Putting EU regulations for the protection of test subjects in developing countries on the agenda

The successful lobbying by WEMOS and SOMO, and the research by SOMO which formed the basis for it, have resulted in the European Medicines Agency (EMA) really getting to work now. The EMA will be implementing the current EU legislation on the testing of medicines for the European market on people outside Europe.

The EU legislation states that testing of medicines on people outside Europe must comply with the same ethical guidelines as those inside Europe, and that these ethical guidelines must be based, among other things, on the Helsinki Declaration. Nevertheless, up to now the European authorities which grant market access to medicines have not been monitoring this. In May 2010, the EMA published a paper providing a practical elaboration of the ethical guidelines which must be complied with in future in order to gain market access. This elaboration contains almost all the lobbying points of SOMO and WEMOS. An international consultation process on this elaboration was started in September 2010, with a large international meeting attended by all important organisations, interested parties and authorities worldwide.

Research by SOMO has shown that a huge shift is taking place in medicine testing, to low-wage and developing countries.  In many cases, it involves medicines which are used primarily in the West. The reasons for this are that it is much cheaper, the approval of research protocols is much quicker because the monitoring bodies are less strict, and finding test subjects is easier than it is in Western Europe. But the rights of test subjects are less well ensured than in the West. As the test subjects are usually poor and vulnerable, ethical guidelines such as those described in the Helsinki Declaration should be complied with as set down in law. Using several case studies, SOMO has demonstrated that this is certainly not the case. For example, certain placebo tests - which are no longer approved in Western Europe - are carried out outside Europe, and patients have suffered demonstrable lasting damage as a result.

The steps taken in the research and lobbying process included:

• In 2005, SOMO carries out a comparison of the 20 largest pharmaceutical companies, in terms of corporate social responsibility. The major shift in medicine testing to developing countries, along with its major ethical problems, turns out to be a subject which has not been taken up by social organisations, although critical questions have already been raised in the European Parliament.
• SOMO will be working together with WEMOS: the organisations will be publishing a briefing paper containing an overview of unethical medicine testing in 2006.
• In 2007, SOMO develops a number of case studies in detail which demonstrate that unethically tested medicines in developing countries gain access to the European market without any problems.
• WEMOS carries out research among EU authorities, which all admitted that they do not monitor tests carried out outside Europe on the basis of ethical guidelines, as stated in law.
• An expert meeting is held in Brussels at the end of 2007, organised by WEMOS. The meeting is attended by companies, NGOs from countries where tests are carried out, such as India, SOMO and MEPs.
• Questions are put to the European Commission by MEPs at the start of 2008, on the basis of SOMO research and lobbying by WEMOS.
• An expert meeting is held in The Hague in December 2008, attended by companies, SOMO, WEMOS, the CBG and members of the Dutch parliament.
• SOMO is commissioned by the European Parliament to write a report containing concrete recommendations as to how the rights of patients in developing countries can better be protected.
• The EMA draws up a work programme for 2008, in order to tackle the problem.
• A strategy paper of the EMA appears in December 2008, containing a plan of action. The references refer to two SOMO publications and a WEMOS publication, alongside the EU legislation.
• In 2009, the EMA sets up a working group, and in May 2010 the Reflection Paper of the EMA is published, containing a good practical elaboration of the ethical guidelines which must be met in future in order to secure market access.
• SOMO and WEMOS are invited to attend the International Workshop of the EMA for consultation in September 2010, and both give presentations.
  

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