EU: NO LICENCE FOR MEDICINE IN GM GOAT MILK

An application to licence the world's first medicine to be produced from a genetically modified (GM) animal was turned down by the European Medicines Agency (EMEA) on 24 February. GTC Biotherapeutics, a company based in the US, engineered goats to contain a human gene that codes for anti-thrombin, an anticoagulant. The result was goats that produce in their milk a substance that inhibits blood clots from forming. The medicine, called Atryn, would have been used by people with an inherited disease leaving them prone to developing blood clots. However, the EMEA decided that the company applying for the licence had failed to demonstrate the benefits of the drug outweighed its risks. EMEA said the testing process on patients giving birth or undergoing surgery was insufficient and not supportive. On the other side of the Atlantic, the US Food and Drug Administration (FDA) is continuing to consider a preliminary report that showed that meat and milk products from cloned farm animals and their offspring were as safe for human consumption as conventional animals, though a regulatory decision on food from cloned animals has been postponed for several months and is expected soon (see Bridges Trade BioRes, 24 June 2005, http://www.ictsd.org/biores/05-06-24/inbrief.htm#6). The World Organization for Animal Health (OIE) at its last General Session decided to undertake further investigations on the need for international standards on the use of animals that have been genetically engineered to produce medicines or chemicals (see Bridges TradeBioRes, 10 June 2005, http://www.ictsd.org/biores/05-06-10/story3.htm).

ICTSD Reporting; "'Pharmed' goat drug not approved," BBC NEWS, 24 February 2006; "'Pharmed" goats seek drug licence", BBC NEWS, 22 February 2006.

 

Web Link: http://www.ictsd.org/biores/06-03-03/inbrief.htm#5