Mandatory Genres: The Case of European Public Assessment Report (EPAR)

TitleMandatory Genres: The Case of European Public Assessment Report (EPAR)
Publication TypeJournal Article
Year of Publication2008
AuthorsAskehave, Inger, and Karen K. Zethsen
JournalText & Talk
Keywordsgenre, patient communication, translation

The aim of this article is to consider the nature of mandatory genres (legallyregulated genres) emanating from European Union directives and
point to the challenges that such genres pose due to their legal origin and
complex text production and text reception processes. Taking its point of
departure in one of the most recent mandatory genres within an EU medicinal
assessment and approval context (the European Public Assessment Report
[EPAR] summary) the article presents the results of an empirical
study of 15 EU-approved, Danish EPAR summaries, testing whether the respondents
believe the EPAR summaries live up to their declared purpose.
The article concludes that the majority of the respondents do not think the
EPAR summary fulfills its communicative purposes of providing information
about The Committee for Medicinal Products for Human Use’s review
and recommendation of the product and providing information that is understandable
and useful to laypersons, respectively. The article points to
some of the reasons why, in spite of careful preparation, and extensive
guidelines prior to its ‘launch’ into the discourse community, the EPAR
summary apparently fails to fulfill its communicative purposes.