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Bilingualism, how the rules on drugs work for the province of Bolzano

Bilinguismo a Bolzano

Article 80 of Legislative Decree no. 219 of 24 April 2006 – i.e. the Italian implementation of Directive 2001/83/EC (as amended) on the Community code relating to medicinal products for human use, as well as Directive 2003/94/EC – establishes the norms regarding the language to be used for the drafting of the product information of the medicinal products sold in the province of Bolzano.

In particular, under comma 1, it is provided for that the information referred in the provisions of articles 73 (immediate and secondary packaging), 77 (labelling) and 79 (signs and pictograms) of the same Decree are supplied also in German in this province.

The availability of this information also in German is a rather delicate issue, which pharmaceutical companies often struggle to understand, especially if foreign companies; however, the application of the rules on bilingualism is very important and should not be underestimated.

A bit of history

The Italian Region Trentino Alto Adige is – together with Valle d’Aosta, Friuli Venezia Giulia, Sicily and Sardinia – a region with a special charter.

This charter is provided for by the Italian Constitution and grants special forms of autonomy to these Regions, in consideration of historical and geographic reasons.

In this way, some specific characteristics of these Regions – with potential impact on their management – were acknowledged: the insular nature of the territory, in the case of Sicily and Sardinia; and the presence of substantial linguistic minorities in the case of Valle d’Aosta, Friuli Venezia Giulia and Trentino Alto Adige.

The latter, due to historical reasons dating back to the first world war, presents the peculiarity to have a whole province with German native speakers, and has in turn divided its territory in two autonomous province (Trento and Bolzano) to better manage the needs of the linguistic group. Article 80 of Leg.Dec. no. 219/2006 exactly serves the purpose of protecting such needs in the field of pharmaceutical services.

Drug bilingualism for Bolzano

Beyond the rules, let’s see how bilingualism works in the field of drugs. When a drug is authorised by the Italian Medicine Agency, the MA holder has the obligation to provide the whole set of information of this product in a bilingual version, i.e. in the Italian and German languages.

The Italian texts are those authorised by the Italian Competent Authority (AIFA) during the product registration and supplied directly with the authorisation decree. These are just the texts to be translated into German to market the drug in the province of Bolzano.

It happens, in fact, that companies with products authorised via European procedures have the product information already available in German for the Member States where this is the official language. However, it should always be remembered that, also in the case of European procedures, there are national requirements to be complied with, and that the patients of the province of Bolzano, although being German native speakers, are still Italian citizens.

The German translation of the package information leaflet and labelling of a drug, as authorised by the Italian Agency, must therefore be performed and then sworn by a translator registered at a court, to confirm its faithfulness and accuracy.

Such translation is then sent in a special format (along with coloured pictures of the relevant packs in Italian) to the service offered by Unifarm, the Pharmacist Union of Trentino-Alto Adige, that will make it available for the pharmacies on the province’s territory.

Comma 1 of article 80 establishes in fact that “the version of the package leaflet in German can be made available to the users at the pharmacy upon purchase”.

The modality applied by Unifarm, i.e. the printing of the package leaflet by pharmacists when a German-speaking patient buys the products, protects on one side the right of the patients to have access to the drug information in their language, on the other it saves money that companies should spend in additional costs for re-packaging.

On this regard, it should be reminded that Leg.Dec. 219/2006 also provides for the complementary use of foreign languages, but this solution is usually not taken into account, also and especially due to a lack of space on the packs.

Finally, the rules on bilingualism impose that only the labelling and the package information leaflet should be available in German in the province of Bolzano: holders have no obligation to provide the SmPC translated into German, and they are also exempted in case of drugs not intended to be provided to patients directly.

Written by: Maria Pia Felici

Foto di Tumisu da Pixabay