[Ip-health] EU wants to simplify drug tests on humans

Riaz K Tayob riaz.tayob at gmail.com
Thu Jul 19 02:14:11 PDT 2012


[Bush wanted to have liability for drugs reduced... now we have 
regulatory competition... but can they really reduce standards as much 
as Nigeria (where Pfizer killed some Africans, but they are cheap so EU 
will have a tough job...making it profitable)...]

European Commission


  EU wants to simplify drug tests on humans

18 July 2012
Presseurop
Berliner Zeitung
Berliner Zeitung 
<http://www.presseurop.eu/en/content/source-information/80511-berliner-zeitung>, 
18 July 2012

"The EU wants to control drug tests," headlines German daily /Berliner 
Zeitung/. The proposed regulation 
<http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:121:0034:0044:EN:PDF> 
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/ 
<http://www.fr-online.de/wirtschaft/medikamententest-versuche-an-menschen-werden-einfacher,1472780,16646448.html>. 
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.




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