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). 

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As part of this research, we have created a database of initiatives that appear to fund, implement or facilitate pharmaceutical R&D in a manner that differs from the traditional business model. 

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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. 

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

• Mission (e.g., equity, health impact, joint profit and health goals),

• 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 different phases of the R&D process (e.g., academic institutions conducting later-stage development),

• Approach to research and knowledge management (e.g., open science, public and private collaboration, data sharing, no patenting, non-exclusive licensing, or participating in patent pools), 

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

• Manufacturing strategy (e.g., small scale, collaborative agreements), 

• Distribution strategy (e.g., prioritizing disease-endemic developing countries), 

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

• Home country (e.g., low- or middle-income, international network)

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The initiatives included in the database differ from the traditional business model in at least one of these characteristics, often more than one, but not necessarily all.

 

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 had identified a total of 130 initiatives involved in alternative R&D models. The most common type of organization in our database are not-for-profit organizations (46 initiatives), followed by academic and other research institutions (25). For-profit organizations in our database adopt different types of organizational forms (31): private companies (15), publicly-traded companies (7), public benefit corporations (8) or Limited liability partnerships (1). We also included national government agencies (18) and intergovernmental organizations (6). The wide range of organizational forms reflects the diversity of approaches being taken towards developing alternative business models.