KNOWLEDGE PORTAL
on innovation and access to medicines

INTRODUCTION

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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.

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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).

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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.