Request for Proposal
– Expanding MPP’s Impact Framework to include Technology Transfer

Summary

The Medicines Patent Pool (MPP) is expanding its impact assessment framework to reflect its growing role in facilitating the transfer of technology to manufacturers in low- and middle-income countries (LMICs).

To-date, MPP’s impact methodology, launched in 2021, has focused on voluntary licensing. Central to this methodology[1] are:

1. a chain of effects or ‘theory of change’ that links licensing to health and economic outcomes, including patient-years treated, deaths averted and costs-saved, and
2. the modelling of factual and counterfactual scenarios, i.e. with and without an MPP licence, where the difference between the scenarios represents the change (i.e. impact) that is estimated to have occurred (or is projected to occur) as a result of concluding a voluntary licence agreement through MPP.

The methodology is robust and highly regarded[2], and will remain a key and central part of MPP’s impact framework in the future. However, in parallel with the development of its upcoming 2026-2030 strategy, MPP is now keen to expand its impact assessment framework to include additional impact pathways and measures that reflect the results of MPP’s technology transfer activities and are complementary to but not currently captured in its licensing impact models, such as local/regional production, supply security and pandemic preparedness.

As such, MPP is seeking to engage a consultant to develop two case studies that will illustrate and quantify the impact of MPP’s technology transfer activities. Based on the learning gathered through these case studies, the consultant will also be mandated to propose a new theory of change pathway and related impact metrics and modelling tool that can be used more systematically by MPP to demonstrate the contribution of its technology transfer activities to the achievement of its vision: “A world in which people in need in LMICs have rapid access to effective and affordable medical treatments and health technologies”.

About the Medicines Patent Pool

The Medicines Patent Pool (MPP)[3] is a United Nations-backed public health organisation working to increase access to, and facilitate the development of, life-saving medicines in LMICs through voluntary licensing and technology transfer.

Voluntary licensing is fundamental to MPP’s mission and vision. As such, MPP has been working since 2010 to prioritise and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations. To date, MPP has signed agreements with 22 patent holders for 13 HIV antiretrovirals, one HIV technology platform, three hepatitis C direct-acting antivirals, a tuberculosis treatment, a cancer treatment, four long-acting technologies, a post-partum haemorrhage medicine, three oral antiviral treatments for COVID-19 and 16 COVID-19 technologies.

Some of these licences, in addition to providing freedom to operate on intellectual property (IP) rights, have also included a technical know-how package that was made available by the innovator(s) and supplied to the licensees. On some occasions, MPP, through its own staff or aided by external consultants, provided technical and regulatory support to licensees to accelerate the development of the licensed product or address specific technical or regulatory challenges, including support for product development, bioequivalence, regulatory filings, answering deficiencies during regulatory review and in-country filings.

In 2021, as MPP expanded its mission and began to work on mRNA vaccine manufacturing technology (as part of the mRNA Technology Transfer Programme, or “mRNA Programme”[4]), other biologics[5], and more complex formulations of long-acting medicines[6], MPP’s technology transfer role was reinforced with the establishment of a dedicated technology transfer team at MPP, with the objective to broaden the range of technology transfer services and expertise offered.

In addition, in the context of MPP’s licences on COVID-19 antivirals, MPP began to expand the range of manufacturing partners it works with, broadening its criteria for the selection of licensees so as to incorporate in its network manufacturers that have a more regional/local geographical footprint. In some such circumstances, additional technical support has sometimes been required, particularly when engaging with companies that have never sought WHO Prequalification or approval from a Stringent Regulatory Authority before.

In sum, to support the regional manufacturing of key health technologies, and to facilitate access to more complex technologies (long-acting, biologics, mRNA), technology transfer is now a key pillar of MPP’s strategy and mission[7] alongside voluntary licensing, and it is expected to continue to be a key growth area for MPP going forward.

MPP’s Approach to Technology Transfer

Technology Transfer is the process of sharing knowledge, skills, scientific and technological developments between two or more parties. Despite appearing straightforward, the technology transfer process includes several steps that can encompass a significant level of complexity and whose effectiveness and success hinges on many factors (see figure 1).

Figure 1: MPP’s approach to technology transfer and key factors influencing the level of complexity.

MPP’s role in terms of technology transfer depends on various factors, including the nature of the product (e.g. small molecules vs more complex products such as biologics, mRNA, long-acting products) and the technical maturity of the manufacturing partner/licensee.

To date, a flagship technology transfer project for MPP is the mRNA Programme that MPP co-convenes with WHO. Notably, the focus of MPP’s implementation role in this Programme has been on providing technical support, project management, coordination, and oversight across multiple phases in the project. These stages encompass product development aspects such as the processes and analytics of drug substance/active pharmaceutical ingredient (API) and drug product/formulation, quality and regulatory matters, and pre-clinical and clinical studies. For technology transfer activities, this support extends to aiding in the transfer of know-how, compiling documentation, evaluating facility infrastructure and equipment gaps and needs, and assessing training requirements for the workforce. The objective is to equip the recipient/licensed company with the capability to fully integrate the technology and cultivate the essential manufacturing competencies.

As of end-2024, the Programme, launched in 2021, is on track to have supported the establishment of 11 state-of-the-art good manufacturing practices (GMP) certified mRNA manufacturing facilities across 10 LMICs by 2030, with a further five facilities following later. As such, it is estimated that the network will be capable of producing at least 60 million vaccine doses annually, scalable to two billion in a pandemic[8]. What’s more, with all 16 manufacturers in the mRNA Programme working on R&D across various diseases (as part of regional R&D consortia), this network is now equipped to meet the Global South’s R&D and mRNA vaccine needs, and, as such, stands ready to respond to any future pandemic to secure mRNA vaccine access across continents.

Key Considerations related to Impact & Technology Transfer

When considering how to expand its current impact methodology to include technology transfer, MPP is keen to address the following questions:

1. To what extent can the impact of technology transfer activities be measured through indicators related to health and economic impact (including existing indicators used by MPP)?
2. How do we best articulate and measure pathways to impact that capture:
   1. strengthened manufacturing capacity (be that in terms of increased interpandemic regional capacity, production efficiencies/cost-savings, increased expertise and know-how, and/or workforce development),
   2. pandemic preparedness (e.g. regional manufacturing readiness, and supply security and resilience),
   3. increased innovation (e.g. R&D for new health products, increased funding credibility, pipeline expansion)?
3. How best can MPP evidence the contribution of its technology transfer activities to the achievement of MPP’s vision considering that product sales may in some cases not be expected until many years following an MPP intervention (and likely not until after the 2026-2030 strategy period)?
4. In the absence of sales data, what data needs to be collected to inform technology transfer impact assessment?
5. How would a counterfactual scenario best be constructed?
6. How should a trade-off between potentially increased costs (of production, of health products) in the short term and the case for investment in regional manufacturing be addressed?
7. How best to ensure MPP’s impact assessment approach incorporates the contribution of partners and other key stakeholders?

Scope of work

• Develop a data collection and analysis methodology that will allow for the exploration and assessment of the qualitative and quantitative impact of technology transfer activities undertaken or planned by MPP in relation to two case studies.
• Identify and confirm the health technologies/products that will be most appropriate for the impact case studies:
  • The first case study should focus on the impact of the mRNA vaccine platform technology established as part of the mRNA Programme.
  • The second case study should consider the impact related to a specific health product (ideally a drug product & substance) for which MPP expects to support the technology transfer in the future.
• Collect the data and apply the impact assessment methodology for the two case studies, in order to qualify and quantify the impact of each and summarise this in two case study reports.
• In light of the case studies, propose:
  • a logical narrative and a set of metrics (with definitions) for measuring the impact of MPP’s technology transfer activities going forward.
  • a methodology and related impact assessment/modelling tool (that considers both counterfactual and factual scenarios) for informing the proposed impact metrics.
• Examine best practice amongst the global health community and, as far as possible, ensure the case studies and impact measurement approaches align with it.
• Ensure that the impact is easy to communicate to a lay audience, as well as potential funders and the global public health community.
• Work closely at all stages with MPP and possibly other relevant stakeholders to align on assumptions.
• Project manage all of the above.

Deliverables and timeline

• By end-April 2025: Inception report outlining: the methodology and process for case study development, data collection tools (both qualitative e.g. interview questions, and quantitative), a data analysis plan/draft modelling tool, a workplan and timeline.
• By end-June 2025: Final report that includes the following sections:
  • An assessment of peer organisations’ approaches to impact measurement related to technology transfer to-date.
  • A write-up of the 2 impact case studies, including summary and analysis of the data collected and the (potential) impact identified.
  • A proposal of a theory of change/results pathway for MPP’s technology transfer work along with:
    1. a set of impact metrics (and definitions)
    2. a related impact assessment methodology and modelling tool that can easily updated, expanded and adapted when generating MPP’s annual impact statement going forward.

Profile of consultant

Essential skills:

• Expertise in impact measurement, including both qualitative and quantitative methodologies.
• Knowledge of end-to-end production processes for vaccines, biologics, or similar technologies.
• Experience in evaluating capacity-building, local production, or technology transfer activities.
• Strong communication and stakeholder engagement skills, with a flair for presenting compelling arguments using evidence and analysis.
• Proven ability to produce high-quality written materials.

Desirable skills:

• Prior experience of working with Unitaid, CEPI or other global public health actors and/or donors on impact assessment.

Place of work and frequency of interaction: a combination of in-person and remote work to be defined depending on cost and time considerations.

Application process

Interested consultants should submit the following:

1. A brief project proposal (maximum 5 pages) outlining:
   • Understanding of the project
   • Proposed approach and methodology.
   • Estimated timeline and budget.
2. Presentation of your company, including CVs.
3. Examples of previous work relevant to the project.
4. Contact details for two professional references.

Evaluation criteria of the received proposals are as follows:

• Quality and feasibility of the proposed approach.
• Relevant expertise and experience.
• Cost-effectiveness.
• Availability and timeline

Working language: English

Proposals are to be submitted no later than 28 February 2025 to recruitment@medicinespatentpool.org

For any questions and clarifications, please write to rfp@mppf.ch.

[1] More information is available at: https://medicinespatentpool.org/progress-achievements/impact

[2] The methodology was published as a peer-reviewed paper in the Lancet Public Health: Morin, Barron Moak, Bubb-Humfryes, von Drehle, Lazarus & Burrone (2022) The economic and public health impact of intellectual property licensing of medicines for low-income and middle-income countries: a modelling study. The Lancet Public Health, 7(2): E169-E176.

[3] www.medicinespatentpool.org

[4] https://medicinespatentpool.org/what-we-do/mrna-technology-transfer-programme

[5] https://medicinespatentpool.org/what-we-do/biotherapeutics

[6] https://medicinespatentpool.org/what-we-do/long-acting-hub

[7] https://medicinespatentpool.org/who-we-are/strategy

[8] https://medicinespatentpool.org/news-publications-post/from-vision-to-reality-mrna-technology-transfer-programme-building-sustainable-vaccine-manufacturing-ecosystems-in-lmics