Global demand for medicines is set to rise as the population increases, ages and faces more disease. The 10 largest drugs companies control over one-third of the global pharmaceuticals market. Six of these are based in the United States and four in Europe.
A large and ever-rising proportion of clinical research is done in multi-country trials, and most drugs that are marketed in the US are developed or manufactured abroad.
CROs are conducting clinical trials worldwide on behalf of pharmaceutical companies. While this increases the patient pool, and the opportunity to get data from diverse ethnic backgrounds at a reduced cost, there is a greater need for accuracy in communication.
Although English is the ‘lingua franca’ of medical and pharmaceutical research and international scientific communications, this research is being conducted on behalf of millions of patients around the world. Not only do they participate in clinical studies and must fully comprehend the risks and benefits of the research they agree to be a part of, they are also at the centre of attention of the medical practitioner’s daily efforts and will ultimately use the medical devices and pharmaceutical products developed. Patients should therefore be addressed in a language they understand.
Accurate localisation is not just about translation. Done properly it involves cultural customisation, which requires an understanding of the culture, customs, local laws and regulations of the target country. For example, to successfully recruit participants for clinical trials, all patient-facing collateral must be specifically adapted to the language and culture in every respect.
European medical device directives state that each device must be accompanied by the information needed to use it safely, and that member states may require this information to be provided in their national language(s).
In some countries, even much of the study documentation addressed to investigators, such as clinical study protocols, has to be translated into the official language of the country in which the study is performed.
Conversely, study-specific documents written in the native language, such as essential correspondence with ethics committees, investigators, insurance companies, or national authorities, must be translated into English to be accessible to health authorities throughout Europe and beyond as part of the trial master file.
SmPCs and PILs issued by pharmaceutical companies have to meet the requirements of the drug regulatory authorities in the country/countries where the drug will be sold. For European Community countries, on top of the requirements of the country’s own drug regulatory authority this also means meeting the requirements of the European Medicines Agency (EMEA).
For medicines, the EMEA and the various national medicine evaluation agencies require that the Summary of Product Characteristics (SmPC), the Patient Information Leaflet (PIL), and the packaging and labelling texts be presented at least in the official language or languages of the Member States in which the medicinal product is placed on the market.
When more than one language is used, all the texts must be in each individual language and the contents of all language versions must be identical.
A manufacturer cannot apply for a drug registration without submitting the relevant translated and properly localised versions of these documents to the European or national regulatory authorities.
Although the direct cost of translation services is very small, translation can have a surprisingly large effect on several key factors. These include the total cost of the trials, the time to market, the possibility of lawsuits or rejection by regulators, and even the safety and efficacy of the marketed product.
