We’ve blogged about medical translators and interpreters for Colorado hospitals, clinics and doctors’ offices and about professional pharmaceutical and technical translation services in the context of patent cases. As the cost of developing drugs within the pharmaceutical industry has skyrocketed to nearly a billion dollars in the United States, more and more companies are conducting their research and development and trials in foreign countries.
However, this raises issues of which laws govern the development program – the US or the foreign country?
US law sets out very strict regulations on drug development and testing, particularly on human subjects. Often times pharmaceutical companies run their test in developing countries, where regulations are less strict or even non-existent. Although US law has taken some steps to fill this gap, overall the laws today are unclear – leaving foreign clinical subjects without any grounded legal protections or options.
Case law has made more headway in granting these protections. For example, a recent Second Court decision allowed injured Nigerians to recover under the Alien Tort Statute. Another area where courts (and legislation) can increase regulation of this outsourcing trend is in the basic rules of contract law, which traditionally holds that informed consent is required. When operating in a foreign country, this means that the informed consent must be provided not only with a foreign language translation, but also in terminology that can be understood by individuals not affiliated with pharmaceutical industry.