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Grand Committee

Volume 711: debated on Monday 8 June 2009

Grand Committee

Monday, 8 June 2009.

Before the noble Baroness, Lady Howarth of Breckland, moves the first Motion, I remind noble Lords that the Motions before the Committee will be that the Committee do consider the Select Committee report and the statutory instruments in question. The agreement of the Committee to the Motions will not affect the status of the statutory instruments, all three of which are negative. If there is a Division in the House, the Committee will adjourn for 10 minutes.

Healthcare: EUC Report

Considered in Grand Committee

Moved By

That the Grand Committee do consider the Report of the European Union Committee on Healthcare across EU borders: a safe framework (4th Report, HL Paper 30).

This is rather an interesting day for the nation in terms of Europe. I did not think that I could begin without at least acknowledging that interesting things were happening.

I know from the work of the sub-committee and the whole European Union Select Committee how important our influence is and should remain. Indeed, one hopes that it will increase, as we cannot afford to lose that influence about the everyday issues affecting people in our nation. One of those people—Mrs Watts—in 2006 investigated the possibility of hip arthritis treatment on the basis of an E112 form. This scheme allows nationals of EU member states to travel to other member states for treatment at the cost of the relevant authority in the home member state, as long as they have been authorised by that authority. Mrs Watts’s request was refused because the projected one-year wait for the operation was within government targets and therefore could be considered “without undue delay”; that is one of the criteria for E112 authorisation. Having failed to secure authorisation on appeal, Mrs Watts proceeded with treatment in France. She finally took her case to the European Court of Justice, which found in her favour.

In the history of case law over the past 10 years, individuals uncertain about their legal rights or challenging the decisions of their healthcare providers have continued to take their cases to the European Court of Justice, and a history of case law has been established in the field of cross-border healthcare. The EJC has consistently confirmed the right of patients from EU member states to travel to another member state to receive healthcare. However, uncertainty has remained over how that right should function in practice, which has acted as a barrier to cross-border treatment for many patients, and current levels are low, with the Commission estimating that cross-border treatment accounts for only about 1 per cent of public expenditure on healthcare. The European Commission has therefore introduced a proposal for a directive on the application of patients’ rights in cross-border healthcare to overcome these barriers and to provide a safe framework for the delivery of cross-border treatment throughout the EU. That proposal was the subject of an inquiry and subsequent report, which your Lordships have, from the European Union Sub-Committee dealing with social and consumer affairs.

During the inquiry, the committee heard from many interested parties and received a wealth of evidence. We spoke not only to the Minister, Dawn Primarolo, but to the Health Commissioner. The report is well timed to influence both the UK and EU-level approach to the dossier, as the discussions and negotiations progress. The committee concluded that the proposal is justified and necessary as an attempt to codify the case law in this area but the demand is at best unclear and is likely to differ significantly across the European Union, with demands greater in countries sharing land borders or for reasons of size—like certain specialities. The precise mechanics required to deliver it are equally unclear. Our report identifies some of the challenges to be met, which are unresolved in the directive as drafted, such as delivering a smooth pathway of care for patients, ensuring that patients and practitioners are able to communicate with one another—the language problem—and collating and disseminating information on what is available through cross-border healthcare. In short, a large number of practical issues remain to be resolved. Since producing our report, we have received the government response, which is largely in accord with our findings and recommendations. In addition, the European Parliament has completed its first reading and negotiations are ongoing in Council working group, but it is unclear when a common position will be reached—possibly even more unclear than when I wrote the speech.

The European Parliament has underlined the position taken by the committee and the UK Government that healthcare is a member state competence, and therefore that entitlement may be decided at national, regional or local level. That was a key issue for the committee, as prior authorisation by a GP or other appropriate healthcare professional is essential to establish clinical needs and ongoing care. The ECJ decisions have confused the issue, but I understand that the European Parliament has said that prior authorisation should be refused only in the context of a “fair and transparent” procedure, and that reasons for refusal should be made known in advance. I ask the Government whether they will continue to press for the right to set up a national authorisation scheme. I also understand that the Parliament has removed the comitology—the delegated requirement—to reach an EU definition of “hospital care”, leaving it up to member states to define what constitutes hospital care for the purpose of applying prior authorisation. I also ask the Minister whether the Government will continue to press for clarification about the finer details of delegated or comitology committees, where rules might go further than those required by the legislators.

The committee concluded that many benefits could accrue from providing a safe framework for cross-border healthcare, such as the reduction of waiting lists, an increase in standards of care, and certainty and peace of mind for patients travelling abroad to receive care. There are benefits for patients with rare diseases, disabilities and life-threatening conditions, where it appears that the European Parliament is making an exclusion from the requirement to seek prior authorisation. Does the Minister agree with that position? Is the Government’s view that prior authorisation should be sought for all patients?

I want to say just a word on the apparent exclusion of organ donation from the scope of the directive, recognising that it does not mean that European case law is similarly disapplied. The committee has an interest based on one of our previous reports as well as this one, and would be interested to hear if the Government had any thoughts about how that would be taken forward.

The committee had a major concern about equity, echoing many of our witnesses, especially those representing patient groups. A system where a patient had to pay up front for their care only to be reimbursed at a later date would exclude those without the necessary financial resources from using cross-border treatment. The European Parliament, like the committee, appeared to suggest that there be a system of state-to-state payments, but the UK Government seem to see any such system as open to fraud and impacting on patients who cannot or will not travel for healthcare. How will the principle of equity ensure that all groups have equal access, whether or not they travel abroad for their care?

The committee heard a range of views and evidence on the cross-border recognition of prescriptions. The Commissioner told us that, while a rule existed on the subject, it was difficult to implement in practice. To facilitate it, the Commission intends to develop a community prescription template and other measures to safeguard public health. The committee recommended that it would be also helpful for the Commission to develop a set of detailed rules for the cross-border recognition of prescriptions, but the Government appear to think that this is not practical. Given that differences in prescribing practices in the health of patients who travel exist, how can these patients be protected during their stay abroad and their continued care at home, thus ensuring that they have proper prescriptions?

I congratulate the Government on their success in having the definition of “harm” amended in the directive. The committee was concerned that this might have included avoidable harm, leaving medical practitioners liable for such cases. We understand that under the present proposals, harm will be defined by reference to the existing legal framework of the member state of treatment. However, in relation to redress generally, will the Minister clarify the UK’s response to a recent suggestion that has come from the Commission that a European patients’ ombudsman service should be established?

I know that colleagues will speak about many other aspects of our report, but this is a complex and fast-moving scenario. The European Parliament’s opinion has responded to many of the areas of concern we raised in our original report, but we must remain vigilant and continue to assert that the delivery of healthcare is a member state competence. The EU Parliament completed its first reading after voting to adopt John Bowis’s draft with amendments. He was unable to give direct evidence to the committee, but he kept in touch. As he leaves the EU this session, I should like to pay tribute to his work in social care and healthcare in Europe. He has been exceptional and has kept this work far above politics.

However, the work continues. One difference we have with the Government is the timescale for assessment of the scheme. The number of cross-border patients at the moment is proportionately small. The Commission believes that mobility of patients is a limited phenomenon, but we do not know. We have no idea of the level of inflow of patients from other EU countries to the UK and statistics seem to be generally lacking. One of our key conclusions was to review whatever is put in place within three rather than five years of commencement. Member states then would learn the lessons sooner rather than later. The Government agree that it was difficult to predict future demand, but say that the directive must not place a disproportionate burden on health systems in terms of data collection. Without evidence, how can we assess the impact of any changes in our healthcare system? Surely statistics are already being collected that could be adapted for this purpose.

My colleagues on the committee would have wished to cover other areas. I know that the noble Lord, Lord Kirkwood of Kirkhope, will do so, raising the concerns of the General Medical Council, which has taken a particular interest in our report. But the choice of the day was not a good one for our members, most of whom would have liked to take part. However, I commend the report to the House. It has been well received by the Government and the Commission.

It is my signal pleasure to follow my chairman in this important debate. It also was a pleasure to serve under the calm and authoritative leadership that she gave the committee. She is very good at picking subjects of much wider interest across the House. We are lucky and grateful to the business managers of the House that we have found time for this debate. It has captured the interest not only of those stakeholders in the area and the Euro-anoraks; it has captured a much wider interest than that, which is rightly so because this is a very important subject. In our sitting, my chairman makes my Thursday mornings quite bright: I am never bored and always fascinated by what we learn. I was fascinated by some of the evidence that was presented. I should declare an interest as I am the new lay member of the General Medical Council, and I enjoy that work too. There is obviously an overlap.

The noble Baroness, Lady Howarth, rightly said that this is an important European day, and I agree. What strikes me is the disjunction between the work necessary to get the scrutiny done to make sure that the United Kingdom’s interests are protected and the complete absence of any content in the political debate in the European campaign. If the British public knew what was being done in their name, their interest would be more easily captured, and they would better understand what is at stake. This is important work, these are important subjects and it is a privilege to be part of the scrutiny process. Having spent many years in the House of Commons, I do not think that it has the time to do this kind of work to this depth and level apart from in the Select Committee work that I did latterly. Therefore, it is important that it is done in this House.

The more experience I get in some of these new policy areas, I realise there is an important interface with the devolved legislatures. This House has to remember that, and we were satisfied that proper steps were taken by the Government to make sure that the devolved authorities in the other constituent legislatures of the United Kingdom were properly consulted. I hope that throughout this debate it will be understood, as it is well enough understood in the department, that that is an important part of getting this policy right because there is a lot of argument to go on when the fine print becomes more established as the European codecision process unfolds.

I was sceptical about the need for this. When I started, I thought it was not worth the candle. There was a question in my mind about proportionality and the things that have to be put in place to guarantee that this is all done right for the proportion of the cross-border flows of patients. I had great doubts. I think they have been assuaged, but I only think so. The proof of the pudding will be in the eating. As the noble Baroness, Lady Howarth, said, there is a complete absence of any information about demand, flows or anything, and I underscore her call for the Government to look for an early review. The proposed five-year review might be too long. Coming from the United Kingdom where there is an expanse of water as well as a boundary between our nation and our sister European nations, perhaps we take a different view. Coming from the north end of the United Kingdom, that might be worse for me. We have to bear in mind that our perspective is perhaps not the same as that of somebody in Luxembourg about treatment in Germany. That is important. We need to do more research and stay on top of what happens if this right to transfer treatment in other states is developed to a point that it becomes something that a lot of people use.

As a lawyer, why it is has taken 10 years to get this directive on the road to some sort of completion is a puzzle to me, because case law is certainly not a safe basis. The committee went into that in some detail. The article on which the European Court of Justice made its basic finding was flawed. It should have been Article 95 rather than Article 49. Lawyers will no doubt argue about that for a long time and charge big fees for doing so. If we are going to do this, we must do it by way of the directive. We must make sure that case law is put back into the courts where it belongs and get on with practical provision that helps ordinary people.

I now think that ideas about practicality and patient safety are more important than I formerly did. There is a need for clarity. We need to be absolutely sure that people do not think that this is an NHS referral. The right to have treatment in another country is not an NHS referral. It is quite separate and it is qualitatively different in all sorts of ways. We need to ensure that that is absolutely clear to those in the United Kingdom who may be thinking of taking advantage of this. The Minister used the very good phrase of stepping “outside” the NHS to think about how you can look after your own healthcare in another country. That is important.

The noble Baroness, Lady Howarth, is absolutely right to mention minimising bureaucracy. If we have made some progress with the comitology and influence in this, everyone is deeply suspicious of devolving some of these key definitional details to squads of highly professional people. I am always impressed when I talk to them, but they are in a different context from the front-line services of NHS hospitals in the United Kingdom. They cannot be expected to know the consequences of some of the definitional work. We have to be really clear and we need to limit as far as we reasonably can the use of comitology to develop this policy. We need to safeguard the NHS. The department gets that message loud and clear, but we need to protect staff as well. If professionals are making arrangements for pathways of care, the liability attached to that if it all goes wrong could become extremely messy, particularly when lots of our sister European nations have a no-fault compensation basis of redress, which we do not have. We have a well developed system of negligence and the two systems are chalk and cheese. That needs to be made clear to those who are thinking of going abroad.

Information transfer is extremely important too. Medical notes need to remain available and language barriers need to be overcome. I want to make a point from a General Medical Council point of view, which is that the regulatory information needs to be available. Fitness-to-practise information needs to be available to those who are going abroad. At the moment, there are 20,000 EEA medical doctors practising in the United Kingdom and some of them could have fallen foul of fitness-to-practise conditions in their countries of origin. That is true for the whole of Europe. I would like to think that the General Medical Council is a leader in this area because it is transparent and deals in real time on its website. I can take you to an IT terminal and show you whether there is a question mark about a registered medical practitioner's fitness to practise in the UK.

If we are sending people to Romania or wherever, it is important that there is an exchange of information so that there is confidence in the fact that there are no questions about medical competence in other areas. The GMC did a very useful survey on this. I shall give you two figures. It asked the public about patients’ rights in cross-border healthcare and about proactive sharing of fitness-to-practise information: 94 per cent of respondents said that they,

“agree or strongly agree that if a doctor is struck off in another European country the authorities there should inform the GMC in the United Kingdom”.

In my view, that is a no-brainer and it should be an absolute red line for the United Kingdom Government. When we talk about information available to patients, another interesting statistic is that,

“80% of respondents agreed they would be put off getting health treatment in another European country … if they did not fully understand how to complain in the event that something went wrong”.

Again, that is a no-brainer and I hope that the department has that loud and clear.

Following my new interest in the General Medical Council, I am struck by the need for systems of performance enhancement and assessment across the United Kingdom to be looked at. There is very little EU research done about comparability of NHS systems. In many ways, they are very different, which is not perhaps surprising. That may change over time. Assessment and performance enhancement are essential and the EU must be put on its mettle to ensure that, over the three to five-year period that we are doing this, it gives some assurance on the comparability of our systems.

I shall say a little about language competence. In my experience since I joined the committee earlier this year, you can have really excellent EEA doctors who just cannot do the job because they cannot speak the language. The GMC is incapable of stopping them practising at the moment under current law. It is a real worry, and we need to do something about it very quickly. We need to look at the ability of the medical workforce in Europe; the GMC is concerned about that.

Finally, on the development of e-health services, the question of who regulates the doctors in charge of e-medicine is very interesting. Who has regulatory authority over an operation in Bucharest that is being remotely controlled from Edinburgh? Is it the doctor in Edinburgh or the people who are actually overseeing the procedure overseas? It is important to resolve these things if we are to evolve in a way that is safer for our patients across Europe. I now think that this is a very important subject; again, I changed my mind as a result of exposure to the committee’s inquiry. It is a very important part of public policy.

The committee has done a good job. I agree with the chair that lots of colleagues would have been here but for other commitments, which enables me to speak for a little longer. The Government need to remain vigilant. I acknowledge that the response was very positive, and the committee is right to want to maintain its interests, as I am sure it will. It has been a pleasure to serve on it, and I look forward to hearing what the Government have to say.

I, too, begin by noting that this is a timely reminder of the European Union’s role in promoting the well-being and prosperity of citizens of the United Kingdom. It is good to be able to say that today. It is also a timely example of the work of this House. This House is under varying degrees of attack from all sorts of quarters these days, but this report is a shining example of why the House of Lords needs to exist and of the high-calibre work that it can do on issues that are not immediately high profile but which are none the less extremely important.

I congratulate the noble Baroness, Lady Howarth, and her committee for producing this report, which brings into sharp perspective a raft of complex and unclear issues that have been growing in significance for the past 10 years. I welcome her statement that all EU citizens, not just the wealthy or well informed, must be able to benefit, and that the report therefore recommends that patients should not have to pay for their treatment up front and that member states should be responsible for informing their citizens of the options that are open to them for cross-border healthcare. That is the fundamental principle in the report.

The issue of access to cross-border healthcare in the EU first came to my attention back in 2002 during a debate on the Health Bill. In response to a very innocent question from me about whether PCTs would have to inspect health service facilities abroad should someone elect to go, the noble Lord, Lord Hunt of Kings Health, the then Minister, said yes, much to the amazement of the noble Earl, Lord Howe, who was in the Chamber with me that day. The noble Lord, Lord Hunt, went on to say that, as part of this Government’s intention to open up choice to patients, there would indeed be much more cross-border healthcare. At that point, the noble Earl, Lord Howe, and I weighed in with a raft of questions, and it is interesting to see that six or seven years on, those questions remain and are only now being addressed in much greater detail. I am glad that they are. As my noble friend Lord Kirkwood said, we on these Benches welcome the report and the recognition it brings that patients, who have far greater access to information today, can and do exercise their choice to access treatment abroad—not only in the EU but in the United States and India.

It is important to state at the beginning that maternity services, which are elective services, are often used as exemplars; indeed, mention is made of them in this report. But we should recognise that maternity care is different. People who receive maternity care are not ill; they are also mobile and in a different position for exercising choice. As we know, maternity care is very much rooted in people's emotional and cultural experience. Therefore, from the outset, will be Government consider making a slightly different provision for maternity services?

I, too, was struck by the fact in the report that there are no statistics for the numbers of people who travel to the UK from the EU seeking treatment. Like the noble Baroness, Lady Howarth, I believe that if we are to have evidence-based policy, we need that information. The noble Baroness, Lady Thornton, will recall from our recent deliberations on the Health Bill that government policy has to an extent rested on the myth of health tourism to this country. Not only the public health risks but the potential risks to the provision of acute care are now so considerable that we need to know the exact facts about that.

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 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 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.

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, 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.

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.

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.

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

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 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.

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.

The noble Baroness, Lady Howarth, asked whether the Government support the proposal from the European Parliament for an EU health ombudsman. We need more information about the proposed role of such an ombudsman. As noble Lords will be aware, the directive will require all states to have appeal processes in place for decisions on authorisation and reimbursement. Those appeals may be referable to an NHS ombudsman, so we would want to avoid duplication at that level.

The noble Lord, Lord Kirkwood, spoke of the devolved Administrations. There is regular contact between the Department of Health and the devolved Administrations to agree overall negotiating aims so that we present a co-ordinated United Kingdom position in Brussels. The noble Lord, Lord Kirkwood, the noble Baroness, Lady Barker, and, I think, the noble Earl raised the issues of a professional’s fitness-to-practise data and patient safety. The overall view of the Government is that this directive should be about codifying and clarifying existing case law on patient mobility and its scope should not be extended to other issues. However, it is UK policy to support sharing fitness-to-practise information, and we have been doing so since the UK’s 2005 EU presidency. Therefore, we continue to support the thrust of sharing data on professional registration through voluntary arrangements and in due course potentially through other EU workforce-related proposals, which can deal with healthcare professionals who have been struck off in other countries. I am not completely clear about where the responsibility for holding that register would be. I am not sure whether that is because I am not clear or whether it has not been decided. I shall return to that in writing.

I am grateful to the Minister. Could the Green Paper on the European Workforce on Health, which is currently in play in the European debate on this issue, be appropriate? I understand the point she appropriately made about not getting the focus wrong on this directive, but the Green Paper seems to be an obvious place. There are real problems about data privacy, which sister European nations are using to block transfer of fitness to practise. I encourage the Minister to strengthen the Government’s hand in making these arguments, and the most appropriate place might be the Green Paper discussions that are going on.

That is a helpful comment. The EU workforce-related proposal is obviously where we need to look. I shall come back in writing on that.

The noble Baroness, Lady Barker, and the noble Lord, Lord Kirkwood, asked who has responsibility for e-health. We understand that under the draft directive the member state responsible is the state where the service provider is located. I am told that that is the person who has hands on the patient. The noble Baroness, Lady Barker, asked about the epSOS pilot on e-health. I understand that it is still ongoing, but we will be working to learn the lessons for e-health. This is one of the reasons why we have concerns with some of the provisions on co-operation because we want to learn the lessons from this pilot before we work on the finer details of the comitology.

The noble Lord, Lord Kirkwood, and the noble Earl, Lord Howe, raised language. It is clearly a serious issue. We do not think that a legal responsibility on member states to address language barriers should be created in this directive. Covering costs needs to be considered in the context that paying for translation services so that patients can obtain healthcare in another member state would constitute an additional cost for the NHS. There is no obligation on the NHS to pay for or provide translation services associated with existing Regulation 1408/71 when patients get planned treatment in another member state. In addition, where patients need to access emergency healthcare abroad using the EHIC system, we do not pay for translation services. This is a challenge still to be outlined. My access to healthcare abroad is almost completely limited to France, so I suppose I am fortunate that language is not a barrier, but I can see that it is an issue.

The noble Baroness, Lady Barker, asked about maternity care. She is correct that maternity care is different, but it is still planned care, as far as that is possible, in most EU states, and certainly under the NHS. In the data that we provided to the committee on the number of E112 referrals, it was shown that a large proportion was for maternity care. If women have good grounds for feeling that their baby should be born in another EU state, this might be the preferred route.

She also asked about data on the number of patients coming into the UK. As far as we are aware, there are very few requests for treatment in the UK under the E112 scheme. Many countries, such as the Republic of Ireland and Malta, have contractual arrangements with individual NHS providers. These matters are devolved management arrangements for the NHS, and the data are not collected centrally.

She also asked whether we would press for hospital care to be defined with reference to episodes of acute treatment and immediate after care. While that may seem attractive, given the 27 healthcare systems, it would probably be very difficult to seek out a detailed definition of hospital care that works for each member state.

The noble Earl, Lord Howe, raised the issues of top-ups and additional private care. The directive is not about extending entitlements for patients. It is about enabling patients to access healthcare to which they have an entitlement in the UK and other parts of the EU. The draft text of the directive already helpfully refers to that, but we are seeking to ensure that the directive is completely clear on the issue and that we are supported by other member states. We think that the overall principles of the Richards review will apply, but we need to consider this further in practice, including in the final text of the directive.

In conclusion, this is an important directive for clarifying patients’ rights and the rights and responsibilities of healthcare systems to manage patient mobility in a sustainable way. Without this directive, the rules on patient mobility will continue to be developed solely through the courts and not through the political process. There is a significant risk, therefore, that the number of legal disputes will accelerate in the short term if member states cannot reach agreement. We need this directive to clarify rights and to minimise the risk of further legal challenge. I agree with the noble Baroness, Lady Barker, that we need to play a full part, and we will not shirk from ensuring that we not only play a full part but that we play a leading part.

I am afraid that I cannot predict when we will have the final directive, nor the detail of its provisions. The directive is currently subject to negotiations within European institutions—goodness me. The European Parliament has recently completed its first reading and tomorrow European health Ministers will hold a debate on some of the key questions facing the Council. As a result of this debate, I am happy to join the Euro-anorak group mentioned by the noble Lord, Lord Kirkwood. I thank noble Lords for this report and for their contributions to the debate this afternoon. We will take account of the recommendations as negotiations move forward and I know that the Committee will return to consider this again.

I thank all noble Lords who have taken part in this debate. When I expressed concern to the noble Lord, Lord Kirkwood, that we were short on numbers, he said, “Never mind. It's not quantity but quality that counts”, and this debate has absolutely lived up to his comment. It has been a debate of exceptional quality.

When we set out on this journey as a committee, we thought that the issues would be relatively simple. We were naive. For that reason, we did not employ a specialist adviser. Therefore, I want to give particular thanks to our Clerk and the adviser to the committee, who between them teased out the issues that the committee were trying to gather from the witnesses and brought some sort of order to this very complex information. They deserve a strong round of thanks for that.

I am grateful to the Minister for a number of issues of clarification, but I shall begin by saying that I was struck by the description of the noble Earl, Lord Howe, of choice being brave, determined and desperate. Listening to witnesses, particularly those who represented the patients’ point of view, it was significant that they would prefer to have good quality healthcare at home. Their objective was to make sure that what they needed was available in their locality. Only for specialised treatment would they need to go elsewhere, be authorised and then be followed through by their own clinicians. One hopes that if our health service continues to provide excellence, the numbers may well not increase.

I wanted to make one point about borders. We were reminded several times in our committee that the UK has a number of its own borders. The noble and right reverend Lord, Lord Eames, who is a member of our committee, reminded us particularly of northern and southern Ireland and the cross-flow of patients, and we have one or two other borders of a similar nature, which throw up their own particular difficulties.

There is still concern over two issues. Equity is still a difficult issue. For example, you may be poor, you discover that there is something abroad that could be life-saving and you want to go. The fact that you cannot pay and someone else could is a real issue. Again, however, I hope that someone in our health service would give you priority so that you came under the other scheme, which is continually confusing. Some of our witnesses suggested that our own scheme and the scheme under the directive should somehow be merged so that there was not this confusion. It might also simplify a number of other practical issues.

I tried to give an alternative word to comitology, because a distinguished member of the EU Committee recently told us off for not having good English. I was very relieved, as I am usually the person who raises that issue. Let us hope that we can get some decent words that ordinary folk can understand.

I am grateful to noble Lords for this discussion. The committee will continue to oversee this issue. It might also look briefly at the Green Paper, to which the noble Lord, Lord Kirkwood, referred, as that might be helpful to the Government. The paper is about the workforce, and the workforce falls within our remit. We are still concerned about where organ donation fits into the framework—the Minister said nothing about this—but I assure her that, even if the Government have difficulty collecting data, the committee will continue to collect its wits and its information and, I hope, to provide excellent reports for debate.

Motion agreed.

Medicines for Human Use (Miscellaneous Amendments) Regulations 2009

Considered in Grand Committee

Moved By

That the Grand Committee do consider the Medicines for Human Use (Miscellaneous Amendments) Regulations 2009 (SI 2009/1164).

Relevant Document: 16th Report from the Merits Committee.

In moving the Motion standing in my name on the Order Paper, I shall speak, with the leave of the Committee, to the other two Motions, which are also in my name. These Motions are intended not only as a vehicle by which to probe the content of three important statutory instruments but to provide a convenient means of doing what is proper and necessary in the current circumstances: to ask the Government for a progress report on the spread of the H1N1 virus in this country and their plans for countering it.

Pandemic flu no longer occupies the newspaper headlines, but it is still a public health matter of the utmost seriousness and urgency. The total number of cases in the UK now stands at about 500 and is rising daily. Two people in England, as I understand it, are extremely ill and in intensive care, and another two people are critically ill in Scotland. Schools are being closed and many hundreds of people are being treated with anti-virals as part of the containment strategy.

We do not yet officially have a pandemic, but medical and scientific opinion is clear that we could face one—most likely next autumn if the pattern of the flu outbreak of 1918-19 were to be replicated. Ministers’ policy of containment of the virus, which they have pursued up to now, has met with reasonable success, but continued success is far from guaranteed and, quite rightly, the Government are looking to make provision for a time when a pandemic has been officially declared. We need to move from a policy of containment to one of mitigation. The statutory instruments before us are part of that process of contingency planning.

One obvious consequence of a pandemic is that the NHS would be under considerable pressure, so the ability of people to be diagnosed and treated for the virus is likely to be constrained. I therefore welcome the first set of regulations, which will give children readier access to anti-viral treatments. Tamiflu is currently not licensed for use in children under one year of age. The regulations allow the active ingredient in Tamiflu to be dispensed to children in the form of a solution if, in a pandemic, there was a serious risk to the child's health.

I have two points to make on this. First, what reporting procedures would be put in place for adverse reactions to Tamiflu taken by children? Secondly, why do the regulations not appear to specify who will be permitted to prepare the anti-viral medicine in solution? The report of the Merits Committee suggests that only certain licensed hospital pharmacy units will be able to do this. That is clearly a sensible restriction, but I hope that the Minister can reassure me that there is no danger of the public gaining access to a medicine prepared by anyone other than a reputable and competent hospital pharmacy manufacturing unit.

In the second statutory instrument, which I also welcome, changes are made to two existing orders. The first would enable a pharmacist to dispense an emergency supply of a prescription-only medicine without a prescription for up to 30 days rather than the current maximum of five days. This amendment has been welcomed by the pharmacy profession as a permanent measure, not just one that would apply temporarily during a pandemic. I appreciate its benefits.

However, the second change is to absolve pharmacists of the duty to interview a person before making an emergency sale or supply during a pandemic, or in anticipation of a pandemic. All they would need to do would be to satisfy themselves that the person to be treated with a prescription-only medicine has been prescribed the medicine before and that the dosage is appropriate for that person. Again, I can understand why this should be thought to be a useful relaxation of the current rules. However, taken together, these changes pose obvious risks for fraud and abuse. I will be grateful if the Minister can tell me how the system is to be policed to prevent such abuse. In particular, what criteria will be used by pharmacists to determine how many days’ worth of medicine to dispense within the 30 days’ maximum allowed for? Indeed, how will it be possible in practice for a pharmacist to know whether someone whom they do not meet, and for whom no prescription is produced, has been prescribed a medicine on a previous occasion? For that matter, how will he or she know whether that person actually exists? Lastly, how is a pharmacist supposed to know or judge whether he can legitimately sell or supply a medicine, in the words of the SI,

“in anticipation of a disease being imminently … pandemic”?

Are the operating protocols specific on these matters?

The third statutory instrument waives the charges that would otherwise be payable to the NHS for drugs to treat pandemic influenza, as well as the charges that would be payable by overseas visitors who are treated in hospital for pandemic flu. We could not possibly dissent from the thought underlying these changes. However, once again, can the Minister say what criteria will govern a decision by a pharmacist or an NHS trust to supply treatment,

“in anticipation of a disease being imminently … pandemic”?

We are currently at phase 5, one rung below phase 6, which, if triggered, would signal that a pandemic was upon us. Is being at phase 5 sufficient grounds for a pharmacist to judge that an imminent pandemic is anticipated? If, as I suspect, the answer is no, what more would need to happen for that situation to obtain?

On visitors to this country who are admitted to hospital with pandemic flu and who either develop complications that also need to be treated in hospital or have pre-existing co-morbidities that are treated alongside the influenza, what charges, if any, would be payable by the patient in those circumstances? Would it be practical or realistic for a hospital to arrive at a calculation of that element of the cost of treating the patient that did not relate to the influenza?

Finally in this context, the regulations refer to “overseas visitors”. Can the Minister say how they affect illegal immigrants and failed asylum seekers who are treated in hospital for pandemic influenza?

As I signalled earlier, I hope the Minister will not mind if I use this opportunity to ask him to update the Committee on the general situation as regards the spread of the virus. Will he tell us about its prevalence in the rest of the world, and can he brief us on the number of cases in this country? How successful does he believe we have been in containing those numbers? Of the new cases we are now seeing, how many have a direct link of one kind or another to Mexico and how many do not? If Mexico is still seen as a hub of infectivity, it would make sense to try to prevent the virus from spreading on aircraft travelling back to this country. Has the HPA issued specific advice to airlines to protect their cabin crews?

Turning to the measures that are being put in place to combat the virus, perhaps I may ask the Minister about the existing protocols relating to those who come into close contact with an infected person or someone who is believed to be infected. He may have seen a letter in the British Medical Journal of 27 May from a GP, Dr Ellen Wright. She recounted the advice she received when symptom-free, which was to carry on working even though she had been in contact with her son who had been diagnosed as having probably contracted H1N1. She compared this with the advice given to her husband who was told that he could carry on working even though he was suffering from mild symptoms, and with the completely contrary advice given to her sister-in-law and niece who were told to stay at home even though they were completely well. If confusion of this sort exists among the medical community, it must surely exist more widely. What steps are the Government taking to make sure that the advice given to those in contact with actual or probable cases is reasoned and consistent?

The Minister will be aware that there have been a number of school closures following the identification of infection in one or more pupils. Is this policy under review? A powerful body of opinion says that school closures are pointless because contact between the infected person and others at the school will already have taken place and that it is therefore too late to try to prevent it. In the United States, the policy of school closures has been dropped because, given the apparent mildness of the virus, the benefit of closure is not seen as compelling when measured against the obvious detriment to the education of children.

If a pandemic were to be declared and we were faced with a large increase in the number of cases, it is likely that a decision would be taken by Ministers to move from a policy of containment of the virus to a policy of mitigation. At what point would the grounds for such a decision look compelling, and what would it mean in practice? In other words, how high would the volume of cases need to be for the change of direction to be triggered? If such a change were triggered, what would its practical effect be on the eligibility of individuals to receive antivirals? Would we still distribute antivirals to everyone who had come into recent contact with the virus, or would that kind of prophylaxis be much more restricted?

I should like to turn briefly to another issue falling under the heading of prioritisation: critical care capacity. The UK has many fewer critical care beds per head of population than other countries in the developed world. The occupancy rate of those beds is already very high. How are we to arrive at an accepted protocol for prioritising their use in a pandemic? Who will decide these matters? It is not just a question of comparing clinical need between patients who have contracted the virus. It will also be necessary to make some kind of comparative judgment between those suffering severely from the virus and those whose need for critical care stems from different reasons altogether. Relative clinical need is not an exact science, and some invidious value judgments will almost certainly need to be made. How, if at all, are the guidelines for that kind of judgment to be communicated to the general public? We really need to take care here. I quote the honourable member in another place, Norman Lamb, who made a very powerful point. He said that,

“in the last two pandemics in this country … more people died of conditions other than flu. There was a higher excess mortality of people suffering from other conditions who were displaced from hospital by those who went there because of the flu pandemic”.—[Official Report, Commons, 14/5/09; col. 1076.]

It would be helpful if the Minister could reassure us on the situation as regards vaccine supply and whether we are likely to have adequate stocks of seasonal flu vaccine as well as vaccine for H1N1 by the autumn. I realise that vaccine production is a lengthy process but will we be able to obtain early supplies of the HIN1 vaccine before the autumn? What about the supply of masks? In another place last month the then Secretary of State announced that an order had been placed for 226 million face masks. For whom precisely are these masks intended and will the guidance be clear? We know that there is very little benefit to be derived from an ordinary member of the public wearing a face mask during a pandemic. However, there would seem to be a lot more benefit for an infected person or someone who has been in close contact with an infected person wearing a mask. If that is so, how will face masks be distributed to the relevant people? Can the Minister reassure me that these matters will be made clear?

I turn finally to the whole issue of local preparedness. The story of the flu line is an unfortunate one. It would appear that the Treasury took more than seven months to approve the business case, with the result that the system will not be up and running until the autumn, when we ought to have had it last Christmas. I do not know how it will be physically possible to stress-test the flu line in advance so as to provide the necessary assurance that it will work but perhaps the Minister can tell me. Meanwhile, there is an interim system based on an 0800 number. How is that being publicised?

Not a great deal has been said publicly about the preparedness of PCTs for a pandemic. It would appear that many PCTs have still not finalised their collection points; that is to say, the places where antivirals will be collected in the event of a mass outbreak. Indeed, concerns have been expressed to me that the final plans adopted by some PCTs will place excessive reliance on community pharmacies as collection points, which could place a severe strain on such pharmacies and thereby run the risk of disrupting the supply of medicines to non-flu patients. Can the Minister comment on the preparedness of PCTs and, more broadly, can he reassure me that those to whom the general public are likely to turn for immediate advice, including GPs, the police, the CAB and others, have been adequately briefed on what to say and do?

I have asked more questions than I usually do in these debates but that is simply an indication of the uncharted nature of the waters we are in. I am certain that the Minister will welcome the opportunity to place on the record as many of the answers as he can.

The Minister will be relieved to know that I do not have as many questions as the noble Earl, but I welcome the opportunity to consider this matter in a period of relative calm. At present there is no media hysteria on this and, although about 500 people are affected by the virus in the UK, we are not yet at a pandemic level.

I want to make a point which may seem trivial but which is quite important. This virus is commonly known in the United States as H1N1. Will there be an international designation of the virus and will there be common terminology for it? If nothing else, since a point back in early May, we have realised that this is going to be an international problem. Therefore, all existing systems for public health observation, such as the CDC in Atlanta and its European and Asian counterparts, will have to work together. I would like to think at the very least that we could have a common terminology.

That prompts me to ask my first and general question. Will the Minister update the Committee on work that has been done in conjunction with the CDC, and in particular that done in Mexico to establish the exact pattern of the epidemic there? Also, I understand that within the group of people who have been seriously infected by the virus we now have medical staff. Will the Minister update us on the extent to which patterns of infection of front-line medical staff are now becoming apparent in this country and in the United States and Mexico?

During the week after the initial cases were diagnosed in this country, the Chief Medical Officer and others appeared on the radio and television to outline the Government’s plans and their advice to the public. When questioned, they talked at that point of the priority that would be given to studying the strain of flu which is now designated as H1N1 and talked about the length of time that it would take for researchers to track any variance and develop new forms of anti-retrovirals. A number of weeks on from those initial statements, how far has that work progressed? I think that I am correct in saying that the threat of a variant of the virus becoming widespread in the autumn rather than the virus which occurred in Mexico earlier on this year is one of our most important focal points.

On the Medicines for Human Use (Miscellaneous Amendments) Regulations, I understand entirely the need to produce a form of vaccine that is appropriate for administration to children under one year. Is that something that the Department of Health will work on in future? It has long been known that children’s medicines are in many ways inadequate. Across the board, we frequently treat children solely with drugs that are meant for adults, and they are not suitable. At the very least, will the Minister say whether the work done in the administration of this particular children's version of the anti-retroviral will be monitored and used in determining more widely the wider question of how we go about the development of medicines for children?

I, too, noticed that the period for which a pharmacist can prescribe emergency medicines without prescription has increased from five to 30 days. I note in the statutory instrument that the Government are quite open about the fact that they have planned to do that for some time. What is the basis of the Government’s wish to do that? What is their case? It is clearly not directly related to this outbreak. I, too, was struck by the potential for abuse, but perhaps the noble Earl, Lord Howe, and I have watched “The Third Man” too many times. Will the Minister say how this change will be monitored and whether it will be possible in future to determine whether it is routinely open to abuse or, in the greater scheme of things, of benefit to patients?

On the other two statutory instruments, I am delighted that it has been agreed that treatment will be made free to overseas visitors. That is absolutely the right thing to do in an emergency, but will the Minister say why it is confined to patients who are treated in hospital if we are seeking to mitigate the effects of the virus in the population as a whole? Someone may be highly infectious but does not go to hospital. To require them to pay for treatment may not be in the best interests of public health. Those are my questions.

I am grateful to the noble Earl for giving us the opportunity to appear before the Committee today to discuss these regulations. It is right that the special legislative amendments that we passed last month are subject to the scrutiny of the Committee. Equally, I am sure noble Lords will appreciate why it was necessary for them to be passed immediately using the negative procedure, given the potential urgency of the situation at the time.

These pieces of legislation have the single objective of making sure that the public can get access to the medicines that they need at a time when the usual routes will be under severe pressure. Although the changes have been brought into force quickly, they are the product of my department’s long-term planning for mitigating the effects of pandemic disease. These provisions have therefore been in development for some time and have been the subject of wide consultation among the public as well as stakeholder bodies.

The changes to medicine legislation apply throughout the United Kingdom. The regulations on NHS charges apply to England only, but I understand that the devolved Administrations have brought forward similar provisions. It may help if I briefly outline the purpose of these provisions. The Medicines for Human Use (Miscellaneous Amendments) Regulations 2009 include provisions to enable the wholesale distribution of an unauthorised medicinal product in response to a suspected or confirmed pandemic disease to support the manufacture of a soluble antiviral for children under the age of one year and to simplify labelling requirements. The regulations also ease time limits for the notification of urgent safety measures in clinical trials. The noble Earl talked about the competencies of those who produce the antiviral. We have guidelines and protocols, and these preparations will be made in the right environment under the supervision of a certified pharmacist.

The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2009 increases the period for which the pharmacist can make an emergency supply of certain medicines without a prescription. This is a permanent change that will be particularly beneficial for people with long-term conditions who, for one reason or another, run out of medication and cannot visit a prescriber. In addition, during a pandemic, the pharmacist could make an emergency supply without interviewing the person requesting the medicine. Interviewing the patient will not be practical if the patient is also sick with flu and has been advised to stay indoors. The noble Earl raised the very important issue of the possibility of fraud in such circumstances. Our advice to pharmacists, as to many other professionals, including doctors, who constantly receive phone calls from patients, is to base their judgment on records in their pharmacy or to validate, even in a phone call to the general practitioner, the address and age of the patient and whether the patient has such a condition.

This order also enables antiviral medicines to be supplied without prescription and without the involvement of a pharmacist under a protocol authorised by an NHS body or the Health Protection Agency, for example. During a pandemic, antivirals will be distributed through the PCT-designated antiviral collection points rather than pharmacists. Protocols will be in place to govern which medicines can and cannot be dispensed and which patient can receive them. This will ensure that, at a time when the health service is under extreme pressure both in demands for its services and with its own staff being ill, medicines can be supplied to those who require them within a framework of safety and a framework to prevent any fraudulent requests.

The National Health Service (Charges) (Amendments Relating to Pandemic Influenza) Regulations 2009 provide that no prescription charge is levied where medicines are supplied under the authorised protocols referred to in medicines legislation, including where supply is made directly by an NHS body to a patient in response to a pandemic influenza outbreak. They will also mean that no charges are made to overseas citizens and non-UK residents who receive NHS treatment for pandemic influenza. That includes asylum seekers who happen to be in the country; they will be under the same category. These measures will ensure that there are no cost barriers to seeking or receiving treatment.

These measures are the first tranche of a set of legislative provisions that we will need to support our full response to a pandemic. They are the key measures that we judged to be essential to maintain our state of preparedness when the World Health Organisation raised its pandemic alert to level 5. Further changes are being prepared that would give pharmacies that provide NHS services the ability to vary their opening hours and open and close temporarily at short notice in response to staff sickness or to cover for pharmacies that cannot open. Further changes are also planned to medicines legislation to expand current arrangements for occupational health schemes to enable the supply of antiviral medicines to members of their employees’ households; to ease imports of unlicensed medicines by removing restrictions on quantities and shortening the waiting period before import can commence to one week; and to introduce new time limits for the statutory reports required under the Blood Safety and Quality Regulations 2005. These changes are being prepared now and, once ready for enactment, will be kept in readiness for when they are needed.

The Home Office and the Northern Ireland Executive also plan to make changes to their prospective legislation governing the misuse of drugs to enable pharmacists to exercise professional discretion in dispensing prescriptions for the treatment of addiction and to ensure that patients receive their treatment and receive it as safely as possible. Provisions will also enable the emergency supply of some controlled drugs by pharmacists to complement the measures that I have just outlined.

Noble Lords asked me many questions. I shall try to go through most of them and I promise that I shall write back on others. The noble Earl, Lord Howe, asked me for an update. We now have 621 cases in the UK: 426 in England and 189 in Scotland, two in Wales and four in Northern Ireland. Onward transmission from human to human has been confirmed in the UK. Several of these cases have been admitted to intensive care, as we have known for the past week or 10 days, including one man who may not have an underlying health condition. That raises the question of whether this is a mild illness or not, but at least we have one patient who has been admitted without an underlying illness.

The noble Earl also asked what there was to report on the state of play globally. In Mexico 5,563 cases have been reported, and in the USA 13,217. Those data are also available on various websites.

In relation to our preparedness, I do not think I can say more than what I have said before. I congratulate many of the officials working in the Department of Health on the effort they have put in in the past four or five years in getting us prepared to the stage we are at. In the past, I have mentioned that the WHO ranks the United Kingdom and France as being the two best-prepared countries. However, we have taken further action since the Questions we answered in the Chamber. I am delighted to report that Ian Dalton, the chief executive of the North West Strategic Health Authority has been appointed as the national director for NHS pandemic preparedness further to strengthen the line of communication and, more importantly, the implementation of policy by PCTs and any organisations that are responsible for the NHS flu plans.

The noble Earl also asked about the advice that we are giving staff. They are vital in making sure that we maintain our resilience in the management of this flu if it moves to a pandemic stage. With the communication there has been, I am slightly surprised at the advice that that general practitioner received. I would have exercised my professional judgment in certifying myself ill and staying at home. However, I am more than happy to look into that. Antiviral Tamiflu is currently available for all staff who come into close contact with individuals with swine flu, whether they are symptomatic or have had a post-exposure. Post-exposure prophylaxis is part of our policy.

The rationale for seven-day school closures is based on the best evidence. The Health Protection Agency assesses the maximum incubation period for the virus as seven days. As part of the local risk assessment, the Health Protection Agency advises the school and local NHS and public health officials when individual schools should close. We are basing this on the advice from the Health Protection Agency.

The noble Earl, Lord Howe, raised an important issue in relation to critical care and capacity needs if this becomes a pandemic or epidemic in this country. On 1 May 2009, the Department of Health published guidance for the NHS, Pandemic Flu: Managing Demand and Capacity in Health Care Organisations. This includes advice from the Intensive Care Society on ways of increasing intensive care capacity, including suspending elective procedures requiring post-operative critical care—which would render me redundant for that period of time—withdrawing or reducing critical care outreach services and increasing the use of agency staff for support. However, we also acknowledge that at the peak the reasonable worst-case scenario may arise, and pandemic intensive-care capacity may well be inadequate, even after these measures have been adopted. The guidance therefore attempts to support staff by providing an ethical framework for decision-making and detailed proposals for triaging patients in the event of demand outstripping supply.

It is essential that distribution services are prepared if we move from the containment stage into the mitigation stage. The noble Earl asked when we will know that that has happened. That will be based on scientific advice and will also be dependent on the number of cases at the time and our stocks of antivirals. However, the Civil Contingency Committee—COBRA—will ultimately take the decision to shift our framework from containment to mitigation. It is essential that during the mitigation phase there will be a system for ordering and distributing antivirals. As I have previously reported, the flu line was delayed and will not be ready before the autumn, but we are fairly confident that through that distribution network—obviously it will be tested and validated before it becomes live—we will have the necessary systems in place for the distribution of antivirals from the PCTs or the antiviral storage areas.

I am sorry about this; I am trying to answer most of these questions. On vaccines, the National Institute for Biological Standards and Control—NIBSC—has produced a swine flu vaccine candidate and has alerted vaccine manufacturers. The noble Baroness asked whether these vaccines will be available. We have an agreement that has been signed between the UK Government and vaccine manufacturers to secure supplies of up to 90 million doses of the pre-pandemic H1N1 vaccine before a pandemic begins. I am also delighted to say that if you look at the manufacturer’s timeline, the manufacturing of the seasonal flu vaccine will come to an end by mid-July, so we have the capacity to start developing the H1N1 vaccine.

The noble Baroness also raised the important question of how we keep vigilant over the possible mutation of such a virus. We should be proud of having the best scientific base in this country by constantly looking at the mutation possibilities of this very unstable virus with no more than eight genes. We are keeping a close eye on that, which may have an impact, as has been correctly pointed out, on the vaccine in the future.

I have tried to address most of the questions here but, as I said, I will be happy to address some of the others once I read Hansard, and will write back on those. I am grateful for the opportunity for this debate. Swine flu presents a real threat to our nation’s health and it is important that we are ready to put the necessary steps in place quickly should the situation escalate. I hope that I have been able to respond to the concerns that the noble Earl and others may have. I hope that I have reassured them that the Government are taking the proper precautions. I make the final point that we will maintain our resilience during the summer period and, hopefully, build further in anticipation of the worst.

The Minister has covered a great deal of ground in his reply, for which I am grateful, conscious as I am that I ranged rather widely in my questions to him. I found his answers reassuring and thank him for that. I congratulate the many scientists and officials involved in planning the measures that are needed to combat what is undoubtedly a serious public health threat. I have no doubt that we shall return to this issue periodically—I hope not at such length.

Motion agreed.

Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2009

Considered in Grand Committee

Moved By

That the Grand Committee do consider the Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2009 (SI 2009/1165).

Relevant Document: 16th Report from the Merits Committee.

Motion agreed.

National Health Service (Charges) (Amendments Relating to Pandemic Influenza) Regulations 2009

Considered in Grand Committee

Moved By

That the Grand Committee do consider the National Health Service (Charges) (Amendments Relating to Pandemic Influenza) Regulations 2009 (SI 2009/1166).

Relevant Document: 16th Report from the Merits Committee.

Motion agreed.

Committee adjourned at 5.29 pm.