Access to Medical Treatments (Innovation) Bill
(Limited Text - Ministerial Extracts only)
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The Parliamentary Under-Secretary of State, Department of Health (Lord Prior of Brampton) (Con)
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.
Baroness Masham of Ilton
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.
Lord Prior of Brampton
My Lords, all my experience over the last 15 years is that openness and transparency are critical to get improvement and innovation into the NHS, but we have to accept that patient confidentiality is also extremely important. If we in any way compromise or give people reason to think that patient confidentiality will be in any way intruded on, we may unwittingly undermine everything else that we are trying to do. We have seen that in other areas in the health service in the last year or so. We have to be very careful in this area, but I understand the importance of the noble Baroness’s point.
The Bill does not seek to add an extra burden on doctors, as the GMC’s guidance already sets out requirements on doctors to record their work clearly in clinical records. Doctors are required to have regard to such guidance as part of maintaining their licence. However, through the use of NHS contract guidance, doctors will be required by their providers to have regard to the requirement to record their innovations and, crucially, all associated outcomes.
Lord Blencathra
I appreciate that no Minister at the Dispatch Box would dare make any commitment about more time for a Bill or rescheduling, which is the complete province of the Chief Whips and Leaders on both sides, but will my noble friend the Minister make some representations to the usual channels that we seem to be in complete agreement here and that we need to find, within the rules of the House and without creating precedents, some means of making sure that we get the Bill through before the shutters of the House of Commons come down at 2.30 pm on Friday 11 March?
Lord Prior of Brampton
I was going to come to that point right at the end. The noble Lord, Lord Hunt, raised it as well. I give complete assurance that the Government will do everything they can to work with the noble Lord opposite and others to ensure that the Bill goes through. It clearly commands the full support of the House. It is a hugely important Bill, which the Government fully support, both in the other place and here. I certainly give that undertaking.