The first two Directives came into force in UK law on 8 February 2005 as the Blood Safety and Quality Regulations 2005 (BSQR),2 with their requirements becoming effective in November 2005. They set standards of quality and safety for the collection and testing of human blood and blood components, whatever their intended purpose, and their processing, storage and distribution when intended for transfusion. The regulations also cover the collection and testing of blood and blood components for autologous use. In effect, therefore, they cover the whole process from donor to patient – from ‘vein to vein’.
The latter two Directives came into force in August 2006 and relate specifically to traceability requirements and notification of adverse reactions and events, and introduce EC standards and specifications relating to a quality system for Blood Establishments. They also added provisions relating to record keeping and traceability of blood and blood components to a new category of facility, defined as a hospital, another facility or service owned or managed by a health service body, a care home, an independent clinic, a manufacturer or a biomedical research institute.
The Directives define certain activities which can only be undertaken by Blood Establishments, namely:
Hospital blood banks are not permitted to undertake these activities unless licensed as Blood Establishments, but are able to store, distribute and perform compatibility tests on blood and blood components for use within hospital facilities.
Following implementation of this Directive into UK law, users of in vitro devices must ensure that any stock produced and introduced into the supply chain is CE marked, and that only CE-marked stock can be purchased and used. There are a number of other obligations placed upon users; for example, they can be held criminally liable if they knowingly encourage the supply of non-CE-marked in vitro devices. The main implication for the Blood Services surrounds the provision of reagents to third parties for their use, where CE marking is required, even if there is no payment for the reagent supplied. This is a complicated piece of legislation. Blood and Tissue Establishments and hospital blood banks are significant users and producers of in vitro devices, and they should ensure they are compliant with the legislation and should take appropriate advice to ensure they work within the legislation.
This Directive has been brought into UK law. It was, however, amended by Directive 98/79/EC to recognise the definition of an in vitro diagnostic device, which was not originally defined, and to ensure there were common definitions between the two Directives, such as the precise meaning of ‘putting into service’. It is anticipated that, while Blood and Tissue Establishments and hospital blood banks may not manufacture medical devices, they are key users of such devices, from blood bags to donation beds, so knowledge of the legislation may be beneficial.
At the time of writing (late 2012) a European Consultation is in progress to review the effectiveness of the European Devices legislation.
The Human Tissue Act 2004 replaced the Human Tissue Act 1961, the Anatomy Act 1984 and the Human Organ Transplants Act 1989 as they relate to England and Wales, and the corresponding Orders in Northern Ireland.
The Human Tissue Act 2004 covers England, Wales and Northern Ireland. It established the Human Tissue Authority (HTA) to regulate activities concerning the removal, storage, use and disposal of human tissue. Consent is the fundamental principle of the legislation and underpins the lawful removal, storage and use of body parts, organs and tissue. Different consent requirements apply when dealing with tissue from the deceased and the living. The Human Tissue Act 2004 lists the purposes for which consent is required (these are called Scheduled Purposes).
There is separate legislation in Scotland – the Human Tissue (Scotland) Act 2006.
While provisions of the Human Tissue (Scotland) Act 2006 are based on authorisation rather than consent, these are essentially both expressions of the same principle.
These Directives establish a harmonised approach to the regulation of tissues and cells across Europe. They set a benchmark for the standards that must be met when carrying out any activity involving tissues and cells for human application (patient treatment). The Directives also require that systems are put in place to ensure that all tissues and cells used in human application are traceable from donor to recipient.
The HTA, as one of the Competent Authorities in the UK under the EU Tissues and Cells Directives, has responsibility for regulating tissues and cells (other than gametes and embryos) for human application.
The Directives were fully implemented into UK law on 5 July 2007, via the Human Tissue (Quality and Safety for Human Application) Regulations 2007. The HTA’s remit includes the regulation of:
of tissues and cells for human application.
Establishments where these activities are carried out will normally need a licence. To obtain this, establishments carrying out the above activities are required to meet the standards which are detailed in the Guide to Quality and Safety Assurance for Human Tissues and Cells for Patient Treatment14 as implemented by HTA Directions 003/2010.
The HTA also publishes Codes of Practice, which provide guidance and lay down expected standards for each of the sectors it regulates (see www.hta.gov.uk).