European Scrutiny Committee Contents

13 Quality and safety of human organs for transplantation




COM(08) 818

+ ADDs 1-2




COM(08) 819

+ ADDs 1-2

Draft Directive on standards of quality and safety of human organs intended for transplantation

Commission staff working documents: impact assessment and summary of assessment

Commission Communication: Action Plan on Organ Transplantation (2009-15): Strengthened cooperation between Member States

Commission staff working documents: impact assessment and summary of assessment

Legal base(a) Article 168(4)(a) TFEU; co-decision; QMV

(b) —

Basis of considerationMinister's letter of 28 June 2010
Previous Committee ReportHC 19-iii (2008-09), chapter 5 (14 January 2009); HC 19-viii (2008-09), chapter 6 (25 February 2009);

HC 19-xiv (2008-09), chapter 5 (22 April 2009); and HC5-xv (2009-10), chapter 2 (24 March 2010)

To be discussed in Council28 June 2010
Committee's assessmentPolitically important
Committee's decision(a) Cleared.

(b) Not cleared; further information requested


13.1 Article 168(1) of the Treaty on the Functioning of the European Union (TFEU) provides that action by the EU on public health should complement national policies and be directed to the improvement of public health and the prevention of illness and disease. Article 168(2) requires the EU to encourage cooperation between Member States to improve public health. Article 168(4)(a) authorises the Council to adopt measures setting standards of quality and safety for human organs, blood and other substances of human origin. Article 168(7) requires EU action to pay full respect to the responsibilities of the Member States for the organisation and delivery of health services and medical care and says that measures adopted under Article 168(4)(a) "shall not affect national provisions on the donation or medical use of organs".

13.2 Similar provision was made in Article 152 of the EC Treaty; in particular, Article 168(4)(a) and Article 168(7) TFEU are word for word the same as Article 152(4)(a) and Article 152(5) of the EC Treaty.

13.3 In 2007, the Commission published a Communication on organ donation and transplantation.[55] It suggested ways in which the EC and Member States might increase the supply of organs and improve the quality and safety of transplantation. The Commission advocated the preparation of an Action Plan to encourage cooperation between Member States and EC legislation to establish basic principles of safety and quality.

Previous scrutiny of the documents (a) and (b)

13.4 The draft Directive (document (a)) and the proposed Action Plan (document (b)) are the documents the Commission had advocated in the Communication.

13.5 Document (a) specifies common quality and safety standards for the donation, storage, transport and transplantation of human organs. For example, it provides that Member States should ensure that:

  • there is a national framework for quality and safety to ensure compliance with the requirements of the Directive;
  • the donation of organs takes place in a "procurement organisation" (that is, in a hospital or other body authorised by the national competent authority to procure organs in specialised facilities which minimise risks of contamination);
  • transplantation takes place in an authorised "transplantation centre"; and
  • all organs can be traced from donor to recipient and vice versa and that the relevant data is kept for a minimum of 30 years.

13.6 The Commission's Action Plan for 2009-15 (document (b)) includes proposals for cooperation between Member States and the Commission to increase the number of organs donated and improve access to transplantation. The Plan would not be legally binding and each Member State would be invited to draw up its own programme and set its own priorities.

13.7 In December 2008, the then Minister of State at the Department of Health (Dawn Primarolo) told the previous Committee that the Government supported the proposed Directive but would argue strongly that the common standards should be kept to the minimum necessary to ensure safety and quality, should not be excessively bureaucratic and should not impose requirements beyond those which were clinically justified.

13.8 In the Conclusion to its report of 14 January 2009,[56] the previous Committee noted that the Commission had cited Article 152(4)(a) of the EC Treaty as the legal base for the draft Directive and that Article 152(5) expressly said that the measures referred to in Article 152(4)(a) "shall not affect national provisions on the donation of or medical use of organs". The Human Tissue Act 2004 and the Human Tissues (Scotland) Act 2006 make national provision on those matters. It was not readily apparent to the previous Committee, therefore, that the draft Directive complied with Article 152(5).

13.9 In the course of the subsequent Council negotiations, amendments were made to the draft Directive which satisfied the previous Committee that the measure would be compliant with Article 152(5) EC (and now Article 168(7) TFEU).[57]

The Minister's letter of 28 June 2010

13.10 In her letter of 28 June, the Parliamentary Under-Secretary of State for Public Health at the Department of Health (Anne Milton) tells us that the Council and the European Parliament have reached a First Reading deal on the Directive.

13.11 The Minister also tells us that the vast majority of the UK's negotiating aims have been achieved. For example:

  • the draft Directive has been amended to permit national competent authorities to delegate their functions or to be assisted by other bodies (this will permit existing organisations in the UK — such as NHS Blood and Transplant — to perform some of the competent authority's key functions);
  • the draft Directive has also been amended to give Member States discretion to maintain protective requirements which are more stringent than the minimum standards set out in the Directive's Technical Annex;
  • provision has been introduced to allow medical teams, on the basis of a risk analysis, to proceed with transplants even if not all the information required by the Directive has been received; and
  • the Commission's delegated powers to make subordinate legislation have been reduced.

13.12 The Minister says that she hopes that the Committee will understand that, because the UK has achieved most of its negotiating aims, the Government intends to take part in the adoption of the Directive even though it is still under scrutiny.[58]


13.13 In the circumstances the Minister describes, we accept that it was reasonable for the Government to give its agreement to the adoption of the Directive. Accordingly, we clear the Directive from scrutiny. But we ask the Minister to send us progress reports on the consideration of the Action Plan; meanwhile, we shall keep document (b) under scrutiny.

55   (28686) 9834/07: see HC 41-xxvii (2006-07), chapter 6 (27 June 2007). Back

56   See HC 19-iii (2008-09), chapter 5 (14 January 2009). Back

57   See HC 5-xv (2009-10), chapter 2 (24 March 2010). Back

58   The Council adopted the Decision on 28 June with the Government's agreement. Back

previous page contents next page

House of Commons home page Parliament home page House of Lords home page search page enquiries index

© Parliamentary copyright 2010
Prepared 22 September 2010