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Ovary banking in UK stopped by EU tissue directive

6 January 2006
By BioNews
Appeared in BioNews 340

New European rules on the use and storage of human tissue could deny young British women undergoing cancer treatment the chance to preserve their fertility, according to a report in the Times newspaper. The requirements of the new EU (European Union) Tissues and Cells Directive make it prohibitively expensive for many centres to store ovary tissue that could be re-implanted to restore fertility, says Geoff Trew, a consultant at Hammersmith Hospital in London.

The new directive, which came into force in 2004, must be implemented in EU member states by 7 April this year. It covers the donation, procurement, testing, processing, preservation, storage and distribution of all human tissues and cells (and products derived from them) intended for use in people. It requires that the preparation and storage of human tissues is carried out by laboratories that conform to 'good medical practice' (GMP) standards of sterility, which include the use of filtered air and air locks.

Many doctors feel that  while necessary for tissue transplants between two different people, GMP standards are 'excessive' for storing ovary tissue, which would only be returned to the person from which it was taken. The Hammersmith Hospital has access to GMP facilities and so is continuing to bank ovary tissue for patients. But, says Mr Trew, the new regulations have increased the cost of the procedure by up to £4000. 'This technique has almost been stopped before it has started', he told the Times, adding 'most of the clinics that were doing it simply aren't since the directive came to light'.

So far, there have been only two confirmed births following transplants of ovary tissue - one in Belgium in 2004, and one in Israel last year. In both cases, strips of frozen ovarian tissue were thawed and implanted close to the remaining, non-functioning ovary, in women who had become infertile following cancer treatment. About 200 UK women have had ovarian tissue frozen, but many centres have now stopped offering the service. Tony Rutherford, a consultant at Leeds General Infirmary, told the newspaper: 'We did much of the early research on this, and we have had to put it on hold. We are still being approached by patients and oncologists, and we're having to say, "we can't help you"'.

According to Adrian Lower, who used to freeze ovarian tissue at St Bartholomew's Hospital in London, before it too stopped the procedure, there is no evidence that ovary tissue samples need to be prepared to such strict standards. 'The tissue is already being taken in an environment that is quite sterile enough for sperm and eggs and it is harsh to say we can't do ovarian tissue banking in the same environment', he said. But according to the UK's Human Tissue Authority, there is no compelling reason why ovarian tissue should be treated differently to other tissues used in medical procedures. It says there are about 60 centres in Britain with GMP facilities, which clinics could contract to prepare tissue.

SOURCES & REFERENCES
Cancer survivors' hopes for children dashed by red tape
The Times |  31 December 2005
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