By Margrete Auken MEP - 21st November 2011
Clinical trials are a necessary evil. Drugs need to be tested on humans before they can be deemed safe. However, whether they should take place in developing countries is not so easy to accept
Margrete Auken MEP
The EU has a responsibility to ensure that clinical trials are undertaken in developing countries in the safest possible manner, writes Margrete Auken.
Lack of information, treatment for side effects, regulation. The problems are numerous when it comes to drug trials in developing countries. For drugs tested within the EU there are ethical concerns to be dealt with, and we have regulations in place to do so.
However, pharmaceutical companies increasingly follow the profit margin to test new drugs in poorer countries, where the cost is lower, the participants more willing and regulations less stringent.
Clinical trials are a necessary evil. Drugs need to be tested on humans before they can be deemed safe. However, whether they should take place in developing countries is not so easy to accept.
People in developing countries must be considered more vulnerable, economically and socially, and vulnerable people should not be allowed to participate in clinical trials.
Many of the horror stories I have heard about this topic revolve around desperate people, so poor that they have no other choice than to participate in drug trials that might harm or even kill them.
They are often uneducated and unable to make an informed decision about the trials they participate in, even if poverty had not left this as their only remaining option of survival. They are not informed about the danger of participating in more than one trial at a time and it is almost certain that they will not receive follow-up treatment or compensation if something goes wrong.
And unfortunately, most of these drugs will never benefit the people participating in the trials. Most research is meant for the European and American markets and yet we only take them when all kinks have been worked out. We pay a poor person to risk his live for us, like a modern day food-taster.
We have heard this story before. This is not the only case in which desperate people are willing to harm themselves physically in order to get money to help their families survive.
However, there is much more knowledge among Europeans when it comes to issues like sex-tourism and the trade in human organs. The same knowledge, disgust and contempt is necessary when it comes to European pharmaceutical companies conducting unethical clinical trials in developing countries.
There are two things I think the EU must do in order to combat unethical, unsafe and illegal clinical trials done outside the borders of the union. First, we have to increase the transparency of clinical trials conducted outside the EU.
The trial sites should all be included in the public EU clinical trials register and thus be treated in much the same way as trials done within the EU. The ethical aspects should be dealt with by a report on pharmaceutical companies’ compliance with ethical guidelines.
If that is not enough, and I worry that it won’t be, then we as European legislators must take over. We did so when combating child sex tourism and have since 1996 put a concerted effort combating this horrible crime. The same can be done for illegal and unethical clinical trials.
We have to give our courts extra-territorial jurisdiction in this area. They should be allowed to punish any wrongdoing, even when the crime is not provided for under the laws of the country in which it was committed.
We, as European legislators, have a responsibility to ensure that no poor person is harmed due to European companies’ search for profit. We have the tools to act, and I for one will try to convince the commission on the need for legislation to combat this horrifying problem.
