Healthcare across EU borders: a safe framework - European Union Committee Contents

CHAPTER 3: Legal and regulatory considerations

The issue

42.  In this chapter we examine whether the Commission's proposed legal base for the proposal is appropriate, and whether the proposal respects the relative competences of the Member States and the Community in the field of healthcare. We also examine whether the proposed Directive is sufficiently clear in setting out how it relates to other relevant legislation.

Legal Base

43.  Every piece of EU legislation must have a legal base in one of the EU Treaties.[19] This sets out the power for the Institutions to act and the procedure for doing so. The Commission has based this draft Directive on Article 95, TEC, under which the Community is able to adopt harmonising measures to facilitate the establishment and functioning of the internal market. Article 95(3), TEC further stipulates that any Article 95 proposal relating to health must ensure a high level of human health protection. A measure can be properly adopted under Article 95 if it would genuinely assist in overcoming the restrictions on the provision of healthcare services.

44.  Although not its legal base, the proposed Directive also refers to Article 152, TEC which provides for limited Community action in the area of public health. It states specifically that a high level of human health protection shall be ensured in the definition and implementation of all Community policies and activities (which include the internal market). Article 152(5) specifies that "Community action in the field of public health shall fully respect the responsibilities of the Member States for the organisation and delivery of health services and medical care." Any measures that harmonise the laws and regulations of the Member States are excluded from Article 152, which means that the proposed Directive could not rely on that Article as a legal base.

45.  When deciding on the appropriate legal base, it is necessary to compare the aim and content of the proposal against the powers conferred by the particular legal base (see paragraph 43 above). The Commission indicates in the Explanatory Memorandum to its proposal that the aim of the proposal is to "establish a general framework for provision of the safe, high quality and efficient cross-border healthcare in the European Union and to ensure free movement of health services and a high level of health protection, whilst fully respecting the responsibilities of the Member States for the organisation and delivery of health services and medical care".[20] The Commissioner explained to us that, as the ECJ had determined that Article 49 prohibits restrictions to the free movement of health services, it was necessary to adopt the legislation under the internal market legal base (Article 95), but she also emphasised that Article 152 is at the centre of the Directive, thus respecting the competence of the Member States in healthcare. (Q 379) The Minister considered that Article 95 was "the correct legal base for negotiation" while acknowledging that a legal base can sometimes shift in the course of negotiations. (Q 52)

46.  The choice of Article 95 as a legal base was, however, questioned by the Law Society for England and Wales. Their concern related to the question of whether the full content (rather than the objective) of the proposal is in line with Article 95. They acknowledged that health policy is not excluded from being the subject of measures adopted under Article 95 but "the existence, extent and limitations of Article 152 are, we believe, significant." (p 166) In particular, they questioned whether Article 95 could legitimately be used as a legal base for laying down the responsibilities of Member States (Article 5 of the draft Directive) and for the co-operation mechanisms relating to e-health, European reference networks and the management of new health technologies (see Chapter 8).

47.  We understand that similar concerns have been raised in the Council of Ministers, particularly as regards the extent to which paragraphs one and three of the draft Directive's Article 5 are in accordance with Article 152(5) of the Treaty. Paragraph one of Article 5 lays down the responsibilities of the host Member State and paragraph three allows the Commission to develop guidelines to assist Member States in meeting those responsibilities.

Right of host State to refuse

48.  An argument that was advanced by a number of witnesses in defence of the proposed legal base was that, under the draft Directive (recital 12), Member States would not be required to accept for planned treatment, or to prioritise, patients from other Member States to the detriment of other patients with similar health needs. The Minister agreed that Member States' ability to take their own decisions on capacity was important, stating that "our first duty is to the overwhelming majority and that is how we plan and manage the Health Service nationally." (Q 60) PA Consulting supported this clause in the Directive but indicated that clarification was required on what was meant by "detriment". (Q 11)

49.  The Commissioner assured us that Member States will have this right of refusal as long as it is applied in a non-discriminatory fashion, based on a Member States' capacity to provide care. (Q 380)

Delegating legislative power to the Commission

50.  EU legislation frequently gives the Commission power to make subordinate regulations or take other action, overseen by committees made up of representatives of the Member States, and this Directive does so. This procedure is known as "comitology", and is governed by Community rules.[21] Under the proposal, the Commission would have the power to take decisions on a range of details, including the definition of "hospital care" for the purposes of prior authorisation (see Chapter 4). That power is subject to the Regulatory procedure, which is one of the more stringent procedures available. Under this procedure, the Commission proposal needs the approval of a qualified majority of the committee in order to be adopted by the Commission. If the proposal does not secure such approval, it is referred to the Council for a decision. The proposal can then be adopted if the Council either agrees it by a qualified majority or fails to secure a qualified majority against it.

51.  Among our witnesses, one notable source of concern in discussion of the legal base and the possibility that the rights of Member States as provided under Article 152(5) might be infringed was the widespread reliance in the draft Directive on the delegation of decisions using this comitology procedure. The Minister questioned why it was necessary to delegate these decisions to such committees if the primary aim of the Directive was to codify ECJ case law. She warned that "there is always the danger that either inadvertently or by design it goes further than we intended". (Q 52) UNISON considered that these provisions would give powers to the Commission that were never intended. (Q 334) The General Medical Council asserted that the role of the implementing committees should be defined and limited in order to avoid future "disproportionate, unanticipated and inappropriate spill-over into the national regulatory role." (p 74)


52.  Article 5, TEC, states that "the Community shall take action … only if and in so far as the objectives of the proposed action cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale or effects of the proposed action, be better achieved by the Community" and that this "shall not go beyond what is necessary to achieve the objectives of this Treaty."

53.  The Commission argues in its impact assessment[22] that Community level legislation on cross-border healthcare is necessary for two reasons. First, the uncertainty surrounding the interpretation of ECJ jurisprudence means that it is difficult for Member States to manage their healthcare systems properly and the necessary clarity could not be realised by Member States acting alone. Second, it is crucial to ensure that cross-border healthcare is as safe and efficient as possible but there is uncertainty about which country is responsible for what. Again, clarity cannot be provided without Community level action.

54.  The Minister took the view that the general principle of healthcare in the draft Directive was that the standards of host Member States apply in their healthcare systems and that such an approach was in line with the principle of subsidiarity. (Q 85) In their Explanatory Memorandum, the Government said that the establishment of a clear framework for the provision of cross-border healthcare within the EU might require action at Community level but that it would be important to ensure that the level of detail did not go beyond what was necessary to achieve this objective.[23]

55.  Most of our witnesses agreed with the Government and the Commission that clarity about the provision of cross-border healthcare was required and therefore that Community-level action was justified (see paragraphs 21-25). However, a number of our witnesses emphasised the need to respect the principle of subsidiarity. The British Medical Association cautioned that the Directive must recognise the fact that healthcare systems differ considerably across the 27 Member States. (p 117) The NHS Confederation warned that "any EU legislation … should not interfere unduly with the organisation, funding, and delivery of healthcare, which remains a national competence." (p 88)

56.  UNISON expressed the view that the Directive undermined the principle of subsidiarity, explaining that, in reality, it was more than a framework for action. They were particularly concerned that the Directive would run counter to the NHS's founding principles, "the system by which we ensure universality and equality of treatment for all". (QQ 334, 338)

Overlap with Regulation 1408/71

57.  In a number of places, the proposal states that the original texts of other instruments take precedence over this Directive. The most closely related piece of legislation is Regulation 1408/71 (see Box 1), which includes the "E112 clause" in its Article 22. According to Article 3(2) of the proposed Directive, the provisions of Article 22 of Regulation 1408/71, rather than of the Directive, would apply to cross-border healthcare when the conditions for its application are met (that is in cases of "undue delay"). When the E112 provisions are applied, the articles of the proposed Directive laying down the responsibilities of the Member States, information obligations and co-operation mechanisms would nevertheless continue to apply. The Commissioner took the view that the Directive as drafted is suitably clear as to how it could work in parallel with the existing E112 procedure under Regulation 1408/71. (Q 383)

58.  A number of witnesses, though, were not convinced and expressed concern about the potentially confusing interaction between the two instruments. The Royal Pharmaceutical Society (RPS) "would like to see the interaction between the current regulation and this directive made explicit." (Q 165) Without referring explicitly to the confusion between the two instruments, the Minister expressed the Government's view that it was necessary for patients and governments to have a clear understanding of the rules that apply to cross-border healthcare. (p 16)

59.  A lack of clarity over the concept of undue delay, which lies at the heart of the E112 procedure, was highlighted by witnesses as a reason for the confusion between the two instruments. The RPS stated that "a framework for determining what undue delay actually is" would be useful in order that patients were able to make an informed decision. (Q 165) The Government noted that the ECJ had stressed that decisions on "undue delay" must be based on a clinical assessment of what is a medically acceptable period for the individual clinical circumstances of the patient, and that this assessment needed to be kept under review while the patient was waiting for treatment. (p 18)

60.  The BMA agreed that the legal framework was confusing and required clarity, noting that the essence of the question was how to draw the distinction between the limited E112 right based on undue delay and the more general right under the draft Directive. They suggested that clarity might be so difficult to establish that "the E112 route may disappear if the Cross-Border Healthcare Directive is drawn sufficiently broadly" and they considered that this could successfully resolve the conflict. (QQ 317-318)

Conclusions and recommendations

61.  Article 49, within which the freedom to receive healthcare services falls, forms one of the fundamental freedoms of the Community and is one of the key principles underpinning the internal market. Article 95 is the legal base for measures which have as their object the establishment and functioning of the internal market. Article 152(5) states clearly that Member States retain full responsibility for the organisation and delivery of health services and medical care. We agree that Article 95 is the appropriate legal base for the Directive but emphasise the principle embodied in Article 152(5) and urge the European institutions to ensure that Member States' responsibility for the organisation and delivery of health services is fully respected in the negotiation and implementation of this Directive. Particular attention must be paid in that regard to the requirements laid down in Article 5 of the draft Directive.

62.  The Commission relies heavily in the draft Directive on delegation of the finer details to comitology committees. We caution that delegated legislation runs the risk of creating rules that go further than intended by legislators, but we recognise that it is sometimes necessary. Recourse to the comitology procedure should be restricted to genuine and appropriate questions of detail, such as the provisions on the mutual recognition of prescriptions. (See paragraph 161)

63.  If Member States are to be able to organise and deliver their own health services and medical care, it is critical that they are able to manage the capacity of health services. The recital in the draft Directive stating that Member States will have the right to refuse incoming patients is therefore welcome but would benefit from some strengthening and from clarification of the term "detriment".

64.  The freedom to receive healthcare services is protected by virtue of Article 49, TEC, and the stated aim of clarifying the European Court of Justice's rulings can only be pursued by Community level action. We are therefore content that the proposal is consistent with the principle of subsidiarity as long as it does not go beyond the action required to clarify and to put into effect the principles laid down the by the ECJ.

65.  Regulation 1408/71 is closely linked to the draft Directive but we were concerned to learn that there is some confusion as to how the two pieces of legislation may interact. We therefore urge that consideration be given to incorporating the relevant provisions of Regulation 1408/71 into the text of the Directive in order to clarify in which circumstances patients may be able to rely on those provisions rather than those of the Directive as currently drafted.

19   Either the Treaty on European Union (TEU) or the Treaty establishing the European Community (TEC), depending on the issue.  Back

20   (COM (2008) 414) (p6) Back

21   Council Decision 1999/468/EC laying down the procedures for the exercise of implementing powers conferred on the Commission. Back

22   SEC (2008) 2163, 02.07.2008 (pp16-18) Back

23   Please see the Cabinet Office website:  Back

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