How The Next NIH Director Can Ensure Global Equitable Access To Medical Technologies – healthaffairs.org
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When Francis Collins, MD, PhD, recently stepped down as director of the National Institutes of Health (NIH), it marked the end of two contemporaneous eras. The first was a time of indisputable success leading the world’s most important and single largest public funder of biomedical research. The second was a laissez-faire period of turning a blind eye to worsening inequities in global access to publicly funded medical technologies despite persistent need.
The Biden administration stands at an important crossroads where the choice of the next director—whether Acting Director Lawrence Tabak or someone else—may determine whether the NIH moves in a new direction. The decision should be mindful that government-funded scientific developments do not exacerbate global disparities via failures to address equity and access, and attentive to the practical ways to implement meaningful changes to NIH funding agreements and licenses without stifling innovation. There is a process question and a technical question at stake for the administration. First, should the NIH convene varying stakeholders to find consensus around workable approaches to proactively address these issues? And, relatedly, can the NIH attach contractual language to its grants and licenses for taxpayer-funded inventions allowing for significant grantee/licensee autonomy while still creating an affirmative obligation for equitable access?
The answer to both questions is yes. Innovation and equitable access are not a zero-sum game, the NIH’s attention or disregard of these issues has global repercussions, and the NIH is past due for an update in its approach.
Access to affordable medicines remains a major concern for patients, government health budgets, and public health organizations. Most low- and middle-income country (LMIC) health budgets are so constricted as to be unable to afford many important new medicines, leaving health a privilege for only the wealthiest people rather than a right of all.
Discussion surrounding access to medicines often focuses on proffered downstream solutions such as compulsory licenses or march-in rights. Most countries have laws providing for the compulsory license of patents including the United States, which routinely relies on compulsory licenses in the defense and aerospace fields. Moderna even recently cited US compulsory licensing law as a defense to patent infringement claims. Nevertheless, conversation over use of such laws for medical technologies quickly devolves into a complicated and polarizing fight over the role that intellectual property plays in spurring innovation, with advocates and academics frequently pointing to the public health imperatives of affordable access, and investors/industry pointing to strong intellectual property protection as critical for continued investment in research and development.
However necessary these downstream remedies are as options for any government to retain, they are by nature limited in scope, often addressing high prices or anticompetitive behavior relating to a single drug, or for a particular disease area. In their very existence, compulsory licenses highlight the failure of governments to attach clear conditions for equitable access in their research institutions’ funding agreements and licenses.
The NIH has tremendous financial leverage to play a leading role in implementing such conditions; the agency annually spends $41.7 billion dollars of public money on medical research, with such funding supporting all drugs approved by the Food and Drug Administration (FDA), often including their late-stage development. But the NIH has thus far avoided using this leverage to push the entire biomedical research ecosystem toward ensuring equitable global access to research benefits.
The COVID-19 pandemic is a prime exhibit of how not to address global equitable access of essential health technologies. One bright spot amidst a bleak pandemic has been the astonishingly fast development of groundbreaking mRNA vaccines, thanks in large part to significant investment from the NIH. The Moderna vaccine, for example, was developed with $2.5 billion in public money, and its pivotal trial supporting authorization and approval was conducted together with the NIH’s National Institute of Allergy and Infectious Diseases with further funding support from the Biomedical Advanced Research and Development Authority. But in spite of the NIH’s significant role in the development of these vaccines, the government has largely avoided any meaningful conditions affirmatively requiring equitable global access. They have even gone so far as to use contracts relying on “Other Transactional Authority” to sidestep the few conditions that would otherwise properly exist under the Bayh-Dole Act, including march-in rights and royalty-free rights clauses that permit the government to further license federally funded health technology to third parties. Instead of attaching conditions for equitable access, the US has relied on limited or largely failed mechanisms to allocate vaccines across LMICs, including COVAX, and costly bilateral agreements for doses that have led to tradeoffs and diverted funds for critical on-the-ground distribution efforts.
This has been the latest chapter in a distressingly recurrent story in which public funds help spur critical medical innovations without attaching serious conditions regarding global access, to predictable ends. For instance, although the NIH funded the pivotal clinical trials for lenalidomide, a cancer drug that proved its efficacy in treating multiple myeloma, the drug remains unavailable or unaffordable in various LMICs.
The NIH recently signaled awareness that it should be addressing equitable access further upstream. In May 2022, the NIH licensed 11 COVID-19 medical technologies to the World Health Organization (WHO) COVID-19 Technology Access Pool (C-TAP) via the Medicines Patent Pool (MPP). These included research tools for drug and vaccine development, vaccine candidates, spike proteins, and other technologies, all requiring further development, and representing the first NIH licenses to MPP since the inaugural license for the patents to the HIV medication darunavir in 2010. Whether or not these newly licensed technologies ever come to fruition, the NIH tacitly admitted that it can be doing more to address global equitable access. Recently, the NIH followed up on this news by announcing that the US National Institute of Allergy and Infectious Diseases would share materials and know-how for mRNA vaccine development with Afrigen as part of the WHO/MPP mRNA hub.
These actions should mark the beginning of a new approach to equitable access by the NIH. The licenses and technical support are for only a handful of technologies in one disease area and are the result of political decisions that may just as easily not have happened at all. More needs to be done to move away from a product-by-product, disease-by-disease approach.
The NIH can begin to focus on equitable global access by increasing transparent public dialogue with disparate stakeholders. Engaging with leaders from civil society, industry, academia, patient groups, and foundations to articulate problems and agree upon workable contractual solutions would signal a newfound responsiveness and recognition that answers require thoughtful collaboration. At minimum, a diversity of perspectives would demonstrate that the NIH wants to move past an era in which a close relationship with industry and lobbyists has opened the government up to criticism. This convening could precipitate the formation of a more formal and permanent advisory committee on global access issues relevant to NIH technologies as a manifestation of the NIH’s commitment.
With funding support from the NIH and the Department of Defense, researchers at the University of California, Los Angeles (UCLA) developed a prostate cancer drug later licensed by the university to a company acquired by Pfizer and eventually marketed by Astellas Pharma as Xtandi. The absence of access conditions tethered to the drug’s public funding allowed a convoluted scenario to play out in which the university, contractually obligated by the licensed manufacturers to litigate the drug’s patents, effectively blocked production of an affordable generic alternative in India by successfully appealing a lower court’s rejection of the patent. The move prompted outcry at UCLA and elsewhere by student members of the global nonprofit Universities Allied for Essential Medicines (UAEM) and other advocates. In a display of commitment to its public service mission and seeking to further promote global access in its licensing, UCLA’s Technology Development Group (TDG) responded by collaborating with the UAEM and MPP to develop a binding contractual obligation for equitable access in LMICs while maintaining a non-prescriptive approach to avoid putting off prospective licensees or investors. The language, referred to as the Affordable Access Plan (AAP) has been used by UCLA TDG in its exclusive biotech/pharmaceutical licenses since July 2020 with what the university has described as “minimal pushback from its licensees” and “encouraging feedback from … industry representatives and attorneys who regularly represent UCLA licensees.” As UCLA TDG wrote, “encouraging discussions early in a licensee’s marketing and commercialization planning provides the greatest likelihood that licensees will take meaningful steps to address affordability.”
The AAP requires licensees to create a plan within a set time from an agreed upon marker (for example, FDA approval, successful completion of a Phase III trial, and so forth) that includes a list of LMICs in which they do not intend to commercialize and time-bound strategies for how to address affordable access in LMICs, including the non-commercialized countries. Moreover, the AAP applies to the licensed product rather than to an individual patent that may be only one of many needed for a particular health technology. Licensees are also encouraged to invite a third party with public health expertise to participate in discussions to develop and implement the AAP. Finally, the licensee must also regularly report on progress in implementing the AAP.
The AAP’s non-prescriptive wording recognizes that industry executives and investors often reflexively recoil from mandates, and some, for example, seem to have difficulty understanding the difference between voluntary licensing and compulsory licensing. This is obviously not true for every company; many have licensed important medical technologies to MPP, often with royalties, and some, such as Gilead’s HIV Global Access Program, have done so with the explicit intention of maintaining a self-sustaining business model.
The AAP concretely requires a plan, while leaving the contours to be devised by the licensee, and that flexibility implicitly recognizes that not all medical technologies are alike. While voluntary licensing may work well in some cases, different types of partnerships may be more pragmatic in others. Where voluntary licensing may efficiently address affordable access in LMICs, the AAP leaves the terms and conditions to the licensee to work out while maintaining some oversight over the nature of the plan and its implementation. Other prominent research institutions and key funding entities have adopted similar flexible approaches to global equitable access, such as the Bill and Melinda Gates Foundation’s Global Access requirements.
Moreover, the AAP could easily be expanded upon to include similar requirements for underserved populations in the United States.
Nevertheless, as it will be years before a licensed technology would be at the stage of development in which the AAP’s provisions would be triggered, it is difficult to predict how compliance will play out. The AAP could thus benefit from a complementary provision explicitly affording the licensor the right to issue additional non-exclusive licenses as needed in furtherance of equitable access, such as, the way that the Gates Foundation or University of California, Berkeley’s licenses may contain a “humanitarian reservation of rights” to license intellectual property to third parties for humanitarian purposes. The NIH already typically retains rights to further license under the Bayh-Dole Act, but additional language specifically on a reservation of rights connected to the purposes of the AAP would help avoid unnecessary spats over the intentions of the Bayh-Dole Act.
The AAP additionally requires that the licensee create a non-confidential version of the plan that could be shared with third parties. The NIH could create a regularly updated portal to compile plans and progress reports in a way that may help companies to understand best practices while fostering accountability. The NIH already has several portals designed to increase transparency and accountability, and allowing the public to understand whether and how equitable access is being furthered on specific products would ensure public oversight while encouraging the sharing and adoption of best practices.
It will take various pilot approaches building on these baseline recommendations to realize the NIH’s potential in ensuring equitable access to medical technologies. Ultimately, the NIH will only continue to duck the challenges of and responsibility to global equitable access if the Biden administration is willing to allow maintenance of the status quo. By appointing an NIH director who will commit to changing course and to formulating new ideas, the administration can make global equitable access no longer an afterthought, but instead an inseparable aspect of the biomedical innovation ecosystem.
Author Andrew S. Goldman is an employee of Roivant, parent company to Genevant, a plaintiff in the case mentioned above on patent infringement laws. Reshma Ramachandran is board president of Universities Aligned for Essential Medicines (UAEM) North America.
DOI: 10.1377/forefront.20220823.180659