A Conversation with Dominic Way about the views of patients and doctors on EMA's transparency policies
The GW Regulatory Studies Center, U.S. Department of Agriculture Office of Risk Assessment and Cost-Benefit Analysis, and the National Capital Area Chapter of the Society for Risk Analysis hosted Dominic Way to discuss the results of his paper, "From Accessibility to Comprehensibility: Comparing the Views of Patients and Doctors on EMA’s Transparency Policies."
- Over the past 20 years or so, scientific regulatory agencies across the Atlantic - such as the European Medicines Agency (EMA), US Food and Drug Administration and Health Canada - have firmly committed to a wave of transparency policies. The overwhelmingly majority focus on releasing scientific information online and providing open access to regulatory data. Yet, few have critically examined the effectiveness of the regulators' policies on the achievement of public policy objectives (e.g. building trust). This study adds empirical evidence on the effects of European pharmaceutical transparency policies on the end-users of 'transparent' information (i.e. doctors and patients). Through conducting a large European survey (N=2,015) comparing the views of medical doctors (N=1,010) and patients (N=1,005) from Spain, Germany, France and the UK, the study found that the types of transparency policies adopted by European regulators are likely to be ineffective in achieving its policy objectives: building doctor and patient trust and providing a better understanding of Agency decision-making (e.g. why a medicine was approved). The large majority of respondents were found to have poor knowledge of how the regulators assess the safety of medicines, and would be unconfident in interpreting what safety-related information means (e.g. as contained in documents being made publically available). Doctors and patients were also found to differ significantly over key transparency issues including when safety information should be made publically available in the first place. The presenter concludes by discussing recommendations on improving transparency discussions that centre on achieving positive outcomes for patients and healthcare professionals.
About Dominic Way
- Dominic completed a B.A. Geography degree (1st Class, Hons.) and M.Sc. in Risk Analysis (Distinction) at King’s College London. His undergraduate dissertation (First Class) examined the experiences of visually impaired adults from a phenomenological perspective (nominated for the best UK health geography dissertation), while his Master’s dissertation (Distinction) explored how risk communication theory can be applied to (hospital) patient safety. Dominic is now finishing his Ph.D. at King’s. His primary research focuses on the history, idea and concept of ‘transparency’ as well as empirically measuring and evaluating the effects of various transparency policies on building trust in institutions and confidence in decision-makers (esp. the European Medicines Agency & European Food Safety Authority). Dominic has written about and lectured on risk regulation, management, communication and assessment (e.g. on transparency, behavioural economics, patient safety, pharmaceuticals, food safety and chemical regulation) to both public and private institutions at international conferences, workshops and other events (e.g. at the US Food and Drug Administration, Health Canada and EU regulatory agencies). Dominic has also recently finished lecturing as a visiting research fellow at Maastricht University, has organized high-level international workshops on transparency and is an active member of the Society for Risk Analysis (SRA): treasurer/secretary for the Risk, Policy and Law (RP&L) Speciality Group (2013-2015).
We appreciate support from our co-hosts:
- Society for Risk Analysis
- US Department of Agriculture