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This article provides a theoretical understanding of the potential contribution of digital platforms to the co-creation of public value. On the basis of insights from different academic disciplines, a layered model is developed for the relations between technology, governance, users and societal outcomes. The theoretical model proposes that these layers can result in basic configurations – consistent combinations of the four elements – but also hybrid configurations. We identify three basic configurations: (1) a closed platform controlled by a private sector organisation, (2) an open platform controlled by a government organisation and (3) an open platform run by a civil society organisation. The configurations are illustrated with examples of digital platforms from all over the world. The configurational understanding of digital platforms for the co-creation of public value provides the basis for a systematic analysis of these rapidly growing practices in countries around the world.

This article provides a theoretical understanding of the potential contribution of digital platforms to the co-creation of public value. On the basis of insights from different academic disciplines, a layered model is developed for the relations between technology, governance, users and societal outcomes. The theoretical model proposes that these layers can result in basic configurations – consistent combinations of the four elements – but also hybrid configurations. We identify three basic configurations: (1) a closed platform controlled by a private sector organisation, (2) an open platform controlled by a government organisation and (3) an open platform run by a civil society organisation. The configurations are illustrated with examples of digital platforms from all over the world. The configurational understanding of digital platforms for the co-creation of public value provides the basis for a systematic analysis of these rapidly growing practices in countries around the world.

Drug regulatory agencies around the world increasingly implement expedited regulatory pathways allowing for approval of medicines that intend to address unmet medical needs based on lower evidentiary standards than would be conventionally required. Few studies have investigated how companies and regulators utilise these pathways. We therefore conducted a longitudinal analysis of the emergence and implementation of the conditional marketing authorisation (CMA) instrument in the European Union. Drawing on archival documents, procedural data and interviews, we show that there was substantial ambiguity among regulators and companies about how to strike a new balance between evidentiary requirements and patient needs. As ambiguities were left unresolved, parties became reluctant to use CMA and in the majority of procedures did not use the pathway in a prospectively planned fashion. Rather, CMA became an option for regulators and companies to apply when submitted data were not strong enough to justify standard approval. Particularly, incumbent companies profited from this. The results stress the challenges of realising institutional change in drug regulation by showing how interest-driven actors can act upon ambiguities in attempts to shape regulatory outcomes and stretch rule interpretations.

The exclusive position of scientific expertise in pharmaceutical regulation is being increasingly challenged. Several authors suggest that lay knowledge could play a role in governing risks. We use the literature to develop ideal-typical regulatory arrangements with low and high lay stakeholder involvement: a technocratic and a democratic arrangement. We propose that a more technocratic arrangement will yield a better process and output performance while a more democratic arrangement will result in more stakeholder satisfaction. These propositions are explored through two case studies of pharmaceutical regulation in the Netherlands: in pandemic influenza and in HIV. Our study shows equivalent process and output performances but we found indications that the democratic approach results in more stakeholder satisfaction. We conclude that in pharmaceutical regulation, there is no a priori reason to limit involvement to experts: in situations of fundamental uncertainty, democratic monitoring of pharmaceutical risks can contribute to the system's robustness.

The exclusive position of scientific expertise in pharmaceutical regulation is being increasingly challenged. Several authors suggest that lay knowledge could play a role in governing risks. We use the literature to develop ideal‐typical regulatory arrangements with low and high lay stakeholder involvement: a technocratic and a democratic arrangement. We propose that a more technocratic arrangement will yield a better process and output performance while a more democratic arrangement will result in more stakeholder satisfaction. These propositions are explored through two case studies of pharmaceutical regulation in the Netherlands: in pandemic influenza and in HIV. Our study shows equivalent process and output performances but we found indications that the democratic approach results in more stakeholder satisfaction. We conclude that in pharmaceutical regulation, there is no a priori reason to limit involvement to experts: in situations of fundamental uncertainty, democratic monitoring of pharmaceutical risks can contribute to the system's robustness.

Current research into patient advocacy focuses on attempts of patient groups to mobilise resources and to influence researchers, pharmaceutical companies and policy-makers. This paper adopts a 'framing political opportunities' approach to draw attention to other kinds of advocacy strategies. In a case study of breast cancer patient advocacy of Herceptin reimbursement, it is shown how patient groups tried to gain access to policy-making by means of three different opportunity-framing strategies. Articulation aims at creating awareness through public-agenda building. Negotiation aims at frame alignment between interdependent stakeholders by arranging meetings. Politicisation is a strategy to influence the agendas of political arenas. Patient organisations succeeded in creating awareness and support, which had a considerable impact on other stakeholders. These impacts in turn aided the politicisation of the issue. However, the final impact on reimbursement procedures was only partially achieved due to depoliticising counterstrategies based on persistent ideas buttressing a particular division of responsibilities in the organisation of healthcare. According to these ideas cost control in healthcare is a medical responsibility, not a political one.

Given that online platforms disrupt established industries and challenge existing institutions, they can only be successful if their innovation becomes both legal and legitimate. This requires 'institutional work' that changes perceptions and regulations within society. Rather than only focussing on the online platform as the sole agent engaging in institutional work, our study analyses institutional work as a collective process. We investigate the case of home-sharing platform Airbnb and the process of institutional change its introduction prompted regarding short-term rental in Amsterdam, London and New York. We find, contrary to the popular view of online platforms as disruptive entrepreneurs, that the platform mainly focusses on creating new institutions rather than disrupting existing ones, and that users and non-users undertake most of the institutional work activities. We also show that different types of actors carry out different types of institutional work suggesting that the process of institutional work is highly distributed.