Chapter Two
28
compliance with several templates and linguistic conventions, among
which lists of standard and patient-friendly terms, etc.). The translation
process is illustrated in the following chart (Figure 3):
Figure 3. Interlingual translation of SmPC and PIL.
This “one-to-many” approach (Pym 2004: 126) implies that the
respective (original) English version of SmPCs respectively PILs has to be
translated and adapted to all EU languages and cultures. Despite the
inherent difficulties^10 this translation is possible because there are enough
macro- and microstructural correspondences between the source- and
target language texts based on shared conceptual meaning (i.e. both sender
and receiver of SmPCs respectively PILs have common mental
representations of the events described). This is in line with Faber and
Ureña Gómez-Moreno (2012: 74) who assume that “[...] selected parts of
a general conceptual network are activated by means of the different
languages”, the latter being the “lexicalizations of entities, activities,
attributes and relations” shared by the sender and the target audience.
Even though the translation proper of medico-pharmaceutical
documents is not the topic of the present chapter it should be mentioned
that it charges the translator with responsibilities that exceed the pure
linguistic level (for a detailed discussion see Schäffner 1999: 98; Zethsen
Korning 2009; Wermuth, forthcoming 2016). In fact, the above mentioned
(interlingual) translation of SmPCs and PILs into different languages is a
good example of how challenging this task is. Their adequate translation
implies, among other things, a good understanding of the domain (e.g.
technical descriptions of substances and (pre)clinical studies in SmPCs),
compliance with EC guidelines and templates (e.g. Guideline on Summary
of Product Characteristics (2009) and Guideline on the Readability of the
Labelling and Package Leaflet of Medicinal Products for Human Use
(^10) A number of problems are discussed in recent research on patient leaflet
readability (Motós Martínez 2012; Nisbeth Jensen 2012; Nisbeth Jensen and K.K.
Zethsen 2012).
SOURCE
TEXT:
SmPC/PIL
Language 1-n
TARGET
TEXT:
SmPC/PIL
Language 1-n