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Good regulation is all about the implementation: Lessons learnt from implementing new legislation

3 July 2008
By Imogen Swann
Head of Regulation, Human Tissue Authority
Appeared in BioNews 465
On 5 July Regulations will be enforced that will require the procurement (collection) of cells and tissues for human treatment, including cord blood, stem cells in bone marrow and peripheral blood stem cells, to take place under a licence from the Human Tissue Authority (HTA). The Regulations require that staff are appropriately trained to ensure that:
  • The health and safety of the donor is put first.
  • Appropriate consent has been taken.
  • The best quality donation is collected.
  • The risk of contamination is minimised.
  • All samples are traceable from their collection to their use in treatments.

The Regulations, derived from the Human Tissue (Quality and Safety for Human Application) Regulations 2007, will also ensure that procured tissues and cells are processed and stored in environments that meet regulatory requirements - thereby further safeguarding the quality and safety of the tissues and cells.

The implementation of the Regulations has been an interesting process for the Human Tissue Authority, and we have learnt a lot in the last year.

In the early stages, the complexity of the legislation raised areas of interpretational uncertainty. In view of this, the HTA took the decision not to enforce the full requirements of the Regulations until clarification had been achieved. Over the last year the HTA has arranged workshops with stakeholders and been in dialogue with the Department of Health and the European Commission.

This period of dialogue and consultation led to a greater understanding of the impact of the Regulations and how they could be best implemented. For example, some private cord blood banks were concerned that maternity units may not apply for a licence, and those giving birth in these hospitals would not have the option of collecting cord blood. The HTA has been able to clarify that the Regulations allow for cord blood to be collected on unlicensed premises in a set of defined circumstances. Private cord blood banks can put in place a legal agreement - called a 'third party agreement', with appropriately qualified persons, that allows them to enter unlicensed premises and procure cord blood on behalf of the licensed cord blood bank. Persons that may be appropriate to carry out this function could be staff trained at the maternity unit, or staff employed by an organisation that specialises in cord blood procurement

This arrangement allows the samples to be collected in accordance with the law (with all the benefits that this entails), in hospitals that do not require a licence for any other purpose.

It has also been important to resolve the issues raised by directed donation of cord blood, which includes 'saviour siblings'. This tends to involve the collection of cells for the future treatment of someone in the family who has an illness, or is likely to develop an illness. The sample collected has known clinical potential, but as these cases are extremely rare (one hospital estimated they may see one case a year) the maternity unit may not have applied for a HTA licence. Again, the HTA has sought to reach a pragmatic solution. In the above situation the HTA has recommended that the transplant consultant refer the case to NHSBT (NHS Blood and Transplant) - licensed by the HTA, the cord blood can then be collected at the maternity unit under a third party agreement put in place by NHSBT. In situations where this arrangement is not appropriate the HTA will offer advice and guidance as to the most appropriate solution. 

So what have we learnt from this process? Firstly, we have seen that engaging stakeholders has a hugely positive impact in shaping the implementation of this legislation. Clinicians, nurses and other stakeholders have been extremely engaged in explaining their needs and working with us to find the best solutions. Secondly, this process acts as a reminder that implementing legislation is complicated and requires the Regulator and stakeholders to work together to ensure that a proportionate regulatory framework is arrived at.

Moving forward, the EU is currently considering creating a new regulatory framework for organ donations. The HTA is involved in informing the content of this new legislation, and will continue to work with the EU and others to try to ensure the resulting legislation is pragmatic and delivers the most benefit to donors and recipients. 

In summary, implementing a new piece of regulation takes time and continual dialogue with those people it will impact on. We know that we don't have all the answers; we have learnt, and continue to learn from the sectors that we regulate. For those who would like to find out more about the Human Tissue Authority, please visit our website on www.hta.gov.uk.

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