Constitutional asymmetry and pharmaceutical policy-making in the European Union

This paper offers a theoretical perspective on pharmaceutical policy-making in the European Union, and shows the lack of a single European market in medicines to be the result of a clash between the supranational free movement rules and national healthcare policy competencies. The paper considers the roles of the European Commission, the member states, the industry and consumer interests (patients) as the main stakeholders, and frames the discussion within an integrated macro- and meso-level approach. Here we draw on Wilson's ‘politics of (regulatory) politics’ typology, tying it to Scharpf's ‘constitutional asymmetry’ perspective on EU policy. This enables the development of a broad sphere of analysis, allowing us to make observations on the EU regulatory arrangement for medicines as a whole. Specifically, the paper shows the extent to which industrial rather than health(care) policy interests have driven the development of regulatory policy in the sector, and seeks to understand the political dynamics shaping the on-going evolution of the regulatory framework

Patient consent to publication and data sharing in industry and NIH-funded clinical trials

Abstract Background Participants are recruited into clinical trials under the assumption that the research will contribute to medical knowledge. Therefore, non-publication trials—and, more recently, lack of data sharing—are widely considered to violate the trust of trial participants. Existing practices regarding patient consent to publication and data sharing have not been evaluated. Analyzing informed consent forms (ICFs), we studied what trial participants were told regarding investigators’ intention to contribute to medical knowledge, publish trial results, and share de-identified trial data. Methods We obtained 98 ICFs of industry-funded pre-marketing trials for all (17) antibiotics approved by the European Medicines Agency and 46 ICFs of publicly funded trials from the National Heart, Lung and Blood Institute Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) data repository. Three authors independently reviewed ICFs to identify and extract what was stated or implied regarding: (1) publication of results; (2) sharing de-identified data; (3) data ownership; (4) confidentiality of identifiable data; and (5) whether the trial will produce knowledge that offers public benefit. Consensus was obtained from the two reviewers with the greatest overall agreement on all five measures. Disagreements were resolved through discussion among all authors. Results Four (3%) trials indicated a commitment to publish trial results; 140 (97%) did not commit to publishing trial results; six (4%) indicated a commitment to share de-identified data with third party researchers. Commitments to share were more common in publicly funded trials than industry-funded trials (7% vs 3%). A total of 103 (72%) ICFs indicated the trials will or may produce knowledge that offers public benefits, while 131 (91%) ICFs left unstated who “owned” trial data; of those with statements, the sponsor always claimed ownership. Patient confidentiality was guaranteed in 137 (95%) trials. Conclusions Our results suggest that consent forms rarely disclose investigators’ intentions regarding the sharing of de-identified data or publication of trial results