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House of Commons

Friday 29 January 2016

The House met at half-past Nine o’clock


[Mr Speaker in the Chair]

Tom Pursglove (Corby) (Con): I beg to move, That the House sit in private.

Question put forthwith (Standing Order No. 163), and negatived.

Access To Medical Treatments (Innovation) Bill

Consideration of Bill, not amended in the Public Bill Committee

New Clause 1

Action plan for an off-patent drug pathway

(1) The Secretary of State shall require the Department of Health to produce an action plan for developing a pathway for off-patent, repurposed drugs where strong evidence of their effectiveness in a new indication exists, with the aim of securing their routine use in such an indication.

(2) The action plan under subsection (1) must be published within 12 months of this Act coming into force.

(3) The Secretary of State shall have a duty to seek to work with the devolved administrations to develop consistent approaches.—(Nick Thomas-Symonds.)

Brought up, and read the First time.

9.34 am

Nick Thomas-Symonds (Torfaen) (Lab): I beg to move, That the clause be read a Second time.

Mr Speaker: With this it will be convenient to discuss the following:

New clause 2—Identifying evidence on off-patent repurposed drugs and passing to relevant bodies

(1) The Secretary of State shall require the National Institute for Health Research to develop and introduce a mechanism for—

(a) gathering and recording existing evidence on off-patent, repurposed drugs, including clinical trial evidence, and

(b) passing this information to relevant bodies.

(2) The Secretary of State shall determine the relevant bodies under subsection (1) and may revise that determination from time to time.

New clause 3—Appraisal in new indications

(1) Where there is an off-patent, repurposed drug with strong evidence of its effectiveness in a new indication, the Secretary of State shall direct the National Institute for Health and Care Excellence (NICE) to conduct an appraisal in relation to the drug in its new indication.

(2) An appraisal under subsection (2) should include a cost-effectiveness analysis.

New clause 4—National commissioning policy for off-patent new drugs

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Where there is an off-patent, repurposed drug with strong evidence of its effectiveness in a new indication, the Secretary of State shall require NHS England to produce and disseminate a national commissioning policy.

New clause 5—Accessibility of the licensing process

(1) The Secretary of State shall require the Medicines and Healthcare products Regulatory Agency to consult key stakeholders about steps to be taken to make the licensing process more accessible to organisations or individuals other than pharmaceutical companies.

(2) For the purposes of subsection (1), key stakeholders shall include, but not be limited to—

(a) patient organisations,

(b) medical research charities,

(c) relevant academics, and

(d) the British Generic Manufacturers Association.

New clause 6—British National Formulary: inclusion of off-patent drugs

The Secretary of State shall require NICE and the British National Formulary (BNF) to review their processes for registering off-label uses of repurposed drugs where there is strong evidence of their effectiveness.

Amendment 10, in clause 1, page 1, line 3, after “treatments” insert “(including treatments consisting in the off-label use of medicines or the use of unlicensed medicines)”

Amendment 13, in clause 5, page 3, line 44, at end insert—

“(1A) For the purposes of section 2(2), the kinds of medical treatment that may be innovative medical treatments include (amongst other things)—

(a) the off-label use of an authorised medicinal product, and

(b) the use of a medicinal product in respect of which no marketing authorisation is in force.

(1B) In subsection (1A)(a), the reference to the off-label use of an authorised medicinal product is a reference to the use of the product—

(a) for a purpose other than one for which its use is specified,

(b) in relation to a person who is not within a description of persons for whom its use is specified, or

(c) in any other way in which its use is not specified.

(1C) In this section—

(a) ‘authorised medicinal product’ means a medicinal product in respect of which a marketing authorisation is in force;

(b) ‘marketing authorisation’ and ‘medicinal product’ have the same meanings as in the Human Medicines Regulations 2012 (S.I. 2012/1916);

(c) ‘specified’, in relation to a medicinal product, means specified in its marketing authorisation.”

Nick Thomas-Symonds: These new clauses and amendments, which I support, relate to off-patent drugs. I think it would be useful for me briefly to set out the context in which they arise. The Off-patent Drugs Bill, a private Member’s Bill that I introduced—it was debated on Second Reading on 6 November—is a UK-wide Bill that would create a duty on the Government to make cheap drugs available when pharmaceutical companies had no incentive to do so. The problem, put simply, is that if a drug is shown to be useful for a new purpose after its original patent has expired, a pharmaceutical company has no financial incentive to sponsor that off-patent treatment through the processes normally used to license it and ensure its adoption on the NHS.

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Those off-patent or off-label treatments are certainly available at low cost. The issue is simply that although clinicians can of course prescribe them, they tend not to be prescribed consistently across the medical sector, or indeed geographically.

The Off-patent Drugs Bill ran out of time that day, but I think it is accurate to say that the Government supported its aims but not the mechanism it proposed. None the less, in recognising that there is a problem, and with a shared position on both sides of the House on the need to encourage greater consistency in off-label prescribing, a lot of work has since been done, and on a cross-party basis. I am proud that new clause 1 stands in the name of Members from no fewer than eight political parties. The concept of encouraging greater use of off-patent drugs, and indeed my Bill, have significant support across the House and outside. I pay tribute to Jonathan Evans, the former Member for Cardiff North, who first introduced such a Bill in 2014. His successor, the current Member for Cardiff North (Craig Williams), has also supported my Bill.

Carolyn Harris (Swansea East) (Lab): I congratulate my hon. Friend on the excellent work he has done on the Off-patent Drugs Bill. Given the consensus across the House, does he agree that now is the time for a firm commitment from the Government on that Bill?

Nick Thomas-Symonds: I am grateful to my hon. Friend for that intervention. I hope to hear such a commitment today, so I look forward to what the Minister for Life Sciences has to say in that regard.

That wide support for my Bill was shared by medical research charities, NHS clinical commissioners in England, the British Medical Association, thousands of members of the public who wrote in, and four medical royal colleges. Indeed, 40 eminent clinicians wrote to The Daily Telegraph in support of my Bill.

Since then, I am pleased to say that there have been good attempts on both sides of the House to build on that good will in relation to off-patent drugs. I want to thank the hon. Member for Daventry (Chris Heaton-Harris) for the highly constructive and pragmatic way in which he has been willing to take the off-patent agenda forward when speaking about his private Member’s Bill. I thank the hon. Member for Bury St Edmunds (Jo Churchill), who brings a strong personal perspective to the debate. Her sense of what is good for patients has been highly constructive in the debates we have had over the winter months. The hon. Member for Central Ayrshire (Dr Whitford), who used to be a breast cancer surgeon—in fact, she still practises—has brought a great level of expertise and experience in recent months, for which we are extraordinarily grateful. I also pay tribute to the Minister, who has been extraordinarily generous with his time and that of his officials in order to try and take this agenda forward, and for that I am extremely grateful.

I want first to make a point about clauses 3 and 4. While there is something of a consensus around responsible innovation, I had strong concerns about those clauses, as did many across the medical profession who thought that they might encourage a more dangerous type of experimentation, if I may put it that way. Looking at the amendments tabled by the hon. Member for Daventry,

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I can see that his intention is to remove clauses 3 and 4 altogether, which would be a very welcome step. That would mean that the principal remaining part of the Bill relates to the database of innovative medical treatments. The hon. Gentleman’s amendments 10 and 13 would bring the off-patent concept firmly into the purpose of this Bill, and therefore into the database. A lack of data was one of the barriers identified to more consistent prescribing of off-label treatments. The amendments would be an extremely welcome step forward, because they would not only enshrine in law the off-label aspect, but bring the data into the database so that it became more widely and readily available, assisting clinicians on the frontline. I sincerely hope that the amendments will be positively received by the Minister.

New clause 1 sets out an action plan for developing a pathway for off-patent repurposed drugs where strong evidence of their effectiveness in a new indication exists, with the aim of securing routine use. Put simply, this is an action plan with clear timeframes for progress. Again, this would be a welcome step forward.

New clause 2 would require the National Institute for Health Research to develop a mechanism for gathering and recording evidence on off-patent repurposed drugs, including clinical trials evidence, and passing it to the relevant bodies. The NIHR already has a dedicated horizon-scanning centre, but this would set up a dedicated stream for off-patent repurposed drugs to speed up getting them to the frontline and into routine use.

New clause 3 proposes that where there is strong evidence of effectiveness in a new indication, the National Institute for Health and Care Excellence should be directed to conduct a technology appraisal, including a cost-effectiveness analysis. While these drugs are extraordinarily cheap, some level of cost-effectiveness analysis would none the less be desirable, since to achieve routine commissioning, in England for a start, a persuasive business case clearly needs to be put to local hospitals and clinical commissioning groups.

New clause 4 is about having a national commissioning policy for off-patent drugs. It also requests that the Minister work with the devolved nations to produce something that is genuinely UK-wide. This has already happened in the case of NHS England working with Prostate Cancer UK to produce a commissioning policy for an off-patent repurposed drug called Docetaxel.

New clause 5 would make the licensing process more accessible. What would that mean in a practical sense? For example, an initial meeting where there is a discussion of the case and the likelihood of successful treatment could be free, a representative of patient organisations could be designated within the Medicines and Healthcare Products Regulatory Agency for patient organisations, and there could be a guidance document for non-pharmaceutical applicants.

9.45 am

New clause 6, which I want to push very strongly with the Minister, would require NICE and the “British National Formulary” to review the process for registering off-label uses of repurposed drugs where there is strong evidence of their effectiveness. The “British National Formulary” is a reference book used by prescribing healthcare professionals. The point has been made frequently and very well by the hon. Member for Central Ayrshire that in the modern-day NHS there are a variety

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of prescribers, not just top consultants, and this measure would make a significant difference right across the UK. At the moment, there is something of a chicken and egg situation: the BNF includes what is already routinely used, but for some repurposed drugs to be routinely used, they need to be in the BNF. We would like the BNF to be able to identify treatment indications where there is enough evidence for them to be considered for a licence but they remain unlicensed due to the lack of a pharmaceutical sponsor.

These amendments form a package of measures to encourage greater consistency in off-label prescribing across the UK. I am very pleased with the cross-party work that we have been able to do on this in recent months. The creator of the national health service, Aneurin Bevan, said on 8 June 1949:

“The language of priorities is the religion of socialism.”

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.

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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 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

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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 to 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

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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.

10 am

The biomedical research unit is conducting studies in this area and has been successful in drafting an interim policy to provide a framework for governance. The register has been successful in recruiting 400 patients to date. I am hopeful that such an exemplar of best practice could be used to encourage the NIHR to establish a dedicated stream for researching off-patent, repurposed drugs in a more broad-based way.

We need patients and the public to take part in research. The NIHR has a research system that is more inclusive and representative of the population than anywhere else in the world. We need to use it to harness information to benefit patients. Interestingly, it is well documented that those who take part in clinical trials experience better outcomes, so it is a win-win. The opportunities that the NIHR affords us need to be fully explored and, if it is not the most appropriate body, I would like the Minister to commit to finding out what is.

In tandem with any assessment, there will need to be cost-effectiveness to get the drugs into routine commissioning, thereby allowing them to benefit patients.

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A lighter-touch approach that makes better use of NICE’s resources should be explored, as it could have the benefits of acting as a business case for adoption, reducing duplication and speeding up access to treatments. A commitment from the Minister to introduce such guidance today would be nothing short of great.

New clause 4, which stands in my name and those of my colleagues, states:

“Where there is an off-patent, repurposed drug with strong evidence of its effectiveness in a new indication, the Secretary of State shall require NHS England to produce and disseminate a national commissioning policy.”

Let us get treatments that are effective and safe to the patients who can benefit from them. A precedent for this is NHS England’s recent work with Prostate Cancer UK to draw up a policy for—you guessed it—an off-patent, repurposed drug. It strikes me that where there’s a will, there should be a way. If there is a way for us in England, I am sure that it is possible to ensure that there is a co-ordinated approach for our friends in Wales, Scotland and Northern Ireland.

In this place last November, I referenced the use of tamoxifen and other drugs as a preventive pathway. The purpose of new clause 5 is to look at introducing more accessibility into the system to make organisations such as academia and charities more connected with the licensing process. We are hoping for a commitment that the Department of Health will work with the MHRA to achieve that.

Finally, I will speak to new clause 6. Back in November, when the hon. Member for Torfaen told us why we needed the Off-patent Drugs Bill, I stated that drugs such as tamoxifen, simvastatin and zoledronic acid, among others, were not getting to patients. Tamoxifen and zoledronic acid, in particular, could benefit the women I have spent many years campaigning for, whose fight against breast cancer is often not only one of the most difficult things they endure, but one of the most difficult any member of their family goes through. We still lose 12,000 women a year to this disease. If there is something that we can do to ensure that fewer women die, we should do it.

In November, the hon. Member for Central Ayrshire, with the expert knowledge of a senior clinician, explained that although there was the ability to prescribe, it did not happen. We therefore propose that the “British National Formulary” includes off-patent, repurposed drugs to end the situation whereby experts are prescribing, but other professionals do not feel confident to do so. Like a bilingual dictionary, whichever way someone approaches the BNF—by disease type or drug—it tells them what they need to know as a prescriber, whether they are a pharmacist, a doctor or a nurse practitioner. The BNF generally includes all the licensed indications of a drug. If it supported the adoption of well-evidenced, off-label treatments, it would serve to provide validity. We hope for a commitment that the Minister will fully explore that proposal with NICE and the BNF.

I commend the Minister for his complete openness in engaging with our group of interested, committed MPs from across the House and across the parties to move the situation forward and find solutions. I urge him to look at the accelerated access review, the interim report of which says that we should put the patient “centre stage” and

“accelerate and manage…emerging products”.

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The AAR did not mention repurposed drugs, so I will call them emerging products. It also speaks of, “Supporting all innovators”. We are being innovative. It challenges the NHS to galvanise itself to

“adopt new products and systems”.

What we are discussing could be a new system. Finally, it speaks about, “Delivering change”. I look to the Minister to make those five commitments work with off-patent, repurposed drugs for everyone in the UK.

Dr Philippa Whitford (Central Ayrshire) (SNP): I rise to support new clauses 1 to 3, 5 and 6 and amendments 10 and 13. The only reason new clause 4 does not stand in my name is that it relates to NHS England, which is outwith my purview.

People are well aware of my objections to clauses 3 and 4. Many Members in this House and medical voices outside the House have real concerns about the danger to patients of doctors having to convince only one colleague before trying a completely unproven approach. As well as the danger to patients, I feel that there is a danger to our clinical trials system. Why would someone go through applications, a year of paperwork and phases 1, 2 and 3, when they could just cut to the chase?

I pay tribute to the hon. Member for Daventry (Chris Heaton-Harris) for being willing to sit around a table with the Members who were named by the hon. Member for Torfaen (Nick Thomas-Symonds) and the Minister, and to start with a blank sheet of paper and work out how we could do something useful. It has been a great procedure. I welcome the fact that later in the day, the hon. Member for Daventry will propose the removal of the clauses on innovative practice and litigation.

Turning to the off-patent drugs proposals, 6 November was a very frustrating day in this House. Every single Member who spoke from the Back-Benches spoke in favour of the Off-patent Drugs Bill, but the time ran away during the Minister’s response—not the Minister who is here today. That debate showed the appetite across the House to get something done on off-patent drugs.

The hon. Member for Bury St Edmunds (Jo Churchill) has explained most of what I was going to explain. There is still the issue that while specialists are steeped in the evidence and used to using drugs off label, those who are not are less sure. There is no automatic place where they can check a dose or an indication. Sometimes, it is the general practitioner who does not carry it through. We have had lots of discussions in this House about the changes in the NHS and the evolution to multidisciplinary teams out in the community. That means that there are far more non-medical prescribers. The further someone is from the expert prescriber, the less comfortable they are. They do not have easy access to somewhere they can check when they think, “Is that just my bad handwriting or is that really what I mean?” That is what new clause 6 on the BNF could achieve.

The BNF is used by everyone and is on every desk in the NHS. As the hon. Member for Bury St Edmunds said, people can either check a drug that they have had a letter about from the hospital or look something up when they think, “I don’t have anything for this. What exists?” We will also discuss that when we come to the database proposals. I welcome the fact that the database has been changed from being a registry of people doing their own thing to a place where information is shared.

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On new clause 5, which I tabled, although the inclusion of off-patent drugs in the BNF will achieve the sharing of information and will, in a sense, give them a slightly informal kite mark, I feel that it is important to look eventually at providing a licence. The reason for my concern relates to the drug simvastatin, which is used all over the place to control people’s cholesterol and has been found to be useful in multiple sclerosis—a disease that plagues many people and causes a lot of suffering, and for which, frankly, we do not have a lot to offer. That drug is incredibly cheap, but if a company decides to tweak a little molecule of it, call it something else and put it out as a new wonder-drug for multiple sclerosis, we will be having debates in Westminster Hall about a drug that costs fifty grand and that the NHS cannot afford. Under General Medical Council rules, the cascade is still that a doctor must prescribe a licensed drug over an unlicensed or off-label one, regardless of cost. If a doctor was faced with fifty grand for simvastatin-new versus sixpence for the simvastatin we all know, they would have no choice, and we would be right back in the same position—relentlessly discussing the NHS’s access to drugs.

The drugs we are talking about are already safe. They have had a patent and been used for so long that they are now off patent, which means that they have been around for a decade. We know their side effects, the common dosages and what to look out for. They should not have to start at point zero of the licensing process. We need a short licensing system, so that patient groups, academics, charities and the British Generic Manufacturers Association can say, “We think there is something useful here.” We have put provisions in new clauses 2 and 3 for the NIHR and NICE to have capacity in their systems to provide a funnel for evidence on such drugs.

These drugs are not developed by big pharma, so there are not huge costs that have to be recouped. The purposes of them are usually found by academics and clinicians, so pharmaceutical companies should not make a massive profit out of them. The benefit of them should be that the NHS can afford them and patients can access them. We have many debates about access to medical treatments in the House, usually in Westminster Hall and usually about drugs that are eye-wateringly expensive. In this case we are talking about drugs that are proven and cheap. We need to come up with a system that makes them accessible to patients.

I commend the Minister for the time, that, as others have said, he has given the four of us around a few tables, hammering these provisions together. I hope that we will be supported in working them through and actually doing some good for the NHS and our patients.

Anne Marie Morris (Newton Abbot) (Con): It is with great pleasure that I rise to speak in support of this important Bill, introduced by my hon. Friend the Member for Daventry (Chris Heaton-Harris), and the amendments he has tabled. Specifically, I rise to support amendment 13. I am sure that the hon. Member for Torfaen (Nick Thomas-Symonds) will be disappointed that his private Member’s Bill did not make it to Committee stage, but I hope that he is happy to see some of it included in this Bill.

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I had my reservations about the Bill as it stood originally, and I have reservations about some of the amendments, but I believe that amendment 13 will increase the use of off-label drugs in a safe and secure way. Those drugs can often be a cheaper and quicker way to tackle a disease, as they do not have to go through the rigmarole of being developed and licensed, which can take many years and many billions of pounds. NICE states that an unlicensed medicine is one that

“does not have a UK marketing authorisation and is not expected to do so in the next 2 years”,

whereas an off-label medicine is one

“with an existing UK marketing authorisation that is…used outside the terms of its marketing authorisation”,

and for which

“it is not expected that the existing UK marketing authorisation will be extended to cover this use in the next 2 years.”

The inclusion of off-label use classes in the database as innovative medical treatments will allow the medical profession to see where off-label use has been effective, even if it is at the other end of the country. However, we must be careful not to place off-label uses on a pedestal and allow people to cling on to false hope. They are the most vulnerable people in our society, often looking for any treatment that may help them, but we must ensure that any drug that is prescribed off label is used responsibly and ethically. I believe that the database will help by allowing doctors to see what is effectively a large sample trial that gives them more information on a particular treatment. I therefore support amendments 13 and 10.

Mrs Flick Drummond (Portsmouth South) (Con): I thank my hon. Friend the Member for Daventry (Chris Heaton-Harris) for bringing this important private Member’s Bill before the House and for his work in ensuring that all parties agree with it. It seems that a lot of work has gone into it by Members throughout the House, and as someone who was not part of those discussions, I am grateful to them for doing that work for everybody else.

The NHS benefits from one of the most rigorous health technology assessment organisations in the world, which provides clear and robust evidence of the clinical benefits of new interventions. However, the introduction of innovative treatments is complex, not straightforward, and the difficulty for the life sciences industry in getting new treatments to the market means that UK patients are often the last to see the benefits of new innovations in their disease area.

10.15 am

I am not a doctor or a lawyer but a lay person, and I was at first disappointed that clauses 3 and 4 in the Bill as it originally stood were to be removed rather than amended to make them suitable for purpose. A compensation culture has developed, and I fear that it has stopped doctors innovating. In 2014-15, clinical negligence expenditure, including interim payments, cost the NHS more than £1.1 billion, and the NHS Litigation Authority does not expect that bill to fall any time soon.

I am fortunate to have reached the age of 53—[Hon. Members: “Really?”] Thank you, but I have reached the age of 53. However, 14 of my very close friends and family members did not. Some of them would have benefited from innovative treatments, including those

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with cancer, and one of them took part in a trial. I hoped that the Bill would help doctors have the confidence to try different treatments. However, it seems that there are ways to innovate, and I hope that new clauses 1 to 6 will ensure that off-label drugs that are found to work in different ways, and new drugs that are found to be effective, are quickly passed through NICE and disseminated throughout the NHS.

I am pleased that the NHS in Portsmouth and Southampton has trialled new hepatitis C treatments. Throughout 2013, a new range of drugs was tested on patients at Queen Alexandra hospital. The trials cured patients with hep C, with success rates of between 90% and 100%—a vast improvement on historical treatments. What is more, the patient experience was improved, as doses were lower and taken over a shorter period. Those transformative hepatitis C trials are now being replicated in other parts of the country, and the evidence gathered has enabled many other people to benefit from new treatments that were previously unavailable to them. I would like to see more such collecting and sharing of evidence, and I expect that is why the database is being established under new clause 2. I hope that the passage of the Bill will lead to more examples such as the groundbreaking work at QA hospital whereby evidence is shared for the good of all.

The interim accelerated access review said that the NHS has one of the most rigorous assessment processes in the world. Decisions are based on a wealth of robust evidence of the clinical and economic benefits of new interventions. The proposed database will strengthen that assessment process and potentially increase the availability of life-saving treatments. However, if we are to encourage the NHS to embrace more innovation, it is important that it retains the public’s trust. Medical trials that go wrong have the potential to undo the enormous trust in and admiration for our NHS, and I know that both professional and voluntary organisations and Members of the House had significant concerns about that in relation to the Bill. I welcome the pragmatic move that my hon. Friend the Member for Daventry has made in removing the clauses that caused those concerns, which will enable the NHS to expand the range of treatments it can offer while retaining the support and backing of all interested parties.

I am sure that a majority of Members support the idea of innovation in our NHS, which will be critical to meeting the increased demand on our health service. As the conditions that our NHS treats become more complex, enabling our doctors to innovate will be key to ensuring that the public receive the very best treatment available. I therefore welcome the Bill and trust that the amendments will ensure that the Government accept it completely.

Heidi Alexander (Lewisham East) (Lab): I congratulate the hon. Member for Daventry (Chris Heaton-Harris) on navigating the Bill to this stage. His pursuit of legislation in this area has sparked an important debate on the Floor of the House about how we can improve access to innovative treatments.

I welcome the opportunity to speak on this group of amendments, and I support the broad thrust of all of them. I commend the hon. Member for Bury St Edmunds (Jo Churchill) for her speech and the contribution that she has made—she spoke with great knowledge and passion.

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I am particularly pleased that my hon. Friend the Member for Torfaen (Nick Thomas-Symonds) has tabled new clauses on the important issue of off-patent drugs and off-label uses, which he has championed. I was sorry to see his Bill fall on Second Reading in November and hope we can make more progress with the Government today.

Improving access to off-patent drugs so that people, no matter where they live or by whom they are being treated, are offered well-evidenced treatments that might not be routinely commissioned, is an ambition shared by many in the House, regardless of political persuasion. The Minister shares those objectives. Over the past few weeks and months, he has worked with key stakeholders and discussed the issue with them.

I express my support for new clause 1, which requires the Department of Health to produce an action plan for developing a pathway for off-patent, repurposed drugs, where strong evidence of their effectiveness in a new indication exists, with the aim of securing their routine use in such an indication. I hope the Minister can commit to such an action plan and put forward a clear timetable for progress, which is long overdue. I also hope he can offer the House reassurance on the proposals in new clauses 2 to 6, all of which have merit and deserve proper consideration by the Government.

Rebecca Harris (Castle Point) (Con) rose—

Mr Speaker: Order. The hon. Lady had wished to contribute but toddled out of the Chamber at the appropriate moment. I would have called her but did not because she was not here. Does she still wish to speak?

Rebecca Harris: Very briefly, Mr Speaker.

I support the Bill and commend all those who have worked towards it in the many iterations it has been through in this House and the other place—I can see that Members of the other place are taking an interest in our proceedings today.

I am chairman of the all-party parliamentary group on brain tumours. Brain tumour research has desperately lagged behind other areas of cancer research, and we desperately need to find new sources of treatment. Sadly, brain tumour is still the biggest cancer killer of the under- 40s—children and young adults. The Bill could be a great step forward in the sharing of information.

I commend the Minister, as all hon. Members have. Without wishing to sound too toadying, we have a Minister who is committed to taking forward progress on research in a way that we have not seen previously.

It should be pointed out that the NHS is a superb innovative organisation that does huge amounts of research. We do not hear that said often enough of the NHS. From my point of view, the most important bit of the Bill is the database, which will mean we can take forward the research we do in the NHS so that people can have access to information—not just patients, but clinicians, who might not know as much as we or they would hope. I very much hope the Bill makes progress.

The Parliamentary Under-Secretary of State for Life Sciences (George Freeman): It is a great pleasure to take part in the debate and to support a package of amendments that have been agreed by Members on a cross-party

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basis over the past few weeks and months. Very often in private Members’ business, the Government take the view that the intentions are fine but the mechanism is flawed, and that the Government legislate while MPs raise issues. However, with this Bill, we have struck a blow for joined-up thinking and cross-party working in pursuit of patients’ interests—I will say more about that on Third Reading.

With my hon. Friends the Members for Daventry (Chris Heaton-Harris) and for Bury St Edmunds (Jo Churchill), and the hon. Members for Torfaen (Nick Thomas-Symonds) and for Central Ayrshire (Dr Whitford), and with the help of Opposition Front Benchers, we have managed to deal with three Bills with which the House has been preoccupied in recent months—the Bill initiated by Lord Saatchi, which looked to change the culture of innovation; the Bill introduced by the hon. Member for Torfaen, which promoted the use of off-patent repurposed drugs; and this Bill, introduced by my hon. Friend the Member for Daventry, which seeks to promote access to innovative medicines. With the package of amendments we have agreed, we will end with a Bill that moves forward on those three areas of concern for Members in all parties of the House. Today is a rare and rather wonderful moment because the amendments are supported by every party in the House—I cannot speak for the United Kingdom Independence party because I have not heard anything from it, but all other parties support the Bill.

We have three groups of amendments to get through so I will try to be brief in dealing with the specific points, many of which have previously been raised and discussed. I should take this opportunity to pay tribute to and thank my officials who, over the past three to six months, have tirelessly worked with Members on both sides of the House in an unusual way to help to draft amendments that we can all support. I thank them for their diligence in doing so.

Broadly, the intention of the package of amendments is to introduce off-label repurposed medicines in the Bill, and to put it four square at the heart of the agenda. As the hon. Member for Torfaen said, I wholeheartedly supported the intention of his Bill and its predecessor, but not the mechanism. We now have a mechanism that will work.

I appreciate that the new clauses are probing and that hon. Members are seeking my reassurance on how the Government will take things forward. New clause 1 is a request for an action plan. Nobody seriously thinks that we should put an action plan in the Bill, but let me set out my commitment and that of the Government to pursuing this agenda with time and rigour. As I have said in other places, the truth is that the world of drug discovery is changing profoundly. The transformational power of genomics and informatics create a wholly new opportunity both to discover new medicines and target them at individual patients much more quickly, and to discover repurposed uses of existing drugs in a way that we have not been able to do previously. The 100,000 Genome Project, which the Government have initiated and funded, has already begun to identify existing drugs that have uses in indications that were not hitherto known. The pace at which new drugs are being developed and discovered is increasing, which is a credit to the creativity of the sector.

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That sets the backdrop for the creation of my post and the accelerated access review that I have launched. As all hon. Members know, I am committed to putting in place a landscape that accelerates the use of NHS resources to support research. When we launched the strategy, the Prime Minister said that every patient should be a research patient and that every hospital should be a research hospital. We are determined to ensure that the daily footprint of diagnosis and treatment is used more intelligently to support research.

The accelerated access is review is looking at that in a lot of detail and is an extensive piece of work. Colleagues have referred to the interim report—the final recommendations are due to arrive on my desk at Easter. I am very happy to give a commitment that, in our response to that report, we will pick up the points made in the debate and in the Bill on ensuring that we look at repurposing and off-label uses of existing drugs as much as we look at innovative medicines.

In new clauses 2 and 3, hon. Members are probing me to give details on how the National Institute for Health Research and the National Institute for Health and Care Excellence can put into practice the mechanism that we have discussed. On new clause 2, there are very open mechanisms currently for applications to the NIHR to research existing medicines. The NIHR—I am delighted that we have reconfirmed our £1 billion a year funding for it—conducts research every year into existing medicines, and there is a clear process for that. It would not be appropriate to legislate in a Bill to tell organisations that are subject to the Haldane principle, which is sacrosanct for the Government, what to do. We want research to be led by that principle, but I am happy—I will say more about this in a moment—to ensure that, through the process, we explore mechanisms for ensuring the NICE can look at evidence and develop evidence-based guidance on off-label medicines, so that doctors are aware of which drugs are being used in an off-label indication.

On new clause 3, I am delighted to confirm that, after discussions, NICE is now looking at ways to collect evidence on repurposed medicines. It is looking at taking evidence and how it could use, through its existing evidence review process, evidence on repurposed medicines specifically. I have asked whether we might be able to put a mechanism in place to find a way to somehow put that into the “British National Formulary”. I would not want to put that mechanism into the Bill, because we need the freedom to evolve the mechanism and to get it right. I hope that is a helpful reassurance.

10.30 am

Clinical staff using the BNF daily—the hon. Member for Central Ayrshire highlighted that it is a really powerful mechanism for getting information to doctors—will ensure that prescribers have information on off-label drugs. I would like to get to a point where we can give busy doctors on the frontline, at the click of a mouse, information on drugs their patients might be eligible for, and which are coming through in clinical trials. That information—on drugs already in use with an evidence-based off-label indication that NICE has looked at, and on unlicensed drugs in early-access-to-medicine schemes, which, with patient and doctor consent, patients might be eligible for—already exists, but I would like to get it to doctors in a way that is very easy. I have asked NICE, the MHRA and my officials to work on the details of that mechanism.

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New clause 4 sets out a proposal for the Department of Health and NHS England to implement a new system of national commissioning of repurposed medicines. I think hon. Members understand that I cannot agree in statute, for a whole host of reasons that I will not detain the House with right now, to bind NHS England to that commitment. I will, however, just say this: NHS England is very seized on looking at how it can improve the efficiency of the system and deliver the £22 billion efficiency savings it has committed to. Efficiencies in medicine procurement and prescribing sit four square in that. The NHS is hungry to look at all options for promoting off-label and repurposed drug use. I do not think hon. Members need worry that NHS England needs instructions from me to that effect, but we need to ensure we are giving clinicians access to information on both innovative drugs and innovative uses of existing drugs, so that they are able, with confidence, to recommend and prescribe for their patients medicines that may be appropriate for them.

The hon. Member for Central Ayrshire will understand why I am very wary of legislating to interfere in any way with clinical sovereignty. Much as we in this House might want certain things to happen, we need to be careful not to undermine the sovereignty of clinician and patient, which must be absolutely key.

New clause 5 sets out a proposal for the Government to set out a list of statutory stakeholders. This is a familiar issue dealt with in many Bills. I think hon. Members know that it would not be appropriate for us to set out that list in statute, but I am very happy to give the undertaking that the bodies listed in the new clause should, and will be, consulted on and involved in our work plan as we take the proposals forward.

New clause 6, which deals with the question of the “British National Formulary”, is very helpful in terms of giving me a chance to talk about the mechanism that I propose and have just touched on. I am reluctant to name the BNF explicitly in the Bill, not least because it is a commercial product that is not in my gift to control. There are no plans to change its format, but I would hate for us to have legislated for one particular mechanism of information and then find in a few years that it has changed in some way and is no longer appropriate. I am, however, very happy to give an undertaking at the Dispatch Box that we are actively exploring this option and have no reason to think it cannot work. NICE tells me it thinks there is a very good mechanism for it to use its existing powers for gathering evidence to pull together, as part of an evidence review, an evidence-based reassurance to clinicians that a drug has a legitimate off-label, off-patent use, and to include that in the appropriate registry. Today I think that would be the BNF, but that may change in due course.

Nick Thomas-Symonds: I would just like to make two points. First, the “British National Formulary” is UK-wide. Secondly, and just to probe the Minister further, is he able to give an approximate timeframe for when he thinks the process might be complete?

George Freeman: The hon. Gentleman makes two good points. This is, of course, UK-wide. One of the challenges, as a UK Minister, is to put in place a framework that will support this across the UK while respecting the different mechanisms in the devolved Administrations.

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I hope the Bill will provide a basis for a similar mechanism in areas where there are different formats. I believe that in Scotland, Northern Ireland and Wales, but particularly in Scotland and Northern Ireland, there is a hunger to do that. I believe the Bill will support those existing mechanisms.

Dr Philippa Whitford: We have moved on from talking about the BNF. I accept the comments about listing groups that would be considered in new clause 5. Does the Minister accept, however, that we still need to deal with the cascade of prescribing to ensure doctors are not forced to prescribe a licensed medicine, which is actually just a minimal moderation of an off-patent drug at a vastly expensive cost? That means we still need some kind of change to the licensing or short licensing process in the future.

George Freeman: The hon. Lady makes an important point about the classification of different drugs available to clinicians. Without detaining the House with too long a peroration on that classification, it is worth setting out that there is a clear cascade.

Clinicians can use unlicensed medicines in situations where, in their clinical judgment, and with patient consent, they believe it is the right thing to do. They are subject to all their usual professional undertakings. There are then off-label uses of drugs: drugs that do not have a licence for a particular indication but which the clinician, on the basis of evidence, is able to prescribe when they feel that evidence is compelling. The Bill now goes to the heart of that and will help to provide reassurance. For many clinicians, being able to click on a mouse with their patient and say, “For your condition there are one, two, three or no off-label medicines available for which NICE has looked at the evidence,” would be a powerful catalyst in helping to promote off-label use. There are generic drugs, which have been patented and brought to market, that are available at a heavily discounted open price.

There are then on-patent drugs, which have been brought to market and are still subject to a patent. The manufacturer has an exclusivity, which is the period in which their sunk costs in bringing the medicine to the system, can be reimbursed. That is an important protection to make sure we continue to have a thriving life science sector that can take the risks of investing in new drugs. Typically, new drugs take 15 years and £2 billion to develop. If there were no patenting mechanism, there would simply be no enthusiasm to do that research, which has a very high failure rate. In law, there is a key point of principle, which is that a licensed drug should be used first and that an unlicensed drug cannot be used purely on the basis of cost. That is a really important principle. An unlicensed drug can, however, be used on the basis of evidence. That is why the mechanism will allow NICE to look at the evidence and to signal to clinicians that they have the evidence basis on which to use the drug in an off-label indication.

One of the issues we have dealt with in discussions is the whole question of the European licensing of medicines. If we were to go down that route—I know the hon. Member for Central Ayrshire understands this—I can assure the House we would be here not just for weeks and months, but years. I am leading for the Government on reforming the European landscape of 21st medical

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research. The central role of protecting innovators’ sunk costs is really important to our life sciences sector, and the new clauses and amendments create a mechanism by which we can accelerate off-label use without running a coach and horses through that.

Dr Whitford: I accept the Minister’s points, but my concern remains that if in 10 years we have simvastatin in its current form versus a new name that is just a tweaked simvastatin at a thousand times the price, doctors will, under GMC rules, have to go for the one with the licence, as opposed to the off-patent one, even if it is in the BNF. I accept that the BNF mechanism will absolutely increase usage, but we still need to consider the longer term, given that in the future we might have huge numbers of off-patent drugs with new purposes.

George Freeman: The hon. Lady makes an interesting, important and useful point that I undertake to pick up in our consultation in response to the accelerated access review. The landscape will continue to change fast over the next few years. The Bill, as amended, will promote the greater use of off-label medicines. Crucially, the database mechanism, which, I reassure everybody, is very different from the original registry proposed in a precursor Bill—it is to make clinicians aware of what drugs are available—will generate data that will be incredibly powerful in helping the system to adapt and use the freedoms I hope to give it through the accelerated access review. That will ensure we are better and faster at getting these repurposed medicines into use.

I am delighted to say that the Government are happy to support amendments 10 and 13. Amendment 10 would set out in the Bill that its purpose specifically includes promoting access to the innovative use of licensed medicines outside their licence indications. It puts four square at the heart of the Bill the aims of the Off-patent Drugs Bill, which was promoted by the hon. Member for Torfaen (Nick Thomas-Symonds), and which, as hon. Members across the House have commented, had a lot of in-principle support. I am pleased, therefore, that we have found a form of words that moves it forward. At the heart of it, there is a clever protection for clinical sovereignty. We are not telling clinicians what they have to prescribe or putting in law a requirement that they prescribe in a particular way. We are giving them information on evidence-based off-label drugs. The feedback from clinicians so far is that it genuinely will help them to understand, promote and prescribe off-label uses.

Amendment 13 seeks to clarify the definition in the Bill of innovative medical treatments to make it clear that it includes off-label and unlicensed medicines. I mentioned earlier the pace at which genomics and informatics were uncovering new uses for drugs—some have referred to it as finding diamonds in the dustbin. There are extraordinary applications among the existing pharmacopoeia of tens of thousands of drugs. We now realise that many of them have particular impacts and effects. That is all to the good. It is thanks to the power of our life sciences sector that we are beginning to uncover those, and the Bill will support that.

With those comments in support of amendments 10 and 13, I hope I have given hon. Members enough reassurance and that they feel able to withdraw or not

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press the probing new clauses. I will be happy, following Third Reading, to put in place, through the accelerated access programme, a clear plan for keeping on top of the system’s implementation and tracking the use of repurposed medicines. We will continue with the work we did with charities through the winter and with the very helpful discussions we had with the charitable sector, and the Department will look annually at the data and whether the landscape is changing, and if it is, we will keep that under review.

10.45 am

Nick Thomas-Symonds: I am grateful to Members across the House for their contributions and to the Life Sciences Minister for his clear response to the six probing new clauses. I am pleased to hear that the Government will accept amendments 10 and 13. As I said in my opening speech, having off-label treatments in the Bill and the database will make a significant difference and help move things forward. I was also pleased with his reassurance to the hon. Member for Central Ayrshire (Dr Whitford) that we will continue to review the system, as, I hope, the number of off-label treatments and prescriptions increases.

In view of the Minister’s commitments and acceptance of amendments 10 and 13, I do not propose to press new clauses 1, 2 and 3. New clauses 4, 5 and 6 are in the names of the hon. Members for Bury St Edmunds (Jo Churchill) and for Central Ayrshire (Dr Whitford). I beg to ask leave to withdraw the motion.

Clause, by leave, withdrawn.

Clause 1

Access to innovative medical treatments

Amendment made: 10, page 1, line 3, after “treatments” insert

“(including treatments consisting in the off-label use of medicines or the use of unlicensed medicines)”—(Chris Heaton-Harris.).

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)

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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”

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“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

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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.

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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.

29 Jan 2016 : Column 553

Criminal Legal Aid

11 am

Andy Slaughter (Hammersmith) (Lab) (Urgent Question): To ask the Under-Secretary of State for Justice if he will make a statement on the provision of legal aid services.

The Parliamentary Under-Secretary of State for Justice (Mr Shailesh Vara): As the Lord Chancellor and Secretary of State for Justice announced yesterday, the Ministry of Justice has had to play its part in reducing the budget deficit, and economies have had to be made in every area of expenditure. In the last Parliament, spending on legal aid was reduced from £2.4 billion to £1.6 billion. Further changes in the legal aid system were due to be implemented in the current Parliament, with a second reduction in litigation fees in July 2015.

At the time when the fee reduction was proposed, the market was made up of about 1,600 legal aid firms. After careful negotiation, the then Justice Secretary decided to adopt a system of “dual contracting” to drive greater efficiency and consolidation in the market. Over time, however, opposition to that model has increased. Solicitors’ firms feared that it would lead to a less competitive market, and barristers feared that choice and quality would diminish. Besides, a process of natural consolidation was already taking place in the market.

Although we understood those arguments, we also needed to deliver reductions in expenditure, but since July 2015 there have been two significant developments. Her Majesty’s Treasury has given us a settlement that allows greater flexibility in the allocation of funds for legal aid, and it has become clear that there are real problems with pressing ahead. We currently face 99 legal challenges and a judicial review of the entire process. Litigation will be time-consuming and costly for all. We have therefore decided not to go ahead with the introduction of the dual contracting. We have also decided to suspend for 12 months the second fee cut. The Legal Aid Agency will extend current contracts to ensure that the service continues until replacement contracts come into force later this year.

We will review progress on joint work with the profession to improve efficiency and quality before returning to any decisions on the second fee reduction and market consolidation.

Andy Slaughter: This is a happy day. A serious threat to the integrity of the justice system and the livelihoods of thousands of hard-working professional people—the mainly small and local solicitors’ firms that are the bedrock of local justice—has been lifted, and we welcome that.

Nothing is more important to securing access to justice than the ability of citizens to obtain competent and timely legal advice when accused of criminal conduct, but that basic human and civil right was put at risk by the Government’s ill-conceived plans. What on earth was the Department playing at in the first place? This is the latest in a series of U-turns, and once again a written statement was issued at 3 pm on a Thursday. We are only here today thanks to you, Mr Speaker, because you granted the urgent question.

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Everyone who cares about the criminal justice system in our country has been saying that the Government’s proposals for new criminal contracts were a disaster from the day on which they were proposed, in June 2013. That was not only my view or that of the Law Society, the Criminal Law Solicitors’ Association, the London Criminal Courts Solicitors’ Association and the Justice Alliance; it was the view of everyone in the justice system, and I pay tribute to them all for the magnificent campaign they have fought. It was also the view of the Government’s own experts, but the former Lord Chancellor still failed to register the chaos over which he was presiding. I credit the current Lord Chancellor with having the common sense to bring this farce to an end, but I wish the Government had listened to my right hon. Friend the Member for Tooting (Sadiq Khan) when he proposed the scrapping of the scheme exactly a year ago.

What we cannot do is draw a line and forget what has happened. Questions remain to be answered, and I ask the Minister to answer the most urgent of them today. How much public money and civil service time have been spent on the abortive tendering processes, the court cases and the consultations in the past three years? Will the Minister refer his own Department to the National Audit Office, so that it can be independently investigated? Will he apologise to the firms that have closed, laid off staff or cut salaries when faced with losing contracts, and also to those who have spent thousands of pounds on bidding and winning contracts and, in many instances, taking on extra staff whom they will not now need? Will he go further, and establish what assistance can be given to those firms? Will he remove the remaining uncertainty over the second fee cut? Given that he imposed it and has now decided to remove it for at least a year, what timescale and criteria will he apply to future fee levels?

Finally for today, given the NAO’s and the Public Accounts Committee’s scathing criticisms of the civil legal aid cuts—incidentally, I learned just before entering the Chamber that the NAO has also reported a £1.1 million loss by the aborted Just Solutions International, the commercial arm of the Ministry of Justice—will the Minister bring forward the review of the Legal Aid, Sentencing and Punishment of Offenders Act 2012?

This has been an appalling use of taxpayers’ money. It has posed an existential threat to a fundamental part of our legal system, and it has caused uncertainty, failure and distress to thousands of hard-working small businesses throughout the country.

Mr Vara: I welcomed the comments made by the hon. Member for Hammersmith (Andy Slaughter), although they were very brief. I must add, however, that his attempt to criticise what has been described as the Lord Chancellor’s sensible decision was opportunism, pure and simple. He obviously has a selective memory. I remind him that in 2009, when Jack Straw was Justice Secretary, he abandoned the criminal legal aid best value tendering scheme at a very late stage, just before the 2010 general election. I do not recall the hon. Gentleman’s grumbling to his boss at the time, and Jack Straw certainly does not recall hearing his voice. This needs to be put into proportion.

Let me now deal with the hon. Gentleman’s questions. When we embarked on the dual contract process, we had the support of the Law Society; the hon. Gentleman

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may wish to reflect on that. We have said that we will suspend the second fee cut for a year. We will then work with the professions, and will form a definite view in due course. As for the Legal Aid, Sentencing and Punishment of Offenders Act, the hon. Gentleman knows only too well—because I have said it many times at the Dispatch Box—that a review will take place within three to five years.


The hon. Gentleman is chuntering away, as he is wont to do on a regular basis. He says, “How much money?” He knows full well that all shades of Government, both Conservative and Labour, if they have listened to people and feel that a decision needs to be changed, will make that change. Just as the Labour Government made decisions to change policies, we have made such a decision. I do not recall previous Governments wasting time and effort in trying to make calculations when they have made a change of direction.

Our decision has been welcomed by the profession, and we are pleased about that. We now want to look forward and move ahead.

Robert Neill (Bromley and Chislehurst) (Con): The intelligent lawyer and the intelligent decision maker are alert to the dictum attributed to Keynes: “When my information changes, I change my conclusions.” Surely the Lord Chancellor should be commended rather than criticised for doing that on this occasion.

Will my hon. Friend give us some more details of the particularly welcome initiative to involve the professions themselves through the proposed advisory council?

Mr Vara: My hon. Friend is right to say that the Lord Chancellor should be commended. Mark Fenhalls, QC, the chairman of the Criminal Bar Association, said yesterday:

“It takes courage to make such decisions.”

Perhaps the hon. Member for Hammersmith will reflect on that sentiment.

The Lord Chancellor has his advisory board, and he will be working with the profession to ensure that as we progress further, the public will benefit, and the taxpayer who funds the legal aid budget will gain the maximum possible value.

Sarah Champion (Rotherham) (Lab): Steve Hynes, director of the Legal Action group, has said:

“In its planning and execution the MoJ has demonstrated shocking incompetence with this tender exercise.”

Will the Minister now launch a review of his own Department’s competence?

Mr Vara: I appreciate that the announcement was made a relatively short time ago, and that the hon. Lady has probably not had an opportunity to hear what the profession has said. The profession has wholeheartedly welcomed the proposals, and I think she should note those comments, rather than individual comments.

Oliver Colvile (Plymouth, Sutton and Devonport) (Con): Will my hon. Friend write to me, explaining what impact the proposal will have on lawyers in the

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west country, especially those in my constituency, which contains, at Charles Cross, the busiest police custody suite in England?

Mr Vara: I urge my hon. Friend to look at the details of the statement made by my right hon. Friend the Justice Secretary yesterday, wherein the way forward is stated, but I will happily write to my hon. Friend with further details.

Nick Thomas-Symonds (Torfaen) (Lab): I should first say that I used to be a barrister before entering Parliament, and remain a non-practising door tenant of Civitas Law in Cardiff.

A year ago, the previous Lord Chancellor said these very reforms were both sustainable and essential. I thought that was completely wrong and I am delighted that the current Lord Chancellor agrees with me, but can the Minister tell us why the previous Lord Chancellor got so many things so badly wrong?

Mr Vara: It lowers the tone of this debate when, not for the first time, the hon. Gentleman takes his lead from the hon. Member for Hammersmith by resorting to personal abuse. There have been two significant developments, which have allowed us to make the announcement. First, thanks to the economies we have made elsewhere in the MOJ, Her Majesty’s Treasury has given us a settlement that allows us greater flexibility in the allocation of funds for legal aid; and it has also become clear, as I have said, that there are real problems in pressing ahead as initially proposed. We recognise those issues and we want to do the best for the profession, and that is why we have taken this decision.

Mr Steve Reed (Croydon North) (Lab): The Minister’s Department has wasted close to £15 million now on ill-judged projects. What does this latest U-turn bring the running total to?

Mr Vara: The hon. Gentleman talks about millions of pounds; may I just remind him of the billions that were squandered and wasted when his party was in government, and that if it was not for its squandering and mismanagement, this Government would not have had to take the tough decisions we are having to take?

Conor McGinn (St Helens North) (Lab): The Saudi prison contracts, the secure college, the book ban, the outsourcing of the collection of fines by courts, the criminal courts charge, and now two-tier, the latest in the long line of U-turns by the Justice Secretary on measures taken by his predecessor. If he is looking for his next U-turn, may I suggest he looks at the repeal of the Human Rights Act—and, of course, the closure of the court in St Helens?

Mr Vara: I am sure the hon. Gentleman’s constituents will be grateful that he managed to slip in that last bit concerning his court. As I have told him previously, no firm decisions have been taken on that issue. On other matters, I am pleased that the hon. Gentleman pays such detailed attention to what is happening in the MOJ.

Carolyn Harris (Swansea East) (Lab): I welcome the Justice Secretary’s move to scrap the two-tier system. He said HM Treasury has given him a settlement that

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allows him greater flexibility in the allocation of funds for legal aid. Will he give us more detail about the settlement and whether it will extend further than what he has already said?

Mr Vara: I refer the hon. Lady to the Chancellor’s autumn statement. He said he would be allowing £700 million-plus for the courts reform programme and there would be £1.3 billion for reforming the Prison Service. We in the MOJ are also consolidating our estates programme generally in terms of the offices and space we use. If the hon. Lady reads the statement, she will also be aware that my Department will be making 50% administration cuts by 2019-20.

Mike Kane (Wythenshawe and Sale East) (Lab): The Justice team must be spinning like tops at the moment. Would the Minister care to estimate how many U-turns there have been since the new Secretary of State took his position?

Mr Vara: I will just mention that Labour’s 13 years of squandering taxpayers’ money, which has meant that we have to take these decisions, puts into total insignificance the very cheap jibe that the hon. Gentleman seeks to aim at this Government.

29 Jan 2016 : Column 558

Closure of St Paul’s Place BIS Office (Sheffield)

11.14 am

Louise Haigh (Sheffield, Heeley) (Lab): (Urgent Question): To ask the Secretary of State if he will make a statement on the announcement by the Department for Business, Innovation and Skills online yesterday morning that it is to close its St Paul’s Place site in Sheffield, which houses 250 jobs, and relocate them all to central London.

The Minister for Small Business, Industry and Enterprise (Anna Soubry): The Department for Business, Innovation and Skills is committed to delivering efficiency savings and contributing to the Government’s deficit reduction targets. As such, we have developed the BIS 2020 strategic plans to modernise the way BIS works, reduce operating costs, and deliver a simpler, smaller Department that is more flexible and responsive to stakeholders and businesses. As part of these plans, the Department has announced its intention to close the BIS office in Sheffield at St Paul’s Place by January 2018.

All staff and departmental trade unions were informed of this decision yesterday, 28 January, and the statutory 90-day consultation process will now begin. Those staff most affected by this decision have been fully briefed and comprehensive support to all those facing a potential change or loss of job will be provided. This will include professional, external careers advice; professional outplacement support; working with the Department for Work and Pensions to host a jobs fair; allowed time out of the office to find jobs; and financial advice workshops.

This decision has not been taken lightly. Our current locations are based on what we call legacy decisions—decisions taken some time ago—and what can at best be described as ad hoc organisational changes. In future, our structures need to be designed in a more streamlined, efficient way. To support this effort, we will bring the number of locations we operate down from around 80 now to approximately seven centres, supported by a regional footprint for work at a local level. Each centre will focus on a key business activity and will bring together expertise and help to build our capability.

We have, and will continue to have, many more people based outside London than inside London.

Louise Haigh: Thank you, Mr Speaker, for granting this urgent question on an issue of such importance to people in Sheffield and to the Government’s hopes to build a northern powerhouse, because this decision came out of the clear blue sky for my constituents yesterday morning. The first any of them heard of it was when the permanent secretary arrived in their office at 9.30 yesterday morning. It speaks to this Government’s London-centric focus and contempt for the north of England that they think a consolidated

“combined central HQ and policy centre”

has to be, by rights, in London rather than in Sheffield where the operating costs are cheaper and the perspective on UK investment is much broader.

So why, despite Lord Maude of Horsham’s commitment to end “Whitehall palaces”, has the proportion of the civil service workforce in the capital gone up since 2010?

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The House will be aware that this is just the thin end of the wedge, as part of the BIS 2020 strategy, so can the Minister tell the House exactly when she is going to bother to announce which offices are going to be closed—or will civil servants have to wait uneasily at their desks for an appearance from the permanent secretary?

Secondly, the board at BIS must have seen a business case for the BIS 2020 report, prepared by McKinsey & Company at great cost. Will the Minister publish the business case so that we can see how the Government can possibly hope to reduce operating costs by moving to central London?

Indeed, is it not economically irresponsible to create more jobs in central London, which is suffering an incredibly overheated housing crisis? Given that there is a 40% cut to partner organisations coming down the line, can the Minister rule out today, categorically, that the Insolvency Service and the Skills Funding Agency based in Sheffield will not be closed?

Sheffield has already lost 500 jobs at HMRC, 100 jobs at Forgemasters and 400 jobs at the local authority. People in my city will be right to ask: why have the Tories got it in for Sheffield?

Anna Soubry: As somebody who was born and bred only 17 miles from Sheffield, I do not need any lectures from the hon. Lady, and in particular not from the Labour party given that the last Labour Government closed offices in York and Liverpool and axed over 1,500 jobs in Preston and across the Fylde coast as part of a major rationalisation of DWP offices.

The hon. Lady may not be familiar with, and understand the nature of, the Sheffield city regional deal, which was supported by people from all political parties, and rightly so, and I find it very sad, and somewhat shameful, that the hon. Lady seems to in some way criticise the northern powerhouse—[Interruption.] She laughs, and I hope Hansard will record that. The northern powerhouse has been supported, as I said, notably by some of our outstanding Labour leaders of councils across the whole of the north, and rightly so.

As I have said, there will be six business centres around the United Kingdom, including the following: a business-facing centre, likely to be in south Wales; an institutional and research centre, likely to be in Swindon, but which may initially also include Bristol; a further education funding centre, whose location is yet to be decided, but we are seriously considering Coventry; one or two higher education student finance centres, initially in Glasgow and Darlington; and a regulation centre in Birmingham. Conservative Members understand the need to ensure that taxpayers’ money is spent wisely, efficiently and effectively, and that is what we will do. All of this is our clearing up of the mess that was left by the previous Labour Administration.

Mr Gordon Marsden (Blackpool South) (Lab): I congratulate my hon. Friend the Member for Sheffield, Heeley (Louise Haigh) on her urgent question. Today’s announcement that the Department for Business, Innovation and Skills is scrapping its office in Sheffield, which has 247 jobs, is a hammer blow to the people there. It is also a huge worry and a warning to the 12 other BIS regional offices, six of which are in the north, that

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they are at risk from this so-called restructuring. What assurance can the Minister give us that there will be no compulsory redundancies in Sheffield, and will she tell the House what offers of relocation expenses or even relocation itself there will be?

The BIS press statement talked vaguely about six business centres, which the Minister also mentioned in her answer, but they are servicing a centralised headquarters in London. Will the Minister say precisely where those centres will be—we have been told that possibly five will be in the south, and one in the north—and how many people will work in them? Are they simply a hastily drafted afterthought? Will they be just fig leaves, ministerial post boxes or possibly even digital fig leaves?

The BIS statement also said that the closure would reduce operating costs, so will the Minister tell the House what savings there will be from this closure, which comes on the backs of the people of Sheffield? The union, Prospect, said yesterday, that it was given only 30 minutes’ notice of this announcement. What discussions did Ministers have with workers and trade unions before the announcement was made?

The announcement comes on the back of the latest Centre for Cities report, which places Sheffield in the low wage, high welfare economy—half of the UK’s biggest cities are in that report. The report underlines the stark north-south divide and undermines all the Chancellor’s spin and rhetoric about a rebalanced economy. It is no wonder that civil servants told Radio Sheffield that they felt betrayed.

In the light of the 100 jobs lost at Sheffield Forgemasters and HMRC’s November announcement, to which my hon. Friend the Member for Sheffield, Heeley has already referred, I have to ask whether this is what the Tory industrial strategy amounts to—cutting and running. This is not a strategic approach; it is a kick in the teeth. The Financial Times said that 20% of civil service jobs had been lost in the regions since 2010 as opposed to only 9% in London. With infrastructure spending in the north standing at £539 a head and London’s at £3,386, BIS is shifting more jobs to the Chancellor’s Whitehall comfort zone and exposing the empty rhetoric of his northern powerhouse.

Did the Minister’s Department discuss the decision with the Secretary of State for Communities and Local Government who is busily promising devolution to local authorities while her officials are undermining it, and did the Minister’s Secretary of State discuss the closure with the Chancellor and did he approve it? Did BIS speak to council leaders in Sheffield and across West Yorkshire to see whether an alternative package could be put together? This Government need to tackle our skills emergency. [Interruption.] Perhaps the Minister should listen. The Government have dithered and missed opportunities—[Interruption.] Will the Minister stop chuntering from a sedentary position? They have missed opportunities to save our steel industry—[Interruption.]

Mr Speaker: Order. This speech will be heard—[Interruption.] Order! Minister, you have had your say, and you will have further says. There is something here about a basic dignity. Just sit and listen. It is not about you; it is about the issue. It is not about the hon. Gentleman either. Be quiet and listen. That is the end of it. It is not a request; it is an instruction.

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Mr Marsden: As I was saying, the Government need to tackle our skills emergency and poor productivity, but they have dithered and they have missed opportunities to save our steel industry. They are now abandoning a great historic steel town. They are comprehensively failing to deliver enough of the high-skilled, better paid jobs for England’s regions that Labour wants to see. Let me see whether the hon. Lady will be as candid in expressing disappointment about BIS pulling the plug on Sheffield as she was about the Chancellor’s poor tax fix for Google.

Anna Soubry: Thank you, Mr Speaker. It is not about me; it is not. It is about the workers. I am very proud of, and pay tribute to, all those civil servants who work in the Department for Business, Innovation and Skills, and indeed I am proud of all our civil servants, which is why Conservative Members understand how important it is to have a sustainable civil service and to spend public money wisely.

There were so many questions in what apparently was a speech that I have not got the time to answer them all. [Interruption.] If I have to shut up and listen in silence, so, too, does the hon. Member for Blackpool South (Mr Marsden). What is goose for the gander is also goose for that hon. Gentleman.

Of the 20,000 staff paid for by BIS, only some 2,000 —about 10%—work at No. 1 Victoria Street. The vast majority are spread around the country. I pay particular tribute to the 60 who work in BIS local and provide an outstanding service not only locally, but to us working in the ministerial team at No. 1.

Let me repeat this: members of staff who have been affected have been fully briefed. Comprehensive support will be provided. Some of the staff will be able to transfer and apply for jobs in London; others will of course take voluntary redundancy. Mr Speaker, I do take great exception to Labour Members who stand up and talk down the great city of Sheffield, which has an outstanding city deal. That is recognised locally, which is why it has been supported by political parties of all colours in Sheffield. Labour Members might do well to listen to their own members locally before spouting nonsense and talking down the great city of Sheffield.

Conor McGinn (St Helens North) (Lab): I do not know why the Minister seems to be taking criticism of her decision so personally. The people who should be doing that are the hundreds of workers whose jobs are at risk and who have not heard a shred of sympathy or regret from the Minister. Local government leaders in Sheffield and places such as St Helens do not need to receive the praise of the Conservative party; they are already doing fantastic work in encouraging investment and jobs to come to our areas. Public sector jobs provide the economic ballast for our areas. The Government cannot keep cutting jobs and services and expect us to build a northern powerhouse. We are the people who are working on the ground in communities and we do not need to hear from the Minister on a day when people might be losing their jobs.

Anna Soubry: I am sorry, Mr Speaker, but there was no question there. The hon. Gentleman made a speech. It was not accurate and it was rubbish.

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Mr Speaker: It was also perfectly orderly of which I am the judge. The hon. Lady should stick to the discharge of her responsibilities to the best of her ability. I am the arbiter of good order. I handle those matters, and I certainly do not require any advice from a junior Minister.

Robert Jenrick (Newark) (Con): Representing the Nottinghamshire communities—we are 15 to 20 miles from Sheffield and many of my constituents commute into Sheffield for work or to use public services—which include the childhood home of my right hon. Friend the Minister and of her mother, who is a formidable lady, it gives me no pleasure to hear of the job losses today. None the less, it is surprising to hear Labour Members criticise the Sheffield city deal, because my constituents in Nottinghamshire explicitly want to be part of it, as do the constituents of my friend and neighbour, the hon. Member for Bassetlaw (John Mann), because it is such a good deal, creating as it does both jobs and opportunities.

Anna Soubry: Dare I say it, Mr Speaker, I do not think there was a question there. As it happens, I agree with everything that my hon. Friend said.

Mr Speaker: It was also orderly.

Sarah Champion (Rotherham) (Lab): I do not recognise any of the criticisms that are being laid on my party about Sheffield. We are very proud of it, which is why we are here today. I would like the Minister to explain simply why taking jobs from Sheffield to London is in any way supporting the region or the Government’s ideal of a northern powerhouse.

Anna Soubry: I hoped that I had explained that to the hon. Lady. We are having to ensure that we spend public money wisely. Unfortunately, that means that we have to reduce the number of people who are working for us. We must make sure that we use the money to best effect, which is why we considered the decision so very carefully, as I hope that she understands we would. Nobody on the Government Benches takes any pleasure whatsoever when anybody loses their job. That is why we are so keen to make sure that we put the support in. We are confident that many of the workers will choose to take new jobs down in London. The simple truth is that we have to take tough decisions. We took tough decisions during the five years of the previous Government and we saw the fruits of that in the reduction in the deficit, a reduction in debt and our economy once again getting back on its feet so that there are now more than 2 million people in work who did not have a job before.

Neil Coyle (Bermondsey and Old Southwark) (Lab): In my short time in Parliament, this is perhaps the most undignified spectacle at the Dispatch Box that I have seen. Is it not also undignified for the Department for Business, Innovation and Skills to spend £200,000 of taxpayers’ money developing a business case to shut down jobs? When will that full business case be published?

Anna Soubry: I shall make inquiries. If I can assist the hon. Gentleman, I will. As I say, in difficult times when we have to make sure that we continue with our long-term economic plan, difficult decisions have to be made, but we take the view that this is the best way to spend public money more efficiently and more effectively.

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Mike Kane (Wythenshawe and Sale East) (Lab): I do a lot of training of young people who aspire to public life and I always tell them is it important to comport oneself well in public life. The Minister has fallen below that standard this morning, unfortunately. However, I agree with her that there are great Labour leaders across the north of England. One of those is Julie Dore, who is the leader of Sheffield city council and the driver behind the Sheffield regional deal. In relation to this matter, she said:

“Yet again the actions of this government speak far louder than their empty words about commitment to the north.”

Does the right hon. Lady agree with one of our great northern Labour leaders?

Anna Soubry: As I say, the Sheffield city regional deal is an outstanding deal for the people of that city and that area. As a result of it, I understand that the number of people in work in Sheffield has risen and unemployment continues to fall.

Mr Steve Reed (Croydon North) (Lab): May I invite the Minister to do what she has so spectacularly failed to do so far this morning—apologise to the people who are at risk of losing their jobs and just show a little human compassion for people who this morning are fearful for their livelihoods, for themselves and their families?

Anna Soubry: I am sure Hansard will record that as I said to the hon. Member for Sheffield, Heeley (Louise Haigh), nobody enjoys it when people lose their jobs and nobody takes any pleasure in it. We will do everything we can to support those people who will have to be made redundant if we reach that stage. It is rich coming from Labour, which brought this country almost to the level of bankruptcy, which resulted in millions of people losing their jobs. I am delighted that we have now got 2 million more people in work, thanks to our long-term economic plan.

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Access to Medical Treatments (Innovation) Bill

11.32 am

Debate resumed

Anne Marie Morris: I shall resume my comments on amendment 2, which would remove clause 3. The argument goes that innovation has fallen in recent years owing to the legal complexities and doctors fearing a negligence claim against them if something goes wrong. There is no evidence of this, according to the Medical Protection Society, the Medical Defence Union, the General Medical Council or various other medical bodies that have spoken out on the issue. They claim that the Bill needs to be completely rethought and that no amount of amendment would make it acceptable. I would like to think that the work that my hon. Friend the Member for Daventry (Chris Heaton-Harris) has done will go some way to meet the concerns expressed before Committee stage.

Those most likely to benefit from innovative medicine are likely to be those most in desperation. Those who have nowhere else to turn will often be allured by the carrot on the end of the proverbial stick, but we must make sure that the treatment is right for that particular person. The UK has a proud history of research through universities, research institutes, the private sector and, of course, the NHS. According to the UK Clinical Trials Gateway, there are currently 3,754 trials recruiting, and that does not include the innovation that goes on day to day in the NHS.

According to the Association of the British Pharmaceutical Industry, it can take over 12 years to develop a new medicine to the standards of quality, efficacy and safety that are laid down in legislation. It will typically cost £1.15 billion to do all the research and development necessary before a new medicine can be licensed for use. For every successful medicine, 25,000 compounds are tested, 25 of these in clinical trials, with five receiving approval for marketing. The pharmaceutical industry invests more in research and development than any other industry—£11.2 million is spent every day—and employs around 23,000 people in R and D. My hon. Friend the Minister for Life Sciences stated in September last year:

“Research and innovation in the NHS are critical for addressing ...challenges.”

I agree and therefore wholeheartedly support amendment 2.

Amendment 3, which would remove clause 4, was tabled by my hon. Friend the Member for Daventry, with the support of the hon. Member for Central Ayrshire (Dr Whitford) and my hon. Friend and neighbour the Member for Totnes (Dr Wollaston). It is important to address the legal aspects of the Bill and medical negligence. The common law test, which is the main test for medical negligence, has been around since 1957 and derives from the case of Bolam v Friern Hospital Management Committee. The Bolam test states: that if a doctor reaches the standard of a responsible body of medical opinion, he is not negligent. This rule has served us well over the past 55 years and I believe it will continue to serve us well. However, if it needs to be amended, our judges are in a suitable position to do that. The 1997 case of Bolitho v City and Hackney Health Authority, where the courts refined the Bolam test, is a great example of our common law in action.

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Although I am sure some will point out that the Bill does not explicitly change the Bolam test and clause 4(3) appears to address the concerns that were expressed about the Saatchi Bill, I worry that lawyers would still find a way around this. Why tempt fate to change something that is not broken? Judges and lawyers know where they stand with the common law, so maintaining the status quo will give both doctors and patients the protection they need from negligent treatment. If the removal of clause 3 is agreed to, it is right that clause 4 should also be removed as it would no longer be necessary, and the common law of negligence and the Bolam test can continue to operate effectively, as they have done for 55 years. I therefore support amendment 3.

Heidi Alexander: This group of amendments, and in particular those which leave out clauses 3 and 4, are very welcome and have my full support. I appreciate that making such extensive changes to a Bill at this stage is not easy, but the hon. Member for Daventry (Chris Heaton-Harris) has been true to his word, and has rightly decided not to proceed with these clauses in the face of strong opposition.

Members who were present on Second Reading will have heard some of the grave concerns expressed by medical royal colleges, research charities and patient groups. I think it would be fair to the hon. Gentleman if I say that those concerns, which I shared, were more about the unintended consequences of clauses 3 and 4, than about the stated aim of his Bill. However, the effect of these amendments, if they are passed, is that the sole purpose of this Bill is now to give the Secretary of State the power to establish a database. The hon. Gentleman knows that on Second Reading, along with many other hon. Members, I said that I believed the Secretary of State already had this power.

The Association of Medical Research Charities has said that primary legislation is not required to set up a database of innovative medical treatments. According to the House of Commons Library, section 254 of the Health and Social Care Act 2012 gives the Secretary of State power to direct the Health and Social Care Information Centre to establish a system for the collection or analysis of information. Indeed, in Committee, the Minister signalled his intention to introduce such a database, regardless of whether this Bill becomes law. He said at that time:

“If the Bill does not, for whatever reason, reach the statute book, I would happily proceed towards establishing such a database”.––[Official Report, Access to Medical Treatments (Innovation) Public Bill Committee, 16 December 2015; c. 22.]

With that in mind, I have to question whether what is left of this Bill is needed at all.

There also seems to be some confusion, even in the Minister’s own mind, about the purpose of the Bill. The Daily Telegraph claimed on 22 January that the Minister had told it that changes in the reworked Bill could help to cut the length of time it took to bring a new drug to market by a third, from 15 years to 10 years. Yet when my hon. Friend the Member for Ellesmere Port and Neston (Justin Madders) received a written answer to a question on this very subject on 28 January, the Minister’s reply was:

“The Bill is not specifically designed to reduce the length of time it takes to bring a new drug to market”.

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I would be grateful if the Minister could clarify the apparent contradiction in those remarks. Having said all that, I support all the amendments in this group. Indeed, they represent a positive step forward in terms of the overall Bill.

George Freeman: The amendments seek to remove the part of the Bill that sought to take forward the original proposals put forward by Lord Saatchi to provide reassurance to clinicians that fear of negligence should not be a barrier to innovation. I want to say something about the Government’s position on this point, which, as the hon. Member for Lewisham East (Heidi Alexander) has said, has been a point of some contention.

The Government share the ambition that fear of negligence should not be a barrier to innovation. Indeed, we have looked carefully at the provisions of the original Saatchi Bill and of this Bill, and taken legal advice in order to be sure that the proposed mechanism would in no way have changed medical negligence law, and that is indeed the case. Notwithstanding that, I have also repeatedly made it clear that if the Bill’s provisions were to create confusion, undermine patient, public and clinician trust and confidence and trigger a lawyer-fest of discussion about whether the mechanism did or did not have that effect, it would have had the opposite effect to that which it was seeking. In those circumstances, the Bill could trigger more confusion about medical negligence.

My hon. Friend the Member for Daventry (Chris Heaton-Harris) has done a sterling job in the past few months to get round all the various parties and reassure them that, in law, the proposed mechanism did not change the legal framework for medical negligence. However, as he himself has candidly said, such as been the level of opposition—and indeed some misunderstanding, not least because there are three Bills on this subject in the House—that this proposal has started to have the opposite effect. As I said on Second Reading and elsewhere, we would never be able to support a Bill which, despite its intentions, undermined public and patient trust and confidence in our world-class medical and clinical research landscape. The fact that a coalition of lawyers, clinicians, patients and charities was concerned about the clause meant that it would inevitably have to be removed if the Bill was to receive any support from the Government. I congratulate my hon. Friend on doing his very best to develop the debate and, in the end, deciding that it would be better to remove the clause and focus on the areas on which there is agreement.

In accepting the amendments that remove the provisions on medical negligence from the Bill, it is worth pointing out that I do not want the hon. Member for Lewisham East to misrepresent my position on this. Both the chief medical officer and the NHS medical director had advised us that they believed the proposal was safe, and we had no fear that it would in any way endanger patient safety. The point is that if it triggers legal, political or patient concern, it is self-defeating.

As I have said repeatedly at the Dispatch Box, fear of negligence is just one concern in a whole field of barriers to the adoption of innovation. I do not believe that it is the biggest barrier; I never have. The biggest is the difficulty of getting information to clinicians on the busy frontline of our national health service on the pace,

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scale and volume of innovative medicines that are coming through the system. That is why I believe that my hon. Friend’s refocusing the Bill on that, and on the introduction of a new mechanism for getting information on off-label drugs and innovative medicines in development, is very helpful and powerful.

In the consultation on the previous Bill on this subject, we received some evidence from clinicians that there was an issue about fear of negligence. Indeed, some Members have talked about the scale of the negligence bill that now confronts the NHS every year. I want to put on record, notwithstanding my earlier comments, that it is absolutely right to remove this mechanism from the Bill because it is having the opposite effect. There is an issue in our system, and we need to ensure that doctors and clinicians are not operating under the sword of Damocles because of the fear of negligence. It is equally important that patients should know that the system is there to protect them, and we do not want them to fear that medical negligence provisions are being undermined in any way. I strongly welcome the removal of this clause, but in so doing I do not want the hon. Member for Lewisham East to misrepresent our position by saying that we accepted that the mechanisms were in any way dangerous. Patient safety has always been our No. 1 concern.

Heidi Alexander: Will the Minister tell us why it is taken him so long to reach this conclusion? Will he also be clear about the contact that his officials at the Department of Health might have had with the hon. Member for Daventry (Chris Heaton-Harris) or Lord Saatchi on previous incarnations of this Bill? It strikes me that the Department has supported this Bill for a number of months and years in its different incarnations.

George Freeman: I am absolutely delighted that the hon. Lady has asked me that question, because it gives me the chance to deal with this matter directly. I am surprised at her question, in an age in which people want the Government to work in a cross-party way and to support private Members’ Bills and enable Back Benchers to get business through, and I have gone out on a limb to work in a cross-party vein. Sadly, however, the hon. Lady seems stuck. I thought this morning might have been a day on which to celebrate that joined-up work. Let me deal with the specific points that she has raised.

Right at the beginning, I said that I supported the aim of Lord Saatchi’s Bill to tackle the issue, such as it is, of medical fear of negligence if it is getting in the way of innovation. Indeed, we made it clear that we supported the aims of the Off-patent Drugs Bill, but not the mechanism involved. We also made it clear that we supported the aim of the Bill introduced by my hon. Friend the Member for Daventry to promote access to information about innovative medicines. I am surprised that the hon. Lady cannot get away from wanting to criticise that attempt. I believe that it is a good thing that we have reached joined-up consensus today on a package of amendments.

The hon. Lady should not believe everything that she reads in the papers. The article in The Daily Telegraph to which she referred talked about the accelerated access

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review, which I am leading and which I would like to think she welcomes and supports. My comments on speeding up the pace at which we can get innovative medicines to patients were in connection with that. I read the piece too, and it was misleading because it gave the impression that I thought this Bill would have the effect that I want the accelerated access review to have. I was merely making the point that the Bill in its current form could support the wider accelerated access review and the landscape that I am trying to put in place.

Heidi Alexander: I should like to state for the record that it has never been the Opposition’s desire to play political games with this Bill. We have always been concerned about what is in the best interest of patients, and I would like to make that point clear to the Minister and place it on record.

George Freeman: I am grateful to the hon. Lady for that clarification; it is most welcome.

I want to deal with the point that the hon. Lady and one or two others have made about the necessity of the Bill, given the powers that Ministers already have in relation to data. The Health and Social Care Information Centre, created under section 254 of the 2012 Act, can collect data, but there are restrictions on who it can disclose those data to. The Bill will enable disclosure to doctors, which could be limited by using just section 254. The 2012 Act also contains specific provisions relating to the HSCIC having a role in establishing other databases, so this approach is more in keeping with the general approach in the legislation.

The Bill might not pass in its current form, as it still has to go to the House of Lords. However, the point I made in Committee was that although I support the intention of that database provision, the law regarding the use of data in the NHS is complex and difficult, as Members know well. If the House wants the database to be created, having a Bill that makes very clear what it wants the database to do and requires Ministers to come back with proposals for it would be extremely helpful. In conclusion, I support these amendments.

Amendment 1 agreed to.

Clause 2

Database of innovative treatments

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

“In this section, “innovative medical treatment” means medical treatment for a condition that”.—(Chris Heaton-Harris.)

Heidi Alexander (Lewisham East) (Lab): I beg to move amendment 8, page 2, line 20, at end insert—

“(b) the General Medical Council,

(c) the British Medical Association,

(d) the Association of Medical Research Charities,

(e) the Royal Colleges,

(f) the Academy of Medical Sciences,

(g) the Medical Research Council,

(h) the National Institute for Health and Care Excellence,

(i) the Medicines and Health Products Regulatory Agency, and

(j) any other body or individual that the Secretary of State considers it appropriate to consult.”

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Mr Deputy Speaker (Mr Lindsay Hoyle): With this it will be convenient to discuss the following: amendment 9,  page 2, line 20, at end insert—

“(6A) Regulations under subsection (1) may not be made unless the Secretary of State is satisfied that the regulations have the approval in principle of—

(a) the HSCIC,

(b) the General Medical Council,

(c) the British Medical Association,

(d) the Association of Medical Research Charities,

(e) the Royal Colleges,

(f) the Academy of Medical Sciences,

(g) the Medical Research Council,

(h) the National Institute for Health and Care Excellence,

(i) the Medicines and Health Products Regulatory Agency, and

(j) any other body or individual that the Secretary of State considers it appropriate.”

Amendment 15, in clause 5, page 4, line 1, leave out subsection (2) and insert—

“( ) 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).”

This amendment makes it clear that the database for which clause 2 provides may contain information about treatments carried out for the purposes of medical research (including, for example, in the context of a clinical trial).

Heidi Alexander: Setting aside the fact that I question whether what is left of the Bill is necessary, if the database is to be created, it is important that we get its design right. The Association of Medical Research Charities has expressed concern that the database might adversely impact patients and medical research. For such a database to be effective, it will need to be appropriately regulated and quality controlled. I believe that it can only command the confidence of the medical profession if it is developed in consultation with it. With that in mind, amendments 8 and 9 deal with the bodies that the Secretary of State must consult and get approval from before introducing regulations establishing a database of innovative treatments.

As the Bill stands—this is set out in clause 2(1)—to make those regulations the Secretary of State need only consult the Health and Social Care Information Centre. Restricting the statutory consultees to only one organisation seems highly restrictive and is inconsistent with the Bill’s explanatory notes, which state: