Frederic Bouder

The changing nature of communication and regulation of risk in Europe

The regulation and communication of risk have changed significantly over the past 20 years or so, partially as a result of a number of regulatory scandals in Europe and elsewhere, which have led to greater public distrust of regulators and policy‐makers. This increase in public distrust has resulted in a phasing‐out of consensual‐style regulation, and the emergence of a newer model of regulation based on variables including public participation, transparency and increasingly powerful non‐governmental organisations (NGOs). This paper discusses some of the consequences of adopting this new model of regulation through a series of case studies.

Transparency and the Food and Drug Administration-A Quantitative Study

In Europe and North America, there is increasing political pressure being put on health regulatory agencies to become more transparent. To date, however, there has been little academic evaluation—let alone analysis—of these transparency initiatives from a risk communication perspective. This review examines whether the U.S. Food and Drug Administrations Adverse Event Reporting System quarterly signal postings, put in place after the passage of the Food and Drug Administration Amendments Act 2007, will assist patients and doctors in their decision-making processes, on the basis of results of a quantitative Internet survey of 433 physicians and 1,000 American adults. The results indicate that there is significant disagreement between physicians and the public about when medical safety issues should be communicated in the first place, with physicians opposed to early signal postings while the public in general is in favor. In addition the findings show that if the public were to find their drugs listed on the Adverse Event Reporting System signals web postings, more than a quarter would stop taking their medicine. Going forward, the Food and Drug Administration needs to work to a greater degree with social scientists in developing scientific-based communication strategies, rather than developing transparency initiatives on the basis of stakeholder consultations.

Medicines transparency at the European Medicines Agency (EMA) in the new information age: the perspectives of patients

The concept of transparency has gained widespread appeal in the European pharmaceutical domain, not least at the European Medicines Agency (EMA). Agency policies have two main objectives: (1) to enable the reuse of data (e.g. clinical study reports) and (2) to empower patients to directly and indirectly make more informed decisions on medicines. Past research has almost exclusively focused on the perspectives of external researchers intending to reanalyse data made publically available. Few studies, however, have explored what can be learnt from the perspectives of other actors (e.g. health care professionals, patients, the regulators themselves, industry and others). This empirical study explores the EMA’s transparency policies from the perspectives of patients. After presenting the results of a survey (N = 1010) with a sample of individuals diagnosed with five specific medical conditions (HIV/AIDS, multiple sclerosis, rheumatoid arthritis, osteoporosis and idiopathic pulmonary fibrosis) from four EU countries (Germany, Spain, France and the UK), the authors argue that EMA’s transparency policies do not adequately address the real-world complexities of communicating with patients. In turn, the paper concludes that the perspective of patients provides an essential contribution to understanding the full net effects (positive, negative and/or limited) of EMA’s transparency policies.

Transparency of medicines data and safety issues–a European/US study of doctors’ opinions: what does the evidence show?

Over the past 10 years, European pharmaceutical regulators (especially the European Medicines Agency [EMA]) have enacted a wave of transparency policies. Since 2010, the overwhelming majority have focused on releasing more scientific medicines information online and providing open access to regulatory data. Amongst other benefits, EMA expects its policies to build public trust and provide outsiders with a better understanding of regulatory decision-making. Yet, few studies have empirically examined the EMA’s transparency policies, especially on the end users of ‘transparent’ information (e.g. medical doctors or patients). This paper presents standout findings from a November 2014 survey conducted in Spain, Germany, France and the United Kingdom with a sample of 1005 general practitioners and medical specialists treating either multiple sclerosis, rheumatoid arthritis, osteoporosis, idiopathic pulmonary fibrosis or HIV/AIDS. The study found that 76% of respondents think it is a bad idea to release information into the public domain before possible safety issues have been investigated by the regulators and (relevant) pharmaceutical company. The results also suggested that medical doctors in Europe have a poor understanding of pharmaceutical regulatory activities. In particular, the majority were largely unaware of the current activities of the EMA, did not have good knowledge of how the regulators assess the safety of medicines (e.g. only 17% said they had good knowledge of how EMA assess the safety of medicines) and were unfamiliar with regulatory documents frequently used by regulators and industry to discuss the safety of medicines (e.g. in approving a medicine).

Pharmaceutical Benefit–Risk Communication Tools: A Review of the Literature

This paper reviews the main tools for communicating benefit–risk medicines information to patients that are used, or could be used, by pharmaceutical regulators. One highly successful tool from the food safety sector (front-of-package traffic-light labelling) and the mental models approach (which provides a framework for developing new tools) are also reviewed as they show great promise for being usefully adapted to the pharmaceutical context. The evolution of benefit–risk medicines communication is first contextualised within the broader risk communication literature. Three distinct goals are then made explicit before critically examining the evidence for and against tools developed in the US (e.g. at the Food and Drug Administration [FDA]) and Europe (e.g. at the European Medicines Agency [EMA]). These goals are (i) sharing information (e.g. publishing clinical trial and adverse event data online); (ii) changing patients’ beliefs by conveying factual knowledge (e.g. patient information leaflets and the drugs facts box); and (iii) changing behaviour (e.g. patient alert cards and warning labels). The mental models approach and traffic-light labelling, developed outside the pharmaceutical context, are then examined. Ultimately, the paper provides a helicopter view of the variety of benefit–risk communication tools that are used, or could be used, by pharmaceutical regulators in the US and Europe.

Risk-based governance against national obstacles? Comparative dynamics of Europeanization in Dutch, French, and German flooding policies

Comparative studies have recently highlighted obstacles related to continental European countries’ proclivity for adopting risk-based governance. However, so far, the interface between risk-based policy-making in the EU and potential policy change in reluctant member states has been underexplored. We compare flooding policies in the Netherlands with those in France and Germany to establish the extent to and conditions under which EU-level risk-based policies can transform national governance approaches. Drawing on the concept of Europeanization, we compare national adaptation pressures stemming from the EU floods directive, investigate adaptation dynamics, and account for transformations towards risk-based thinking. We find that Europeanization enabled a mainstreaming of risk-based flooding policies in France and Germany, as national actors used the EU as a venue to entice a desired policy rationalization and centralization. By contrast, and somewhat unexpectedly, the Netherlands partially retrenched from EU procedures because the directive’s reporting mechanisms were considered to breach The Hague’s aspirational policy approach. Overall, the paper identifies a strong potential for even ‘soft’ EU policies to ease national reluctance to risk-based governance approaches, but it also indicates limits where member states use risk-based techniques within an aspirational protection framework.

Risk Perception and Communication

Many risk events whether natural or man-made have potentially devastating effects. For several decades, risk scholars, regulatory agencies and businesses have invested sustained efforts in developing and improving risk communication. Their attention has been focused on a number of risk situations from nuclear reactors [15, 19] to chemical plants [14] and radon [3]. Risk analysis has uncovered general drivers and patterns of communication that can be adapted beyond these distinct sectors. This considerable amount of research [6, 7] has helped to grasp with fundamental questions such as: are people rational or irrational when it comes to catastrophic events? Is there a way to develop sensible communication? And what role does perception play to inform communications? Evidence strongly suggests that effective risk communication is a crucial component of a robust strategy for improving disaster resilience and mitigation. Arguably, the major achievements of risk perception/risk communication have been therefore to.

The Ditchley transparency manifesto

This manifesto is based on the discussions that have taken place since the Workshop on Transparency, organized in Ditchley Park, Oxfordshire, United Kingdom, on June 17 and 18, 2010. The authors present a strategic view on the concrete measures that must be taken for a European pharmaceutical transparency initiative to be successful.

Towards a concept of genetic risk tolerance: a risk analysis perspective

The starting point of the MindTheRisk project has been to raise socio-political questions about whether lay public’s understanding is satisfied about the genetic information they receive, and to what extent regulators do take this aspect on board when they decide to allow or restrict genetic testing or to develop communications about genetic testing. This article draws on the concepts that have emerged among the risk research community to tackle “risk tolerance’’. It explores the application of those concepts to the sharing and regulating of genetic risk information. We start with a conceptualisation of risk acceptability/tolerability in the genetic context, before turning to concrete hurdles that need to be overcome and questions that need to be answered. Finally, we suggest some direction for policy. The paper is based on an in-depth review supplemented by pilot interviews conducted with the European Medicines Agency, National regulatory agencies, academic and members of a patient organisation, all directly involved in policy.

Genetics and risk - an exploration of conceptual approaches to genetic risk

Many readers of the Journal of Risk Research may be aware of the surge in studies since the middle of the twentieth Century that have analysed different types of risks from nuclear energy to vaccines and from space travel to radon in homes. In recent years, scholars have become increasingly preoccupied with the need to better communicate ‘dreaded’, ‘complex’ and ‘systemic’ risks in post-trust societies where confidence in science and institutions has become fragile (Löfstedt 2005). Over the last decade, the so-called genomic revolution is raising new questions for risk research. Information about our personal genetic make-up may be perceived as opportunities to discover more about our risks of developing multifactorial diseases such as diabetes and cancers. Furthermore, genetic information is personal yet shared by many relatives and is multi-generational. The information is intimate in a way since it comes from our own body, yet it may also seem very unfamiliar and ambiguous for those who are unaware of the science of genetics and genomics and the ultimate meaning of the results. A more thorough attention to the relationship between genetics and the notion of risk is therefore pertinent at this time, in order to accompany the recent developments in human genetics, including the fields of genomics and epigenetics. This special issue provides a multi-disciplinary view of different concepts of genetic risk and genetic risk information. It regroups the work of scholars from the social and medical sciences as well as humanities who share a common purpose: exploring conceptual approaches and advancing empirical investigations about genetic risk as a way to better understand its different meanings and uses in different domains. Dealing with situations of risk is a characteristic of modernity (Beck 1992). The notion of risk here is related to special risks of technological progress, and the use of technology such as nuclear power as well as the use of legal, socio-economic and technical concepts to manage the risk (Slovic 1987, 1993, 2010; Behrens, Pigeot, and Ahrens 2009). In a risk society, everybody can be affected by adverse events and as such, society evolves measures for risk management. Genetic risk has a double structure, with individual health risk connected to genetic information as well as individual health behaviour on the one hand and social aspects of public health on the other hand. The individual meaning ascribed to such events as well as the (normative) evaluation can vary broadly. Individual interpretation doesn’t necessarily match scientific risk assessment (Hansson 2004; Möller 2012). The evaluation of risk varies between persons but also with regard to time and place; anticipating a possible future event can differ significantly from the evaluation of the same event that has already taken place. Furthermore, cultural and social factors have an impact on the evaluation of adverse events and risk and need to be taken into account when discussing risk communication (Fischhoff 1995; Renn 2008a, 2008b; Bennett et al. 2010).