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Medical translation is a complex area that presents various challenges, as such translations require subject matter knowledge and complete accuracy both linguistically and medically, which is why professional medical translations need to be done by linguists with appropriate expertise and experience.
Being quite a broad area, medical translation can be further divided into smaller subareas, such as medical device translation, patient record translation, pharmaceutical research translation, translation of medical guidelines and information for the general public, clinical trial translation (including patient-facing documents and content for the study staff and the relevant authorities), medical patent translation, SmPC/PIL translation, and others.
In the European Union, product descriptions for medicines are referred to as SmPC and PIL documents.
An SmPC, which stands for Summary of Product Characteristics, can be defined as a detailed document that describes the properties and composition of and the benefit-risk assessment for a medicine (known as a medicinal product), as well as the conditions for its use. SmPCs serve as the key sources of information about a medicinal product and are intended for medical professionals.
A PIL, which is short for Patient Information Leaflet (aka Package Leaflet), is a document that describes the main characteristics of a medicinal product. PILs are intended for patients and caregivers. PILs are based on SmPCs and include the most important information on how to take the medicine, written in simple language that people without specialized medical knowledge can understand.
To make matters more interesting, this is just the terminology for the EU, and another set of terms is used in the United States, where the document included in the packaging of a medication is called a Package Insert, while the patient-facing document is referred to as a Patient Package Insert.
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:
Now, let’s look at each of these challenges in more detail.
While medicines are unique and used to treat or prevent a variety of different conditions - and their properties and prescription information are different - all SmPCs and PILs have a fixed structure, which follows QRD templates. Developed, reviewed, and updated by the European Medicines Agency’s (EMA) Working Group on Quality Review of Documents (QRD), the templates for medicines are available on the EMA website.
In order to receive marketing authorization (resulting in the pharmaceutical company receiving a licence to market and distribute the medicines), the original SmPC/PIL documents must be drafted in accordance with the QRD templates. When translating them into European languages, the translations must also be QRD-compliant.
For example, when translating SmPC/PIL documents for human medicines, the linguist doing the translations is obligated to make sure that the translations are in line with the corresponding target language templates, which they can find by navigating to the appropriate section of the EMA website and selecting the relevant templates.
Achieving QRD compliance in SmPC/PIL translations is far from an easy task, as it requires meticulous work in which the linguist compares the source English text to the English QRD template and, if it matches, uses the corresponding translation from the target language QRD template, with the first step being to identify the correct template to use.
The EMA website provides access or reference links to all of the templates that may be relevant, as well as additional resources, including terminology resources (such as MedDRA), specific guidelines (for example, on guidelines on the labelling of product packages specific for Denmark, Finland, Iceland, Norway, and Sweden), and more. Navigating this wealth of information and the abundance of requirements is a challenge for translators, revisers, and QA specialists working on SmPC translation projects.
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:
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.
<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:
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.
Translating Updates to the Source Text
The source text for SmPC and PIL documents may be updated after the initial draft, and the updates are often implemented in tracked changes mode. If the initial draft has already been translated, the translator may receive the updated source text with the updates tracked and may be required to translate those changes accordingly, to make sure that the changes made to both the source and target texts can be identified and checked quickly.
Consider this simple example where the source text has been updated, with the corresponding tracked changes implemented in the target text.
English source text with an update in tracked changes:
For storage conditions after first opening of the medicinal product, see section 6.3.
Example Latvian translation with the update translated accordingly in tracked changes:
Uzglabāšanas nosacījumus pēc zāļu pirmās atvēršanas skatīt 6.3. apakšpunktā.
In this example, the original sentence was ‘For storage conditions after dilution of the medicinal product, see section 6.3’, which was later updated to ‘For storage conditions after first opening of the medicinal product, see section 6.3’ in the tracked changes.
This is particularly important, for example, if the translation of the original draft version has already been reviewed and confirmed, and it is only necessary for a reviser to check the changed content, i.e., the tracked changes. Imagine that you have a 100-page document and just a few words or sentences updated here and there in the source text. If the translator were to just translate the changes without marking them in any way, it would make it very difficult for anyone checking those translations to find the changed content. This may get rather challenging, however, when the source text contains a lot of changes, including updates to the parts of the source text that are in line with the QRD template, or updates to any graphics in the document and layout updates, which may be challenging to implement in tracking. Therefore, it is important for SmPC translations to undergo careful revision and QA checks before the work is finalized.
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.
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