The Top 4 Challenges in Translating Medicinal Product Information

Besides the challenges of medical translation mentioned above, which are also present here, SmPC and PIL translation comes with its specific challenges that either do not exist or are less common in other areas of medical translation. The four key challenges are:

• Compliance with QRD templates
• Dealing with deviations from QRD templates in the source text
• Translating for the target audience: medical professionals and patients
• Translating updates to the source text

Now, let’s look at each of these challenges in more detail.

While translating a QRD-based SmPC document, the linguist must compare the source text to the English QRD template and use the relevant translation in the target text where appropriate. However, besides identifying the parts of the source and QRD template that match, the linguist must also be able to identify those that do not, or only partially, match. For example, when translating section 5.3 ‘Preclinical safety data’ of an SmPC document, the linguist may come across a situation similar to this:

Source text:
Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use and development.

QRD template:
 <Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.>

This example shows that the source text is very similar to, but still slightly different from the corresponding template text, where the only actual difference is in the addition of ‘and development’ in the source.

It is the linguist’s task to be able to identify differences like this and to ensure that the translations for the matching parts correspond to the template, while making sure that the translated text also accurately reflects the non-matching parts. This example might appear as quite straightforward, but the differences may be slight and nuanced, they may be consistent or inconsistent within the same document, or they may be intentional or unintentional, and resolving them may require the linguist to ask the client to step in and provide guidance.

The ability to effectively deal with situations like this in SmPC translations is a skill acquired over time. Simply having experience in other types of medical translations does not, by itself, prepare the translator for this challenge, which underscores the importance of involving experienced SmPC linguists in your SmPC translation projects.

Instructions for medicines contain two main parts: the Summary of Product Characteristics (SmPC) - a document intended for healthcare professionals - and the Package Leaflet, known as a Patient Information Leaflet (PIL), which is aimed at patients and anyone else who needs to read and understand the information and is not a medical professional, such as a parent who needs to understand how to use the medicine to treat a child.

Based on SmPCs, PILs are aimed at providing the most important information about the medicinal product to the user in plain and clear language. For example, PILs explain what the medicine is used for, what you need to know before using it, how to use the product, what the possible side effects are, and how to store the medicine. Just like a practicing physician may find it difficult to explain complex medical conditions and diagnoses to the patient, the authors of Package Leaflets - and the linguists translating them - must make sure that the explanation correctly describes any concepts from the medical point of view, while making sure that it is patient-friendly and that the patient or user of the medicine will actually understand it.

PILs can be thought of as simplified versions of SmPCs and may include additional explanations. Consider the following example of the same side effect that could typically be found in the SmPC and PIL documents for a specific medicine:

SmPC:
Guillain-Barré Syndrome

PIL:
Guillain-Barré Syndrome (an immune system disorder that causes nerve inflammation and can result in pain, numbness, muscle weakness, and difficulty walking)

In the SmPC example, the syndrome is simply named, while in the second example it is additionally explained in brackets. An additional explanation is not provided in the SmPC version, as healthcare professionals are expected to either be aware of or be able to quickly find and understand information on the particular syndrome, while an explanation is added in the patient-facing PIL document. It is the job of the linguist working on the translation to make sure that both the SmPC and PIL versions are translated accurately with the target audience in mind.

SmPC and PIL translations are a specific subfield of linguistic work in the medical domain with specific challenges. Besides experience in translating medical content, professional SmPC and PIL translators must be aware of and closely follow QRD templates, including dealing with deviations from the templates in the source text, they must be aware of the target audience for specific documents - physicians and users of the medicine - and, in addition to translating complete documents from scratch, they must be able to deal with updates to the source text where it is only necessary to translate the parts of the source text that have been changed.

At AD VERBUM, medical translations are performed by experts in the field with years of experience, who follow the strict ISO-approved quality standards to ensure compliance of your SmPC and PIL translations with regulatory requirements, and to make the process as smooth as possible for you. Find out more on our website, in our blog, and contact us to get started with your SmPC translation projects.