PILs (patient information leaflets) are instructive texts presenting consumer medicine information that inevitably affects the patient’s behaviour towards medicinal products. Although PIL standardising procedures aim to ensure absolute clarity of patient information, adduced disparities relating to usability and legibility indeed influence the end-result. In her contrastive analysis of British and Italian PILs, Cacchiani suggests that “British and Italian PILs represent highly culture-specific genres” (2006, p. 38) and that “culture-specific genre conventions are of primary importance to the translation process” (2006, p. 28). Accordingly, it may be argued that the most striking differences between the Italian and the English PIL genres are mostly connected to the legislative and cross-cultural aspects characterising the use of language in the two countries where these inserts are available, also including the intrinsically diverging doctor-patient relationship existing in both countries, thus entailing a number of predictable implications in translation.
PILs require particular emphasis, register, terminology and grammar in transmitting comprehensible information, especially via well-established linguistic configurations which vary across English and Italian and which may be distorted or manipulated only to a certain degree in translation. In brief, despite the harmonisation efforts enacted by the EMA (European Medicines Agency) on a European scale, deviating national legislative requirements and traditional TA (target audience) readership expectations indicate that PILs are never entirely stripped of their culture-specific content, leaving a trail of inescapable translation issues in their wake.
It may be observed that the main differences between Italian and English PILs are related to the greater user-friendliness and readability of the latter. Although Italian PILs comply with national legislation, by no means all of them adhere to the European schemata set in place by the EMA, which is why most still result in a more inflexible and remote package insert dominated by expert syntax and specialised lexicon. However, Italian PILs have started taking the first steps towards adopting the new EU frame of reference, which in turn has implied a higher match in design and layout, print, font, use of symbols and pictograms and inevitably in syntactic and stylistic terms. It goes without saying that in the long run such adjustments also lead to macrostructural and lexical simplification by allowing for a more consistent patterning across languages and, as a result, fewer shifts in translation are likely to take place.
Resurrecció & Davis (2007, p. 47) aptly observe that “as a medical translator it is important to be aware of the dynamism and complexity of medical communication”. Consequently, medical translators faced with the prospect of translating English PILs into Italian are required to negotiate an abundance of problematic issues relating to differing textual organisation, verb tenses, stylistic devices and myriad micro-level properties, whereby accurate content transfer is dependent on a full understanding not only of the ST (source text) but also of TT (target text) and target culture (TC) requisites.
This perspective indicates that apart from a solid command of the linguistic and practical intricacies of the original text, a strong awareness of the challenges posed by diverse recipient expectations across languages and cultures is paramount in the translation of a specialised context such as a PIL. It also implies that priority should be given to the communicative aim of the medical text as well as the intended readership, for an improved accuracy and consistency of translation, especially as the PIL genre is directed at a TA made up of increasingly questioning and inquisitive patients who expect to receive, in fact demand, unequivocal and transparent information. In short, as stressed by Kenny et al (1998, p. 476) patients actually want the information contained in PILs.
Finally, it is hoped that by exposing the need to bridge the gap between currently available PILs and the information which patients actually require, greater attention may be given to the improvement of PIL legibility and usability across EU languages.


BIBLIOGRAPHY:

Cacchiani, S. (2006). Dis/Similarities between patient information leaflets in Britain and Italy: Implications for the translator. New Voices in Translation Studies 2, 28-43. Retrieved from http://www.iatis.org/images/stories/publications/new-voices/Issue2-2006/cacchiani-paper-2006.pdf

Kenny, T., Wilson, R.G., Purves, I.V., Clark, J., Newton, L.D., Newton, D.P., & Moseley, D.V. (1998). A PIL for every ill? Patient information Leaflet (PILs): A review of past, present and future directions. Family Practice, an international journal, 15(5), 471-479. Retrieved from http://fampra.oxfordjournals.org/content/15/5/471.full.pdf+html

Resurrecció, V. M., & Davies, M.G. (2007). Medical translation step by step – Learning by doing. Manchester: St. Jerome Publishing.


RESOURCES:

Decreto Legislativo 24 aprile 2006, n. 219 [Legislative Decree of April 24, 2006, n. 219]. Retrieved from http://www.aimn.it/lex/DLgs_219_2006_medicinali.pdf

Decreto Legislativo 30 dicembre 1992 n.540. Attuazione della direttiva 92/27/CEE concernente l’etichettatura ed il foglietto illustrativo dei medicinali per uso umano [Legislative Decree n. 540 of December, 30, 1992. Implementation of directive 92/27/EEC on the labelling of medicinal products for human use and on package leaflets]. Retrieved from http://www.salute.gov.it/imgs/C_17_normativa_579_allegato.pdf

Devitt, A. (2004). Writing genres. Carbondale, IL: Southern Illinois University Press.

Directive 92/27/EEC. Council directive 92/27/EEC of 31 March 1992 on the labelling of medicinal products for human use and on package leaflets. (1992). Official Journal L - 113 , 30/04/1992, 0008–0012. Retrieved from http://www.ikev.org/docs/eu/392L0027.pdf

Directive 2001/83/EC of the European Parliament and of the council of 6 November 2001 on the community code relating to medicinal products for human use. (2004). Official Journal L – 311, 28/11/2004, 67– 128. Retrieved from http://www.edctp.org/fileadmin/documents/ethics/DIRECTIVE_200183EC_OF_THE_EUROPEAN_PARLIAMENT.pdf

Directive 2004/27/EC of the European Parliament and the council of 31 March 2004
amending directive 2001/83/EC on the community code relating to medicinal products for human use. (2004). Official Journal L – 136, 30/04/2004, 34– 57. Retrieved from http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:136:0034:0057:EN:PDF