Saturday, 7 November 2015

Off patent drugs bill The Debate

Here is the transcript of  the debate  for the Off-patent Drugs Bill

The central tenet of the argument put forward by the Government is that we do not need to legislate to licence drugs because there is already the ability to prescride off-label. So why bother.


Maybe ProfG/DrK, SNG who is are the coal face will put forward some arguments against this view.

(a) Doctors are liable for their actions and their may be insurance issues if a problem occurs. The licence protects the doctors. Therefore some will and some will not prescribe. With a licence you will get more uniformity of care.

(b) Specialist doctors will be aware of their prescribing potential non-specicalises will not and so create an imbalance. If they gave a green light to off label prescribing would it cost the government more in getting doctotrs to try things for the people in their care.

(c) Licence holders need to monitor for rare adverse events in phase IV. If doctors are prescribing in a hap hazard way without any registry then these will go unmissed endangering patients. e.g. Alemtuzumab autoimmunities were not a big issue in non-MSers, therefore there are differences between patient groups and their co morbidities and so you cannot assume safe in one group is the same safety in another group. Waiting for case reports is not the best way for finding these out.

(d) Cladribine is effective and so we should be able to prescribe it for RRMS. This has more evidence than simvastatin for progressive MS and is more effecitve than many MS drugs. This will save money to address the Tory MP. However, a licenced drugs comes along and it them becomes illegal in Europe to prescribe the off-label drug against a licenced drug and therefore you need to stop prescribing. This then leaves the NHS to pay more for the treatment.  Is this the motive for not doing this bill. 

I believe that it has been difficult to get hospitals to pay for rituximab for PPMSers for the next couple of years until ocrelizumab comes along any PPMSer with gadolinium lesions could argue that that their neuro should be offering rituximab off-label their are two trials supporitng the fact that PPMSers can benefit from this treatment. If rituximab was licenced and NICED there would not be an issue...problem is pharma is in the hunt for ocrelizumab.

(e) With a licence and NICE cost effectiveness, there should not be an issue of paying for treatment they would be in the British National Formulary

(f) The Government can come up with a solution of being the licence holder and the purchaser, they can set up an independent body. The government used to control Interest rates for political gain and made it independent. The Government used to own East Coast Railways, did that mean MPs could travel to Edinburgh Newcastelr York, Leeds, etc because of a conflict. Their are bright people in the country that can come up with solutions to problems.

Can you think of things

1.8 pm
Nick Thomas-Symonds (Torfaen) (Lab):

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

It is an honour to be drawn in the ballot and to bring forward a private Member’s Bill on such a key issue. My grandmother, who inspired me to go into politics, died of breast cancer, and it is poignant for me that this Second Reading debate takes place in the week that would have been her birthday.

I am grateful to those who have sponsored this Bill, and to Members from across the House who have supported it. I thank the former hon. Member for Cardiff North, Jonathan Evans, whose Off-patent Drugs Bill was debated last year, and his successor, the hon. Member for Cardiff North (Craig Williams), for his support for this slightly refined version of the Bill. I thank my constituents for all their support, and I also thank Jenny Goodare from Breast Cancer Now for her help in preparing the Bill.

The Bill is a UK-wide Bill that creates a duty on the Government to make cheap drugs available when pharmaceutical companies have no incentive to do so. There is a problem: if a drug is shown to be useful for a new purpose after its original patent has expired, there is no financial incentive for a pharmaceutical company to sponsor that off-patent treatment through the processes that are normally used to licence it, and to ensure its adoption on the NHS.

Such off-patent treatments are usually available at low cost, but the current system is not set up to make them routinely available when they have been repurposed. Put simply, without a licence to act as a kitemark of safety, and a cost-effectiveness appraisal to give the NHS a mandate to provide it, there are multiple disincentives to treatments being prescribed, meaning that they are not routinely made available.

I have a letter from a clinician dated 15 October 2015 that I have permission to read out—the personal details have been redacted. He says he was contacted by a lady because she was advised that she had a high risk of breast cancer, and that raloxifene, which is an example of a drug that would benefit from the Bill, could be prescribed to help to prevent it. The key passage in the letter states:

“Unfortunately, I am unable to prescribe this as it is not licensed with this indication.”

[Interruption.] The Minister shakes his head, but I am quoting directly from a letter written by a clinician only in the past few weeks. That affects real people and has had a great impact on somebody’s life.

The Bill proposes a Government responsibility to step in and address that market failure in the public interest. Part 1 of the Bill introduces the duty of the Secretary of State to seek licences for off-patent drugs in new indications. The idea is to make those cheap, off-patent drugs routinely available. The president of the Royal College of Surgeons of Edinburgh recently said that, at the moment, there is significant variation, leading to variation of access across the UK.

There are barriers to the drugs being regularly available. Lack of awareness is a problem, but it is not all about that. General Medical Council guidance states that licensed treatment should be considered before an off-label or unlicensed treatment. In addition, GMC guidance is clear that a doctor takes on an extra level of personal liability when prescribing off-label.
Carolyn Harris (Swansea East) (Lab):

A Government spokesman was quoted in The Independent this week saying that the only thing general practitioners need is more information. Does my hon. Friend agree that that was both unhelpful and ill-informed? Deluging GPs with yet more information is certainly not productive.
Nick Thomas-Symonds:

My point is precisely that it is about more than information.

A licence for off-patent drugs would make a big difference. The all-party parliamentary group on off-patent drugs, which I chair, met on 15 October and took evidence from experts across the board. Pan Pantziarka, a repurposing specialist, said that granting a new licence triggers a “whole cascade of things”: the British National Formulary gets updated, clinical commissioning groups and specialist bodies take note, and guidance is updated. He said that, without that, we are dependent on doctors reading the literature and prescribing off-label, and that that is not the solution we want.

Sir John Burn, professor of clinical genetics and a non-executive director of NHS England told our inquiry:

“The other problem is making decisions in a short time scale—we haven’t got time to look at the bundle of evidence presented. The whole point of the licensing process is to distil that for the physician”
Anne Marie Morris (Newton Abbot) (Con):

Will the hon. Gentleman clarify something for me? Under his proposed scheme, when a drug gets relicensed, what will the impact be on pricing? When a drug goes off-patent, one benefit is that it effectively becomes cheaper because any company can manufacture it, which is clearly a benefit for the NHS. With relicensing, is there a risk that the company will effectively re-price, landing the NHS with extra costs?

Nick Thomas-Symonds:


I do not accept that that is a risk of the Bill. As the hon. Lady knows, the drugs are available for pennies a day. Under the Bill, the Government would step in to address a market failure. The Bill will not have the impact that she believes it will have. She makes a reasonable point, but it is not one that will arise under the apparatus and structure proposed by the Bill.

The alternative to the Bill—I firmly believe that if this Government do not do this, a future Government will have to legislate—is to continue to encourage more off-label prescribing. Even if that were desirable, very little has happened. In a letter dated 2 November, the Royal College of Physicians states:

“As there has been no meaningful progress on a non-legislative solution to this issue, we believe that your Bill is an important first step towards expanding access to these vital drugs.”

The proposal was debated a year ago and we have had a year to see whether there is a non-legislative solution to the problem.

The Bill has incredibly wide support across the professional spheres. I apologise in advance for not naming every charity that supports it.
Christina Rees (Neath) (Lab):

The Bill has the support of a huge number of medical research charities, which lead the way in research on the use of repurposed drugs. Currently, there is no route to market for off-patent drugs in new indications. Does my hon. Friend agree that the Bill will fix that anomaly?
Nick Thomas-Symonds:

I agree entirely with my hon. Friend. Twelve medical research charities back the Bill; the NHS clinical commissioners in England back the Bill; and the British Medical Association backs the Bill. More than 10,000 members of the public have written to their MP in support of it. That is in addition to the 20,000 who wrote last year to the former Member for Cardiff North. Four of the medical royal colleges support the Bill. Forty eminent clinicians wrote in recent weeks to The Daily Telegraph to support the Bill. It has incredibly wide support across parties and among the professions.
Albert Owen (Ynys Môn) (Lab):

I congratulate my hon. Friend on the Bill and pay tribute to Jonathan Evans, a thoughtful Member of Parliament who introduced a Bill in the previous Parliament. In addition to the long list of experts that my hon. Friend has quoted, I am sure he has had other lobbying letters. I had one from a multiple sclerosis sufferer. He eloquently put his case and said: “Please be there to give us hope.” Does my hon. Friend agree that the Bill will give us hope for cures for the future?
Nick Thomas-Symonds:

I agree entirely with my hon. Friend.
Liz McInnes (Heywood and Middleton) (Lab):

We are talking about people who support the Bill. The Association Of the British Pharmaceutical Industry says that it supports the principle of the Bill, but that it is concerned that it could discourage the development of new medicines. Does my hon. Friend agree that the Bill in no way precludes the normal process of research and development for the manufacture and discovery of new drugs?
Nick Thomas-Symonds:

I agree entirely with my hon. Friend. Repurposing is becoming increasingly common. Approximately 10% of the Brain Tumour Research portfolio is in repurposed drugs. For the Cure Parkinson’s Trust, the figure is 50%, and for the Alzheimer’s Society it is 13.6%. My hon. Friend makes a powerful point.
Liz Saville Roberts (Dwyfor Meirionnydd) (PC):

The debate is poignant for me. Breast Cancer Now is very supportive of the Bill, and my best friend and the mother of my goddaughter is currently in hospital recovering from her second treatment for breast cancer in 10 years. I should like to take the opportunity to say this. Christine Lennon, the most organised, capable and scary of my friends: we all want you home as soon as possible. [Hon. Members: “Hear, hear.”]

Some 850,000 people suffer from dementia, and that number is likely to increase to 1 million in 10 years’ time. The matter raised by the Bill is relevant to 20% of the drugs that the Alzheimer’s Society support, and it claims that the Bill will enable it to work on off-patent drugs. Does he agree that that is very significant, given that the disease affects so many people?
Nick Thomas-Symonds:

On the second part of the hon. Lady’s intervention, I entirely agree that it would assist the Alzheimer’s Society. On the first part, I am sure the whole House wishes her best friend a speedy recovery.

Given the time restraints, I will touch on just one benefit that the Bill would have. zoledronic acid, a type of bisphosphonate, was originally used to treat bone fractures in advanced cancer and osteoporosis, but it can also reduce by 28% the risk of breast cancer spreading to the bone in post-menopausal women. If it were routinely available to 34,000 women, it could save 1,000 lives a year, at the cost of about 5p per day per patient. That is precisely the kind of benefit the Bill could bring.
Dr Rupa Huq (Ealing Central and Acton) (Lab):

My hon. Friend talked about cost. Does he agree with my constituent, Elena, of west Ealing, who wrote to me on this subject to say that it would help MS sufferers in particular and that

“it is crucial that affordable treatments are used to their full potential particularly at a time when NHS resources are stretched. The Bill will tackle this issue head on and stand to benefit hundreds of thousands of people in Ealing and beyond.”?
Nick Thomas-Symonds:

I agree entirely with my hon. Friend. It is precisely that kind of benefit that the Bill would bring.
Rachael Maskell (York Central) (Lab/Co-op):

Today, a constituent of mine, Mark Hamilton, is laying to rest the ashes of his father, who lost his life very suddenly in September. Had these drugs been available then, he might well be with us today. Is that not why it is so important that the Bill proceeds to its next stage?
Nick Thomas-Symonds:

I am grateful for that intervention, because the Bill could have a positive impact on the lives of many people. That is why it should move forward.

This is a common-sense solution to an acknowledged problem. There is even a precedent for it. The Secretary of State, who is not in his place, but whom I am sure will be ably represented by the Minister, is the licence holder for a chemotherapy drug called Erwinase. It is manufactured by a state-owned pharmaceutical company called Porton Biopharma Ltd, which was established in July and in which the Secretary of State is the sole shareholder. There is, therefore, a precedent for the type of intervention I am talking about to deal with this market failure. The Bill will bring enormous benefits to people. It is a sensible solution to the problem.
Chris Stephens (Glasgow South West) (SNP):

I congratulate the hon. Gentleman on bringing the Bill before the House. A constituent of mine, Tracey Hardie, is a cancer survivor, but this is not just about her; it is about other people, and those who have survived cancer are very supportive of the Bill.
Nick Thomas-Symonds:

The hon. Gentleman is absolutely right. The Bill could really assist people out there in the country, which is why it should proceed.
Anne Marie Morris:

The hon. Gentleman has not talked about the consequences for off-label drugs. I do not think that anybody would disagree with using good drugs for alternative purposes. Most of the concerns I have heard about the Bill are around the methodology and the process and the impact on off-label drugs. At the moment, drugs not on the agreed list can be prescribed, and I would be concerned if there was any threat to the ability to do so.
Nick Thomas-Symonds:

With respect, that is precisely what the Bill seeks to do. We are talking about drugs that have been on patent for a particular purpose and that have a licence in that indication, but which also have another purpose. At the moment, theoretically, they can be prescribed off label, but that simply does not happen consistently across different spheres of medicine or across the country. The letter I read out from the Royal College of Physicians, dated 2 November, made that exact point.

The Bill is a common-sense solution that commands support across parties, in different spheres of the medical profession and from other stakeholders, and I commend it to the House.

1.24 pm
Marcus Fysh (Yeovil) (Con):

It is a great pleasure to take part in such an important cross-party debate that has engendered such interest among leading health agencies and campaign groups, and I congratulate the hon. Member for Torfaen (Nick Thomas-Symonds) on bringing it forward.

After discussing this issue with my constituents and key stakeholders based in my constituency over the past few months, I can now say that I welcome the fact that the Bill has reached its Second Reading. I am persuaded to be a firm advocate of the proposal for the Government to step in to license and approve off-patent drugs for new uses. Support for the Bill is consistent with the advice of health organisations in my constituency, such as the Ribbon Trust, which is a partner of Breast Cancer Now. The trust was set up by a fantastic group of cancer sufferers and survivors and their families around Chard in the western part of my constituency. They do an inspiring job of looking after each other and are determined to campaign for better options and treatment.

These brave ladies and their families have convinced me of the importance for breast cancer sufferers of accessing low-cost drugs for new purposes. For example, the use of zoledronic acid would save the lives of thousands of secondary breast cancer sufferers a year. Similarly, the Treat Me Right campaign, run by the Multiple Sclerosis Society and promoted by its Yeovil and Sherborne branch, supports the Bill, as it would give 65,000 secondary progressive MS sufferers nationwide access to the first treatment that can slow the cruel disease of MS.
Jo Stevens (Cardiff Central) (Lab):

Of the many constituents who have written to me about this excellent Bill, two suffer from progressive MS. If the Bill becomes law, cheaper drugs would be available. Would not making this medicine available save the NHS money on the treatment of progressive diseases?
Marcus Fysh:

That is a good point and one I will come to in a moment.

One of my Yeovil constituents, Heather Moore, wrote to me this July, asking me to vote in favour of the Bill. She wishes it to become law not only because it would give patients wider access to the benefits of new treatment options, but because it would give financial advantage to the NHS by providing some very low-cost treatments. At this time of pressure on health services from demography and budget pressure, the improvements in cost-effectiveness that could stem from the Bill are essential.

A similar private Member’s Bill, sponsored by the previous Member for Cardiff North in the last Parliament, made it to Second Reading but was regrettably stopped short of becoming law. I believe that today’s Bill outlines an even more compelling case for approval, since it specifies the need for the Government to seek licences for off-patent drugs in new indications.
Kit Malthouse (North West Hampshire) (Con):

Like my hon. Friend, I am extremely supportive of the Bill—it is a very sensible measure—but there is a difference between what is being proposed and what is already available. I am patron of the Andover and Rural District branch of the Multiple Sclerosis Society. As I understand it, these cheaper generic drugs are already available for prescription off label. I think the Bill is trying to make the point that that is not being advertised enough to the clinical community and that the addition of a licence for particular treatments would promulgate their effectiveness much more widely. If I have missed the point of the Bill, please forgive me, but it seems to be as much about information as the ability to prescribe. The two are not mutually exclusive. We can provide more information to clinicians and provide licences at the same time.
Marcus Fysh:

My hon. Friend makes a good point. The General Medical Council says that, traditionally, doctors have been reluctant to do that, partly because they may be wary of prescribing drugs for new uses owing to the increased level of personal liability that they may encounter.

Providing a way to overcome this reluctance, where efficacy has been demonstrated through licensing, deals with the argument made by the Under-Secretary of State for Life Sciences, my hon. Friend the Member for Mid Norfolk (George Freeman), in the debate on the previous Bill that the current law best meets the individual clinical needs of patients. The flexibility clinicians currently have to prescribe medicines, which my hon. Friend described, is fine, and it is each doctor’s solemn prerogative, but it should not be used as a structural excuse not to pursue new treatments where they have been shown to be effective for non-clinical reasons. In practice, that can encourage a lack of consistency and assurance for the patient because of the lack of NICE approval in the form of a technology appraisal. NICE is, in fact, in a very good position to conduct studies that test efficacy on particular subsets of patients, with their consent.

A partnership in my constituency between Yeovil District Hospital NHS Foundation Trust, Somerset clinical commissioning group, South Somerset GP federation and Somerset County Council was selected this March by a rigorous NHS England process to be one of 29 partnerships spearheading new ways of working—a vanguard project in finding new models of care. This partnership, called Symphony, is looking in particular at the integration of health and social care, bringing together GPs, hospitals, community hospitals, mental health and social services, and is focused on joint commissioning based on outcomes for patients. The intention is for the lessons learned in implementing this new model to be taken on board in replicating the integration process across Somerset and beyond. We need to learn the lessons and move forward together—fast.

I believe that this vanguard, which is led by very committed and talented people in each partner organisation—I congratulate and encourage them today—could act as a leader not only in developing this new care model, but in working with NICE in its role under the Bill to conduct technology appraisals for new uses of off-patent drugs.

This has particular application to one of the most difficult issues of our time—the fact that our population is ageing rapidly. There are areas of Somerset, as elsewhere in the country, where a majority of people are of retirement age—and that is likely to increase dramatically over coming years. The management of conditions that are becoming more prevalent as our population ages must be taken forward with every tool available to us.

A report written by the governors at Yeovil district hospital in October last year shows that there has been an increase in the number of local patients with suspected cancer. Indeed, Somerset has one of the highest proportions of cancer prevalence in England. This may come as no surprise, as it is a very attractive place to live and work, and it has attracted many people moving from other parts of Britain, with many choosing to retire in the area.

I strongly support the new cancer drug fund that this Government have implemented, which has given more cutting edge treatment options to those with cancer, but we can go further by increasing access to new treatments through off-patent drugs, which can be much cheaper.
Mr Christopher Chope (Christchurch) (Con):

My hon. Friend, like me, strongly supports the Bill. Time is of the essence, so I think the best thing we can do as supporters of the Bill is to reserve what we wish to say until Committee, so that the Government can respond to this very important measure. [Laughter.]
Marcus Fysh:

I thank my hon. Friend, who makes a good point—I am almost finished!

Given the seriousness of our healthcare challenges, I believe the Government should seek licences for off-patent drugs in new indications, thus increasing equality of access to proven treatments at an affordable price for more individuals and their families across our nation. I commend the Bill to the House.

1.33 pm
Dr Philippa Whitford (Central Ayrshire) (SNP):

I was interested to hear the hon. Member for Torfaen (Nick Thomas-Symonds) mention the research into zoledronic acid. I took part in the AZURE study, which indeed means that this bisphosphonate, which strengthens bone, will help bone to avoid getting invaded in the first place. We already use it in breast cancer for patients who have bone metastasis, but it provides of perfect example of where a second use can be found.

The hon. Member for Newton Abbot (Anne Marie Morris) expressed concern about prices going back up, but that simply does not apply. These drugs have been through the whole process, so we know about their safety and their side-effects; they are now cheap and generic. They are made by lots of different companies, and the reason they do not get licences is that it is simply not worth while because the companies cannot put the price back up. If a formulation is changed—if it was a tablet and is now an injection, or if it was an injection and is now a tablet—it is possible to apply for a new patent. If it is exactly the same drug, even with a new use, the company cannot get a new patent. It is not willing to spend the money on sponsoring it.

I have heard people say, “It is in the guidelines”—and believe me, many of these drugs are in NICE guidelines. NICE guidelines say exactly what was said at the beginning of the debate, which is that tamoxifen should be made available to patients who are at high risk of breast cancer. However, it is not licensed for them.

I am a breast cancer surgeon, and in my practice we carry out an operation called sentinel node biopsy. Instead of taking all the lymph nodes out of a woman’s axilla and giving her lymphedema—which some Members will have seen, either in their families or in their constituents—we try to remove only one or two, and we use dyes to target them. One is a blue dye called patent blue dye. It is so old that it is not even made in this country any more, and it literally costs pennies, but it is unlicensed. One of its possible side-effects is anaphylactic shock. That is very rare, thank goodness, but there it is. According to all the UK guidelines, that is the approach that must be taken to breast cancer patients.

I used to have to sign a form before every case that I handled, stating that I accepted personal financial liability if the patient suffered. Eventually I said, “Wait a minute: I am not putting my house on a piece of paper for every case when I would be in trouble if I did not handle that case.” Thankfully, my health board was eventually willing to underwrite it.

The idea that guidelines give us protection is unfortunately not true. When guidelines were introduced, the medical profession was reassured that they did not handcuff a clinician, and if a patient was treated off-guidelines, because patients do not fit in cubbyholes, there would not be an issue. Similarly, following guidelines slavishly does not give any protection. Doctors carry legal responsibility for any drug that they prescribe. So the specialists will prescribe off-patent drugs, and we will be using them.
Kit Malthouse:

I am slightly confused. Doctors are absolutely responsible for what they prescribe, but only if they do so negligently. The hon. Lady would not expose herself to litigation if she had, for instance, used the dye on a patient who then suffered from anaphylactic shock if that had been an appropriate and responsible thing to do given the patient’s condition at the time.
Joanna Cherry (Edinburgh South West) (SNP):

There is a risk.
Dr Whitford:

There is indeed a risk, as my QC expert has muttered. Part of the case would be that the doctor had prescribed an off-licence drug.

Experts in the field will prescribe many drugs that are off-patent for the treatment of secondary cancers. We are aware of the evidence, and we will use such drugs when we have the experience, but general practitioners will not. If a drug is not in the British National Formulary, they cannot check the dose, which might be different from the dose for the other usage.

We are seeing more and more non-doctor prescribers. We are seeing nurse prescribers and physio prescribers. We do not want to limit the use of future drugs that may be discovered by not sorting out the present position. It should not be beyond the wit of man. The NHS is surrounded by organisations, such as quangos, that could surely be used to deal with it.
The Minister for Community and Social Care (Alistair Burt):

Given the hon. Lady’s experience in this area, her presence in the House provides me with an opportunity that is too good to miss. Let me ask a question that goes to the heart of the reason for the Government’s concern about the Bill.

If I understand the hon. Lady correctly, it is not impossible to prescribe off-label if there is an indication that, say, the prevention of breast cancer may be aided by the use of tamoxifen. There is nothing to preclude that, although it may be difficult in the circumstances that she has described because of possible considerations of liability. Is she arguing that there should be no off-label prescribing because everything should be licensed, or not? I do not know whether it should be one or the other—[Interruption.] It is not a stupid question. We believe that if it is possible to prescribe off-label, the Bill is not necessary, but if it is not possible because of the difficulties that the hon. Lady has identified, perhaps that should not happen. Her experience is vital in this regard.
Dr Whitford:

As I was trying to suggest, someone who is an absolute expert in a field will be comfortable prescribing off-label, because they are using the drug every day, and they know exactly what it does and how to use it. But our patients spend the majority of their time in primary care, and a GP, who is unable to look up and check the dose or indication, will be a little more uncomfortable. People who are non-consultants—those at staff grades, who are at other grades—will be less comfortable. We see that exactly in the prevention of breast cancer; this drug has not come on stream at the speed that would have been expected, because people are uncomfortable. There is certainly not enough protection to mean that nurses are going to prescribe a drug that is not licensed, and the vast majority of drugs do not have guidelines, so what the Minister describes is not a protection.
Alistair Burt:

I just want to be sure about this. If I understand the hon. Lady correctly, that hesitation could apply to any off-label prescribing now, but off-label prescribing goes on—doctors and GPs do find the information and do it. I would not want to take the implication from her that off-label prescribing is wrong. It just needs the appropriate amount of information to make sure that it is right—otherwise, we do have to license everything.
Dr Whitford:

When a drug is proven and is going to be in common usage, it should be licensed—otherwise, we are suggesting, “Why bother with licensing any drug?” We are talking about drugs that could make a big impact, but they will do that only if they are in common usage. Expecting doctors to face any potential that they are signing away their mortgage on their house by prescribing something is simply bizarre. Of course there is off-label prescribing as a drug develops, but once we have something with rock-solid evidence behind it, which we expect everybody of every grade and every profession within the NHS to use, we should give them the reassurance of licensing.
Joanna Cherry:

My hon. Friend speaks knowledgeably about the treatment of breast cancer, but a number of my constituents who are living with multiple sclerosis have also written to me about this Bill. Scotland has one of the highest incidences of multiple sclerosis in the world. Can she confirm that the Bill will be of particular benefit to patients with multiple sclerosis in Scotland?
Dr Whitford:

Yes, absolutely; a drug called simvastatin is simply used for lowering cholesterol but it has been shown significantly to reduce brain atrophy in patients with a certain type of MS.

We do not know what is in the future. Other drugs will be found to have a second use, so why would we not take this very practical Bill through and allow ourselves to deal with a bizarre anomaly? As I say, this is not beyond the wit of man. Let us pick one of the quangos around the NHS and get this job done.

1.42 pm
Jo Churchill (Bury St Edmunds) (Con):

I congratulate the hon. Member for Torfaen (Nick Thomas-Symonds) on his success and on introducing this important Bill to the House today. I stand here as someone who has had cancer twice. I served on the advisory group of a national breast cancer charity and I am a breast cancer ambassador. In this House, I serve as vice-chair of both the all-party group on cancer and the all-party group on breast cancer. But I also stand here for all those survivors and for all those sufferers of MS, cancer and the many other conditions for which we know this Bill could provide effective treatment. It raises an issue that touches the lives of hundreds of thousands of people across the UK, including many of my constituents, who are living with or beyond serious diseases that have a profound effect on not only their lives, but those of their families.

For me, the Bill is about three core things: the patients, through improving access and outcomes; saving lives; and raising awareness. Although this House will debate the technicalities of the Bill as it progresses, today we are debating the principles. Why are we here? I can say from personal experience that patients and their families want to know simply that where there are treatments that could help them, they will be able to access them, regardless of where in the country they are and by which doctor or other medical professional they are being treated. For patients, the Bill serves as a lifeline. It could mean the difference between living beyond cancer or dying from it, or, for other diseases, between having an extended life or having quality of life. For those living with conditions that have fewer treatment options, it offers one simple thing: hope. It could ensure that we continue to make progress, and that our brilliant scientists make fresh breakthroughs—as they inevitably will—and when they do, people will benefit.

The Bill could have a significant impact on breast cancer, as, according to the hon. Member for Central Ayrshire (Dr Whitford), it would ensure the wider availability of preventive drugs. For women who have a family history of breast cancer and therefore a higher risk of developing the disease, Tamoxifen and Raloxifene have been shown to reduce the risk of the disease occurring in the first place by a third, which is not an insignificant amount.

Ministers have argued that this Bill is not needed. Indeed, we have just heard a Minister quite rightly questioning a Member, who is an expert on this matter, about the nuances of it. The argument is that the Bill merely regulates something that is possible for the medical profession to do already—none of us likes unnecessary regulation—but prescribing statistics show that that is simply not happening for all the reasons that have just been discussed. Such regulation could make a big impact, but the drugs have to be prescribed through every grade. That treatment is not being offered to many women, for if it were I would not be standing in this House today arguing for faster progress in this matter; I would be in my constituency.

Sometimes, Tamoxifen has side effects. Some women may not wish to use it as a preventive treatment, but the point is that they should have the choice, which they do not always have now. A woman with a high risk of breast cancer does not have many options. Sometimes, their only choice is a double mastectomy. I think of all the women around me—those in my constituency and my own daughters—and ask: is that really the only choice? This Bill would empower clinicians to offer and prescribe drugs such as Tamoxifen for as little as 6p a day. Those drugs could deliver effective treatment options and, crucially, those women at an increased risk of breast cancer could have the ability to choose the right course of treatment for them.

However, this debate goes wider than just drugs for breast cancer. A friend who was at a reception in this place last week has had a double mastectomy. She also has MS. The drug Simvastatin, which was referred to earlier and was originally licensed for cholesterol, has been shown to slow down brain atrophy by almost 40%. It also would help those who suffer from Parkinson’s. My friend also has type 2 diabetes, and there is some evidence to show that drugs for the treatment of that disease will also be potentially beneficial for those suffering from Alzheimer’s. By the way, she told me last week that she was volunteering as well as holding down her normal job—amazing.

As the research, which is also amazing, shows us, bisphosphonates that were developed to treat osteoporosis are now commonly used in the treatment of secondary breast cancer, and some 36,000 women live with secondary breast cancer in this country. zoledronic acid, a type of bisphosphonate, has been shown to reduce the risk of breast cancer spreading to the bone by 28%. Arguably, it is one of the biggest breakthroughs in terms of reducing mortality that we have seen in breast cancer research in the past 10 years. If this drug were routinely prescribed, it could save up to 1,000 lives per annum. However, it saves not only lives, but emotional trauma, physical impact, the cost on all those involved and the cost to the NHS.

I welcome the work that the Government are doing into the accelerated access review, but in the interim report that was published only last week, I saw no mention of off-patent or repurposed drugs, although I am more than happy to be corrected on that.

My personal view in this area and across the whole drugs arena, including the cancer drugs fund—where we have seen yet another removal of avostatin this week, although, thankfully, Kadcyla has remained—is that we need speedy decision making. That will help everybody in the industry, which needs to make a profit because it is seriously expensive to bring drugs from the bench to the patient, but will benefit patients and clinicians as well.

The Government support the intentions of the Bill. I feel confident that all clinicians have the ability to deliver what is best for their patients. Indeed, the cancer strategy, set out by NHS England and supported by the Government, aims to deliver a patient-centred approach. It puts saving the lives of cancer patients and improving their quality of treatment at the heart of the “Five Year Forward View”. By unlocking access to off-patent and life-saving drugs, the Bill would do that, too.

I believe that the Bill can deliver, in saving lives, in empowering clinicians, in ensuring patient choice and in saving money for the NHS—so what’s not to like? I hope therefore that my right hon. Friend the Minister will consider carefully the issues raised in the Bill.

1.50 pm
Albert Owen (Ynys Môn) (Lab):

It is seriously a great pleasure to follow the speeches made not only by the hon. Member for Bury St Edmunds (Jo Churchill), but by the hon. Members for Yeovil (Marcus Fysh) and for Central Ayrshire (Dr Whitford), who brought great expertise to the debate early on. I congratulate my hon. Friend the Member for Torfaen (Nick Thomas-Symonds) on introducing the Bill. In his short time in the House is already gaining his predecessor’s reputation of being well respected across the Chamber.

I pay tribute the former Member for Cardiff North, Jonathan Evans, who pushed this proposal through with great vigour during the last Parliament. Unfortunately, it fell on deaf ears in the Government. I hope this time that this sensible Bill, proposed by a sensible Member and spoken to by sensible Members in their speeches and interventions, will get a sensible response from the Minister. I know him to be a decent man, and he will do the decent thing.

This is the shortest speech that I will make in the House without a time limit on speeches, because the Bill is hugely important. The details discussed by the hon. Member for Central Ayrshire and others need to be dealt with in Committee. Therefore, we need today, on this Friday afternoon, in a time-limited debate, to get the Bill into that Committee, so that many Members on both sides of the House can speak with passion and knowledge to get the right result for our constituents.

I never speak in the House about personal circumstances, but my wife had a brain tumour in 2002. It was non-malignant and she has made a near-full recovery, but she had major surgery and it impacted on the life of our family, and there are many families like ours. The Bill could afford the release of certain drugs that could shrink such tumours in the future and that could help people in that position. Members of my family have had Parkinson’s, MS and other prolonged conditions. They have lobbied me today to say that the Bill provides hope for them, for their families and for the future.

So that is why I hope that the Minister is really listening to the debate and that he will assist us to get the Bill into Committee, where it deserves to be. Our constituents deserve it to be there. I support its Second Reading, and I hope that Members across the House will also do so. I await the Minister coming along with us, to make a difference to lives, to make intervention real and to make it the right thing to do.

1.53 pm
Simon Hoare (North Dorset) (Con):

It is a pleasure to speak in this debate. I endorse every word just spoken by the hon. Member for Ynys Môn (Albert Owen). I support the Bill. Given the weight of opinion in the House expressed already, the expert testimony from the hon. Member for Central Ayrshire (Dr Whitford) and the personally moving stories from my hon. Friend the Member for Bury St Edmunds (Jo Churchill), I ask my right hon. Friend the Minister to consider what harm would take place were the Bill to be committed to a Committee, to try to iron out any creases that are believed to exist between those who sit on the Treasury Bench and the Bill’s promoter. I personally see no harm in it, and rather like the hon. Member for Ynys Môn, I think that it should receive further debate in Committee.

I have the honour to be the chairman of the all-party parliamentary group for multiple sclerosis. Other Members have mentioned the Bill’s potential benefit for people who suffer from that cruel and pernicious disease. The Bill will give access to Simvastatin, which had been licensed for cardiovascular disease. It will help to augment support. It goes with the grain of the narrative of what the Government are trying to do on welfare reform, getting people back into work and reducing costs where possible of drugs and medical treatment. It ticks all the boxes: if people suffering from degenerative diseases can in some way be helped to lead a longer, more active—and more economically active—life, that would chime very well with the bean counters in the Treasury.

I am going to take the advice of my hon. Friend the Member for Christchurch (Mr Chope) and be brief. Finally—I think the hon. Member for Central Ayrshire referenced this—a wider group of people is prescribing drugs. It is not just GPs and consultant surgeons; it is far wider than that. We live in an increasingly litigious age, and I have heard from colleagues in the House that there is a detectable reticence among those people to go off-licence for fear of being exposed to action in the courts. That is not in the interests of the patient, of the prescriber or of the NHS, so I support the Bill.




I have to eat a few words about the MS select committee

1.56 pm
Craig Williams (Cardiff North) (Con):

It is a pleasure to follow my hon. Friend the Member for North Dorset (Simon Hoare). I commend the hon. Member for Torfaen (Nick Thomas-Symonds) on introducing the Bill and on paying tribute to my predecessor, Jonathan Evans, who tried to introduce a similar Bill in the previous Parliament. I shall be brief, but there are a couple of things I should like to add the debate. I feel strongly about this Bill, and I am here debating it even though it means missing a meeting with my constituents. I am not sure how I can get an apology to them for that, but hopefully that explanation helps.

A number of charities back the Bill, which has cross-party support. I have served as the vice-chair of the all-party parliamentary group on these issues, and I want to pay tribute to Breast Cancer Now, which has given us terrific support. It pioneered the way and has guided us through the Bill. The hon. Member for Torfaen knows that better than I do.

I want to dwell on the licence gap and the points that have emerged about GPs and off-label prescriptions. Some clinicians and GPs, as well as the wider group of people who can prescribe, have confidence and belief in the drugs. I think it is more an issue of confidence than one of off-label. The big issue for me and my predecessor, Jonathan, is the postcode lottery. Some GPs know that there is access and which off-patent and off-label drugs they can heartily recommend to their patients, and they willingly prescribe them. However, there are some clinicians who will not do so.
Antoinette Sandbach (Eddisbury) (Con):

The chair of the breast cancer clinical reference group, Professor Ian Smith, joined 39 other eminent clinicians in pledging public support for the Bill last week. Does my hon. Friend agree that there is an identifiable problem, which is likely to arise, with the insurance liability for prescribers?
Craig Williams:

My hon. Friend makes an excellent point, and adds to the body of evidence. That issue could be looked at further in Committee.

In closing, I want to add one point. This Government and the coalition Government set up the cancer drugs fund, on which I commend them. I only wish it was available in Wales. The Bill would enable that fund to be used to apply for cheaper drugs, which would mean that the money went a lot further. Although I will continue my campaign to get our dear friends the Welsh Labour Government to initiate a cancer drugs fund, I commend the Bill to the Minister as it would help to deliver that fund, and to do so far more cheaply and effectively.

I have teased out the off-patent, off-label issue as I wanted to do, and I hope the Minister takes that and my colleagues’ points on board to pull this sector and the charities together, regardless of what happens to the Bill. However, I commend the Bill, I thank the hon. Member for Torfaen for leading on it and I once again commend the work of my predecessor, Jonathan.

2 pm
Mr David Nuttall (Bury North) (Con):

I was delighted to be a co-sponsor of the Jonathan Evans version of this Bill. I am equally delighted to be a co-sponsor of this Bill, and I very much look forward to hearing what the Minister has to say.

2.1 pm
Justin Madders (Ellesmere Port and Neston) (Lab):

I congratulate my hon. Friend the Member for Torfaen (Nick Thomas-Symonds) on bringing this Bill before the House and the eloquent way in which he introduced it today. He has been in this place for only six months, but today and on other occasions he has spoken with assurance and authority that already mark him out as an accomplished parliamentarian.

As we know, this Bill builds upon the work of the former Member for Cardiff North, whose Bill was defeated almost exactly a year ago to the day, but it also very helpfully speaks to some of the concerns raised by the Government on that occasion. I am pleased to speak in support of the Bill, but in the interests of progress I will keep my remarks as brief as I can.

The adoption of this Bill could allow us to deal simply and effectively with a serious lacuna in the licencing system and a clear failure in the market. It would ensure that people who are at risk of or have been diagnosed with conditions such as multiple sclerosis, Parkinson’s disease, breast cancer, leukaemia and prostate cancer may have access to treatments that they would otherwise be denied. Although I note that the Government opposed the Bill last time, I hope they acknowledge the steps taken by my hon. Friend to address their concerns about the previous Bill and will offer their support to ensure that this Bill is moved on as swiftly as possible.

When the previous Bill fell on Second Reading, a non-legislative solution was presented by the Minister at the time as the alternative to the Government supporting the Bill. However, in the 12 months since then little progress appears to have been made, despite clear promises both on Second Reading and in subsequent ministerial answers to parliamentary questions. In the meantime, the problems persist and the market failure is still there for all to see.

One such example is zoledronic acid, a repurposed drug, which has been shown to reduce the risk of breast cancer spreading to the bone in post-menopausal women by 28% and the risk of death by 18%. Definitive published evidence to this effect has been available since July, yet the treatment has not yet been made routinely available, despite the fact that it costs just 5p per day per patient and could save 1,000 lives every year. Everyone should have equal access to this treatment, but this will not happen unless it is licensed.

The problem is clear for everyone to see and it can be addressed if this Bill is enacted, so it is imperative that we allow it to progress today. Many Members have spoken in favour, and in particular the contributions from the hon. Member for Bury St Edmunds (Jo Churchill) and the hon. Member for Central Ayrshire (Dr Whitford) contained great personal knowledge and experience of the benefits of this Bill. So let us listen to those Members, let us listen to the medical royal colleges, the clinicians, the commissioners, the charities and our many constituents who have contacted us about the Bill, and let us support it today.

2.3 pm
The Minister for Community and Social Care (Alistair Burt):

I thank the hon. Member for Torfaen (Nick Thomas-Symonds) for the way in which he introduced a Bill brought forward last year by my good friend Jonathan Evans. I thank all the right hon. and hon. Members who have made a contribution today.

The Government are in a difficult position. To take a position contrary to that of a breast cancer charity or a number of charities, and to resist action requested by a number of right hon. and hon. Members who speak with knowledge and passion, the Government must be pretty sure of their position and their actions. The hon. Gentleman has had a meeting with the Under-Secretary of State for Life Sciences, my hon. Friend the Member for Mid Norfolk (George Freeman), the charity and others, and he knows that the Government still do not support the Bill. I will defend that position.

No sensible Government would seek to resist people having access to drugs in any way. The reason for resisting what is proposed is that the Government believe that there is another pathway. However, I am also persuaded by what I have heard today and feel sufficiently uncomfortable about the current situation to know that this is not an end of the matter. I will resist the Bill today, but my advice to colleagues in the Department of Health will certainly reflect the mood of the House and what has been said.
Albert Owen:

I am disappointed by what we have heard so far from the Minister. If he will not listen to me, will he listen to his hon. Friends on the Government Benches who have made a plea for the Bill to go through to Committee? He talks about difficult decisions, and the Prime Minister and his colleagues have been at the Dispatch Box saying that there are difficult decisions to take. I ask the Minister to take a difficult decision by doing a U-turn and supporting the Bill.
Alistair Burt:

The difficult decision is to stick to the position that I believe to be correct. The onus is on me to explain why, in the face of the debate, I believe the Government’s position is right, and that is what I intend to do. I want to be very upfront about the situation. I have heard the debate very loudly, from colleagues on both sides of the House, and I have heard nothing that is not deeply felt and passionate. It is not always the case that something brought forward by a charity, and indeed advocated passionately by colleagues, is the answer. The difficult decision in government is often to say, “That is not the answer; this is the way forward.” We have all been in that position. I also understand the degree of concern about this—I listened carefully to the hon. Member for Central Ayrshire (Dr Whitford)—and I want to reflect on it.

In the time available before half-past 2—and I make it very clear that I will talk until then, because that is the procedure here—[Interruption.] Well, that is what I am following. In the time available I want to explain why the Government think that what is available to people now is access to the drugs. The most important message that I want to come out of this debate is not that drugs are not available, which I think is highly dangerous, but that treatment is available. If the message that comes out of this debate is that there is only one way forward for people, then there is only one way forward for hope, as colleagues have said, and that is through the Bill. I do not believe that is correct. If it stops anyone from seeking treatment because they think that doctors cannot or will not provide off-label, I think that is wrong. That is what I will set out, because that is the evidence we have.
Several hon. Members rose—
Alistair Burt:

I will take interventions, but it is only fair to the House that I respond to the debate and answer some of the charges that have been made—[Interruption.] It is not disgraceful; it is the right answer.
Nick Thomas-Symonds:

Will the right hon. Gentleman accept two points? First, he made clear his objections to the Bill, and they were firmly answered by the expertise of the hon. Member for Central Ayrshire (Dr Whitford). Secondly, the Government have had a chance to put forward a non-legislative solution to the problem in the past year, but they have completely failed to do so, so why is he still refusing to allow the Bill to proceed to Committee?
Alistair Burt:

After I have dealt with the other interventions, I will deal with the actions since last year’s Bill.
Mark Durkan (Foyle) (SDLP):

We listened to a debate earlier in which we heard about many much-loved fictional characters. This Bill is about real people with real conditions and making real-life differences for them, and we are yet to hear a real argument against it. I remind the Minister of what he said at the conclusion of the last debate about not denying sunshine. Why is he acting as an agent of darkness on this Bill?
Alistair Burt:

Because if the message that goes out from this debate is that there is only one way to get these drugs, and if people feel that they cannot get them because of what has been said here, that would be darkness indeed. That is not the truth. That is not the position.
Dr Whitford:

I find it bizarre that the right hon. Gentleman says that we must not bring in this change because it would undermine access to other drugs, because that tends to suggest that we should not have any licensing at all. Why is he happy to have drugs licensed but also feels that we should have unlicensed drugs?
Alistair Burt:

Because current medical practice appears to be that drugs are available on licence for indications that are already there, but it may then become clear that some drugs are also useful for things that were not previously indicated. If the patent position is as we have discussed, then no licence process is put forward and people can prescribe off-label, as they do in many cases. Accordingly, the system works with both. The Government’s worry about this Bill is that, because of the attention paid to what is being said, it will be suggested that there is some sort of prevention mechanism that does not enable people to get the treatment they need. I am very anxious to state that that is not the case, as I think the hon. Member for Central Ayrshire also said. These drugs can indeed be prescribed. That has to be the message.
Dr Whitford

rose—
Alistair Burt:

I will give way, but then I want to set out what the position is rather than what it is believed to be.
Dr Whitford:

As I said, there is still an implied risk to people, and those who are distant from the research will not do this. The only reason these drugs are not licensed is that it is not worth the company’s while. Surely letting the Bill go into Committee would allow us to iron out all the issues to the satisfaction of the Government.
Alistair Burt:

The issue about licensing could apply to any off-label prescribing. What we are talking about for some would, in theory, have to apply to all, because there is a risk to everything. That suggests a provision of licensing for all, which is not where we are going. This matter is not closed—let us be quite clear about that. If this measure does not go through today, the matter is not closed.
Paul Flynn (Newport West) (Lab)

rose—
Peter Dowd (Bootle) (Lab)

rose—
Alistair Burt:

I will deal with these two interventions, and then, if colleagues do not mind, I will have to make progress.
Paul Flynn:

I have long known the right hon. Gentleman and greatly respect him, but today the House has spoken on this with one voice, from both sides, with expert opinion and personal opinion. Only one voice has been silent in this debate, and that is the voice of the industry, the ABPI, which has an interest in its profits. Is its plea to keep its profits intact the only reason he is making this piffling objection to the Bill?
Alistair Burt:

I have known the hon. Gentleman for a long time, and that last bit was rather unworthy of him. I have not seen anything from the ABPI, but having picked up this measure from my colleague, the Under-Secretary of State for Life Sciences, dealt with the evidence, as I have seen it, and had conversations with officials, I am perfectly convinced.
Peter Dowd:

I have been sent here by my constituents, and the Minister said on his website, in response to a constituent regarding the Assisted Dying (No. 2) Bill:

“I believe that human life is intrinsically valuable and sacrosanct.”

I respect that view, but does he not agree that having rejected that Bill just a few weeks ago, this House has a responsibility, through this Bill, to facilitate, without reticence, access to medicines that would give practical and humane effect to the will of this House for those who have a terminal illness or for the prevention of that terminal illness?
Alistair Burt:

Yes, of course. Why would a Government not wish to do that? I quite understand the hon. Gentleman’s point. I am trying to explain that that is exactly what happens now, and that to suggest otherwise carries a degree of risk.
Marcus Fysh (Yeovil) (Con):

Am I right in thinking that the Government’s position—it may from one point of view be a valid one that needs to be considered—is that what we are saying today does not affect the current prescription of off-patent drugs? I do not quite understand why the Government will not at least allow us the space to try to fix this Bill and try to make it law.
Alistair Burt:

When I get a chance to make a little progress, I can explain to my hon. Friend why that is the case.
Mr Chope

rose—
Alistair Burt:

I will take one last intervention.
Mr Chope:

I am grateful to my right hon. Friend, and I feel his pain. He says that he is concerned that he will not have sufficient time today to explain the Government’s position. In that case, why does he not allow this Bill to go into Committee, where he would have oodles and oodles of time in which to explain fully the Government’s position?
Alistair Burt:

Because I still do not believe fundamentally that the passage of legislation is what is needed in order to reassure people that they have access to the drugs that they need.

Let me make a little progress and deal first with the concerns expressed by the hon. Member for Torfaen about what has happened since last year.
Mr George Howarth (Knowsley) (Lab):

Will the Minister give way?
Alistair Burt:

No, I will not on this occasion, because I have taken every intervention since I stood up and I cannot do my job unless I explain what people are concerned about.

As the Government promised when similar measures were discussed in the House this time last year, we held a round-table discussion bringing together some of the key stakeholders. We looked at what action short of legislation the Government could take.
Albert Owen:

On a point of order, Madam Deputy Speaker, the Minister said earlier that, according to the procedure of this House, he is able to speak until 2.30 pm. I think that is incorrect. Can you give me some guidance? If the Minister sat down one minute before 2.30 pm, would my hon. Friend the Member for Torfaen (Nick Thomas-Symonds) be able to put the question so that we can have a vote and the democratic will of this House can be heard?
Madam Deputy Speaker (Natascha Engel):

The hon. Gentleman is absolutely right. That is not procedure, but it is the choice of the Front Bencher how long they speak for. He has put it on the record.
Alistair Burt:

I am happy to be corrected in relation to procedure. The procedure of the House allows the Minister to speak until 2.30 pm. [Interruption.] I am not obliged to do so—that is correct—but I am choosing to do so because I believe that I would not be performing my duty if I were to allow a Bill that I think is wrong and potentially harmful to go through.
Nick Thomas-Symonds

rose—
Alistair Burt:

I am not going to take any further interventions; otherwise, I will take it that the House does not want to hear from me. I have to make some progress.
Carol Monaghan (Glasgow North West) (SNP):

How many people will die as a result of this?
Alistair Burt:

Oh, shroud waving—thank you very much. That’s all we need.

On action flowing from last year, the Government had an extremely useful meeting that brought together the National Institute for Health and Care Excellence, Breast Cancer Now, the Cure Parkinson’s Trust and Cancer Research UK.
Mr George Howarth:

On a point of order, Madam Deputy Speaker. Given the context of the Bill, do you not think that the use of the term “shroud waving” is at the very least inappropriate?
Madam Deputy Speaker:

I think what is happening is that the Chamber is getting very passionate and very heated. Members on both sides of the House ought to calm down the debate a bit. We are discussing very serious matters and we are being watched not just by people in the House but by people outside the House as well. I think all of us need to calm down a little bit.
Alistair Burt:

I withdraw the remark immediately and apologise to the hon. Member for Glasgow North West (Carol Monaghan).

I am seeking to find a bit of space to explain, in the face of a House that plainly does not accept it, why the Government hold their position. I am very anxious to convey it, because I believe there is a risk that people outside will take the view that something is preventing people from getting access to drugs that they may want. I think that that position is wrong, and that is why I want to make clear the Government’s position.

Since last year, the Government have had a series of meetings with the people involved. We have received input from the MS Society and the General Medical Council. It is clear from the conversations the Government have had that this is a very complex area with a number of factors at play, including easy access to robust evidence for prescribers; information about licensing status and what it means; and clear and more accessible information for researchers and charities on how to get research findings into the system and through to licensing, if that is the approach they wish to follow. What is also clear is the genuine commitment to work together to make those things happen and to investigate whether there are other non-legislative improvements that can be made to support appropriate medicines use and benefit NHS patients.

We know that there are issues with access to medicines, but they are in no way unique to unlicensed or off-label medicines use. There are areas where there is far too much variation in the use of licensed, NICE-appraised medicines, and we are working hard with the NHS to address that, but there is no single magic bullet. The measures before us today are more likely to impede access than to facilitate it. What is more, they would be of benefit to only one medicine, one condition and one group of patients at a time.

We are committed to working with NHS England, the Medicines and Healthcare Products Regulatory Agency, NICE, the GMC, the all-party group on off-patent drugs, and patient and professional groups, to address the issues that the round-table group identified. MHRA, NICE and the GMC are committed to working together to improve the understanding of the differences in licence status and how clinicians can practically work with that. The GMC is preparing a topic for its website to dispel myths and confusion about off-label prescribing and to explain how its guidance applies. NICE and the GMC are also considering further joint work to support clinicians in discussing and sharing knowledge.

As doctors may prescribe unlicensed medicines where it is necessary to do so to meet the specific needs of individual patients, and given that patients need sufficient information to allow them to make an informed decision along with their doctor, NICE is looking at making more use of patient decision aids further to support implementation of its clinical guidelines, to help individuals work through the pros and cons of different treatment options.

We are looking at how we might provide better information to help researchers and other stakeholders know how they can propose subject matter for NICE’s clinical evidence summaries and for updates to NICE guidance. NICE will be working with the “British National Formulary” to ensure that off-label uses are included where there is robust evidence to support them and that they are presented in a standard way to help clinicians to use them.

We are committed to working with the research community to set out the pathways and options for bringing research evidence to the attention of clinicians more systematically. This will involve working with a number of bodies in the research community, including the Association of Medical Research Charities, and I know there is a commitment to do so. The outcomes of the accelerated access review will also feed into that.

Let me say a little on the detail of why I do not think the Bill is the right way forward and about what is the best way forward. The Government do not support the Bill, just as the then Government did not support the virtually identical measure introduced by Jonathan Evans last year. I want to be absolutely clear about why that is the case: when it comes to the primary objective, which is to make sure that our NHS can treat everyone according to the most up-to-date and robust evidence, the hon. Member for Torfaen and I are in complete agreement. However, legislating in this way is not the way to achieve that goal.

There are clear benefits in using licensed drugs based on evidence about their safety profile, side effects, efficacy and so on. The guidance from the Medicines and Healthcare Products Regulatory Agency and the General Medical Council is clear that a licensed medicine being used within its licence indications should be the first choice for patient care, and that is exactly as it should be. However, the guidance also makes it clear that clinicians are free to use their clinical judgment to treat their patients with a licensed medicine used outside its licensed indication—off-label prescribing—or, indeed, an unlicensed medicine where such a medicine is the best clinical choice for the patient or there is no licensed medicine to meet the particular need. In fact, the guidance from the MHRA and the GMC sets out a hierarchy of medicine use.
Paul Flynn:

The right hon. Gentleman prays in aid the MHRA, which is entirely funded by the pharmaceutical industry. Why does he not confess that he has taken this cruel and unfair stand of following what the industry has told him to maximise its profits and put patients last?
Alistair Burt:

That is not the case.
Ian Blackford:

On a point of order, Madam Deputy Speaker. Will you give us some guidance? Given the feelings being expressed throughout the Chamber, what can we do to move a closure motion so that the views of the House can be expressed properly in this debate?
Madam Deputy Speaker (Natascha Engel):

The hon. Gentleman is perfectly entitled to move a closure motion, and it is for the Chair to decide whether or not to accept that motion.
Ian Blackford

claimed to move the closure (Standing Order No. 36), but the Deputy Speaker withheld her assent and declined to put that Question.
Alistair Burt:

The guidance says that in treating their patients, clinicians must first consider using a licensed medicine within its licensed indication. If that will not meet their patient’s needs, they can consider a licensed medicine outside its licensed indication, and only if that is not suitable should they consider using a medicine that is not licensed at all. We know that a great many medicines can offer benefits to patients when prescribed outside their licensed indications.
Antoinette Sandbach:

Will the Minister give way?
Alistair Burt:

Not at the moment, because this point is absolutely crucial to put on the record.

Prescribing in that way is part and parcel of normal, everyday clinical practice, as the hon. Member for Central Ayrshire confirmed. It is very common in prescribing for children and in treating some forms of pain. Most doctors, particularly GPs, will do it every day in their clinical practice. That has already been covered in relation to tamoxifen and raloxifene for the prevention of familial breast cancer. As was rightly identified by the hon. Member for Torfaen, the issue is compounded when drugs come off patent and new evidence suggests that they would be appropriate in the treatment of new indications.

The hon. Gentleman has gathered a lot of support for the Bill, but it does give the impression that such drugs are not being made available to patients. It also suggests that licensing is required to make these drugs available for patients, and that a NICE technology appraisal is required as well.
Nick Thomas-Symonds:

I did not say that.
Alistair Burt:

If the hon. Gentleman is happy to say that that is not the impression given, I am pleased to correct what I said.
Nick Thomas-Symonds:

I never said that the drugs were not available. I said that they could theoretically be prescribed, but that it did not happen consistently by sector or across the country. That is what I said. It is on the record.
Alistair Burt:

In that case, I am more than happy to again let the message go out from the Chamber today that these drugs are available and can be prescribed. Where it is clinically appropriate, they should be prescribed. Seeking this legislation will not change that availability.

Members of the House are doing a highly effective job of bringing their constituents’ concerns to the attention of Ministers and asking our help to resolve this issue. We are not aware of colleagues bringing examples of people who have been refused treatment. It is vital to know if there is evidence of people being refused treatment. As I said, the clinician’s letter that the hon. Member for Torfaen read out was wrong. Unless there is a clinical reason for not supplying the drug, there is nothing to prevent the doctor from doing so.
Dr Philippa Whitford:

I simply make the point that we are now not just talking about doctors prescribing. It is unrealistic to expect physiotherapists and nurses to prescribe drugs off licence. It just will not happen.
Alistair Burt:

I understand that point. We want more people to have prescribing powers and the information that they have will be vital.

A number of our exchanges have raised the questions of what information there will be and how easy it will be for clinicians to access it. We maintain that such access will be possible. The Access to Medical Treatments (Innovation) Bill will assist that still further.
Matthew Pennycook (Greenwich and Woolwich) (Lab):

The Minister has been exceptionally generous in giving way. I hold him in very high regard personally. However, given the weight of evidence that has been brought to the Chamber, he is doing himself a disservice. I appeal to him personally, as someone who has constituents who would benefit from the Bill, to allow it to go to Committee.
Alistair Burt:

I certainly did myself a disservice with a silly, offhand remark. I entirely accept that. It is not like me and I apologise.

The stance that I am taking as the Minister representing the Government is that I do not believe this is the right vehicle to achieve what Members want. I am also concerned—
Nick Thomas-Symonds:

On a point of order, Madam Deputy Speaker. With the greatest of respect to the Minister, he has had a bit more time since the last point of order and it is quite clear that he has run out of arguments and is now talking to the clock. I beg to move that the Question on closure be put.
Hon. Members:

Hear, hear!
Madam Deputy Speaker (Natascha Engel):

As I said previously, I am not prepared to accept that the Question be now put.
Albert Owen:

Further to that point of order, Madam Deputy Speaker. The Minister has definitely run out of arguments and he has indicated that he wants us to run out of time. What help and support can you give us to have a closure motion, so that Members who have stayed here today at the request of their constituents can have their names put on the record?
Madam Deputy Speaker:

Two closure motions have now been moved and twice I have said that I am not prepared to accept them. I am afraid that is just how it is.
Patrick Grady (Glasgow North) (SNP):

Further to that point of order, Madam Deputy Speaker. Given what you have said, let the record show that at least 13 Scottish National party Members have given up their Fridays in their constituencies to come here on behalf of their constituents. This is an outrageous abuse of parliamentary procedure.
Madam Deputy Speaker:

Can we please stop it there? Two Members have tried to move the closure and I have refused to put the Question. If any more Members try to put that Question, they will be challenging the Chair.
Alistair Burt:

The reason I said earlier that I would go on until 2.30 and beyond is that I have not even begun to deal with the licensing arguments and the problems—[Interruption.] Hon. Members just said that I had run out of arguments, but I have not even covered the difficulty of the Secretary of State being put in the position of being the regulator and someone who applies for licences. There are plenty more arguments that need to be put and I think that we will run out of time.
Antoinette Sandbach:

Given the Minister’s clear support for the principles behind the Bill, will he agree to meet the various organisations to see whether there is a non-legislative means of achieving the aims of the Bill?
Alistair Burt:

I am certain that the Under-Secretary of State for Life Sciences will meet people soon at my request to carry on our discussion. It is clear that the House is not in any way comfortable with the Government’s position in resisting this Bill, so before the matter is considered again it is essential that the Government look at it further. If a message had gone out from the House that there was only one way for people to get access to the drugs they need, that would be wrong—
Hon. Members:

Five, four, three, two, one.
Madam Deputy Speaker (Natascha Engel):

Order! Enough now.

2.30 pm

The debate stood adjourned (Standing Order No. 11(2)).

Ordered, That the debate be resumed on Friday 4 December.


So the Minister talked it Out of Time

2 comments:

  1. Thanks for posting this. I tried to follow a link on services.parliament.uk to any debates on the bill but it resulted in nothing!

    The government talked it out of time but it wasn't killed off - the debate will go on. (I hope I understand it correctly.)

    Pressure was put on the government for non-legislative measures - which, if effective, (by definition) would be sufficient. The whole "licencing", etc. protocol is put under scrutiny by the government. In part, they seem to have the position that it would be too much work for the Secretary of State. The answer (to them, I think) is to put more work on clinicians. (More ideology that will lead to the break down of the NHS?)

    ReplyDelete
  2. Captain Brock said
    **** you Alistair Burt I hope the Mods don't block this post

    ReplyDelete

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