New HTA regulations on collection of cord blood

13 May 2008

On 30 April 2008, the UK Human Tissue Authority (HTA) announced the release of regulations that will, for the first time, govern the collection of umbilical cord blood at birth. As stem cells present in cord blood can potentially be used to treat serious diseases such as leukaemia, there is an increasing trend among parents to collect and store the blood for use in the event that the child requires future medical treatment. Various companies will store the blood in a cord blood bank, which acts as an ‘insurance policy’ by securing a source of stem cells that is tissue-matched to the child (see previous news). The practice has raised some concerns, including the potential for commercial exploitation of parents in light of the very low risk that future disease will actually transpire. Commercial services might also divert efforts away from public sector banks such as the NHS Cord Blood Bank.

The new rules, which will take effect from 5th July 2008, emanate from the European Union Tissue and Cells Directive, which was implemented in the UK on 5 July 2007 by the Regulations on Human Tissue (Quality and Safety for Human Application) under the Human Tissue Act. The rules are intended to ensure safety and traceability by requiring that only specially trained individuals may harvest the cord blood, using approved procedures, in hospital maternity units that meet essential standards. An HTA license will require the unit to demonstrate not only that cord blood will be harvested in the proper manner, by qualified staff, but also that procedures are in place to prevent medical attention being drawn away from mother or child during the collection (see BBC news). HTA Chief Executive Adrian McNeil commented: “We are introducing this regulation to make sure that the best quality samples are taken in the safest way…The Human Tissue Authority is one of the frontrunners in Europe for implementing this legislation, which puts patients’ safety at the heart of the process” (see press release).

The Virgin Health Bank, which - unlike most commercial cord blood storage facilities - requires donors to make a portion of each blood sample publicly available (see previous news). has objected to the move, saying: “We already know that there is a critical shortage of cord blood units and there is little incentive for NHS Maternity units to apply for these licenses which may result in further constraint on the availability of cord bloods for lifesaving transplants” (see press release). Notably, procurement centres that do not already hold a suitable HTA licence will probably be charged a licence fee: 2007/8 HTA fees are £7600 for new applications, and £1000 for additional licences for the same centre (see HTA licence fees).

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