"The EU wants to control drug tests," headlines German daily Berliner Zeitung. The proposed regulation presented by EU Health Commissioner John Dalli on July 17, aims to simplify procedures for clinical trials on humans.
Currently, the pharmaceutical industry, which finances international clinical trials, faces a number of legal discrepancies within the EU, a complementary article in the Frankfurter Rundschau. The industry has thus left Europe to proceed with trials elsewhere, preferably in emerging nations. The number of clinical tests made in Europe fell from 5,000 in 2007 to 2,800 in 2011.
In emerging Asian and South American nations as well as in Russia, where the requirements are less costly, 20,000 medical drugs are tested on human guinea pigs each year, according to Wemos, a Dutch patients' rights organisation. The 40% difference in cost is a weighty argument for the laboratories because clinical tests can represent half of a medical drug's development budget – about 1 billion euros on average per product.
To adapt to the hard facts, the European Commission is seeking to kill two birds with one stone: to make Europe more attractive by simplifying authorisation procedures through the creation of a central authority competent in all European countries; to ensure that European clinical trial standards are respected by all European firms operating outside of Europe.
This second measure concerns India, in particular, since it eased clinical trials on human guinea pigs in 2005. Many of the test subjects, who must confirm by signature that they are informed of all the possible side-effects, are illiterate or minors lacking parental consent.
The Council of Ministers and the European Parliament must now discuss the proposed regulation, which would be more binding than the current directive on clinical trials. It is expected to come into effect in 2016.