Access to Medical Cannabis

Chris Heaton-Harris Excerpts

Monday 8th April 2019 Commons Chamber

[Matt Hancock]

We have ensured that all the patients who received access to medicinal cannabis on an exceptional basis before the law changed on 1 November can continue to access it. If that is not the case in any instance, I want to know about that so that we can fix it. Alfie Dingley would be eligible for these drugs if a clinician were prepared to sign off the benefits for Alfie, and such decisions must be led by clinicians. I am doing everything I can to get the evidence and second opinions in place and to ensure that the process works as well as possible. That is what I can do. What I cannot do—it would be unreasonable for any Health Secretary to do so—is overrule clinical decision making in individual cases. That would be wrong, and I do not think that any Member of this House would propose that I should do it.

[Chris Heaton-Harris (Daventry) (Con)]

A number of us have been written to by constituents about such cases, and I have corresponded with the Secretary of State about Julie and Stuart Young, the parents of Lloyd, for example. Clinical trials have been mentioned across the House, but a piece of legislation is already in place. The Access to Medical Treatments (Innovation) Act 2016, which was sponsored by me in the Commons and by Lord Saatchi in the other place, seems ideally suited to help us through this sticky situation.

[Matt Hancock]

Yes, we are looking carefully at how we can use that legislation as effectively as possible. Understanding the medical consequences of any use of a drug is incredibly helpful evidence for where it should be prescribed further, and that is the thrust of the 2016 Act.

Southern Health NHS Foundation Trust

Chris Heaton-Harris Excerpts

Tuesday 3rd May 2016 Commons Chamber

[Alistair Burt]

I hope my hon. Friend will forgive me, but I will not say things from the Dispatch Box that I do not know, and I do not know the precise powers of the improvement director, although I know the CQC has exactly the powers my hon. Friend suggests. However, the purpose of appointing the improvement director, and indeed of NHS Improvement’s appointment of the new chair, Tim Smart—the former chief executive of King’s College Hospital NHS Foundation Trust—is to put in place people who know what they are doing, know what they are looking for and can authorise others to make sure that nothing is being covered up and that everything is transparent.

[Chris Heaton-Harris (Daventry) (Con)]

In this sorry saga, what assurances can the Minister give about current levels of care and safety to the families of patients with learning disabilities who are in the care of Southern Health?

[Alistair Burt]

I think the best thing, genuinely, is to refer to the CQC report. It highlights good practice and good work in relation to staff in a variety of places and community pathways and in relation to work being done for those with learning disabilities. This is a large trust, covering many areas and many different facilities, and it would be quite wrong to assume that the standard of care is uniform across the board in terms of the criticisms that have been made. The criticisms are very real and very strong, but the work done by individual members of staff caring for people is reported by the CQC to be good. Again, in terms of safety, I am reassured that the CQC has powers and that it has assured me that, if it needed to use those powers in relation to safety and risk to patients, it would do so.

Access To Medical Treatments (Innovation) Bill

Chris Heaton-Harris Excerpts

Friday 29th January 2016 Commons Chamber

I do not say for a moment that I have converted other hon. Members to socialism over the winter, but I certainly think that we have all spoken the language of priorities in saying what we really think is important in taking these issues forward. My mother always told me that compassion was everything. These measures certainly do represent compassion, but compassion combined with a common-sense approach to a problem the solving of which has multi-party support. I very much look forward to hearing what the Minister has to say in due course.

[Chris Heaton-Harris (Daventry) (Con)]

Members may be aware that unlike the initial stages of my Bill, the journey of the Off-patent Drugs Bill promoted by the hon. Member for Torfaen (Nick Thomas-Symonds)—which is, coincidentally, further down on the Order Paper today—enjoyed widespread support from Members of this House, and outside this place among a whole host of charities and non-governmental organisations. My old colleague Jonathan Evans, a former Member of the European Parliament and the former Member for Cardiff North, introduced a similar Bill on these matters, which also gained widespread support. I have watched the progress of these Bills closely and read the briefings provided on them by several charities, and I could not help but notice the obvious links with my Bill and the importance of the subject it covers—increasing the use of effective off-label drugs.

The amendments that we are considering seek to work with the ideas of the Off-patent Drugs Bill and meet the same goal of spreading the use of off-label drugs. I am very grateful to the hon. Member for Torfaen for working with me, and others, so closely to include some of his very good ideas and thoughts in my Bill. He deserves a huge amount of credit for the work he has put into this, alongside the hon. Member for Central Ayrshire (Dr Whitford) and my hon. Friend the Member for Bury St Edmunds (Jo Churchill), who have been unbelievably strong champions of these issues.

The new clauses and amendments I am supporting do not reflect exactly the original Bill introduced by the hon. Member for Torfaen. That Bill sought to require the Secretary of State to seek licences for off-patent drugs in their new purposes. As the Government stated at the time, as the licensing authority in the UK, the Secretary of State cannot take up such a duty. However, that does not mean that a similar end result of increasing the use of such drugs cannot be achieved by other means. I very much hope that we can do so through this Bill.

Breakthroughs in research mean that several existing drugs have been found to be highly effective in treating conditions other than the ones for which they were originally produced. They potentially have huge life-saving effects and can alleviate the suffering of many people for many conditions. There are so many well-known examples. They were widely discussed on Second Reading of the Off-patent Drugs Bill, so I will not repeat all of them. The list includes the likes of tamoxifen and zoledronic acid, and of course the simple drug aspirin, which has so many other benefits in so many areas. The examples mentioned when we debated the hon. Gentleman’s Bill speak for themselves in showing us why his new clauses and amendments are so important.

As the hon. Gentleman has said in support of his Bill, doctors are nervous of prescribing off-label drugs. Even if a GP strongly believed in prescribing an off-label drug to a patient, they could well be put off. There are several reasons for that, and they were detailed in briefings circulated at the time. One is the matter of personal liability, which I will talk about in relation to other amendments. General Medical Council guidance shows that clinicians can currently prescribe off-label drugs, but that there are significant disincentives to do so. It states that a licensed treatment should be considered before an off-label or unlicensed treatment. It also indicates a greater level of responsibility for the doctor prescribing off-label, and therefore a potentially greater risk of liability, which would be a disincentive for a doctor in prescribing an off-label drug. Before a clinician has even started down this track, they are wary of picking an off-label medicine.

There is little incentive for a pharmaceutical company to pay for a licence when a drug can be manufactured generically. There is no incentive for any company to market the drug for a new indication, and there is no proper guidance for the use of such a drug. Without any stamp of approval, any marketing or any mechanism to provide guidance, there is nothing to encourage clinicians to use an off-label drug, other than their own medical knowledge.

Drugs without a licence for their second use are not marketed, so there is a lack of awareness, and the prescribing of them therefore varies when a new indication arises. There is no trusted and simple way to spread information about off-label drugs that are working. That means that some doctors may use the drug if they know of the indication, but lots may not. Without a system for sharing such information and spreading knowledge about these drugs, medical professionals deciding whether or not to prescribe them have to spend a huge amount of time reading the literature and undertaking research. The explicit mention, through the new clauses and amendments, of the inclusion of such drugs in the database will ensure that information about them is shared and reviewed, and that appropriate evidence is provided. By spreading awareness, the new clauses and amendments will therefore help to make prescribing more consistent.

On Second Reading of the Off-patent Drugs Bill, the hon. Member for Central Ayrshire said that experts in certain fields will prescribe many off-patent drugs whenever they feel it is necessary. For example, off-label prescribing is quite common in the treatment of secondary cancers. Experts in that area will have experience and will be aware of the evidence for use, but many other medical professionals will not be in such a position. If a drug is not in the “British National Formulary”, the dose cannot be checked.

When a clinician uses a drug every day or a specialist in a field sees conditions regularly, they know what works and what is best, and will therefore feel very comfortable in prescribing off-label. However, every medical professional is not an expert in every field. For the majority of the time, patients are not with such specialists. Their first point of call is not a clinical physician working in only one field, but a GP in their local practice or a nurse in their local surgery. I believe that the database has huge potential in helping to spread the knowledge and expertise required for better and further use of such drugs.

I hope that the amendments I have tabled will be agreed by the House—I believe they represent common sense—and that the Minister will listen to Members who have tabled the other amendments and new clauses. Although some of them are probing amendments, a huge amount of effort has gone into all of them. He is aware of the time and cross-party work that has gone into getting the Bill to this point. That has basically been driven by the hon. Members for Torfaen and for Central Ayrshire, my hon. Friend the Member for Bury St Edmunds and, to a certain extent, me. I would like to think that we will have got to a certain place by the end of today’s sitting, and that we can all leave the Chamber feeling that we have done some good.

[Jo Churchill (Bury St Edmunds) (Con)]

I congratulate my hon. Friend the Member for Daventry (Chris Heaton-Harris) on his success in bringing the Bill so far. The fact that we have reached even this stage is no small testament to his hard work on the Bill, particularly the discussions about the removal of the areas of concern—clauses 3 and 4—and the fact that he has been gracious enough to allow me and the hon. Members for Torfaen (Nick Thomas-Symonds) and for Central Ayrshire (Dr Whitford) to badger or cajole him into allowing us to table new clauses 1 to 6, but specifically my new clauses 4 and 6.

The Minister was not in the Chamber on 6 November to hear the arguments of the Members who proposed and supported the Off-patent Drugs Bill. Since then, however, he has engaged with many of us, for which I thank him. We felt that his Department’s response simply was not correct. Doctors may have been able to prescribe medicines for uses outside their licence or off-label where that was in the best interest of their patients, as the guidance says, but they just did not do so, or at least not consistently throughout the medical profession or the field and irrespective of the patient’s postcode. The prescribing of such drugs is more common in oncology, paediatrics, pain management and palliative care, which adds to the lottery effect for the patient.

The need for an action plan for an off-patent drug pathway is undeniable. When there is a strong indication of effectiveness, their routine use for an alternative indication should be secured. For example, the use of bisphosphonates, which were originally developed to treat osteoporosis, are now commonly used by 36,000 women living with secondary breast cancer in this country. Those drugs have already been through phased trials. No one in this place is suggesting that the highest levels of safety should not be applied to drug research and licensing at all times, but efficacy should drive clinicians’ decision making.

Patients, too, have a voice on this issue. I found my patient’s voice after my second primary cancer, and I wanted to use it for the benefit of others. Here I am now asking the Minister—not for the first time—to use his position to find a way to unleash the potential of research in this country and to unblock the system for everyone. My oncologist told me that a second primary cancer was luck—bad luck, but just luck—and I hope that we can all improve the odds just a little bit today.

I believe in the power of patients, clinicians, charities and pharmaceuticals to do the right thing—to increase their knowledge for those whose daily lives are dominated by serious disease and debilitating illnesses, and to ensure that treatments exist to help them. Particularly in the area of off-patent repurposed drugs, they need to be supported by key players, such as NICE, the MHRA, NHS England and medical research charities.

I assure the Minister that it is not mere chance the new clauses and amendments are supported by Members from all four corners of our nation. It is to show solidarity with our constituents—north to south, east to west—who want a co-ordinated approach. One of the most frustrating things for patients is the clogged nature of our drugs pathway. It seems to be beyond us to get drugs licensed, whether repurposed or not, and to the patient in a timely way. I ask the Minister to provide a timeline to support any action that can be taken.

New clauses 2 and 3 would require the National Institute for Health Research to develop and introduce a mechanism for gathering and recording evidence. Last week, I was surprised to learn from Professor Bruce, a clinician at the NIHR working in the musculoskeletal biomedical research unit, that in 50 years only one drug has been licensed for the treatment of lupus. Sadly, that licensed drug has spent four years being considered by NICE and is not available for wider use. To avoid the heavy use of steroids for the condition, rituximab is often used—a drug that was originally developed for lymphoma and rheumatoid arthritis.

--- Later in debate ---

[Mr Deputy Speaker (Mr Lindsay Hoyle)]

We now come to amendment 1—

[Chris Heaton-Harris]

On a point of order, Mr Deputy Speaker. I am unsure of the process. What happened to amendment 13?

[Mr Deputy Speaker]

It comes later. It is about three pages further on in the dossier. It has not been lost, and we will be coming to it, so the hon. Gentleman can rest assured. It is there.

[Chris Heaton-Harris]

I beg to move amendment 1, page 1, leave out lines 7 to 9.

[Mr Deputy Speaker]

With this it will be convenient to discuss the following:

Amendment 11, page 1, line 18, in clause 2, leave out from beginning to “involves” in line 19 and insert

“In this section, “innovative medical treatment” means medical treatment for a condition that”.

Amendment 2, page 2, line 26, leave out clause 3

Amendment 3, page 3, line 19, leave out clause 4

Amendment 4, page 3, line 40, in clause 5, leave out “this Act” and insert “section 2”

Amendment 12, page 3, line 42, in clause 5, leave out paragraph (b)

Amendment 5, page 4, line 1, in clause 5, leave out “this Act” and insert “section 2”

Amendment 6, page 4, line 3, in clause 5, leave out “this Act” and insert “section 2”

Amendment 14, page 4, line 8, in clause 6, leave out “Sections 1 to 5” and insert “Sections 1, 2 and 5”

[Chris Heaton-Harris]

I just thought I would check about amendment 13, Mr Deputy Speaker. This whole experience has been a steep learning curve when it comes to procedure in the House. Perhaps we have invented a few things on the side as well, given how we have gone about our business here. I do not want to speak too soon, but if we could conduct all our health debates in the positive and constructive tone that has characterised these debates and the process behind the Bill, we might improve our heath service in leaps and bounds, rather than getting caught up in unnecessary politics. But that is where we are.

My amendments 1, 2 and 3 would remove, among other provisions, two clauses on clinical negligence. I want to talk about the reasons for their removal and the original idea behind the clauses. As right. hon. and hon. Members who have been following the progress of my Bill will know, many of the ideas in it came from Lord Saatchi’s Medical Innovation Bill in another place. Those ideas have not had the smoothest of journeys in this place. I have been regularly reminded by hon. Members—I thank those here today—and others outside this place that these clauses have not enjoyed the support of stakeholders.

Such concerns have been around since before the Bill was even drafted. Unfortunately, the echoes of those concerns haunted the first mention of the word “innovation” in the clause, and I decided from conversations I have had that those concerns could not be quelled in time. Throughout the process, I was clear that I wanted to listen to everybody with something to say on this matter. I have met and read the briefings of everyone who has contacted me wishing to share their views, and I hope it has been evident that I have been up front, honest and very clear about my intentions. I tried to solve the concerns of Members and the medical community who believed the clause would have negative and unintended consequences. That is why I tabled these amendments.

I hope that this process reflects favourably on Parliament and shows how a piece of possible legislation can evolve with a huge amount of stakeholder engagement and with parliamentary opinion taken on board. Since the beginning, I have focused on the sharing of good practice and transparency—and, indeed, on the failures of treatments through a database. Those ideas are reflected in clause 2 and have received much support.

I wanted to maintain the camaraderie built up around the Bill and have been unable to find the support I needed for the more controversial clauses, 3 and 4. Clause 3 sets out the steps that a doctor would need to take to show that he or she had acted responsibly using the Bill. They were intended to reflect the steps that a responsible doctor could be expected to take under common law when innovating. In relation to a proposed treatment, clause 3 would require the innovating doctor to

“obtain the views of…appropriately qualified doctors”

with

“appropriate expertise and experience in dealing with patients with the condition in question.”

Clause 4 expressly preserves the common-law Bolam test, the key precedent for judging whether a doctor has acted negligently.

The two clauses received strong opposition, which I will not go into too much. However, I worked closely with many officials from the Department of Health, and I want to thank them, because I had read the briefings that were so adamant in saying how dangerous parts of the Bill would be, so it was nice to have some of the best and brightest legal and parliamentary counsel remind me again and again that they viewed them as perfectly safe and did not see them as a danger to patients.

[Dr Philippa Whitford]

Does the hon. Gentleman understand the danger of undermining our clinical trials systems, in that, using the Bill, a doctor would have to convince only one colleague before they could go ahead and try something completely new? The recent tragedy of the patient who died while taking part in a phase 1 trial shows the need for steps and procedures to reduce the risk.

[Chris Heaton-Harris]

The hon. Lady knows that I would obviously have preferred to retain clauses 3 and 4, but I have to agree with her: the body of opinion stands on her side of the argument, not mine, so the simple answer is yes.

I remind the House, though, that there was a decent and honourable purpose behind clauses 3 and 4. Dr John Hickey, the former head of a primary care trust, contacted me to say that,

“as a registered medical practitioner, a former NHS Trust Chairman and with 30 years’ experience in the field of legal medicine with the Medical Protection Society (last five years as Chief Executive), I believe I am adequately qualified to comment on your Bill.”

He went on to say:

“Over the last 30 years I have seen how doctors have increasingly practised defensive medicine…because of the fear of litigation and disciplinary action by their regulators; this defensiveness is not in patients’ best interests.”

In fact, it may interest Members to hear that, in reading the debates on the Bill introduced by the hon. Member for Torfaen (Nick Thomas-Symonds) and the recent debate on the Mesothelioma (Amendment) Bill, I have seen much stated that supports the action I wanted to take in clauses 3 and 4 to reassure doctors who fear litigation. For example, the British Medical Association’s parliamentary brief for the Second Reading of the Off-patent Drugs Bill stated that there were

“two barriers to the use of off-patent drugs in a new indication: 1) Clinicians’ confidence in prescribing: clinicians take on a personal and professional liability if they prescribe an off-patent drug in a new indication”,

and therefore they require reassurance. The brief goes on:

“GMC guidance also indicated a greater level of responsibility for the doctor prescribing off-label and therefore potential greater risk of liability which would be a disincentive for a doctor prescribing off-label drugs”.

That is a simple statement of the purpose of clauses 3 and 4: to give doctors a supplementary way to assure themselves that they are doing the right thing where they might want to do something they believe to be in their patients’ best interests, in a fully evidenced, responsible and honest way.

Similarly, the Multiple Sclerosis Society’s brief on the same subject states:

“Guidance from the General Medical Council is clear that a doctor takes on an extra level of personal liability when prescribing off-label, which would be a significant disincentive to prescribing”.

Breast Cancer Now says that, because of personal liability,

“doctors can be unwilling to prescribe drugs for new purposes, even where…clinical evidence is strong”.

As Lord Freyberg stated in the mesothelioma debate in the other place,

“The fastest way to save lives is to see if the drugs for common cancers work on the rarer ones as well, given the shared mechanism of disease across cancer. This is off-label research and until we fix the issue of liability, as advocated by the noble Lord, Lord Saatchi, we will continue to send thousands, like my sister, to an early grave.”—[Official Report, House of Lords, 20 November 2015; Vol. 767, c. 407.]

There was therefore plenty of reason and evidence to support clauses 3 and 4, but I guess politics is all about being pragmatic, and I believe that the provisions that we have already discussed are worthy in themselves of inclusion in a sensible Bill, because they will do some positive things. It is therefore with some reluctance, as I am sure the House will understand, that I have decided to table these amendments, which strike the elements relating to clinical negligence from my Bill.

[Anne Marie Morris]

I support my hon. Friend’s amendment 2, which would remove clause 3—the responsible innovation clause—from the Bill. I know that his heart was absolutely in the right place when he first put the Bill before the House; however, I am glad he has tabled the amendment, as I am sure the majority of us, if not all of us, are present in the Chamber to ensure that the rest of his Bill, particularly the provisions dealing with the database, gets through.

I have received briefings from all manner of medical bodies, as I am sure all colleagues have, stating that the Bill would do more harm than good for patients. A letter signed by nine different medical bodies, including the Academy of Medical Royal Colleges, the British Medical Association and the Patients Association, says that

“this Bill will actually harm good innovation by weakening patient protection, adding unnecessary bureaucracy and undermining good scientific practice.”

By removing clause 3, amendment 2, along with amendment 3, will allay those fears. There will no longer be any fears about doctors using quackery, as some people outside the Chamber have put it. Instead, there will merely be a database, set up by the Secretary of State, who may by regulation confer functions on the Health and Social Care Information Centre, although I note that the hon. Member for Lewisham East (Heidi Alexander) has tabled amendments seeking to change who the Secretary of State has to consult before making any regulations.

At a constituency level, a number of concerns have been raised with me by those in the healthcare sector who believe this Bill, or at least this clause, would do more damage than good. There was a misconception among some people that it remained a carbon copy of Lord Saatchi’s Medical Innovation Bill, which was introduced in the last Parliament. Although my hon. Friend’s Bill is indeed similar to Lord Saatchi’s, the amendments he has tabled will completely dispose of any similarity at all. Innovation sounds like such a good idea. To most people in the street, it sounds like a marvellous thing and therefore taking “innovation” out of the Bill must be a bad move. However, innovation must be achieved through the correct means and must not pose any danger to patients.

The argument goes that innovation has decreased in recent years owing to the legal complexities and doctors’ fears of negligence claims against them if something goes wrong. There is no evidence of that, according to the Medical Protection Society, the Medical Defence Union, the General Medical Council and various other medical—

Debate interrupted.

Access to Medical Treatments (Innovation) Bill

Chris Heaton-Harris Excerpts

Friday 29th January 2016 Commons Chamber

[Jo Churchill]

I apologise. Yes, I have confused the two, because I really believe that if we are not careful, what we do today will have an effect on our ability to bring that second broader database to fruition, which would give us the information we need to drive the trials, the life science industry and so on. Databases need to be fit for purpose. I could not have put it better than the hon. Lady did. We want the database that we are talking about today to be fit for purpose, but we do not want to put too many constraints or too much rope around it if that will stop us moving forward with clinical trials and with the whole area of genomics and patients.

I want every life to mean or have meant something. A patient should be able to choose to give knowledge as their legacy. Data hold the answers—the answer for my constituent whose two-year-old had a brain tumour; the answer for a family I know who have diabetes in several generations; the answer for a family member whose humour is tested by Parkinson’s that attacks his body. Personalised medicine should be a reality. As was pointed out in a paper yesterday, we are doing great things with CRISPR—clustered regularly interspaced short palindromic repeats—and across the piece.

Like me, every patient is somebody’s parent, partner, child or friend. That must not be forgotten. If the database we are discussing allows for information to be given that is appropriate to the individual, with care taken by the clinician right through the pipeline, it has to become a force for good. We should not wrap it up in too many constraints, but should allow it to develop. We must allow the Under-Secretary of State for Life Sciences to give us a lead in how to proceed in this field in the most effective manner.

The use of data offers the possibility to accelerate medical trialling from seven to two years and to link research together to find new insights. My glasses are not rose-tinted. I would want assurances about the use of my data, as any sensible person would. I want the recommendations of the accelerated access review to be implemented. The use of health data will be central to solving this country’s health challenges, not least in terms of cost, and its economic challenges. Our medical future will be uncertain unless we unleash the potential of information about patients for patients. I therefore support the Minister’s proposal.

[Chris Heaton-Harris]

It is always a pleasure to follow my hon. Friend the Member for Bury St Edmunds (Jo Churchill). Her knowledge and the way she goes about her business in the Chamber on this subject mean that it is always worthwhile to listen to her. What she says is powerful and she beats a trail that many will follow. She will get to the place she wants to get to eventually. I am very hopeful that this process today is one step along the way. I hope she gets some comfort from the fact that she is beginning to open doors, open minds and, in this case, open up information to registered medical practitioners about a host of treatments that they might not have known existed.

First, I will deal with what I perceive to be a Government amendment, amendment 15, which was tabled by my hon. Friend the Minister. I will then deal with the amendments tabled by the hon. Member for Lewisham East (Heidi Alexander).

--- Later in debate ---

[Mrs Drummond]

That was a very moving story about Emma. Does my hon. Friend envisage that the database will include international research and data from around the world?

[Chris Heaton-Harris]

Strangely enough, the Bill confers only a general power on the Secretary of State to provide such a database, and stakeholders and practitioners want clarification on how the database will operate and what sort of thing it might contain. Ideally, in the future, perhaps we could include what my hon. Friend suggests—who knows?—but the Bill confers a very simple power on the Secretary of State at this point in time. The very simple answer is, as it stands, no.

[Mrs Drummond]

My hon. Friend mentions that Emma got her treatment from the United States, where there is a lot of innovation and research. Would it not be great if we could expand that database to include research from around the world?

[Chris Heaton-Harris]

Yes, but in responding to amendments 8 and 9, which were tabled by Her Majesty’s loyal Opposition, I know that, when the Secretary of State and the Minister choose to use the power conferred on them in the Bill, they will confer far and wide on how the database is set up and used. Perhaps my hon. Friend will have an opportunity at that time to put her point in the consultation on how wide and extensive the database should be.

I mentioned Emma’s story because it was about evidence sharing within our existing system, which every single Member would like. Of Emma’s treatment, the NHS stated that it could not find evidence to approve the effectiveness of the operation that saved Emma’s life, and then withdrew funding for it. However, in its consultation on the matter, the NHS did not talk to the surgeons at the hospital where Emma was treated. There is a general point. I could tell hundreds if not thousands of stories in which a simple flow of information and data, or innovation or other things in our NHS, could improve the quality and type of care that is given to patients.

Amendment 15—the Minister’s amendment—states:

“References in section 2 to medical treatment include references to treatment carried out for the purposes of medical research (but nothing in section 2 is to be read as affecting the regulation of medical research)”.

That is an important amendment because it signals the Government’s intention to use the database wisely when it comes to dealing with research. Research has come on in leaps and bounds, meaning that a huge number of new treatments are coming into our NHS through clinical trials and innovative ideas everywhere in the system.

[Dr Philippa Whitford]

Although people who work in an academic unit will be very aware of trials—a lot of trials are UK-wide, but European Organisation for Research and Treatment of Cancer trials are Europe-wide and occasionally there are worldwide trials—people who work in district general hospitals, where there might be greater numbers of certain types of patients, are often less aware. Adding a listing of trials under any disease topic or area of clinical practice could be helpful in attracting clinicians to say, “I am aware that you can access a trial in Birmingham or Manchester.” The measure might promote trials to the busy clinician who is not directly involved in academic research.

[Chris Heaton-Harris]

I thank the hon. Lady, and I completely concur. I can foresee great benefits for those in the outer reaches of the NHS who do not necessarily come across information about many of the trials that are taking place. One of the biggest criticisms of the original formulation of my Bill was the fear in connection with getting people on to clinical trials. I would like to think that we have not just overcome that issue, with the amendments we are discussing and the latest version of the Bill, but have gone some way along the line to help improve the ability of registered medical practitioners to have knowledge of such trials. I completely concur with the hon. Lady’s point. We have innovation everywhere, so there is a real purpose behind having a database, regardless of whether the Minister has had the ability to set one up before now.

On research, Lord Winston made a very important point particularly well in the other place on Second Reading of the Mesothelioma Bill. He stated:

“There is no question that in the field of treatment there is a great deal of research.”

He had a list of a number of chemotherapeutic agents that were being looked at, saying:

“In recent years I can count at least 10 or 11”.

He then went on to name them. They are impossible for me to pronounce, so I will not do so here today. He said that,

“there are various combinations of those therapies with other well-known mitotoxic agents. These have included trials”.

He went on to say:

“Other treatments have been researched: of course there is surgery…and there are now attempts to try to reduce the tumour inside the lung membranes.”

He spoke about three trials that Cancer Research UK is conducting to emphasise the wide range of “stuff”, as he put it, that is going on.

“One is some work with HSV1716, which is a virus that acts against dividing cancer cells. It comes from the herpes virus…a very good example of where we might make a breakthrough in treatment. Then there is a different strand of research with ADI-PEG 20, which in combination with other drugs such as cisplatin affects a particular amino acid in the chain of cell division”—

which could prevent cancer cells from multiplying.

“That has been specifically targeted for the treatment of mesothelioma. A compound, GSK3052230, developed by GSK, is I think about to enter phase 3 trials very shortly. That attacks the FGFR1 gene, and therefore stops cancer cells growing.”

This is where he makes the point exactly:

“There is now an increasing emphasis on understanding that, if we are going to improve outcomes for patients with a variety of different cancers, and other chronic long-term conditions, we need to move away from a generalised approach to managing disease towards personalised, precision medicine”.—[Official Report, House of Lords, 20 November 2015; Vol. 767, c. 395-7.]

Medicine is going to change. Research is going to change. Spreading the information about that across our NHS, and how quickly we can do that and learn from success and failure in our NHS, is a very, very important matter.

[Anne Marie Morris]

Does my hon. Friend believe that personalised medicine should become a reality over the next little while and not a research project, and that unless we have freedoms within the database we will never have the knowledge to find out that we can truly have personalised medicine?

[Chris Heaton-Harris]

I truly believe that personalised medicine will become a reality. I would like to think that a database would aid the spread of knowledge about how individual medicines are being used and who they might affect in different ways, so yes, I nearly completely agree with my hon. Friend.

[Dr Whitford]

I have two small points. First, personalised medicine, particularly for breast cancer, has been evolving for years. Right from when we could tell whether a cancer fed on the female hormone oestrogen or not, we were targeting the treatments towards patients. We have been moving that way and it will accelerate.

I know it is not the subject of the Bill, but I hope that the accelerated access review will consider in general how we get drugs to patients—a subject that we debate relentlessly in Westminster Hall. I see a negative feedback loop coming from among colleagues who used to be trialists, such as myself. We registered patients and did all the work to take part in research, but when the drugs were finally made available, the NHS could not afford them. We need a totally different way of accessing those drugs. The companies want to sell them, and we and patients want them.

[Chris Heaton-Harris]

The hon. Lady speaks with way more experience and knowledge than I do, but from everything I found out during my research for the Bill, I completely concur.

[Oliver Colvile]

rose—

--- Later in debate ---

[Chris Heaton-Harris]

I give way to my hon. Friend the guinea pig.

[Oliver Colvile]

Does my hon. Friend also recognise that an enormous amount of research is taking place in many of our medical schools, especially Peninsula medical school in my constituency and the one in Exeter?

[Chris Heaton-Harris]

Clinical research and innovation is happening across our NHS every day. Would it not be wonderful if every registered medical practitioner could see what was going on, without too much effort or work, by tapping into a database and getting a better understanding of the picture around them?

This is the crux of the matter. Treatments are not what they used to be; there is not a one-size-fits-all policy. As medicine progresses and personalises even further, the mind boggles trying to imagine the sheer number of treatments that will be available in our NHS in the future. How can we expect every clinician to know about all the possible treatment routes? How can we not, therefore, provide them with somewhere to record them and their outcomes?

As Lord Giddens stated in the debate I mentioned earlier, we are experiencing a digital revolution. Given how far technology has come in our lifetimes and what is now possible, we can truly say we are living through a different age of digital capability. It is moving at such a pace that we struggle to keep up with it ourselves. It is not unfounded to say we might be living through a period of unparalleled innovation in medicine and other frontier areas of science more generally. Thanks to the strides in treatment and the speed of technological development, we have an opportunity to create and record life-saving data like never before. It is surprising that we do not have such a database already. The Bill sends an unambiguous political signal to the Government that we would like them to get on with it.

The Bill defines innovation as a situation where a doctor departs from the existing range of accepted medical treatments for a condition. This will be well understood by doctors, who are best placed to know whether treatments are acceptable and responsible. The definition of what can go on the database is deliberately wide because I want the Minister to have as wide an ambit as possible.

I want quickly to mention another stakeholder I met, Nutricia, a company dealing with advanced medical nutrition. It kindly welcomed the Bill:

“This Bill marks an opportunity for patients managing a range of diseases and conditions to get access to the most innovative medical care, and to actively support their inclusion in patient pathways in an on-going manner. This should not simply be confined to pharmaceuticals, as patients can benefit from innovation across a range of sectors, for example medical nutrition.”

Medical nutrition—otherwise known as medical foods—describes a special category of foods designed to meet the needs of patients whose disease or health concern requires medically determined nutritional support. Medical nutrition is a scientifically formulated food that is available in many different formats. Applications can range from those with rare conditions, such a child who inherits a metabolic condition meaning that the consumption of a specific amino acid commonly found in normal foods can lead to brain damage, right through to people with common cancers who may as a consequence lose weight rapidly and be at risk of malnutrition for a period of time. Nutricia was therefore keen that we maintained the widest possible definition for how the database could be used.

Medical nutrition also provides benefits in the treatment pathways of other diseases, including various cancers, strokes, cerebral palsy and pressure ulcers. Nutricia has stated that,

“we must seek to streamline the adoption of innovative care of all kinds—not just pharmaceuticals—so that clinicians have a resource which will mean that there are no more missed opportunities, and patients have every available chance to manage their condition.”

[Bob Stewart (Beckenham) (Con)]

I am very ignorant compared with a lot of people in this Chamber, so my question is probably a question from a fool. I do not mean it to be, but when I go to a doctor and they are sitting in front of a computer, I make the assumption that if they have a question, they go into the computer and get an answer. Am I wrong in saying that cannot or does not happen, and would this new list work much better?

[Chris Heaton-Harris]

I will give way to the hon. Member for Central Ayrshire, who will give a much more informed answer.

[Dr Philippa Whitford]

I think the hon. Member for Beckenham (Bob Stewart) has a much greater admiration for what a computer on a desk can access at that moment when a GP has a 10-minute appointment. What they are actually looking at is the patient’s records. They also have the ability to prescribe, but to track something down they would have to shut those systems down and go into something else, as with searching the internet. They cannot do that live, in front of a patient, and that brings up an important point. If the new system is meant to be used live, in front of patients, it will have to interact with the NHS computer systems, which someone can literally click on and use to look things up relatively easily, in the way we look things up in the BNF at the moment.

[Chris Heaton-Harris]

I thank the hon. Lady for her explanation to my hon. and gallant Friend the Member for Beckenham (Bob Stewart).

It is important that doctors are aware of the changing methods by which care is being delivered. Innovation in the delivery of care must be recognised in the tapestry that is our wonderful national health service. I fully welcome the Minister’s amendment to my Bill. It makes it more worth while. The improvements we are making to the Bill today are dramatic, but they have not come out of thin air; they have come from a great deal of work. A great deal of thought has gone into them, which I very much appreciate.

Finally, and briefly, let me turn to amendments 8 and 9, in the name of the right hon. Member for Lewisham East (Heidi Alexander).

[Heidi Alexander]

Honourable.

[Chris Heaton-Harris]

Soon to be right honourable—I shall try to get her promoted to that position. I am sure there are some Privy Council positions awaiting on the Labour Benches.

I completely understand where the hon. Lady is coming from in trying to ensure the widest range of consultation on, actually, pretty much anything. Forget this Bill; when the NHS does something, it should try to interact with stakeholders who have direct and indirect concerns. As it stands, the list in her amendments looks like a preferred list of consultees, although I have a range of concerns about the listing, the order and so on. Given the way we have gone about this Bill—there has been a great deal of understanding and working together—I would like to think that when my hon. Friend the Minister answers this point and indicates what the Secretary of State would do with the power, how he would consult and which groups he would consult with, the hon. Lady will perhaps consider not pressing her amendments, in the full knowledge that there will be the widest possible consultation, should this Bill become law.

[George Freeman]

I shall deal with amendments 8 and 9, tabled by the hon. Member for Lewisham East (Heidi Alexander), and amendment 15, which I tabled on behalf of the Government. I shall also deal with some of the important points that Members have raised.

I have to say that I am not here every Friday, but I think that today’s debate is setting a high standard, both in terms of the issues that are being raised and the way in which it is being conducted. I hope that those who take a close interest in the Bill and are watching the debate are observing the cross-party nature of our discussion of some very important issues.

I thank the hon. Member for Lewisham East for her support for the spirit of cross-party working. The sector needs to be confident in the knowledge that the House is paying close attention to the issues that underlie the Bill—issues relating to data, informatics, genomics, drug trials and research—in a cross-party spirit. As the hon. Lady knows, in the course of my work I have paid tribute to the last Labour Government’s pioneers, Lord Drayson and David Sainsbury, who did so much to create the Office for Life Sciences. I think the debate reflects that spirit, and I welcome the hon. Lady’s restatement of her support for it.

I also welcome amendments 8 and 9, which specify and flag the importance of a wide group of consultees. I entirely agree with the principle of the amendments. Indeed, I would go further and include a range of patients’ groups, charities and others. I give the hon. Lady—and the House—a commitment, which I am happy to put in writing, that I will seek to involve all the organisations on her list, and indeed others, in the consultation that will take place following the Bill’s enactment.

As an experienced parliamentary operator, the hon. Lady knows that including lists of organisations in a Bill is always a mistake, because in the end it creates more problems than it seeks to resolve. However, I will happily write to all the bodies that she has mentioned, and to all Members as well, with a list of those who I think should be involved in the consultation.

--- Later in debate ---

[Madam Deputy Speaker (Natascha Engel)]

We now come to amendment 5. With the leave of the House I will put the questions on amendment 5, 6 and 14 together.

[Chris Heaton-Harris]

On a point of order, Madam Deputy Speaker. I was under the impression that amendment 5 would be called only if amendment 15 was not carried. Please could you give me some clarification on that point?

[Madam Deputy Speaker]

The hon. Gentleman is right; we will take amendments 6 and 14 together.

Amendment made: 6, page 4, line 3, leave out ‘this Act’ and insert ‘section 2’.—(Chris Heaton-Harris)

Clause 6

Extent, commencement and short title

Amendment made: 14, page 4, line 8, leave out ‘Sections 1 to 5’ and insert ‘Sections 1, 2 and 5’.—(Chris Heaton-Harris.)

Third Reading

[Chris Heaton-Harris]

I beg to move, That the Bill be now read a Third time.

It is a tiny bit of a relief to get to this point in the proceedings. I guess I should start by thanking a number of people, the first of whom is the inspiration for this Bill. As I explained in my Second Reading speech, I followed in some detail what Lord Saatchi had been doing in another place, especially when his Bill reached its Report stage and Third Reading, and I thought some of his ideas were very much worthy of legislation in this place. Unfortunately, the inspiration for his Bill was the terrible loss that he suffered, but I would like to think that what we have done here today will be a true and lasting legacy for him to remember his wife by.

I should also like to thank the Under-Secretary of State for Life Sciences and all the officials in the Department who have given me advice—nearly always constructive and helpful—especially a gentleman called Peter Knight, who very kindly hosted a round-table for a whole host of organisations, and anyone else who was interested. It was only the people who were being really stroppy about the Bill who refused to come. He kindly explained what the database could and should be doing, and what its potential was, which alleviated a huge amount of concern. He also enlightened a number of people on the direction of travel that we were taking. I thank my hon. Friend the Minister and all his officials for their help and understanding.

Most of all, however, I would like to thank the hon. Members who are in the House today. I was a Member of the European Parliament, and I guess we have Europeanised the system here. I am not a great European—I like to consider myself a decent Eurosceptic—but there are some practices in the place where I used to work that enable you to listen to people on all sides of an argument, and that allow you to evolve and learn from their better experience and knowledge and put that into your own work. I want to thank the hon. Members for Torfaen (Nick Thomas-Symonds) and for Central Ayrshire (Dr Whitford), and of course my hon. Friend the Member for Bury St Edmunds (Jo Churchill), who is an unbelievable force of nature. I am sure that she will make waves for the Minister if he does not stick to some of the promises he has made today. I also thank Her Majesty’s loyal Opposition, who all the way through this process have been willing to engage with me, to listen and to criticise, completely and correctly. I therefore thank the hon. Members for Lewisham East (Heidi Alexander) and for Ellesmere Port and Neston (Justin Madders).

Where we have got to now is not a bad place. I have received a briefing from Empower, which is one of the charities that is keen to ensure that patients get the best treatment. I will quote from its briefing, because this is not something I would ever say about myself. It states:

“We are particularly pleased by the ingenious step of absorbing Nick Thomas-Symonds’ Off-Patent Drugs Bill into the amendments. Mr Heaton-Harris’ database of innovation combined with off-patent access to medicines is a hugely positive step forward, and one Empower fully supports.”

The briefing included a note from Graham Silk, a gentleman who was doing some media on this yesterday, having joined Empower’s drive for spreading innovation. He said:

“I was diagnosed with leukaemia in 2001, and I’m still here today because of medical research facilitated by the patient data of the leukaemia community. I was one of the lucky ones by being in the right place at the right time. But we need to start taking luck out of the equation by spreading this information faster and wider. This database could have the power to do just that.

Indeed the drug that saved my life has already shown early promise in other conditions, the off-patent provisions in the Bill could also see patients granted access to a far broader set of treatments which would really open up our health system.

I am looking forward to continuing Les Hatpin’s legacy”—

Les was the power behind Empower—

“by working with Parliament, policy makers, and frankly anyone who will listen, to see our health service modernise and digitise to the benefit of patients.”

[Jo Churchill]

That clearly encapsulates what we need to be doing: putting the patient at the centre, backed up by a charity, such as that leukaemia charity, and supported by clinicians. We could not want a more virtuous situation.

[Chris Heaton-Harris]

I completely concur with my hon. Friend. I would like to think that Graham, when he looks at our proceedings today, will be pleased at where we have got to, and the process by which we have got here, and is looking forward to his wishes becoming fact.

There have been some questions about whether the database is required at all. I will talk about this gently, because I do not want the cross-party consensus to break down at such an important moment in proceedings. I know—I have learned a huge amount in this process—that there are many mechanisms already available for sharing treatments, but they are far from being available to all medical practitioners, and in my view they are insufficient. Besides that, there is no comprehensive database of treatments that are not regulated under the Medicines and Healthcare Products Regulatory Agency; there are just many smaller ones, such as registries for specific diseases or databases for particular regions.

For example, the most recent figure I could find for the total number of registers used by medical professionals 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 that there were well over 200 registers in existence in England. The number of disease registers already in existence in England was obviously large, although possibly larger than was generally appreciated. Even though the review was not exhaustive, it identified about 250 registers. The report stated:

“We would not be surprised if there were more than 400 specific registers in existence in England.”

That rendered the situation on data collection at best confusing, and at worst it makes finding evidence and navigating through that data almost impossible. I hope that the database set out in the Bill will provide clarity through the vast web of registries, information and data that already exist and help clinicians find evidence for innovative treatments simply and quickly.

That is particularly important today, because 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. There is great potential for what this could do. South London and Maudsley NHS Foundation Trust has developed a computer system that allows it to carry out research using the information from the trust’s clinical records. The system is known as the clinical record interactive search system, and it is anonymised. It is hoped that it will make a very real and positive difference to future treatments and care. The system allows clinicians and researchers at the hospital to look at real life situations in large quantities. This makes it easier to see patterns and trends such as what works for some and does not work for others. For example, case registers have been used extensively in mental health research, which was commented on earlier. Recent developments in electronic medical records and in computer software to search and analyse these in an anonymised format have the potential to revolutionise this research tool. The case register has been hailed as representing a new generation of this research design, building on a long-running system of fully electronic clinical records and allowing for in-depth analysis of data while preserving anonymity through technical and procedural safeguards.

Historically, medical records of some kind have always been kept. In keeping with the tradition of careful, methodical scientific observation, they have frequently been developed into disease registers through which the incidence, course and health service use of specified diseases can be monitored and investigated. In the context of changing social, political, professional and technological factors, a large number of psychiatric registers were constructed throughout the 20th century. However, owing to the expense of maintenance, often then carried out manually, the limited information available, which relied on data sheets completed by clinicians in addition to their routine workload, the practical difficulties of monitoring data quality, and limited funding, many of these programmes closed, and a vast amount of the information collected, which could have been useful, was lost.

Now we live in a time in which rapid technological advances and other developments over the past decade have led to new possibilities for the development of data-sharing. With electronic clinical records increasingly complementing handwritten notes, large volumes of clinical information are contained in an electronic format. The possibility of what we can do with this is unbelievably exciting. So far, we have not really harnessed the data that we already have. There is so much potential to make great changes, and this Bill is a tiny pigeon step in the right direction.

There has obviously been a huge amount of interest in this Bill from a whole host of groups. Some have concluded that the database is not needed, some have concluded that it is a good idea, and some have raised a number of questions about it. I would like specifically to thank the Association of the British Pharmaceutical Industry for its briefing on my Bill, which was circulated to Members of Parliament this week. It states its concern that the Bill will promote the prescription of unlicensed medicines and says that that is worrisome because there is hierarchy of risk involved with prescribing off-label and unlicensed medicines that makes unlicensed treatments the more risky route. It is completely correct. Promoting the prescription and use of these treatments when that is best thing to do for patients, is, I would like to think, exactly the sort of information that the Bill will share around the place to enable people to do the best thing.

With the amendments tabled today, the Bill promotes treatments in clinical trials, which are by their very nature unlicensed, as well as off-label drugs, other licensed but perhaps underused or very new treatments, and other unlicensed treatments. Clearly, it will not change the fact that, under MHRA guidance, more risk is involved when using unlicensed drugs. This, rightly, will remain the case, as these drugs have not received regulatory approval and are not yet deemed safe for use. No guidance or law of liability is changed at all by this Bill, with the tabled amendments. However, the Bill will spread information behind how these drugs are being used and allow responsible registered medical practitioners to access more information, much more quickly, to make better decisions for themselves.

The ABPI also wrote that the database undermines the UK medicines regulatory system and gives doctors the ability to prescribe unlicensed or off-label medication. As I have said, that is perhaps not terribly bad, but I would like to think that we are not undermining any regulatory system. The Bill simply does not contain provisions that would do so. I want to give the ABPI some help with its questions, and I would like to think that this debate—the points made by the Minister about how he will use the power, and those made by hon. Members on both sides of the Chamber underlining the cross-party nature of the provisions—shows that the Bill is worthy to be sent by this House to the other place and that it will do patients, registered medical practitioners and our NHS the world of good.

--- Later in debate ---

[George Freeman]

I will happily come back to the hon. Gentleman on licensing. We have discussed this at some length, but I am happy to confirm the situation. There is a very strong legal set of constraints on how we handle licensing, but I will happily write to him to confirm the position.

I would like to respond to the request, by the hon. Member for Lewisham East (Heidi Alexander) from the Opposition Front Bench, to take very seriously the design of the database. I agree. We need to make sure it works well. Datasets are already available, but we need to connect them up better to give clinicians the right information they need. I am absolutely happy to give an undertaking to engage very closely with the medical profession, and all who have taken an interest in the Bill, to ensure this measure has the intended effect. I also give an undertaking to the House that I want to put the patients’ voice right at the heart of this and to invite the Association of Medical Research Charities and others, as we put the proposals together.

I want to take up the point raised by my hon. Friend the Member for Wellingborough (Mr Bone) and update the House on the range of initiatives, which the database will sit in the middle of, that we are putting in place. As the landscape for drug discovery changes profoundly, the Government are intent on making sure the country leads in this new model of personalised, targeted, patient-led research, moving from a world in which a drug is traditionally developed around a notional theoretical target that is normally developed in an academic laboratory and then, if it is lucky, put through a process to raise money and be spun out or partnered. That original target is turned into a drugable target that a pharmaceutical company can make a drug against. The early synthetic chemical compounds are tested against vast libraries. With luck, they are taken through pre-clinical testing and extensive in vitro and in vivo testing. They then go “over the wall” as the industry refers to it, into development to phase 1, phase 2, phase 3 and phase 4 trials, through MHRA and European Medicines Agency safety approval, to NICE for health economic approval and then to the NHS to decide how to best use the drug.

That landscape still works for many drugs and is still the conventional system in which drugs are developed. In truth, however, the breakthroughs in genomics and informatics mean we can, and are, developing a different landscape. The Government are investing in the cell therapy catapult and the precision medicine catapult so that we lead in academic research, working with industry partners on the new model of personalised and precision medicine. It is why we set up the biomedical catalyst to support quick funding for small companies and academic groups developing key technologies in this space.

It is why I am delighted that we announced, in the autumn statement, ring-fenced funding for the Medical Research Council and the other research councils. That budget is now £700 million a year for leading research around the UK. It is why we confirmed the £1 billion-a-year commitment to the National Institute for Health Research, an embedded clinical research network at the heart of our NHS all around the country that is the jewel in the UK crown, and the establishment of the NIHR Office for Clinical Research Infrastructure, allowing innovators internationally to come in and work in our research hospitals. The progress of NIHR means we now have over 200 industrial studies on new medicines in the UK. We are increasing year-on-year the number of patients enrolling on clinical trials, including, importantly, first-in-man and first-in-patient studies. The UK is now going back up the international league for drugs having their first exposure to people, here in the NHS and the NIHR.

It is why, on informatics and genomics, we launched the Genomics England programme. In 2012, the Prime Minister announced that we would be the first nation on earth to sequence 100,000 entire genomes—those of NHS patients—and link them with their hospital records. The project has captured the world’s imagination—I have called it the NASA of 21st biomedicine—and triggered phenomenal academic and industrial investment in the UK. It is already driving new diagnostic insights into rare diseases and insights into how we can use existing medicines better.

It is also why we have invested in the clinical practice research datalink and the aggregating of the NHS’s long-term cohort studies. These are phenomenal resources for research. Before coming to the House, I was involved in one, funded by the MRC and Cancer Research UK, that involved 250,000 women at risk of ovarian cancer. As a part of that, we collected blood, tissue, genomic and medical record information. I am proud that, after the academic study was finished, a group of medics at University College London, along with MRC Technology, UCL Ventures and CRUK, used that database to form a company called Abcodia Ltd, an ageing biomarker company. The database contains biomarkers that allow us to diagnose not just cancers but a range of diseases in ageing women much earlier. The scale of that dataset allows us to lead.

My hon. Friend the Member for Daventry mentioned Professor Simon Lovestone, at King’s College London, who led the world in the use of informatics and integrated medical records in mental health and who has now gone to Oxford University to pioneer that work. The Government are investing in genomics and informatics because it is a transformational technology that is changing the way drugs are developed.

I want to entice the House to think about where this might go and the direction the Bill points us in. This new world is coming fast. The first genome to be sequenced, 10 years ago, cost £10 billion. It now costs $5,000 and can be done in 24 hours. Not least because of the leadership of Genomics England, it will soon be possible to do it in minutes for a few pounds and pence. That will allow the NHS, when patients arrive with cancer, rare diseases and, increasingly, any disease, to identify the right genomic diagnostic and profile the right treatment and drug much more quickly. When a patient arrives, whether at a GP practice, hospital or clinic, we will, in due course, be able to do a quick and easy genomic diagnosis.

Thanks to the Bill, front-line clinicians will be able much more quickly to identify innovative drugs from which their patients might benefit. That will not happen overnight; it will not happen by Easter; it will not happen by the end of this parliamentary Session, but it is a quiet revolution of 21st century medicine that we are leading, and data and information sit right at its heart. My hon. Friend has taken three Bills that were generating more heat than light, crystallised their essential purpose, which was noble and well-intended, and brought them together in one Bill. I hope that it will be treated in the Lords in the way that this debate and cross-party consensus invite and that it will not be significantly re-amended, not least because, if it is, it will probably run out of time to reach the statute book.

Many people comment that the House spends too much time doing yah-boo politics for its own sake. Today, we have struck a blow for joined-up government and parliamentary process. It is wonderful to see MPs from all mainstream parties—I have not heard anything from UKIP—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 am happy to commend the Bill to the House and to congratulate all those involved, and I am delighted to have done my bit to help strike a blow for joined-up government.

[Chris Heaton-Harris]

On a point of order, Madam Deputy Speaker. Would it be in order for me to thank Abigail Bishop-Laggett, my member of staff who has worked so hard on getting the Bill to this point?

[Madam Deputy Speaker (Natascha Engel)]

That is a very nice comment, but not a point of order.

Question put and agreed to.

Bill accordingly read the Third time and passed, with amendments.

Infected Blood

Chris Heaton-Harris Excerpts

Thursday 21st January 2016 Commons Chamber

[Jane Ellison]

The consultation is being undertaken by the Department of Health in England, but anyone in the United Kingdom can respond, and we continue to work with all the UK Health Departments. My officials have been working closely for months with officials in devolved Administrations. I offered to speak to my ministerial counterparts on the phone this morning, and had a helpful conversation with both Shona Robison and the Welsh deputy chief medical officer. I note that the chief medical officer for England also contacted her opposite numbers.

As I have said, we are in touch with all the devolved Administrations. Because health is now a devolved matter, they are responsible for providing financial support for those affected in each country, and I know that Scotland is consulting on scheme reform in its own right. However, all the devolved Administrations will have the option of joining our new scheme in the future, and an assessment will be made of the financial contribution that is necessary. I had a useful conversation with Shona Robison about some of the transitional arrangements, and about how we can work together. I said that we would try to be as helpful and supportive as possible, and I have every confidence that we will continue in that spirit.

[Chris Heaton-Harris (Daventry) (Con)]

I welcome the statement, I welcome the consultation, and I certainly welcome, on behalf of my constituents, the extra money that seems to be available.

The Minister has said that she wants the widest-ranging consultation. Every Member will have received letters from their constituents about this issue, and those letters have been have passed on to the Department. My constituent Matthew Harris, for instance, has been campaigning actively for a very long time. Will the Department be able to contact those constituents, and ensure that those who are directly affected, and with whom the Minister has already been in contact, can take part in the consultation?

[Jane Ellison]

I assure my hon. Friend that we will make every effort to reach people. My officials have already put in place extensive plans to publicise the consultation—they have met the heads of the charities and those running the current schemes, and will be writing to those who are registered with those schemes—and we will make it as easy as possible for people to get involved. One of our reasons for organising a 12-week consultation is that we recognise that some people may not be online, and we want to make sure that everyone has a chance to comment.

I will reflect on what my hon. Friend has said about direct contact. That may already be being pursued through some of our plans, but, as I have said, we have extensive plans to publicise the consultation, and it goes live today. Of course I shall welcome Members’ contributions on behalf of their constituents.

ACCESS TO MEDICAL TREATMENTS (INNOVATION) BILL

Chris Heaton-Harris Excerpts

Wednesday 16th December 2015 Public Bill Committees

[The Chair]

Before I call the Bill’s promoter, I have allowed quite a lot of latitude but it is important in Committee to focus specifically on the amendments that we are deliberating, which the hon. Lady did without referring to them. That is the way forward and that is our system.

[Chris Heaton-Harris (Daventry) (Con)]

It is a pleasure to serve under your chairmanship yet again, Mr Streeter. I hope you will be as gentle with me this time as you were last time.

[The Chair]

Unlikely.

[Chris Heaton-Harris]

It was worth a try. I welcome the speeches that we have just heard and I certainly welcome the engagement that I have had with the shadow spokesman and a whole range of people across the House on my Bill. I thank the Minister for his engaged help and that of his officials, who have been unbelievably helpful behind the scenes and have set me right on a whole host of issues as I have been through the process—a process that has been very enjoyable but that I never intend to undertake again.

In talking about amendments 1 and 2, we probably just had the stand part debate for clauses 3 and 4. I am sure there will be a better debate at that point but, essentially, that is the major area of controversy in the Bill. I know that the hon. Member for Central Ayrshire has some concerns about the database. She has been unbelievably constructive in her approach to the Bill and I know that we can sit down and get to a point where her concerns are listened to and taken on board. I am very happy to work with her on amendments for Report, if she has any then, to get the Bill to that position.

On the amendments, the Minister said—I will not repeat all the Minister’s words because they were wise, and wise words need to be heard only once by any parliamentary Committee—and parliamentary counsel gave me the same advice, that the Bill does not change medical negligence law. In fact, that is stated in the Bill. However, is there an actual need for it?

The Minister set out what happened in the consultation, as to whether there was a need and whether doctors were concerned about litigation. I want to put a couple of things on the record to show that I have not just made up the concern based on a casual hearing of what the Minister said about the consultation. On Second Reading, I read out a quote from Dr John Hickey. I will read it out again because I am not sure that many people heard it at the time. He said:

“As a registered medical practitioner, a former NHS Trust Chairman and with 30 years’ experience in the field of legal medicine with the Medical Protection Society (the last five years as Chief Executive), I believe I am adequately qualified to comment on your Bill. Over the last 30 years I have seen how doctors have increasingly practised defensive medicine both because of the fear of litigation and disciplinary action by their regulators; this defensiveness is not in patients’ best interests. I believe that your Bill, if approved by Parliament, would assist in meeting the concerns of clinicians treating such patients . . . I believe there are adequate safeguards in your Bill, particularly with respect to consent, to prevent the potential ‘quackery’ about which some of the critics of your Bill and Lord Saatchi’s previous Bill have expressed concern.”

He was actually the chairman of my local NHS trust and I have a great deal of respect for him.

We all received a host of briefings; I know Committee members have enjoyed the briefings on the Bill they have received over the past few days. I apologise for any extra work I might have created.

--- Later in debate ---

I hope that I have given the hon. Gentleman enough reassurance and explained the rationale. I strongly support his intentions and will happily talk to him about amendments we might table, but I cannot accept the mechanism proposed.

[Chris Heaton-Harris]

I will be brief. I have listened to the debate. The hon. Member for Torfaen put his case strongly, and there is a constructive and helpful offer on the table from the Minister. I simply ask the hon. Gentleman to withdraw his amendment and to take up the offer to return to this on Report, having worked on something with the Minister, the team from the Department of Health and me. Hopefully we can then get to a good place on the off-label use of drugs.

[The Chair]

Our timing is good. We might have a Division downstairs shortly, so we have plenty of time for Mr Thomas-Symonds to respond.

--- Later in debate ---

[George Freeman]

I will be brief. Following our earlier conversation about the database provisions, I emphasise that they are the part of the Bill that the Government most strongly support. The database is not envisaged as it was in the predecessor Bill—if I may call it that—as a registry for recording ad hoc innovations by clinicians, but as a fundamental database to give all clinicians access to information on innovative medicines, including off-label uses of medicines and medicines that are either unlicensed but in use, as in the early access to medicines scheme, or in clinical trials, in which a patient might be eligible to enrol. The clause gives the Secretary of State the power to make regulations conferring functions on the HSCIC, 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.

I am pleased that my hon. Friend the Member for Daventry proposed the database for recording such treatments and for getting information on them out to clinicians. The measure is important in the promotion of innovation. Crucially, the measure would give doctors the ability to search the database for innovations, so the position is very different from that under the Bill introduced in the House of Lords last year, which proposed a database as a registry on which innovative doctors could log what they had done. The database proposed in this Bill is completely different, which is why I strongly support it.

The database could result in better care and health outcomes for patients and a faster uptake of new treatments, and it could support our work to make Britain a world-leading centre for innovative medicines. The pace of progress in genomics and informatics is profoundly changing the way in which new drugs are developed, but our databases and systems information have not kept up, so that is among the things that are being considered under the accelerated access review. While the Secretary of State might already have the legal power to create a database, the Bill helpfully sets out that provision may be made to give instructions to HSCIC to create a specific database, which I would welcome. If the Bill does not, for whatever reason, reach the statute book, I would happily proceed towards establishing such a database, but it would be helpful if the provision were set out clearly in legislation.

The Government do not support amendment 5 because it is not exhaustive. Although it represents a helpful list of consultees, such a provision would need to include many more organisations. While I understand the intention behind the amendment, restricting the process would not be helpful, but I would be happy to write to members of the Committee about our approach. I undertake to write to all the relevant organisations and to ensure that they are consulted, but I am old enough and ugly enough to know that well-intentioned lists of statutory consultees can quickly become out of date. They can create weird anomalies whereby parties that really have nothing to say are statutory consultees, yet those who have a lot to say are not. I am happy to discuss what other steps we can take to ensure that those who, rightly, need to be informed about the Bill and the mechanisms it proposes are properly informed.

The Government do not support amendment 6 for the same reason—because the list is not exhaustive—but I will be happy to put in a place an alternative mechanism to ensure that those parties listed the amendment and others are properly informed. I would not want to put in law a list of consultees that we might well need to amend quite quickly. I, for one, do not want to find myself back in Committee considering a statutory instrument to amend a list of statutory consultees established by a well-intentioned proposal, so I hope that the hon. Member for Ellesmere Port and Neston will withdraw the amendment.

[Chris Heaton-Harris]

Obviously, I agree with the Minister, and I have discussed the matter with the shadow Minister. I know from my consultation on the Bill with stakeholders that we would need longer lists than those in the amendments. I hope that the hon. Member for Ellesmere Port and Neston will agree to the Minister’s generous offer and therefore withdraw the amendment.

[Justin Madders]

Our debate has shown that a well-intentioned proposal might have unintended consequences, so I accept what the Minister and the hon. Member for Daventry say about the need for comprehensive lists. I think that the lists in the amendments are pretty comprehensive, but I accept that other bodies might emerge or feel that they should be included. I am happy to work with the hon. Gentlemen to ensure that we reflect the intention behind the amendments, yet do not create additional work a few years down the line because we have to amend the legislation. I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 2 ordered to stand part of the Bill.

Clauses 3 to 5 ordered to stand part of the Bill.

Clause 6

Extent, commencement and short title

Question proposed, That the clause stand part of the Bill.

--- Later in debate ---

[The Chair]

This debate is an opportunity for Mr Heaton-Harris to say something nice about the Chair.

[Chris Heaton-Harris]

Thank you, Mr Streeter. What a wise Chairman you are—one of the best Committee Chairmen ever.

I thank all members of the Committee for their forbearance, especially those who have distinct issues with parts of the Bill. The offers I made are real, and, if I cannot get the controversial parts in clauses 3 and 4 into the right place quickly, I intend to table amendments to delete them, as I said to the hon. Member for Torfaen, so that there is absolute clarity. I look forward to working with anybody who wants to work with me on getting all the other provisions in the Bill into the right place.

I thank you very much, Mr Streeter, and would like to wish a very merry Christmas to every member of the Committee and staff, especially the departmental staff. There is a gentleman called Mr Peter Knight who helped convene a workshop last week for me to explain to interested organisations what the database could look like and how the consultation on it might proceed, which shed a lot of light on this issue and clarified things.

[George Freeman]

I would like briefly to add my thanks to you, Mr Streeter, for chairing the Committee.

We have had a constructive discussion with all parties represented on the Committee, with some front-line advice from clinicians. I thank my hon. Friend the Member for Daventry for his clear offer. I pay tribute to him for the clarity of that offer. The Government are concerned that this Bill, with the noblest of intentions, is still not in a place where it has widespread support from all parties. A Bill that elicits concerns and opposition from both industry and charities, patient groups, lawyers and the General Medical Council is a Bill whose nobility of purpose is not yet reflected in unanimity of support.

I am grateful to my hon. Friend, and I know that he is keen to get the Bill to a point where it can be distinguished from a predecessor Bill that generated a lot of heat and some opposition. I genuinely believe he is trying to get to that point, particularly on the database provisions. I urge him to keep his foot to the pedal, particularly on the negligence provisions, on which we have a bit more work to do. I repeat that if a well-intentioned Bill has the inadvertent effect of undermining patient and public trust in the world-class status of our research medicine and clinical trials, it will be self-defeating and I would find it impossible to support. However, we have a chance to avoid that.

I thank you for your excellent chairmanship of the Committee, Mr Streeter, and add my thanks to the officials sitting on both sides of you, who have guided us through this process. I hope we can get to a point where we can go back to the House on Report and say that this Committee has managed to rescue a noble cause and, with the help of my hon. Friend the Member for Daventry, put forward a proposal we can all support.

Junior Doctors Contract

Chris Heaton-Harris Excerpts

Monday 30th November 2015 Commons Chamber

[Mr Hunt]

I do agree. I think that improving seven-day services across the NHS should unite both sides of the House and, indeed, should unite the Government and the medical profession. It is extremely unfortunate that we have got into this position, but there is now an opportunity to put things right and I hope that that happens.

[Chris Heaton-Harris (Daventry) (Con)]

I welcome the statement, and I very much welcome the conversations that are going on. Many vulnerable and sick people have had letters from their local hospitals today saying that their operation tomorrow has been cancelled. Should we get good news later this evening, is it too late to allow those operations to take place, bearing in mind that in many rural constituencies—and city constituencies —transport has to be arranged for those patients?

World Prematurity Day

Chris Heaton-Harris Excerpts

Tuesday 24th November 2015 Westminster Hall

[Chris Heaton-Harris (Daventry) (Con)]

I beg to move,

That this House has considered World Prematurity Day.

It is a pleasure to serve under your chairmanship, Mr Hollobone. This subject does not get enough attention in this place, or indeed in the media. In the previous Parliament—in a Westminster Hall debate and elsewhere—I raised the subject of stillbirth, as I have a very good friend who suffered possibly one of the worst stillbirth events that I have ever heard of. I asked lots of questions in this place on that subject, including at Prime Minister’s questions, because I truly believe that we need to raise awareness of these matters. I worked very closely with Sands and with a charity called Bliss, whose strapline is,

“for babies born too soon, too small, too sick”.

Those organisations really care passionately about neonatal issues.

[Nick Thomas-Symonds (Torfaen) (Lab)]

It is a pleasure to serve under your chairmanship, Mr Hollobone. I warmly congratulate the hon. Gentleman on securing this very important debate. I have received a number of emails about the debate, including from a constituent, Samantha Evans, whose son Dylan was born in the 27th week of pregnancy. Across the emails I have had, there is a wonderful sense of how great the care provided by the NHS to premature babies is. I absolutely praise that, but suggest that perhaps in policy development in future, it might be useful to look at what support can be provided to the parents of premature babies.

[Chris Heaton-Harris]

I thank the hon. Gentleman for his intervention. He is absolutely right, and I will come on to that later. I, too, have had a lot of contact from my constituents on this issue. In fact, at my very first surgery—or advice centre—as a Member of Parliament back in 2010, a lady called Catherine Allcott came in, and it is through her that I got involved with the charity Bliss. I asked whether she would mind if I read out a couple of paragraphs about what happened to her and why this issue is so important to so many parents such as her and her husband, Nigel. She very kindly agreed, so to set the scene for Members, I will read out Catherine and Nigel’s story.

Their twins, Luke and Grace, were born in the early hours of the morning of 4 May 2006, at 26 weeks’ gestation. The twins’ premature birth caused serious health problems, including brain bleeds, suspected meningitis, necrotising enterocolitis and heart problems. Although Grace is now a happy, healthy child, sadly, Luke died nearly four months after being born. Catherine tells me:

“One of the things we found hardest to deal with at that time was the fact that there was often only one nurse in the NICU”—

the neonatal intensive care unit—

“usually to three or four babies.”

She was on the unit so much because of the issues she was experiencing and because she felt so uneasy about that situation, and that is why she has been involved ever since.

Catherine says:

“When I was there sometimes I would have to help the nurse on duty by running into the next room to fetch help. I often wondered what happened when I wasn’t there. When the nurses would tell me not to spend so much time on the unit, what was I to do? Tell them I didn’t trust them with so many babies to look after?”

She goes on to say:

“As a committed campaigner for high quality neonatal care I am saddened to think that in ten years very little has changed in terms of staffing units safely and effectively. How many babies have died or now endure life changing illnesses because there simply weren’t enough nurses to care for them appropriately, and what cost is that to the NHS?”

Catherine’s story is really significant. She took me on to the Gosset ward—the neonatal ward—in Northampton general hospital. I was told by a junior doctor who works there that it has all completely changed; it has been refitted and is a much nicer space. There is no doubting the passion and the care that the staff on the ward give, but equally, there is no doubting the pressure that they are under and the fact that we can help to improve the conditions for them.

World Prematurity Day takes place on 17 November every year—we have just missed it, but this was the closest time to World Prematurity Day that I could get for the debate. The day is aimed at raising awareness of the issues facing premature babies. It is co-ordinated by a global coalition of charities and groups, including Bliss, each year.

The global statistics are quite astonishing: 15 million babies are born prematurely worldwide each year—that is 29 babies every minute, and one in 10 of all babies born—and in the UK, that equates to nearly 60,000 babies born prematurely each year. Bliss estimates that 113 babies who need specialist care to help them survive and thrive are born every year to parents living in my constituency. About 61 of those babies are born prematurely, at under 37 weeks’ gestation. Those born at under 32 weeks’ gestation are considered very pre-term. Those babies are born before they are fully developed and often spend the longest time in neonatal care.

Obviously, most premature births have no clear cause, whereas others are induced due to medical necessity. There is evidence that risk factors for premature birth include smoking, drinking alcohol, substance abuse, low or high maternal age, infection, high blood pressure and multiple births. There is lots of research—although we could always do more on this subject—showing that socio-economic factors also have an impact.

I want to underline the fact that prematurity is a global issue, which is why we have World Prematurity Day. It is the world’s biggest cause of death for young children. Of the 15 million babies that are born prematurely worldwide each year, more than 1 million do not survive. We are fortunate in the UK to have the resources to care for all babies born prematurely, but there is a long way to go before babies and their parents are given the best possible chance.

[Julian Knight (Solihull) (Con)]

I congratulate my hon. Friend on securing this important debate and on his unstinting work for the families of those who are facing the challenges of a premature birth. Often, one of the most acute problems facing families in that situation is meeting the costs of constant hospital visits. Will he join me in calling on all hospital trusts across the country to follow the Government’s guidelines on hospital parking charges, which would see concessions and even free parking for families of babies who often stay in hospital for months on end?

[Chris Heaton-Harris]

I concur with my hon. Friend on that matter. I have heard many a story about that. I have also visited the John Radcliffe hospital to see its neonatal unit and talked to parents. In Northampton general hospital’s case, there is a way for someone to get their parking charge back, although actually, if they are the parent of a premature child who is not doing very well, the last thing they think about is where they are going to park and how they are going to pay for the ticket. The grandparent of a baby born prematurely who is not very well does not think about the parking charge when they go in, but it is one of their worries when they leave. We need to do better on that issue and spread some of the best practice that exists in the NHS when it comes to parking charges. Those charges seem like a minor element in the scheme of things, but they are such a big deal to parents, grandparents, friends and family—the support mechanism that builds around a family when a baby is born prematurely and especially when a baby is born unwell. My hon. Friend is completely correct to raise that issue.

As I said, we have a long way to go before all babies born too soon have the best possible chance of survival and of living a good-quality life. The UK mortality rate for babies is quite high for a western European country. I have previously raised in this place an article in The Lancet, going back probably five years now, saying that we ranked 33rd of the 35 top western countries in stillbirth mortality rates. We were in a very poor place, and I struggle with the massive regional variation across our country. I would like to think that we have best practice that spreads across the NHS, but there will always be somewhere that has a number of staff sick and where there is pressure on a unit. However, there should not be a massive regional variation. The Lancet article said that stillbirth was a third more likely in the east midlands than in the south-west, so there are significant issues to deal with. Surely that rate should be equal across the piece.

If the UK could match the mortality rates achieved in Sweden and Norway, for example, the lives of at least 1,000 babies could be saved every year. One thousand babies—that is such a significant statistic. I have met parents of stillborn children and know what they have gone through. Some 1,000 babies each year could be saved with best staffing and better equipment, although the issue is not so much about resources. It is about spreading throughout the whole NHS the best practice that I have seen in various hospitals up and down the country. Concerns about variation in care were highlighted in this year’s Bliss baby report, which found that two thirds of neonatal units do not have enough nurses and two thirds do not have enough medical staff to meet Government standards for safe, high-quality care.

We must talk about this significant issue and raise awareness of it. I sat on the Public Accounts Committee for five years and raised it there when we had the chief maternity officer in front of us, because we should talk about such issues whenever we get the opportunity. I know that those working in the NHS get it—I have spoken to all sorts of people from the top to the bottom of the NHS, and they obviously all care passionately for the parents and want the best outcome for their babies—but we have a long way to go to improve the care available to mothers, fathers and their babies. We need to raise the matter at every opportunity, and when I did so in the Public Accounts Committee the chief maternity officer took me to one side afterwards and said, “We are really working hard on this. This is an issue that we know we can do better on. The Government have announced a strategy to reduce infant mortality by, I believe, 50% by 2030. That is obviously welcome and recognises that we could and should be doing better.

I want to raise a few points about the 2015 baby report by Bliss, which has done so much work in this area. I know that plenty of other charities do fantastic work, but Bliss is one of the biggest, and I have worked closely with it through my constituents, the Allcotts. I very much respect its work. The report, entitled “Hanging in the balance”, found that funding shortfalls, national skills shortages and problems with training and recruitment are leaving many neonatal units without the staff they need to meet Government and NHS standards for safe, high-quality care. It states that 64% of neonatal units do not have enough nurses to meet national standards of safe staffing levels; two thirds do not have enough specialist nurses; two thirds do not have the medical staff they need to meet national standards; and 41% have no access to a trained mental health worker—one of my hon. Friends will raise that point, so I will not go into it in detail—leaving parents and staff without the vital support they need to help them cope.

I emphasise that it is not only parents who need help. When I went to the John Radcliffe hospital, I unfortunately went on a morning when three babies had died the night before. None could have been helped, but although the staff are professional people who know exactly what they are doing and the situation they are working in—they have a huge passion for their role, deliver a huge amount of care and become attached to families in a big way—it was palpable that the unit was feeling down that morning. In fact, I felt that I was getting in the way, so I left as soon as I could. It is not just parents who need trained mental health workers available to them; the staff also need them to help them cope in such situations.

There are insufficient funding accounts for three quarters of nursing shortfalls in neonatal units, and 72% of units struggle with at least one aspect of nurse training and development. From all the time I have been involved with the matter, especially when seen through the glasses that I have put on as Daventry’s MP and from standing beside Catherine Allcott on Gosset ward at Northampton general hospital, I know that attracting people to go into this area of nursing is quite a job. Those who go into it find it remarkably rewarding, but it is also a remarkably tough role. That is one reason why vacancies in this field of nursing specialism have historically been high, and we must address that. The rewards are massive, but occasionally there are unbelievably bad days at work.

We should have a whole host of ambitions nationally. I want to be able to look my constituents, Catherine and Nigel, in the eye and say that I have done everything I possibly can to ensure that what happened to them does not happen to anyone else.

[Mr Gregory Campbell (East Londonderry) (DUP)]

I congratulate the hon. Gentleman on securing this debate. He is talking about improvements nationally, and I hope that we all concur. Does he agree that the Government should ensure that international best practice and improving statistics in several countries are closely investigated and, where possible, replicated?

[Chris Heaton-Harris]

I thank the hon. Gentleman for his intervention, and he is absolutely right. Statistics regularly prove that we are not doing as well as our Scandinavian colleagues, and we should look at that. I know that we are doing so—a lot of work is going on in the Department of Health and elsewhere to see where we can improve.

I really want to be able to say to my friends who suffered from a full-term stillbirth that the care available to parents in similar situations is much better than it was for them. I said in my 2010 speech that the mother of the full-term stillborn baby was told at the beginning of a weekend that her baby had passed away, but she was sent away because an anaesthetist was not available, so she had to come back on the Monday to have the baby delivered.

I do not deny that there will always be stillborn and premature babies, but what matters is how we look after the parents and how neonatal units look after the babies. I am absolutely sure that in this Chamber and this Parliament, and across society, we all want to deliver the best possible care in those situations.

[Mr Philip Hollobone (in the Chair)]

The format in Westminster Hall is that we have the Back-Bench speeches and then, no later than 10.30 am because we are due to finish at 11, we will have the first of the Front-Bench speeches, from the Scottish National party, and then hear from the official Opposition and from the Minister, but if we get to the Front-Bench speeches before that, so be it.

--- Later in debate ---

[Chris Heaton-Harris]

May I thank, through you Mr Hollobone, the Backbench Business Committee for allowing me and the House the time to discuss this important issue? I thank the hon. Member for Croydon North (Mr Reed), my hon. Friend the Member for Banbury (Victoria Prentis), the hon. Member for Strangford (Jim Shannon) and my hon. Friend the Member for Colchester (Will Quince) for their contributions, and also the Front-Bench spokespeople for the consensual and cross-party basis on which they made their speeches, which is the basis from which we should attack issues about premature babies.

Many important issues have been raised, including mental health care and the acknowledgement of the Government’s ambition to halve the rate of stillbirths and neonatal and maternal deaths by 2030. The Royal College of Paediatrics and Child Health issues an annual national neonatal audit programme report, and the 2014 report came forward with some interesting points, some of which we have talked about today. Sometimes, unfortunately, in Britain in 2014 we were still missing development checks for premature babies, and that is raised in the report. It also mentions something I find shocking, which we have all talked about in our speeches today. We are doing better, and we are focused on the ambition of doing the best we can for parents with a premature baby, but one in 10 families is still not recorded as having a consultation with a senior member of the neonatal team within 24 hours of their baby’s admission. It is unbelievable that that can happen when the parents are at their most stressed and worried.

I thank the Minister for his reply and thank everyone who has taken part. I thank Bliss and other charities for their work in this area, and I especially thank my constituents Catherine and Nigel for their magnificent work in trying to ensure that no one else goes through what they had to go through.

Question put and agreed to.

Resolved,

That this House has considered World Prematurity Day.

Access to Medical Treatments (Innovation) Bill (Money)

Chris Heaton-Harris Excerpts

Tuesday 3rd November 2015 Commons Chamber

[Chris Heaton-Harris (Daventry) (Con)]

I thank the Government for introducing, as is the convention of this place, the money resolution on my private Member’s Bill.

Several colleagues have expressed their concerns about the Bill, as the Opposition spokesman has just done. I must say to them, and to the Association of Medical Research Charities and other bodies, that many of the briefings seem to relate to the previous iteration of the Saatchi Bill that went through three Readings in the other place and have not been changed for this Bill, even though this Bill is massively different from that brought forward by Lord Saatchi in the House of Lords.

The Bill has two elements. It proposes that a database of innovation be established for only registered medical practitioners to use when they innovate or depart from standard medical practice. As we have already heard, doctors and surgeons say that they regularly innovate.

[Dr Phillip Lee (Bracknell) (Con)]

I would never question my hon. Friend’s intentions in this area, but the AMRC’s summary states:

“we do not see the need for this legislation and do not believe the Bill will achieve its aim of encouraging medical innovation.”

It goes on to say that

“this Bill…as it stands is unnecessary and may adversely impact on patients and medical research”.

That view is supported, among others, by Cancer Research UK, the British Heart Foundation and the Wellcome Trust. Does that not give him pause for thought before he proceeds with the Bill?

[Chris Heaton-Harris]

Yes, it does. I have talked to those organisations constantly from the conception of the idea of stealing these two ideas from the Saatchi Bill, and I will continue to talk to every organisation that wishes to talk to me about the Bill. If that was a bid to be on the Bill Committee to offer an alternative view and help me pick through the details of the legislation to ensure that it does what I intend it to do, I welcome my hon. Friend’s approach because a couple of people who would have added great value to the process and the Bill are not able to sit on the Committee.

I gave the example on Second Reading of a surgeon who had innovated and saved the life of his patient, but who was unable quickly to communicate that to his peers as there was no comprehensive means of doing so. The database has been called for by many of the medical colleges, as is acknowledged in the briefings that my hon. Friend will have read. The database is important in spreading the best innovations, because it will include not just the successes of any innovation, but its failures. That will allow best practice to spread quickly and for other registered medical practitioners to learn from any innovation. It will not be available for patients to access and will be held by the Health and Social Care Information Centre, as we have just heard, which is where the money resolution directs the money towards.

The database will not cover research and will not hamper recruitment to clinical trials. Nothing in the Bill will allow doctors to bypass any process or requirement that has been set by their trust in relation to undertaking innovative treatments in the NHS, including the requirement to ensure that commissioners will fund any treatment that is not provided by the NHS. As we all know, individual innovation is incredibly important, but it is not a suitable substitute for medical research, which usually tests the efficacy of treatments in a systematic way. I hope that successful innovations will lead to systematic research projects as the evidence builds around a particular specialty and that they will thereby encourage more clinical trials.

The second part of the Bill, which I fully acknowledge is much more controversial, will give registered medical practitioners a supplementary method of demonstrating that they have acted responsibly while innovating. It closely mirrors the existing legal test, the Bolam test, that is used when clinical negligence proceedings reach the court stage. It brings the test forward and enables doctors to use it to demonstrate that they have acted responsibly before they enter the courtroom. It does not change the common law.

[Mr Baron]

I fully respect the good intentions behind the Bill and those of my hon. Friend. I suggest to him that his last point perhaps misses the more fundamental point that it is the fear of litigation that may deter doctors and medical professionals generally from innovating, and thereby put patients at risk. Does he accept that that is at least a valid concern?

[Chris Heaton-Harris]

I am not convinced that that is the case because doctors and registered medical practitioners innovate daily across the national health service. Litigation might be a consideration in the back of their minds, but they are all responsible doctors doing the best for their patients. I do not quite see my hon. Friend’s point.

Doctors have to demonstrate that they have acted responsibly and that remains the case under my Bill. If they have not acted responsibly, they will be subject, as they are now, to the full force of medical negligence law and bodies such as the General Medical Council.

I would argue that my Bill provides extra safeguards to protect patients from medics who peddle treatments that are dangerous or misguided. First, any doctor must act responsibly and in the best interests of his or her patients. They must also be able to demonstrate that they have done so—as they do now—if it gets to a court of law. Secondly, when an innovation is listed on the database, its successes and failures have to be listed. If a rogue doctor’s peers are able quickly to see the exact results of their innovation, would that doctor not be almost exposing themselves and their quackery to their peers?

My Bill has massively evolved from Lord Saatchi’s Medical Innovation Bill from which many of the criticisms levelled against it come. I have been working with the Department of Health, and others, to ensure that the Bill achieves its central aim, and I know that I have a long road ahead should the Bill get through Committee and its other stages. I fully intend to work with everybody who wishes to make suggestions and help constructively so that we can get to a point where we have a database of innovation that can help spread best practice across our NHS.

Access to Medical Treatments (Innovation) Bill

Chris Heaton-Harris Excerpts

Friday 16th October 2015 Commons Chamber

[Chris Heaton-Harris (Daventry) (Con)]

I beg to move, That the Bill be now read a Second time.

Not a day goes by without those practising medicine in our national health service innovating. Talk to any doctor, and especially any surgeon—in fact any registered medical practitioner—and they will show how they have been innovative and, in being innovative, how they have helped those they are trying to treat. The levels of innovation are, without doubt, inspiring.

Let me give an example to demonstrate what I mean. An eminent surgeon was telling me only the other day of how he had helped a patient who came to him with a particular stomach tumour. At the time of surgery, he found this tumour to be so large that if he had continued with his original plan of removing it, it would probably have killed the patient. This surgeon had just a few nights before read about a drug called Glivec. Glivec creates a mutation called C-KIT, common in chronic leukaemia, where it is a succeeding treatment. Reports appeared indicating that the type of tumour this patient had carried had the same sort of mutation, so rather than trying to remove the tumour, a bypass operation was performed to overcome the obstruction and allow the patient to take the drug.

When the surgeon put his patient on this drug, the tablets were tolerated. The tumour disappeared. Years later that patient occasionally visits his surgeon to say thank you for being innovative and saving his life. In fact, as that surgeon will confirm, there is only one thing wrong with what happened that day. There was no way of recording the innovation on a database that could share it with other surgeons preparing for a similar operation and show how it had worked.

[Mr David Nuttall (Bury North) (Con)]

Will my hon. Friend confirm that the doctor in that particular case would have had to obtain his patient’s consent before proceeding with that innovative treatment?

[Chris Heaton-Harris]

I believe that the decision was taken while the patient was unconscious, but there would then have been a conversation, absolutely, because the doctor would have acted responsibly, as would any surgeon.

This was a life-saving decision, but there was no simple, quick way to tell anyone about it and, in so doing, perhaps save someone else’s life. Earlier this year, when we in this place were getting excited and building up to some sort of election campaign, the House of Lords was passing Lord Saatchi’s Medical Innovation Bill. It passed through all its stages in the other place and, as with many Bills, ideas were refined and concepts were introduced in Committee, on Report and on Third Reading. One of the new ideas that was introduced into the Bill is the central idea that I have plagiarised for my Bill—namely, the introduction of a database for innovative treatments conducted by registered medical practitioners.

[Dr Sarah Wollaston (Totnes) (Con)]

Would my hon. Friend accept that such a database could be set up anyway, without this Bill, and that what is really needed if we are to record medical innovations is adequate funding? This does not require legislation.

[Chris Heaton-Harris]

I shall come to that point in a moment.

When this idea was introduced during the passage of Lord Saatchi’s Bill, it was not a novel one. Several of the royal medical colleges, among others, had already called for such a database. The Academy of Royal Medical Colleges has recently stated that it believes that there should be

“an explicit requirement for the results of an innovation to be properly recorded with the outcomes made available to clinical colleagues for scrutiny and learning…The Academy believes that this is an essential requirement.

The Association of Medical Research Charities has said of data collection:

“This is a key aspect of innovation since new interventions require an evidence base to demonstrate safety and efficacy and to ensure effective uptake in practice.”

[Sir Edward Leigh (Gainsborough) (Con)]

I am not opposed to my hon. Friend’s Bill, which he is presenting in a very effective way, but I want to ask him a question about scrutiny. Might not a bureaucratic procedure that required medical practitioners to put innovations on to a database prevent some of those innovations from being carried out in the first place because people would fear being called to account? Might that not hold people back?

[Chris Heaton-Harris]

I will continue, if my hon. Friend will allow me, because in the depths of my speech I shall come to that point and go into detail about how this will work. I am simply proposing to confer on the Secretary of State the power to establish this process, and I hope to be able to give my hon. Friend a detailed answer to his question in due course.

The Royal College of Surgeons has stated:

“The value of innovation is severely diminished if we cannot learn from it. Registration of the results of an innovative treatment, whether positive or negative, ensures that clinicians can consider the data to learn from mistakes or spread instances of good practice.”

[Dr Wollaston]

My hon. Friend has quoted a number of organisations. Does he accept that all those organisations oppose the Bill? He needs to make that explicit to the House. It is not fair to quote the Royal College of Surgeons, for example, without making it clear that it has explicitly opposed this Bill.

[Chris Heaton-Harris]

I would like to think I am making the point that although we all recognise that we need to encourage innovation in the NHS, and there is tons of it going on, it is not captured in a way that is easily spread throughout the NHS. All the royal colleges I am citing, which do not like parts of this Bill, do accept the concept of spreading innovation, which is something I am trying to do through this Bill.

The Royal College of Psychiatrists has said that

“a register that is available to other doctors would allow sharing of knowledge about a potential innovation and this would be beneficial.”

The Royal College of Physicians add to the list, by stating:

“Innovation relies on a culture of knowledge sharing and a collaborative environment that stimulates ongoing improvement.”

The concept of innovation being spread is welcome throughout the medical community, and I hope to capture it in this Bill. A way of encouraging and recording innovation, and spreading knowledge about it throughout medicine, is widely recognised by most of the royal colleges as being a solidly good thing.

That is also recognised by individual doctors, patients and families. It seems that most people know and understand that there is a need for a culture change in knowledge-sharing and the reporting of success and failure. In researching for my Bill, I was told a story by a dad named Alex Smith, and it is as follows:

“Four years ago, my wife Donna and I were told by a paediatrician to take our son Harrison, who had been diagnosed with Duchenne Muscular Dystrophy, home, love him, give him a good life, there’s nothing we can do, he’s going to die.

How is it possible that our specialist doctors and GPs were, AND STILL to this day are, not willing to try something to help save our son’s life?...every day something we all take for granted as simple as opening a jar is taken away from him, in the last month alone his ability to get off the floor unaided has almost left him and one day in the not-too-distant future his ability to breathe and his heart to beat will be taken away and we will lose him, way, way too soon.”

Mr Smith believes:

“With a robust framework to allow our doctors to innovate safely and responsibly and share that data, the chance to save this generation could become a reality.”

It therefore should come as no surprise that an idea that has been called for by so many worthy and excellent minds, including people such as Alex, Donna and Harrison, who are facing such horrendously difficult times, should be taken up by a legislator, especially given that for decades this simply has not happened.

[Wendy Morton (Aldridge-Brownhills) (Con)]

I am no clinician, but I am a patient, like many of us here. In today’s world, where we so often go on the internet to search for solutions, would it not make sense that when clinicians and the medical profession are seeking innovation, we do all we can not only to encourage them, but to share it, so that others in the medical profession have access to that information? That must, however, be done safely and in the correct manner.

[Chris Heaton-Harris]

I completely agree with my hon. Friend. The only surprise is that such a database of innovation does not already exist. Like generations of previous politicians, I therefore now rise to claim as my own a fantastic idea, which so many cleverer minds than mine have conceived. Thus, the first half of my Bill seeks to confer a power on the Secretary of State for Health to create a database of medically innovative treatments. I strongly believe that the creation of such a database will help to share ideas and spread good practice.

[Heidi Alexander (Lewisham East) (Lab)]

I asked the House of Commons Library whether the Secretary of State has this power already, and it suggested to me that section 254 of the Health and Social Care Act 2012 does give the Secretary of State the power to direct the Health and Social Care Information Centre to establish such a database. Does the hon. Gentleman accept that?

[Chris Heaton-Harris]

I am not sure I do. I would like to think that this Bill completely clarifies how this database can be set up and builds a foundation on which the Secretary of State can do such a thing. My Bill does not build this database; all it does is confer on the Secretary of State the power, which the hon. Lady talks about, to build such a database. If the Secretary of State for Health chose to use the power, it would only be after detailed consultation. However, as we would all expect, when given the opportunity to take a private Member’s Bill through into law, any Member of Parliament, myself included, would endeavour to consult widely on the matter in hand. Thus over the summer I have met pretty much everyone who has expressed an interest in this Bill—either for or against—to endeavour to allay any concerns about its content and direction of travel and to listen to what they have to say.

[Mr Nuttall]

Is it the case that the introduction of the database into this Bill is really in response to the concerns that were expressed in the other place when Lord Saatchi’s Bill was being debated? There were concerns that, if his Bill was allowed to go through without the database, there would be difficulties? Is that not the case?

[Chris Heaton-Harris]

Absolutely, my hon. Friend is completely right.

The Minister will be pleased to hear that I have been working closely with some of the excellent officials in his Department to ensure that there is a little more detail in the Bill specifically to deal with some of the concerns that have been raised with me. First, after a great deal of thought and research, I suggest that the database is held by the Health and Social Care Information Centre. The HSCIC has experience of dealing with big data, and although a number of details would have to be worked out, it seems that it would be the obvious place in the existing health infrastructure to hold such a database.

How the database would work would be detailed outside my Bill by those best placed to do so. However, it is envisaged that a registered medical practitioner, having consulted with his or her patient, would flag up on the patient’s notes that they were innovating. I recognise the pressure that medical practitioners are under, so I am determined that this database should not add much to their already heavy workload, and, hopefully, through this system it would not.

The Health and Social Care Information Centre already has in place a strong set of legal safeguards to protect privacy and confidentiality, which, again, makes it an ideal organisation to host the database. Clearly, privacy issues will be a core part of any consultation that takes place on the detail of the database.

Importantly, the Bill stipulates that outcomes, not just the process of innovation itself, will be on the database. Successes and failures would be recorded on an ongoing basis. There are a number of very, very good reasons for doing that. Of course sharing success is simple to explain. Sharing ideas is in itself a great idea. Letting others see that a treatment has been a success when that treatment might not be widely known is clearly helpful, perhaps even lifesaving. When we know that treatments can differ between NHS trusts and between individual surgeries, it seems clear that we should be encouraging a spread of the good innovation that comes from every individual medical practitioner, such as the surgeon I mentioned earlier and his use of the drug, Glivec.

We must also realise the potential of transparently sharing all outcomes of innovation—not just successes, but failures too. Critics of Lord Saatchi’s Bill were rightly concerned about “quackology”—their term, not mine. There are some doctors who sell to desperately sick people treatments that do not work and that, in some cases, are dangerous. Having a database on which the whole of the registered medical practitioner community can see what an innovation is and then watch the results come in removes quackology from the database in a stroke.

I might well be on the lookout for someone who can cure my male-pattern baldness. Undoubtedly, it would require an innovative treatment; some would say a miracle cure. Currently, there are many treatments on offer to people such as myself. Many adverts will offer me an innovative cure, but there is no way of checking on the successes or failures of the treatments on offer.

[Andrew Bingham (High Peak) (Con)]

My hon. Friend is making quite a powerful case. I do not wish to dwell on his receding hairline, but let me touch on the adverts that we all see for receding hairlines or whatever. Does he envisage an advert carrying a quality mark to say that the treatment is on the database with results that are proven, which would give it more credibility?

[Chris Heaton-Harris]

I am not particularly worried about what is going on up top, but what I would envisage is that if I wanted to get an extra bit of thatch put on I could go to my doctor, have a conversation with him and he would be able to look on the database and say, “There is nothing there. This is all pie in the sky, hokum pokum stuff and not worth going for.” The database gives people a way of checking on the success or failure of the various treatments on offer, and if innovations such as this miracle cure for baldness are not there at all, there must be questions to be asked.

Perhaps some of the treatments on offer do work, but I doubt that the quacks out there would want their supposed innovations placed under the spotlight of transparency in both practice and outcome that the database would offer. There is another much more compelling reason for having a database that records the outcomes of medical innovation, be they successes or failures. It is impossible to learn, to move forward or to spread best practice if innovation is conducted in a silo and if no one else in the health community knows what is going on.

[Sir Edward Leigh]

My hon. Friend and I are fellow Conservatives and we have battled over the years to stop more and more bureaucratic burdens being put on professionals. Our ethos is that we should trust professionals and if they have a good treatment, they will want to test it in their own time and put it on the database. What worries me is that if we have this great bureaucratic mechanism with piles and piles of untested information poured into it, although it might discourage good doctors it will not necessarily discourage quack practitioners. Does he see my point? How does he meet this Conservative objection to the Bill?

[Chris Heaton-Harris]

There are many elements to this genuine concern. My hon. Friend was the Chairman of the Public Accounts Committee and I served on that Committee for five years. We have seen plenty of IT action in the health service space that has not worked at all, but we have moved forward into a new era of big data and can now manipulate it sensibly and shrewdly. All that would be required from the medical practitioner would be a coding on the patient’s notes that would go into the system electronically. All the work would be done behind the scenes to make that visible to the rest of the registered medical practitioner community. Hopefully, it will mean a very small amount of work in exchange for a huge amount of best practice being spread across the NHS.

I have been reading a truly great book by the author Matthew Syed, which is called “Black Box Thinking”. Essentially, it makes the case for the database, for the recording of success and failure and for trying to encourage the reporting of failure so that lessons can be learned. To paraphrase, he basically says that it is rare for someone to come across “a eureka moment” without a huge amount of previous work. In fact, although most invention comes from innovation, most of it comes from innovation in tiny steps that occasionally build up to a large leap.

In a recent radio interview, the author said that healthcare needs a

“scientific mind-set that allows people to learn from their mistakes”

and to be “brutally honest about failure”. He said:

“For senior doctors, who have spent years in training and have reached the top of their profession, being open about mistakes can be almost traumatic. Society, as a whole, has a deeply contradictory attitude to failure.”

He went on:

“Preventable medical error is one of the biggest killers in the UK—when doctors make mistakes they are worried about litigation so they are not open about mistakes and they are made again and again.”

If preventable medical error was a disease, we would devote a whole medical specialty to dealing with it. Among the many causes of that disease would be fear and a culture of blame rather than learning that lead many doctors to conclude that the best option is not to be open about mistakes, which are then repeated again and again. As Matthew Syed says

“at a collective level…success can only happen when we admit our mistakes, learn from them, and create a climate where it is, in a certain sense, ‘safe’ to fail.”

So the database would do several important things. It should increase transparency in innovation, creating an even clearer trail of evidence which not only improves patient safety but encourages further innovation. It would, hopefully, encourage a culture of information sharing, spreading good ideas and also learning from less successful ones. Additionally, I want registered medical practitioners to know and feel confident that they can use the database to innovate and to discover the innovations of others, and this is partly behind clause 3.

I want to provide clarity and give confidence to doctors about how they can demonstrate that they have acted responsibly when innovating, while using the database or not. The second part of my Bill, therefore, does one thing: essentially, it brings forward what the medical community knows as the Bolam test. Currently, the Bolam test is applied only when proceedings have gone to court. However, bringing it forward to an earlier stage would allow a responsible doctor to take a series of steps to prove that they are being exactly that—responsible when providing treatment. This does not change common law. A doctor can continue to rely on the existing Bolam test before the court.

The Bill supplements the existing law; it does not replace it. The Bill will not stop a doctor being sued for clinical negligence. It simply allows a registered medical practitioner to demonstrate what their actions were and with whom they consulted. It gives a doctor that extra bit of confidence that they can prove that what they are doing is responsible and therefore not negligent. The Department of Health did a consultation on Lord Saatchi’s Medical Innovation Bill that revealed that some doctors do find the threat of litigation to be a block to innovation, although this view is not universally or widely held.

However, given that that engagement has identified that some respondents feel constrained from innovating, there is a case for addressing this through legislation. This Bill is aimed at reassuring those doctors, even if that is just an underlying fear, and to encourage the culture change I described earlier.

As Dr John Hickey told me:

“As a registered medical practitioner, a former NHS Trust Chairman and with 30 years’ experience in the field of legal medicine with the Medical Protection Society (the last five years as Chief Executive), I believe I am adequately qualified to comment on your Bill.

Over the last 30 years I have seen how doctors have increasingly practised defensive medicine both because of the fear of litigation and disciplinary action by their regulators; this defensiveness is not in patients’ best interests.

I believe that your Bill, if approved by Parliament, would assist in meeting the concerns of clinicians treating such patients . . . I believe there are adequate safeguards in your Bill, particularly with respect to consent, to prevent the potential ‘quackery’ about which some of the critics of your Bill and Lord Saatchi’s previous Bill have expressed concern.”

I hope that my Bill is given the chance to fulfil the expectations of Dr Hickey, and many others who have contacted me to express their support for it.

I know that this Bill comes in the context of perhaps a new era in treatment, where patient choice is at the heart of decision making. Following on from the Montgomery v Lanarkshire ruling by the Supreme Court earlier in the year, I think it is fair to expect that all registered medical practitioners are now consulting their patients in a full and responsible manner and involving their patients in decisions about their ongoing treatment. So following these appropriate consultations a doctor might choose to innovate in the treatment of their patient and should feel confident to do so.

This Bill is not about research or about testing on patients. It is about harnessing the trust in the common law and the already well respected, tried and tested Bolam test. The Bill just provides clear steps to evidence Bolam, but before treatment takes place. It has always struck me as bizarre that although our national health service is constantly innovating, it rarely captures the innovative practice itself, let alone the results of that innovation. Out there right now in GP practices and in hospitals registered medical practitioners are innovating to help their patients. It is beyond belief that we fail to capture these innovations and allow others to understand and learn from them and then develop them to help others. That is the intention behind my Bill and I commend it to the House.

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[Dr Wollaston]

As my hon. Friend the Member for Daventry pointed out, many of these bodies would like to have such a register, but they would also like to be able to guide how it should look and to have it within the existing research framework.

The Bill suggests that doctors are not already innovating, and that this is about fear of litigation. The original Bill was based on the premise that fear of litigation was stopping innovation. In fact, the position is very clear if we read what a number of bodies have said. My hon. Friend quoted some individual examples, but the vast majority of opinion from the medical community and the research community is that, genuinely, it is not fear of litigation that stops innovation. Every aspect of this Bill is based on a false premise, I am afraid. I do not want to detain the House by reading out all the various quotes on why the fear of litigation does not stop innovation, but he will know that that is the case.

We face the danger of confusing the existing legal framework. Many have expressed their concern that we will end up with a sort of Heaton-Harris defence for those who have undertaken perhaps rather dangerous experimental treatments billed as innovation. My hon. Friend cited the case of the children who suffered from Duchenne muscular dystrophy, and that is very sad, but the Bill has an underlying assumption that all innovation is a good thing whereas the lesson of history is that it can be extremely dangerous and harmful. We need to be very careful about what we mean by innovation, and to accept that there are also very dangerous innovations. If, as a result of this well-intentioned Bill, we inadvertently end up with people being, in effect, experimented on by irresponsible doctors who are able to get off scot-free, we will have to come back to this place and amend it.

I would like to give my hon. Friend an example based on the case of somebody from my constituency who wrote to me to say that he was concerned that the Government were not doing enough with regard to experimental treatments. His specific example was a bogus treatment called GcMAF. The company promoting this entirely bogus treatment—it has a number of clinics in Europe and Guernsey—is very concerned that it cannot use it in this country because it is prevented from doing so by the current legislative environment. Well, jolly good. It puts out literature saying

“we state that if you have terminal stage 4…cancer, have not had chemotherapy, and you do the GcMAF protocol, you have an 80% chance of being cancer free in a year.”

That is the kind of claim that such doctors put out. In other words, the company is not only promoting its own product, but actively discouraging people from having a treatment that could help.

[Chris Heaton-Harris]

My hon. Friend is surely making the case for the database because successes and failures would have to be recorded. She would therefore be able to benchmark and see the evidence behind such a claim. A company cannot choose just to record successes on the database.

[Dr Wollaston]

I must say that I do not think my hon. Friend understands how this works. Companies will simply direct people to their successful treatments. Yes, they may have to record their failures as well, but it is only by comparing the results for bodies of patients having such treatments that people can see whether treatments are entirely bogus. This company cannot currently operate in the UK—quite rightly—and I am afraid that we would see this kind of bogus treatment.

My hon. Friend’s Bill would require doctors who want to undertake so-called innovative treatments to consult at least one other doctor. Seven doctors operate in the clinic concerned. We can see how, if a doctor is working in a clinic with others who are profiting from bogus treatments, it will be very easy for them to pop down the corridor and get one to agree that their bogus treatment is an absolutely fantastic treatment for cancer.

I am afraid that the Bill is based on a false premise, and such a randomly searchable database of unconnected treatments is very dangerous. In addition, if someone wants to start a trial of a new product but there are one or two examples on the database of the treatment not working, the Bill might inadvertently end up killing off a potentially useful treatment. Such things need to be established as part of a research trial. Databases that are randomly searchable by the public will be an absolute quacks charter.

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[Chris Heaton-Harris]

My hon. Friend will know—in fact, we had a meeting about this just before the Bill was first drafted—that I do not tackle research in the Bill; it is specifically excluded. She will know that learning from failure is one of the most important things people can do. She will know that she is describing doctors not acting responsibly, but my Bill does nothing to change the current position: if a doctor acts irresponsibly, the full weight of medical negligence legislation will still come down on top of them. She is painting a picture that simply will not and could not exist if the Bill comes into force.

[Dr Wollaston]

I am afraid that I disagree. My hon. Friend’s Bill would not allow us to learn from failure. We learn from failure through medical research. He says that it will not undermine medical research, but I have read him a long list—I am happy to read it out again—of members from across the entire research community who are deeply concerned that it will undermine research for the reasons I have set out.

If someone was absolutely desperate—as in the very tragic case of the family my hon. Friend cited—and was persuaded not take part in a clinical trial by an unscrupulous doctor, why would they do so? They would mortgage their house to go to such a clinic if it persuaded them to do so, thinking that it was their best hope of a cure. The fact is that that hope is likely to be dashed. They are best off going to an established research community.

The Bill will undermine recruitment to clinical trials. Although my hon. Friend does not mention medical research, very vulnerable people will end up circumventing genuine medical research. He will set back the progress of science, and when that comes to pass we will have to come back to the House to amend the legislation. I very much regret that he has been persuaded to take up this Bill. He knows of the long list of members of the research community who are profoundly opposed to it, for the reasons I have set out.

I urge the Government to be very clear that they support medical research and that they want genuinely to move forward on that basis. My hon. Friend the Minister is right to be looking at the accelerated access review. Let us use that review to look genuinely at the barriers to research and to getting products rapidly into use for NHS patients.

I urge colleagues to read the briefings on their desks from the entire research and medical community, and robustly to reject the Bill.

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[Heidi Alexander]

I am keen to find a way for doctors to innovate, but to do so using safe and effective treatments.

I was saying that the problem with the Bill is that it undermines a patient’s ability to hold doctors to account when things go wrong. The hon. Member for Daventry claimed that this is not Lord Saatchi’s Bill, but the wording of clause 3 is very similar to clause 1 of the previous Bill. Clause 3(2)(a) in today’s Bill requires a doctor to

“obtain the views of one or more...doctors”—

which, in practice, could mean just one doctor—

“with a view to ascertaining whether the treatment would have the support of a reasonable body of medical opinion.”

Will the hon. Gentleman confirm that that relies on someone’s interpretation of a “reasonable body”, as opposed to seeking a view from a responsible body directly? Does the Bill not boil down to one doctor who wishes to deviate from accepted medical treatments asking another doctor whether he or she thinks there is a reasonable body of medical opinion that would support such a treatment? As long as that second doctor perceives such an opinion to exist about support for the proposed treatment, this provides cover for the patient’s doctor to proceed. I cannot say that I am particularly convinced by that.

[Chris Heaton-Harris]

To allay that concern, the Bill states that nothing in it would override existing common law. All it aims to do is bring forward the step of the Bolam test, so that the doctor himself or herself can make a judgment at that time on whether he or she is doing something correctly. It does not stop clinical negligence cases coming forward; it just helps to prove that the doctor might or might not be acting in the responsible way that he or she should be.

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[Philip Davies]

I take my hon. Friend’s point. She is an expert in her field in a way that I am not, and I certainly do not want to decry that. My perspective on the narrow point she raises, however, is slightly different. I would want to set the framework of the law for the overwhelming majority who are doing a good job. Let us try to find other ways to weed out those who are not doing so. Putting in place arrangements that apply to everybody in order to deal with the very small number of doctors about whom my hon. Friend speaks is probably the wrong way of going about it. I am happy to have this conversation with her in a different setting; I do not want to deviate too far from the Bill in going into how many doctors are noble and how many are chancers. I do not know the answer to that; perhaps my hon. Friend does, but I am not getting into that today.

My hon. Friend the Member for Totnes (Dr Wollaston) made the point that the Bill is unnecessary—the shadow Minister made the same point—and that there is no need for a legal requirement for medical innovation to be made, particularly when the current common law Bolam test is appropriate. Although it may not be popular, however, I believe it important to give serious consideration to this part of the Bill.

The Medical Innovation Bill, although criticised, showed an appetite for more legal work in the area of medical innovation. After a commitment from the Secretary of State for Health, the Medical Innovation Bill was put to consultation in the last Parliament. Many organisations shared their views, some of which have already been mentioned. I shall highlight a couple of those views because they are relevant to today’s Bill.

Cancer Research UK stated in its consultation response:

“There is clearly patient and clinician demand for more innovation to help treat people with cancer. We do sometimes see exceptional responses to treatments from individual patients, and therefore want to be in a position to innovate. Cancer Research UK is supportive of efforts to bring innovative treatments to patients faster and to improve the uptake of innovative treatments in the NHS. Any new legislation seeking to promote innovation should be drafted to ensure doctors have to establish there is sufficient intellectual underpinning and safety data about a treatment before proceeding. There should also be appropriate consultation with other doctors in the same or a related field to ensure patients receive the best care at all times.”

I understood from previous contributions to this debate that Cancer Research UK was against today’s Bill, but it does not strike me from the response I have cited that it was opposed to it. It seems to me that it was looking for ways to bring about more innovation to help treat people with cancer. It seems to be open to the possibility that the Bill might be able to do that.

[Chris Heaton-Harris]

I fully admit that there are a number of critics of the Bill, but not so many critics of the central idea in the Bill. I welcome what the hon. Member for Lewisham East (Heidi Alexander) said about trying to work with those who are genuinely interested in spreading best practice and innovation across the NHS. If one of the Bill’s core features is widely welcomed, even by some of the harshest critics of its later parts, I put it to the hon. Lady that it is surely it is worth taking the Bill forward into Committee to examine the provisions in greater detail, when we could debate it with expert witnesses and others.

[Philip Davies]

My hon. Friend makes a very good point. A Second Reading is, of course, a debate of a Bill in principle, so that we can establish whether people object to it in principle. I have been somewhat confused by the voices in opposition to the Bill because I cannot work out whether they consider the Bill to be dangerous or unnecessary because what it proposes is already being done. It seems difficult to argue that it could possibly be both. Either the Bill’s provisions are already in place so there is nothing to be done, or the Bill is a terrible and dangerous thing.

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[Philip Davies]

It is not for me to advise other Members how to pursue their own agendas. My hon. Friend is a wonderful exponent of ways of implementing her views, but my advice to her, for what it is worth—which she may think is not a great deal—is that if she wants to see more innovation in medicine, as she said at the beginning of her speech, but does not believe that the Bill is the right way forward, she should support its Second Reading and then seek to amend it in Committee so that it achieves the innovation that she would like to see. We shall then review the matter on Third Reading, and she can decide at that point whether the Committee stage has delivered to her what she feels would be a useful way of getting more innovation into the NHS. It seems to me bizarre that someone should stand up and say, “I want to get more innovation into the NHS”, and then block on Second Reading—and this is the principal point of the Bill—any attempt that might actually facilitate the introduction of improved innovation into the NHS. But that is just the way I see the matter; it is up to individual Members to pursue their agendas in the way that they see fit.

[Chris Heaton-Harris]

I believe that the Bill should go into Committee, because it is an evolution: it is a process that we are going through in trying to get the position right. The Royal College of Physicians says that it “generally welcomes” the first part of the Bill, which enables the Secretary of State for Health to establish a database of medical treatments. However, it issues plenty of caveats in respect of how the detail should run. Those should be discussed in Committee, and that is where I want the Bill to go.

[Philip Davies]

My hon. Friend has made a very fair point.

I now want to say something about the medical innovation database provision, which is one of the main differences between the Medical Innovation Bill and the Bill that we are discussing. Clause 2 provides for the Secretary of State to make regulations enabling the Health and Social Care Information Centre to establish a database containing information about innovative medical treatments and their outcomes. As a layman, I consider that to be a significant and fundamental part of the Bill. A central database recording all innovative treatments strikes me as a useful tool from which doctors can learn when tailoring medical treatments for their patients. Again, I speak as a layman, but I think that the creation of a system to enable that knowledge to be shared is a logical step towards medical innovation.

Having said that, I should add that the proposal is not without its worrying aspects. I wanted to raise them earlier, but the interventions from my hon. Friend the Member for Totnes delayed me. One of the main criticisms of clause 2 comes from the Royal College of Surgeons of Edinburgh, which states:

“The proposed database could only be effective if it is compulsory, regulated, has robust quality assurance and be journal-led, ethically framed and rigorously peer reviewed. It will also require an honest culture in which participants are just as likely to register failures as successes”.

The clause provides for the Health and Social Care Information Centre to specify what information should be recorded and how it should be assessed. More experienced people than me will be able to note what standards and specifics need to be recorded to make the database useful and usable. It is certainly not for me to make any suggestions. The database will also be designed in consultation with professional bodies and organisations.

The clause contains the important provision that the database will cover all individual patient innovations, not only those in respect of which doctors have chosen to rely on the steps in the Bill to demonstrate that they have acted responsibly. It is a significant inclusion, as it means that the database will include and cover all treatments and their outcomes—both positive and negative —that take place in England. That is my understanding of the clause, but if my hon. Friend the Member for Daventry wants to correct any misunderstandings, he is welcome to do so. Therefore, this national database not only spreads the knowledge of successful innovations, but also has the benefit of ensuring that innovative treatments that do not work, or perhaps have harmed patients, are not repeated by other clinicians. That should go some way towards reassuring those with concerns. It will also, therefore, create a standard practice that all innovative medical treatment should be recorded in this database, which can be a useful tool for other doctors to draw information from when they are doing their own innovation.

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[Philip Davies]

My hon. Friend makes a good point. I have not heard anything so far today to suggest that the Bill should not at least go into Committee for further scrutiny, and perhaps even for some improvement, if I may be so bold as to suggest that may be possible. I do not think I have heard anything today that suggests the Bill should be stopped in principle on Second Reading. I hope that my hon. Friend the Member for Totnes will appreciate, however, that I am also trying to be balanced in setting out some of the concerns that have been expressed, perhaps so they can be considered if we do get into Committee, which would be a useful exercise.

Another concern raised by some of my constituents is that the database may compromise patients’ anonymity. Innovative medical treatments will be applied on a case-by-case basis with a specifically honed technique for one particular individual. The fear is that a degree of detail will be needed in the register, which would end up compromising a patient’s anonymity. That is a valid concern, and protections would need to be put in place to ensure all information is stored securely within the database to protect anonymity. However, that may be at the cost of using innovative treatments. There may well be a tension between those two factors.

While the information stored in the database should only be accessible by doctors, it will need to remain confidential aside from access for medical purposes and, ultimately, it should be the patient’s choice whether to use an innovative treatment that will be recorded for medical purposes. Furthermore, in an age when we want more doctors to spend more time with patients and not at their desks, we need to be careful to ensure that the register does not become overwhelming to the point where doctors are put off from using innovative techniques for the sake of the amount of paperwork and red tape that would accompany it. The Academy of Medical Royal Colleges said

“current experience in the NHS show that establishing an effective register for far more standard procedures is a complex task. Establishing and maintaining a register of innovations would be a costly and potentially burdensome and bureaucratic task.”

My hon. Friend the Member for Totnes made that point. That is another factor that needs to be considered when the database is created. Of course the database and the information gathered should be rigorously checked and regulated. However, that is not always easy when doctors are already busy.

Overall, I believe this clause, originating from an amendment to Lord Saatchi’s Bill, is one of the key clauses. For rare diseases such as some cancers there is a lack of published evidence on which to rely when determining treatments to try. It is also widely regarded that some methods used to treat some types of cancers have remained similar for many years, with only slight modifications to the techniques. With this in mind, a database that allows knowledge to be stored and accessed at a doctor’s level will be not only desirable but probably essential for allowing doctors to innovate responsibly. It will encourage a culture of knowledge sharing, which, importantly, will include both successes and failures. This is a vital part of the Bill, and indeed I do not see how the power to innovate can move forward without the inclusion of a database recording the results of these treatments. I therefore commend my hon. Friend the Member for Daventry on including this clause.

We need to look at what we consider to be a responsible innovative treatment. Clause 2(2) states that a treatment is regarded as

“‘innovative’ if it involves a departure from the existing range of accepted medical treatments”

for a condition. We can therefore assume a wide scope to cover the cases that should be recorded in the new database.

However, concerns have been raised regarding the distinction between innovation and research. While clause 5(2) specifically states that this Bill does not apply to medical research, some medical organisations have raised concerns as to how this would work in reality. The Academy of Medical Royal Colleges states:

“We do not understand the distinction between ‘individual patient innovation’ and ‘research’. The distinction seems false and potentially dangerous. As a college president stated ‘Innovation without research isn’t innovation, it’s more often just advertising’.”

Although the Bill uses the two in harmony, it is important to raise these points and for them to be considered in Committee.

One of the main differences that separates the two is that this legislation allows doctors more freedom to modify and specifically cater treatments towards the individual they are treating. That is very important and worthwhile. Although they will not be finding a brand new cure for cancer, it allows doctors to cater treatment plans more specifically to the patient’s needs and wishes. Many patients will benefit from that, and often would prefer it.

We have discussed the Bolam test. By working from the current common law Bolam test, the Bill identifies the steps a doctor can take to show that they have acted responsibly before innovating. The common law Bolam test is defined as the test

“used to determine the standard of care owed by professionals to those whom they serve, e.g. the standards of care provided to patients by doctors.”

Established from the case Bolam v. Friern hospital management committee in 1957, it shows that if a doctor acts in accordance with a responsible body of medical opinion, he or she will not be negligent. Subsequently this standard of care test was amended—the Bolitho amendment—to include the requirement that the doctor should have behaved in a way that “withstands logical analysis” regardless of the body of medical opinion.

This determination of whether a professional’s actions or omissions withstand logical analysis is the responsibility of the court. The Bill, through clause 3, aims to reflect as closely as possible the steps under the current common law which a responsible doctor could be expected to satisfy when innovating. However, clause 3 has caused specific concern for many of my constituents and I would like to raise some of their concerns today.

Most groups and individuals from the medical profession seem to be satisfied with the current Bolam test as a standard for regarding medical innovation, with the Royal College of Surgeons regarding it as “adequate”, so there are concerns that, instead of clarifying the legal position, clause 3 will confuse the current mechanism for judging responsible innovation.

Subsection (2)(a) requires a doctor to

“obtain the views of one or more appropriately qualified doctors in relation to the proposed medical treatment, with a view to ascertaining whether the treatment would have the support of a responsible body of medical opinion”.

This implies that the innovating doctor need only rely on an interpretation of a responsible body, and need not gain the support from a responsible body itself. In practice this might not be a problem, however, as the Bill specifically states that those supporting views must be obtained from “appropriately qualified doctors”—that is, those with appropriate expertise and experience in dealing with patients with the condition in question. It may therefore be taken that the doctor is qualified in the relevant field, which would provide reassurance. It is this clause that many of my constituents are concerned about, however.

This brings me to another point that was raised by my hon. Friend the Member for Totnes. Some of my constituents fear that the database could be used as a tool by quacks, crooks and charlatans, giving them the flexibility to use devious experimental treatments. Indeed, that concern has been echoed by the Royal College of Surgeons, which claims, in reference to clause 3(2)(a):

“This sub-clause could also provide post-hoc justification for an unethical treatment from a doctor asserting s/he sought the view of one other doctor.”

We must be sure, therefore, that appropriate safeguards are in place to protect patients from such doctors. I do not think that many of them exist, but I do not know. My hon. Friend the Member for Totnes and I might have some disagreement about that. The important point is that there needs to be a safeguard, because it is inevitable that some such doctors will exist.

[Chris Heaton-Harris]

Those safeguards do exist. A doctor has to act responsibly, and if he does not do so, the full weight of the GMC and the law will come down upon him. That situation will not change at all as a result of my Bill.

[Philip Davies]

I take my hon. Friend’s point, and we should recognise the work of the General Medical Council in ensuring that high quality people are in the profession.

Much of the debate has rightly focused on the impact that the Bill would have on doctors and the medical profession, and on whether it would give them further freedom to innovate or whether it could be misused. However, it seems to me as a layman that much of the focus should also be on the patient. Ultimately, it is the patients who will bear the consequences of this legislation. Many of my constituents, on both sides of the debate, have contacted me to offer opposing views on the effects the Bill would have on patient safety. Some are concerned that it would move the focus from determining whether a patient’s care had been negligent to whether the doctor’s decision had been responsible.

However, the Bill would provide another layer of protection for patients in that the assessment would be carried out before the innovative treatment took place. By following the steps of the common law test, the doctor would obtain the views and support of a responsible body of medical opinion before innovating, so that they could be confident in the knowledge that they had support and would thus not be found negligent. This would of course provide reassurance to the doctor administering the innovative treatment, but more importantly, it would also be in the patient’s interest. Patients could therefore be satisfied about the treatment plan they were undergoing. Any innovative treatment plan must, by definition, come with concerns, but at least the patient could be assured that the doctor had satisfied legal and sound tests to show that the proposed treatment was responsible.

The Bill also sets out that during their research enquiries, the doctor must act and record views in a responsible manner. Therefore, if an appropriately qualified doctor were to consult on the proposed innovative treatment and express reservations about it, the innovating doctor could not disregard those reservations without being found negligent. That is an important point that should not be forgotten. Presumably, the powers of the GMC could kick in at that point to deal with any parts of the medical profession that we might not be altogether pleased with. My hon. Friend the Member for Totnes should not discount the fact that this legislation could highlight some of those cases and bring to account certain people who are hidden from such exposure at the moment. The aim of these provisions is to preserve the existing safeguards of the common law for the patient while giving the innovating doctor the additional choice of taking steps to show that they have acted in a responsible manner prior to innovating, thus aiming to encourage most doctors to do so without fear of litigation.

It is also important to touch on the possibility of unintended consequences. On Fridays, we often debate Bills that have a worthy sentiment behind them—indeed, that applies to most of the Bills that we discuss on Fridays—but they often turn out to be accompanied by unintended consequences. Some of the potential unintended consequences of this Bill have been raised with me by my constituents. One such concern is that the Bill could inadvertently undermine the work of clinical trials or discourage patients from participating in clinical trials, instead leaving doctors to focus on individuals on a case-by-case basis.

Clinical trials, by definition, test methods that aim to be of general benefit in combating a disease collectively—that is, they aim to find a common solution that can work with all, or nearly all, patients. The concern is that if doctors are encouraged to use innovative treatments when treating their individual patients, this could harm the development of research and clinical trials, as they may bypass the need for a regular clinical trial, leaving innovation to develop on an individual level. That seems to be a reasonable point for my constituents to have raised.

Having said that, the proposal could provide an opportunity to enhance the work of clinical trials and research. I hope that my hon. Friend the Member for Daventry will look further in Committee at any unintended consequences, and determine what, if anything, needs to be done to the Bill to prevent any harm from being done to clinical trials. It could boost clinical trials, but there is the potential for both consequences, and we must ensure that it results in a good conclusion rather than a bad one.

If a doctor were to use an innovative treatment on a patient that seemed to be successful, and subsequently recorded it on the medical database, a larger-scale clinical trial could be established to determine whether the treatment provides an inclusive solution for the disease or is suitable only for that individual. I hope that such a complementary consequence will occur as a result of the Bill, and that the understandable concerns of my constituents will be unfounded. The Bill does not create the climate for innovative treatment to begin. Doctors already have the freedom to innovate in individual cases, and that has not yet caused any difficulties or concerns for researchers or clinical trials, so there is no reason why it should do so in the future.

When considering the unintended consequences, we must also consider the unintended positive consequences, such as the one highlighted by the Royal College of Surgeons. It has stated:

“We…believe the Bill could potentially help to prevent poor practice in the private sector where decisions to try unconventional treatments are, in some rare instances, taken without adequate evidence or support from a multi-disciplinary team (MDT decision-making is less common in the private sector).”

Passing the Bill, and setting a more robust legal framework, would automatically set a precedent in the medical community for the procedures that would be expected to be followed when using innovative treatments.

--- Later in debate ---

[Philip Davies]

I do not think that anyone would disagree with my hon. Friend. Everybody is concerned about patient safety. I have stated at length some of the concerns that my constituents have raised about, for example, anonymity and safety. I hope that all those points will be considered by my hon. Friend to see whether anything further needs to be done in Committee. No one disagrees with that, but saying that we cannot have a Bill that does not protect patient safety is probably not the same as my perspective.

[Chris Heaton-Harris]

What my hon. Friend the Member for Totnes (Dr Wollaston) has to answer is what provision she would put in place to recognise failure of innovation. If this database is not the right way forward, what is?

[Philip Davies]

I do not propose to be the central hub of a three-way conversation involving my hon. Friends. I am sure that they are perfectly capable of sitting down in the Tea Room afterwards and going through this in some detail with each other, and they can leave me alone. They do not need me to speak on their behalf. We will leave the three-way conversation there, and I will press on.

Finally, I wish to raise the accelerated access review, which my hon. Friend the Member for Totnes mentioned. In 2014, an external review of the development, assessment and adoption of innovative medicines and medical technologies—the accelerated access review—was announced. This is expected to make recommendations to Government on speeding up access for NHS patients to cost-effective, innovative medicines, diagnostics and medical technologies. Some medical organisations have said that they wish to wait to see the recommendations of this review before implementing changes to rules around innovating treatments. I think that was the main thrust of the speech of my hon. Friend the Member for Totnes. The Royal College of Surgeons said:

“The Government’s consultation on the Accelerated Access Review recently closed and this is likely to prove a more productive route for identifying ways to encourage innovation.”

However, in an article earlier this year, my hon. Friend the Minister for Life Sciences—just to prove that I do read his articles—linked this Bill specifically to the Government's accelerated access review. He stated:

“The Medical Innovation Bill highlighted some of the important issues and obstacles to the adoption of innovation in the NHS. The growing pressure from patients and medical charities for faster access to innovation, and the potential of the NHS as a world beating research ‘engine’ in 21st century life and health science creates an opportunity for the UK to deliver benefits for patients, NHS and economy. This is the aim of my accelerated access review of NHS adoption of medical innovation. I look forward to working with Chris Heaton Harris to help him shape a Bill to help unlock this exciting opportunity.”

I look forward to the Minister’s comments in due course, but it seems to me that, rather than the accelerated access review being an alternative or something different from this Bill, the thinking is that these two things can go hand in hand with each other, and that one does not contradict the other.

Although the AAR is expected to report recommendations back to Government at the end of the year, its briefing specifically lists

“barriers that currently prevent the uptake of transformative healthcare within the NHS and the healthcare industry.”

Three areas are specifically mentioned: insufficient skills to adopt innovation; lack of leadership support for innovation; and lack of accountability for innovation. Those are just three points I have picked out from the list of areas identified for recommendations by the AAR. It seems that it is those issues that my hon. Friend’s Bill aims to target and it is therefore within the scope of what the AAR is trying to achieve.

In conclusion, this Bill attempts to provide leadership and support for innovation by setting a precedent that innovation should be encouraged and nurtured. It specifically pinpoints accountability by providing doctors with a test to satisfy prior to the beginning of any innovative treatment in such a way that satisfies doubts that the innovating is of a responsible nature. Finally, and most significantly, it sets a base for sufficient skills to adopt innovation by providing a database from which other doctors can work together and learn.

Ultimately, this Bill is not only for doctors; it must and should focus on the patients it affects. Although doubts are cast over whether the regulation to ensure innovating treatments are created responsibly, we must also consider the principle that responsibility can be satisfied before the innovating treatment is administered, thus reassuring the patient as well as the doctor. There is also a compelling argument that those patients who want innovative treatments—they may not be able to wait for lengthy research and approval systems—should be given the option to use innovative treatments. Those treatments should not be withheld because a doctor fears litigation. The patient should always be at the centre of what we do, and we should provide legislation that allows them to use the medical treatments of their choice that have that doctor approval.

I commend my hon. Friend for introducing this Bill, because he has hit on something that matters to a great deal of people. I have constituents on both sides of the argument. There are legitimate concerns, but I have heard nothing today that does not persuade me that this Bill should go forward from its Second Reading. I hope that some of the concerns that I have outlined today will be considered by my hon. Friend in Committee and that we end up with a Bill that is welcomed by those who support it and that deals with all the concerns that have been raised.

[Mr David Nuttall (Bury North) (Con)]

As always, it is a great pleasure to follow my hon. Friend the Member for Shipley (Philip Davies), who has set out with his usual clarity the reasons why the Bill should receive the support of the House today. I too rise in support of the Bill.

I warmly congratulate my hon. Friend the Member for Daventry (Chris Heaton-Harris) on his success in coming second in the ballot for private Members’ Bills and on choosing such an important subject to bring before the House this morning. As we have seen, it is a Bill that is not without some controversy. Often, private Members’ Bills are technical and minor in nature and do not receive much public attention, but it is fair to say that this one very much has. It brings before the House—I think that I am right in saying that it is the first time that these issues have been debated on the Floor of the House—the issues that were considered in the other place when the Lords debated the Medical Innovations Bill, which was piloted through all its stages by the noble Lord Saatchi in the previous Parliament. I note, incidentally, that the noble Lord reintroduced his Bill on 8 June. I hope that he does not fear for the possible success of this Bill; perhaps he is just hedging his bets. I certainly hope that this Bill will proceed safely through this House and arrive in the other place.

The Bill builds on the work of Lord Saatchi’s Bill in that it deals, I think adequately, with some of the criticisms of it. The purpose of this Bill, as we have heard, is to promote the use by doctors of innovative medical treatments and it does that by allowing for the establishment of a database of such innovative medical treatments and by setting out the steps that doctors can take to demonstrate that they are acting responsibly in carrying out such treatments.

I have to admit at the outset that an impressive array of bodies have lined up either in outright opposition to the Bill or with at least some reservations about it. When I was considering the evidence, I had to take that into account. I had to decide whether in the light of that evidence I should simply go with the flow and decide that if all those people said that it is a bad thing, it must be a bad thing, or whether I should think about the other side of the coin. I did that, and on balance, I came down on the side of what I like to think of as my constituents’ view. I believe that the Bill has the potential to improve the lives of my constituents if they are struck down by a rare disease that means that they require innovative medical treatment.

It is appropriate to try to deal with the concerns that have been raised by so many eminent bodies in the medical world. As we have heard, last year, many organisations responded to the consultation on Lord Saatchi’s Bill. Like my hon. Friend the Member for Shipley, I shall try to deal with some of their concerns. The professional body for doctors, the British Medical Association, often described as the trade union for doctors, said in its consultation response to the Medical Innovation Bill:

“The BMA believes strongly in the value of innovation in medicine. Whilst the BMA would have concerns if the draft Medical Innovation Bill was to become law, if there was a need identified, we would support the exploration of other initiatives through which responsible, safe and effective innovation can be promoted to doctors.”

In its 2014 response to the consultation on that Bill, the AMRC, the Association of Medical Research Charities, a national organisation made up of 137 leading research and medical charities from across the UK that, incidentally, spends about £1.3 billion a year on research, welcomed the ambition of the Bill but was concerned about its unintended consequences. In February this year, it welcomed the idea proposed in the other place about the importance of collecting data. I am pleased to note that the Bill we are considering today appears to address that concern by establishing a database to collect the results of innovative medical treatment.

Without wanting to create confusion, I want to refer to another body that raised concerns, another AMRC—not the Association of Medical Research Charities this time, but the Academy of Medical Royal Colleges, a body that comprises 20 medical royal colleges and faculties from across the UK and Ireland. It agrees with the idea that research and innovation are vital to the NHS, but does not support the Bill as a whole because, in its words, it is not clear what it is trying to achieve.

It is therefore a considerable challenge for my hon. Friend the Member for Daventry and those of us who support the Bill to demonstrate the need for it. To put it simply, I believe that it will provide access to innovative treatments to best meet a patient’s desires and needs when other treatments might not achieve the best results. People might well ask why we need the Bill now. The law on medical negligence has not changed for decades and in those decades medical innovations have been made. The law might not have changed much, but society certainly has—it is more informed, less deferential and more litigious. The number of lawsuits filed against the NHS has doubled in five years and last year’s pay out, which has also doubled in that time, was £1.2 billion. The Treasury provision for claims against the NHS has now reached £26 billion, so it is no surprise that doctors increasingly feel frightened of being sued and therefore, understandably, feel less likely to be able to innovate.

It is worth noting that back in 2013 the Health Service Journal stated:

“It is a popularly held view that the NHS is resistant to innovation. Despite several laws and policy directives and many successful examples of innovative approaches resulting over the years, the NHS is still seen to a late adopter of innovation—inventive but not creative.”

I believe that the Access to Medical Treatments (Innovation) Bill has the potential to counter that problem by putting innovation on a statutory footing.

NESTA, the independent charity in the UK that works to increase innovation in the UK, considered the whole question of innovation in the healthcare system in its 2014 report, “Which doctors take up promising ideas?” It highlighted the early adoption of drugs by general practitioners since 2010 to treat conditions such as diabetes, chronic constipation in women and deep vein thrombosis as well as to prevent stroke in patients with atrial fibrillation as an alternative to warfarin. The study also found that 86% of doctors found out about other innovative treatments from other doctors. It is a crucial component of this Bill that it places a responsibility on any doctor wishing to undertake innovative treatment to talk to another doctor about the proposed treatment.

NESTA’S report also recommended that there should be clear instructions on innovation to encourage early adoption, which is what I believe that the Bill aims to do, to provide reassurance, and to provide instructions to doctors to allow them to adopt life-saving treatments only when it would be in the best interests of their patients. The Bill would extend and encourage the idea sharing that is already going on between doctors and give them confidence in that process.

One of the key objections made by bodies such as the BMA was the “unproven threat” of litigation against doctors. In the summer, it was reported in the press that between 2010 and 2013 there was a 64% increase in the number of complaints to the UK medical regulator, the General Medical Council, and a 42% increase in the number of doctors struck off or suspended from the UK medical register. Let me make it clear that I believe that patient safety must be paramount. It is right that patients have access to our world-class justice system if, sadly, things go wrong. It is, however, a curious observation to make that there is an “unproven threat” of litigation when the bill for legal fees paid out over clinical negligence claims in 2013-14 was £259 million, with many believing that there is an increasing culture of litigation.

The Royal College of Ophthalmologists expresses a common view:

“Without unequivocal GMC and NICE support, ophthalmologists are understandably concerned that they may be assuming unacceptable personal liability by using a unlicensed drug when a licensed alternative exists … Consequently, patients may not be getting treatment when they need it and not getting the best results.”

Of course, the Bill must not be seen as a licence to experiment on patients, which is one of the more sensational claims I have seen about the Bill. I believe it clearly preserves the existing safeguards of the common law, which protect the patient while giving the doctor the option to take steps to demonstrate that the action they have taken has been taken responsibly before carrying out any innovative treatment.

As the guidance notes make clear, if another qualified doctor expresses reservations, those would have to be taken into account or, quite appropriately, the prescribing doctor could be found negligent. I do not believe that this Bill is simply a “get out of jail free” card for negligent doctors. It does not override the Bolam test, which was first set out in the leading 1957 case of Bolam v. Friern Hospital Management Committee. In that case Justice McNair said in his judgment that a doctor

“is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art”.

Therefore, a doctor would be negligent under the current law if they treat or manage a patient in a way in which no responsible body of doctors would have acted. That test was extended to include a requirement that they must also act in a logical manner, which is called the Bolitho test, established in the case of Bolitho v. the City and Hackney Health Authority.

I believe the Bill contains the appropriate reassurances that doctors cannot use it to run roughshod over the existing law. The necessary reassurance is contained in particular in clause 3(5), which explicitly states:

“Nothing in this section permits a doctor to carry out treatment for any purpose other than the best interests of the patient.”

To ram home that point clause 4(1) clearly states:

“(1) Nothing in section 3—

(a) affects any rule of the common law to the effect that a departure from the existing range of accepted medical treatments for a condition is not negligent if supported by a responsible body of medical opinion, or

(b) is to be read as limiting the circumstances in which any such rule of the common law may be relied on”.

I do not believe, therefore, that the Bill would limit redress in the event of negligence. A doctor would still be negligent if they acted in a way that was not in the best interests of their patient. However, the Bill would put into legislation a workable framework to allow responsible innovation where that would serve the best interests of the patient when a conventional treatment or lack of treatment might not meet the same goal.

I turn to the concerns of the Royal College of Surgeons, a professional membership organisation and a registered charity, which exists to advance surgical standards and improve patient care, with 20,000 members in the UK and abroad. That body has issued a parliamentary briefing on the Bill and one of its concerns is:

“The wording of the Bill confers the decision-making power on the doctor rather than the patient. There is a risk it misunderstands the doctor-patient relationship.”

The RCS may think there is such a risk, but having read the Bill and the guidance notes I fail to see that. As I have mentioned, the Bill clearly states the importance of the doctor acting only in the best interests of the patient and consideration being given to the patient’s views.



Clause 3(2) states:

“For the purposes of taking a responsible decision to depart from the existing range of accepted medical treatments for a condition, a doctor must in particular . . .

(c) obtain any consents required by law to the carrying out of the proposed treatment”.

The guidance notes for clause 3 clarify that that means that

“the Bill does not affect the legal requirement for a doctor to obtain a patient’s informed consent to any treatment proposed”.

It could not be clearer. The Bill does not affect that legal requirement for a doctor to obtain the informed consent of a patient. Indeed, only this year in the Supreme Court was the issue of consent and a patient’s understanding of treatment considered in the case of Montgomery v. Lanarkshire Health Board, when it was held that it would be a mistake to view patients as uninformed, incapable of understanding medical matters, or wholly dependent on information from doctors. It was said that an adult of sound mind was entitled to decide which of the available treatments to undergo, and their consent must be obtained before treatment is undertaken. Doctors are under a duty to take reasonable care to ensure that their patients are aware of any material risks involved in proposed treatment, and of the reasonable alternatives available.

This seems to be in accordance with guidance from the General Medical Council which, as one would expect, provides lengthy guidance on the question of consent and outlines the steps a doctor should take to communicate in

“clear, simple and consistent language”

to a patient and to work on the presumption that patients have the capacity to make decisions about their own care.

The RCS is also concerned that

“the emphasis in the Bill is on proving the doctor’s decision was responsible. Courts are not asked to deal with whether a patient’s treatment has been negligent.”

I do not understand that comment. It seems to me that the courts would clearly be invited to deal with the question of negligence if something went wrong and the patient could establish that the necessary steps had not been taken by the doctor. I cannot see how the courts would not be asked to deal with whether a patient’s treatment had been negligent. As I hope I have demonstrated, the Bill makes it clear that it does not seek to override the law on negligence. The focus is all about providing a framework in which a doctor can act responsibly.

NESTA’s 2014 report found that 73% of GPs surveyed said that they would be most likely to collaborate with other doctors when adopting innovations. Therefore, three out of four doctors—the vast majority—are already familiar with talking to their peers and working with them in a collaborative manner in this area. The requirement for consultation is simply what for them would be the natural course of action.

With people becoming ever more inclined to look for someone to blame when things do not turn out how they had hoped, and therefore with the threat of legal action increasing, it must be right that this House looks across the board at ways of making the vital work that our doctors do easier. I believe that allowing for responsible innovation as a means of treating patients who wish to receive such treatment is a positive way to help them.

A further concern from the BMA is that it believes doctors can already innovate as much as they need to. It states:

“The BMA has received anecdotal reports from members that funding requests for innovative treatment are submitted and approved, often on condition that the results will then be distributed, adding to the wider body of medical knowledge.”

I think that the very use of the word “anecdotal” suggests that we need a much greater degree of standardisation of approach. As far as I can see, that is precisely one of the problems that the Bill seeks to address: the fact that, at present, there is no standard basis for the recording of innovative medical treatments.

I am pleased to see that one of the changes in the Bill, compared with Lord Saatchi’s Medical Innovation Bill, is the establishment and maintenance of a database, to be held and managed by the Health and Social Care Information Centre, because I believe that will provide an additional method of evidence-building for doctors. I note that the Royal College of Surgeons has suggested that a clinical society might instead manage the database, if it is limited to one area of medicine. Although that suggestion might warrant further examination, I have a couple of concerns about it.

First, taxpayers’ money has gone into the establishment of the Health and Social Care Information Centre, which is an executive non-departmental body under the care of the Department of Health. It is the national provider of information, data and IT services for commissioners, analysts and clinicians in the health and social care sector, so it seems to me to be the ideal body to carry out that function. I have no doubt that taxpayers would expect it to carry out that work.

Secondly, I believe that there are considerable advantages in having a single database that doctors can consult, as the Bill proposes, rather than several. A database that shares innovative medical treatments would help improve the spread of best practice. The Government’s competitiveness indicator report showed that medicines in the third year after launch were used in the United Kingdom at a level that was, on average, only one third of the average usage in the comparator countries, which included France, Germany and the United States. I believe that the creation of the database would go some way towards closing that gap.

The Academy of Medical Royal Colleges has expressed a concern that the database would be a substitute for research and might even sidestep clinical research. I take the view that the purpose of the database, which is to be a collection of reports on individual innovative treatments outside conventional methods, would not have that consequence. The academy has also expressed concerns about the complexity of establishing a database and maintaining confidentiality. There is no doubt that the confidentiality of medical records is something that we must all take seriously. However, I do not believe that just because something is complex is grounds for us not doing it at all. I appreciate those concerns, given the roll-out of the care.data scheme, but the database proposed in the Bill would be very different. It would be much smaller in scope, in terms of the number of people it would relate to, than the care.data scheme, which has the records of virtually everyone, unless they have opted out.

The Royal College of Surgeons accepts the need for research to be made available, but it does not see the need for the database proposed in the Bill. It states:

“Surgeons in England have been the first in the world to publish their individual outcomes from surgery. We support this level of transparency in all areas of surgery including research and innovation. The College expects all researchers conducting trials, including those we directly support, to register the trial in a publicly accessible database. However, we do not see the need for a new database of innovative treatments in surgery. A number of audits in surgery already exist and it is unclear what different data this additional database would cover. It would be helpful for the Government to clarify what data it envisages collecting under this Bill”.

I am sure that the Minister will cover that in his remarks later today. I believe that most patients who benefit from a particularly innovative treatment, especially if they are the first to benefit, would have no objection to their treatment being recorded anonymously.

The Royal College of Surgeons also states:

“We believe the Secretary of State already has the power to establish a non-statutory database of innovative treatments without legislation.”

Well, if that is the case, there is nothing in the Bill for it to worry about. What is clear is that if the Secretary of State does have that power, he has not used it. Indeed, I believe that there is scope to strengthen the Bill, if it proceeds to its later stages, to clarify when the establishment of the database can be expected.

The NHS’s 2011 publication “Innovation: Health and Wealth” lamented

“brilliant examples of pioneering work”

so often being “isolated examples”. As a principle of furthering innovation, therefore, surely gathering evidence in the database would be helpful to medical advancement. If treatments look like they are working, it must be right that the public and, of course, doctors know about it.

As with any new piece of legislation, we must be mindful of the cost to the public purse. That is one of the areas where I believe we still need more information at this stage. We do not yet have any real sense of what the financial implications would be, although I note that a full impact assessment is promised before the Bill goes to Committee. NHS England has forecast an annual cost increase for drugs in specialised services of 11%, rising from £2.4 billion in 2013-14 to £4.5 billion in 2019-20. I sincerely hope that the impact assessment will give some estimate of the impact that increased use of innovative treatments will have, for example on drug expenditure in the longer term.

I also believe that the impact assessment should consider what effect the Bill would have on the early access to medicines scheme, which was not in operation when the Medical Innovation Bill was first debated. The scheme allows patients to access medicines at an earlier stage in their development, following a risk-benefit assessment and subject to ongoing data collection.

A lot has been said about this Bill being potentially dangerous for patients. Yet doctors are currently prevented from carrying out reckless or dangerous treatments by the risk of proceedings being taken against them—either civil proceedings or, in the worst cases, criminal proceedings. Nothing in the Bill makes that risk any less likely. All the safeguards that are in place in law at the moment would simply remain in place.

[Chris Heaton-Harris]

I completely underline what my hon. Friend is saying. If a doctor is acting responsibly, they have nothing to fear; if they are acting irresponsibly, this Bill does not help them, and they will suffer the consequences of their actions.

[Mr Nuttall]

I am grateful that the sponsor of the Bill agrees with me on this, because it is the key point of the whole debate. Those who oppose the Bill have alleged that it will somehow put patients at risk. If that were the case, I would not be supporting it. I am supporting it because having read it carefully, and having considered all the evidence and all the views of all the professional bodies that are ranged against it, I have come to the conclusion that patients would have all the safeguards after the Bill has been passed that they do now.

The Bill has the potential to increase and improve the range of medical treatments available to my constituents.

[Mr Nuttall]

I am grateful to my hon. Friend. The arguments are finely balanced. As he said, he has constituents who support the Bill and constituents who are against it. If the Bill receives its Second Reading, as I hope it will, the concerns of those who have reservations about it, and those who go further and are outright opposed to it, can be considered in detail in Committee and, if possible, reflected and taken into account by way of appropriate amendments at that stage or on Report.

[Chris Heaton-Harris]

I assure my hon. Friend and all other Members who have spoken, and everybody I have been in consultation with to get the Bill to this stage, that should it get through its Second Reading, I will continue to consult, to listen, to talk to and to take advice from all organisations with an interest to make sure that we take into account and deal with as many as possible of the concerns outlined by him, by other hon. Friends, and by Opposition Members.

[Mr Nuttall]

I hope that my hon. Friend’s intervention will go some way towards satisfying the concerns of those who are opposed to the Bill.

From what we have heard, there seems to be a general acceptance of the principle in the Bill that there should be greater access to medical innovation. Even looking at the views of the various medical bodies—an impressive array, as I said—the best interpretation is that some are outright opposed and others are ambiguous. Either way, they all share the view that medical innovation is a good thing. It seems to me that the devil is in the detail. I hope that my hon. Friend’s confirmation that if the Bill proceeds he will be generous in speaking to people and looking at all possible ways of dealing with their concerns will persuade the House to give it a Second Reading.

Research and innovation are crucial to the continued success of healthcare. The NHS faces increasing demands: a growing population with an increasing lifespan, which is a good thing; an increase in its own capability, fuelled by advances in knowledge, science and technology; and ever-increasing expectations from the public it serves. We should not shy away from new ideas that put the patient first and offer chances that they may not otherwise have. This Bill will increase the likelihood of life-saving solutions being found where they did not previously exist. It will mean more choice for patients—for my constituents. It will provide doctors with a mechanism to enable them to use innovative treatments giving them the best possible chance to do what they do best—help patients. I support the Bill and trust it will receive its Second Reading.

--- Later in debate ---

[Chris Heaton-Harris]

Even though there has been some negativity, this has been a very positive debate. I have enjoyed trying to work with various colleagues and all the royal colleges—the list of organisations, actually, that my hon. Friend the Member for Totnes (Dr Wollaston) read out—and I hope that if the Bill has its Second Reading, I can continue to try and work with them, because I think the aspiration and concept behind the Bill, of spreading best practice and innovation quickly throughout our national health service, has widespread support. If this Bill is not the right mechanism, as I said earlier I am very willing to work in Committee to amend and change and to get to the point where I would like to think I could allay any concerns. So I thank everybody for their contributions, give them that assurance, and commend this Bill to the House.

Question put, That the Bill be now read a Second time.