Many health technologies of significant public health importance are originally created in universities or public research organisations (PROs); many also receive funding from government funding agencies or charitable foundations. Such institutions often have a public interest mandate and a stated objective to promote the sharing of knowledge to improve the well-being of populations. Nevertheless, discussions with several such institutions have demonstrated that many have struggled to translate such objectives into concrete provisions in licensing and funding agreements.
Since 2020, MPP has worked with a number of universities to develop licensing language to ensure that entities developing health products based on technology licensed from them will develop an affordable access plan for low- and middle-income countries (LMICs). Similarly, MPP has collaborated with Unitaid and other funders to explore ways to ensure that health technologies receiving R&D funding from agencies or foundations become accessible in LMICs if and when they are successfully developed.
Affordable Access Plan Provisions
Including ‘affordable access plan provisions’ in licensing or funding agreements is one approach that universities, PROs and funding agencies may apply to support future access to technologies they develop or fund. If a technology were to be successfully developed into a health product, the licensees or awardees would be required to demonstrate in detail how they would achieve affordable access for the product(s) in LMICs.
In the case of the affordable access plan provisions developed by MPP together with university partners, the plan would only have to be submitted within a specified period after regulatory approval. This allows the licensee to focus energy on the critical R&D activities needed to advance a technology, and envisions collaboration as an important aspect of how this clause can facilitate successful outcomes.
The provisions seek to substantially improve universities’ licensing templates with regard to affordable access in LMICs. The provisions should be amenable to a variety of stakeholders but with early-stage, often preclinical technologies, overly prescriptive terms may be both impractical and off-putting to potential partners.
The provisions were first adopted by the University of California Los Angeles (UCLA) Technology Development Group and have now been adopted (in some cases with some adaptations) or supported by a number of other universities, including, for example, the University of California Berkeley IPIRA (the clause can be found in sections 4.9/8.1 of their exclusive licence template), the Innovative Genomics Institute, and Columbia Technology Ventures.
The Role of Implementing Partners
In addition to including affordable access provisions in agreements, technology transfer offices or funders can forge collaborations with potential implementing partners who may be able to assist with the implementation of access plans developed by licensees and awardees. MPP is partnering with funders and technology transfer offices to support this area of work. This is undertaken in different ways, including memoranda of understanding (MOU).
The MOU with the Global Health Innovation Technology Fund (GHIT) is one such example.
In 2020, the Medicines Patent Pool (MPP) was invited to collaborate with the UCLA Technology Development Group (UCLA TDG) to develop a workable clause that would meaningfully improve the university’s exclusive licensing template for early- stage medical technologies with regard to affordable access in low- and middle- income countries (LMICs), with the important proviso that the clause should be amenable to a variety of stakeholders.
With that in mind, MPP and UCLA developed an affordable access plan provision that:
- Requires licensees to
- submit a plan of how they will achieve affordable access for the licensed product(s) in low- and middle-income countries, with strategies and timelines.
- identify countries in which the licensee has no intention of
- Only requires the submission of the plan when it is reasonably certain that the licensed product will be commercialised – i.e., within a specified amount of time of having received regulatory approval, which allows the licensee to focus energy and resources on the critical research and development activities needed to advance a technology and only develop the plan if/when the product is ready for market launch.
- Allows the licensor to call upon a “designated entity” with relevant public health expertise to assist in conversations with the licensee regarding the access plan.
During the course of the discussions, MPP and UCLA vetted this language with various stakeholders, including venture capital firms, IP law firms, civil society groups and others, and UCLA has used this provision in its exclusive biopharma licences since then without issue.
In addition to UCLA TDG, University of California Berkeley Intellectual Property & Industry Research Alliances (IPIRA), Columbia Technology Ventures, the Innovative Genomics Institute (IGI), and others have begun incorporating a version of this provision into their exclusive licences.
Bill and Melinda Gates Foundation – Global Access1
CARB-X – Stewardship and Access Plan (funded by BARDA, Wellcome Trust, Gates, etc.)
In many disease fields and across many types of health technologies, companies will only focus commercialisation strategies on a small subset of high-income countries (HICs) where returns are typically the greatest, and often do not consider access issues in LMICs until several years after receiving regulatory approval, if at all. At times, this may result in key health technologies, originally discovered by universities or public research organisations, not being available or affordable to people needing them in many LMICs. This provision focuses attention on the access issue at an earlier stage while affording licensees a significant degree of flexibility in choosing the appropriate strategy.
Many universities, public research organisations, and funders have a public interest mandate or have otherwise indicated in mission statements that they maintain a commitment to equitable access but have struggled to find concrete ways to implement these commitments. The provision potentially advances global health equity in a pro-active manner that may complement other contractual provisions in use, and does so with a flexible, collaborative approach that is conducive to innovation while aligning with access-oriented missions and/or mandates.
The provision does not specify the modality of how access should be addressed, inherently recognizing that different contexts may require different solutions. There may be some technologies for which licensing to manufacturers based in LMICs may be very appropriate, but in other cases there may be other suitable approaches. The nonprescriptive nature affords industry partners control over the activities anticipated to achieve access and allows them to identify options that make sense for their company, and which may in fact yield opportunity for market expansion rather than financial loss. This could be through licensing but may also be through other types of partnerships with organisations that exist to improve affordable access in LMICs.
MPP is very willing to assist universities and its partners in evaluating and discussing submitted access plans when they relate to technologies/areas in which MPP has expertise.
There are a variety of global health non-governmental organisations operating with express mandates to advance access in LMICs through partnership and/or other models of working such as FIND (diagnostics), the Global Antibiotic Research & Development Partnership (antibiotics), PATH (medical devices, in-country technical assistance), the Clinton Health Access Initiative (market shaping), and TB Alliance (tuberculosis) just to name a few. Many routinely collaborate with industry to facilitate equitable access in LMICs.
MPP would be willing to facilitate introductions to these or others that may find this approach of interest.
Universities Allied for Essential Medicines played an instrumental role in facilitating the negotiation of this language with UCLA and continues to be vocal in support of universities and other institutions that want to adopt similar provisions.
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