Thank you, Chairman. I thank the committee for the opportunity to discuss the proposed EU directive. I would also like to record the Minister's appreciation of the work of the committee on this subject. In particular, the committee's report on this subject has been of assistance to the Department in the negotiations which are continuing on the directive.
The draft directive was brought forward by the Commission to codify and clarify the application of European Court of Justice case law on patients' rights in cross-border health care. This case law has established that as part of EU freedoms to obtain services and freedom of movement, patients have the right to access health care in another member state and be reimbursed for this up to the cost of the treatment in their own state. Therefore, previous ECJ rulings have established a legal basis under existing treaties for patients to access health care in another member state. For example, the Watts judgment of the ECJ on 16 May 2006 made clear that the requirement in Article 152 of the treaty to "fully respect the responsibilities of the member states for the organisation and delivery of health services and medical care" does not exclude recourse to other aspects of community law so as to allow access by patients to health services in other member states. Other treaty provisions of particular relevance are the right to free movement of services under Article 49 of the treaty, and the considerations that have to be taken into account in harmonising rules related to the Internal Market under Article 95. That latter article supplies the legal basis for much of the Commission text.
Undoubtedly and very importantly, health care is seen as having distinguishing characteristics from other services, in particular the responsibility of member states to protect the health of their citizens. However, these particular features of health care, including the responsibility of members states identified in Article 152, do not provide unlimited or arbitrary discretion for member states as to whether and to what extent other treaty provisions or community measures are respected. Restriction of freedoms provided elsewhere in the treaties must be proportionate and justifiable by reference to what is necessary to protect public health and to maintain and regulate their own health care systems.
It is important to note that the ECJ jurisprudence is evolving and there can be debate as to how the rulings in particular cases might be more generally applied. This is not a particularly satisfactory situation, since patients and members states would benefit from more settled law and greater clarity and consistency as to its application. The proposal for a directive in this area is an effort to address this problem.
The current proposal follows on from the Commission's withdrawal of its earlier attempt to include provisions dealing with the rulings of the ECJ on free movement as it applies to health services in a directive on services in the Internal Market initiated in 2004. However, in response to concerns on the part of both the European Parliament and Council, the health care provisions were dropped from the services directive. It was felt that the particular features of health services required that it be looked at separately from other services. The Commission, therefore, has taken that advice from the Council and the Parliament in bringing forward this directive.
The Commission proposal was published in July 2008. From the outset, the Department identified this draft directive as being of considerable significance for Irish patients and health care administration. In July 2008, the Department initiated a public consultation process and liaised with key stakeholders. We began the process of systematically assessing its implications. In addition to establishing our key interests and points of concern, we recognised that decisions on the text are subject to qualified majority voting. Accordingly, we have constructively engaged with other member states and the Presidencies to achieve common understandings. Since the proposal will be addressed in association with the European Parliament under the co-decision process, we have also liaised with Irish MEPs and the rapporteur appointed by the Parliament.
Our approach has been to influence the content of the proposed directive as much as possible in order to achieve the key objective of codifying the existing legal position in a way that is workable, and to the greatest degree possible, consistent with existing legal, policy and administrative arrangements in Ireland.
Before dealing with areas where we have sought to achieve improvement, it is important to highlight the benefits attaching to the proposed directive. The first and foremost benefit is the increased patient choice provided for in the draft directive. While it can be expected that citizens will usually continue to prefer to receive health care close to where they live, there are always specific circumstances where it may be more beneficial or preferable to receive health care abroad. Facilitating people who wish to access care abroad will be much more easily achieved using the arrangements between member states that are proposed under the directive. For example, patients who live in border regions may find health care provided across the border is closer to home, work or family support. On other occasions patients may wish to access expertise available in another member state, such as for certain highly specialised treatments. In such a case, patients will have the right to receive health care in another member state and be reimbursed for that health care up to the cost of treatment in Ireland. We see that as a very important benefit set out in the directive.
The directive also provides legal clarity for patients and member states in cases where definite rights to cross-border health care exist but the mechanisms to ensure these rights are respected are anything but clear. Explicitly, the directive also recognises that member states are responsible for the organisation and delivery of health services and medical care and, in particular, they are responsible for determining which rules apply to the reimbursement of patients and the provision of health care. It is also worth noting that the directive provides no new entitlement or eligibility for citizens beyond the entitlement and eligibility to services that they enjoy in their home member state. That is important in respecting the role of member states. The directive provides for co-operation in a range of very fruitful areas such as e-health and networks of centres of reference.
The proposal for a directive on patient rights has been examined by the Council working party on public health over the past 18 months. It has been discussed by Ministers at two Council meetings and two other informal Council meetings. The draft directive has been subject to progress reports from the French and the Czech Presidencies. Over the process of negotiation, the French, Czech and now the Swedish Presidency have addressed a number of issues of concern. I include in this prior authorisation, gatekeeping processes, mutual recognition of prescriptions and co-operation between member states.
The process of consideration is by no means complete but many of our concerns in these areas have been addressed. Work continues in other areas, including the treatment of non-contracted providers, which includes in our case private health care providers, as set out in the committee's report at paragraph 3.3, and the relationship with regulation 883. That is set out in the committee's report and we continue to seek to address those issues in the negotiations.
Our understanding at this stage is that the Swedish Presidency intends to seek a political agreement at the next Council meeting in early December. Negotiations have not yet reached a point where the position to be tabled by the Presidency or the views of member states are finalised. Once the Presidency text is available, the Minister will consider the position to be adopted when she meets the other health Ministers in Council. Meanwhile, contacts with other member states and the presidency are continuing via the Council working party on public health, COREPER meetings of the permanent representatives and through bilateral discussions.
Under the COREPER decision procedure, if agreement is achieved at the December meeting of Council, it would open the way for negotiations with the European Parliament, and they would likely get under way early in the new year. The European Parliament has already completed its own first reading of the directive in advance of the last elections. Essentially, it is on hold waiting for the Council to come back with its view. The Parliament made significant modifications to the Commission text and it is also expected that the Council will make significant modifications. It will therefore fall to the next Presidency to negotiate the outcome with Parliament.
Depending on progress, it is possible that agreement on the directive could be achieved late in 2010 under the Belgian Presidency or early in 2011 under the Hungarian Presidency. Following a second reading agreement, there would be a 12-month transition period prior to implementation. On that current schedule, it could be during the course of 2012.
I hope the presentation has been of assistance to the committee and I am happy to hear the views of members and take questions.
