Unitaid to address intellectual property-related barriers for broader access to health technologies with new call for proposals 

Submissions are welcomed until 1 February 2023 at 12:00 (noon) CET.

Intellectual property rights are an important incentivizing mechanism to accelerate the development of innovations to respond to global health challenges. But while they can be effective in stimulating and rewarding innovation in global health, they can also contribute to inequitable access to new products, as has been increasingly recognized over the course of the COVID-19 pandemic.

TRIPS flexibilities – legal mechanisms allowing countries to overcome or reduce the potential negative impact of patents in response to specific public health needs – are intended to address equity barriers.

Unitaid seeks to fund projects that will support the use of TRIPS flexibilities and other solutions to prevent or remove unwarranted intellectual property barriers. Unitaid is particularly interested in ensuring the availability and affordability of health products for HIV, tuberculosis, hepatitis C, and other diseases and conditions outlined in the 2023-2027 Strategy.

Without intervention, inequitable access will only widen, and populations that are already vulnerable and marginalized will face increasing risk of disease, poverty, reduced quality of life and even death. This work will contribute to enhancing equity between countries as it benefits low-income and, importantly, middle-income countries that are typically not included in voluntary licensing agreements.

Through this call for proposals, Unitaid aims to improve access to health products of public health importance, with a particular focus on affordability, increased supply and adoption, and a diversification of the supply base in low- and middle-income countries.

Learn more about this latest funding opportunity here

Media contact:

For more information and media requests:

Maggie Zander

Communications officer

M: +41 79 593 17 74

zanderm@unitaid.who.int

Unitaid issues call for proposals to help avert the most common causes of death among people living with HIV 

Proposals are welcomed until 20 January 2023  

Geneva – Significant advances in the screening and treatment of HIV over the past decades have transformed HIV-infection into a manageable chronic condition. Despite this, more than 600,000 people die each year from AIDS-related causes, the majority of which occur in low- and middle-income countries.  

Children are disproportionately affected: they represent only 5% of all people living with HIV, yet account for 15% of all deaths.  

Many AIDS-related deaths occur when a person goes too long without antiviral treatment for HIV infection and becomes severely immunocompromised. This is known as advanced HIV disease, and those affected are at high risk of opportunistic infections such as tuberculosis, pneumonia, cryptococcal meningitis, and other fungal infections.   

With highly effective rapid tests and treatments for HIV, and tools to prevent and treat common co-infections associated with more severe stages of disease available, the current rates of AIDS-related deaths are unacceptable.  

Unitaid is now accepting proposals for projects that will further simplify the management of advanced HIV disease, including for children. This builds on previous investments that have significantly improved access to a package of care that includes some of the most impactful medicines and diagnostics recommended by the World Health Organization (WHO) for advanced HIV disease. 

Unitaid aims to increase equitable access to optimal products for managing advanced HIV disease in adults and children by supporting proposals aimed at:  

  • Developing optimal strategies for rapid diagnosis, prevention, and treatment of infections associated with HIV in children 
  • Facilitating the adoption and implementation of the WHO STOP AIDS toolkit for children to expand access to care for advanced HIV disease and enable further scale-up for this very vulnerable population 
  • Demonstrating decentralized delivery models of care to prevent loss to follow up  
  • Further simplifying and increasing uptake of optimized advanced HIV disease packages that integrate newer tools to address the main drivers of death, including cryptococcal meningitis and other fungal infections

Engagement with affected communities is a critical determinant for project success and all proposals must clearly indicate how community engagement and collaboration will guide project design, development, and implementation.   

Find out more about this latest funding opportunity here

Media contact:

For more information and media requests:

Maggie Zander

Communications officer

M: +41 79 593 17 74

zanderm@unitaid.who.int

Best-in-class second-line HIV treatment rolls out in Zambia and Nigeria

Unitaid landscape report identifies new technologies and innovative delivery strategies that hold promise for reducing vertical transmission of HIV, syphilis, hepatitis B, and Chagas

Geneva, Switzerland – 4 August 2022. A new report examining the landscape of tools and interventions for preventing mother-to-child transmission, also known as vertical transmission, of HIV, syphilis and hepatitis B and Chagas, identifies several actionable opportunities to accelerate progress towards global elimination goals.

The report analyzes current challenges in eliminating this important route of transmission and outlines a number of new, emerging or underutilized products and interventions which could help expand access and overcome the public health and market challenges identified.

In addition, several service delivery innovations have the potential to facilitate more rapid, consistent, and equitable access to existing tools and strategies.

Expanding access to these innovative approaches and products as well as addressing product development gaps is critical to achieving the World Health Organization’s ‘Triple Elimination’ agenda, which seeks to encourage countries to pursue an integrated and coordinated approach to eliminating vertical transmission of HIV, syphilis, hepatitis B, and in countries where it is endemic, Chagas disease.

 

About Unitaid

Unitaid is a global health agency engaged in finding innovative solutions to prevent, diagnose, and treat diseases more quickly, cheaply, and effectively, in low- and middle-income countries. Its work includes funding initiatives to address major diseases such as HIV, malaria, and tuberculosis, as well as HIV co-infections and co-morbidities including advanced HIV disease, cervical cancer, and hepatitis C, and cross-cutting areas, such as fever management. Unitaid is now applying its expertise to address challenges in advancing new therapies and diagnostics for the COVID-19 pandemic, serving as a key member of the Access to COVID-19 Tools (ACT) Accelerator, co-leading with Wellcome the Therapeutics Pillar and participating in the Diagnostics Pillar. Unitaid is hosted by the World Health Organization.

Media contacts:

Unitaid

Maggie Zander
Communications officer
M: +41 79 593 17 74
zanderm@unitaid.who.int

Pooled data analysis from three large-scale clinical trials reveal long-term effects of dolutegravir-based treatment regimens on people living with HIV

Montreal, 30 July 2022 – Joint analysis from three HIV clinical research studies investigating the long-term effects of dolutegravir-based antiretroviral treatment regimens at 192 weeks’ follow-up showed it to remain safe and better tolerated than the previously recommended first-line drug efavirenz, with higher rates of viral suppression and lower risks of drug resistance.

These results are based on pooled data from the ADVANCE, DolPHIN2, and NAMSAL-ANRS-12313 clinical trials that evaluated the long-term risk-benefits of antiretroviral medicines in first-line HIV treatments.

In addition, a combined analysis of more than 1000 pregnant women living with HIV across five randomized trials, including ADVANCE,  DolPHIN-2, and  NAMSAL, showed no significant difference between dolutegravir and efavirenz in the risk of neonatal deaths, stillbirths, or mother to child HIV transmission. These findings also support the World Health Organization’s recommendation of the use of dolutegravir as the preferred HIV treatment for all populations.

However, though most patients who were started on dolutegravir-based regimens did well and were happy with the medication, the three trials revealed varying levels of weight gain experienced by certain populations of people living with HIV that did not seem to halt even beyond four years of treatment.

This was observed mostly among Africans, and more commonly among African women than men. This warrants urgent additional research to understand the causes and potential treatment responses to new concerns related to obesity, metabolic syndrome, and risk of cardiovascular disease in addition to physical and emotional discomfort. This should include potential ways to control weight while maintaining dolutegravir-based regimens, including the use of other medications and measures to diminish the undesirable effects.

This work highlights the critical importance of early inclusion of diverse populations in clinical trials to ensure all people have access to the best treatments possible. It is because of the joint and broad analysis conducted through these three trials that this issue was able to be identified and it is hoped that this will encourage further research to quickly develop adequate solutions.

The results are based on data from ADVANCE, DolPHIN2, and NAMSAL, led by Ezintsha, University of Liverpool, and University of Montpellier-IBB-ANRS, respectively, with funding support from Unitaid.

 

About Unitaid

Unitaid is a global health agency engaged in finding innovative solutions to prevent, diagnose, and treat diseases more quickly, affordably, and effectively, in low- and middle-income countries. Its work includes funding initiatives to address major diseases such as HIV, malaria, and tuberculosis, as well as HIV co-infections and co-morbidities including advanced HIV disease, cervical cancer, and hepatitis C, and cross-cutting areas, such as fever management. Unitaid is now applying its expertise to address challenges in advancing new therapies and diagnostics for the COVID-19 pandemic, serving as a key member of the Access to COVID-19 Tools (ACT) Accelerator, co-leading with Wellcome the Therapeutics Pillar and participating in the Diagnostics Pillar. Unitaid is hosted by the World Health Organization.

Media contacts:

Unitaid

Maggie Zander
Communications officer
M: +41 79 593 17 74
zanderm@unitaid.who.int

AVAC, CIFF, MedAccess, Unitaid, and ViiV Healthcare announce collaboration to catalyse more affordable access to long-acting injectable cabotegravir for HIV prevention

Geneva, Switzerland – 28 July 2022. At the 24th International AIDS Conference, AVAC, the Children’s Investment Fund Foundation (CIFF), MedAccess, Unitaid, and ViiV Healthcare announced a strategic collaboration to speed equitable access to injectable cabotegravir for HIV pre-exposure prophylaxis (PrEP). This collaboration demonstrates the commitment of global health partners and ViiV to work together to accelerate access to a new HIV prevention option as part of a comprehensive response to reduce the number of new HIV infections and advance efforts to end the HIV epidemic by 2030.

Cabotegravir long-acting (LA) is an injectable form of PrEP that is given every two months by trained healthcare workers. Cabotegravir LA for PrEP, which was approved by the U.S. Food and Drug Administration (FDA) in December 2021, is the first and only long-acting injectable PrEP option available.

Global health partners and ViiV are committed to making cabotegravir LA for PrEP more accessible in resource-limited settings in the near term, while working in parallel to accelerate market entry of quality-assured generic products. This two-pronged strategy is fundamental to meeting current demand for the product and establishing a sustainable longer-term market.

In order to increase access to cabotegravir LA in the near term, ViiV, AVAC, CIFF, MedAccess, and Unitaid will:

  • Hold discussions on pricing, with the aim of identifying a pathway for cabotegravir LA for PrEP to be offered to public sector purchasers at a more affordable price
  • Examine the potential role of innovative financing mechanisms to deliver on this goal
  • Include civil society in planning and decision-making to accelerate equitable access
  • Share responses to frequently asked questions on procurement channels and requirements
  • Track and share regulatory submissions and approvals across priority countries

“Stagnating rates of new HIV infections underline the importance of getting effective prevention tools to the people who need them as quickly as possible,” said Michael Anderson, CEO of MedAccess. “By combining expertise in science, innovative finance and global health, this collaboration has the potential to catalyse access to cabotegravir LA at a sustainable price. MedAccess will work urgently with all partners to find solutions that unlock access for thousands of people as quickly as possible.”

Efforts to increase access to cabotegravir LA for PrEP will be especially impactful for key populations such as women and girls, who account for a disproportionate number of new HIV infections. Every week, 5,000 adolescent girls and women[1] (15-24 years) contract HIV globally. For key populations, who have a 13-30 times higher risk of acquiring HIV infection[2] as compared to the rest of the population, a long-acting prevention method could help overcome pill fatigue, stigma, and adherence issues[3].

“Cabotegravir for PrEP has the potential to transform HIV prevention efforts by offering people an additional option for HIV prevention, but only if we can make it available with urgency, with equity and at scale. While no one method will work for all people – or for any one person all of the time – this new approach significantly reduces frequency of dosing and may be easier for some people versus taking a pill a day,” said Mitchell Warren, Executive Director of AVAC.

Deborah Waterhouse, CEO of ViiV Healthcare said: “We are pleased to join this ambitious new collaboration as an active partner, working to find solutions to enable at-scale access to innovative HIV prevention options as quickly as possible. Together with our new voluntary license agreement with the Medicines Patent Pool, we are making significant progress towards our common goal of expanding access to cabotegravir LA for PrEP, which we believe has the potential to be a game changer in HIV prevention and to play an important role in ending the HIV epidemic.”

In response to civil society’s calls to make cabotegravir LA equitably available as soon as possible, global health partners and ViiV Healthcare are stepping up their collaboration to accelerate product access. HIV community groups, advocates and ministries of health are eager to add cabotegravir LA for PrEP to the HIV prevention toolkit, as choice is critical to meeting the needs of those most at risk of acquiring HIV.

These efforts build on the recent announcement that ViiV and the Medicines Patent Pool (MPP), which was founded by Unitaid, have agreed a voluntary license for cabotegravir LA. This will enable generic cabotegravir LA for PrEP to come to market in the coming years and should significantly expand the reach of this important prevention tool in low- and lower middle-income, least developed, and sub-Saharan African countries.

The collaboration announced today and the voluntary license agreement between ViiV and MPP, are  part of a broader package of interventions being discussed by a coalition of partners to accelerate affordable and equitable access to long-acting PrEP in low- and middle-income countries. The coalition, currently being formalized, will comprise a wide range of partners including funders, communities, civil society organizations, ministries of health, and United Nations agencies, and will be co-convened by Unitaid, the World Health Organization (WHO), the Global Fund and UNAIDS. These partners will jointly identify barriers to access for cabotegravir LA and develop a roadmap to overcome them.

“Oral PrEP took over a decade to be accessible in low- and middle-income countries. This strategic partnership and the broader coalition being formed will ensure that we leverage lessons learned from past experiences to make this promising long-acting solution for PrEP quickly available at an affordable price for everyone who could benefit from it,” said Dr Philippe Duneton, Executive Director of Unitaid.

ViiV Healthcare is also donating product to support initial implementation science projects that will provide critical information on the feasibility, acceptability, and future adoption of cabotegravir LA for PrEP into national programmes in access markets. The partners in this collaboration will ensure these projects are coordinating to address critical questions across the widest possible range of populations and geographies.

“People need more ways to protect themselves from HIV that fit with their lifestyles and environments,” said Miles Kemplay, Executive Director of Sexual and Reproductive Health and Rights at CIFF. “Cabotegravir promises to be one of those choices – but only if it is available at a cost that health systems can afford. We are looking forward to working with ViiV to figure out how to make cabotegravir accessible to those who need it today.”

 

References:

[1] Global HIV & AIDS statistics — Fact sheet | UNAIDS, Published: 1 Dec 2021.

[2] New HIV infections increasingly among key populations | UNAIDS (2019 data), Published: 20 Sept 2020.

[3] Sued O, et al., Key population perceptions and opinions about long-acting antiretrovirals for prevention and treatment: a scoping review, Current Opinion in HIV and AIDS: May 2022 – Vol 17, Issue 3, p145-161.

 

About the partners

AVAC: Founded in 1995, AVAC is a non-profit organization that uses education, policy analysis, advocacy and a network of global collaborations to accelerate the ethical development of and global access to effective HIV prevention options, as part of a comprehensive and integrated pathway to global health equity. Follow AVAC on Twitter @HIVpxresearch and find more at www.avac.org and www.prepwatch.org.

The Children’s Investment Fund Foundation (CIFF) is an independent philanthropic organisation, with offices in Addis Ababa, Beijing, London, Nairobi and New Delhi. Established in 2002, CIFF works with a wide range of partners seeking to transform the lives of children and adolescents in developing countries. Areas of work include adolescent sexual health, maternal and child health, opportunities for girls and young women, tackling child slavery and exploitation, and supporting smart ways to slow down and stop climate change.

MedAccess is a UK-based social finance company with a mission to make global healthcare markets work for everyone. Its core purpose is to make medical supplies more widely available at lower prices in under-served markets. By applying the rigour and skills of business finance, it provides a novel solution to the challenge. MedAccess offers financial guarantees and debt products that reduce commercial risk and allow medical manufacturers to accelerate supplies into new markets at affordable and sustainable prices. In this way, vaccines, medicines, diagnostic tests and medical devices can reach patients far sooner than existing market forces would allow.

Unitaid is a global health organization engaged in finding innovative solutions to prevent, diagnose, and treat diseases more quickly, affordably, and effectively, in low- and middle-income countries. Its work includes funding initiatives to address major diseases such as HIV/AIDS, malaria, and tuberculosis, as well as HIV co-infections and co-morbidities such as cervical cancer and hepatitis C, and cross-cutting areas, such as fever management. Unitaid is now applying its expertise to address challenges in advancing new therapies and diagnostics for the COVID-19 pandemic, serving as a key member of the Access to COVID-19 Tools (ACT) Accelerator. Unitaid is hosted by the World Health Organization.

ViiV Healthcare

ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV. Shionogi joined as shareholders in October 2012. The company’s aims are to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.

For more information on the company, its management, portfolio, pipeline, and commitment, please visit www.viivhealthcare.com.

Media contacts:

Unitaid

Maggie Zander
Communications officer
M: +41 79 593 17 74
zanderm@unitaid.who.int

A new agreement will allow for generic production of first and only long-acting injectable HIV prevention in 90 countries where majority of new HIV infections occur

Geneva, Switzerland – 28 July 2022. A voluntary licensing agreement for patents relating to cabotegravir long-acting (LA), an injectable form of HIV prevention, or pre-exposure prophylaxis (PrEP), will help enable access to generic formulations of the product in least developed, low income, lower-middle income and sub-Saharan African countries[1].

PrEP is a highly effective method of HIV prevention, but until recently was only available in pill form, taken daily or, in some cases, before and after sex. Cabotegravir LA for PrEP is an important advancement as it can provide two months of continuous protection against HIV infection through a single intramuscular injection, therefore mitigating challenges related to pill burden.

Announced today by the Medicines Patent Pool (MPP), founded by Unitaid in 2010 to facilitate affordable access to quality-assured generic products, and ViiV Healthcare (ViiV), the agreement will give selected manufacturers the opportunity to develop, manufacture and supply generic versions of cabotegravir LA for PrEP in 90 countries where over 70% of all new HIV infections occurred in 2020. This announcement comes just seven months after the first regulatory approval of cabotegravir LA for PrEP in the world, and it is hoped that the agreement will contribute to enabling at-scale access to lower-cost generic supplies of the product in record time.

Each year, approximately 1.5 million people become infected with HIV worldwide, mostly among people living in low- and middle-income countries. Efforts to increase access to cabotegravir LA for PrEP will be especially impactful for groups that experience particularly high rates of infection, such as men who have sex with men, sex workers, transgender women, adolescent girls and young women.

In sub-Saharan Africa, the epicenter of the HIV epidemic, the HIV infection rate of adolescent girls aged 15-19 is six times that of their male peers.

While oral PrEP is now available in many countries, challenges with adherence and stigma have limited their impact in most populations. Access to an effective long-acting HIV prevention option could significantly contribute to the goal of ending HIV transmission and ending the epidemic by 2030.

The agreement responds to Unitaid’s March 2022 call for ViiV to develop a transparent access policy for cabotegravir LA and assure a generic pathway to broader access. This is a key milestone for a broader coalition, formally launched today, that builds on longstanding collaborative efforts to accelerate affordable and equitable access to long-acting PrEP in low- and middle-income countries. Co-convened by leading global health agencies Unitaid, the World Health Organization, the Global Fund and UNAIDS, the coalition brings together a wide range of partners and civil society actors to jointly identify and address access barriers for LA PrEP products, both from ViiV and generic manufacturers, as well as for future PrEP products in the pipeline.

To ensure this new option for PrEP can reach people in resource-limited settings as quickly as possible, Unitaid is simultaneously funding some of the first large-scale implementation of cabotegravir LA in South Africa and Brazil. The work, which began earlier this year, will answer remaining questions about optimal use and demand generation that will lay the groundwork for scaling up cabotegravir LA for PrEP in low- and middle-income countries around the world.

 

References:

[1] Country classifications as defined by the World Bank: https://data.worldbank.org/country

 

About Unitaid

Unitaid is a global health agency engaged in finding innovative solutions to prevent, diagnose, and treat diseases more quickly, cheaply, and effectively, in low- and middle-income countries. Its work includes funding initiatives to address major diseases such as HIV, malaria, and tuberculosis, as well as HIV co-infections and co-morbidities including advanced HIV disease, cervical cancer, and hepatitis C, and cross-cutting areas, such as fever management. Unitaid is now applying its expertise to address challenges in advancing new therapies and diagnostics for the COVID-19 pandemic, serving as a key member of the Access to COVID-19 Tools (ACT) Accelerator, co-leading with Wellcome the Therapeutics Pillar and participating in the Diagnostics Pillar. Unitaid is hosted by the World Health Organization. For more information, please visit www.unitaid.org

Media contacts:

Unitaid

Maggie Zander
Communications officer
M: +41 79 593 17 74
zanderm@unitaid.who.int

Landscape of innovative tools and delivery strategies for eliminating vertical transmission of HIV, syphilis, hepatitis B, and chagas in endemic areas