Legal base	(a) Article 152(4)(a) EC; co-decision; QMV (b) —
Department	Department of Health
Basis of consideration	Minister's letter of 31 March 2009
Previous Committee Report	HC 19-iii (2008-09), chapter 5 (14 January 2009) and HC 19-viii (2008-09), chapter 6 (25 February 2009)
To be discussed in Council	No date set
Committee's assessment	Legally and politically important
Committee's decision	(Both) Not cleared; further information requested

Background

5.1 Article 152(1) of the EC Treaty requires action by the Community on public health to complement national policies and to be directed to the improvement of public health and the prevention of illness and disease. Article 152(2) requires the Community to encourage cooperation between Member States to improve public health. Article 152(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 152(5) requires Community 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:

"In particular, measures referred to in [Article 152(4)(a)] shall not affect national provisions on the donation or medical use of organs".

5.2 In June 2007, we considered a Communication by the Commission on organ donation and transplantation.[27] 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.

5.3 In our report to the House on the document, we recognised the potential benefits of cooperation between Member States to disseminate best practice and agree common standards for the safety and quality of donated organs. But we endorsed the Government's view that vigilance would be needed to ensure that Community action was consistent with the principle of subsidiarity. We also drew attention to the need to ensure that the proposed Directive was compatible with the requirement in Article 152(5) EC that the measure should not affect national provisions on the donation or medical use of organs.

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

5.4 In January 2009, when we first considered the draft Directive (document (a)) and the proposed Action Plan (document (b)), we noted that these were the documents the Commission had advocated in its Communication.

5.5 The proposed Directive 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 quality programme 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 body to procure organs in specialised facilities which minimise risks of contamination); transplantation takes place in an authorised "transplantation centre"; and that 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.

5.6 In parallel with the draft Directive, the Commission proposes a 10 point Action Plan for 2009-15 (document (b)) 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.

5.7 The Minister of State at the Department of Health (Dawn Primarolo) told us 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 are clinically justified.

5.8 In the Conclusion to our report of 14 January 2009,[28] we said that Article 152 of the EC Treaty appears to be internally inconsistent. On the one hand, Article 152(4)(a) expressly authorises the Council to adopt measures setting standards of quality and safety for human organs. On the other hand, Article 152(5) says 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 Minister had told us that the Human Tissue Act 2004 and the Human Tissue (Scotland) Act 2006 make national provision on those matters. It was not readily apparent to us, therefore, that the draft Directive complied with Article 152(5). We asked the Minister for her views on the matter.

5.9 In her reply of 11 February , the Minister said:

"The Government's view is that there is a distinction to be drawn between provisions about the quality of organs (which are to be donated) and rules about donation of organs (such as consent, who may receive an organ, priorities for receipt of an organ, whether organ donation can take place at all, whether there can be donations from living persons etc.). Making quality rules about organs which are to be donated is not about donation of organs, but rather a different matter — the quality of the organs. The Human Tissue Act 2004 and the Human Tissues (Scotland) Act 2006 make national provision in relation to consent and use of organs and not in relation to the quality and safety standards that should be applied to those organs. Even though parts of these Acts may be amended by the Directive, for example to ensure that quality and safety fall within the regulation of the Human Tissue Authority, this would not affect the national rules on consent and use of organs. Therefore the Government is content that Article 152(4)(a) provides sufficient legal basis for the Directive."

5.10 When we considered the Minister's reply,[29] we agreed with her that a distinction can be drawn between, on the one hand, legislation on the donation of organs and, on the other, legislation on the quality and safety of organs intended for transplantation. It appeared to us that she considers that the draft Directive draws that distinction and does not contain provision on the donation of organs. We found this surprising because:

• Article 2 of the draft Directive specifically states that the Directive applies to the donation of organs intended for transplantation;
• Article 13 requires Member States to ensure that donations are voluntary and unpaid; to prohibit the advertising, for advantage, of the need for or supply of organs; and to ensure that the procurement of organs is done on a not-for-profit basis; and
• Article 15 contains mandatory requirements about the action Member States should take to protect potential donors.

We remained doubtful, therefore, that the draft Directive fully complies with Article 152(5) of the EC Treaty. So we asked the Minister for her further comments.

5.11 We also noted from the Minister's letter of 11 February that the Government thought that some of the draft Directive's provisions might be too prescriptive and that it would be seeking clarification of others. We asked the Minister to include information about the negotiations on those Articles in the progress reports she would be sending us.

The Minister's letter of 31 March 2009

5.12 In her reply of 31 March, the Minister tells us that, at the meeting of the Council Working Group on 6 March, the Government asked:

"for transplantation to be removed from Article 2 as it falls within Member State's competence.[30] This view was supported by a number of Member States and we await a draft revised text from the Commission to determine whether the UK's concerns in this area have been addressed."

5.13 As to whether some provisions of the draft Directive are inconsistent with Article 152(5) of the EC Treaty, the Minister's letter says:

"In relation to Article 13 [which requires Member States to ensure that donations are voluntary and unpaid], it is important for donations to be altruistic and voluntary as part of ensuring that quality is not jeopardised, for example by people abusing the system by hoping to gain financially. Article 13 also seeks to prevent not just the remuneration for, but also the trade and trafficking of, organs. The requirements under this Article also help facilitate the lawful cross-border movement of organs as there might be concerns that financial inducements in other Member States might compromise the safety and quality of the donated organ.

"In relation to Article 15 [which contains mandatory requirements about the action Member States should take to protect living donors], we believe that requiring that donations are given with informed consent ('authorisation' in Scotland) ensures that there is less of a risk of quality and safety being undermined by other pressures, such as financial inducement, trade and trafficking. Article 15 also facilitates movement across borders by removing concerns that any organs might have been donated in ways that might not satisfy UK requirements. We would draw to the Committee's attention that this Article does not affect or require any changes to the law on consent in Member States.

"We also draw to the Committee's attention that there are precedents for regulation within the Blood Directive and the Tissues and Cells Directive."

5.14 In reply to our request for information about the negotiations on certain Articles which, in the Government's view, might be too prescriptive, the Minister tells us that the discussions have only just begun. She will, therefore, include the information in the progress reports she will be sending us as the negotiations proceed.

Conclusion

5.15 We are grateful for the Minister's reply. We shall reserve comment on the amendments to Article 2 until after the revised text has been deposited in Parliament.

5.16 We regret that we continue to differ from the Minister's view that the draft Directive complies with the requirement in Article 152(5) of the EC Treaty that measures such as this one must not "affect national provisions on the donation or medical use of organs". We are not persuaded the requirements in Article 13 of the draft Directive that donations be voluntary and unpaid are necessary only or mainly to ensure the quality and safety of organs for transplantation.

5.17 Article 15(1) provides that Member States:

"… shall take all necessary measures to ensure that potential living donors are provided with all the information necessary, as to the purpose and nature of the donation, the consequences and risks, and on alternative therapies for the potential recipient to enable them to make an informed choice. The information shall be supplied in advance of the donation."

It seems to us, on a plain reading of the Articles 13 and 15(1), that they are concerned solely with the conditions for donation.

5.18 We should be grateful if the Minister would reflect further on the question and tell us her conclusion when she provides her next progress report on the negotiations. Meanwhile, we shall keep documents (a) and (b) under scrutiny.

28   See headnote. Back

29   See HC 19-viii (2008-09), chapter 6 (25 February 2009). Back

30   Article 2 of the draft Directive says:

"1. This Directive applies to the donation, procurement, testing, characterisation, preservation, transport and transplantation of organs of human origin intended for transplantation.

"2. However, where such organs are used for research purposes, this Directive only applies where they are intended for transplantation into the human body." Back