Chapter 1
The regulatory
environment in the United Kingdom in 2005
Introduction
Development of the 'Red
Book'
The Guidelines for the
Blood Transfusion Services in the United Kingdom were first published in 1990 by
HMSO. They were compiled by experts from the then Regional Transfusion Centres and
the National Institute of Biological Standards and Control (NIBSC), and aimed to
define guidelines for all materials produced by the United Kingdom Blood Transfusion
Services for both therapeutic and diagnostic use. The driving force for this joint
initiative, which started in 1987, was the imminent EU Directive which would bind
member states to introduce product liability by July 1988. It was understood that
human blood and substances derived from it would be defined as 'products' in terms
of this Directive, and guidelines against which manufacturers could be inspected
would be required.
Since then six editions
of the 'Red Book' (as the guidelines became known) have appeared. They are compiled
by a group of experts involving many from outside the blood transfusion services,
now called the Joint UKBTS/NIBSC Professional Advisory Committee (JPAC).
There are four National
Blood/Blood Transfusion Services in the United Kingdom:
the
National Blood Service in England (NBS) is managed by the National Blood Authority
(NBA). From 1 October 2005 it will be managed by the NHS Blood and Transplant Authority
(NHSBT)
the
Scottish National Blood Transfusion Service (SNBTS) is managed by NHS National Services
Scotland
the
Northern Ireland Blood Transfusion Service (NIBTS) is managed by the Northern Ireland
Blood Transfusion Special Agency
the
Welsh Blood Service (WBS) is provided and managed by Velindre NHS Trust.
These are blood establishments.
Between them they deliver services through approximately 20 centres (sites).
Following devolution
of governments in the United Kingdom, the UK Blood Services Forum was established
in 1999 comprising the chief executives and medical directors of