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Medicines for Human Use (Miscellaneous Amendments) Regulations 2009

Volume 711: debated on Monday 8 June 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.