The move towards patient engagement and patient involvement in healthcare decisions (“shared care”) has triggered a raft of new guidances from regulatory authorities, accompanied by new regulations mandating that pharmaceutical companies engage with patients and the general public in a way that has been improbable up to now. While this has generally been supported and welcomed by both industry and patients, the initiative has brought with it considerable challenges. Producing complex scientific and medical information in health-literate language that is appropriate and helpful for the general public (“plain language”) requires skills beyond those usually required for communicating with healthcare professionals and regulatory authorities. Medical writers are highly trained in a specific technical writing style and tone that is aimed at readers with a very high level of literacy, and often considerable scientific and medical knowledge. Translating this information into plain language for readers who may have low health literacy, and perhaps little or no scientific or medical knowledge, is a significant challenge – as reflected in the level of information currently available
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