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Friday, June 19, 1998 Published at 15:39 GMT 16:39 UK


Controls wanted on sale of human tissue

BBC Science Specialist Matt McGrath explains how the tissue is used
The trade in human skin, bone and other tissues is booming and European scientists say it needs to be better regulated.

The industry is already worth millions of dollars worldwide. In North America, two Canadian companies that set up skin banks have recently been given the go-ahead to sell the tissue commercially to burns victims.

The European Group on Ethics in Science and New Technologies (EGE) wants European Union governments to legislate to protect the interests of patients.

New technology

Human tissues play an important role in medicine. They are used to diagnose illness and to treat conditions - bone marrow, for example, is transplanted into patients suffering from leukaemia. But scientists are developing novel uses all the time.

Skin cells can be grown in the laboratory and, when sufficient numbers have been produced, grafted onto a patient with burns.

In contrast to organs, tissues do not require immediate transplantation and can be stored for a period of time. This raises serious issues of safety.

Storage banks

The EGE says new legislation should include tissues such as skin, bone, corneas, placentas and umbilical cords.

The EGE says the storage facilities that already exist are virtually unregulated, unlike the more familiar blood banks in every country.

It is particularly concerned that tissue might be removed from patients without consent and without payment.

Consent issue

Noelle Lenoir, the Chair of the EGE, says the UK is one of the more forward-looking countries.

"In England, even if there is no real regulation of human tissue banks, the common law principle of consent is very strong," she says.

"Compare this to France, where surgical residues, which are the main sources of human tissues, can be collected without consent. They are considered as belonging to the public at large."

The group has made four main recommendations:

  • Licensed banks should be given the responsibility of collecting human tissue to ensure its safety and that donation is free, voluntary and anonymous.
  • Consent should be absolute.
  • Information should be improved to encourage donation.
  • Tissue banks should operate on a non-commercial basis.
The group feels that this would send a strong signal to third world countries where tissue and organs often change hands for money.

"In the end we decided to keep the principle of free donation, with some compensation perhaps. We don't want to see the poor sell their organs or their tissues for the benefit of the rich," says Noelle Lenoir.

Regulation and risk

The growing use of skin and other non-organ tissue in medicine highlights some important safety questions. According to a British member of the EGE, Dr. Anne Mclaren, it is not just the dangers to the patient that concern her.

"Unless tissue samples that are going to be used for human therapy are guaranteed to be safe, there is a risk to the people who receive them. Also to the handlers," she says.

"So it is very important that the procurement of the samples, and the storage, and what happens to them later, are all properly regulated and supervised.

The use of the Internet to store information about sample donors means that European ideas about patient confidentiality are difficult to enforce. Even if the group's recommendations become EU law, it will be impossible to control the global trade without worldwide agreement, at the very least on donor information.

"We will try to ensure the rules are correctly enacted in Europe, but we think that an international agreement concerning the transfer of data through the Internet could be very useful," Noelle Lenoir says.

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