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Transparency in Risk Regulation: The Case of the European Medicines Agency

Student thesis: Doctoral ThesisDoctor of Philosophy

Transparency has risen to prominence in risk regulation leading government authorities in Europe and North America to introduce an avalanche of new policies. While transparency promises to achieve many instrumental objectives, there is insufficient empirical evidence on the effectiveness of the actual policies being implemented. This study first explored the ambiguity of transparency in risk regulation. This informed a review of the seriously fragmented literature and an original typology, which clarified what is being made transparent by risk regulators (objects), how (mechanisms), why (goals) and for whom (audiences). An indepth case study was then conducted on transparency at the European Medicines Agency (EMA), the EU agency responsible for pharmaceuticals. The four case methods were extensive historical and contemporary documentation; direct observations and interviews conducted between 2012 and 2016; and multi-national surveys (UK, France, Germany, Spain) of medical doctors (specialists and general practitioners) and patients diagnosed with one of five medical conditions (HIV/AIDS, idiopathic pulmonary fibrosis, multiple sclerosis, rheumatoid arthritis, osteoporosis) (N=2,015). After providing an in-depth historical analysis of transparency at EMA (1995-2016), the case study evaluated three salient policies, which all seek to make the data that underpins decision-making in EMA’s scientific committees more ‘visible’ to outsiders.

EMA’s policies have important strengths and weaknesses for achieving the regulator’s objectives. Transparency was also found to have serious unwanted effects including significantly increasing legal action against EMA, enabling unrestricted (high and low quality) re-analyses of benefit-risk data, and consuming substantial agency resources. Simply publishing large quantities of raw data online is unlikely to be the most effective way of achieving the regulator’s transparency objectives. Rather, effective transparency requires understanding (1) the limits of full disclosure, (2) the desired quality of transparency (for multiple audiences), (3) the capacity of expert and non-expert audiences to assess transparent information, and (4) the ability of intermediaries to re-package and communicate benefit-risk information effectively. Choosing the right transparency policies ultimately means resisting becoming captivated by quantity and must take opportunity costs into careful consideration. The thesis concludes by strongly arguing that transparency should be re-conceptualised as a (risk) communication process in order to improve policy effectiveness.
Original languageEnglish
Awarding Institution
Award date2017


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