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”.—[Official Report, 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”.—[Official Report, 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”.—[Official Report, 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”.—[Official Report, 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”.—[Official Report, 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.
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