Select Committee on European Union Fortieth Report


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 human applications.

  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 HTA—the 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 2005—well 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 Regulations—the 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 Council.


  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

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