US firm suspends import of human tissue from Ukraine
its German subsidiary Tutogen Medical. The International Consortium of Investigative Journalists reported in July on RTI’s relationship with morgues under investigation for allegedly forging documents or bullying families into signing donor consent forms.
“We comply with comprehensive regulations, both from U.S. regulatory authorities and those of other countries, that govern each and every activity performed by tissue banks,” RTI said.
Ukrainian law, like U.S. law, requires donors or their loved ones give express consent before tissue can be recovered.
The trade in human parts is a billion-dollar industry that is growing and changing so rapidly, legislation has a hard time keeping pace. It is illegal in most countries to buy or sell human parts, but companies can charge fees for handling the tissue. RTI is a publicly-traded company that warns its stockholders, “the supply of human tissue has at times limited our growth, and may not be sufficient to meet our future needs.”
Sept. 6 statement of RTI Biologics
RTI obtains tissue from more than 30 procurement agencies in the United States as well as in places such as Ukraine. The company supplies hospitals in more than 30 countries and in all 50 states. Records show the company has offered Ukrainian tissue to hospitals in New York.
German officials had planned a September inspection of 10 Ukrainian morgues that supply Tutogen, according to Ines Schantz, a spokeswoman for the Upper Bavarian government in Germany. But the company withdrew its licenses to import tissue from Ukraine into Germany on August 20.
The German government subsequently cancelled its plans to inspect the foreign tissue agencies. “After the removal of all the institutes from the import license, there was no legal basis any longer to perform the planned inspection,” Schantz said.
She said German authorities continue to investigate human tissues already imported from the Ukraine.
The International Consortium of Investigative Journalists’ eight-month investigation revealed that Tutogen, which was acquired by RTI in early 2008, has for years relied on its Ukrainian suppliers for a significant amount of human tissue in spite of concerns raised within the company more than a decade ago and a series of subsequent investigations.
In a 2001 memo marked “Strictly Confidential!!!!” Tutogen urged an exit strategy from Ukraine. Operating in Ukraine was “high risk,” company executives wrote.
Their middleman there, Igor Aleschenko, was asking for more and more money to play the role of intermediary between the regional satellite morgues around Ukraine and Tutogen in Germany.
“The flow of money is difficult to track,” the memo read. “Direct control over our resources is impossible.”
“We can’t control the activities of the middlemen, and commitments are not being honored,” the memo read.
On the other hand, remaining in the country would “buy us time to win over other donor countries,” the memo read. “Rebuilding a source of donors is crucial... More donors are required.”
The company didn’t pull out of Ukraine and it continued to work with Aleschenko.
Since then, Ukrainian authorities have launched at least four criminal investigations into allegations of illegal issue recovery by Tutogen suppliers, all of which are registered with the Food and Drug Administration, the U.S. agency that oversees the trade.
Families in Kyiv complained to police in 2005 that a morgue supplying Tutogen was taking tissue without proper consent. The criminal case was closed after an initial investigation. Prosecutors determined that, under Ukrainian law, they couldn’t prove a crime had been committed if they couldn’t prove that the tissue had been transplanted into someone, court records show.
Frozen, preserved skin from corpses is defrosted in water and then stretched out so its application to humans during surgery is easier. This is from the Queen Astrid Military Hospital in Brussels, Belgium. (Mar Cabra/ICIJ)