Foreign Language Translation, Pharmaceuticals and International Property Rights

We’ve blogged about legal document translation and legal protections against research on human subjects in developing nations. One of the ongoing debates in international trade law is how to balance access to medicines with the intellectual property rights of the developers. And professional pharmaceutical and legal translation services play an important part in this process.Typically, this debate comes down along the lines of developed versus developing countries. Developed countries typically push for the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights to be interpreted as conferring price inflating monopolies over drugs that are neither patented nor patentable via guarantees of exclusive rights to clinical testing data needed to secure marketing approval.

On the developing country side, such an interpretation makes little sense as it allows wealthy foreign drug companies to sell life-saving drugs at a premium price. They believe that allowing later registrants to ‘free ride’ on the submitted data prevents waste and facilitates competition in the drug markets.

The result is an ongoing debate on what regulations should apply so as to strike a balance between the two competing interests of maximizing drug developers’ incentives to obtain new drug marketing approvals in developing countries and fostering free and fair competition in drug markets. As with any debate involving the interpretation of international law, various languages are involved. From the debate to the actual interpretation of the laws of the various involved countries, foreign language translation plays an essential role in the resolution of this issue.

Up Next: Legal Translation and Unfair Competition Under the Rome II Regulation