MPP releases analysis on the vital role of licensing in increasing access to medical countermeasures, with a focus on low- and middle-income countries

October 10, 2023

Pooled voluntary licensing may be key to revolutionizing access to essential medicines, which remain inaccessible in many parts of the world.[1] The Medicines Patent Pool (MPP) stands out in its goal to provide tangible health solutions by collaborating with patent holders, ensuring that life-saving treatments can reach the masses. In a recent journal article, MPP outlines its innovative and transparent approach to IP licensing. This may not only be game-changing, but also lifesaving for millions without access to essential medicines.

Voluntary licensing serves as one of several options for expanding access to crucial health technologies and medications in low- and middle-income countries (LMICs). This is particularly pertinent in the face of pandemics and non-communicable diseases (NCDs) and may even leverage emerging biotherapeutic treatments and long-acting technologies. Despite the evident achievements of voluntary licensing arrangements in public health, there remains a persistent call for refining licensing paradigms, and broadening their [geographical] application to jurisdictions that are often left out of the MPP licensing scope.[2]

MPP plays a significant role in this landscape, negotiating licenses with patent holders and subsequently sublicensing these to multiple manufacturers in LMICs. Since its inception in 2010, MPP has signed 34 licenses for a variety of health technologies, facilitating access to 30 billion doses of treatment. MPP in a recent peer-reviewed article seeks to foster an understanding of the merits of its model in disseminating health technologies and to enrich ongoing dialogues concerning international frameworks aimed at augmenting access to these vital resources.

The peer reviewed article

The recent publication, released on September 5, 2023, titled “Negotiating public-health intellectual property licensing agreements to increase access to health technologies: an insider’s story”, featured in British Medical Journal Global Health, provides a deep dive into the workings of the MPP’s operational framework. It encompasses the challenges, intricacies of negotiations, and the necessary compromises. The analysis outlines the case for public-health voluntary licensing, in particular as implemented by MPP. The publication also explores the way that MPP works, elucidating the benefits it can bring to improving public health and highlighting how this model remains an underutilized tool with immense potential to enhance access to essential medicines.

The MPP model

Recent publications, including the WHO-WIPO-WTO Trilateral Study and the information note “Integrated health, trade and IP approach to respond to the COVID-19 pandemic”,  highlight the large-scale impact of the MPP model on public health.

Established in 2010 by Unitaid, the MPP collaborates with patent-holding pharmaceutical companies to grant licenses for their medicines’ IP to multiple generic manufacturers. This strategy fosters competition in producing affordable, quality-assured versions of these medicines for LMICs, while the patent-holding companies continue selling their branded products in commercial markets. MPP has boosted the distribution of WHO-recommended HIV and hepatitis-C medicines. Building upon this success, it has expanded its mandate to cover medicines for tuberculosis, and later, to COVID-19 health technologies, long-acting technologies, biotherapeutics, and drug formulations. MPP’s licenses are considered a good practice for public health licensing. However, MPP notes that there is still a vast, untapped potential in public-health licensing.

Selection of medicine for a public-health voluntary licensing

To make the case for seeking an MPP-style license for a health technology, a detailed assessment of the public health need for the medicine in question has to be carried out. This includes analyzing clinical data and regulatory pathways as well as the needs of affected communities,  

MPP typically also holds conversations with clinical experts, governments, and relevant United Nations agencies and affected community groups. This process may take up to a year and considers elements like disease burden, unmet need/demand for available treatments, equity concerns, both favorable and unfavorable public opinions, geographic scope, and license management, which MPP undertakes pro bono. Additionally, it also weighs cost-effectiveness and investor preferences, such as intersections with environmental, social and governance (ESG) frameworks.

Negotiating MPP licenses

The most critical part of developing a licensing agreement involves the negotiation of terms and conditions between the parties. This can take up to several months. Occasionally, the parties fail to reach an agreement. MPP relies on external levers such as treatment advocates, governments, investors, and public opinion to influence patent holders’ decisions. Furthermore, an external validation process of proposed licensing agreements is carried out to ensure that the needs of patent holders, generic companies, and other stakeholders are balanced to create triple-win solutions.

Motivations for patent holders to consider an MPP-style license

Companies holding patents may have little presence or experience in LMICs. Expanding their commercial activities to regions where they have less experience or knowledge of the ecosystem of potential partners may appear unwarranted given low anticipated returns, especially considering the substantial costs involved in registering and distributing a product in a new country. MPP’s specialized experience, which it contributes pro bono, alleviates human and financial burdens needed for license management. MPP licenses can also at times lead to significant returns to the originator from royalties.

The desire to bolster their reputation as enablers of access to medicines also drives companies’ engagement in MPP-style voluntary licensing. The Access To Medicine Index (ATMI), for example, provides a formal tool to assess some of the largest pharmaceutical companies according to the quality of their LMIC access programs. As investors in originator companies become increasingly engaged with ESG issues, a tangible benefit can be reaped from implementing a strong access program such as an MPP-style LMIC licensing program, which would be reflected on the ATMI. Voluntary licensing to generic manufacturers can also help overcome the challenge of external reference pricing, or the practice of setting maximum prescription drug prices in one country based on the price in others, that pharmaceutical companies face for their commercial markets in higher-income countries when exploring discounted pricing options for LMICs.

Key features of MPP licenses

The essential parts of MPP licenses include: the territory where the generic product can be manufactured and/or sold; what the licensees can do (for example, which active ingredient or formulations they can manufacture and sell); what the product can be used for; quality requirements; compliance monitoring and sublicensee management aspects, including sales reporting; royalties, if applicable; technology transfer, when required; and compatibility and complementarity with other access mechanisms.

The MPP aims to address issues related to voluntary licensing for medicine access in LMICs by balancing the interests of both originator companies (not just for the product under discussion but for their overall portfolio) and public health. Its licenses cover a wide geographic area while also being financially attractive for generic companies, ensuring a sustainable market with economies of scale to drive prices down. This balance considers the commercial goals of originators. MPP's commitment to transparency, reflected by putting the licenses into the public domain, aims to create precedents and standards. MPP’s licenses are generally more access-friendly and have fewer restrictions compared to bilateral agreements between patent holders and generic manufacturers without MPP's involvement as a mediator.[3]

The MPP model of public-health voluntary licensing of IP has demonstrated significant successes in increasing access to essential medicines in LMICs. While the model is not without challenges, its impact suggests that it should be further promoted and incentivized, especially in the context of pandemic preparedness and response. Understanding the complexities of this model can help in refining its applications and addressing ongoing access inequities in global healthcare.

WIPO’s Global Health work

Linkages between global health and innovation, as well as intersecting disciplines like licensing and technology transfer can be very complex. The Global Health Unit at WIPO seeks to raise awareness around how scientific and technological innovation contribute to advances in public health, including through collaborations with key stakeholders such as MPP. It also seeks to leverage IP as a tool that contributes to meeting the world’s most pressing health needs.