Medication Information for Patients with Limited English Proficiency: Lessons from the European Union

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Applicant companies must translate English-language versions of medication information into 24 languages, for a total of 25 languages, plus Braille. These 25 languages consist of Bulgarian, Croatian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Icelandic, Italian, Latvian, Lithuanian, Maltese, Norwegian, Polish, Portuguese, Romanian, Slovak, Slovene, Spanish, and Swedish. Twenty three of these 25 languages are official languages of the E.U. Norwegian and Icelandic are not official languages of the E.U., but Norway and Iceland take part in the Agreement on the European Economic Area, which includes them in many E.U. processes that reduce trade barriers, including the Centralized Procedure. Additionally, Croatia is not a member of the E.U., but is widely expected to become a member on July 1, 2013, and EMA regulators have directed companies to translate new medication information into Croatian. Braille translations must be available in all E.U. countries at the consumer's request. In countries with multiple official languages (e.g., Belgium), translations must be made available in each of the official languages of that country. Irish is the only official E.U. language not required for translation. The E.U. recognizes five regional languages as “semi-official” languages, such as Catalan, but none is required for medication information translation.

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See European Parliament and the Council of the European Union, supra note 48.

See European Commission, supra note 50.

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See European Parliament and the Council of the European Union, supra note 48.

See European Medicines Agency, supra note 46.

The guidance does not specify the precise translation process or method (e.g., back translation) pharmaceutical manufacturers must use to prepare the translations. For more information, see European Commission, Guideline on the Readability of the Labeling and Package Leaflet of Medicinal Products for Human Use, available at <http://ec.europa.eu/health/files/eudralex/vol-2/c/2009_01_12_readability_guideline_final_en.pdf> (last visited December 10, 2012).

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Personal communication with a pharmaceutical executive, 2011.

See U.S. Census Bureau, supra note 10; Institute of Medicine (Workshop Summary), supra note 1.

See Heidenreich , supra note 61.