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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

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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.

Lord Kirkwood of Kirkhope: 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.

Baroness Thornton: 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

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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.

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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.

Baroness Howarth of Breckland: 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.

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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

Copy of the Order
16th Report from the Merits Committee

Considered in Grand Committee

4.47 pm

Moved By Earl Howe

Earl Howe: 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

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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,

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

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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,

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

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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,

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

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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?

5 pm

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.

Baroness Barker: 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.

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