NHS: Health and Social Care Act 2012
Countess of Mar Excerpts(10 years, 10 months ago)
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Earl Howe
My Lords, we are back to that one. As the noble Lord knows, the strategic risk register for the department is something that we are entitled to keep confidential, as all Governments have done. The Cabinet took the decision that the transition risk register should remain confidential because of the principle of the need to preserve private space for civil servants when advising Ministers.
The Countess of Mar (CB)
My Lords, some months ago I led a debate on the lack of clinical governance between health and social care. I was promised a meeting with the noble Earl by the noble Baroness, Lady Jolly. One of the big problems is the fact that there is no governance framework between health and social care, and as a result a lot of people are falling into a black hole. Can the noble Earl say when that meeting will take place?
Health: Human Papilloma Virus
Countess of Mar Excerpts(11 years ago)
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The Countess of Mar (CB)
My Lords, I am grateful to the noble Lord, Lord Patel of Bradford, for bringing this question to our attention this evening. I am afraid that I do not share his enthusiasm or that of my noble friend Lady Gould for HPV vaccines.
I know that the Minister is aware of my concerns about the safety of human papilloma virus vaccination when it is used in girls. The problems that I have taken to him over the past two years do not apply only to girls and young women in the UK. Wherever HPV vaccine programmes exist there also exist high numbers of adverse reaction reports. After only six weeks, the Japanese Government withdrew their recommendation for the administration of HPV vaccine as a result of adverse event reports for Gardasil that were 26 times higher, and those for Cervarix 52 times higher, than those for the annual flu vaccination. One-quarter of these adverse events were considered serious. Denmark has recorded a quarter of adverse events as serious, while Italy reports adverse events at a rate of 219 per 100,000, 10 times higher than most of the other vaccines administered in Italy. According to the High Court in India, where 24,000 girls were vaccinated during demonstration projects, an estimated 1,200 were left with chronic health problems and/or autoimmune disorders. In the USA, HPV vaccines account for nearly 25% of the entire Vaccine Adverse Event Reporting System, or VAERS, a system that was established in 1990—and HPV vaccines were not introduced before mid-2006. In France, Spain and Colombia, there are ongoing court cases relating to girls who are suffering chronic ill health following HPV vaccination. In the USA, the National Vaccine Injury Compensation Programme has awarded $5,877,710 dollars to 49 HPV vaccine-damaged victims, and to date there have been 200 claims filed. This demonstrates that my concerns are not confined just to the UK.
Merck, the manufacturers of the vaccine Gardasil, admits in its own research documents, where Gardasil is compared with a new vaccine, Gardasil 9, that of 7,378 girls who were vaccinated, 2.5%—that is, 185—suffered serious adverse events. It also admits that 3.3%—that is, 240—suffered autoimmune disorders. A serious adverse event must fit one of the following criteria: death; life-threatening; disability or permanent damage; hospitalisation; congenital abnormality or birth defect; or the requirement to intervene to prevent permanent impairment. It is likely that such events in the general population would be higher because certain at-risk groups are excluded from clinical trials but not from vaccination programmes.
Cancer rates are always quoted as so many per 100,000; in the case of the Gardasil clinical trial, there would be 2,500 serious adverse events per 100,000 vaccinated. UK cancer cases are identified as 8.8 per 100,000 and with deaths as three per 100,000. UK HPV vaccine yellow card adverse reaction reports have been identified at 341 per 100,000, with serious reports numbering 108 per 100,000. We must not lose sight of the fact that the MHRA admits that possibly only 10% of adverse events are reported. A report represents a person and, within that report, the symptoms experienced by the individual are listed. The MHRA identifies the number of reports received, and the number of symptoms from individual reports are put under the appropriate headings in the MHRA statistics.
Interestingly, at the meeting of the JCVI HPV sub-committee, the MHRA reported:
“No significant new safety concerns have been identified during 2012/13 since Gardasil was introduced”.
In the light of what I have already said, I ask the Minister just how significant a serious reaction must be before it becomes a safety concern. How many have to report serious reactions before preventive action is taken? Are more than 108 per 100,000 young people to have their lives destroyed in order to save a possible 8.8 per 100,000 lives from cancers which, if detected early by the PAP screening programme for cervical cancer, which is not known to cause deaths or serious side-effects, can be treated?
Had the Minister been at the meeting of the All-Party Parliamentary Group for Vaccine Damaged People last week, he would have heard of the tragic lives many of the young women are leading. He would have seen videos of two young women who are bedridden—young women who, had they not been vaccinated with Cervarix or Gardasil, would have been leading active lives and, instead of being totally dependent on their parents, would have been about to fly the nest, go to university and be productive members of society. They represent many more in the UK and worldwide whose lives have been totally destroyed.
Gardasil has been on the market in the USA since June 2006 and has two of the high-risk HPV strains, 16 and 18, which are believed may lead to cervical cancer. The VAERS is now receiving reports from Gardasil-vaccinated women who have developed HPV infection, cervical dysplasia or cervical cancer. There are some 15 high-risk strains of HPV which are thought to be cancer-causing. These reports could well represent only the tip of the iceberg. Even the Minister’s honourable friend Anne Milton acknowledged on 7 July 2011 that:
“There is a possibility that other HPV strains could replace HPV 16 and 18 following the introduction of the HPV vaccination programme. However, there is no data with which to determine whether and how quickly this would take place”.
I have read the JCVI interim position statement on HPV vaccination of men who have sex with men, dated November 2014. It seems that the jury is still out as to the science behind offering HPV vaccination to this group, though they would appear to be the most vulnerable to HPV infection. I believe that the JCVI is rightly cautious. I understand that the human papilloma virus has never been proven to cause cancer by itself and that HPV vaccines have never been proven to prevent a single case of cancer. Other risk factors must be present for cancer to develop. According to the World Health Organization, only 0.15% of all people exposed to any high-risk strain of HPV will ever develop cervical cancer. There is no guarantee that eliminating one risk factor for the development of cancer will have any impact on the disease incidence or mortality rate, and there is no guarantee that any suppressed oncogenic HPV type will not mutate over the next 20 years to become more dangerous.
I have seen what has happened to our girls and young women when vaccination goes wrong. Do we really want all young boys to be just as vulnerable?
The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, I begin by congratulating the noble Lord, Lord Patel of Bradford, on securing this debate and on bringing this important subject to your Lordships’ House. I understand the noble Lord’s concerns on this issue. Vaccines provide vital protection from a large number of diseases, including the human papilloma virus. We need to ensure that they are used as effectively as possible and that those who would most benefit from them are included in any vaccination programmes that we implement.
As has been mentioned, the Government are advised on all immunisation matters by the statutory body, the Joint Committee on Vaccination and Immunisation. The JCVI keeps all immunisation matters under review, providing advice and recommendations to Ministers on all current and potential vaccination programmes. It is, therefore, to the JCVI that we look for expert advice when considering issues such as those raised today.
The UK’s current HPV vaccination programme, based on advice from the JCVI, began in 2008, and its aim is to prevent cancers relating to HPV infection, specifically cervical cancer. HPV is a sexually transmitted disease. Our main objective, therefore, is to provide HPV vaccine to young women before they reach an age when exposure to HPV infection increases and vaccination would become less effective because many would have already been infected. For that reason, the vaccine is offered to all girls in school year 8—that is, at ages 12 to 13 years. As HPV is responsible for virtually all cases of cervical cancer, prevention of this disease remains the primary aim of the current programme.
The UK’s HPV vaccination programme has been a considerable success. Almost 8 million doses have been administered across the UK since 2008 and this country has among the highest rates of HPV vaccine coverage achieved in the world. In England, 86.7% of girls eligible for routine vaccination in the 2013-14 academic year completed the three-dose course and 89.8% have received at least two doses of vaccine.
The noble Baroness, Lady Hollins, asked about herd immunity. When recommending introduction of the programme in 2008, the JCVI considered that once 80% coverage among girls was achieved, which we have now attained, the vaccination of boys was likely to provide little additional benefit in preventing cervical cancer in girls. As the noble Lord, Lord Patel, made clear, with high uptake of HPV vaccine among girls, many boys will also be protected against other HPV-related cancers such as anal cancer and head and neck cancers, because transmission of HPV between girls and boys should be substantially lowered.
However, as I mentioned, the JCVI keeps all vaccination programmes under review and has recognised that under the current programme the protection that accrues from reduced HPV transmission from vaccinated girls may not be provided to men who have sex with men, or MSM, because they are less likely to have sexual contact with vaccinated women. Given increasing evidence of the association between HPV infection and oral, throat, anal and penile cancers, and the impact of HPV vaccination on such infections, the JCVI set up an HPV sub-committee in October 2013 to consider a number of key issues around HPV vaccination, including the question of potentially extending the programme to MSM and adolescent boys—that is, to protect those who may go on to become MSM—or to both. The committee has also noted the public, parliamentary and third-sector concern about this issue and agreed that evaluation of potential extensions to the programme to include MSM, adolescent boys, or both, should be a priority.
Your Lordships may be aware that last November, following very careful consideration of the evidence, the JCVI published for consultation provisional advice that a targeted HPV vaccination programme should be introduced for MSM aged between 16 and 40 years attending genitourinary medicine and HIV clinics. The JCVI consultation ended on 7 January 2015 and we await the committee’s final advice on this matter.
The JCVI’s HPV sub-committee is also giving consideration to work modelling the impact and cost-effectiveness of extending HPV vaccination to adolescent boys. I am advised that it is currently anticipated that a model being developed at Warwick University could be presented to the sub-committee in the second half of this year. A separate model being developed by Public Health England may not now be completed until early 2017. I also understand that the JCVI and its HPV sub-committee may need to consider both studies before taking a final view on the impact and cost-effectiveness of extending HPV vaccination to adolescent boys and may therefore not be in a position to do so before early 2017. The JCVI has noted that the cost-effectiveness of an HPV programme for adolescent boys is not certain, because the high coverage rates achieved for adolescent girls are highly likely to interrupt HPV transmission and provide indirect protection for boys to such an extent that there may be little additional benefit to be accrued from extending the programme. However, the committee agreed that a detailed cost-effectiveness analysis was required to fully understand the potential benefits of any proposals.
The noble Baronesses, Lady Gould and Lady Wheeler, asked why there has to be this two-year delay. Work to model the impact and cost-effectiveness of vaccinating adolescent boys with HPV vaccine is dependent on the completion of work by PHE on an individual-based model for HPV screening, as the intention was to use the completed screening model as a basis on which to model adolescent male vaccination. An individual-based model is critical to proper assessment of an adolescent boys’ vaccination programme. Individual-based models are very complex and mathematical; they simulate the impact of an intervention on individuals within a population through time and take a considerable amount of time and resource to develop. The screening model is now not due to be completed until early this year. Although disappointed that modelling work on the cost-effectiveness of HPV vaccination of adolescent boys by PHE will not begin until early 2015, the JCVI agreed that in order to expedite the work it would not be advisable to take any shortcuts, which could undermine the validity of the outputs. As I said, the PHE model may not now be completed until early 2017. The HPV sub-committee will meet during 2015 to review the progress of these studies and will report its findings to the JCVI following consideration of work modelling the impact and cost-effectiveness of extending HPV vaccination to adolescent boys.
Your Lordships will be aware that the NHS budget is a finite resource. New vaccination programmes and extensions to existing programmes will usually represent a significant cost to the health service, in terms of both vaccine purchase and its administration to individuals. It is therefore essential that any advice or recommendations from the JCVI on changes to the national vaccination programme be supported by evidence to show that they would be a cost-effective use of resources.
The noble Lord, Lord Patel, asked about an equalities assessment. An equality impact assessment was completed in 2008 for the introduction of the national HPV vaccination programme for girls. At that time, vaccination for boys for HPV was considered to be not cost-effective for the prevention of cervical cancer.
The noble Countess, Lady Mar, raised the issue of the Japanese experience. HPV vaccines, in fact, remain licensed for use in Japan and continue to be available for girls and women who wish to receive them. The decision of the Japanese authorities temporarily to stop their active recommendation for immunisation due to reports of chronic pain was a precautionary move while they gathered more data. However, EU regulators have reviewed the issue and concluded that there is currently insufficient evidence to indicate that HPV vaccines may be a cause of chronic pain or chronic pain syndrome, which has also been associated with needle injection itself—that is to say, not specific to the vaccine. It remains the case that a causal relationship with HPV vaccines has not been established.
The Countess of Mar
My Lords, I am sorry to interrupt, but even the manufacturers recognise autoimmune dysfunction as a result of their vaccines.
Earl Howe
My Lords, I will take that point away and respond to the noble Countess in writing, as I do not have briefing on it. Suffice it to say, lest there be any doubt, we consider vaccine safety to be of paramount importance. The Medicines and Healthcare products Regulatory Agency has closely evaluated the safety of the HPV vaccine since it was first introduced in this country. The agency takes every report of suspected adverse reactions very seriously and keeps safety under continual review. Again, the view remains that there is currently insufficient evidence to indicate that illnesses are a side-effect of the vaccine.
The MHRA recently completed an epidemiological study of myalgic encephalomyelitis and chronic fatigue syndrome following HPV vaccination. This found no evidence to suggest that the vaccine may be a cause of the condition. The results of the study were published in a peer-reviewed scientific journal in 2013, as I am sure the noble Countess is aware. It is estimated that more than 30 million females worldwide have been vaccinated with HPV vaccine. The United States health authorities have also extensively reviewed HPV vaccine safety and the World Health Organization is assured by its safety.
Time is against me, so I will write to noble Lords on those points that I have not been able to cover. Let me just say that this is very much work in progress. Clarity on timelines cannot be achieved until the JCVI HPV sub-committee has met and reviewed the available evidence. We anticipate that sufficient evidence for the JCVI to be able to offer final advice on the vaccination of men who have sex with men will become available during 2015 but that sufficient evidence for the JCVI to be able to offer advice on the vaccination of adolescent boys may not now become available until 2017 at the earliest. I am afraid that I cannot give any comfort on an earlier date. I recognise that 2017 seems a long way off. However, I hope that the noble Lord will agree that it is essential that the JCVI does its work thoroughly and comprehensively before finalising its advice to the Government. He asked whether Ministers will meet the JCVI to discuss this. I will pass that recommendation to my honourable friend Jane Ellison MP, the Minister for Public Health.
The noble Baroness, Lady Hollins, requested that the issue of men with learning difficulties should specifically be brought to the attention of the JCVI. All girls are covered, regardless of disability, so this is an issue that could be brought to the attention of the JCVI and officials will do that.
Finally, I thank the noble Lord once again for initiating today’s debate. I very much hope that the discussion has been helpful in providing reassurance of our commitment.
NHS: Medical Competence and Skill
Countess of Mar Excerpts(11 years, 1 month ago)
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The Countess of Mar (CB)
My Lords, I, too, am grateful to the noble Lord, Lord Parekh, for introducing this Question for Short Debate this evening.
I encounter almost daily cases where people with ME/CFS and others with medically unexplained physical symptoms, known as MUPS, are treated abominably by members of supposedly caring professions. For example—and it is by no means an isolated example—a young man of 17 had problems with tolerating foods since he was a small baby. Standard tests could provide no clear reason. By the time he was 16 he was diagnosed by consultant paediatricians at both St Thomas’ and Great Ormond Street hospitals as being extremely reactive to almost all foods and was restricted to a prescribed liquid diet, as none of the consultants had any other resolution. Eventually he was admitted to an environmental medicine polyclinic, where I am also treated, where he has been treated with low-dose immunotherapy and nutritional supplementation. Over a period of a few months, from being able to tolerate no foods he is now eating 33 different foods with few problems.
On his 17th birthday, he went out with some friends for a meal and during that night he developed very severe abdominal pain and, after his GP had refused to visit, his mother managed to get him to the polyclinic. There acute appendicitis was diagnosed and immediate admission to his local hospital in Oxford was recommended. The paediatric consultant’s first response was to ask, “What has the mother of this boy done now?”. On arrival at the hospital the consultant informed the mother that he knew that nothing was wrong with the boy but he would keep him for observation. He scheduled a scan and then went home for the weekend. The boy was left screaming and in acute pain for a further 24 hours, without pain relief or other medication. By the time he was operated on, his appendix had perforated, making treatment much more complex than necessary.
To this day, despite all the evidence of the extremity of his reactions to foods and the failure of our two flagship hospitals to treat this young man’s condition, his Oxford consultant insists that there is nothing wrong with him, that he should stop the polyclinic treatment and that he should eat a normal diet, apparently because standard allergy tests do not provide confirmation. This results in great stress and distress to the boy and his mother.
In fact, substantive evidence in numerous publications proves that the safety and efficacy of immunological changes after treatment with oral immunotherapy for cow’s milk allergy, nut allergy, allergic rhinitis, wheat desensitisation and other specific foods and chemicals is well recognised. The treatments are validated and are neither experimental nor complementary medicine.
I have long wondered why there should be such particularly unreasonable treatment for people with MUPS and I have come to several conclusions. Medicine is supposed to be a very rewarding profession, whether the practitioner is a doctor, nurse or ancillary worker. The patient consults, the doctor diagnoses and prescribes and the patient gets better or at least no worse. On the occasions when the patient’s condition deteriorates and he or she dies, it is usually because the illness is well understood and this is part of a normal process. This is clearly not the case with MUPS. Modern doctors are highly reliant on technology. Test reports taken at face value can dominate the diagnostic process without taking into account factors such as clinical presentation and history and the possibility of false positive or negative results. Additionally, medical practice has become a cost-benefit calculation, with treatments either enforced or rejected on this basis rather than on patient need. I have the distinct impression that, because some doctors and other medical practitioners fail to understand some disease processes, they grow impatient, even intolerant, when their patient fails to respond and then they blame the patient.
The skills that medical practitioners acquire during training are essential to good practice for the rest of their working lives. Unfortunately, the natural scientific curiosity of the profession seems to be stifled in the course of their training. There are still far too many medical professionals who hold that MUPS are “all in the mind” and that patients simply need to pull themselves together, perhaps with the help of a little cognitive behavioural therapy. Somehow, current research findings are not filtering down to doctors who deal with patients.
Are the time constraints on appointments and the dependence on technology reducing a doctor’s ability to listen and to communicate effectively? Is it because GPs and consultants work such long hours that they have neither the time nor the energy to do their own research on problems concerning chronically ill patients? Is it because complex investigations cost money and initial investigations come back as being within normal ranges that the current view is that further tests would not be cost effective? Or is it because doctors have become so demoralised that they can see no reason to go the extra mile on behalf of their patients?
The NHS is excellent for acute management of illness because clear guidelines are usually followed assiduously by all staff. Chronic complex conditions are problematic because clinicians seem to deal with only one symptom at a time. Specialisation means that patients with ME/CFS are rarely looked at holistically. I have heard of one doctor’s surgery with a notice on the door which reads, “One complaint at a time”. The trouble is that frequently it is the combination of symptoms which will point to a clear diagnosis.
I have confined my speech to one aspect of competence and skill, one which falls far short of the excellence that should be the norm. I am interested to hear how the Minister proposes to improve the position for some 250,000 patients with ME/CFS and the many more who have other medically unexplained symptoms.
Ebola
Countess of Mar Excerpts(11 years, 4 months ago)
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Earl Howe
My Lords, I am grateful to the noble Lord. Existing technology used by the Border Force can inform it about individual passengers coming to this country and identify those who have recently travelled from Liberia, Sierra Leone and Guinea on routes with onward connections to the UK. Systems are therefore in place. We know that fewer than 1,000 passengers arrived by air from the affected countries in September. We are not therefore dealing with huge numbers. We know that around 85% of such people arrive at Heathrow, which is why we are starting there. However, it is important to look as widely as we can; the noble Lord is right. Again we should be reassured by the fact that there is screening on departure from Liberia, Sierra Leone and Guinea but we are starting the in-country screening in the UK at the three ports I mentioned, with the intention of scaling up screening, based on our experience. Plans are in place for a further rollout to other UK ports, if that should prove necessary.
The Countess of Mar (CB)
My Lords, my noble friend Lady Finlay of Llandaff has asked me to apologise to the House for her absence; she had to go to Wolverhampton. I hear the noble Earl saying that the department will consult the BMA and the RCGP about getting the message across to GPs. My noble friend asked me to ask whether a diagnostic algorithm was going to be posted on all appropriate websites, including those of the royal colleges and the BMA.
Earl Howe
I am not aware that the system being conveyed to GPs, which is not for diagnosis but for the referral of patients, can be called an algorithm, but there is a checklist of questions that we are recommending GPs use. That advice has been adapted for use in all healthcare settings, including NHS 111, as I mentioned in the Statement. Naturally, we shall take advice on whether the questionnaire and the sequence of questions are adequate. If it needs amending, we shall certainly not hesitate to do that.
NHS: District Nurses
Countess of Mar Excerpts(11 years, 7 months ago)
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Earl Howe
I do not have the figures, but of course this process started under the previous Government with the “Transforming Community Services” programme, which very often hived off the community provision into social enterprises. If I have statistics on this I will gladly send them to the noble Baroness.
The Countess of Mar (CB)
My Lords, I recently received a letter from a lady whose daughter has ME and is confined to bed. She is under the age of 16, and was given a male care assistant who would not perform certain tasks for her. When her mother went to the surgery to ask if a district nurse could come and do those tasks, she was told no because the girl was under 16. Is this correct?
Earl Howe
I am happy to look into that case, but clearly we need to ensure that there are the right skills for the right patients, and this is what the health service increasingly aims to achieve. The district nursing team has to contain those multidisciplinary skills. If there is a case of someone being inappropriately looked after, then that is certainly a cause for concern.
NHS: Rural General Practitioner Dispensing
Countess of Mar Excerpts(11 years, 7 months ago)
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Earl Howe
My Lords, the phasing out of the minimum practice income guarantee is being gradually implemented over seven years to give adequate time for GP practices to adjust. In fact, most practices stand to gain under that arrangement. I would encourage any practice to take the matter up with the local area team at NHS England if it has particular concerns. The provisions governing whether a doctor can continue to provide dispensing services to eligible patients when a new pharmacy opens nearby, which is a separate issue, have been in place for a long time and are subject to a long-standing agreement. If an application for a new NHS pharmacy is made to NHS England that would affect, for example, the noble Lord’s dispensing practice, that practice is able to make its views known. There is an appeals process as well. If a new pharmacy were approved that does affect the practice’s dispensing patients, it is open to NHS England to phase in gradually the shift from using the practice’s dispensary to a pharmacy for those patients affected.
The Countess of Mar (CB)
My Lords, does the Minister agree that this agreement arose from the 1911 Act—well over 100 years ago—and that there is extreme unrest among patients who are forced to go to a pharmacy when they have been used to using a dispensing doctor? Does the Minister intend to continue subsidising what are known as essential small pharmacies and not give patients a choice?
Earl Howe
My Lords, I do not think that it is a question of opposing choice against the rules that we have in place. The rules are there as a result of very long-standing agreements between the medical profession and the pharmacists. I do not think that there is an appetite on either side to open those rules up for renegotiation. A balance has to be struck somewhere and the professions are content with the balance that has been struck.
Health: Folic Acid
Countess of Mar Excerpts(11 years, 11 months ago)
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Earl Howe
My Lords, the Scientific Advisory Committee on Nutrition is the body charged by government to advise Ministers, and the decision will be taken by Ministers. But we have thought it prudent and sensible to take into account the latest data on the folate status of the population. The information that SACN drew from is more than a decade old, and we do not think that that is a sensible basis on which to take a decision one way or the other. So we must wait for that evaluation.
The Countess of Mar (CB)
My Lords, does the Minister agree that there is an equal conundrum with adding fluoride to water? Her Majesty’s Government seem to be quite happy that fluoride should be added to water, yet there is a possibility of overdose if people have fluoride tablets, fluoride toothpaste and all sorts of other things. What is the difference between that and folates?
Children and Families Bill
Countess of Mar Excerpts(12 years ago)
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The Countess of Mar (CB)
Does the noble Lord realise that if the Secretary of State makes regulations, they will have to be done by statutory instrument? Statutory instruments are either affirmative or negative. In the case of a negative instrument we can pray against it, and in the case of an affirmative one we can debate it. Both Houses will have the opportunity to consider them.
Lord Naseby
While it is true that there is an opportunity to debate a statutory instrument after the Statutory Instruments Committee has looked at it and decided that it wishes to do so, nevertheless—
Lord Naseby
Let me just finish. Your Lordships know full well that there is absolutely no way that we may amend any statutory instrument; we either take it as it comes or we reject it. I am just pointing out that this is a change to the procedures of this House that we have had hereto. The noble Countess may disagree with me—it happens quite often in law that people disagree—but I have had advice. Perhaps she also had advice on her intervention. I leave that aspect; it is on the record now.
I turn specifically to the amendment and its contents. There are three aspects of it that I draw to the House’s attention. First is the matter of intellectual property rights. Such rights are a key dimension to any industry, particularly in the packaged goods world, where I had the privilege to work for some 20 years. Those rights are something that most of those industries have had for centuries. They distinguish between one product and another from a competitor; importantly, they produce a quality assurance for those who buy the product; and they provide for the businesses to have valuable assets that they can produce innovations from and so create competition. Those are assets to those companies that should not lightly be cast aside. There may be particular reasons why some of them should be confined at certain times in certain circumstances, but personally I think that society needs to tread very carefully.
In relation to this amendment, there is the legal situation. I am not a lawyer, but I have had a look and sought advice on the exact legal situation as matters stand at the moment. As I understand it, there are four constraints on Her Majesty’s Government. When my noble friend winds up, I hope he will be able to reassure me that all these issues have been dealt with. Otherwise, the Government will have to deal with them before this part of the Bill becomes law.
The constraints are: first, Article 34 of TFEU covering the free movement of tobacco products; secondly, Article 13(1) of the tobacco products directive which affects the free movement of goods; thirdly, it would produce a disproportionate and unjustified interference with a company’s property rights, which are specifically protected in the UK by, surprisingly, the Human Rights Act 1998 and in the EU by the European Charter of Fundamental Rights and would cut across the UK’s obligations made under international law, several World Trade Organisation agreements, particularly the agreement on trade-related aspects of intellectual property rights, and other agreements. Finally, I understand that fewer than five countries are taking action against the EU in relation to what this amendment addresses. My first question to my noble friend is, am I right in what I have been advised is the situation? If I am right, what action are the Government taking successfully to overcome what I see as considerable hurdles ahead?
I am not going to go through the whole of standardised packaging because this is not the appropriate time to do that but, in the round, as far as I see it as a marketing man looking at the evidence, there is as yet no real hard evidence. There are lots of assumptions and attitudes from surveys, but there is no hard evidence that consumption of cigarettes will fall if we have standardised packaging. Consumption is already falling without standardised packaging, and I am sure it will continue to fall in future, but I do not see any hard evidence that that will come.
What I do see is that it will be very bad for CTNs—confectionary, tobacco and newspaper shops—of which there are well over 100,000 in the United Kingdom. About 20% to 25% of their business is dependent on tobacco products. It is exceedingly bad news for them. It is pretty bad news for the 60,000-odd people employed in the industry. It is exceedingly good news for the counterfeiters, and we see increasing evidence of the number of counterfeit products. It is no good the noble Lord shaking his head—these are facts. We have facts on the importation of counterfeit products.
NHS: Accident and Emergency Units
Countess of Mar Excerpts(12 years, 2 months ago)
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Antibiotic-Resistant Bacterial Infections
Countess of Mar Excerpts(12 years, 6 months ago)
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The Countess of Mar
My Lords, I am grateful to my noble friend Lord Crisp for enabling us to debate this important subject today. I draw the Committee’s attention to my interests in the register, and I am also a member of the All-Party Parliamentary Group on Antibiotics.
We have been given warnings of the dire effect of the overuse of antibiotics that results in antibiotic resistance for many years. In 2011 Dr Margaret Chan, director of the World Health Organisation, warned:
“The implications go beyond a resurgence of deadly infections to threaten many other life-saving and life-prolonging interventions, like cancer treatments”—
which my noble friend mentioned—
“surgical operations, and organ transplantations”.
As both Dr Chan and the Chief Medical Officer have stated, the R&D for new antimicrobials has practically run dry.
Noble Lords have given graphic examples of the cost of antibiotic resistance. I will try to look ahead and inject a glimmer of hope into the current gloomy scenario, and expand a little on what my noble friend Lord Crisp proposed. If modern medicine is to progress, the infrastructure of academic and industrial antibiotic research discovery and development needs to be rebuilt. We know that the current estimates for one new drug to reach the market range from $100 million to $10 billion, with antibiotics at the lower end of that scale. For 20 new classes to reach the market, the costs are phenomenal.
What can be done? There needs to be an overarching framework within which the very best knowledge is brought together. The key to progress will be the development of well informed guidelines and information to help current and future research activities to focus on well funded innovation. Because the problem is potentially so huge and widespread, there is a need for a global initiative as well as a UK one. For the global initiative, it has been suggested that something along the lines of the post-war Marshall plan, which helped to rebuild Europe, might provide the beginning of a solution. This would have to be paid for at a continental level—for example, by the European Union, the USA and Asian countries.
Antibiotic Discovery UK is a network of leading academic researchers and universities, together with SMEs, that have a common goal of revitalising antibiotic research in the UK. It has recently circulated to the Medical Research Council, the Biotechnology and Biological Sciences Research Council, the Engineering and Physical Sciences Research Council and the National Institute for Health Research a proposal for a cross-research council antibiotic research programme—CRCA for short—modelled on the Farr Institute and the MRC’s AIDS-directed programme of 1987, with the aim of conducting fundamental and developmental research into antibiotics for the prevention and treatment of bacterial infections. The programme plans to include work on basic bacteriology, antibiotic resistance, epidemiology, chemistry, drug design and drug evaluation. The CRCA would add to existing investment by research councils and charitable bodies. It believes that its programme would further enhance the UK’s international reputation and that it would provide a significant stimulus to the UK economy, and in particular to the pharmaceutical sector.
Members of Antibiotic Discovery UK point out that the UK is home to a wide range of outstanding scientists with innovative medical, biological and physical science skills. The CRCA programme would link at least eight universities across the UK and would foster strong links with industry as well as international co-operation. They acknowledge that this is an ambitious proposal but I believe that, if we are to crack this problem, a programme such as this is vital.
A multi-pronged approach such as that proposed by Antibiotic Discovery UK would include antibiotic discovery and development by discovering new molecules, mining past leads and exploiting natural products. It would improve researchers’ understanding of pharmacokinetics so that new combinations of drugs could be developed such as those currently used to treat TB and HIV. This would enhance antibiotic stewardship and research into antibiotic resistance through surveillance, diagnostics, epidemiology and mechanisms of resistance.
There is a clear need better to engage and fund academics alongside industrial partnerships to help to deal with this threat, but no one academic group or single institutional centre has the capacity or the capability to make significant inroads. There is great strength in numbers. Best practice and knowledge can be shared between academics and industry within the network, and innovation can flourish. There is a need for multi-institutional centres of excellence to tackle well validated targets such as cell wall biosynthesis, protein biosynthesis and DNA replication, as they offer multiple targets to hit. We now know that therapy should avoid hitting single targets, which will only result in the further speedy emergence of resistance.
On the subject of novel treatments for antibiotic-resistant conditions, I was interested to read that Professor Tony Maxwell of the John Innes Centre, together with a European consortium of researchers, is researching a compound derived from the South African toothbrush tree which inactivates a drug target for tuberculosis in a previously unseen way. Miracles come from all sorts of places.
The situation is not hopeless, but we need to ensure that researchers are encouraged to work together and that they are adequately funded. This matter is too important to be left to industry alone to deal with.
As I have a few minutes in hand, I will read to noble Lords the e-mail that we have all received today from Sue Davie, the chief executive of the Meningitis Trust. She says:
“I understand you are participating in a Speaker debate on ‘antibiotic resistant bacterial infections’ this afternoon. In light of the announcement today that the JCVI will not be recommending the Meningitis B vaccine, we would be grateful if you could raise the following issues, on behalf of Meningitis Trust/Meningitis UK … We welcome the Chief Medical Officer’s focus on antibiotic resistant bacterial infections and the efforts the government is making on this issue ... It is accepted that one of the best ways of limiting the rise of antimicrobial resistance is to properly use the interventions we do have available to combat infectious diseases—an excellent example of these are vaccines ... Can Earl Howe comment on the interim position statement of the Joint Committee on Vaccination and Immunisation (the independent body which advises the Government on vaccination) which has said that a vaccine which could prevent meningitis B disease will not be made available in the UK? … Meningitis is a disease with a very rapid onset, its symptoms are vague and unspecific. When a case is suspected the medical personnel need to flood the systems of these babies and children with antibiotics ... Kind Regards, Sue Davie”.
There is nothing worse than seeing a baby who lost their limbs because they had meningitis B and were not reached in time with antibiotics. Can the Minister give me a response on that?