We’ve blogged about pharmaceutical translations in the context of the European Union’s fast track approval process for US pharmaceuticals, and about professional translations of foreign regulatory evidence in products liability cases. Professional pharmaceutical and technical translations provided by multilingual translation experts are equally important for the new sector of international law, pertaining to the use of human subjects for pharmaceutical testing and research. Since this practice is heavily regulated in the United States, many companies are turning to developing nations that typically lack such protections. As regulations and protections are being implemented – thus creating a new sector of international law- and as with any law involving various foreign jurisdictions, foreign language translations play an important role.
The foundation of this body of law arises with the post-World War II Nuremberg Trials, where Nazi physicians who engaged in human experimentation were charged with war crimes and crimes against humanity. The result was what is referred to as the Nuremberg Code, which sets the framework for both US federal regulations and international guidelines as applied to human experimentation.
The Nuremberg Trials led to the founding of the World Medical Association and the subsequent adoption of the Declaration of Helsinki, a body of international law that specifically addresses the ethics of research on human subjects. Further, the Council for International Organization of Medical Sciences – in collaboration with the World Health Organization – publishes international human subjects ethical guidelines based on the principles of both Nuremberg and Helsinki.
In terms of the United Nations, the International Covenant on Civil and Political Rights (ICCPR) addresses the subject. According to the ICCPR, “no one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment. In particular, no one shall be subjected without his free consent to medical or scientific experimentation.”
See Wollensack, Amy F. 2007: “Closing the Constant Garden: The Regulation and Responsibility of U.S. Pharmaceutical Companies Doing Research on Human Subjects in Developing Nations”. Washington University Global Studies Law Review. Vol 6:747.