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
the four Services and JPAC became accountable to the medical directors who themselves are accountable to their chief executives. The close working relationship with NIBSC has been maintained through the director of NIBSC.
JPAC, with its standing advisory committees, undertakes regular review of the Guidelines in the light of developments in the field, both scientific and regulatory. The overall aim is to ensure as far as possible the safety of blood transfusion in the UK.
The current Standing Advisory Committees (SACs) of JPAC are shown in Figure 1.1.
EU Blood Directives and UK Blood Regulations
Directives 2002/98/EC(1) and 2004/33/EC(2) constitute the 'Blood Directives' in 2005. Two further Directives, one on haemovigilance/traceability and one on quality systems, are expected in 2006.
The Blood Safety and Quality Regulations 2005 transpose these Directives into UK law.(3) The Regulations apply throughout the UK, including the private sector and come into force on 8 November 2005.
The Regulations use the term 'blood establishment' for organizations that collect, process and distribute blood and blood products. In the UK the blood establishments are the four national blood services (NBS, SNBTS, NIBTS and WBS). The regulations retain the term blood bank for the laboratories within hospitals that hold, match and supply blood components to individual patients.
Several Articles in the Directives apply to hospital blood banks and these have been transposed into the Regulations. The Directives on quality systems and haemovigilance/ traceability will also impact on hospital blood banks. These will lead to amendments of the Regulations. The EU Directive on Tissues (2004/23/EC) will become legally binding in the UK from April 2006.
The EU Directives and UK Regulations are available on www.transfusionguidelines.org.uk.
Role of JPAC in developing guidelines, standards and regulations for the UK blood transfusion and transplantation services
The 'Red Book' contains guidelines reflecting best practice, sets standards to be met by the products, describes technical details of the processes involved and states the legally binding requirements introduced in 2005 under the Blood Quality and Safety Regulations, Statutory Instrument 2005 No. 50.(3)
Guidelines reflect best practice and are developed by professionals in the field. JPAC consists of such professionals in blood transfusion and tissue transplantation, appointed for their expertise from throughout the UK. The 'Red Book' reflects their work as it is implemented in the UK. The book concentrates on the products rather than their use; to do so effectively it provides technical details for all the processes involved.
Clinical use of blood and blood components is outlined in the Handbook of Transfusion Medicine,(4) produced by collaboration between JPAC and the British Committee for Standards in Haematology (BCSH).
Professional guidelines are not legally binding but, as they reflect consensus best practice, may be taken into account by the UK judiciary. Such national guidelines have to be taken into account when EU Directives are formulated. EU Directives have to be transposed – that is, written into UK laws – and these are legally binding.
Professionals throughout the EU member states are involved in deciding which guidelines should have the force of law. The wording of the law is the remit of lawyers and department of health officials, but the essence of what becomes law rests with the judgement of the professionals in the field. JPAC is represented on the Council of Europe and European Union expert working groups.