Access to Medical Treatments (Innovation) Bill
Lord Blencathra Excerpts(8 years, 2 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.