'Badge of Honour' or Protective Shield? Are the HTA the new arbiters of the cord blood industry?

In the 21st Century, the collection and use of stem cells from umbilical cord blood (UCB) is anything but a new phenomenon. Since the first successful UCB transplant in 1988, the use of UCB for transplantation purposes has been used in over 6,000 treatments worldwide and has proved to be a viable treatment option where suitable supplies of bone marrow fail to exist. Current human applications have included the treatment of blood cancers and genetic blood disorders and research has shown that UCB might in the long term play a significant role in cell therapy and regenerative medicine.

UCB can be procured at the moment of birth and stored for either private use or donated to a public bank. In the UK, NHS Trust midwives typically carry out the collection process for those wishing to store privately as a gesture of good will at the request of the pregnant woman. However, things are about to change. The Human Tissue Authority (HTA) have announced this week that as of 5 July 2008, all facilities that collect UCB will need to apply for a licence to do so - a certification the HTA's Chief Executive colloquially declares 'a badge of honour'. To achieve such an accolade, they will need to demonstrate that fully trained specialist staff collect the cells on premises that meet the necessary standards and that best practice ensures the third stage of labour will not be jeopardised. Furthermore, facilitators will need to show that any cells collected for future use can be traced for identification and monitoring purposes.

So what has been the driving force behind the need for reforms in the collection of such a potentially valuable resource and why is it such an honour for a facilitating premise to be deemed worthy to collect? Essentially, the HTA have implemented the new regulations in response to the legal requirements of the European Tissue and Cells Directive, which were transposed into UK law in July 2007. However, the regulations appear to resonate with an underlying purpose. The HTA raises fears that unqualified collectors, such as fathers, have become involved in the collection process, a fear that may not be unfounded.

In spite of the fact that only a handful of NHS Trusts in the UK allow midwives to facilitate the collection process, many have policies that allow third parties to collect on their premises on the expectant woman's behalf. This poses a number of concerns including the third party's lack of expertise in collection techniques and methods and unfamiliarity with safety and hygiene procedures within a clinical setting. These concerns are particularly worrying given that in order for the collected cells to be of any viable future use, they must be of sufficient quality and quantity.

Although there has been a disparity of opinion amongst experts in the field as to which collection method should be adopted, research carried out by the Institute of Medicine (IOM) between January 1993 and 2003 concluded that those who receive specialist training produce acceptable results. The Royal College of Obstetricians and Gynaecologists (RCOG), who report that bacterial contamination rates fall when trained staff perform collection, support this view. Clearly, the HTA's requirement for only qualified personnel to undertake the procedure ensures the best possible return for those willing to pay up to £1500 for a private storage option and sufficient protection for that financial investment.

But what sort of protection is afforded the health care professional willing to help patients collect their UCB? Essentially, they face the possibility of being held personally liable should they collect insufficient cells, the samples become contaminated or mislabelled, their attention is diverted from essential procedures necessary in the third stage of labour in favour of collection or experience personal injury hazards associated with the use of multiple collection needles. Furthermore, midwives may not be familiar with the different types of collection kits that each individual commercial company manufacture and sell to their clients. Given that they voluntarily collect the cells in a selfless act of altruism in the full knowledge that the NHS Litigation Authority will not indemnify them if they choose to do so, these facilitators who vocationally act within an era of health care choice deserve to be protected from potential legal liability, as do the NHS Trusts that employ them. This is particularly relevant given that the commercial sector predominantly relies on their good will but does not bear any of the legal responsibilities. Furthermore, it is the commercial sector that reaps the financial reward for their efforts. It is for these reasons, together with competing evidence associated with the real potential for the future use of privately stored cells, that the RCOG and The Royal College of Midwives have advised NHS Trusts to refrain from allowing its personnel to collect UCB.

It would therefore appear that the aims of the new HTA regulations are not only to ensure a financial safeguard for potential UCB clients in that that the most sufficient cells are secured on their behalf, but also the legal protection of those who altruistically put themselves in a position to make the procurement of UCB a reality. Notwithstanding the fact that the NHS and its staff remain open to potential negligence actions, to shield those who put themselves on the line for another's benefit is surely something worthy of legal protection. What may be compromised, however, is the lack of choice for those in a position to engage in an opportunity to collect and store what they deem to be a service option worthy of financial commitment. The 'badge of honour' may offer protection, but it may also act as a bar to potential choice.