Criticisms of Gilead's Voluntary Licence and Access Arrangements From Leading HIV Organisations
| Organization . | Criticism of Gilead's Lenacapavir Voluntary Licence . |
|---|---|
| UNAIDS [18] | “The exclusion of many middle-income countries from the licence is deeply worrying and undermines the potential of this scientific breakthrough” − Criticism of Gilead's lack of transparency on price and costs − Criticism of exclusion of middle-income countries, highlighting high incidence in these regions − Exclusion of South Africa-based generic companies − Criticism of limiting treatment to “heavily treatment-experienced patients” |
| MSF [19] | Current pricing for lenacapavir as treatment “undermines the potential of this scientific breakthrough and slows the global effort to turn the tide on HIV and AIDS.” − Criticism of Gilead's lack of transparency on price and costs − Advocates for generic supply to all LMICs − Advocates for VL through the MPP |
| Unitaid [20] | “Countries and populations with high, growing, concentrated HIV epidemics—including countries that have led foundational work to make PrEP a reality, like Brazil—cannot be excluded from licensing agreements, and registration plans” − Criticism of Gilead's lack of transparency on price |
| International AIDS Society [21] | “many countries with high HIV incidence are not included in the licensing arrangements, which will slow access” − Criticism of exclusion of high-incidence countries − Criticism of exclusion of PURPOSE-2 countries |
| Statement signed by 31 HIV advocacy organisation sin Africa, coordinate by KELIN Kenya [22] | “No country should be left behind in access to life-saving medicines.” − Criticism of exclusion of countries from the voluntary licence, particularly Algeria and low- and middle-income countries in South America and Asia − Criticism of limiting generic manufacturers to six with only one in Africa as undermining regional self-sufficiency − Criticism of diversion clauses |
| International Treatment Preparedness Coalition [23] | “Gilead's voluntary license (VL) will prevent millions of people especially key populations from accessing LEN.” − Criticism of exclusion on MICs in South America − Criticism of VL's potential to worsen global health inequity − Criticism of diversion clauses − Criticism of limiting generic manufacturers to six as undermining local manufacturing capacity, regional self-sufficiency and long-term sustainability, particularly in Africa, Eastern Europe and Central Asia |
| Health Justice Initiative [24] | “Governments should take compulsory measures [against Gilead] to ensure two things: generics, everywhere in the world…and affordable, transparent prices…” − Criticism of exclusion of countries from the voluntary licence − Criticism of Gilead's lack of transparency on price |
| AIDS Healthcare Foundation Brazil [25] | “key HIV-affected countries excluded from the deal—particularly those in Latin America and others—must also have affordable access to this breakthrough treatment” − Criticism of exclusion of MICs, particularly in South America − Criticism of exclusion of generic manufacturers as undermining local manufacturing capacity and regional self-sufficiency, particularly in South Africa − Criticism of Gilead's lack of transparency on price |
| ACT-UP [26] | “If this licence included all low- and middle-income countries it would allow other manufacturers to produce the drug, helping bring the price down through generic competition whilst also enabling greater supply to meet demand and ultimately help to end new HIV transmissions” − Criticism of lack of engagement with MPP |
| Treatment Action Group [27] | “it still leaves far too many behind” − Criticism of exclusion of middle-income counties − Criticism of diversion clauses − Criticism of exclusion of PURPOSE-2 countries − Criticism of the current price of lenacapavir as treatment |
| HealthGAP [28] | “Gilead's access strategy for lenacapavir will unnecessarily prolong the HIV pandemic” − Advocated for inclusion of all LMICs − Criticism of Gilead's unilateral control of supply and price − Criticism of exclusion of PURPOSE-2 countries as unethical − Criticism of diversion clauses |
| People's Medicines Alliance [29] | “This exciting news is marred by Gilead's refusal to work with the UN-backed Medicines Patent Pool to license a generic version of this medicine for developing countries.” − Criticism of exclusion of MICs − Criticism of lack of transparency in definition of “high-incidence resource-limited” countries − Criticism of lack of transparency on price |
| Organization . | Criticism of Gilead's Lenacapavir Voluntary Licence . |
|---|---|
| UNAIDS [18] | “The exclusion of many middle-income countries from the licence is deeply worrying and undermines the potential of this scientific breakthrough” − Criticism of Gilead's lack of transparency on price and costs − Criticism of exclusion of middle-income countries, highlighting high incidence in these regions − Exclusion of South Africa-based generic companies − Criticism of limiting treatment to “heavily treatment-experienced patients” |
| MSF [19] | Current pricing for lenacapavir as treatment “undermines the potential of this scientific breakthrough and slows the global effort to turn the tide on HIV and AIDS.” − Criticism of Gilead's lack of transparency on price and costs − Advocates for generic supply to all LMICs − Advocates for VL through the MPP |
| Unitaid [20] | “Countries and populations with high, growing, concentrated HIV epidemics—including countries that have led foundational work to make PrEP a reality, like Brazil—cannot be excluded from licensing agreements, and registration plans” − Criticism of Gilead's lack of transparency on price |
| International AIDS Society [21] | “many countries with high HIV incidence are not included in the licensing arrangements, which will slow access” − Criticism of exclusion of high-incidence countries − Criticism of exclusion of PURPOSE-2 countries |
| Statement signed by 31 HIV advocacy organisation sin Africa, coordinate by KELIN Kenya [22] | “No country should be left behind in access to life-saving medicines.” − Criticism of exclusion of countries from the voluntary licence, particularly Algeria and low- and middle-income countries in South America and Asia − Criticism of limiting generic manufacturers to six with only one in Africa as undermining regional self-sufficiency − Criticism of diversion clauses |
| International Treatment Preparedness Coalition [23] | “Gilead's voluntary license (VL) will prevent millions of people especially key populations from accessing LEN.” − Criticism of exclusion on MICs in South America − Criticism of VL's potential to worsen global health inequity − Criticism of diversion clauses − Criticism of limiting generic manufacturers to six as undermining local manufacturing capacity, regional self-sufficiency and long-term sustainability, particularly in Africa, Eastern Europe and Central Asia |
| Health Justice Initiative [24] | “Governments should take compulsory measures [against Gilead] to ensure two things: generics, everywhere in the world…and affordable, transparent prices…” − Criticism of exclusion of countries from the voluntary licence − Criticism of Gilead's lack of transparency on price |
| AIDS Healthcare Foundation Brazil [25] | “key HIV-affected countries excluded from the deal—particularly those in Latin America and others—must also have affordable access to this breakthrough treatment” − Criticism of exclusion of MICs, particularly in South America − Criticism of exclusion of generic manufacturers as undermining local manufacturing capacity and regional self-sufficiency, particularly in South Africa − Criticism of Gilead's lack of transparency on price |
| ACT-UP [26] | “If this licence included all low- and middle-income countries it would allow other manufacturers to produce the drug, helping bring the price down through generic competition whilst also enabling greater supply to meet demand and ultimately help to end new HIV transmissions” − Criticism of lack of engagement with MPP |
| Treatment Action Group [27] | “it still leaves far too many behind” − Criticism of exclusion of middle-income counties − Criticism of diversion clauses − Criticism of exclusion of PURPOSE-2 countries − Criticism of the current price of lenacapavir as treatment |
| HealthGAP [28] | “Gilead's access strategy for lenacapavir will unnecessarily prolong the HIV pandemic” − Advocated for inclusion of all LMICs − Criticism of Gilead's unilateral control of supply and price − Criticism of exclusion of PURPOSE-2 countries as unethical − Criticism of diversion clauses |
| People's Medicines Alliance [29] | “This exciting news is marred by Gilead's refusal to work with the UN-backed Medicines Patent Pool to license a generic version of this medicine for developing countries.” − Criticism of exclusion of MICs − Criticism of lack of transparency in definition of “high-incidence resource-limited” countries − Criticism of lack of transparency on price |
Abbreviations: HIV, human immunodeficiency virus; LMIC, low- and middle-income countries; MIC, minimum inhibitory concentration.
Criticisms of Gilead's Voluntary Licence and Access Arrangements From Leading HIV Organisations
| Organization . | Criticism of Gilead's Lenacapavir Voluntary Licence . |
|---|---|
| UNAIDS [18] | “The exclusion of many middle-income countries from the licence is deeply worrying and undermines the potential of this scientific breakthrough” − Criticism of Gilead's lack of transparency on price and costs − Criticism of exclusion of middle-income countries, highlighting high incidence in these regions − Exclusion of South Africa-based generic companies − Criticism of limiting treatment to “heavily treatment-experienced patients” |
| MSF [19] | Current pricing for lenacapavir as treatment “undermines the potential of this scientific breakthrough and slows the global effort to turn the tide on HIV and AIDS.” − Criticism of Gilead's lack of transparency on price and costs − Advocates for generic supply to all LMICs − Advocates for VL through the MPP |
| Unitaid [20] | “Countries and populations with high, growing, concentrated HIV epidemics—including countries that have led foundational work to make PrEP a reality, like Brazil—cannot be excluded from licensing agreements, and registration plans” − Criticism of Gilead's lack of transparency on price |
| International AIDS Society [21] | “many countries with high HIV incidence are not included in the licensing arrangements, which will slow access” − Criticism of exclusion of high-incidence countries − Criticism of exclusion of PURPOSE-2 countries |
| Statement signed by 31 HIV advocacy organisation sin Africa, coordinate by KELIN Kenya [22] | “No country should be left behind in access to life-saving medicines.” − Criticism of exclusion of countries from the voluntary licence, particularly Algeria and low- and middle-income countries in South America and Asia − Criticism of limiting generic manufacturers to six with only one in Africa as undermining regional self-sufficiency − Criticism of diversion clauses |
| International Treatment Preparedness Coalition [23] | “Gilead's voluntary license (VL) will prevent millions of people especially key populations from accessing LEN.” − Criticism of exclusion on MICs in South America − Criticism of VL's potential to worsen global health inequity − Criticism of diversion clauses − Criticism of limiting generic manufacturers to six as undermining local manufacturing capacity, regional self-sufficiency and long-term sustainability, particularly in Africa, Eastern Europe and Central Asia |
| Health Justice Initiative [24] | “Governments should take compulsory measures [against Gilead] to ensure two things: generics, everywhere in the world…and affordable, transparent prices…” − Criticism of exclusion of countries from the voluntary licence − Criticism of Gilead's lack of transparency on price |
| AIDS Healthcare Foundation Brazil [25] | “key HIV-affected countries excluded from the deal—particularly those in Latin America and others—must also have affordable access to this breakthrough treatment” − Criticism of exclusion of MICs, particularly in South America − Criticism of exclusion of generic manufacturers as undermining local manufacturing capacity and regional self-sufficiency, particularly in South Africa − Criticism of Gilead's lack of transparency on price |
| ACT-UP [26] | “If this licence included all low- and middle-income countries it would allow other manufacturers to produce the drug, helping bring the price down through generic competition whilst also enabling greater supply to meet demand and ultimately help to end new HIV transmissions” − Criticism of lack of engagement with MPP |
| Treatment Action Group [27] | “it still leaves far too many behind” − Criticism of exclusion of middle-income counties − Criticism of diversion clauses − Criticism of exclusion of PURPOSE-2 countries − Criticism of the current price of lenacapavir as treatment |
| HealthGAP [28] | “Gilead's access strategy for lenacapavir will unnecessarily prolong the HIV pandemic” − Advocated for inclusion of all LMICs − Criticism of Gilead's unilateral control of supply and price − Criticism of exclusion of PURPOSE-2 countries as unethical − Criticism of diversion clauses |
| People's Medicines Alliance [29] | “This exciting news is marred by Gilead's refusal to work with the UN-backed Medicines Patent Pool to license a generic version of this medicine for developing countries.” − Criticism of exclusion of MICs − Criticism of lack of transparency in definition of “high-incidence resource-limited” countries − Criticism of lack of transparency on price |
| Organization . | Criticism of Gilead's Lenacapavir Voluntary Licence . |
|---|---|
| UNAIDS [18] | “The exclusion of many middle-income countries from the licence is deeply worrying and undermines the potential of this scientific breakthrough” − Criticism of Gilead's lack of transparency on price and costs − Criticism of exclusion of middle-income countries, highlighting high incidence in these regions − Exclusion of South Africa-based generic companies − Criticism of limiting treatment to “heavily treatment-experienced patients” |
| MSF [19] | Current pricing for lenacapavir as treatment “undermines the potential of this scientific breakthrough and slows the global effort to turn the tide on HIV and AIDS.” − Criticism of Gilead's lack of transparency on price and costs − Advocates for generic supply to all LMICs − Advocates for VL through the MPP |
| Unitaid [20] | “Countries and populations with high, growing, concentrated HIV epidemics—including countries that have led foundational work to make PrEP a reality, like Brazil—cannot be excluded from licensing agreements, and registration plans” − Criticism of Gilead's lack of transparency on price |
| International AIDS Society [21] | “many countries with high HIV incidence are not included in the licensing arrangements, which will slow access” − Criticism of exclusion of high-incidence countries − Criticism of exclusion of PURPOSE-2 countries |
| Statement signed by 31 HIV advocacy organisation sin Africa, coordinate by KELIN Kenya [22] | “No country should be left behind in access to life-saving medicines.” − Criticism of exclusion of countries from the voluntary licence, particularly Algeria and low- and middle-income countries in South America and Asia − Criticism of limiting generic manufacturers to six with only one in Africa as undermining regional self-sufficiency − Criticism of diversion clauses |
| International Treatment Preparedness Coalition [23] | “Gilead's voluntary license (VL) will prevent millions of people especially key populations from accessing LEN.” − Criticism of exclusion on MICs in South America − Criticism of VL's potential to worsen global health inequity − Criticism of diversion clauses − Criticism of limiting generic manufacturers to six as undermining local manufacturing capacity, regional self-sufficiency and long-term sustainability, particularly in Africa, Eastern Europe and Central Asia |
| Health Justice Initiative [24] | “Governments should take compulsory measures [against Gilead] to ensure two things: generics, everywhere in the world…and affordable, transparent prices…” − Criticism of exclusion of countries from the voluntary licence − Criticism of Gilead's lack of transparency on price |
| AIDS Healthcare Foundation Brazil [25] | “key HIV-affected countries excluded from the deal—particularly those in Latin America and others—must also have affordable access to this breakthrough treatment” − Criticism of exclusion of MICs, particularly in South America − Criticism of exclusion of generic manufacturers as undermining local manufacturing capacity and regional self-sufficiency, particularly in South Africa − Criticism of Gilead's lack of transparency on price |
| ACT-UP [26] | “If this licence included all low- and middle-income countries it would allow other manufacturers to produce the drug, helping bring the price down through generic competition whilst also enabling greater supply to meet demand and ultimately help to end new HIV transmissions” − Criticism of lack of engagement with MPP |
| Treatment Action Group [27] | “it still leaves far too many behind” − Criticism of exclusion of middle-income counties − Criticism of diversion clauses − Criticism of exclusion of PURPOSE-2 countries − Criticism of the current price of lenacapavir as treatment |
| HealthGAP [28] | “Gilead's access strategy for lenacapavir will unnecessarily prolong the HIV pandemic” − Advocated for inclusion of all LMICs − Criticism of Gilead's unilateral control of supply and price − Criticism of exclusion of PURPOSE-2 countries as unethical − Criticism of diversion clauses |
| People's Medicines Alliance [29] | “This exciting news is marred by Gilead's refusal to work with the UN-backed Medicines Patent Pool to license a generic version of this medicine for developing countries.” − Criticism of exclusion of MICs − Criticism of lack of transparency in definition of “high-incidence resource-limited” countries − Criticism of lack of transparency on price |
Abbreviations: HIV, human immunodeficiency virus; LMIC, low- and middle-income countries; MIC, minimum inhibitory concentration.
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