In 2024, people living with HIV have more, and more varied, access to HIV prevention and treatment options than ever before. Thanks to global activism efforts forcing pharma to step up, and the establishment of some vital institutional structures in the first decade of the millennium, access is up, while incidence and deaths are down. However, the job is not yet complete, with several access gaps still existing – especially in poorer countries and in marginalised communities.
PEPFAR & the Global Fund: Massive Impact
The early 2000s marked a turning point in access to HIV treatment and prevention. With many patients in low- and middle-income countries (LMICs) priced out of HIV medications and therefore left to die, the US moved to establish PEPFAR (President’s Emergency Plan for AIDS Relief) in 2003, one of the largest commitments by any nation to combat a single disease. PEPFAR has provided billions of dollars in funding for HIV/AIDS treatment, prevention, and care services globally and been crucial in providing antiretroviral therapy to millions of people, reducing the number of new infections, and supporting health infrastructure in many countries.
Its establishment came just one year after the creation of The Global Fund to Fight AIDS, Tuberculosis, and Malaria. This is an international financing organisation which invests more than USD four billion annually to support programs run by local experts in countries and communities most in need. It has played a key role in scaling up antiretroviral therapy, reducing the cost of HIV medications, and funding prevention and education programs.
The impact of these two initiatives on access to lifesaving HIV medication and lower incidence has been seismic. The number of people on antiretroviral therapy increased significantly from 0.8 million in 2001 to 27.5 million in 2020, new HIV infections decreased from 3.1 million to 1.5 million in the same time period, and HIV-related deaths dropped from 2.0 million to 0.6 million, all as per UNAIDS data.
As PEPFAR’s Deputy US Global AIDS Coordinator for Program Quality Dr Emily Kainne Dokubo explains, her organisation has acted as a guarantor that allows companies to bring their products to patients in markets that would otherwise go without. “In many of the places where we work, governments have limited ability to provide treatment to their populations on their own,” begins Dr Dokubo. “Therefore, PEPFAR, by purchasing HIV-related commodities, brings in the volume and guarantees our pharmaceutical partners that we will procure to supply to those countries.”
She continues, “For example, PEPFAR is rolling out the limited available doses of long-acting PrEP, and we plan to deliver doses to more countries soon. This means that PEPFAR is helping to support the R&D of innovative therapeutics through our rapid scale-up of long-acting prevention tools, along with some of our other innovative strategies. This has the potential to accelerate the downward trajectory of new HIV infections globally.”
Voluntary Licensing: A Revolution in Access
Another major milestone in the fight for access to HIV drugs came in 2010, when the World Health Organisation’s Unitaid group moved to set up the Medicines Patent Pool (MPP), a public health innovation that asks Big Pharmas with new, patented (and expensive) HIV drugs for a license to those drugs. It then sublicenses them to generic manufacturers who are able to produce affordable versions for a wider population (see below chart)
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The MPP model acknowledges that many originator companies cannot make the economic case for selling their (high-priced) medicines at an affordable level in LMICs. These companies would therefore not be present in these countries at all were it not for this mechanism. It not only provides an opportunity for local generics manufacturers that have lower overheads with a market opportunity, but also medicine access to patients that would otherwise go without.
However, convincing the innovative pharmaceutical industry to voluntarily part with its intellectual property – traditionally its jealously guarded lifeblood – was no easy task. “For the first couple of years, it was difficult to persuade companies to participate,” admits the MPP’s executive director, Charles Gore. “It was a new idea and we had to communicate that it was not about pharma giving away IP. Instead, it is about reaching people they otherwise would not with a version of their product that has the same quality but is made much more cheaply by generic manufacturers that do not have the overhead costs of developing the drug.”
He adds, “Furthermore, the products are for markets that do not compete with the originator’s primary commercial market. Overall, there are good reasons why the program makes sense for the industry, but it has required us to educate pharma as to the advantages.”
This process of voluntary licensing has had a massive impact on access to HIV medication for those living in the world’s poorest countries. As Jayasree Iyer of the Access to Medicine Foundation, an organisation which tracks Big Pharma’s access efforts in LMICs explains, “voluntary licensing via the MPP has proven highly effective in bridging global access gaps, and most – but not all – of the HIV products on the market are being made available through this mechanism.”
She adds, “The MPP has been pivotal in facilitating negotiations between original patent holders and generic manufacturers to expand access to several new treatments. This model has increased the number of countries that can access medications under more favourable terms than bilateral agreements typically allow. The non-exclusive nature of these agreements, combined with the ability to procure necessary active ingredients, addresses several logistical barriers. Essentially, the MPP’s approach serves the public interest by ensuring that essential medicines reach those who need them most.”
Today, all the leading HIV treatment and prevention innovators (AbbVie, Boehringer Ingelheim, BMS, Gilead, J&J, MSD, and ViiV) have struck voluntary licensing deals with the MPP (see below chart).
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A Game-Changing Impact
Looking back, Bettina Bauer of Gilead – the leading company in the HIV treatment and prevention field – is proud of the impact that voluntary licensing of Gilead products has had. “In 2011, Gilead became the first pharmaceutical company to join the MPP. By 2021, HIV medicines were being made available to an estimated 16.5 million people living with HIV (PLHIV) in resource-limited countries around the world through organisations that benefited from licensing agreements with Gilead,” says Bauer, formerly the company’s VP for global commercial product strategy in HIV, COVID-19 and emerging viruses and currently overseeing its US HIV treatment and prevention operations.
Bauer continues, “As these are now generic products, we give licenses to several competing manufacturers … if there are five generic companies producing the same drug, that gives authorities a lot of power to push the prices down. A course of our HIV treatment costs roughly USD 10,000 a year per person in high income markets, but when the licensed version was first launched it was USD 75 a year, and competitive pressure has now reduced that to around USD 50 a year.” Indeed, 2023 MPP data puts the average price drop of all MPP-enabled HIV products at 83.4 percent. This astounding reduction can, however, still represent a sizeable outlay for PLHIV in Sub-Saharan African countries like Uganda and Rwanda where per-capita GDP is less than USD 1,000 per year.
The MPP model has also led to some perhaps unexpected innovations. “Our licenses allowed us to develop a product using a mixture of three drugs,” explains Bauer. “This is now the WHO’s first line recommended treatment. There are similar treatments available, but what we have put together is not available in many higher income markets because it comes from a regimen of drugs across different manufacturers. With the licenses granted to generic companies through the MPP, they have been able to do the science and come up with a series of combined drugs into new fixed doses. That really shows what we can do given the right circumstances.”
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Only One Piece of the Puzzle
However, viewing voluntary licensing as a panacea would be misguided. As Bauer opines, “voluntary licencing is often only one piece of the access puzzle.” She adds that “Gilead is involved in dialogue with governments; we work with communities, and we work with other stakeholders to make sure we expand access and strengthen healthcare systems to equip them to address the need.”
Bruce Richman, founder and executive director of the Prevention Access Campaign, also advocates for a more holistic approach. “Generics need to be made cheaper and more accessible through initiatives like the MPP, but investing in local production facilities in the regions most affected by HIV can also reduce dependency on international supply chains and lower transportation costs.”
He continues, “This not only ensures a more reliable supply of medications but also boosts local economies. Public-private partnerships can drive innovation and resource-sharing to fund research, reduce costs, and streamline the distribution of treatments. It is also vital to strengthen healthcare systems to ensure treatment delivery is effective and PLHIV are supported to reach and maintain an undetectable viral load. This includes training healthcare workers, improving clinic accessibility, and ensuring consistent supply chains.”
Next Steps
While PEPFAR, the Global Fund, and the MPP have clearly had an incredible, life-saving impact, and the access picture in LMICs is much rosier than it was 20 years ago, there is clearly still much more that can be achieved, whether in HIV or elsewhere. PEPFAR’s long-term funding is under threat in the US while some key preventative treatments, such as ViiV Healthcare’s long-acting Cabotegravir are still missing from voluntary licensing schemes. Moreover, in May 2024 300 former world leaders, celebrities and scientists signed a letter urging Gilead to make its “gamechanger” twice-yearly injection Lenacapavir available in LMICs. Whether these industry sponsors step up to the plate once again remains to be seen.
