Draft Human Tissue (Permitted Material: Exceptions) (England) Regulations 2020
Lord Blencathra Excerpts(4 years, 6 months ago)
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Lord Blencathra (Con)
My Lords, I strongly support these regulations but worry that, with them, we could see history repeating itself. The Act from which these regulations flow was regarded by all of us as the right thing to do, but I recall the iniquitous Liverpool care pathway operated by the last Labour Government. It became not a care pathway, but a death highway. It started with the best of intentions and high morality. It was originally for cancer patients, but soon the NHS expanded it to every patient who could be approaching end of life. It was one of the most disgraceful episodes in the history of the NHS.
Doctors, some very junior, concluded that a patient was terminal and then sent them on the death pathway, pumping them full of painkillers, keeping them sedated so that they could not ask for, or get, fluids. With a lack of fluids, they died off pretty quickly. That then justified their decision that the patient was terminal. Patients were denied sustenance for several days before their deaths, while others were written off even though they could have recovered. But many patients, supplied with fluid by caring relatives, survived the death pathway. The trusts were even given a financial incentive for every person they put down this pathway.
The coalition Government ordered an inquiry in 2012 and banned it in 2014, but some in the NHS carried on doing it. NICE had to intervene. Professor Sam Ahmedzai, chairman of the committee at NICE, 18 months after the pathway was effectively banned, said that it was still being used by some “teams” of doctors who
“thought they knew how to give end of life care.”
However:
“It turns out they’re the ones that don’t know.”
NICE finally outlawed the pathway once and for all and said that junior doctors must not to be left alone to make snap decisions about patients’ care; that there had to be an end to the tick-box culture, with patients treated with respect and as individuals; that staff had to be aware that patients who appear to be dying could stabilise or even recover; and that doctors had to ensure that patients had enough to drink.
That is the background perspective with which I read these regulations and code. Like all, I have huge admiration for the individual doctors, nurses and specialist medical people in the NHS but I do not, for one second, trust its slow, unwieldy, bureaucratic machine. When a patient gives consent under these regulations, there are very few worries, but deemed consent is a different matter. The decision on whether to go ahead with organ removal rests with the specialist nurse, not even a doctor, nor yet a registrar. That nurse has a hierarchy of relatives to consult, and the first one to give consent permits the removal to go ahead. How much effort does the nurse have to make to find the first relative who may be resistant to removal? Would there not be a medical bias to find the next relative who medical staff know to be in favour of it? It is much easier to go to a child who is in favour of removal than an equally ranked child who is not.
Codes A and F are 89 pages long, with incredible details for thousands of medical staff to master, including legal concepts. As the noble Baroness, Lady Deech, has just said, there is even the concept of what “a reasonable person” might conclude. We have all seen the nightmare of lawyers playing at being doctors with their second-guessing of medical competence. I do not want our nurses having to guess at what “the man on the Clapham omnibus” might conclude. These regulations and codes are very important, but they have the potential to turn into a Liverpool care pathway where medical staff know best and just tick the boxes. This has to be rigorously monitored so that another scandal does not occur and that this system goes from strength to strength.
Health Protection (Coronavirus, Restrictions) (England) Regulations 2020
Lord Blencathra Excerpts(4 years, 6 months ago)
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Lord Blencathra (Con)
My Lords, I pay tribute to the SLSC for its typically thorough report, which identified errors in the original regulations. But with the changes announced by the Government over the last two days, I look forward to new revised regulations, which I hope will correct one glaring anomaly in the regulations of 26 March.
Regulation 6(2), relating to restrictions on movement, states that a reasonable excuse to leave home is
“the need … to obtain basic necessities, including food”.
Leaving aside the word “need”, which is quite subjective, the term “basic necessities” has led to some police officers boasting that they were patrolling shopping aisles to make sure that consumers were purchasing what the police considered were “basic necessities.” I believe that that behaviour was quickly stamped on, but the law in this regulation still says “basic necessities”.
Schedule 2, Part 3 lists the shops that may stay open. These include supermarkets, petrol stations and hardware shops, among others. The Government have confirmed that consumers can purchase anything at all in these shops which they stock, much of which is not a basic necessity. Supermarkets selling homewares, toys, video games, clothing and compost are perfectly within the law. The term “basic necessities” is confusing and unnecessary. Regulation 6(2)(a) should therefore be changed to say: “to obtain any supplies, including food”, et cetera, “from the businesses listed in Part 3 of Schedule 2”.
Schedule 2 should also have a general provision which states that any shop or retail premises can open provided that it can maintain social distancing. If the supermarkets can limit numbers and space out customers, why not permit, say, Army & Navy Stores, Debenhams or any other retailer to open if they can set up safe systems?
Finally, I commend the statement in the Government’s plan, Our Plan to Rebuild, announced yesterday, that
“the Government will continue to recognise that not everybody’s … risk is the same; the level of threat posed by the virus varies across the population”,
and that the Government expect
“to steadily make the risk-assessment more nuanced … some … may be able to take more risk … The Government will need to consider both risk to self, and risk of transmitting to others.”
Therefore, I hope that the new regulations will make it clear that everyone over 70 is not automatically vulnerable. The same goes for those of us with “underlying health conditions.” These cover a huge range of conditions, and not all of them have equal risk. We must let people over 70 or others in perceived risk categories get out, so long as they do not pose a risk to others. If they endanger themselves, that is their decision, so long as they do not endanger anyone else. I hope that my noble friend the Minister will take those points on board.
The Deputy Speaker (Lord Palmer of Childs Hill) (LD)
Please could we all try to keep to the timings.
Covid-19
Lord Blencathra Excerpts(4 years, 7 months ago)
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Lord Bethell
My noble friend Lord Dobbs is right that there seems to be an opportunity, but I have to be candid with him. Our need for PPE runs into hundreds of millions of items. We have delivered more than 1 billion pieces of PPE since Covid began. I am afraid to say that the manufacturing abilities of Her Majesty’s prisons do not reach to that kind of level.
Lord Blencathra (Con)
As my noble friend the Minister has just said, in January the NHS had to deliver half a million PPE items to 233 hospitals. It now has to deliver 1 billion items to 58,000 health facilities. The experts in logistics are the military, as we saw from the brilliant No. 10 briefing by General Carter yesterday. Will the Government now hand over complete control of distribution to the Armed Forces? Will the Minister comment on reports that the much-vaunted EU purchasing scheme has not delivered a single item of kit to any EU country?
Lord Bethell
I would like to take my noble friend to Skipton House in London’s Elephant and Castle to see the very large room where there is a combination of the diplomatic skills of the FCO, the trade skills of DIT and BEIS, the military skills of the Army and the clinical skills of Health. Seeing all those different skills and abilities work together to deliver the kit that our health workers need is a really impressive sight. That collaboration is the secret to success.
Covid-19: Personal Protective Equipment
Lord Blencathra Excerpts(4 years, 7 months ago)
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Lord Bethell
The noble Baroness is entirely right to commend the sacrifice of hard-working care workers who put their safety on the line and put themselves in harm’s way. She is also correct to allude to the challenge for care homes—15,000 of them—that have previously largely looked after their own procurement arrangements. This Covid disease presents an enormous procurement challenge. The Government have stepped up and are helping care homes in many ways. Nearly a billion items of PPE have been distributed in the last six weeks and we will continue our commitment to support care homes.
Lord Blencathra (Con)
My Lords, first, I congratulate my noble friend on the excellent job he is doing in the department and on his diligence in answering our questions. I ask him this: if handwashing destroys coronavirus on our hands, why on earth do we not launder these 450,000 so-called disposable garments that we throw away each day? Is that not an appalling waste of resources, as well as bad for our environment? Will we radically step up making our own washable PPE, now and for the foreseeable future?
Lord Bethell
The noble Lord makes an entirely reasonable and common-sense request. It is one that I have put to officials myself. The practicalities of PPE are that you have to be prepared to be covered in large amounts of human fluids and for the garments to be waterproof against their impact. Staff are uncomfortable with wearing garments that may have been used in that way previously. In order to maintain levels of hygiene and to rid them of disease, it is very difficult to reuse them. However, we have a committee looking at the potential for reuse, which will be reporting shortly.
Obesity
Lord Blencathra Excerpts(6 years, 4 months ago)
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Lord Blencathra (Con)
My Lords, I congratulate my noble friend on introducing this very important subject. I also congratulate the noble Baroness, Lady Boycott, on her outstanding maiden speech; she delivered it with passion and knowledge, and we look forward to hearing further contributions from her.
To my mind, there are three elements to obesity: first, the type of food that we eat; secondly and most importantly, the quantity that we eat; and, thirdly, the exercise that we take or fail to take. I feel that the debate in this country has focused far too heavily on the first aspect. We have demonised some foods and not paid enough attention to maintaining a balanced died and burning off the calories that we consume. There are no bad foods, only bad diets. Any food eaten in excess and to the exclusion of others is bad for a person.
For years the Department of Health had a vendetta against dairy products—milk and cheese—based on old, discredited research that fat products were bad for one. I can safely say that when I was Food Minister many years ago, every bit of advice that I was told by our health experts to issue to the public was countermanded at least twice over the next few years. Can any noble Lord tell me authoritatively how many glasses of red wine you should take each day? It seems to change every year whether or not one is pregnant. No wonder there is public cynicism about government diktats on food.
Nothing was sillier than taking action against sugary drinks but not against the giant cakes and buns now prevalent in all Starbucks, Caffè Neros and other similar places. A few years ago, a croissant was a little thing about five inches long. Now they are gigantic things about 10 inches long and stuffed with chocolate. Many mornings, I witness people popping into a Starbucks near here and ordering their decaf soy skinny lattes—and then a chocolate chip muffin. We used to have something called fairy cakes or angel cakes when I was a boy, but now there are gigantic muffins at 650 calories apiece, which is one-third of a woman’s recommended daily intake.
That brings me to the second problem: the amount that we consume. The official recommendations for calorie intake are 2,500 for men and 2,000 for women, but those were set way back in 1990 in the US. In fact the Library tells me that the first ones were suggested by a splendid American called Wilbur Olin Atwater in 1888. They are generations out of date and were set at a time when we were a much more active population, when children played outside rather than sitting in their bedrooms texting, when we walked to school rather than being carted, and when more adults were doing manual work. It is nonsensical to retain these grossly excessive calorie levels now. What is worse is that they are being exceeded. Apparently many of those who know about the levels and want to follow them do not realise that they are exceeding them on a daily basis, while the other half of the population either do not know or do not care. We seem to be waiting for a magic pill so that that we can continue our gluttony and our lazy lifestyles in the hope that the NHS will fix it for us without having to change our behaviour one iota. Apparently Public Health England now suggests a guideline of 1,800 calories but does not want to change the advice of 2,500 and 2,000. What stupidity is that?
When I was in the 51st (Highland) Division I would eat a huge fry-up for breakfast, an enormous lunch and an even bigger dinner—about 5,000 calories a day—and I lost weight and was fit. Now I do not do much exercise. In fact I do not do any at all; I sit on my backside all the time. If I consume more than 1,000 calories a day then I put on weight. What a major scientific breakthrough that is: if we scoff more calories than we burn off then we get fat and obese.
Obesity is not an illness; it is a lifestyle choice. We are creating a nation of fat, idle people who will bankrupt the NHS, and we should have the courage to say so in blunt terms. Our strategy must be threefold. First, it must tax excessively sugary foods—all of them, not just some—and penalise excessively large food items. Secondly, calorie intake guidance must be revised downwards to recognise our indolent, lazy lifestyle. We need constant campaigns on that. Planning guidance should force councils not to have high streets full of takeaway food shops; research suggests that locations with supermarkets provide better diets than streets without such shops. Thirdly, we must have a huge campaign to get the whole nation exercising. Exercise alone does not compensate for overeating but it has a part to play. I too commend the Daily Mile initiative, which gets children exercising for a mere 15 minutes per day. It should be compulsory in all schools. My wife has tried to force me to do it as well.
There is no easy answer, but at the moment I do not think we are even asking the right questions.
Access to Medical Treatments (Innovation) Bill
Lord Blencathra Excerpts(8 years, 9 months ago)
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Lord Patel
We would not have had stents put in hearts, bypasses, ablations—
Lord Patel
Yes, we would not have had Marie Curie’s radiation treatment. One of my children is an oncologist, so I know what they do. The noble Lord is quite right: fortunately, such procedures do not have to go through this stringent process. Some argue that they should, but that would be a backward step.
The only minor concern the professional organisations have had is to clarify the definition of medical innovations. It is true that practitioners must clearly understand that they cannot bypass current regulations on patient safety; I have no doubt that the Minister will confirm that. The other matter, which has been mentioned and on which the noble Lord, Lord Saatchi, convinced me in his introduction, is that the database has to be transparent and shared and there must be clear stewardship of it. I hope the Minister will confirm that.
I strongly support the Bill and wish it a speedy passage.
Lord Blencathra
My Lords, I declare an interest in that I would benefit personally if some medical innovation or off-label drug helped my MS problem. I would probably also benefit financially, because I would save hundreds of pounds on all the various vitamin pills and potions that I scoff liberally in the hope that they will make some sort of difference. Mind you, if that were to happen, the shares of Holland & Barrett would crash disastrously.
It is a pleasure to participate in a debate when so many excellent speakers have spoken before me and I agree entirely with every word they have said—all my noble friends and the noble Lord, Lord Murphy. In particular, I mention my noble friend Lord Ryder, with whom I passionately agree. Slightly to misquote my right honourable friend the Lord Chancellor, who was writing about a different issue in the past few days, we have an analogue system trapped in a digital age. Our regulatory system is like an old analogue system which has not kept up to date with the latest scientific breakthroughs, and we need to change that soon—but not in this Bill.
What a pleasure it was also to listen to the noble Lord, Lord Patel. I wish that I had come to him to get some of the off-label drugs that I have been acquiring and testing out myself. No doctor here would prescribe them, but a friend of a friend who, I believe, may work in a major hospital in New York, was able to supply me with some, and I have been testing them out. It is all very well for people like me to be able to go through that back door—legitimately—to acquire drugs to test out. Most people in this country cannot do that, and we need a much faster system to try out off-label drugs, off-patent drugs and cocktails.
I congratulate my noble friend Lord Saatchi on returning to the charge once again with a revised version of his medical innovation Bill. When I first read it, I thought, “Where are all the sections dealing with what is not negligence? We must put them back in”. As I said during the course of his Bill last year, I, and, I believe, 99% of those of us with a condition such as MS, Parkinson’s or the really terrible motor neurone disease are interested only in seeking new treatments which may make a difference to our condition.
When we see our consultants we ask, “What is the latest you have to tell us? Will that stem cell replacement work for me? When can I get it? What about that clinical trial you are now conducting at the National with three different drug cocktails? Can I try it?”. When I asked, the answer was, “No, David, the cut-off age is 60 and you are 61. Never mind, thanks for asking”. We do not go to our consultants with our ambulance-chasing lawyer in tow ready to sue if the innovative treatment does not work.
That is why I found it so disappointing last time that so many lawyers opposed the original Bill because they thought that it could limit their opportunity to sue for failure. Those of us who are searching for treatments which may help us could be deprived of such treatments because doctors—or more likely their health authority—were terrified of being sued. That is utterly, utterly wrong.
However I have listened to the advice of my noble friend Lord Saatchi and my honourable friend, the excellent Chris Heaton-Harris MP, who piloted the Bill through the other place. They say that the Bill before us today has universal support and all-party agreement. Apparently, even the lawyers are not opposed to it. If any colleagues were to attempt to amend it, we would jeopardise that all-party support and we might also run out of time when we return the Bill to the other place. So I shall not try to amend it at all.
The question for me is this: since the Bill now deals only with the database, is it worth while doing it at all? On reflection, I concluded that it is very worth while and, when implemented, there may be no need for a new definition of what is not negligence. Of course, there will be nothing to stop someone in future attempting to bring in a “What is not Medical Negligence” Bill, but it may not be needed.
Let me explain my thinking. One of the principal reasons which may be advanced alleging negligence is that the doctor attempted something innovative which no other doctor has ever done before. It is easy for lawyers to then argue that it was negligent. He did not stick to normal clinical practice; there was no evidence base for his treatment; no one else in the world was doing it; and, therefore, per se, it was negligence. However, if we have a database showing that around the country, five, 10, 20 or 100 or more doctors were also trying that innovation, or something close to it, it cannot be argued that the doctor was off the wall and trying something dangerous, unethical and therefore negligent. Over time, with a sufficient database, we could get the ambulance chasers off our backs.
Furthermore, we need one easily accessible database. If one does a web search for example, as I did yesterday, of the latest MS breakthroughs, one gets hundreds of pages with a dozen hits on each page with studies published by the MS Society, half a dozen top UK hospitals and hospitals in Queensland, Dublin, Paris and a dozen in the USA—and that was only the first two pages on my screen. Then there are studies published in the Lancet, British Medical Journal, Neurology Today or Neurology Now, and countless other publications. It seems that every university medical research centre publishes its own research, then other journals publish other research and then disease-specific societies also publish research. Even a top consultant who specialises in research cannot find the time to search and keep up to date with the myriad organisations publishing research on innovative treatments. Therefore, a common database is vital. It may not be as sexy as legislating for medical negligence, but it is a more important step to pointing all doctors in the same direction with regard to expanding innovative treatment.
Therefore, I hope that the Minister will be able to reassure us that the Government will not waste a second in creating this database and that the funding will be found for it. At the end of the day, it will save the NHS a fortune. Hypothetically, a pill which fixes Alzheimer’s, for example, will save years of medical care and treatment. Finding cures using cocktails of already approved drugs or some of the 70,000 existing compounds that the noble Lord, Lord Patel, mentioned, is infinitely cheaper than paying the pharmaceutical companies to develop a very expensive new, patented one. On that note, I received a briefing note, as I suspect many noble Lords did, from the Association of British Pharmaceutical Industries, saying that, of course, it supports the Bill in principle, but that on the other hand there was nothing right about it. I hope that that will not derail this measure. It may not necessarily be my view, but a cynic would say that of course the association is opposed to it, as it has no interest in finding that a drug which is now out off-patent and dirt cheap may cure some other problem. It would prefer to invent a new patented drug for which it can charge what it likes. Having said that, I pay tribute to our pharmaceutical industries for the innovation that they are doing; I wish that there was a faster regulatory system to get the drug to market faster and cheaper.
I have a few other points for the Minister. This database is for the UK only, or rather England and Wales. As soon as it is established and working properly, then I would ask that it be extended as soon as possible to research published in other countries, especially the United States. I follow carefully every announcement made by the Scripps Research Institute in Chicago, John Hopkins hospitals, Mount Sinai and others in the USA. In some cases, they have made great medical advances faster than us, but in other areas we have made breakthroughs better and faster than them. Without straying into Brexit matters, it has to be said that Britain leads the world in medical research. If we only had as much money to throw at it as the Yanks have, they would not come anywhere near us in the amount or quality of research that we do. Therefore, it is vital for UK doctors to be able to rely on medical innovation happening in the United States, and their results have to be added to the database. Then we need to add other countries from around the world that are respected as medical innovators—or rather, their research findings are respected as legitimate.
I understand that the Department of Health intends to issue instructions or guidance to all doctors that they should submit information to the database about what has worked and what has failed. That is very important. However, I am worried about the term “failed” or whatever is used. Will that not give a green light to our legal friends to sue for negligence just because something did not work? As a non-lawyer, I feel that the concept of negligence is far too wide. Getting it wrong is not necessarily negligence, but I see too many cases where it is alleged that it is. We all hear of hundreds of cases where the NHS has made a tiny mistake, such as losing a patient’s pyjamas, and all the patient wants is a simple apology. However, because of the increasingly grubby trend of suing for everything under the sun, doctors and the health authorities are terrified of saying, “We are sorry we made a little mistake”, because they are afraid a lawsuit will be in the post. Therefore I would like to hear from the Minister what safeguards will be in place that will encourage doctors to record faithfully what has worked and what has not and will remove the threat of them being sued.
Finally, let me say a word about the timings for the remaining stages of the Bill. While I would like to have tried out some amendments, I will not now do so because this Bill is in danger of running out of time. Assuming that it gets a Second Reading today and a committal Motion, we will next look at it on Friday 11 March. However, this morning I went to the other place to see what was happening there and got a copy of its Order Paper. It is dealing with Private Members’ Bills today and on 4 March, and the very last day the Commons has to consider Private Members’ Bills is Friday 11 March, the same day that we will be coming back here to consider my noble friend’s Bill either to discharge the committal Motion or to do Committee and Report stages. I understand that we cannot have Third Reading on the same day. If we were to amend this Bill on 11 March and the Commons finishes on 11 March, the Bill cannot go back there for ping-pong and we would lose it. Therefore, I say to my noble friends, if anyone wants to amend the Bill, please do not.
The last point I shall make is to the government Whip on the Bench. Please tell the Chief Whip that if we cannot do Third Reading on 11 March—at the moment it seems to be the last day we have scheduled for a Private Member’s Bill—can we please find another little slot for the Third Reading of my noble friend’s Bill? I know that as a former Chief Whip it seems a bit hypocritical of me to plead for another day for a Private Member’s Bill because it will set a precedent and everyone will want their Bill taken, but since this Bill has had universal support in the Commons and is getting universal support here, I hope we can find time for a little formal Third Reading to get this Bill on the statute book.
I congratulate Mr Heaton-Harris in the other place on piloting the Bill through the Commons and getting unanimous all-party support, and I again congratulate my noble friend Lord Saatchi on returning to the charge and taking the Bill through this House. I hope and trust that neither time nor procedure will prevent its passage, and I commend it to the House.
Lord Hunt of Kings Heath
My Lords, I thank the noble Lord for bringing the Bill to your Lordships’ House and I commend him for his perseverance and stamina as he sought to take it and the previous Bill through. I, too, pay tribute to the honourable Chris Heaton-Harris for taking the Bill through the House of Commons.
When the noble Lord opened his speech he referred to the adoption of new medicines, and I am very sympathetic to the point he raised. The fact is that we have a shocking record in the UK on the adoption of new medicines. We use fewer branded medicines per person than comparable countries; we tend to use older rather than the latest medicines; fewer patients in the UK receive new, innovative medicines than those in comparable countries; and we have a problem in that NICE-recommended medicines—even those that have been through the NICE process and have been shown to be clinically effective and cost effective—face further reviews and restrictions at local level, even though there is a legal requirement on clinical commissioning groups to make sure that NICE technology appraisals are put into action. For me, that adds to the concerns of the noble Lords, Lord Patel and Lord Ryder, about the position of the UK when it comes to investment in R&D by the pharmaceutical sector. We know that we have a very strong science base and at the moment we have a strong pharma R&D base, but those are at risk, partly for the regulatory reasons that noble Lords have already referred to. I do not think that that is so much the case in this country but I take the point made by the noble Lord, Lord Ryder, about European regulation.
The other big problem we have is that the NHS is hopeless at adopting new medicines. We have the Hugh Taylor Accelerated Access Review, which has been sponsored by Mr George Freeman, to whom I pay tribute for the work he is doing in this area. The review has produced an interim report and the final report will come out in the summer. It is concerned with access to innovative drugs, devices and diagnostics, which it aims to speed up. But however good the recommendations are and will be, unless the NHS and NHS England completely change their perspective and recognise that we have to adopt these fantastic new innovations that are coming to the UK or are developed here, in the end we will not be seen as a country in which it is worth investing. My experience—it may also be the noble Lord’s experience—is that the big problem is that there is a culture within the NHS that regards drugs as a cost rather than a benefit to patients. There is a need to take a very different approach, even in relation to new equipment and clinical staffing. There is a huge cultural barrier that we have to face up to.
Noble Lords, including the noble Baroness, Lady Masham, mentioned that we have received briefings from a number of medical bodies—the ABPI, the BMA and many of the royal colleges—which are still expressing concern, even though the Bill has changed considerably since the noble Lord took it through in the last Session. We know that they still have some concerns about the database and about what they regard as the perverse incentives. Is the Minister confident that his department can help to assuage those concerns? If we are to see this Bill progress—and we all want to see the benefit that the noble Lord wishes to bring to healthcare in the UK—it is important that there be some way of reassuring those bodies that what is intended here will not put at risk some of the things they have put forward.
I also hope that the noble Lord will respond to my noble friend Lord Murphy on the very important point about off-patent drugs. I am not convinced that the authorities in the UK have ever understood the importance of making progress in this area. In the end, only Ministers can kick people to make progress. I agree with him—let us hope that this database is at least a start in giving prescribers confidence to prescribe off-patent drugs.
Finally, I come to the recommendations in the Delegated Powers Committee’s report published on 25 February. I do not know whether the noble Lord has seen it but it makes reference to this Bill and I am slightly concerned about it. The committee is concerned about Clause 2, which,
“enables the Secretary of State, by negative procedure regulations, to confer functions on the Health and Social Care Information Centre … in connection with the database”.
In particular, the regulations may include requiring or authorising the centre to disclose information to specified persons. The Delegated Powers Committee has no problem with the use of subordinate legislation to do that, nor with the use of the negative procedure, but it says that,
“clause 2 appears to envisage no provision, either in the Bill itself or in the regulations, for the enforcement of conditions imposed by virtue of subsection (4)(b), and we draw this matter to the attention of the House so that it may seek an explanation, either from the Member promoting the Bill or from the Minister”.
I do not expect the Minister to be able to respond today. However, if the committee has identified a drafting issue, the question of how it is going to be dealt with is a concern.
I end with the point that the noble Lord, Lord Blencathra, made about timing. Presumably, he is basing his assumption on the Commons rising in May, but he seemed to be saying that 11 March would be the last time in this Session that the Commons would deal with it.
Lord Blencathra
My assumption is not based on when the Queen’s Speech would be or when the Commons rises. In the Commons, the days for Private Members’ Bills are announced at the start of the Session, and Friday 11 March has been announced as the last day. Even if the Commons ran into June or July, there would not be an extension beyond 2.30 pm on Friday 11 March.
Lord Hunt of Kings Heath
But on that basis, even if there were no Committee or Report stage, it would still be too late. Will the Minister join me in asking the usual channels whether we can find some time before 11 March to take this Bill through, even if the Government may need to table a technical amendment? Obviously, a recommendation from the Delegated Powers Committee cannot be ignored. We on this side of the House would certainly support the Minister in doing that.
Lord Prior of Brampton
My Lords, all my experience over the last 15 years is that openness and transparency are critical to get improvement and innovation into the NHS, but we have to accept that patient confidentiality is also extremely important. If we in any way compromise or give people reason to think that patient confidentiality will be in any way intruded on, we may unwittingly undermine everything else that we are trying to do. We have seen that in other areas in the health service in the last year or so. We have to be very careful in this area, but I understand the importance of the noble Baroness’s point.
The Bill does not seek to add an extra burden on doctors, as the GMC’s guidance already sets out requirements on doctors to record their work clearly in clinical records. Doctors are required to have regard to such guidance as part of maintaining their licence. However, through the use of NHS contract guidance, doctors will be required by their providers to have regard to the requirement to record their innovations and, crucially, all associated outcomes.
Lord Blencathra
I appreciate that no Minister at the Dispatch Box would dare make any commitment about more time for a Bill or rescheduling, which is the complete province of the Chief Whips and Leaders on both sides, but will my noble friend the Minister make some representations to the usual channels that we seem to be in complete agreement here and that we need to find, within the rules of the House and without creating precedents, some means of making sure that we get the Bill through before the shutters of the House of Commons come down at 2.30 pm on Friday 11 March?
Lord Prior of Brampton
I was going to come to that point right at the end. The noble Lord, Lord Hunt, raised it as well. I give complete assurance that the Government will do everything they can to work with the noble Lord opposite and others to ensure that the Bill goes through. It clearly commands the full support of the House. It is a hugely important Bill, which the Government fully support, both in the other place and here. I certainly give that undertaking.
Standardised Packaging of Tobacco Products Regulations 2015
Lord Blencathra Excerpts(9 years, 8 months ago)
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Baroness Meacher (CB)
My Lords, I was not planning to speak today, but I have to rise to respond to the noble Viscount, Lord Falkland. If we were to have a logical system in this country for dealing with drugs, tobacco would indeed be illegal. We have lots of drugs that are illegal in this country that are infinitely safer than tobacco, and we all know that, if we were starting today, tobacco would be unlawful. So I simply do not accept the point that, simply because tobacco is lawful, we should allow the market to let rip—very far from it. We know that it is very difficult to make a product such as tobacco unlawful at this stage, but we need to do everything possible to protect the public from the most dangerous drug available in this country today.
Lord Blencathra (Con)
My Lords, I declare an interest as on the register of interests. It is a new interest—I recently joined the Lords and Commons Cigar Club, because I was concerned with how the Government have caved in to some of the fanatics in the anti-smoking brigade. They are fanatics, because they seem to hate e-cigarettes, which are good things for smokers to change to, just as much as they hate tobacco cigarettes. There is a powerful case against smoking—we all agree with that—but I would be more interested in their arguments on plain packaging if they would admit that e-cigarettes were actually a good thing for people to change to.
I deeply regret having to oppose my noble friend the Minister. In my 33 years in Parliament, he is the most knowledgeable Minister for Health that we have had in either House. In addition, he is invariably courteous and the most caring and decent man I have ever met. Therefore, I am sorry that, on this occasion, I think that he is wrong.
One knows that a government department or any organisation is scraping the bottom of the barrel to find arguments when we have 21 regulations over 23 pages, and a memorandum trying to justify them running to 103 pages and 388 paragraphs, most of which have nothing to do with plain packaging but make very powerful arguments against smoking in general. The department has scraped together every possible and bogus argument that it can to support the case. Many of the arguments that I have read in the impact assessment seem to be different from the contents of my noble friend’s speech. Paragraph 230 says that local authorities in 2007 spent £342 million on dealing with cigarette litter alone. What an extraordinary figure. That is absurd nonsense—but it adds to it by saying that plain packaging will lead to further savings on litter collection but that the department cannot quantify them. Dead right it cannot quantify them, because I think that they are quite spurious. This reminds me of the Home Office claim during the draft communications data Bill that it would bring about savings of £6 billion per annum, when that £6 billion was based on terrorist attacks which it considered would no longer take place if the Bill was passed.
All the evidence suggests that standardised packaging will lead to a big increase in the illicit market. That is the view also of Commander Roy Ramm, a former Metropolitan Police commander, who gave evidence to the Lords Select Committee. If even I as an amateur, on my £99 Canon printer, can now easily manufacture a matt standard cigarette packet—and, yes, I can do Helvetica and Pantone grey 42 at 8 point, as per the regulations—what will the big criminal gangs in Romania and Bulgaria do? At least they will increase the market for offset litho printing machines. The impact assessment makes tortuous assumptions to get out of admitting that it has not got a clue on the increase in illicit cigarettes that we will inevitably see. Paragraph 192 says:
“We conclude that there is a sizeable likelihood that there will be no discernible increase in the illicit market. However, we also conclude there is a chance that there will be an increase in the illicit market”.
I invite noble Lords to look at paragraph 192—that is exactly what it says. What a way to make policy. We do not know if it will be good or bad, but we will carry on regardless.
Then there is the Australian experience, which has been cited already, and which the Government call in aid even though it has been running for only 18 months.
Paragraph 93 of the impact assessment says:
“At this time it is difficult to conclude what the impact of standardised packaging on Australian smoking prevalence has been, due to confounding issues of a general decreasing trend and changes to tobacco prices”.
So, although we do not know whether it is working in Australia, we will carry on with our policy regardless. That is not a way to make policy. Australia is conducting a post-implementation review, but we are not even waiting to find the Australian Government’s conclusions.
All the evidence suggests that price is the big determining factor in people giving up smoking. With an increase in the illicit market and the fact that counterfeiters will be able to sell cigarettes more cheaply in the pubs, clubs and other outlets that they use, we are likely to see an increase in consumption of even more dangerous tobacco as criminal gangs are able to sell it more easily—they will use even cheaper, nastier tobacco. Nor will we be able to police it properly: the whole Codentify system is in jeopardy and will not be able to easily identify illegal and dodgy cigarettes. I say to the noble Lord, Lord Faulkner, that the system may not be perfect but it is better than nothing, which is the Government’s policy if they go ahead with plain packaging. The idea that a person in a pub will check the barcode before he buys a £5 packet of cigarettes, rather than go to a proper newsagents and get a £7.50 one, is just nonsensical.
I conclude that this is unfortunately a knee-jerk SI. We should wait until we get proper results and measured evidence from Australia. That is the only sensible way to make policy on this important issue.
Baroness Howarth of Breckland (CB)
My Lords, I had not intended to speak this afternoon, although I want to congratulate the noble Earl. I was with him on the beginning of this journey. I think that he has taken this through with due care and diligence. At the beginning, some of us feared that he would not be on the side of the anti-smoking brigade, but he has taken some of these measures very carefully into legislation. As the noble Lord, Lord Blencathra, was speaking, I realised that I was a fanatic—so as a fanatic, I will make just three points.
First, with the noble Lord, Lord Faulkner, I introduced the first Bill that tested the arguments in this House, the London Bill, when the noble Lord, Lord Faulkner, introduced the Liverpool Bill. At the time we were told very firmly by the smoking lobby that cancer was not caused by smoking, that we would actually take money out of the health service because of taxes and that we would lose money rather than gain it if smoking decreased. We received quite a lot of serious and personal accusations about false information. I began that journey there and was the person who brought forward the order to stop smoking in the Peers’ Guest Room. I think that many people have been grateful for that for a long time.
The second reason that I wanted to speak as a fanatic is that I think that there have been some spurious arguments this afternoon. I spent 10 years in the Food Standards Agency working with the food industry, which has had to change its packaging more than any other industry. If the smoking industry is not flexible enough to do as well as the food industry in organising itself to do something else when it loses this packaging, it does not deserve to be in business. Business has to be innovative.
The third reason I am a fanatic is that I have a niece who I brought up as a daughter. She has two children. The youngest has a heart complaint, which is very serious if she gets into any situation where there is smoke. I say that as a personal comment, but noble Lords will know how strongly and passionately I feel about the protection of our children. It seems extraordinary: if packaging with coloured outsides and attractive labels is not attractive to children and selling the product, why is the industry so keen to save it? That is the sheer, simple logic. If any noble Lords are wavering, perhaps they should wonder why so much money is being spent by the industry to protect packaging if it has no impact; it wants to protect it because it does.
So in some ways I suppose that I am proud of being a fanatic. I hope that your Lordships will be with the Minister and oppose the amendment in the name of the noble Lord, Lord Naseby, as I do.
Medical Innovation Bill [HL]
Lord Blencathra Excerpts(10 years, 1 month ago)
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Lord Blencathra (Con)
My Lords, I say, for the record, that I have been here throughout but below the Bar of the House, so I am not suddenly intervening in the debate.
Inevitably, the Bill of my noble friend Lord Saatchi has been driven by terminal cancer care, and we understand the motivation. As regards the discussions on the first group of amendments, I agree with the noble Baroness, Lady O’Neill, that we have heard from some of Britain’s most distinguished “scalpel” experts but we need to hear a bit more from physicians who have responsibility for long-term and chronic care. That is why I totally support my noble friend’s Bill and the amendments he has proposed but I also support Amendment 6 proposed by the noble Lord, Lord Winston. I support it but I hope that it may not be necessary and that my noble friend Lord Saatchi will see that it is already taken care of in the Bill. However, I would like to flag up in this debate that it is important that the Bill covers innovative drug treatments, including drugs which are not necessarily authorised or approved in this country.
One does not want to get into describing personal medical things—it is a bit grubby. However, as an enthusiast for the Bill, who has experience of innovation approved by medical authorities in this country and has participated in some innovative treatments not approved in this country, I think that the House should hear from the users at the sharp end, so to speak.
I was diagnosed with MS in 1996. It is slow, progressive and each year it slightly tightens its grip. I would say to our distinguished lawyers, as I said at Second Reading, that when one goes to see one’s consultant, one does not go with a lawyer in hand to see whether the consultant makes mistakes and one can sue him. I suspect that, like me, a hundred thousand other MS sufferers and those with Parkinson’s and motor neurone disease all go along to ask, “What is new? Have you seen the latest research? What have you got? Is there anything that will work?”. We know that at the moment there is no cure for MS, although I think that researchers are getting pretty close to finding one, but we want to get palliative care.
As I say, I do not want to go into details but some of the side-effects of increasing MS are pretty nasty and, frankly, life is not worth living unless those side-effects are dealt with. For many MS sufferers, as the nerve endings die, particularly in the legs and feet, the feet drag. No problem there, as one loses some strength in the legs, one can have a wheelchair. But many people suffer a complete loss of bladder control. If one has to go to the loo every 10 minutes, life is just not worth living. An innovative treatment was developed by the Swiss, which was then experimented by the National Hospital in London. Those Botox injections directly into the bladder were not a life-saver but they made life worth living again. Without going into details, I fought my way through to become patient No. 51 in the clinical trials. That treatment has now been approved by NICE after all these years.
I am not saying that I am typical of patients with this sort of slow, progressive disease but I suspect that I am typical of many who will try any innovative treatment. I am 16 days into a treatment with a new drug, Fampridine, which is approved for use in this country but only, I think, in the national neurological hospital in the wonderful Queen Square. I believe that in clinical trials of the drug, 40% of people experienced a 40% improvement in their ability to lift their feet a tiny bit. However, lifting one’s feet a quarter of an inch when one is walking is very beneficial as it stops one tripping over every dead fly on the carpet.
As I say, at the moment there is no cure for MS but these innovative treatments are making life better. After just 16 days of my experimental treatment, I certainly feel a marginal improvement—at least I am not declining further. That may be the only hope one can offer many people—not that we can fix them but we will make the quality of their lives better for the long term and we will try to hold the disease at bay. Therefore, the provisions of Amendment 6 are absolutely apposite.
In October or November of last year, an American research institute, the Scripps Institute, reviewed about 10,000 drugs currently approved in the United States for various conditions and treatments. The staff there discovered, partly by accident, that there was one drug prescribed for Parkinson’s which seemed to repair the myelin sheath, certainly in their laboratory animals suffering from MS. I understand from my research that American doctors have slightly more power to prescribe off-label treatments than do British doctors. If it is in the patient’s best interests, they are entitled to prescribe a medicine which is not authorised or approved for that condition. British doctors do not seem to have that same flexibility or freedom, except perhaps if a drug is prescribed for adults and a child has those same symptoms, they may off-label prescribe a quarter of a pill or half a pill, like half an aspirin given to children with an illness. As I say, British doctors do not seem to have that freedom or flexibility.
The vast majority of people do not have the benefits I have of contacting an American doctor and managing to get my hands on some of those pills. They are prescribed in this country for a certain condition but no doctor can prescribe them for MS patients at present. It will be another five or 10 years by the time all the trials are conducted. I appreciate that this Bill is not about laboratory experiments or turning us into lab rats, although I am happy to go much further than the terms of my noble friend’s Bill and be a lab rat for some of these things. However, unless physicians treating long-term chronic illnesses can prescribe off-label treatments, which they think are in the best interests of the patients, this Bill will have failed. I hope that we can include off-label treatments.
I am obviously not an expert but I am deeply interested—I declare that interest as a patient—in the cocktails of drugs that seem to be available. For many treatments—it is the same for HIV and many others— there is no magic pill about to come on the market that will fix them. However, doctors have discovered that a combination of drugs, cocktails of various things, may have palliative or curative effects. I am on various cocktails of drugs, involving daily injections, weekly pills and various tablets. I can say that most of these are approved in this country but some are not. I am not taking illegal drugs but tablets and pills that have not been approved by NICE but which I, unlike the vast majority of patients in this country, can acquire from abroad. So I hope that if the Bill goes through and if the treatments mentioned in Amendment 6 are automatically included I will, one day soon, able to try those drugs without having to acquire them from doctors in New York. I hope that that would apply to many other patients in this country.
I am supportive of all the contents of Amendment 6 but if my noble friend says that it is not necessary, I am happy to go along with that.
Lord Kakkar
My Lords, I have some concerns about the wording of Amendment 6. Is it intended, for instance, to restrict the use of an agent or intervention that has been tested in a completely different situation—there may be some peer-review publication or some clinical validation in a completely different situation—but where it is proposed to use the treatment for another condition? One will recall that Gleevec was an agent developed principally for the management of patients with chronic myeloid leukaemia; it was an interesting biological compound that targeted a specific mutation in a signalling pathway in cells in that form of leukaemia. Many years later, it was noticed that that signalling pathway mutation was also seen in a particularly rare form of tumour, a gastrointestinal stromal tumour. Those who were innovating decided to use the drug because the genetic mutation appeared to be the same for treating that particular type of tumour to great effect. Would the description of innovation in the amendment have prevented that happening?
Proposed new paragraph (d) of the amendment deals with the question of devices or instruments. What happens if they have been developed and regulated for a particular intervention, and then an innovator decides to use them for a completely different condition? They will have been made available for regulated use but not for the condition in question. Would this amendment therefore restrict that type of innovation?
Health: Multiple Sclerosis
Lord Blencathra Excerpts(10 years, 4 months ago)
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Earl Howe
My Lords, I think that the answer is almost certainly no because the risk-sharing scheme initiated under the previous Government is quite complex to administer and we would need to be persuaded that the administrative burdens associated with it were worth while. Now that we have the NICE process, it is probably best that NICE should look at these drugs in the context of its new clinical guideline, which is what the stakeholder groups thought was preferable.
Lord Blencathra (Con)
My Lords, I declare a personal, though not a financial, interest in this Question. My noble friend may be aware that there is a drug called benztropine which has been approved for the past 10 years for use in Parkinson’s patients. We know that it is not carcinogenic, mutagenic, teratogenic or any other genic—it is safe. US researchers have just discovered that it seems to completely restore the myelin sheath on the spinal cord, at least in laboratory animals. This is of enormous interest to MS patients. Will my noble friend add benztropine to the list of medicines for urgent consideration by his early access to medicines scheme?
Earl Howe
My Lords, we are keen to see candidates being proposed for the early access to medicines scheme. If a body of evidence suggests that benztropine could qualify for designation as a promising innovative medicine—a PIM—the Medicines and Healthcare products Regulatory Agency stands ready to consider such evidence. However, it is for the manufacturer of the drug, not the Government, to decide whether it wishes to propose the drug as a candidate for the scheme.