550:, a pharmaceutical company owned by 660:Bill & Melinda Gates Foundation 632:Bill & Melinda Gates Foundation 606:Canada's Access to Medicines Regime 105:on particular drugs and processes. 1842:Muoio, Dave (September 17, 2015). 499:, was key to increasing access to 279:WTO Ministerial Conference of 2001 14: 2048:Harrington, Mark (20 June 2024). 1126:American Journal of Public Health 81:Patent protection and exclusivity 1608:Juneja, Sandeep; Gupta, Aastha; 324:low- and middle-income countries 1612:; Resch, Stephen (2017-05-25). 796:New England Journal of Medicine 2033:Silverman, Ed (20 June 2024). 1684:MĂ©decins Sans Frontières (MSF) 198:Language and cultural barriers 1: 2077:10.1016/s0140-6736(08)61070-3 1867:Schlanger, ZoĂ« (2015-09-21). 1784:Thacker, Teena (2024-09-17). 1697:AFP Report (March 23, 2001). 1586:10.1016/S2214-109X(19)30266-9 1297:"WTO AND THE TRIPS AGREEMENT" 1082:10.1016/s0140-6736(10)62042-9 478:are in developing countries. 203:about and to take medicines. 1639:10.1371/journal.pone.0177770 841:(12). Leevy, Tara: 834–838. 554:, purchased the rights to a 542:, commonly known as Daraprim 512:Sankalp Rehabilitation Trust 444:vaccine-preventable diseases 442:The majority of deaths from 376:at their current prices. In 273:Further legislation such as 250:international trading system 234:intellectual property rights 1171:Journal of Religious Ethics 470:coverage was only 28%. The 2266: 2131:"Gavi's partnership model" 1036:10.1076/jmep.27.2.179.2989 883:Developing World Bioethics 646:organizations such as the 538:The chemical structure of 472:human papillomavirus (HPV) 246:intellectual property laws 240:guidelines, remedies, and 2250:World Health Organization 2052:. Treatment Action Group. 1918:. JnJ. 29 September 2023. 1387:World Health Organization 1301:World Health Organization 1233:10.1007/s12116-015-9184-4 1120:Crager, Sara Eve (2014). 741:World Health Organization 705:"WHO Access to medicines" 648:World Health Organization 43:World Health Organization 1573:The Lancet Global Health 1262:10.1023/A:1025812716177. 1138:10.2105/ajph.2014.302236 829:Leevy, T. (2006-12-01). 685:Access to Medicine Index 613:MĂ©decins Sans Frontières 347:Differences by geography 341:MĂ©decins Sans Frontières 230:World Trade Organization 134:research and development 99:pharmaceutical companies 1342:10.1038/sj.clpt.6100359 975:10.3389/fmed.2017.00218 621:Treatment Action Group 587:multidrug-resistant TB 548:Turing Pharmaceuticals 543: 360: 216: 180:Lack of Generic Brands 153: 2232:. September 23, 2003. 2159:Law and global health 1520:"VOLUNTARY LICENSING" 962:Frontiers in Medicine 585:for the treatment of 579:Johnson & Johnson 537: 433:Differences by sector 354: 337:Medicines Patent Pool 328:Medicines Patent Pool 214: 151: 51:intellectual property 1393:on February 20, 2008 926:M.D., Robert Pearl. 808:10.1056/NEJMp1613861 546:On August 10, 2015, 524:Indian Patent Office 482:Epidemics and access 448:pneumococcal disease 295:pharmaceutical drugs 254:compulsory licensing 130:developing countries 69:Hindrances to access 26:required to achieve 2230:Africa News Service 1975:www.camr-rcam.gc.ca 1935:www.camr-rcam.gc.ca 1630:2017PLoSO..1277770J 1206:States News Service 790:(9 February 2017). 747:on January 10, 2014 591:Stop TB Partnership 464:Hepatitis B vaccine 320:essential medicines 314:Voluntary Licensing 47:essential medicines 20:Access to medicines 1790:The Economic Times 1579:(9): e1189–e1196. 1524:Knowledge Portalia 1478:10.1111/jwip.12083 1208:. 2 December 2015. 1183:10.1111/jore.12171 895:10.1111/dewb.12105 544: 501:HIV/AIDS treatment 361: 305:Paragraph 6 System 242:dispute resolution 217: 154: 75:market competition 2071:(9634): 205–206. 1732:www.pharmabiz.com 1518:Erickson, Elise. 1076:(9770): 976–977. 574:Tuberculosis (TB) 192:international aid 95:patent protection 88:provide an owner 36:international law 2257: 2234: 2233: 2225: 2219: 2218: 2216: 2215: 2201: 2195: 2194: 2188: 2180: 2154: 2145: 2144: 2142: 2141: 2127: 2121: 2120: 2118: 2117: 2107:"Gavi's mission" 2103: 2097: 2096: 2060: 2054: 2053: 2045: 2039: 2038: 2030: 2021: 2020: 2018: 2016: 2006: 2000: 1999: 1993: 1985: 1983: 1981: 1966: 1960: 1959: 1953: 1945: 1943: 1941: 1926: 1920: 1919: 1912: 1906: 1905: 1903: 1901: 1889: 1883: 1882: 1880: 1879: 1864: 1858: 1857: 1855: 1854: 1839: 1833: 1832: 1830: 1829: 1814: 1808: 1807: 1805: 1804: 1781: 1775: 1774: 1772: 1771: 1748: 1742: 1741: 1739: 1738: 1724: 1718: 1715: 1709: 1708: 1706: 1705: 1694: 1688: 1687: 1676: 1670: 1669: 1659: 1641: 1605: 1599: 1598: 1588: 1564: 1558: 1557: 1555: 1553: 1542: 1536: 1535: 1533: 1531: 1515: 1509: 1508: 1496: 1490: 1489: 1463: 1454: 1448: 1447: 1435: 1426: 1425: 1423: 1422: 1408: 1402: 1401: 1399: 1398: 1389:. 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Archived from 701: 374:AIDS medications 275:Doha Declaration 269:Doha Declaration 114:Data exclusivity 109:Data exclusivity 90:exclusive rights 77:and lack of it. 59:developing world 34:as supported by 2265: 2264: 2260: 2259: 2258: 2256: 2255: 2254: 2240: 2239: 2238: 2237: 2227: 2226: 2222: 2213: 2211: 2203: 2202: 2198: 2181: 2169: 2156: 2155: 2148: 2139: 2137: 2129: 2128: 2124: 2115: 2113: 2105: 2104: 2100: 2062: 2061: 2057: 2047: 2046: 2042: 2032: 2031: 2024: 2014: 2012: 2008: 2007: 2003: 1986: 1979: 1977: 1968: 1967: 1963: 1946: 1939: 1937: 1928: 1927: 1923: 1914: 1913: 1909: 1899: 1897: 1896:. 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Index

medicines
health
right to health
international law
World Health Organization
essential medicines
intellectual property
free markets
developing world
HIV/AIDS
market competition
Patents
exclusive rights
patent protection
pharmaceutical companies
monopoly
Data exclusivity
clinical trial
medication
generic brands
developing countries
research and development
generic drugs

Price gouging
HIV/AIDS
hepatitis C
cancer
infrastructure
international aid

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