The Chairman: Good afternoon. Does a member of the European Scrutiny Committee wish to make a brief explanatory statement about the decision to refer the relevant documents to this Committee?

Mr. Bob Laxton (Derby, North) (Lab): I do, Mr. Martlew. It might be helpful—then again, it might not—if I take a couple of minutes to explain the background to the documents and the reasons why the European Scrutiny Committee recommended them for debate in this Committee.

Since 1998, the European Court of Justice has consistently ruled that patients who go to another member state for health care are entitled to reimbursement of the cost by their home member state if they would have been entitled to the treatment in their home state. The judgments have, however, left a good deal of uncertainty, so in 2006 the Commission held consultations on what actions, if any, might be necessary to clarify the rights and duties of patients, member states and health care providers. In the light of the responses, the Commission produced the documents before the Committee: the first is a communication on the Commission’s proposals for new legislation on cross-border health care, and the second is a draft directive to give effect to the proposals.

The draft directive provides, for example, for patients to be reimbursed, without prior authorisation, for treatment received in another state that did not involve an overnight stay in hospital, provided they would have been entitled to the treatment in their home state. The amount reimbursed would be limited to what the cost of the care would have been in the home state. Similarly, the draft directive provides for reimbursement by the home state of the cost of care in hospital. It allows the home state to require the patient to obtain prior authorisation only if an authorisation system can be justified on specific conditions. The member states in which the care is provided would have responsibilities for the safety and quality of the care and for providing the patient with specified information, redress mechanisms and so on.

The Government told the European Scrutiny Committee in July that they support the draft directive but firmly believe that member states should have unqualified discretion to operate prior approval systems for hospital care. They also want clarification of some of the details. The draft directive is likely to be discussed by the Council of Ministers in December—I stress, in December.

The European Scrutiny Committee recommended the documents for debate because of the importance of and widespread interest in the subject. It asked the Minister questions about the legal base for the draft directive, the reasonableness of one of its provisions, and the extent of the proposed delegation of authority to the Commission to make implementing legislation. The Minister responded to those questions in her letter of 9 September. The European Scrutiny Committee concluded that her answers would contribute usefully to our debate today, and therefore decided to tag her letter to the documents.

That is the position of the European Scrutiny Committee. For my part, I think that the Committee jumped the gun. The matter is out for consultation, and I believe that the European Scrutiny Committee would perhaps have served its purpose better if it had waited until we were in a position—Mr. Cash—to have more detailed information.

The Minister of State, Department of Health (Dawn Primarolo): Mr. Martlew, I welcome the opportunity to serve under your chairmanship and to discuss with hon. Members the recently published proposals from the European Commission for a directive on the application of patients’ rights in cross-border health care.

The draft directive was issued in July and its main rationale is to codify 10 years of European Court of Justice case law. The case law has established that patients have, under the freedoms of the single market, a general entitlement to seek health care in another member state at the expense of their home state. In addition, the Court has established that patients are entitled to reimbursement for health care that their home system provides. The home health system has to pay only up to the equivalent costs of the treatment in the home health system. The health system can require patients to ask for permission before going. Thus far, the Court has held that that can be justified for services delivered in hospitals. When patients need to ask for permission, the Court has said that it must be given if the home health system cannot provide the service in a clinically justified time frame.

The Committee will recall that the Watts case made it clear that case law applies to the national health service. However, its application has given rise to a number of ambiguities, such as the exact level of the reimbursement that a patient should receive, or which country’s legislation should apply when a patient crosses a border. That lack of clarity is unhelpful for patients, health services and Governments. I stress, however, that the case law already applies; what we are discussing already happens.

I am sure that all members of the Committee will agree that it is important for patients to know where they stand. It is also important for the national health service to have clear guidance on its duties and on how the health system should manage the impact of patient mobility. The directive gives us the opportunity to clarify patients’ entitlements. The Government therefore welcome the directive as a means of codifying the application of the case law on patients’ rights in cross-border health care; and, as we heard, the European Scrutiny Committee agrees that such clarification would be helpful. In addition, the Government believe that establishing a framework for how patient mobility should work through the political process is preferable to the rules on cross-border health care being further developed through future ECJ findings and rulings.

Before discussing the draft directive in detail, I emphasise that we must be careful not to confuse it with case law or with existing arrangements under regulation 1408/71, which include the E112 scheme, which provides a route for patients to obtain planned health care on other member states, subject to certain conditions. It also includes the European health insurance card system, which allows tourists to obtain emergency treatment. Those schemes are not affected by the draft directive.

It has been acknowledged that since the European Scrutiny Committee’s discussions in January 2007, the Government have been working to influence the development of the proposal. The draft directive contains a number of helpful principles. It acknowledges, first that it is for member states to run their health services; secondly, that it is for member states to determine what health care they should fund; and thirdly, that member states should be required to reimburse treatment obtained in another member state only up to the level that they would have paid to treat the patient at home, or the actual cost if lower. It also includes a helpful recognition that member states can maintain referral routes—what we call a gatekeeper function—in their health systems, such as the NHS requirement that a patient be assessed by a GP before referral for specialist care.

Those helpful principles underpin the directive, but that is not to say that the text does not need amendment. In many cases, our aim is to strengthen and reinforce existing references to those principles. We also want to clarify the scope of what is proposed, particularly the directive’s suggestion that committees should be established to develop implementing measures. I want to ensure that the text allows for the development of patient mobility in a sustainable way—one that balances patients’ rights with responsibilities and allows member states the flexibility to manage their health services.

We obviously need to know what the impact of patient mobility will be in the UK. We recently issued a consultation document to explore the impact further. We know that the priority for the vast majority of NHS patients is to receive high-quality health care close to home, and we remain committed to providing it.

As I said, the draft directive reflects a number of helpful principles. I believe that it forms an adequate basis for negotiations, and I am keen for the UK to continue to play a constructive role in those negotiations. However, constructive does not mean complacent: we will continue to push on the unsatisfactory parts of the text to ensure that the final directive is the best outcome for the UK.

The Chairman: We now have until half past 5 for questions to the Minister. I remind Members that they should be brief and that it is open to a Member, subject to my discretion, to ask a series of related questions, one after the other.

Mr. Stephen O'Brien (Eddisbury) (Con): May I start by asking whether the Minister can tell us the time frame for the implementation of the directive, and whether it will require primary legislation in the UK?

Dawn Primarolo: On the timetable, we are in the early stages of negotiation, so it is a case of asking, “How long is a piece of string?” The timetable to date is that the Health Council will discuss the matter in December. There could be a First Reading in the European Parliament before it breaks for the European elections next year. I presume that the negotiations will pick up again after the European Parliament has resumed and commissioners have been appointed and portfolios given out. I am afraid that I cannot give the hon. Gentleman a specific time frame.

Mr. O'Brien: I also asked whether there was an expectation that primary legislation would be required when the matter returns here.

Dawn Primarolo: I beg your pardon, Mr. Martlew—I forgot to answer that question. Because we are already complying with the measures, and the fact that in the directive we are simply seeking to ensure that we have to comply with case law and no more, should any changes to our legislation be necessary, it will be done by secondary legislation. It is not definite that we will need to do that—it depends on the outcome.

Mr. William Cash (Stone) (Con): Would the Minister be good enough to elucidate on the role of the European Court of Justice in this matter? When the Court makes a decision, all member states are obliged to give effect to it under sections 2 and 3 of the European Communities Act 1972. Is the Minister satisfied that that should apply to the proposals, given that so much public money is involved and that there could be a significant change in the amount of money that we have to spend on health care as a result of people who make use of the provisions in the UK health service?

Dawn Primarolo: As the hon. Gentleman will know—he follows these debates very closely—during the hearings, the UK representation was that the right to obtain services should not apply in these circumstances. As I explained in my opening remarks, the European Court has made a ruling under article 49. To be frank—I think that he will take the same view—it is appropriate that we have a directive that codifies the present position but does not provide for any other legal interpretation or intervention. That is what we are seeking to achieve in the negotiations.

Sandra Gidley (Romsey) (LD): Unusually, we find ourselves discussing a health provision that does not apply to England only. In the matter of costings, it seems relatively clear that in England there is a tariff for most hospital-based procedures. That is not the system in Wales or, I think, in Scotland—there are different systems in different UK countries. What mechanisms will be available to ensure parity and to help those countries where costings are not so clear?

Dawn Primarolo: The hon. Lady is right in saying that this would be a UK-wide directive. It is therefore very important that I work closely with the Scottish Parliament, the Welsh Assembly and the representatives in Northern Ireland. To that end, the consultation document and the partial impact assessment seek to draw on the likely effect on UK health systems. What I do not have to hand but would be happy to send to the hon. Lady is the advice that has already been provided to the health service in England and the devolved Administrations on how to handle a request under current case law. I am not sure whether that covers the hon. Lady’s point about a unified tariff. I also remind her that the impact assessment shows that in the last year in England, approximately 550 patients underwent the “treatment in another member state” route.

Mr. O'Brien: While we are discussing costs, perhaps the Minister can give us some indication of the cost of the proposal to the Commission and to the UK Government. It would also be helpful to know the likely cost of the data collection. Will the burden fall locally or centrally? Paragraph 60 of the consultation flags up that question. Perhaps I can then broach another issue related to costs in another question about partial impact assessments.

Dawn Primarolo: I am sure that the hon. Gentleman appreciates that the consultation is being conducted because of the lack of data in England and the devolved Administrations on the number of patients currently trying to access treatment. In the past 12 months, 550 patients have done so. Part of the consultation document seeks to find out whether there are any more patients who have not come to light, and to then start putting a cost on the practice. Hence, we have a partial impact assessment at this stage. Until we have the results of the consultation process, which will inform our calculations, it is very difficult to answer the hon. Gentleman’s detailed questions and to say exactly what would be in the draft directive, which is a little further down the route. On the present scale of activity, those matters are dealt with in primary care.

The hon. Gentleman’s point about data collection and further data collection is important. I have no doubt that he will want to discuss security of patients’ data—I certainly want to. The answer to his question will depend on what the final regime looks like and what has been negotiated in the draft directive. Clearly, the hon. Gentleman would expect me to ensure minimum costs and burdens on the NHS and no breaches of patient confidentiality. Patients would have to give consent for their data to be transmitted before they left the UK.