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I strongly agree with the statement in the report that the purpose of the directive must not be to undermine domestic provision but to promote safety of healthcare across borders. Any health service has to

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be built on the needs of the primary population it seeks to serve. That is because health in its widest sense is more than just treatment. It needs to take into account factors such as diet, nutrition and the environment. This report really addresses access to treatment—either treatment that is commonly available but more quickly available in one country than another, or, as is more likely in future, access to pioneering or specialist medical treatment that is not equally available in all EU countries. I rather suspect that that is the light in which the Government should respond to the directive.

I noted the statement made by Unite in its evidence that it does not want to see an EU single market in healthcare. One thing that was missing from the report was an acknowledgement of the extent to which provision of healthcare is becoming a cross-border activity. We already know that United Healthcare—a large American healthcare corporation—is delivering, via its EU subsidiary, primary care services that have gone out to tender in parts of Derbyshire and Camden. If the Government think about that, if national Governments do not respond positively to this directive, rather than shaping cross-border provision and receipt of healthcare they will find themselves picking up the pieces of a free-market free-for-all as provision of healthcare becomes much more of a commodity.

One interesting point that I wanted to pick out from the report is the lack of a definition for what constitutes “healthcare”. Even if one were to use “care that is provided in hospital”, there would be significant variations throughout the EU. Across the EU, nursing care is provided in a whole range of settings that are not hospitals. In their response, will the Government consider stating that the directive should apply only to episodes of acute treatment and the consequent aftercare? Would that be a workable definition?

I agree with the committee’s recommendation that any person who intends to seek treatment abroad should do so only with prior authorisation. That is a necessary condition to ensure that nations have met and continue to meet their obligation to provide an adequate healthcare system for their own population. However, I suspect that, in future, individual patients will be motivated to seek treatment abroad on the basis not of waiting times but of access to innovative treatment. If that proves so, I wonder whether the Government would consider it wise for primary care trusts to acknowledge that that may become a growing phenomenon, and to include policies in their plans that would enable people to travel abroad to receive innovative healthcare, provided that they did so in such a way that there was learning and development of skills for the health service in their home country. I also agree with the noble Baroness, Lady Howarth, that if there is to be a system of authorisation there has to be a framework of transparency and a right of appeal.

I want to look at national contact points. With my noble friend Lord Kirkwood beside me, I remind the committee again that health is a devolved matter. There is considerable anxiety on the part of the health professions about where responsibility for dissemination of information will lie. Will it be with the Department

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of Health or with front-line staff? I rather suspect that, wherever the responsibility lies, in practice there will need to be a national resource point to which front-line staff can refer in order to make sure that they state correctly the position and people’s rights under the directive. I agree that there is no obligation to promote cross-border healthcare, but it is incumbent on the Governments in the UK to advise individuals on not just the provision of healthcare in other EU countries but the systems of redress available to them in those countries. The Government’s response to the report—they say that there should be an,

“onus ... on the patient to be satisfied with the information they have”—

is somewhat unacceptable. I do not know how an individual could reasonably make that judgment without some assistance from healthcare professionals.

I am afraid that the clock has gone wrong, so I do not know what my time is. I simply wish to pick up two further points.

Baroness Howarth of Breckland: You have about 10 minutes.

Baroness Barker: In which case, sadly, I want to pick up on a point made by the noble Lord, Lord Kirkwood. I have not had the pleasure of serving on the GMC, but in its note to us it welcomed the directive as an opportunity to include a legal duty on competent authorities in each country to exchange registration and disciplinary information, and to act on it in the interests of patient safety. We know that the present situation is variable; we saw that most recently in the case of the doctor who was performing an out-of-hours service and whose standard of work led to a terrible tragedy. Will the UK Governments discuss with other member states what would constitute a competent authority in each nation? Are there comparable regulatory bodies in most countries? I imagine that there are for most healthcare professionals.

I, too, agree that a great deal of the benefit of this directive to citizens of the UK will only be recognised if it is properly monitored. Who will be responsible for monitoring the implementation? Will it be the responsibility of the Department of Health, primary care trusts or individual trusts? If monitoring passes to front-line staff on a day-to-day level, is there a case for monitoring of this directive being aligned, within costs, to the work of overseas patient officers?

I note from the report that there is already a pilot project looking at e-transfer of patient data for urgent care: the epSOS system. Any of us who have had a friend or relative become seriously ill abroad will know the efficiency with which healthcare systems can swing into action when they need to. I would be interested to know from the Minister what has been learnt from that pilot and what the UK Government think of the potential of taking what has been learnt from urgent care and applying it to e-systems for monitoring the implementation of this directive.

My noble friend Lord Kirkwood and the noble Baroness, Lady Howarth, are right. Only a small number of people currently choose to go abroad to receive healthcare. I suspect that numbers will grow,

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for a variety of reasons; most of those will be for access to innovative treatments abroad which are seen as life-saving. It is right that people should have that access without it being simply based on their ability to pay.

I welcome the report. I say to the noble Baroness that, whatever the Government’s detailed response, this is their opportunity to shape future European policy to the benefit of citizens of this country and to place the NHS within the context of the European healthcare systems. I hope that, whatever the political situation over the next few years, neither this nor any future Government will shy away from that responsibility. If they do, it would be greatly to the detriment of the people of this country and our neighbours in other European countries.

4.13 pm

Earl Howe: This has been a particularly interesting debate, and I congratulate the noble Baroness, Lady Howarth, not only on her opening speech, which I thought was excellent, but on overseeing the preparation of such a well reasoned and perceptive report. It is perhaps worth adding that there is another body deserving of our congratulations—not a body which we normally shower with much gratitude—and that is the European Commission, which has not only recognised that there is an issue to be addressed but which has also advanced a set of proposals that, in the main, take us forward in a helpful and constructive way. It is to the credit of the commissioner who gave evidence to the sub-committee that she expressed a willingness to take on board any recommendations for improving the content of the draft directive. I very much hope that the noble Baroness will be encouraged by that.

A necessary, and quite revealing, part of the committee's report was the whole chapter devoted to discussing what the point of the draft directive was. Normally, everyone knows what a draft directive is meant to achieve but, in this case, its precise purpose is not entirely self-evident. According to the Commission—which, after all, ought to know—the draft directive is intended to do two things: establish legal clarity around the rights of EU citizens; and establish a general framework for the provision of safe, high-quality and efficient cross-border healthcare. We need to bear those aims constantly in mind during this debate. I make a point of this because of a sentence right at the beginning of the report, which begins:

“The right to access cross-border healthcare presents patients with choice”.

It is clear, once we have read the whole report, that we should not get too hung up on the idea of choice in this context. A citizen of this country has to be brave, determined and a little desperate to exercise their right of choice to be treated abroad. The kind of choice that this represents is not unlike the choice you might have had 100 years ago if you were told that you could cross the Channel either by ferry or by Louis Blériot’s new biplane. The result of opting for the second alternative might be triumphantly successful, horribly disastrous or something in between. No amount of tinkering with the engine of the biplane would have obviated the risks inherent in that mode of travel.

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The same conclusion applies to cross-border healthcare. The EU Commission’s stated aim of creating in the directive the conditions necessary for,

“the provision of safe, high quality and efficient cross-border healthcare”,

is, I am afraid, a pipe dream, at least for the moment. Achieving adequate standards of safety, quality and efficiency for the cross-border patient is shown throughout the report to be impossible in the short term and highly problematic even in the medium to long term.

Of course, I am talking from the perspective of a UK citizen. It may be a different matter if one is a citizen of Luxembourg wishing to access a medical speciality in France, but, for the people of the European Union as a whole, the hopes that are resting on this draft directive should not be too great. For the avoidance of doubt—here, I slightly disagree with the noble Baroness, Lady Barker—we are not talking about creating a single market in healthcare. For one thing, the Commission makes it quite clear that the right to choose to be treated in another member state is trumped by the right of that member state to refuse to treat on the ground that it lacks the spare capacity to do so. The clinical needs of the citizens of each state should always take priority over the needs of someone coming in from abroad. That rule does not apply to the purchase and sale of cheese, but in health services it is entirely appropriate if we are to safeguard the effective delivery of care at a local level.

This issue is by no means central to the problems which the committee identified. Perhaps the most obvious of these problems is the language barrier. The scope for misunderstanding on the part of both clinicians and patients as a result of language difficulties is not to be dismissed lightly. No amount of legislating can remove it. It impacts most critically on informed patient consent, on sharing medical notes, and on very basic things such as prescriptions, where all manner of confusion can arise. If, as a generality, we regard our own doctor as the person who is best placed to give us advice on our healthcare, it is, to put it mildly, quite a tall order to expect him to provide advice on how to access safe care, and the right kind of care, in another country, not least if the language of that country is a closed book to him. Yet any patient depends on having enough information on which to base a reasoned decision.

The committee was therefore quite right to point out that the lack of clarity over who is to provide what information and how is a very serious gap in the wall. It is not clear how it will be tackled. The committee recommends that front-line healthcare providers should be absolved of the responsibility of providing this kind of information, or right, but if they are, who else will provide it? The suggestion is that, for the patient, it is simply tough; he is basically on his own. Indeed, the Minister, Miss Primarolo, said in her evidence that the responsibility for overcoming the language barrier should rest with the patient. The commissioner appeared to back this up when she indicated that the cost of interpretation facilities might well have to fall on the individual, and that it would be too much to expect the providers of healthcare to offer this service. If that is the settled view, simply in the cost of overcoming the language barrier we are dealing with a very significant obstacle to accessing cross-border care.

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Another major deterrent may well lie in the cost of treatment. The committee covered that very well. The proposal in the draft directive is that patients should have to pay for their treatment themselves before receiving reimbursement later. Only a small proportion of people can afford to do that, so if we are serious about breaking down barriers, a mechanism needs to be found to get round that one. But even people who are able to find the money need to be careful, because they may discover that they are not going to be reimbursed for the whole of their financial outlay. Indeed, it seems to be explicitly envisaged that patients will need to finance a proportion of their care themselves, on the lines of a top-up, if the cost of care in the treating country exceeds the cost of the care at home. How do the Government view this issue? Is it something that they see as inevitable or can something be done about it?

The issue of top-ups is of course a delicate one. If, when treated abroad, patients are allowed to top up the cost of their care as a whole, and not just the cost of medication—which was the principal focus of Professor Richards's report—the question arises why patients should not be allowed to do exactly the same thing when being treated in this country. Again, if the Minister feels in a position to comment on this, I should be interested to hear what she has to say.

Even if the problems of language, information and money can be overcome—those are big ifs, certainly in the short term—the central question for any British patient remains the one asked by the noble Baroness: how safe is it for me to be treated by this doctor at this hospital in that country? It is sobering to read how many and how serious the risks to patient safety are. As the noble Lord, Lord Kirkwood, told us, the GMC cannot guarantee to tell you whether a particular doctor in another country is deemed fit to practise. The doctor you are thinking of going to may not be insured. If something were to go wrong with your procedure, the chances of obtaining proper redress may be slim, or non-existent.

Even assuming that your visit abroad is a success as regards one particular episode of care, there is still all manner of scope for misunderstanding about who is responsible for what in terms of the follow-up care that may be needed. The safe pathway of care that doctors in the NHS take for granted cannot be taken for granted when more than one health service is involved. Even in something as straightforward as bringing back a prescription to this country, a British pharmacist has no means of knowing whether the person who has signed the prescription was qualified to do so. Simply telling a patient that they can insure against these risks cannot possibly be the answer.

One is left at the end of the report asking the same question that the committee asked: whether the complexity of the measures envisaged is proportionate to the scale of the issue. On the scale of the issue, we simply do not know yet how many people will want to exercise their right to be treated in an EU member state other than their own. However, if I were a doctor and someone were to come to me asking whether they should exercise this particular legal right, I would tend to compare it to the right to get married. Everybody has that right, but exercising it is not to be entered into lightly,

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unadvisedly or wantonly. Not enough people are aware of that, which is why the messages in this report deserve a wide audience.

4.25 pm

Baroness Thornton: I thank noble Lords for having undertaken this important inquiry and the noble Baroness, Lady Howarth, for her chairmanship and the presentation of the report findings to the Committee. The Government welcome the committee's report, which, at its heart, identifies a key challenge: that of proportionality and the question of balancing the rights of individuals with the responsibility on health services and Governments to ensure effective provision of healthcare for all their citizens. Arriving at a sustainable framework for patient mobility throughout the European Union is a key aim during negotiations.

Noble Lords will be aware that the Government agree with many of the committee's conclusions and recommendations in its published response. Where there are differences of viewpoint, such as the need to mandate information-sharing on healthcare professionals' fitness-to-practise status, they are due to the Government wanting to keep the directive focused on codifying the case law and clarifying individuals' rights—not to extend it into other areas. However, I shall come back to that issue.

As noble Lords will be aware, there is a tension in the European treaty between Article 95, mentioned by the noble Lord, Lord Kirkwood, which covers single market rules, and Article 152, which promotes public health and enshrines the right of member states to manage their own healthcare systems. We need to balance this tension and, as the report identifies, ensure that the directive respects national competence in the provision of healthcare. That is why the committee was right to spend time looking at what the directive meant, as the noble Earl said. Similarly, the report rightly highlights the need for the directive to respect the devolved nature of healthcare within member states such as the UK. The report also finds comparisons with many of the themes the Government found when they conducted their own consultation on the draft directive last autumn, including the importance of patient information and concerns both to protect systems and help patients through prior authorisation schemes.

I do not intend to speak about every aspect of the directive. Instead, I will address the more pressing considerations, which noble Lords have mentioned. The report has concluded that this directive raises questions of equity and has suggested that member states should consider whether to put in place systems of direct payment when a patient has sought prior authorisation. The question of how we address equity raises some really tricky issues. As my right honourable friend Dawn Primarolo outlined in her evidence to the committee, we start from a perspective of considering equity for all NHS patients, not just those who are leaving the NHS to obtain treatment in another member state. When a patient decides to obtain treatment in another member state because he faces undue delay in accessing a treatment, there is already a mechanism under Regulation 1408 for that patient to be granted

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an E112 form and the patient does not need to pay upfront treatment costs, as the noble Baroness, Lady Howarth, said.

At the moment, we do not know how many people want to take up the choice to obtain treatment in another member state for other reasons. Some of the solutions proposed at a European level, such as a European-wide claims house, may be costly, bureaucratic and disproportionate. Therefore, it is too early to say how issues of equity will be addressed, other than to assure noble Lords that the Government will continue to address these issues. We will explore in greater depth the potential impacts of different payment and reimbursement arrangements in the directive, as well as possible solutions in this area.

The Government also agree with the committee on the importance of being able to operate prior authorisation schemes for hospital care, in line with the established case law. Such a system can help to provide a degree of certainty to patients that their treatment costs will be met. Additionally, it would give patients the opportunity to explore some of the quality and safety issues involved with cross-border healthcare. The noble Baroness, Lady Howarth, raised the issue of whether we were pressing for a prior authorisation scheme and would continue to support the deletion of comitology proposals on the definition of hospital care. We will continue to press member states to have powers to use prior authorisations. We also support the European Parliament’s deletion of proposals for comitology on the definition of hospital care.

This brings us on to information and support for patients. The noble Earl is right: people need to think carefully about whether treatment in another country is right for them, as they are effectively stepping outside their home system, with all that that implies. There are fundamental issues to consider: standards of care and aftercare, the distance to travel, language barriers and the broader legal implications of treatment in another state, including redress procedures. PCTs’ ability to know what is going on elsewhere in the Community will be very limited and the NHS will not be in any position to guarantee or verify the competence of overseas providers. We do not want to extend the responsibility of the NHS to matters beyond its control.

The proposed national contact points could fulfil a role here in relation to providing general information to patients about their rights and signposting them to contact points in other systems for more detailed information. British national contact points could also outline to patients from other member states how the NHS works, but I do not think that it would be reasonable for contact points in this system to be able to provide detailed information on every hospital in Germany, for example. Similarly, a legal responsibility on member states for addressing language barriers should not be created in this directive; apart from anything else, it would constitute a significant additional cost to the NHS which is hard to justify. At present, patients must ultimately be responsible for deciding whether they have the information necessary to make a decision on accessing cross-border healthcare.

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Moving on to more technical, but no less important, matters, the Government agree with the committee that there needs to be caution exercised with the amount of secondary legislation in the directive. The challenge of some of the co-operation measures envisaged in the directive, such as e-health interoperability, should not be underestimated. I shall refer to that when I address specific points which were raised. Again, we need a proportionate approach. The UK is already co-operating in many areas of work which the directive could duplicate or even harm, and we are unconvinced of the need to create secondary legislation in these areas. The scope of any secondary legislation must be clear and limited to actions agreed by member states as being necessary at an EU level.

I turn to questions raised by noble Lords. The noble Baroness, Lady Howarth, explored further the issue of co-operation in comitology. I have had to have that word explained to me on several occasions. I am not sure I understand it yet, but I am getting close; perhaps it is something you know when it approaches you, but you are not sure how to describe it. The noble Baroness described it extremely well. The Government agree that co-operation at EU level can have the potential to add value but we need to look at each measure on a case-by-case basis and be sure that we understand the scope of each proposal. As the committee has noted, we need to ensure that the directive is proportionate. That includes co-operation measures, where I agree with the need for the final details to be clear. We agree with the committee that the challenge of e-health interoperability, for example, should not be underestimated and the impacts need to be assessed properly.

Several noble Lords, including the noble Baroness, Lady Howarth, raised the issue of lack of data. In terms of the timeline for a European review of the impact of the directive, it is too early to say what the negotiations may conclude. However, a number of member states have concerns that the data burdens could be considerable. I am acutely aware that there are limited data on cross-border healthcare. Therefore, irrespective of the European timeframe, the Government are considering ways of collecting more data in the mean time. We think, quite rightly, that we should not take these decisions when we do not have the data.

The noble Baroness, Lady Howarth, and the noble Earl, Lord Howe, mentioned prescriptions and recognition. The challenge, quite rightly, is how to ensure a proportionate response, how to get a common template, which can be very expensive with significant implications for national systems, how to ensure protection for patients and how to ensure that pharmacists can refuse to dispense a prescription if they have a legitimate doubt about its authenticity. We are continuing to discuss those issues with our European partners and to consider prescription recognition issues in detail. That is on the agenda, as it is very important.

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