Alternative innovation models for medicines in the public interest: a typology, evidence and comparison with the mainstream model

Introduction Discontent with the mainstream commercial pharmaceutical innovation system’s shortcomings (eg, missing innovation, high prices, limited availability) has catalysed experimentation with alternative innovation models (AIMs). However, the study of AIMs is conceptually and empirically fragmented, with open questions regarding definitions, therapeutic focus, functioning, achievements and comparison with the mainstream. Methods We defined AIMs as having a public interest mission and differing from the mainstream model, for instance, in organisational form, financing, priority setting, role in research and development phases, knowledge management, and regulatory, manufacturing or pricing strategy. We constructed a database of 138 initiatives, conducted interviews with 47 and carried out case studies of three. We iteratively developed novel conceptual frameworks at the system, model and initiative levels and used framework analysis to analyse the data. Results We found ample evidence that AIMs can develop new medicines addressing unmet health needs. AIMs cluster in four ‘niches’ in the innovation system: pandemic preparedness, neglected tropical diseases, rare diseases and antibiotics. AIM initiatives have in common a public interest mission but vary widely in their organisational form and strategies. Nevertheless, we discerned three archetypal AIMs: national government driven, socially redirected private sector and collaborative network, each able to deliver innovation but with different strengths and weaknesses for meeting the public interest. Conclusions AIMs have demonstrated their feasibility, advantages and potential to challenge the mainstream model but remain small scale and relatively fragile. Institutionalising them requires stable expanded public and philanthropic financing; enhanced sharing of scientific, regulatory and manufacturing knowledge; and legal and policy changes that secure the resources they need to deliver.