10 March 2021

Bilingual patient information leaflets: How translation can protect the right to health

Categoria: Linguistic Services

The right to health is a fundamental right recognized in a wide array of official documents, ranging from the Italian Constitution to the Universal Declaration of Human Rights.

For citizens, the choices and opportunities deriving from this right are manifold. It entitles them to live in a healthy environment, receive necessary medical care if they are sick and choose not to be treated if that is their wish.

An important part of this right is having access to patient information leaflets that accompany medicines – in their native language.

It might seem banal, but patient informational leaflets are documents of primary importance because they enable patients to take their prescribed medication safely and correctly.

They include important information such as the composition of the medicine, therapeutic indications, consumption methods and dosages, storage requirements and any side effects.

The information contained in these leaflets complies with the content of the Summary of Product Characteristics (SPC), which is primarily targeted at healthcare workers such as doctors, nurses and pharmacists.

Unlike the SPC, however, the patient information leaflet is – as the name suggests – targeted at patients. As such, it’s important that it be easy to understand. As we all know, taking a medicine improperly can have grave consequences for a patient’s health.

Though it’s certainly true that patient information leaflets should be easy to understand for all patients, it’s also clear that other special factors are at play in bilingual regions such as Alto Adige in Italy.


The importance of translating patient information leaflets for medications


Even though it’s important to heed the advice of your doctor when it comes to taking medicine, the patient information leaflet is still a useful document that the patient can refer back to whenever they have doubts or simply want to get additional or more specific information on the medicine that’s been prescribed to them.

It’s not hard to see why it’s so important to ensure that this valuable document be available in the native language of the patient.

This isn’t an issue in countries where just one language is spoken, but it can become one in regions such as AltoAdige, in Italy, where there is a split between native speakers of German and Italian.

In these areas, where constant compromise is the only reason two languages can coexist side by side, legislators intervened to right a wrong that would have compromised the inhabitants’ right to health.

Previously, patient information leaflets were only available in Italian, but Legislative Decree 283 of 29 May 2001 introduced “mandatory bilingualism in medicine labeling and information sheets”.

Today, all medicine labels and information sheets produced in Trentino Alto Adige must be available in German too, in order to ensure that all citizens can understand them and avoid discrimination.

It’s certainly not a given that all citizens can understand specific medical terms in Italian, which is why it’s important for this information to be provided in German, the mother tongue of a large part of the local population.

Thanks to this change in the law, a German translation of the information leaflet can be printed by the pharmacist when a medicine is handed over.


Translating patient information leaflets is therefore a way of ensuring that the right to health is respected, allowing all to access this information and thus take their prescribed medication properly.


To translate such a document as important as a patient information leaflet for use in bilingual areas, it’s essential to use a professional service that can guarantee terminological accuracy, uniformity, linguistic rigor and reliability.

At Way2Global, we provide quality services that tick all of those boxes, drawing on the experience and ongoing training of our professional, native speaker translators.

In addition to the translation process, we also provide all the additional services required both before and afterward, including formatting, quality control, alignment, back translation (if requested), the production of bilingual patient information leaflets and FIT forms in German Alto Adige.

It’s an honor and a privilege for us to help to protect the health of our fellow citizens through our translation services.

Need a translation for the pharmaceutical sector? Contact us!


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