KNOWLEDGE PORTAL
on innovation and access to medicines
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 appear to fund, implement or facilitate pharmaceutical R&D in a manner that differs from 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.
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)
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).
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.
Fig. 1 - Organizational forms of the initiatives in the database
We also categorized the initiatives based on the main role they play in the system (recognizing that an initiative may play more than one role). These three categories are “implementers” (i.e. those that conduct R&D, 85 initiatives), “funders” (24 initiatives) and “facilitators” (i.e. those that facilitate R&D through a wide range of activities, such as technical assistance, advocacy, or match-making, 21 initiatives).
Fig. 2 - Organizational form by actor typology
The majority of initiatives we found are 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 pharmaceutical R&D capacity has been concentrated in these regions. In addition, many initiatives with a global health focus 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.
Fig. 3 - Geographic distribution of initiatives in the database
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 models are emerging and taking shape.
The database does not capture all relevant initiatives, and continues to evolve. Suggestions for additional initiatives to include are welcome at globalhealthresearch@graduateinstitute.ch
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.
