Tag Archives: Adverse Events

Medical and Pharmaceutical translation

Medical and Pharmaceutical translation is a highly specialised discipline and should only be carried out by translators with appropriate qualifications and sufficient experience. Ideally translators should have a medical or scientific background. Companies in the Life Sciences industry are facing increasing challenges to provide products that are in compliance with country regulations and product labelling standards. It is imperative that translators have a full understanding of the ever-developing medical terms and concepts in both the source and target language and that they are able to convey them in an accurate and completely comprehensible way to the reader, be it medical professional or patient. There is zero margin for error or misinterpretation when human health or life is at stake! And of course they can have serious medical and legal consequences.

Some of the main medical/pharmaceutical documents that are often sent for translation are Summaries of Product Characteristics (SPCs or SmPCs), Patient Information Leaflets (PILs), CTAs (Clinical Trial Applications) and patient discharge forms, as well as their related documentation. When dealing with such texts it is important for the translator to pay particular attention to the target audience. For example, a translator should be careful not to use complex medical jargon in a leaflet that is designed to encourage patients to join a clinical trial. Of course, the register of the source text should give an indication as to the level of language necessary for the translation, but translators should be wary of literal or calque translations, depending on the reader. A French to English medical translator may come across the condition ‘hypertension artérielle’ which could logically (and correctly) be translated as ‘arterial hypertension.’ This may well be appropriate for a document aimed at a medical professional, but it is more likely that the common English expression ‘high blood pressure’ should be used for those texts aimed at patients and non-medical professionals. Essentially, the key terminology should be precise, e.g. ‘study’ or ‘research’ should not be translated as ‘treatment’ and ‘replacement dose’ is certainly not the same as ‘additional dose’, and suitable for the target audience.

One of the areas in which the field of medical translation often overspills is that of law. Understandably, the law surrounding medical devices and medicinal products is extremely strict and any new drug, medicinal product or device must be rigorously tested before it can enter the market. This inevitably results in a vast amount of documentation and paperwork, such as, Clinical Trial Protocols and Agreements, forms detailing the Competent Authority’s authorization and the relevant ethic’s committee’s decision, not to mention any amendments or updates that occur during the process for which approval must be granted. Of course, if a manufacturer wishes to market its product in a country other than where it is based, it will require the use of a translator who is experienced not only in medical/pharmaceutical translation, but also one who has an in-depth and specialist legal knowledge. Such documents must also display the highest level of accuracy: the consequences of mistakes could be fatal and the responsibility put on the translator is great.

One of the most important bodies linked to medical and pharmaceutical translation is the European Medicines Agency (EMA), the organisation responsible for the scientific evaluation of medicines for use in the EU. It publishes templates and glossaries relating to standard wording that must be used in certain documentation, such as the aforementioned SPC’s and PIL’s, as well as with the reporting of Adverse Events (AE’s) or side effects. Any translator dealing with such texts must be fully acquainted with the EMA’s publications and keep up to date with their regular updates.

One of the main difficulties within the medical translation field is that documentation is constantly being changed and updated as new information comes to light from laboratory studies, clinical trials etc… New dosages are created and different pharmaceutical forms are produced, and whilst the authorities in the source language country are amending and updating their source texts, authorities in the target language countries are busy making linguistic changes to the translated documents, which then require checking or updating by an experienced translator. The process is long and often frustrating but it is a small price to pay to ensure the consumer’s health and safety.