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Medicines for Human Use (Miscellaneous Amendments) Regulations 2009

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.