Access to health products

Precedents

2022 WTO Ministerial Decision on the TRIPS Agreement

• “Notwith­stand­ing the pro­vi­sion of patent rights under its domes­tic leg­is­la­tion, an eli­gi­ble Mem­ber may limit the rights pro­vided for under Arti­cle 28.1 of the TRIPS Agree­ment (here­inafter “the Agree­ment”) by autho­riz­ing the use of the sub­ject mat­ter of a patent required for the pro­duc­tion and sup­ply of COVID-19 vac­cines with­out the con­sent of the right holder to the extent nec­es­sary to address the COVID-19 pan­demic, in accor­dance with the pro­vi­sions of Arti­cle 31 of the Agree­ment, as clar­i­fied and waived in para­graphs 2 to 6 below.” (para­graph 1)

• “For greater clar­ity, an eli­gi­ble Mem­ber may autho­rize the use of the sub­ject mat­ter of a patent under Arti­cle 31 with­out the right holder’s con­sent through any instru­ment avail­able in the law of the Mem­ber such as exec­u­tive orders, emer­gency decrees, gov­ern­ment use autho­riza­tions, and judi­cial or admin­is­tra­tive orders, whether or not a Mem­ber has a com­pul­sory license regime in place.” (para­graph 2)

• “An eli­gi­ble Mem­ber may waive the require­ment of Arti­cle 31(f) that autho­rized use under Arti­cle 31 be pre­dom­i­nantly to sup­ply its domes­tic mar­ket and may allow any pro­por­tion of the prod­ucts man­u­fac­tured under the autho­riza­tion in accor­dance with this Deci­sion to be exported to eli­gi­ble Mem­bers, includ­ing through inter­na­tional or regional joint ini­tia­tives that aim to ensure the equi­table access of eli­gi­ble Mem­bers to the COVID-19 vac­cine cov­ered by the autho­riza­tion.” (para­graph 3(b))

• “No later than six months from the date of this Deci­sion, Mem­bers will decide on its exten­sion to cover the pro­duc­tion and sup­ply of COVID-19 diag­nos­tics and ther­a­peu­tics.” (para­graph 8)

2021 WHA Resolution on Strengthening Local Production to Improve Access

• “Urges Mem­ber States, where appro­pri­ate, based on the national con­text: to apply a holis­tic approach in strength­en­ing local pro­duc­tion by con­sid­er­ing, for exam­ple, pro­mot­ing research and devel­op­ment, trans­parency of mar­kets for med­i­cines and other health tech­nolo­gies, reg­u­la­tory sys­tems strength­en­ing, access to sus­tain­able and afford­able financ­ing, devel­op­ment of skilled human resources, access to tech­nol­ogy trans­fer on vol­un­tary and mutu­ally agreed terms for pro­duc­tion and needs-based inno­va­tion, the aggre­ga­tion of national and regional demand, and appro­pri­ate incen­tives for pri­vate-sec­tor invest­ment, par­tic­u­larly in the con­text of achiev­ing uni­ver­sal health cov­er­age.” (para­graph 1(5))

• “Urges Mem­ber States, where appro­pri­ate, based on the national con­text: to engage in global, regional and sub­re­gional net­works related to pro­mot­ing sus­tain­able local pro­duc­tion of qual­ity, safe, effec­tive and afford­able med­i­cines, and to fur­ther enhance mul­ti­stake­holder col­lab­o­ra­tion.” (para­graph 1(6))

• “Urges Mem­ber States, where appro­pri­ate, based on the national con­text: to fur­ther engage in North–South and South–South devel­op­ment coop­er­a­tion, part­ner­ships and net­works to build and improve the trans­fer of tech­nol­ogy related to health inno­va­tion on vol­un­tary and mutu­ally agreed terms and in line with their inter­na­tional oblig­a­tions.” (para­graph 1(7))

• “Urges Mem­ber States, where appro­pri­ate, based on the national con­text: to take into account the rights and oblig­a­tions in the Agree­ment on Trade-Related Aspects of Intel­lec­tual Prop­erty Rights (TRIPS Agree­ment), includ­ing those affirmed by the Doha Dec­la­ra­tion on the TRIPS Agree­ment and Pub­lic Health, in order to pro­mote access to med­i­cines and other health tech­nolo­gies for all.” (para­graph 1(8))

2021 Political declaration on equitable global access to COVID-19 vaccines

• “We call for the rapid scal­ing up and expan­sion of vac­cine pro­duc­tion glob­ally, includ­ing in devel­op­ing coun­tries, through appro­pri­ate dis­sem­i­na­tion of tech­nol­ogy and know-how, e.g., licens­ing in accor­dance with World Trade Orga­ni­za­tions rules, using TRIPS flex­i­bil­i­ties if nec­es­sary, shar­ing knowl­edges, and data related to COVID-19 health tech­nolo­gies.” (para­graph 18)

2021 UNESC Resolution on UNAIDS

• “Calls for urgent action and part­ner­ship by Mem­ber States, the United Nations sys­tem, civil soci­ety, local com­mu­ni­ties, the pri­vate sec­tor and other stake­hold­ers to scale up evi­dence-based HIV pre­ven­tion, test­ing, treat­ment, care and reten­tion ser­vices, includ­ing access to safe, effec­tive, qual­ity and afford­able med­i­cines, includ­ing gener­ics, to ensure that those ser­vices reach the peo­ple who need them the most, includ­ing ado­les­cent girls and young women as well as key pop­u­la­tions that epi­demi­o­log­i­cal evi­dence shows to be glob­ally at higher risk of HIV infec­tion, and chil­dren liv­ing with HIV, who have poorer HIV treat­ment cov­er­age than adults and com­prise a higher rel­a­tive pro­por­tion of AIDS-related deaths.” (para­graph 4)

• “Urges Mem­ber States to urgently remove, where fea­si­ble, obsta­cles that limit the capac­ity of low- and mid­dle-income coun­tries to pro­vide afford­able and effec­tive HIV pre­ven­tion and treat­ment prod­ucts, diag­nos­tics, med­i­cines and com­modi­ties and other phar­ma­ceu­ti­cal prod­ucts.” (para­graph 5)

2021 Political declaration on HIV and AIDS

• “Reaf­firm that access to safe, effec­tive, equi­table and afford­able med­i­cines and com­modi­ties for all, with­out dis­crim­i­na­tion, is fun­da­men­tal to the full real­iza­tion of the right of every­one to the enjoy­ment of the high­est attain­able stan­dard of phys­i­cal and men­tal health, yet note with grave con­cern the high num­ber of peo­ple with­out access to med­i­cine and that the sus­tain­abil­ity of pro­vid­ing life­long safe, effec­tive and afford­able HIV treat­ment con­tin­ues to be threat­ened by fac­tors such as poverty and under­score that access to med­i­cines would save mil­lions of lives.” (para­graph 42)

2021 CSW Report on women and HIV/AIDS

• “The Com­mis­sion may wish to encour­age the United Nations sys­tem and other inter­na­tional actors to advo­cate for the removal of obsta­cles that limit the capac­ity of low-and mid­dle-income coun­tries to pro­vide afford­able and effec­tive HIV pre­ven­tion and treat­ment prod­ucts, diag­nos­tics, com­modi­ties and other phar­ma­ceu­ti­cal prod­ucts tai­lored to or that are more appro­pri­ate for women and to sup­port access to safe, effec­tive, qual­ity and afford­able med­i­cines, includ­ing gener­ics, to ensure that they reach the peo­ple who need them the most, espe­cially ado­les­cent girls and young women.” (para­graph 58(e))

2021 HRC resolution on human rights in the context of HIV and AIDS

• “Urges States to bring their laws, poli­cies and prac­tices, includ­ing their strate­gies for imple­ment­ing the HIV- and other health-related Sus­tain­able Devel­op­ment Goals, fully into com­pli­ance with their oblig­a­tions under inter­na­tional human rights law, and to review or repeal those that are dis­crim­i­na­tory or that adversely affect the suc­cess­ful, effec­tive and equi­table deliv­ery of, and access to, HIV pre­ven­tion, diag­no­sis, treat­ment, care and sup­port pro­grammes for all per­sons liv­ing with, pre­sumed to be liv­ing with, at risk of or affected by HIV, includ­ing key pop­u­la­tions.” (para­graph 7)

2019 Political declaration of the HLM on UHC

• “The high prices of some health prod­ucts, and inequitable access to such prod­ucts within and among coun­tries, as well as finan­cial hard­ships asso­ci­ated with high prices of health prod­ucts, con­tinue to impede progress towards achiev­ing uni­ver­sal health cov­er­age.” (para­graph 12)

2019 UNESC Resolution on UNAIDS

• “Calls for urgent action and part­ner­ship by Mem­ber States, the United Nations sys­tem, civil soci­ety, local com­mu­ni­ties, the pri­vate sec­tor and other stake­hold­ers to scale up evi­dence-based HIV pre­ven­tion, test­ing, treat­ment, care and reten­tion, includ­ing access to safe, effec­tive, qual­ity and afford­able med­i­cines, includ­ing gener­ics, viral load test­ing in pur­suit of achiev­ing viral load sup­pres­sion, and tuber­cu­lo­sis pre­ven­ta­tive treat­ment, to ensure that those ser­vices reach the peo­ple who need them the most, includ­ing key pop­u­la­tions that epi­demi­o­log­i­cal evi­dence shows to be glob­ally at higher risk of HIV infec­tion, ado­les­cent girls and young women, and calls for rein­vig­o­rated efforts to pro­tect human rights and pro­mote gen­der equal­ity and to address social risk fac­tors, includ­ing gen­der-based vio­lence, as well as social and eco­nomic deter­mi­nants of health.” (para­graph 4)

• “Urges Mem­ber States to urgently remove, where fea­si­ble, obsta­cles that limit the capac­ity of low- and mid­dle-income coun­tries to pro­vide afford­able and effec­tive HIV pre­ven­tion and treat­ment prod­ucts, diag­nos­tics, med­i­cines and com­modi­ties and other phar­ma­ceu­ti­cal prod­ucts.” (para­graph 5)

2019 WHA Resolution on antimicrobial resistance

• “Requests the Direc­tor Gen­eral to sup­port Mem­ber States to mobi­lize ade­quate pre­dictable and sus­tained fund­ing and human and finan­cial resources and invest­ment through national, bilat­eral and mul­ti­lat­eral chan­nels to sup­port the devel­op­ment and imple­men­ta­tion of national action plans, research and devel­op­ment on exist­ing and new antimi­cro­bial med­i­cines, diag­nos­tics, and vac­cines, and other tech­nolo­gies, and strength­en­ing of related infra­struc­ture, includ­ing through engage­ment with mul­ti­lat­eral devel­op­ment banks and tra­di­tional and vol­un­tary inno­v­a­tive financ­ing and invest­ment mech­a­nisms, based on pri­or­i­ties and local needs set by gov­ern­ments and on ensur­ing pub­lic return on invest­ment.” (para­graph 4(6))

2018 Political declaration of the HLM on the fight against TB

• “Com­mit to pro­mot­ing access to afford­able med­i­cines, includ­ing gener­ics, for scal­ing up access to afford­able tuber­cu­lo­sis treat­ment, includ­ing the treat­ment of mul­tidrug-resis­tant and exten­sively drug-resis­tant tuber­cu­lo­sis, reaf­firm­ing the World Trade Orga­ni­za­tion Agree­ment on Trade-Related Aspects of Intel­lec­tual Prop­erty Rights (TRIPS Agree­ment), as amended, and also reaf­firm­ing the 2001 World Trade Orga­ni­za­tion Doha Dec­la­ra­tion on the TRIPS Agree­ment and Pub­lic Health, which rec­og­nizes that intel­lec­tual prop­erty rights should be inter­preted and imple­mented in a man­ner sup­port­ive of the right of Mem­ber States to pro­tect pub­lic health and, in par­tic­u­lar, to pro­mote access to med­i­cines for all, and notes the need for appro­pri­ate incen­tives in the devel­op­ment of new health prod­ucts.” (para­graph 19)

2018 Political declaration of the third HLM on NCDs

• “Pro­mote increased access to afford­able, safe, effec­tive and qual­ity med­i­cines and diag­nos­tics and other tech­nolo­gies, reaf­firm­ing the World Trade Orga­ni­za­tion Agree­ment on Trade-Related Aspects of Intel­lec­tual Prop­erty Rights (TRIPS Agree­ment), as amended, and also reaf­firm­ing the 2001 Doha Dec­la­ra­tion on the TRIPS Agree­ment and Pub­lic Health, which rec­og­nizes that intel­lec­tual prop­erty rights should be inter­preted and imple­mented in a man­ner sup­port­ive of the right of Mem­ber States to pro­tect pub­lic health and, in par­tic­u­lar, to pro­mote access to med­i­cines for all, and notes the need for appro­pri­ate incen­tives in the devel­op­ment of new health prod­ucts.” (para­graph 36)

2018 HRC Resolution on human rights in the context of HIV and AIDS

• “Reaf­firms that access to safe, effec­tive and afford­able med­i­cines, diag­no­sis and treat­ment for all, with­out dis­crim­i­na­tion, in the con­text of epi­demics such as HIV and AIDS, is fun­da­men­tal to the full real­iza­tion of the right of every­one to the enjoy­ment of the high­est attain­able stan­dard of phys­i­cal and men­tal health.” (para­graph 9)

2017 Resolution on international cooperation to address and counter the world drug problem

• “Urges all Mem­ber States to enact com­pre­hen­sive mea­sures aimed at stem­ming the abuse of pre­scrip­tion drugs, in par­tic­u­lar through the estab­lish­ment of aware­ness-rais­ing ini­tia­tives tar­get­ing the gen­eral pub­lic and health-care providers.” (para­graph 45)

• “Calls upon Mem­ber States to con­tinue efforts to iden­tify and mon­i­tor trends in the com­po­si­tion, pro­duc­tion, preva­lence and dis­tri­bu­tion of new psy­choac­tive sub­stances, as well as pat­terns of use and adverse con­se­quences, and assess the risks to the health and safety of indi­vid­u­als and soci­ety as a whole and the poten­tial uses of new psy­choac­tive sub­stances for med­ical and sci­en­tific pur­poses, and on that basis to develop and strengthen domes­tic and national leg­isla­tive, reg­u­la­tory, admin­is­tra­tive and oper­a­tional responses and prac­tices by domes­tic and national leg­isla­tive, law enforce­ment, judi­ciary, social and wel­fare, edu­ca­tional and health author­i­ties.” (para­graph 55)

• “Invites Mem­ber States to tar­get the illicit cul­ti­va­tion of crops used for the illicit pro­duc­tion and man­u­fac­ture of drugs and address related fac­tors by imple­ment­ing com­pre­hen­sive strate­gies aimed at alle­vi­at­ing poverty and strength­en­ing the rule of law, account­able, effec­tive and inclu­sive insti­tu­tions and pub­lic ser­vices and insti­tu­tional frame­works, as appro­pri­ate, and by pro­mot­ing sus­tain­able devel­op­ment aimed at enhanc­ing the wel­fare of the affected and vul­ner­a­ble pop­u­la­tion through licit alter­na­tives.” (para­graph 56)

2016 Resolution on Women, the Girl Child and HIV and AIDS

• “Address bar­ri­ers, reg­u­la­tions, poli­cies and prac­tices that pre­vent access to afford­able HIV treat­ment by pro­mot­ing generic com­pe­ti­tion, in order to help to reduce the costs asso­ci­ated with life­long chronic care and by encour­ag­ing all States to apply mea­sures and pro­ce­dures for enforc­ing intel­lec­tual prop­erty rights in such a man­ner as to avoid cre­at­ing bar­ri­ers to the legit­i­mate trade in med­i­cines and to pro­vide for safe­guards against the abuse of such mea­sures and pro­ce­dures.” (para­graph 13(b))

2014 Resolution on efforts to control and eliminate malaria by 2015

• “Urges the inter­na­tional com­mu­nity, inter alia, to sup­port the Global Fund to Fight AIDS, Tuber­cu­lo­sis and Malaria to enable it to meet its finan­cial needs and, through coun­try-led ini­tia­tives with ade­quate inter­na­tional sup­port, to inten­sify access to afford­able, safe and effec­tive anti­malar­ial treat­ments, includ­ing artemisinin-based com­bi­na­tion ther­a­pies, inter­mit­tent pre­ven­tive ther­a­pies for preg­nant women, chil­dren under 5 and infants, ade­quate diag­nos­tic facil­i­ties, long-last­ing insec­ti­cide-treated mos­quito nets, includ­ing, where appro­pri­ate, through the free dis­tri­bu­tion of such nets and, where appro­pri­ate, to insec­ti­cides for indoor resid­ual spray­ing for malaria con­trol, tak­ing into account rel­e­vant inter­na­tional rules, includ­ing the Stock­holm Con­ven­tion on Per­sis­tent Organic Pol­lu­tants stan­dards and guide­lines.” (para­graph 13)

• “Rec­og­nizes the impor­tance of the devel­op­ment of safe and cost-effec­tive vac­cines and new med­i­cines to pre­vent and treat malaria and the need for fur­ther and accel­er­ated research, includ­ing into safe, effec­tive and high-qual­ity ther­a­pies, using rig­or­ous stan­dards, includ­ing by pro­vid­ing sup­port to the Spe­cial Pro­gramme for Research and Train­ing in Trop­i­cal Dis­eases, through effec­tive global part­ner­ships, such as the var­i­ous malaria vac­cine ini­tia­tives and the Med­i­cines for Malaria Ven­ture, where nec­es­sary stim­u­lated by new incen­tives to secure their devel­op­ment, and through effec­tive and timely sup­port for the pre-qual­i­fi­ca­tion of new anti­malar­i­als and their com­bi­na­tions.” (para­graph 20)

• “Calls upon the inter­na­tional com­mu­nity, includ­ing through exist­ing part­ner­ships, to increase invest­ment in and efforts towards research to opti­mize cur­rent tools, develop and val­i­date new, safe and afford­able malaria-related med­i­cines, prod­ucts and tech­nolo­gies, such as vac­cines, rapid diag­nos­tic tests, insec­ti­cides and their deliv­ery modes, to pre­vent and treat malaria, espe­cially for at-risk chil­dren and preg­nant women, and test­ing oppor­tu­ni­ties for inte­gra­tion in order to enhance effec­tive­ness and delay the onset of resis­tance.” (para­graph 21)

• “Reaf­firms the right to use, to the fullest extent, the pro­vi­sions con­tained in the World Trade Orga­ni­za­tion Agree­ment on Trade-Related Aspects of Intel­lec­tual Prop­erty Rights (TRIPS Agree­ment), the Doha Dec­la­ra­tion on the TRIPS Agree­ment and Pub­lic Health, the deci­sion of the Gen­eral Coun­cil of the World Trade Orga­ni­za­tion of 30 August 2003 on the imple­men­ta­tion of para­graph 6 of the Doha Dec­la­ra­tion on the TRIPS Agree­ment and Pub­lic Health, and, when for­mal accep­tance pro­ce­dures are com­pleted, the amend­ment to arti­cle 31 of the Agree­ment, which pro­vide flex­i­bil­i­ties for the pro­tec­tion of pub­lic health, and in par­tic­u­lar to pro­mote access to med­i­cines for all and to encour­age the pro­vi­sion of assis­tance to devel­op­ing coun­tries in this regard, and calls for the broad and timely accep­tance of the amend­ment to arti­cle 31 of the Agree­ment, as pro­posed by the Gen­eral Coun­cil of the World Trade Orga­ni­za­tion in its deci­sion of 6 Decem­ber 2005.” (para­graph 23)

2009 ECOSOC Resolution on UNAIDS

• “Urges Gov­ern­ments to pri­or­i­tize and expand access to the pre­ven­tion and treat­ment of HIV-related oppor­tunis­tic infec­tions, to pro­mote access to and the effec­tive use of safe and effec­tive anti­retro­vi­ral drugs of assured qual­ity, at afford­able prices, and to sup­port both bio­med­ical and socio-eco­nomic research on new prod­ucts to pre­vent HIV infec­tion, includ­ing those con­trolled by women, diag­nos­tics, med­i­cines and other treat­ment com­modi­ties and tech­nolo­gies related to HIV.” (para­graph 11)

• “Reaf­firms the right to use, to the full, the pro­vi­sions con­tained in the Agree­ment on Trade-related Aspects of Intel­lec­tual Prop­erty Rights, the Doha Dec­la­ra­tion on the Agree­ment on Trade-related Aspects of Intel­lec­tual Prop­erty Rights and Pub­lic Health, and the deci­sion of the World Trade Orga­ni­za­tion Gen­eral Coun­cil of 30 August 2003 on the imple­men­ta­tion of para­graph 6 of the Doha Dec­la­ra­tion on the TRIPS Agree­ment and pub­lic health, and, when for­mal accep­tance pro­ce­dures are com­pleted, the amend­ment to arti­cle 31 of the Agree­ment, which pro­vide flex­i­bil­i­ties for the pro­tec­tion of pub­lic health, and, in par­tic­u­lar, to pro­mote access to med­i­cines for all, and also calls for a broad and timely accep­tance of the amend­ment to arti­cle 31 of the Agree­ment on Trade-related Aspects of Intel­lec­tual Prop­erty Rights, as pro­posed by the World Trade Orga­ni­za­tion Gen­eral Coun­cil in its deci­sion of 6 Decem­ber 2005.” (para­graph 9)

2007 WHA Resolution on tuberculosis control: progress and long-term planning

• “Urges all mem­ber states to develop and imple­ment long-term plans for tuber­cu­lo­sis pre­ven­tion and con­trol in line with the Global Plan to Stop TB 2006–2015, in the con­text of over­all health devel­op­ment plans, in col­lab­o­ra­tion with other pro­grammes (includ­ing those on HIV/AIDS, child health and strength­en­ing of health sys­tems), and through national Stop TB part­ner­ships where appro­pri­ate, with the aim of con­trol­ling the emer­gence and trans­mis­sion of multi-drug-resis­tant tuber­cu­lo­sis, includ­ing exten­sively drug-resis­tant tuber­cu­lo­sis, by ensur­ing the high-qual­ity imple­men­ta­tion of the DOTS strat­egy and by prompt imple­men­ta­tion of infec­tion-con­trol pre­cau­tions.” (para­graph 1(1)(d))

• “Urges all mem­ber states to develop and imple­ment long-term plans for tuber­cu­lo­sis pre­ven­tion and con­trol in line with the Global Plan to Stop TB 2006–2015, in the con­text of over­all health devel­op­ment plans, in col­lab­o­ra­tion with other pro­grammes (includ­ing those on HIV/AIDS, child health and strength­en­ing of health sys­tems), and through national Stop TB part­ner­ships where appro­pri­ate, with the aim of: if affected, imme­di­ately address­ing exten­sively drug-resis­tant tuber­cu­lo­sis and HIV-related tuber­cu­lo­sis as part of the over­all Stop TB strat­egy, as the high­est health pri­or­i­ties.” (para­graph 1(1)(e))

• “Requests the direc­tor-gen­eral to strengthen urgently WHO’s sup­port to coun­tries affected by mul­tidrug-resis­tant tuber­cu­lo­sis and espe­cially exten­sively drug-resis­tant tuber­cu­lo­sis, and to coun­tries highly affected by HIV-related tuber­cu­lo­sis.” (para­graph 2(3))

• “Requests the direc­tor-gen­eral to sup­port Mem­ber States in devel­op­ing lab­o­ra­tory capac­ity to pro­vide for rapid drug-sus­cep­ti­bil­ity test­ing of iso­lates obtained from all per­sons with cul­ture-pos­i­tive tuber­cu­lo­sis, to develop con­sen­sus guide­lines for rapid drug-sus­cep­ti­bil­ity test meth­ods and appro­pri­ate mea­sures for lab­o­ra­tory strength­en­ing, and to mobi­lize fund­ing.” (para­graph 2(3))

2007 WHA Resolution on progress in the rational use of medicines

• “Requests Direc­tor Gen­eral in col­lab­o­ra­tion with gov­ern­ments and civil soci­ety, to strengthen WHO’s tech­ni­cal sup­port to Mem­ber States in their efforts to estab­lish or strengthen, where appro­pri­ate, mul­ti­dis­ci­pli­nary national bod­ies for mon­i­tor­ing med­i­cine use, and imple­ment­ing national pro­grammes for the ratio­nal use of med­i­cines.” (para­graph 2(2))

2006 Political Declaration on HIV/AIDS

• “Reaf­firm that the World Trade Orga­ni­za­tion’s Agree­ment on Trade-Related Aspects of Intel­lec­tual Prop­erty Rights does not and should not pre­vent mem­bers from tak­ing mea­sures now and in the future to pro­tect pub­lic health. Accord­ingly, while reit­er­at­ing our com­mit­ment to the TRIPS Agree­ment, reaf­firm that the Agree­ment can and should be inter­preted and imple­mented in a man­ner sup­port­ive of the right to pro­tect pub­lic health and, in par­tic­u­lar, to pro­mote access to med­i­cines for all includ­ing the pro­duc­tion of generic anti­retro­vi­ral drugs and other essen­tial drugs for AIDS-related infec­tions. In this con­nec­tion, we reaf­firm the right to use, to the full, the pro­vi­sions in the TRIPS Agree­ment, the Doha Dec­la­ra­tion on the TRIPS Agree­ment and Pub­lic Health and the World Trade Orga­ni­za­tion’s Gen­eral Coun­cil Deci­sion of 2003 and amend­ments to Arti­cle 31, which pro­vide flex­i­bil­i­ties for this pur­pose.” (para­graph 43)

2005 Resolution on the World Summit outcome

• “To pro­vide, with the aim of an AIDS-, malaria- and tuber­cu­lo­sis-free gen­er­a­tion in Africa, assis­tance for pre­ven­tion and care and to come as close as pos­si­ble to achiev­ing the goal of uni­ver­sal access by 2010 to HIV/AIDS treat­ment in African coun­tries, to encour­age phar­ma­ceu­ti­cal com­pa­nies to make drugs, includ­ing anti­retro­vi­ral drugs, afford­able and acces­si­ble in Africa and to ensure increased bilat­eral and mul­ti­lat­eral assis­tance, where pos­si­ble on a grant basis, to com­bat malaria, tuber­cu­lo­sis and other infec­tious dis­eases in Africa through the strength­en­ing of health sys­tems.” (para­graph 68(i))

2003 WHA on global health-sector strategy for HIV/AIDS

• “Exhorts Mem­ber States, as a mat­ter of urgency to reaf­firm that pub­lic health inter­ests are para­mount in both phar­ma­ceu­ti­cal and health poli­cies, to rec­og­nize the dif­fi­cul­ties faced by devel­op­ing coun­tries in effec­tive use of com­pul­sory licens­ing in accor­dance with the Dec­la­ra­tion on the TRIPS Agree­ment and Pub­lic Health (Doha Dec­la­ra­tion), and, when nec­es­sary, to use the flex­i­bil­i­ties in the TRIPS Agree­ment in order to meet the needs of devel­op­ing coun­tries for drugs against HIV/AIDS.” (para­graph 2(5))

2000 WHA on HIV/AIDS: confronting the epidemic

• “Urges Mem­ber states to increase access to treat­ment and pro­phy­laxis of HIV-related ill­nesses through mea­sures such as ensur­ing the pro­vi­sion and afford­abil­ity of drugs, includ­ing a reli­able dis­tri­bu­tion and deliv­ery sys­tem; imple­men­ta­tion of a strong generic drug pol­icy; bulk pur­chas­ing; nego­ti­a­tion with phar­ma­ceu­ti­cal com­pa­nies; appro­pri­ate financ­ing sys­tems; and encour­age­ment of local man­u­fac­tur­ing and import prac­tices con­sis­tent with national laws and inter­na­tional agree­ments acceded to.” (para­graph 1(16))

• “Urges Mem­ber States to ensure that blood trans­fu­sion ser­vices do not con­sti­tute an HIV risk fac­tor by ensur­ing that all indi­vid­u­als have access to safe blood and blood prod­ucts that are acces­si­ble and ade­quate to meet their needs, are obtained from vol­un­tary, non­re­mu­ner­ated blood donors, are trans­fused only when nec­es­sary, and are pro­vided as part of a sus­tain­able blood trans­fu­sion pro­gramme within the exist­ing health care sys­tem.” (para­graph 1(7))

Expert precedents

2021 Report of the Special Rapporteur on the right to health

• “The Spe­cial Rap­por­teur rec­om­mends that bio­med­ical arti­fi­cial intel­li­gence (AI) tech­nolo­gies must not per­pet­u­ate racism, sex­ism, ableism or dis­crim­i­na­tion based on sex­ual ori­en­ta­tion or gen­der. States must elim­i­nate social and polit­i­cal inequal­i­ties in order to bridge the gen­dered dig­i­tal divide, tak­ing into account the needs of peo­ple with dis­abil­i­ties, which includes offer­ing pro­tec­tions from dis­crim­i­na­tion and vio­lence related to uti­liza­tion of dig­i­tal tools and tech­nol­ogy.” (para­graph 87)

2016 General Comment No.22 on the Right to Sexual and Reproductive Health

• “States par­ties should ensure, in com­pli­ance with their Covenant oblig­a­tions, that their bilat­eral, regional and inter­na­tional agree­ments deal­ing with intel­lec­tual prop­erty or trade and eco­nomic exchange do not impede access to med­i­cines, diag­nos­tics or related tech­nolo­gies required for pre­ven­tion or treat­ment of HIV/AIDS or other dis­eases related to sex­ual and repro­duc­tive health. States should ensure that inter­na­tional agree­ments and domes­tic leg­is­la­tion incor­po­rate to the fullest extent any safe­guards and flex­i­bil­i­ties therein that may be used to pro­mote and ensure access to med­i­cines and health care for all. States par­ties should review their inter­na­tional agree­ments, includ­ing on trade and invest­ment, to ensure that they are con­sis­tent with the pro­tec­tion of the right to sex­ual and repro­duc­tive health, and should amend them as nec­es­sary.” (para­graph 51)

2009 Report of the Special Rapporteur on the right to health

• “Devel­op­ing coun­tries and LDCs should estab­lish high patentabil­ity stan­dards and pro­vide for exclu­sions from patentabil­ity, such as new forms and new or sec­ond uses, and com­bi­na­tions, in order to address ever­green­ing and facil­i­tate generic entry of med­i­cines.” (para­graph 100)

• “Devel­op­ing coun­tries and LDCs should adopt the prin­ci­ple of inter­na­tional exhaus­tion and pro­vide for par­al­lel impor­ta­tion with sim­pli­fied pro­ce­dures in their national laws.” (para­graph 101)

• “Devel­op­ing coun­tries and LDCs need to incor­po­rate in their national patent laws all pos­si­ble grounds upon which com­pul­sory licences, includ­ing gov­ern­ment use, may be issued. Such laws pro­vide straight­for­ward, trans­par­ent pro­ce­dures for rapid issue of com­pul­sory licences. There is also a need to revisit the 30 August deci­sion and pro­vide for a sim­pler mech­a­nism.” (para­graph 102)

• “Devel­op­ing coun­tries and LDCs should specif­i­cally adopt and apply pro-com­pe­ti­tion mea­sures to pre­vent the abuse of the patent sys­tem, par­tic­u­larly in regard to access to med­i­cines.” (para­graph 103)

• “LDCs and devel­op­ing coun­tries should actively pro­mote the par­tic­i­pa­tion of indi­vid­u­als and com­mu­ni­ties in deci­sion-mak­ing processes relat­ing to TRIPS and TRIPS flex­i­bil­i­ties and con­duct impact assess­ments of the same.” (para­graph 107)

• “Devel­op­ing coun­tries and LDCs should not intro­duce TRIPS-plus stan­dards in their national laws. Devel­oped coun­tries should not encour­age devel­op­ing coun­tries and LDCs to enter into TRIPS-plus FTAs and should be mind­ful of actions which may infringe upon the right to health.” (para­graph 108)

• “Flex­i­bil­i­ties were included in TRIPS to allow States to take into con­sid­er­a­tion their eco­nomic and devel­op­ment needs. States need to take steps to facil­i­tate the use of TRIPS flex­i­bil­i­ties.” (para­graph 96)

• “The Spe­cial Rap­por­teur there­fore rec­om­mends that devel­op­ing coun­tries and LDCs should review their laws and poli­cies and con­sider whether they have made full use of TRIPS flex­i­bil­i­ties or included TRIPS-plus mea­sures, and if nec­es­sary con­sider amend­ing their laws and poli­cies to make full use of the flex­i­bil­i­ties.” (para­graph 97)

Evidence

2021 WHO Consolidated Guidelines on HIV Prevention, Testing, Treatment, Service Delivery and Monitoring

• “The lack of access to appro­pri­ate anti­fun­gal ther­a­pies and in vitro diag­nos­tics for rapid detec­tion of histo­plas­mo­sis and the co-occur­rence of other infec­tious dis­eases, espe­cially TB, may affect clin­i­cal out­comes and under­lie the high mor­tal­ity of dis­sem­i­nated histo­plas­mo­sis among peo­ple liv­ing with HIV.” (p. 216)