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Medicines for Human Use (Miscellaneous Amendments) Regulations 2009

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.