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ACTIVE SINCE: 2014

ViiV Healthcare: Antiretroviral (ARV) voluntary licensing

Expanding and accelerating access to dolutegravir (DTG)-based treatment for people living with HIV in low-and middle-income countries
SGDS CONTRIBUTING TO:
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MEMBER COMPANIES:
Generic Manufacturers 17
Global NGOs 1
Pharma (non-IFPMA member) 1
Intergovernmental Organizations and Multilaterals 1
Objectives
  • Scaling up access to treatment for people living with HIV

At ViiV Healthcare* we are committed to playing our part in addressing access to medicines challenges by taking an innovative, responsible, and sustainable approach.

In 2020, 37.7 million people globally were living with HIV, and as of the end of June 2021, 28.2 million people had access to antiretroviral therapy (ART).1 Scaling-up access to treatment to ensure that all people living with HIV have access to people-centred HIV treatment and care is a significant part of the global HIV response and the 2025 UN HIV target to achieve 95% treatment coverage.2 Not only does sustained access to ART lead to better medical and psycho-social outcomes for people living with HIV, there is now a growing body of evidence that shows that effective ART can act as a robust prevention (Treatment as Prevention [TasP]) method and may help halt the progression of the HIV epidemic.

ViiV Healthcare has a well-established commitment to research, developing and delivering antiretroviral therapies which seek to provide people-centred, long term and high-quality care to support people living with HIV to live full, active and productive lives. Progress in HIV science has delivered a wide range of effective treatments which means that people living with HIV who are on stable treatment cannot pass HIV on to sexual partners (U equals U’. Undetectable equals Untransmittable (‘U=U’).

Despite HIV being preventable and treatable, treatment and care for people living with HIV remains a complex challenge driven by policy and legal barriers, which drive HIV-related marginalisation, stigma, discrimination and criminalisation. Tackling these barriers requires a focus on people living with HIV and communities as well as shared responsibility, accountability, leadership and solidarity across the public, private and not-for-profit sectors. This includes – governments, international agencies, civil society, academic institutions, the pharmaceutical industry and others.

To address health inequalities related to medicine access, we take a proactive approach. ViiV Healthcare explores and applies a range of models that are driven by medical and public health needs and priorities to address local HIV epidemics. We use a variety of approaches to support access including research to inform clinical use, policies and guidelines, flexible pricing policy, local manufacturing and capacity building across public health and community systems.

Together with the Medicines Patent Pool (MPP), and generics manufacturers, we collaborate to accelerate the development, registration, and supply of  generic dolutegravir (DTG)-based antiretroviral therapies across all low-income countries (LICs), least-developed countries (LDCs), all lower-middle-income countries (LMICs), and countries in sub-Saharan Africa.3

In November 2020, we also executed a novel voluntary licence agreement with the Medicines Patent Pool (MPP) which was created to enable greater access to DTG-based regimens for people living with HIV in four Upper Middle-Income Countries (Azerbaijan, Belarus, Kazakhstan and Malaysia). 4,5 This novel voluntary licensing agreement for DTG-based regimens aims to increase medicine affordability by allowing generics manufacturers to supply generic DTG-based medicines at a significantly reduced price compared to the prevailing local prices at the time the agreement was executed, whilst also being consistent with ViiV’s approach to tiered pricing in middle-income countries (MICs).

We are dedicated to licensing our patents for cabotegravir long-acting (LA) for PrEP and in May 2022, we committed  to negotiate voluntary licensing terms with the UN-backed Medicines Patent Pool (MPP) to enable access to this prevention health technology as swiftly as possible to help scale-up access across resource limited settings.

*ViiV Healthcare is the only global biopharmaceutical company 100% focused on combating, preventing, and ultimately curing HIV and ending AIDS as a public health threat by 2030. Our shared purpose is to unite science, talent, and technology, to get ahead of a leading chronic and infectious disease for greater health impact. We were established in November 2009, through a science-led partnership between GSK (our majority shareholder) and Pfizer; with Shionogi joining in 2012. We are dedicated to researching and delivering innovative HIV medicines and solutions with an ambition to make HIV a smaller part of people’s lives. In addition, we work in solidarity with HIV communities across the globe, this includes people living with HIV and diverse communities vulnerable to HIV transmission. We collaborate to build multisector partnerships which seek to accelerate progress aligned with the UN Sustainable Development Goals to leave no person living with HIV behind.

Results and milestones

ViiV Healthcare has two voluntary licensing agreements for dolutegravir (DTG) with the MPP and two directly with Aurobindo Pharma – one for adults and one for paediatrics respectively. As of December 2021, there were 16 sub-licensees under the adult DTG licence and 14 under the paediatric licence as well as a novel and separate licensing agreement for four UMICs – with the MPP.

Our ambitious DTG access commitments have enabled:

  • access to generic dolutegravir (DTG)-based antiretroviral therapies to at least 20.3 million people living with HIV across 122 LICs and LMICs (by the end of 2021).6
  • access to at least 87% of people living with HIV on antiretrovirals in low and middle-income countries.6
  • 94% of adults and 99% of children living with HIV in low-and-middle income countries to be covered by our DTG voluntary licences.3
  • along with our majority shareholder GSK we have ranked number one in the Access to Medicine Index, since the inception of the index in 2008. Our approach to voluntary licensing has been recognised as Best in Industry. The index is the longest-running assessment of the pharmaceutical industry’s actions to improve access to medicine in low- and middle-income countries (LMICs).7

References

  1. Fact sheet. Available at: https://www.unaids.org/en/resources/fact-sheet. Last accessed: July 2022
  2. 2025 AIDS TARGETS. Available from https://aidstargets2025.unaids.org/. Last accessed: July 2022
  3. Medicines Patent Pool. DOLUTEGRAVIR – ADULT (DTG). Available from https://medicinespatentpool.org/licence-post/dolutegravir-adult-dtg. Last accessed: July 2022.
  4. DTG-based regimens, as recommended by the WHO and the US Department of Health and Human Services
  5. ViiV Healthcare. (2020). ViiV Healthcare and the Medicines Patent Pool expand access to dolutegravir-based regimens for people living with HIV in Azerbaijan, Belarus, Kazakhstan, and Malaysia with innovative new licensing agreement. Available from: https://viivhealthcare.com/hiv-news-and-media/news/press-releases/2020/november/viiv-healthcare-and-the-medicines-patent-pool-expand-access-to-dolutegravir-based-regimens/. Last accessed: July 2022.
  6. Medicines Patent Pool ‘Access to Medicines tracker’. Data as of December 2021. https://medicinespatentpool.org/progress-achievements/access-to-medicines-tracker. Last accessed: July 2022
  7. Access to Medicines Index. (2021). ATMI Report 2021. 2021 Access to Medicine Index. Available from: https://accesstomedicinefoundation.org/publications/2021-access-to-medicine-index. Last accessed: July 2022.
Geographic Reach
  • Africa
  • Americas
  • Eastern Mediterranean
  • Europe
  • South-East Asia
  • Western Pacific
See Where
Disease Area
  • Infectious and Parasitic Disease
See Disease Areas
Target Population
  • Children
  • People with low incomes
  • Men
  • Women
Partner organizations
Generic Manufacturers

Lupin Pharmaceuticals Inc

Mangalam Drugs & Organics Ltd

MacLeods Pharmaceuticals Ltd

Micro Labs Limited

Strides Pharma Science Limited

Sun Pharmaceutical Industries Limited

Aurobindo Pharma Ltd

Hetero Drugs (India)

Adcock Ingram Limited and Adcock Ingram Healthcare (PTY) Limited

Langhua

Desano Pharmaceuticals

Emcure Pharmaceuticals

Mylan Laboratories Limited (a Viatris Group company)

Arene Life Sciences Limited

Celltrion Inc

Cipla Limited

Laurus Labs Private Limited

Global NGOs

Clinton Health Access Initiative (CHAI)

Pharma (non-IFPMA member)

ViiV Healthcare

Intergovernmental Organizations and Multilaterals

Medicines Patent Pool (MPP)