Before a new drug can be released onto the market, it has to be tested on human subjects in order to assess its efficacy and safety. Increasingly, the pharmaceutical industry is carrying out these trials in developing countries.
For pharmaceutical companies, lower costs are an important reason to undertake trials in developing countries. Trials can also be carried out more quickly because regulatory constraints are less stringent, while the low level of income in developing countries means that people are often more willing to participate. However, there are good reasons to believe that trial subjects in these countries are more vulnerable than those in wealthier nations.
Firstly, the health systems in developing countries often function inadequately, leaving the poor without access to essential treatment. As a result, poorer citizens in need of medical attention may find themselves forced to participate in a trial. In addition, the end of a drug trial often means the end of all treatment, entailing serious risks for the trial subjects.
Secondly, one of the most fundamental requirements for clinical trials is that subjects are well informed in advance about the nature of the trial and the potential risks involved. Any agreement to take part must be voluntary. However, poverty, illiteracy, a hierarchical doctor-patient relationship and lack of access to treatment make this difficult to guarantee.
Thirdly, the care providers who carry out clinical trials in developing countries have not always followed the training needed to conduct such trials according to ethical standards. Furthermore, conflicts of interest may occur when doctors involved in clinical trials are paid large sums of money to recruit patients.