HUMAN TISSUES AND CELLS (10122/03)
Letter from the Chairman to Rt Hon Rosie
Winterton, Minister of State, Department of Health
I am writing to let you know about the progress
in implementing this Directive.
Directive 2004/23/EC was adopted on 31 March
2004 and published in the Official Journal on 7 April 2004. It
sets standards for the safety and quality of all human tissues
and cells (but not blood or organs) intended for or used in all
The Directive consists of a number of articles
aimed at ensuring good practice, safety and efficacy in the way
that tissues and cells intended for human application are procured,
tested, stored, processed and distributed. It covers conventional
tissue banking of bone, skin, corneas, heart valves etc as well
as stem cells, gametes (sperm and eggs) and embryos.
The duty to ensure compliance with the requirements
of the Directive will fall to the nominated "competent authority"
in each Member State. We have agreed that for conventional tissue
banking this will be the Human Tissue Authority (HTA) and for
gametes and embryos, the Human Fertilisation & Embryology
Authority (HFEA). Eventually, this role will be taken by the new
body that will replace the HFEA and the HTAthe Regulatory
Authority for Tissue and Embryos (RATE) once established. The
Scottish Ministers have also agreed that the HTA should be the
competent authority for Scotland for conventional tissue banking
and both the Human Tissue Act 2004 and the Scottish Bill have
been drafted to allow for this.
The Directive is being developed in three parts.
The parent Directive 2004/23/EC came into force in April 2004
and Member States are required to take the necessary steps to
comply with it by 7 April 2006. However, implementation of this
Directive is dependant on the technical detail contained within
two further Commission Directives. These were originally supposed
to be ready by autumn 2005well in time for the April 2006
start date. However, only one Directive (Directive 2006/17/EC)
covering donation, procurement and testing is published. The second
is unlikely to be published until summer 2006.
I have therefore agreed a pragmatic approach
to implementation, and to implement the main Directive as far
as we were able by April 2006, but to await the publication of
both of the Commission Directives before implementing transposition
regulations to come into force on a single date in April 2007.
By 7 April 2006, some 140 conventional tissue
establishments had registered with the Human Tissue Authority
and had been deemed licensed under the requirements of the EU
Directive. Fertility clinics licensed by the HFEA under the Human
Fertilisation and Embryology Act 1990 do not need to comply with
the Directive until April 2007 under derogation provisions allowed
for within the Directive . Clinics that provide fertility treatment
using "fresh" non-donated sperm (ie the clinics that
will be required to register with the HFEA for the first time
as a result of the directive) are encouraged to contact the HFEA
who are issuing guidance and helping them prepare to be licensed
by April 2007.
We propose to transpose the three Directives
into UK law through two sets of Regulationsthe Human Fertilisation
and Embryology Act 1990 Amendment Regulations 2006 and the Human
Tissue (Quality and Safety for Human Application) Regulations
2006 and will undertake a 12 week consultation on both sets of
Regulations between July and October 2006. Both will incorporate
the requirements of the three Directives to enable full implementation
by April 2007. Similar Regulations are being drafted in Scotland
to amend the Human Tissue (Scotland) Act 2006.
This timescale will allow sufficient time for
the detail of the second Commission Directive to be finalised
and for the definitive Regulations to be agreed and laid in Parliament
by December 2006, made in January and to come into force by April
2007. Simultaneously we will work with the HTA and HFEA to ensure
that the necessary guidance is made available to help establishments
meet the requirements.
We have consulted with officials from the devolved
administrations throughout the negotiation of the Directives and
the development of these Regulations. They are content with the
Regulations to date and will work with us during the formal part
of the consultation.
The European Commission first published its
proposal for the above Directive in June 2002 (COM (2002) 319
final). An accompanying Explanatory Memorandum and Initial Regulatory
Impact Assessment were provided by the Department of Health on
the 8 July 2002. They were cleared by the House of Commons and
House of Lords European Scrutiny Committees on the 16 October
and 30 October 2002 respectively.
The Department of Health wrote again on 19 May
2003 informing the Joint Parliamentary European Scrutiny Committees
of the results of First Reading. An Explanatory Memorandum was
sent on 13 June 2003 informing the Committees of the political
agreement reached at the June Health Council. The House of Lords
cleared scrutiny on 17 June 2003 but the House of Commons noted
that in light of the significant additional costs that could arise
as a result of the inclusion of mature gametes within the scope
of the draft Directive, that they would hold the document under
scrutiny pending receipt of a further Regulatory Impact Assessment.
In light of concerns expressed by the European
Scrutiny Committee in July, Ministers wrote on 2 October 2003
outlining the current status of the Directive and enclosing a
revised Regulatory Impact Assessment, the implications of which
were debated in the House of Commons on 12 November when scrutiny
was cleared. On 28 January 2004, we wrote to inform you that the
Directive had completed its Second Reading in the European Parliament
and in April 2004 that the Directive had been adopted by Health
We are to make the provisional Regulatory Impact
Assessment available at the same time as we consult on the transposition
regulations to enable establishments to assess the likely costs
of implementation. You will see that the estimated costs have
been adjusted now as the technical detail in the two Commission
Directive becomes available. We now envisage that the set up costs
of implementation will range from £18 million to £20
million with recurring costs of £4.1 to £12.6 million.
28 June 2006