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

Research output: Contribution to journalArticle

Original languageEnglish
Pages (from-to)1-31
Number of pages31
JournalJournal of Risk Research
Early online date12 Jul 2016
DOIs
Accepted/In press31 May 2016
E-pub ahead of print12 Jul 2016

Documents

  • Medicines transparency at the European_WAY_Accepted31May2016_GREEN AAM

    Way_et_al._2016_accepted_manuscript.pdf, 852 KB, application/pdf

    Uploaded date:13 Jul 2016

    Version:Accepted author manuscript

    The Version of Record of this manuscript has been published and is available in the Journal of Risk Research 12/07/2016 http://www.tandfonline.com/doi/full/10.1080/13669877.2016.1200652

King's Authors

Abstract

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.

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