Second Reading

Access to Medical Treatments (Innovation) Bill – in the House of Lords at 12:49 pm on 26th February 2016.

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Moved by Lord Saatchi

That the Bill be now read a second time.

Photo of Lord Saatchi Lord Saatchi Conservative 12:50 pm, 26th February 2016

My Lords, I beg to move that this Bill be now read a second time. These days, the parliamentarians in another place are often an abused minority who receive very little praise. What they usually get is offhand criticism from people who question their motives and behaviour. However, to those who have eyes to see and ears to hear, the Hansard reports on the well-mannered and illuminating debates on this Bill in another place bear witness to the fact that the place is occupied overwhelmingly by intelligent and responsible people, honestly striving by their own best light to pursue the aims for which the place stands. I would like to thank, in particular, the MP for Daventry, who kindly invited me to bring this Bill before your Lordships today, and I thank noble Lords for the interest, commitment and time that they have given the Bill and its predecessor.

In the House of Commons, I observed many hours of thoughtful and painstaking line-by-line scrutiny of the Bill. I draw the attention of the House to the definite intent in the House of Commons for a cross-party, non-partisan, non-tribal approach. That is a great credit to Chris Heaton-Harris, who searched for consensus throughout the successful passage of this Bill through the House of Commons. I ask noble Lords to consider, for example, the Conservative Member for Bury St Edmunds, Jo Churchill, who is herself a courageous double survivor of cancer. She spoke with real passion and authority on the power of research and data, and on why we need urgently to develop this new landscape to support the speedier adoption of medicines. Noble Lords should also consider the Labour Member for Torfaen, Nick Thomas-Symonds, who generously agreed to include in this Bill some of the provisions of his own widely supported Bill in another place, which was intended to promote the greater use of off-label and repurposed medicines. They may also consider the SNP Member for Central Ayrshire, Dr Philippa Whitford, a greatly respected medical specialist who has also played an important role in bringing the Bill to this point today.

I would also like to acknowledge the late Les Halpin. He founded Empower: Access to Medicine with a passion that his death should not be in vain and might inspire and motivate others to accelerate innovative medicines being brought to patients. The campaign that was started for him continues to grow and build support for the programme that we are discussing today.

Finally, I pay special tribute to the Life Sciences Minister in another place, George Freeman, whose sincerity and consistency in pursuit of the programme at the centre of the Bill is plain for all to see. As he said:

“I have been determined to work with Back Benchers to reach a solution that the House and the Government could support”.—[Hansard, Commons, 29/1/16; col. 593.]

He explained at the end of Third Reading that:

“It is wonderful to see MPs from all mainstream parties … in support of a measure that offers real benefits for patients and front-line clinicians, without undermining the latter’s clinical sovereignty over patients. It is about giving them information, so that they can make the exquisite clinical judgment we all want them to make. I … commend the Bill to the House and … congratulate all those involved, and I am delighted to have done my bit to help strike a blow for joined-up government”.—[Hansard, Commons, 29/1/16; col. 598.]

The MPs whom I have mentioned, and others who spoke in earlier debates in another place, did, as the Life Sciences Minister concluded, bring us to a much better place with a Bill that commands and deserves respect and support.

I thank the officials in the Department of Health. Many noble Lords will have seen the excellent Explanatory Notes on the Bill and the professional guidance note, also prepared by the department. The officials I have worked with throughout the passage of the Bill and its predecessor are true exponents of the Northcote-Trevelyan ethic of public service.

I will give the briefest of brief histories. The Medical Innovation Bill was passed by your Lordships’ House on 23 January 2015. The general election interrupted its progress in another place. In the new Parliament, it was taken up by Chris Heaton-Harris, who I am delighted to see is at the Bar, with government support as this Access to Medical Treatments (Innovation) Bill and passed by the House of Commons on 29 January 2016.

The UK Chief Medical Officer and the medical director of the NHS both confirmed to the Secretary of State that the clinical negligence provisions in the predecessor Medical Innovation Bill, as your Lordships had decided, were safe. But anxiety continued about possible unintended consequences, and it was concluded by all that it was best to focus on the strongest, agreed part of the Bill—the database. From the beginning, the aim has been to move forward a culture of innovation, and all agree that the existence of the database of information, sharing knowledge of best practice, could help achieve that, with popular support in the medical and scientific community.

The Bill gives the Secretary of State the power to make regulations conferring functions on the Health & Social Care Information Centre—the HSCIC—which is the body that develops and puts into place databases such as the one we are discussing in connection with the establishment, maintenance and operation of the database for innovative medical treatments. Clause 2 of the Bill provides a regulation-making power for the establishment of this database by the HSCIC. Conferring this function on the HSCIC is in keeping, I understand, with its existing powers under the Health and Social Care Act 2012, which included the establishment and operation of systems to collect or analyse health and social care information. The HSCIC is, I believe, well equipped to handle information of this type, including ensuring the necessary safeguards are in place. It is intended that information relating to innovative medical treatments and the outcomes of those treatments carried out by doctors in England will be passed to the HSCIC through existing national data flows by using national coding structures derived from patient notes. The information will be presented in a consistent way.

I cannot remember such unanimity and intensity of feeling on any clause in any Bill in your Lordships’ House as there was when we discussed this database during proceedings on the original Medical Innovation Bill. It followed an initiative from the University of

Oxford that was designed to encourage the creation of such a database. It is why the noble Lord, Lord Kakkar, said at Second Reading of that Bill that,

“this is a vitally important Bill … I hope that it will also drive forward a positive culture of putting innovation at the heart of all clinical thinking ”.—[ Official Report , 24/10/14; col. 875.]

And it is why the noble Lord, Lord O’Donnell, arguing that we needed evidence-based medicine, said that:

“Of course there was no evidence; that is the whole point. We have to find ways to generate evidence”.—[Hansard, 24/10/14; col. 878.]

So he strongly supported the Bill. It is also why the noble Lord, Lord Giddens, who is not here today because he has an infection said at Third Reading:

“Science is a collective enterprise. It depends on the accumulation of evidence. It is crucial that that be recognised … as part of the advancement of scientific progress more generally”.—[Hansard, 23/1/15; col. 1583.]

The noble Lord, Lord Giddens, has written to me today saying:

“The radical nature of innovation in medicine today exists because of the overlap of supercomputers, genetics and global data sources”.

That is why he strongly supports this Bill. The noble Baroness, Lady Masham, who has been involved throughout this process, said that,

“it is essential that provision is made for collecting and sharing data to ensure that information, both on beneficial and harmful effects of treatment, is captured for the benefit and subsequent use of patients”.—[ Official Report , 12/12/14; col. 2061.]

It is why my noble and learned friend, Lord Mackay, who also cannot be here today, said:

“If innovative treatment has been successful in a particular case, the details of that case are required to make sure of the extent to which the results might be expected to follow in another case. I regard it as important that that should happen”.—[Hansard, 12/12/14; col. 2061.]

I pay particular tribute to the noble Lord, Lord Hunt of Kings Heath, who took forward in the consideration at Third Reading of the original Medical Innovation Bill the Oxford initiative. He deserves great credit for the fact that we are where we are. The noble Lord, Lord Kakkar, also thanking the noble Lord, said, with the approval of the whole House, that the database would,

“allow colleagues to understand what has been achieved and not achieved … and it will ensure that through transparency we have the best opportunity to ensure the greatest patient protection … The measure enjoys substantial support and will be a vital contribution to this long journey with regard to innovation”.—[ Official Report , 23/1/2015; cols 1582-83.]

The Minister for Life Sciences in the Commons took forward the debate from that point, and another place passed a money resolution on 3 November 2015 to provide funds for the creation of this database. The Minister set that firmly in the context of the new field of personalised or precision medicine, in which he said that this country is leading the field. The Minister launched the accelerated access review to look at how we can better integrate and speed up our landscape for the adoption of innovative medicines using informational genomics and informatics so that NICE and NHS England have more freedom to target particular treatments at the right patients. The interim report on the accelerated access review will arrive shortly, and I am sure that my noble friend the Minister will say something about how this Bill fits into the landscape of that wide review.

I am not going to take much time describing the current position in terms of the maintenance of data, but perhaps only to say this. There were attempts throughout the 20th century to maintain registers and records, as that is of course a requirement of those who treat patients. However, owing to the expense of maintenance, then often carried out by hand, the limited information available, which relied on data sheets completed by clinicians in addition to their routine workload, meant that there were always practical difficulties. For example, the most recent figure available for the total number of registers used by the medical professions is from 2002. Back then, the Department of Health commissioned a report into disease registers in support of the White Paper, Saving Lives: Our Healthier Nation. The report found at that stage that there were more than 200 disease registers in existence in England and stated that they would not be surprised if there were more than 400 specific registers. That rendered the situation on data collection at best confusing and at worst made finding evidence and navigating through the data almost impossible.

I believe that my noble friend the Minister will say that the database set out in the Bill will provide clarity to the vast web of registries’ information and data that already exist and help clinicians find evidence for innovative treatments simply and quickly. This is now very important because, as we read every day, research has come on in leaps and bounds, meaning that a huge number of new treatments are coming into the NHS and innovative ideas are everywhere. I know also that my noble friend will want to confirm that patient safety and confidentiality are the Government’s priorities to ensure patient trust and confidence, and I know that this is of particular importance to the noble Baroness, Lady Masham, and indeed to all noble Lords.

There is a growing movement of patients, charities and campaigners who want us to accelerate access to innovative medicines. The Minister has described seeing many demonstrations outside his office in Whitehall which are, as he puts it, demonstrations asking for progress in access to drugs not to be slowed down but to be speeded up. He has also said that he has taken part in more debates on the subject of access to innovative drugs than on any other subject in his brief. I am sure that my noble friend the Minister will respond to the request in another place made by the opposition Front Bench spokesman, Heidi Alexander, the Member for Lewisham East, to take very seriously the design of the database and the process of consultation. I know that my noble friend will want to give an undertaking to engage closely with the medical profession and all who take an interest in the Bill to put the patient’s voice at its centre as the Government put the detailed proposals together. He has a close relationship with the Association of Medical Research Charities. He will want to repeat the offer made by the Minister in the House of Commons for it to come to the top table and help to shape this landscape for the faster adoption of innovative medicines. Indeed, by putting the patient’s voice and experience—in many cases best expressed by the great research charities—at the heart of this, we can move forward in empowering patients and accelerating innovation.

I do not need to add any more about the purpose of the Bill, only to say that I know my noble friend will want to ensure that, through the process of creating this database, we explore mechanisms for ensuring that NICE can look at evidence and develop evidence-based guidance on off-label medicines so that doctors are aware of which drugs are being used in an off-label indication. I hope that my noble friend will also confirm that, after discussions, NICE is now looking at ways to collect evidence on repurposed medicines. It is looking at taking evidence and how it could use, through its existing evidence review process, evidence on repurposed medicines specifically. That would be a helpful reassurance.

I say to your Lordships what you are all well aware of: the world of drug discovery is changing profoundly, as the noble Lord, Lord Giddens, said. The transformational power of genomics and informatics creates a wholly new opportunity to discover new medicines and to target them at individual patients more quickly, and to discover repurposed uses of existing drugs in a way that we have not been able to previously. The 100,000 Genomes Project, which the Government have initiated and funded, has already begun to identify existing drugs that have uses and indications that were not hitherto known. The pace at which new drugs are being developed and discovered is increasing, as one of the leaders of oncology said this week, at what he called a supersonic pace—a great testament to the creativity of the medical profession. In time, with the Government’s extensive consultation in the medical profession, the model that emerges of this database could supplant the expensive and time-consuming manual surveys currently used for cancer mapping.

I end with this. It is striking to me, and I hope to all your Lordships, that it is 50 years since President Nixon declared America’s war on cancer. Seven Presidents later, in his State of the Union address to Congress two weeks ago, the current US President put all US federal agencies at the disposal of the US Administration’s attempt at what he called a “moonshot” in cancer. He declared that information and data sharing would be at its scientific heart. The next day, the US President told schoolchildren in Baton Rouge, Louisiana, that cancer would be cured in not his lifetime but in theirs. He said that America would be the country that cures cancer. I hope that the Bill will help a little to make it British scientists who make Britain achieve the greatest of great moments in medical history and that your Lordships will join the House of Commons in taking this first step. I beg to move.

Photo of Baroness Masham of Ilton Baroness Masham of Ilton Crossbench 1:08 pm, 26th February 2016

My Lords, first, I congratulate the noble Lord, Lord Saatchi, on his indomitable determination to see something on the statute book concerning access to innovative medical treatments. I have been asked by the noble Baroness, Lady Gardner of Parkes, to say that she would have been here today supporting the Bill but has had to attend the funeral of a good friend, which clashes with today’s business.

My interest in this subject goes back some years, when my brother was dying too early. One was willing on his behalf to try to find something to help him survive. An innovative treatment can give hope if everything else has failed.

At the age of six, a young cousin of mine developed neuroblastoma—an aggressive childhood cancer. His parents did everything they could, including taking him for treatment to the Children’s Hospital of Philadelphia. He was the most resilient, brave boy and he went back to school, but the cancer won in the end and Jamie died at the age of eight. His case illustrates the desperate need for new treatments. I feel that the Bill, which has been so well presented to your Lordships by the noble Lord, Lord Saatchi, may help to drive forward more innovative medical treatments.

The noble Lord knows that I am keen to speed up the process of getting new drugs to desperately ill patients when the usual ones do not work. I am keen on innovation as long as it is safe and in the best interest of the patient. Do the noble Lord, Lord Saatchi, and the Minister think that the Bill is safe enough? I do not want patients to have added discomfort when they are desperately ill, but on the other hand where there is life there is hope, and something new might just help.

The other day I read about a woman who had a cancerous tumour between her ribs and had been told by her doctor to go home and live her life until she died—there was nothing that could be done. She did research on the internet and found a place in America which used CyberKnife for this problem. The money was raised, she had the treatment and now, eight years later, she is well and free from cancer.

The Bill is about having a database to collect data about things that work and things that do not work. Information is vital if there is to be progress. I hope that the database will become available worldwide. It is important, for the sake of patients, that information is shared, so that our people can benefit from countries that are doing better than us. It is depressing that our cancer survival rates are not as high as they should be compared to other countries in Europe. Why, for instance, is Sweden so much better than the UK?

Some time ago I met a remarkable man called Les Halpin, already mentioned by the noble Lord, Lord Saatchi. He had motor neurone disease and he had a passion to find a better way of treating MND. There was, and still is, a desperate need for access to drugs which may be able to help. Les died. People like Les cannot wait. MND takes most people very quickly. Les Halpin’s spirit lives on, and on Tuesday “Empower: Data4Health” was launched to collect data with the patient at its heart. Its aim is to get drugs which can help. I hope that “Empower: Data4Health” and the Bill will work together.

I have some questions about Clause 2. Subsection (2) states:

“The Secretary of State may by regulations make provision conferring functions on the Health and Social Care Information Centre (“the HSCIC”) in connection with the establishment, maintenance and operation of a database containing information about … (a) innovative medical treatments carried out by doctors in England, and … (b) the results of such treatments”.

Does this mean that the NHS will pay for the database? Will the NHS run it? It would be very interesting to know how it will work, if that information is available today. It needs to be open and transparent, with the patient at the centre. Who will be able to access the database? Will patients be able to?

It is time for progress to be made, but communication must be efficient and patients must be safe. There are always risks in life, but there must be safeguards against those who put cash before care.

Photo of Lord Ryder of Wensum Lord Ryder of Wensum Conservative 1:14 pm, 26th February 2016

My Lords, I echo the comments of my noble friend Lord Saatchi on the quality of the debate in the other place, which I followed very closely. I speak as a lay man and shall be brief, referring only to innovation. My interest in the Bill stems from several years as chairman of the Institute of Cancer Research.

I supported the principles of my noble friend’s earlier Bill and I support them again without reservation today. This legislation could provide another valuable piece for a large, complex jigsaw puzzle. “Innovation” is the key word in the title of my noble friend’s Bill. Innovations in the form of breakthroughs in our understanding of genetics and targeted molecular oncology are racing far ahead of our cumbersome regulatory systems and evaluations. Innovations such as targeted personalised medicines now enable us to attack some cancers with drones instead of carpet bombs. We should no longer tolerate regulatory authorities that unduly delay such scientific advances. Fresh regulations are required for clinical trials.

How can we ensure that new and proven drugs are made available sooner and more cheaply? Trials can be stratified using genome sequencing. This will expedite smaller, cheaper trials. More drugs can be licensed after well designed phase 2 trials. Phase 3 trials are by a stretch the most expensive for pharmaceutical and biotech companies. Earlier approvals by the regulatory authorities after phase 2 would cut costs and stimulate more innovation. Sometimes pharmaceutical companies are hampered by fears of rejection by regulatory authorities. Here in the UK, NICE should offer even stronger considerations of whether innovative drugs are tackling cancers by truly novel methods.

A year ago, our admirable Life Sciences Minister warned that overregulation by the European Union through the clinical trials directive could herald what he termed a “new Dark Age” for bioscience, yet this 2001 directive has already prevented untold numbers of UK applications for clinical trials. Minor revisions to the directive are promised, but clinical trials will still be overregulated by this directive through complexities, risks and costs. This cumbersome system inhibits United Kingdom innovation and has harmed us as a country far more than other European nations, because we are global leaders in life sciences. As a result of the directive and other cumbersome regulations, we are losing expertise and markets to the Far East.

We boast many of the foremost scientists, clinicians and research institutes and two of the largest pharmaceutical companies in the world. They combine to contribute surplus billions of pounds sterling each year to our balance of payments. Sometimes I wish that our rulers could devote even a tenth as much time to applauding and advancing the interests of these innovators as they do to protecting our financial services sector. I cannot avoid concluding that, if they did so, we would generate a healthier economy and a healthier people.

Finally, I pay tribute to my noble friend Lord Saatchi for his perseverance and courtesy throughout the past three years from the moment that the two of us first discussed the important legislation that he has brought before the House today. My noble friend is an innovator.

Photo of Lord Murphy of Torfaen Lord Murphy of Torfaen Labour 1:19 pm, 26th February 2016

My Lords, I support the Bill and congratulate the noble Lord, Lord Saatchi, on introducing it in your Lordships’ House. I want to refer particularly to those parts of the Bill that relate to the use of off-patent drugs: Clause 1, which refers to promoting access to,

“the off-label use of medicines”, and Clause 3, which refers to a medicinal product being used,

“for a purpose other than one for which its use is specified”.

As the House will know, the clauses relate to the Off-patent Drugs Bill, which was originally introduced in the other place a year or so ago by Jonathan Evans, the then Conservative Member for Cardiff North. Unfortunately for him, the election intervened and the Bill fell. It was then taken up by my successor as Member of Parliament for Torfaen, Nick Thomas-Symonds, in the House of Commons in November 2015. The Bill received the support of members of eight political parties in the other place but unfortunately it was talked out, much to the anger of many Members of Parliament right across the political spectrum. But because of the level of support for the Bill, on 29 January this year, during the debate on today’s Bill, the Government agreed to support the principle of Nick Thomas-Symonds’ original Bill and hence the parts to which I referred earlier.

As your Lordships will know, many drugs that are used for one disease, such as cancer, can be used to treat other diseases, particularly after the original patent runs out, but they lack a licence for the second sort of treatment. They are used very often by specialists and consultants but not so often by other prescribers, and there is a huge geographical inconsistency in their use in the United Kingdom. Indeed, some general practitioners are deeply reluctant to use them because of the liability that might fall upon them and their profession. But I believe that their use is undoubtedly beneficial.

One example is zoledronic acid, which helps women with breast cancer and reduces the risk of cancer spreading to the bone. I am told that this drug could save up to 1,000 lives a year and, like many of these drugs, it is really very cheap. It costs just 5p a day for an individual patient. Other drugs are repurposed to help in the treatment of multiple sclerosis, Parkinson’s disease, leukaemia and prostate cancer.

The use of these drugs, as my honourable friend Nick Thomas-Symonds said when he introduced his Bill, is supported by four of the royal colleges, including the Royal College of Physicians; 12 medical research charities; the British Medical Association; and NHS Clinical Commissioners in England. In addition, 40 eminent clinicians wrote to the Daily Telegraph supporting that Bill and more than 30,000 people in this country wrote in support of it to their own Members of Parliament.

The Minister will presumably come to this point in his wind-up, but I understand that the Government have agreed to put these off-patent drugs for different use on to the database to which the noble Lord, Lord Saatchi, referred earlier. I am also told that the Bible of the medical profession, the British National Formulary, will now have details of those drugs included. That will give much more confidence to prescribers throughout our country to prescribe these drugs, and enable their use to be much more widespread. I hope the Minister can reaffirm today the Government’s support for this vitally important development. It will help to save the lives of many thousands of people in our country and will be of great comfort to their families.

Photo of Lord Patel Lord Patel Crossbench 1:25 pm, 26th February 2016

My Lords, I am delighted to support this Bill and hope that it will have a swift passage through this House and become legislation. I congratulate the noble Lord, Lord Saatchi, on presenting it in great detail and in his usual style, and—given the difficulties his predecessor Bill had—on his tenacity in listening to people in and outside this House and getting to the position whereby the Bill is now acceptable to all the professionals I have spoken to.

Perhaps I may briefly go off the Bill and come on to some comments that have been made. Before I do that, I will declare my interests. I am, as everybody knows, a doctor by background. I am the chancellor of the University of Dundee, which is one of the key UK universities for life sciences. I chaired until recently the UK cancer research centre in Dundee. I now chair, as a board member, another research group in Dundee that is looking at the scientific evidence as to why cancer outcomes can be worse among people from a poorer background, where they are disastrously worse. I was also responsible in this House for chairing a report on genomic medicine. That led, thankfully, to the developments in genomic medicine in the United Kingdom and the research centre which the Government support through the research councils.

It is true that as we learn more and more about genomics and genetics, we will need to have a huge database from which we can learn. What the noble Lord, Lord Ryder, said is correct: there will be patients who would be appropriate for stratifications of medicines that we know now and which are found to be effective because they are used more generically. If we learn from genomic medicine that stratification makes them more suitable for that treatment, because of their genetic make-up, such drugs will be very beneficial.

It is also true that innovations occur in the United States at a faster rate—the noble Lord, Lord Ryder, referred to this—because the processes of the different trial phases there are much more efficient. Some say they are too quick; I do not subscribe to that view. Let me give one example. The noble Lord referred to this concept briefly. Some of the breast cancer treatments do not work in all women. We know that the drug that is given will work but that it cannot be given in the quantities required because most drugs, as we know, are poison. You can use it in a dosage that will treat the disease but if you exceed that dose, you are likely to do more harm than good. But if you can limit that treatment to only the cancer cells, those drugs will be effective. We now have innovations whereby this can be done by identifying the molecular make-up of the cancer and then loading the drug with that molecular marker, so that it will attack only the cancer cells and leave the normal cells alone.

We need a different way of innovating. My own university also has a drug discovery unit. We have contributed to the development of several drugs, two of which would be regarded as blockbuster drugs, through understanding the science of disease processes—the biology of disease. Such understanding is crucial before you develop a treatment.

However, we need to move away from that to other ways of developing drugs. We try to do this by using 70,000 compounds that were previously identified by pharmaceutical companies but not used because they were not found to be effective in treatment. We are seeing if any could be used for the treatment of so-called tropical diseases that are not infectious, which a huge number of people are affected by. We do this in collaboration with other countries by supplying them with these compounds. I agree that we need to look at different ways of innovating drugs and treatments, particularly as the science develops. There will be other ways of dealing with diseases, such as gene-editing, which was how Layla, a young girl in Great Ormond St, was treated. That may also require the development of other drugs to make sure that side-effects are suppressed.

The point I am trying to make is that the Bill may well act as a catalyst. The noble Lord, Lord Saatchi, should be pleased that people are thinking more widely and outside the box. We have an opportunity to develop good databases, as the noble Lord indicated, and to use them for innovative development of treatments. I hope this will happen. I hope that the Government will bring in wider legislation on the issues that the noble Lord, Lord Ryder, referred to, such as better ways of conducting clinical trials. We need transparency and openness. I do not think the medical profession is averse to that, and it is what the public need. We have to be honest: not all the treatments we try will work, but if we try harder, we will find treatments that work which we have been ignoring.

I have to admit to something here, which I hope the GMC does not hear me say—although it might, and if it does, I do not care. I have used off-licensed drugs on several occasions, with the full consent of the patients I was treating, when no other treatment was working. Lots of my colleagues do this. If any doctor stands up and says they never do it, I would not suggest that they might not be telling the truth, but I would be surprised if they were innovators in the true sense.

Then, there is research. I have done research that I am not very happy about and that I wish I had not done, but at the time I did it with a clear conscience. In retrospect, I now know that it probably did not work as well as expected and was probably not all that good for the patient—I hope it did not do any harm—but if I had not tried it, I would never have known. It is important that we stop arguing at length and trying to regulate and control in the minutest detail innovations in medicine that we can drive forward. We do this more easily with innovations in surgical and other procedures. We are much freer about that and clearly understand that, as doctors, you work with people in other countries to introduce the same procedures and use a common database to learn.

Photo of Lord Hunt of Kings Heath Lord Hunt of Kings Heath Shadow Spokesperson (Health), Shadow Deputy Leader of the House of Lords

Would many current surgical procedures have been authorised if they had had to go through the kind of clinical trial process that medicines do?

Photo of Lord Patel Lord Patel Crossbench

We would not have had stents put in hearts, bypasses, ablations—

Photo of Lord Patel Lord Patel Crossbench

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.

Photo of Lord Blencathra Lord Blencathra Conservative 1:35 pm, 26th February 2016

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 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 they like. 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 want 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.

Photo of Lord Freyberg Lord Freyberg Crossbench 1:48 pm, 26th February 2016

My Lords, I, too, am delighted to support the Bill. I speak today, as many noble Lords do, as one touched by the tragedy of cancer. As some noble Lords may know, my sister died two years of mesothelioma. Recent data from the Office for National Statistics show that 43% of cancers are less common cancers such as mesothelioma. While each is small, collectively they account for well over half of cancer deaths. There is insufficient commercial incentive globally for the current innovation processes to bring new hope to sufferers of these terrible diseases. We can see this in the rate of improvement in annual mortality ratios, which are the number of deaths linked to a cancer divided by the number of incident cancers. In the top five cancers, mortality ratios have improved 12% since 1999, from 49% to 37%. In the less common cancers the improvement was only 4%, and today’s mortality ratio is a shocking 56%, 19% worse than the 37% found in common cancers. That is three times less innovation in less common cancer.

So where have the modern precision drugs been launched? They have been launched for common cancer, of course. What is that? It is economics. At $75,000 per patient, cancer clinical trials are immensely expensive. It can cost billions to bring a drug to market. Where are rational economic agents going to place their research bets? They will do so in the big markets of common cancer, not the small, such as mesothelioma.

What is so unfortunate is that less common cancer has the same underlying genetic causes as common cancer. Modern precision drugs developed for common cancer often, but not always, work in these rarer diseases, but the costs of trials and the challenge of finding patients in rare disease mean that little development happens. That does not matter much in the US, the largest market in the world. There, a physician can prescribe off-label. There is no rationing watchdog like NICE breathing down his or her neck. US insurers will generally pay for the drug, with very limited data, such as a small case series in that cancer. As a result, the largest market in the world has extensive off-label use and does not require costly trials in rarer cancers. By implication, most of the economic incentive for formal label expansion vanishes. Pharma can get revenue without much R&D cost. Sadly, the research potential of this off-label use is not captured in the US, as its balkanised healthcare system does not capture the outcome data needed to close the loop and to discover what works for whom.

It is in this global context that we must evaluate this Bill. In particular, concerns about the Bill overriding UK due regulatory process ignore these economic realities. This is not the 19th century; there is no sea of pink on the maps. The regulatory and reimbursement process that matters globally for the pharma industry is the US, not the UK. We are a paltry 3% of the global market; it is 40%. Also, the US has a system that allows promiscuous off-label use. We must deal with the consequences of those global incentives and not be distracted by due process, as the noble Lord, Lord Ryder, stated.

Let us explore this global context further. As the noble Lord, Lord Saatchi, mentioned, US Vice-President Joe Biden is leading Obama’s $1 billion moonshot on cancer, after his son died of a rare brain cancer. A key part of that initiative looks set to be a database similar to that proposed by this Bill, implemented in willing but small US integrated care systems such as the Veterans Association. These databases have a name: stratified outcome registries. They are large-scale, real-world clinical databases, but upgraded for the 21st century with molecular diagnostic information, treatment outcomes and electronic consents. They capture not only what works for whom but, as importantly, what does not work. They close the learning loop.

I have consulted the supporters of the Bill and will be looking to see that it is appropriately amended—or not, depending on how we come to it in the time limit—to this effect in Committee. That is in line with the recent input from the Association of the British Pharmaceutical Industry on the importance of capturing both the good and the bad in such a database.

I also commend to the House the work that is being done by a small and innovative US not-for-profit, Cancer Commons, in helping to design such registries. In the US, it pioneers the application of these registries for optimising the use of existing drugs in common cancer and extending their use into less common cancer. It points out that such databases have a number of other benefits. They can discover which patients will not respond to costly treatment, saving those patients side-effects for no gain and saving the system money.

As an example, my sister had a molecular test that showed that cisplatin would not work for her cancer and would be more toxic for her than for most. As it is the NHS’s standard cancer treatment for the disease, she was given it. The toxicity occurred as predicted. She suffered horrendously and became ineligible for trial. The NHS faced significant costs in managing those unnecessary side-effects and complications. My sister might have lived a few months longer but for the side-effects.

Another benefit is that these databases have enough molecular information for scientists to hypothesise why a drug worked or did not work and so pump-prime basic research. Where we cannot explain the response, we can feed those exceptional patients to Genomics England, which will make that superb basic research engine more efficient. Finally, over time, the database would generate the information to derisk formal trials in less common disease. That will make such trials more economically attractive to industry and so change drug availability globally.

What may not be known to the House is that the UK is well placed to lead globally on developing these databases. In particular, we have a secret weapon in the National Cancer Intelligence Network registry in England. This covers 280,000 new cancer patients a year and today captures classical presentation, treatment and outcome data and small amounts of molecular data. The best US outcomes registry today covers fewer than 30,000 patients a year.

That volume of patients with clinical data gives us huge power globally. It is the largest in the world by a factor of 10, housed in the country that led the human genome initiative and with an enviable clinical research tradition. We should aim to use it to recraft the NHS to be the workshop for the world in precision oncology. This would win back a significant share of pharma’s global R&D spend, create a huge number of high-value precision medicine research jobs, and have a positive impact on investment flows into the UK. In particular, if we deployed low-cost generic panel-based cancer molecular diagnostics proactively into the NHS and ahead of approved drugs, pharma would supply late-stage research drugs in less common cancer. It would do this because the clinical data generated would both encourage off-label use in the US and give it future expansion options.

The evidence for this can be seen in France, where the Institut National du Cancer has been driving a national molecular pathology programme for over a decade. It is the preferred European partner for large pharma like Pfizer for late-stage clinical trials in precision oncology. That investment also created equality of access to modern molecular diagnostic technologies and prevented a testing postcode lottery. Today in the UK, we have an appalling postcode lottery in molecular testing, as recently highlighted by the Independent Cancer Taskforce and the NHS Atlas of Variation in Healthcare. We need the political will to change how we fund molecular diagnostics in the NHS to alter this. France drove the adoption of such tests by top-slicing the hospital care activity budgets to create a dedicated pool of money for a national testing programme and taking on entrenched vested interests to drive reform. We need to be similarly brave and creative if we are to achieve this here but it will save money and lives.

If we upgraded NCIN to being a stratified registry through the investment in a national molecular pathology service, I am confident that quickly some, but not all, UK patients would also live longer as a result of the increased access to innovative drugs. Over time we will also close some, but not all, of the yawning gap in mortality burden in the less common cancers, and we would have an intelligence system that could manage the risks of real-world innovation.

If such a system had existed when my sister had been ill, it might have helped her. Half of us will get cancer—it might well help you. In short, we can do well as a nation by doing good for the world. We can make the UK the preferred destination for the US drug companies for their clinical development, but only if we reshape the NHS to be a cradle for the sorts of innovation supported by the Bill, not a barrier. Let us use the global drug development system and its perverse incentives to our national advantage. Let us support the Bill and its database of innovation and work together on the many important details that may need ironing out in Committee.

Photo of Lord Hunt of Kings Heath Lord Hunt of Kings Heath Shadow Spokesperson (Health), Shadow Deputy Leader of the House of Lords 1:59 pm, 26th February 2016

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.

Photo of Lord Blencathra Lord Blencathra Conservative

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.

Photo of Lord Hunt of Kings Heath Lord Hunt of Kings Heath Shadow Spokesperson (Health), Shadow Deputy Leader of the House of Lords

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.

Photo of Lord Prior of Brampton Lord Prior of Brampton The Parliamentary Under-Secretary of State, Department of Health 2:07 pm, 26th February 2016

My Lords, it has been a fascinating debate. I was not here when we have had debates about this Bill or the Bill that preceded it, so I am not as familiar with the arguments as many noble Lords are. However, it has been a very insightful and high-quality debate.

I first thank my noble friend Lord Saatchi. This is his Bill really. Before I was in this place, I remember listening on the radio in a casual way to the arguments being batted around, and, without knowing the details of his earlier Bill, the need for a quantum change in the rate of innovation and adoption of new medicines and products in this country resonated with me.

I have just come back from a trip to the USA, and one always comes back feeling that there is such a sense of dynamism, speed and pace in America that we simply do not have in this country or in Europe, or anywhere else in the world. Partly, of course, that is because they have much more money in the US, but it is a state of mind. Even in a highly litigious society such as America, there is an entrepreneurial, innovative drive and that is something we need. We have so much research capability in this country and yet we seem to be so slow at bringing products to the market for the benefit of patients. The speech by my noble friend Lord Ryder absolutely nailed this issue once and for all.

I also thank Chris Heaton-Harris, who is still here—he has stood here throughout this whole debate. The work that he and my colleague in the Department of Health, George Freeman, have done to win cross-party consensus for this Bill has been hugely impressive. I also pay tribute to the noble Lord, Lord Hunt, who brought an amendment for a registry in the previous Bill. That has been changed in the new Bill but, nevertheless, has been very important in bringing the Bill to us today.

Before I come to my main speech, I will pick up a few of the particular questions asked by noble Lords. The noble Baroness, Lady Masham, raised the critical point in many ways, which is this balance between innovation and patient safety. That went to the heart of the debate on the original Bill. She raised a particular question about the guardianship of the database. The database will be established with a quality-control mechanism to ensure its oversight. HSCIC is very experienced in databases of this kind and it will have responsibility for that guardianship. It will establish an independent committee to overview the database to make sure that it will not breach patient confidentiality and the like. That is obviously critically important.

The noble Baroness also raised the issue of who could have access to the database. This may disappoint some noble Lords, but access to the database, certainly to start with, will be for doctors rather than members of the public. Again, that is largely based around the need for proper information governance and patient confidentiality. There is a risk, particularly with rare diseases, which the noble Lord, Lord Freyberg, raised, that individuals can be identified if one is not careful.

The noble Lord, Lord Murphy, and others raised the issue of off-label drugs. I can assure noble Lords that the database can include medicines being used off label as well as the use of unlicensed or off-patent medicines.

The noble Lord, Lord Patel, asked what was the definition of medical innovation—or “innovative medical treatment”, which is the right expression. The short answer to that is that, under the Bill, an “innovative medical treatment” is defined as,

“medical treatment for a condition that involves a departure from the existing range of accepted medical treatments for the condition”.

There is clearly a much longer, more technical answer to his question, but I hope that that will satisfy him today.

My noble friend Lord Blencathra raised a number of important issues. It will cost money to establish this database. The estimate is between £5 million and £15 million. That money will be found by HSCIC and ultimately through the Department of Health. Both my noble friend and the noble Baroness, Lady Masham, thought that it would be wonderful if this database could extend to the USA and worldwide. They are absolutely right—in time, but not immediately.

The noble Lord also raised an important issue about whether, if doctors put their results on to a database and they had failed, it would open them up to legal challenge. The establishment of the database will not change whether or not a doctor would face a successful negligence claim. If a doctor acts responsibly, they will not face a successful claim even if the outcome for that patient is negative. I hope that I will pick up other issues that were raised by noble Lords in what I had pre-prepared to say.

The Bill we have considered today is not the same as my noble friend Lord Saatchi’s original Medical Innovation Bill, but it shares the same desired outcome—to create a culture that promotes greater use of innovative medicines and gives us the best chance of improving outcomes for patients. In response to a point that my noble friend made in his introduction, it is very much going in the same direction as the accelerated access review, which is being conducted by Sir Hugh Taylor. We will see that later in the year. That will, of course, address some of the issues raised by my noble friend Lord Ryder.

The Bill before us today seeks to give doctors access to a database as a source of learning where they can both share their innovations and search for those that other doctors have used. The purpose of the database is to promote access to innovative treatments for patients by giving doctors access to information that they may not otherwise be aware of. Doctors will be able to search the database for innovations, see who else is using new techniques, and which ones are effective for patients. The database could ultimately result in better care and health outcomes for patients, and potentially in the fast uptake of new treatments which are shown to work.

I do not think any of us should be under the illusion that this is going to solve the problem; rather, this is us setting out our stall and saying how important the issue is. It will facilitate things, and it is a stake in the sand to show that we, the Government, and the country take this matter seriously. It is also important to state for the avoidance of doubt that the Bill does not contain any provisions relating to the law of clinical negligence. Those provisions have been removed and are not part of this Bill. The Access to Medical Treatments (Innovation) Bill is concerned solely with conferring a power on the Secretary of State to make regulations requiring the HSCIC to set up and manage a database of innovative treatments.

There are two matters that I would like to address in a little more detail, given the degree of discussion there has been around them. The first is how the database will operate and the consultation that will surround it. The detailed design of the database will be worked out by the HSCIC as the expert organisation in this field working in conjunction with professional and patient bodies, a point raised by the noble Baroness, Lady Masham, and others, and other interested stakeholders. On Report in the other place, the Minister for Life Sciences gave an assurance that should the Bill receive Royal Assent before the establishment of such a database, there will be a period of consultation to inform its detailed design. I would like to clarify that this would not take the form of a government consultation, but rather, engagement to be worked out jointly between the HSCIC, the relevant statutory bodies and stakeholders from the medical community representing those who will be using the database.

The second matter is compulsory recording in the database. I am aware that during the passage of my noble friend Lord Saatchi’s original Bill, the issue of mandatory recording and the data registry was the subject of lengthy debate. I know that the noble Lord, Lord Hunt, tabled an amendment seeking to ensure that doctors would be required to record all outcomes, positive and negative, in the registry. I also understand that the Government opposed the amendment on the basis that including a mandatory registry would change the test of negligence under the Bill. As has been covered extensively, the Bill we are discussing today differs significantly from the Medical Innovation Bill. On the issue of recording, it is important to highlight that the principal difference between the data registry and the database of innovative treatments is that the database will both capture and disclose information, while the data registry is concerned with the registration of a patient linked to a disease, or a specific cohort. Crucially, it is intended that information relating to innovative medical treatments and the outcomes of those treatments carried out by doctors in England will be passed to the HSCIC through the use of coding in patient notes.

While there is nothing in the Bill to compel doctors to record their innovations on the database, it is intended that policy guidance on implementation will be issued to providers of NHS-funded services requiring them to ensure that their staff record information on the database. The Government have subsequently liaised with NHS England as to whether this could be made a contractual requirement. NHS England has confirmed that once such guidance has been issued, it could consult on introducing a new condition in a future version of the NHS standard contract with the intention of making compliance with the guidance a contractual duty for provider organisations. Providers of NHS services need to demonstrate to their commissioners that they are complying with their obligations under the standard contract, so they would need to be able to show that they are implementing any condition that required doctors to record in the proposed database.

I hope that what I have outlined will satisfy noble Lords on the issues associated with mandatory recording.

Photo of Baroness Masham of Ilton Baroness Masham of Ilton Crossbench

My Lords, before the noble Lord finishes, will he agree that the excuse of confidentiality can be a stifling block to innovation? Les Halpin was an example of openness. Surely patients and doctors should be sharing and working together. Therefore, they should have the information.

Photo of Lord Prior of Brampton Lord Prior of Brampton The Parliamentary Under-Secretary of State, Department of Health

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.

Photo of Lord Blencathra Lord Blencathra Conservative

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?

Photo of Lord Prior of Brampton Lord Prior of Brampton The Parliamentary Under-Secretary of State, Department of Health

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.

Photo of Lord Saatchi Lord Saatchi Conservative 2:22 pm, 26th February 2016

My Lords, I thank all noble Lords who have spoken in this debate and earlier debates. As last time, I hope that all noble Lords who have been involved in this Bill and the predecessor Bill take pride in the ability of your Lordships’ House and, as it perhaps surprisingly turned out in the House of Commons, of both Houses of Parliament to avoid tribal party warfare and work together, at least in this area of health. That is a remarkable achievement of which both Houses of Parliament and all of us can feel very proud.

I shall try to reflect the tone of what my noble friend the Minister said. This is a modest step, authorising the Secretary of State to instruct one of the key bodies in the NHS to start to work with medical professionals—the royal colleges, the charities, the patient groups—in assembling this database, which everyone wants. I hope that your Lordships’ House will allow me to ask it to give the Bill a Second Reading.

Bill read a second time and committed to a Committee of the Whole House.

House adjourned at 2.24 pm.