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DATABASE OF ALTERNATIVE R&D INITIATIVES

INTRODUCTION

We are conducting research on the political, economic, scientific and organizational factors required to implement alternative business models of pharmaceutical research and development (R&D) that may better serve the global public interest (e.g. deliver both innovation and global access ).

 

As part of this research, we have created a database of initiatives that could be considered to carry out, fund or facilitate pharmaceutical R&D in a manner that offers important advantages over the traditional business model. We define the traditional business model as one in which a commercial profit-maximizing firm conducts the later stages of R&D (e.g. preclinical to clinical trials) and brings a product to market; competition between companies and market incentives influence which diseases or technologies the firm prioritizes; how it manages knowledge such as data and intellectual property; and its strategies for obtaining regulatory approval, production, marketing, distribution and pricing. Usually, this firm is based in a high-income country.

 

Alternative business models can differ in a number of ways from traditional models, including the organization’s:

  • Mission,

  • Priority-setting process (e.g. unmet health need),

  • Organizational form (e.g., nonprofit, public benefit corporation),

  • Financing (e.g. mixed private and public, philanthropic or social impact investor funding),

  • Role in the R&D process (e.g. academic institutions conducting later-stage development),

  • How it conducts research (e.g., open science, public and private collaboration), including how it manages knowledge (e.g. data sharing, no patenting, non-exclusive licensing, or participating in patent pools),

  • Approach to regulatory standards (e.g. active collaboration with regulator; developing country regulator first),

  • Manufactures (e.g. small scale, collaborative agreements),

  • Distributes (e.g. priority to disease-endemic developing countries) and

  • Prices final products (e.g. affordability caps, limited profit, tiered pricing).

  • The organization may be based in a high, middle or low-income country.

There is no central, recently-updated source of information on such initiatives, nor is there a single definition of an alternative business model. Here we make the database publicly available for further research, and describe the different initiatives we identified (see a description of the data collection method here).

What do alternative R&D initiatives look like?

As of early 2023, we have identified a total of 130 initiatives involved in alternative R&D initiatives. The most common type of organization in our database are not-for-profit organizations (45 initiatives), followed by academic and other research institutions (25). For-profit organizations in our database adopt different types of organizational form: private companies (15), publicly-traded companies (7), public benefit corporations (8) or Limited liability partnerships (1). National government agencies (18) and intergovernmental organizations (18 and 6 respectively) show the relevance of the public sector in this database.

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The initiatives are also divided based on the main role that they play in the system, with implementers (or those that conduct R&D, 86 initiatives) leading, followed by funders (25) and facilitators (those that provide technical information or advice to R&D implementers, 19 initiatives).

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The vast majority of initiatives we found is based in the US and Europe. In part, this may be due to selection bias in our data collection process. In part, it may also be because historically R&D capacity has been concentrated in these regions; in addition, many global health initiatives are based in HICs such as Switzerland and the US. We also identified organizations based in Low- and middle-income countries, including Brazil, Cuba, India and South Africa.

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As the research project has evolved, so has our understanding and conceptualization of traditional and alternative business models. This database reflects this conceptual evolution. It also demonstrates the plurality of actors that populate the ecosystem within which alternative R&D initiatives seek to achieve innovation with access.

The database does not claim to capture all relevant initiatives, and continues to evolve. Suggestions for additional initiatives to include are welcome at:

The database has been developed by the NBM research team: Suerie Moon, Adrián Alonso Ruiz, Marcela Vieira, Kaitlin Large, Iulia Slovenski, Yiqi Liu, Danielle Navarro, Temmy Sunyoto and Surabhi Agarwal.

The website was developed by Bétina Zago and Adrián Alonso Ruiz, with the supervision of Suerie Moon, and the support of Marcela Vieira, Kaitlin Large, Iulia Slovenski and Yiqi Liu.

This work was supported by a Swiss National Science Foundation PRIMA Grant (179842). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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This work is licensed under a Creative Commons Attribution 4.0 International License.