Transparency in Europe: A Quantitative Study

Abstract

In recent years, European pharmaceutical regulators have increasingly committed to heightening access to raw safety-related data as part of a wave of transparency initiatives (e.g., providing public Internet-mediated access to clinical trials data). Yet, the regulators--who are under significant pressure--have not yet benefited from a systematic review of this new policy. In seeking to inject much needed evidence, this article explores the effects of new transparency policies designed to promote meaningful communication of risks and benefits to patients. Results of a cross-national European survey with respondents from Great Britain, the Netherlands, Spain, France, Germany, and Sweden (N = 5,648) shed light on how patients and the public are likely to react to the regulators' new transparency policies. The findings demonstrate clear national variations in how European citizens are likely to react and emphasize the need to develop evidence-based, reasoned transparency policies that integrate benefit-risk communication. The authors conclude by providing six specific recommendations, informed by the study, that seek to improve the European transparency model both within the medical field and across health, safety, and environmental policy domains.

Looking back and going forward: what should the new European Commission do in order to promote evidence-based policy-making?

“…Similarly, while we have found that although public and patients would welcome raw and uncertain scientific data entering the public domain, they would, however, become concerned, worried and/or confused about what the complicated data actually means with many saying that they would stop taking their medicines were it published online on a public website (Bouder et al 2015;Lofstedt and Bouder 2013;Lofstedt and Way 2014a and b). Finally, there is a need to remember that data dumping is not science communication.…”

“…Move away from fish bowl transparency to science based transparency There is a need for science based regulators such as EFSA or EMA to move away from fish bowl transparency and move to science based transparency, where some specific data is shared but at the same time explained (Bouder et al 2015). The push for dumping data on line, putting clinical trials into the public domain, recording scientific debates as well as arguing for ever stricter conflict of interest statements do not lead to more trusted regulatory agencies or better policy making (Bouder et al 2015;Way and Lofstedt 2015).…”

“…The push for dumping data on line, putting clinical trials into the public domain, recording scientific debates as well as arguing for ever stricter conflict of interest statements do not lead to more trusted regulatory agencies or better policy making (Bouder et al 2015;Way and Lofstedt 2015). Rather what we see is that the information from these activities that are put out in the public domain is used as ammunition by the groups attacking the Agency in the first place in order to reduce the credibility of the Agency in question (e.g.…”

Transparency in Health Care: Disclosing Adverse Events to the Public

“…By bringing new information to the table including critique of regulatory follow-up, the regulatory body appeared left with no other option than to re-open the case. They then continued with a strategy of transparency (Bouder et al 2015), uncommon in a Norwegian setting, releasing draft report to the public, inviting experts to provide input, reflecting upon the media role and by making new safety recommendations to a wide range of actors.…”

“…More information and more communication do not necessarily lead to better decisions about risk, and the call for increased transparency may also increase costs and complicate decision-making processes (Han 2015;Hood and Dixon 2015). Some transparency strategies may involve dedicated web portals, publication of recommendations, introduction of public hearings, establishment of safety and quality committees and disclosure of the minutes of meetings and meeting agendas (Bouder et al 2015).…”