Pharmaceutical and Medical Packaging News
Magazine
PMPN Article Index
Originally Published March 1999
LANGUAGE
Long an afterthought, translation has now become a key issue in medical device and pharmaceutical labeling.
by Robert Sprung
Since 1989, Robert Sprung, chairman and founder of Harvard Translations (Boston), has been translating product inserts, specifications, and packaging materials into some 20 languages for companies like Johnson & Johnson and Bristol-Myers Squibb. Two years ago he also began serving as editor of Language International, a magazine covering the language industry. This is the first in a series of bimonthly columns intended to help PMP News readers produce accurate, cost-effective multilingual packaging and labeling.
Much has happened in the past 10 years in both language and healthcare labeling, challenging device and drug makers to keep up with changing international regulations while meeting production demands. To help PMP News readers who do business internationally, this column will address such questions in the coming year as:
- Quality: How can you validate the accuracy of translations?
- Graphics: How do you make the best use of space on product packaging and labeling, especially in light of differing international standards for icons and symbols?
- Technology: What tools, electronic or otherwise, can help streamline translation? Can automated translation replace, assist, or hinder a translator?
To begin to answer these questions, let's consider the challenges faced by companies that market products internationally.
Many U.S. firms once enjoyed a privileged position in international markets--as long as their product was in demand, English-only labeling might suffice. (One argument still heard widely is, "Our clients all speak English anyway.") But the language issue has a fresh urgency today, with the advent of regulations such as Europe's Medical Devices Directive (MDD), which states that in order for a product to be marketed in a given European Union (EU) country, its labeling must be printed in that nation's language. Healthcare product packagers can no longer print only in English, especially if they want to maintain an international presence.
Regulatory affairs professionals at medical device and drug firms have had to adapt quickly to the changes effected by the MDD and similar directives. Used to dealing solely with FDA, these specialists must now devise coherent policies for interpreting and dealing with occasionally divergent standards from international bodies such as the EU.
Since the MDD has only recently gone into effect (in June 1998), there has been no consensus on how to meet its requirements. Leading medical companies have interpreted it differently, resulting in divergent approaches to packaging and applying foreign languages. To market in Europe, a company must determine which languages to apply. For instance, both Finnish and Swedish are official languages in Finland. Some manufacturers who market there (or who expect to) have chosen to include Finnish labeling. Others, perhaps already selling in Sweden, consider Swedish sufficient to cover labeling requirements in neighboring Finland. Still others, consulting with regulatory contacts in Europe, believe English will suffice in Finland.
After a company determines which languages should appear on the labeling, its next task is to figure out how to accommodate the additional text. For every word placed on a package insert or label, there may be as many as 20 additional words if all of the official EU languages are included. Companies must determine whether packages require redesign to fit the transitions and how much text can be eliminated from internal documentation, cartons, and lidding.
Icons, which can eliminate the need for some text, present problems of their own. While the MDD harmonizes the use of icons throughout Europe, these symbols are not well understood in the United States. Some may even conflict with FDA standards. For example, many manufacturers selling in Europe have used the "See instructions for use" symbol (a triangle enclosing an exclamation mark) to refer users to an instructional insert. But FDA may find such an outer label too cryptic.
These are a few of the issues we'll explore in the coming columns. In the meantime, keep an eye on areas of potential conflict for your firm between FDA and emerging international standards, and do your best to minimize English verbiage on packaging. This will help reduce translation time, costs, and package reengineering.
Robert Sprung is the chairman and founder of Harvard Translations (Boston), a firm he started 10 years ago. Two years ago he also began serving as editor of Language International. To contact Sprung, send an e-mail to robert_sprung@htrans.com.
