US firm sus­pends im­port of hu­man tis­sue from Ukraine

Kyiv Post - - News -

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)

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