177 prominent organizations leading the fight against HIV from around the world sent a letter to Merck’s Chairman and Chief Executive Officer, Robert M. Davis, demanding his commitment to a global access strategy for MK-8527 covering price, overcoming patent barriers, product registration and more for all LMICs. MK-8527 is a promising long-acting HIV prevention pill, taken monthly as pre-exposure prophylaxis (PrEP), that is in late stage clinical development.
The letter, available here, calls for transparent and fair pricing, at or below $40 per year for MK-8527 for all low- and middle-income countries (LMICs), comparable with generic daily oral PrEP. Endorsers also demand that “Merck should commit to non-exclusive voluntary licensing agreements, such as with the Medicines Patent Pool (MPP), now, before regulatory approval, to ensure generic production of the active pharmaceutical ingredients and the finished product can begin as soon as possible….Critically, these licensing agreements must include all countries classified as low- and middle-income counries—not just low-income countries and high-incidence nations, or a subset of middle-income countries, but upper-middle-income countries as well.”
More than 1.3 million people contract HIV every year; experts predict new HIV infections will surge because of the Trump Administration’s decimation of many HIV prevention programs in 2025, including US government programs funding daily oral PrEP. Activists warn that, if MK-8527 proves effective, excluding some LMICs from an access strategy will unnecessarily prolong the pandemic.
We will not accept an access strategy from Merck that again excludes us, even while we are participating in Merck’s clinical trials. We refuse to be told we must settle for sub-standard HIV prevention options, while our communities are made even more vulnerable amidst HIV funding cuts and increasing bigotry targeting key populations. Social responsibility means Merck must comply with the policies, principles and capacities of our public health system.
said Veriano Terto, Vice President of the Brazilian Interdisciplinary AIDS Association (ABIA).
Merck must learn from its mistakes–it has an undistinguished access history, in particular regarding licensing HIV antiretrovirals. For example, Merck has made no effort to license its two-drug treatment combination, doravirine/islatravir despite having submitted it for approval to the U.S. FDA. Merck has bilaterally licensed doravirine to only two generic companies that are permitted to supply only 86 sub-Saharan African and lower-income countries—a fraction of those in need. There is no excuse for Merck not to immediately grant open licenses for MK-8527 covering all low- and middle-income countries, such as via the MPP, to allow generic access and to accelerate the end of AIDS.
said Professor Brook Baker of Health GAP.
For more information, read the original press release.
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