Table 1 Analytical questions to ask about social pharmaceutical innovations
LINE OF ANALYSIS | TYPE OF SPIN | ||
|---|---|---|---|
Novel R&D partnerships across the public, not-for-profit and private sectors | Alternative forms of provision and licensing | Alternative regulatory frameworks for coverage | |
Problem-framing & goals of SPIN initiative | How do various stakeholders involved frame the problems -and their causes- they seek to address? | How are IP regimes locking in particular modes of manufacturing and provision? What room is there for distinct forms of IP regimes and manufacturing capacities within the national or regional context in which SPINs are taking place? | How are regulatory and political frameworks constraining novel forms of R&D and emerging forms of medicinal products? How do alternative regulatory frameworks for coverage disrupt the traditional linear model of pharmaceutical innovation? |
Nature of SPIN processes | What is the nature of multi-sectoral partnerships in question (e.g., distributed, decentralised, transdisciplinary), in terms of what they actually do and what they aim for? | How is evidence debated between the various actors involved? How do diverse forms of evidence challenge the statistical reasoning that underlies clinical trials and health technology assessment? | What is the nature of regulatory and institutional change that SPIN contemplates or drives? |
Outcomes of SPIN activities | How have partnerships (re)organised work and activities relative to the medical, practical, regulatory and politico-economic environment? How lasting are the R&D partnerships facilitated by SPINs? Are they one-off cooperatives or more enduring relationships? | What are the outcomes of alternative forms of provision and licensing in terms of changes in access and availability to drugs for rare diseases? | How have alternative policy and regulatory frameworks facilitated transformations in addressing the issue of availability (i.e., R&D and clinical trials) and/or the issue of accessibility (pricing and/or coverage)? |