New rules come into force for collection of cord blood

Regulation for the collection of cord blood came into force today (5 July) to put the safety of mother and child first

Issue date: 5 July 2008

New rules came into force today (5 July) that will require the collection of cord blood to take place under the authority of a licence from the Human Tissue Authority. This is the first time that collection of cord blood at birth has been regulated in the UK, and the new regulation puts the safety of mother and child first.

The trend of collecting cord blood in public or private banks for potential medical applications, including the treatment of leukaemia, has grown more popular in recent years. The new rules mean that cord blood can only be collected by people with specialist training and on premises that meet essential standards.

All maternity units, or third parties engaged to collect cord blood will need to act under a Human Tissue Authority (HTA) licence that will ensure:

• Staff have training in collecting cord blood, raising standards and making sure that best possible quality of sample is taken.
• Procedures which will help prevent any medical attention being drawn away from mother or child during collection.
• The risk of contamination to the sample is minimised
• A system is in place to make sure that the cord blood cells are traceable from collection to their use in treatments. 

Sandy Mather, Director of Regulation at the Human Tissue Authority, said:

“We have been measured and proportionate in the way that we have implemented this regulation. We aim to put patient safety first, while making it as simple as possible for professionals to become compliant with the new rules. We have done our best to help and advise professionals who think they may need to apply for a licence, and have helped many through the application process.”

ENDS

For further information, please contact Dr Claire Bithell, Media Manager at the HTA, on 020 7211 3439 or email claire.bithell@hta.gov.uk

Notes to editors

1. This regulation forms part of the European Union Tissue and Cells Directives (EUTCD).

2. The EUTCD came into force from 7 April 2006 throughout the EU and was transposed into UK law via the Human Tissue (Quality and Safety for Human Application) Regulations on 5 July 2007. The HTA is one of two Competent Authorities in the UK for the EUTCD.

3. This is the first time that the collection of cord blood has been regulated in the UK.

4. Procurement organisations in the UK will need to apply for an HTA licence by 5 July 2008. Some procurement organisations will already have suitable licences, whereas others will need to complete the application process for a new licence.

5. As the regulator under the HT Act, the HTA has a number of statutory functions:

To inform the public, professionals and the Secretary of State for Health about issues within our remit. We meet this requirement for professionals by providing guidance, including codes of practice, to support good practice.

To regulate, through licensing, a number of sectors and to carry out inspections to ensure licence conditions are being met. The licensed sectors are:

•  Anatomy
•  Post mortem services
•  Human application (transplantation of tissues and cells)
• Research
•  Public display

To regulate, through a system of approvals, the donation from living people of solid organs, bone marrow and peripheral blood stem cells for transplantation into others. The HTA also oversees the consent requirements of the HT Act for deceased organ donation.

6. The Royal College of Obstetricians and Gynaecologists’ Scientific Advisory Committee has published an opinion paper on “Umbilical cord blood banking” (revised June 2006)

http://www.rcog.org.uk/resources/Public/pdf/umbilical_cord_blood_banking_sac2a.pdf