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  Ethics: from the shadows to the spotlight

No less than fourteen members of the European Parliament took part in the lunchtime debate that Wemos organized in Strasbourg (on September 14, 2011) on the subject of unethical drug trials in developing countries. Such a large turnout is unique in the history of Wemos and clearly shows the effectiveness of our lobbying strategy. After the debate, Annelies den Boer from Wemos addressed the European Parliament’s Bioethics Committee. She is impressed by the European measures in the pipeline to combat unethical trials.

In addition to members of the European Parliament, representatives of the European Commission, the European Medicines Agency and the pharmaceutical industry took part in the sessions held last week in Strasbourg. They listened to presentations by Wemos, the Centre for Research on Multinational Corporations (SOMO) and India’s Centre for Studies in Ethics and Rights (CSER). Annelies den Boer showed an excerpt from the film Body Hunters (2010), in which an Indian man tells how his son died after taking part in a medical trial.

Reaping the rewards
In determining their message, Wemos, SOMO and CSER consciously focused on the question of what is important to the people in developing countries. Den Boer explains “They should reap the rewards of the research that is being carried out on them or in their country. For example, they should continue to receive good healthcare after participating in a trial. At present, the end of the trial often means the end of their treatment. That goes against current ethical guidelines.” In response to this point, the German member of the European Parliament Peter Liese of the Christian Democrats promised that the European Parliament would work with the European Medicines Agency to find a solution to this problem.

Trump card
Representatives of the European Medicines Agency acknowledged explicitly for the first time in Strasbourg that they hold an important trump card for promoting ethical trials outside of the European Union, in the form of the registration procedure for new medicines. Den Boer sees this as a sign of significant progress compared to one year ago. “They have made genuine advances.” The Agency announced that it would be presenting concrete proposals in October. These include asking pharmaceutical companies to detail the measures they have taken to guarantee access to care once a medical trial has ended. The Agency also plans to include a section about compliance with ethical guidelines in its assessment reports, made public after a market licence is granted. This will make it easier for organizations such as Wemos and SOMO to keep an eye on how pharmaceutical companies conduct themselves. Den Boer observes that such a measure seemed more or less unthinkable until last year.

Constructive approach
The large turnout by members of the European Parliament and the progressive measures being developed by the European Medicines Agency demonstrate how successful Wemos and its partners have been in getting the topic of unethical drug trials on the political agenda and keeping it there. In recent years, Wemos, SOMO and CSER – acting on request and proactively – have been providing technical advice on how ethical guidelines for medical research could be made applicable to people in developing countries. They have also continued to highlight the seriousness of the issue by sharing examples of unethical research with politicians, policy makers and the media. The benefits of this constructive approach are now making themselves felt and people in developing countries – and in particular human test subjects – are better off for it.

Hammering away
In response to the question of what Wemos plans to do in the coming period, Den Boer answers “We will keep hammering away on the issue of human test subjects in developing countries. Not only the importance of good access to healthcare once a trial has ended but also compensation for people who have taken part in an unsuccessful trial and holding companies accountable if they act unethically.” In addition, Wemos is keen to take up a new drugs-related theme which crosses national boundaries: resistance to antibiotics. As Den Boer puts it “By encouraging responsible use and the development of new antibiotics, Wemos wants to contribute to ensuring that antibiotics remain available to future generations, both here and in developing countries."

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Read the paper that SOMO and Wemos wrote for Strasbourg.

More information on Wemos’ work on medicines
 


 

 

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Call for Ethical Clinical Trials
in Developing Countries

c/o Wemos Foundation
Ellermanstraat 15-O
P.O. Box 1693
1000 BR Amsterdam
The Netherlands
Phone +31 20 435 20 50
Site www.wemos.nl
E-mail info@wemos.nl