Rahway, New Jersey – – Merck & Co. Is facing mounting pressure from global health organizations to commit to a comprehensive access strategy for its promising long-acting HIV prevention pill, MK-2587. A letter signed by 177 organizations was sent today to Robert M. Davis, Chairman and Chief Executive Officer of Merck, outlining demands for equitable pricing, voluntary licensing, and streamlined product registration across all low- and middle-income countries (LMICs).
MK-2587, currently in late-stage clinical development, offers the potential for monthly pre-exposure prophylaxis (PrEP), representing a significant advancement in HIV prevention. However, activists and health advocates fear that limited access could undermine the pill’s impact, particularly in regions already grappling with funding cuts and systemic vulnerabilities.
The letter explicitly calls for pricing of MK-2587 at or below $40 per year for all LMICs, aligning with the cost of generic daily oral PrEP. It also urges Merck to adopt non-exclusive voluntary licensing agreements, potentially through the Medicines Patent Pool (MPP), to facilitate generic production of both the active pharmaceutical ingredient and the finished product. Critically, the organizations are demanding that this access strategy encompass all LMICs, including upper-middle-income countries, rather than restricting access to only the poorest nations or those with the highest HIV incidence rates.
The demand comes at a critical juncture. Experts predict a potential surge in new HIV infections in due to the rollback of HIV prevention programs initiated by the previous U.S. Administration. These cuts, impacting programs funding daily oral PrEP, heighten concerns that limited access to newer, more effective prevention methods like MK-2587 could exacerbate 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,” stated Veriano Terto, Vice President of the Brazilian Interdisciplinary AIDS Association (ABIA). “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.”
The call for equitable access is rooted in concerns about Merck’s past licensing practices. Professor Brook Baker of Health GAP highlighted what he described as an “undistinguished access history,” specifically referencing the company’s limited licensing of its two-drug treatment combination, doravirine/islatravir. According to Baker, Merck has only bilaterally licensed doravirine to two generic companies, restricting supply to 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-2587 covering all low- and middle-income countries, such as via the MPP, to allow generic access and to accelerate the end of AIDS,” Baker asserted.
Robert M. Davis assumed the role of Chairman of the Board on , having previously served as President and Chief Executive Officer since . He joined the company in as Chief Financial Officer, later expanding his responsibilities to include Global Services. Prior to joining Merck, Davis held leadership positions at Baxter and Eli Lilly, and Company.
Merck’s response to the demands remains to be seen. The company, known as MSD outside of the United States and Canada, has not yet publicly addressed the letter. However, the coordinated pressure from a broad coalition of global health organizations signals a determined effort to ensure that the benefits of this potentially groundbreaking HIV prevention tool are available to all who need it, regardless of their economic status or geographic location.
The situation underscores the ongoing debate surrounding access to essential medicines in LMICs, a challenge that extends beyond HIV prevention. The outcome of this case could set a precedent for future pharmaceutical innovations and influence the strategies employed by other companies seeking to address global health crises.
The organizations behind the letter emphasize that equitable access is not merely a matter of corporate social responsibility, but a fundamental requirement for achieving the global goal of ending the AIDS epidemic by .
