Business and Public–Private Partnerships for Sustainability: Beyond Corporate Social Responsibility?

This article analyses public–private partnerships (PPPs) in the field of sustainable development from an international relations perspective with insights from the business and ethics literature. We argue that the role of business in these types of arrangements has not been sufficiently explored. After presenting three ways of approaching PPPs to stress the many facets of partnerships across the public–private divide, we discuss the emergence of these novel forms of governance from a demand side and contrast such a functionalist reading with the supply side. Then we look at the micro-economic incentives for corporations to engage in such endeavours. We develop arguments derived from the dominant literature to provide an analytical framework for explaining business participation. Finally, we discuss the role of PPPs in light of input and output legitimacy. We conclude by alluding to the emergence of an expectation-capacity gap and normative issues related to the global PPP architecture.

Report of a European Society of Cardiology-European Association of Percutaneous Cardiovascular Interventions task force on the evaluation of coronary stents in Europe: executive summary.

The evaluation for European Union market approval of coronary stents falls under the Medical Device Directive that was adopted in 1993. Specific requirements for the assessment of coronary stents are laid out in supplementary advisory documents. In response to a call by the European Commission to make recommendations for a revision of the advisory document on the evaluation of coronary stents (Appendix 1 of MEDDEV 2.7.1), the European Society of Cardiology (ESC) and the European Association of Percutaneous Cardiovascular Interventions (EAPCI) established a Task Force to develop an expert advisory report. As basis for its report, the ESC-EAPCI Task Force reviewed existing processes, established a comprehensive list of all coronary drug-eluting stents that have received a CE mark to date, and undertook a systematic review of the literature of all published randomized clinical trials evaluating clinical and angiographic outcomes of coronary artery stents between 2002 and 2013. Based on these data, the TF provided recommendations to inform a new regulatory process for coronary stents. The main recommendations of the task force include implementation of a standardized non-clinical assessment of stents and a novel clinical evaluation pathway for market approval. The two-stage clinical evaluation plan includes recommendation for an initial pre-market trial with objective performance criteria (OPC) benchmarking using invasive imaging follow-up leading to conditional CE-mark approval and a subsequent mandatory, large-scale randomized trial with clinical endpoint evaluation leading to unconditional CE-mark. The data analysis from the systematic review of the Task Force may provide a basis for determination of OPC for use in future studies. This paper represents an executive summary of the Task Force's report.