Drug Treatment Services

Crispin Blunt Excerpts

Tuesday 16th July 2019 Westminster Hall

[Crispin Blunt (Reigate) (Con)]

I congratulate the hon. Member for Manchester, Withington (Jeff Smith) on securing this debate and on speaking so well. Happily, much of what I intended to say I now do not need to, not that I would have time to say it anyway.

I congratulate my hon. Friend the Member for Central Suffolk and North Ipswich (Dr Poulter); he began to get into the systemic problems in this area, which is what I want to focus my remarks on. We have a systemic problem in the assessment of the rate of return on the investment in drug treatment services, particularly compared with the rate of return on investment in law enforcement in drug policy.

According to the Government’s own statistics, we are not getting a satisfactory return at all on drug law enforcement. That is why the police’s operational policy has been progressively to withdraw from doing nugatory work, leading to effective decriminalisation in many parts of the country, simply because that is not a sensible use of resources. It certainly is a sensible use of resources to try to repair the lives of drug addicts. The cuts under the necessity of austerity, and the systemic issue that my hon. Friend referred to in respect of local authorities taking responsibility, have meant that we are making a shocking value-for-money judgment in the application of public resources in this area.

It has to be down to the Minister—no one else can do it—to review how we invest public money for the public good. That is at the kernel of this debate. If we do not make changes, enforcement authorities will continue to progressively withdraw, because they simply will not waste the public money they have been given by running ineffective operations. The just-retired chief constable of Durham, Mike Barton, is a huge authority on that, and I urge the Minister to talk to her Home Office colleagues about his experience.

There is a very clear overlap between the application of the law to drug users and recovery. One then gets into the toxic situation of stigma around those users. There is also a public health budget administered by local authorities, which are under pressure to use those resources elsewhere. People who have used drugs that we have made illegal do not get automatic support in our society, yet they are just as much part of our society as anyone else.

If we do not invest resources properly, we will simply find that we carry the burden of the consequences of the damage that has been done to all those people. There is an infinitely better way to do things, and I urge the Minister to try her hand at effecting the system change that is needed to do things infinitely better.

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[Seema Kennedy]

I will come on to funding.

My hon. Friend the Member for Reigate (Crispin Blunt) takes great interest in this issue. He spoke about the legislative framework for drugs, which is a matter for the Home Office. As I said, I will talk to ministerial colleagues about that. The Government are putting together a formal response to the report on custody-community transitions, with input from many Departments, including the Department for Work and Pensions, the Ministry of Justice and the Home Office. I think we have until the end of the summer to issue that response.

Local authorities will want to increase the provision of naloxone to people who are not in treatment, perhaps through outreach workers, hostels or needle and syringe programmes. Public Health England is working alongside the National Police Chiefs’ Council and Her Majesty’s Prison and Probation Service and recently updated its advice and guidance on naloxone availability in prisons. The problem with drug testing kits is that not all of them are entirely accurate, which might give people false reassurance. More sophisticated testing has been available at some festivals in one pilot, but again this is a matter for the Home Office.

Hon. Members talked about the international evidence that drug consumption rooms can be effective at addressing public nuisance issues and health risks for users and for the wider public, but there is a risk that such facilities would be introduced at the expense of other more relevant, evidence-based drug services for local areas. There is currently no legal framework for the provision of drug consumption rooms, but we support a range of evidence-based approaches to reducing health-related harms. Again, we are committed to widening the availability of naloxone to prevent drug-related deaths. I acknowledge the strength of feeling on drug consumption rooms in the House.

[Crispin Blunt]

This is a narrow point, but I invite the Minister to talk about overdose prevention facilities, rather than drug consumption rooms. One can understand the difference that might make to their reception in local communities; they are about preventing death.

[Seema Kennedy]

I thank my right hon. Friend for that intervention.

Cystic Fibrosis Drugs: Orkambi

Crispin Blunt Excerpts

Monday 10th June 2019 Westminster Hall

[Paul Scully]

The right hon. Gentleman is right to say that Vertex has to be reasonable, because the UK is effectively the biggest market for a pharma company that comes in to tackle CF, for the reasons that I have mentioned. It has to understand that the issue is not all about its share price in the long term. As a free-market liberal economist, I recognise that private companies must be allowed to deliver fair profits for their shareholders, which will further research and future investment, but they are sailing close to the wind if they are profiteering from human suffering.

[Crispin Blunt (Reigate) (Con)]

I am grateful to my hon. Friend for leading the debate. I spoke in the previous debate on the subject in the main Chamber. It is right to focus on Orkambi and Vertex, but the issue is actually the process of the National Institute for Health and Care Excellence. If we cannot assess issues such as antimicrobial resistance and new antibiotics in the NICE system, or get a positive answer about them, we need to look at its assessment. I hope the Minister is open to that.

[Paul Scully]

My hon. Friend makes an interesting point. Clearly, a portfolio of drugs is coming through the system. The original drugs treated only 5% of cystic fibrosis sufferers, but now the figure is 50%. The triple therapy that is being researched can benefit up to 90%, and clinical trials show an increase of 10% in some people’s lung capacity in a single week of using the drug. It is disappointing that Vertex has not included the triple therapy in its negotiations about the portfolio. None the less, my hon. Friend is right that the NICE system needs to be reviewed to take an interesting and innovative approach to drug research in future.

Medical Cannabis under Prescription

Crispin Blunt Excerpts

Monday 20th May 2019 Commons Chamber

[Crispin Blunt (Reigate) (Con)]

It is of course a pleasure to follow the hon. Member for Manchester, Withington (Jeff Smith), my fellow co-chair of the all-party group on drug policy reform. He and I followed the hon. Member for Brighton, Pavilion (Caroline Lucas) and of course Paul Flynn, who were our predecessors as co-chairs. Madam Deputy Speaker, you have quite rightly made the point about Paul Flynn’s incessant campaigning on this issue. Tragically, for four decades in this House, he was shouting from the outside at an establishment that chose not to listen.

I am determined, in the remainder of my time in Parliament, to devote myself—as my priority issue, apart from all the things that affect Reigate and the nation—to drug policy reform. Obtaining the benefit for British patients of medicine from cannabis is an enormous potential public good. I draw the attention of the House to my entry in the Register of Members’ Financial Interests.

I welcome the Minister to her place. Her colleague Baroness Blackwood owns this issue at junior ministerial level in her Department. However, it is critically important that Health Ministers understand the potential benefit as this medicine from cannabis is developed and the potential economic benefit for the United Kingdom if we take a leading place in this industry. We have the opportunity to do so because we already do take such a place.

The Minister will be aware of the difficulties that the Home Office had when it managed this issue. I congratulate my right hon. Friend the Member for Hemel Hempstead (Sir Mike Penning) on setting up the all-party group on medical cannabis under prescription, and him and the hon. Member for Gower (Tonia Antoniazzi) on their leadership on this issue.

The first urgent question on this issue was asked about Alfie Dingley by me, and my right hon. Friend, who was sitting behind me at the time I asked it, indicated his support on this issue, and he thought he had begun to open up this issue in the Home Office. However, we had the absurdity that that urgent question was answered by the Minister for Policing and the Fire Service. He had been handed the responsibility at 24 hours’ notice from the Drugs Minister, the Under-Secretary of State for the Home Department, the hon. Member for Louth and Horncastle (Victoria Atkins), not because she had any particular interest in drugs from a health perspective—obviously, the Home Office’s responsibilities include protecting the public—but because her husband is associated with British Sugar. It supplies the cannabis for a great potential British success story in the form of GW Pharmaceuticals, which is one of the global leaders in producing medicinal cannabis—just not for the British people. That is something we need to change.

I want to put this issue in its global perspective and its historical perspective. Unless we understand why there is a such a lack of understanding about this issue, and why we are so behind in the research on medical cannabis and why the medical profession is so intimidated by it, I do not think we will get the necessary pressure from the Minister and her colleagues to continue to push for the necessary advance in this area.

The reason we are so far behind lies in racist American policing of the 1950s: frankly, because African-Americans smoked this stuff, it was seen as ghastly and very dangerous. Therefore, in total disregard of the scientific evidence, cannabis was listed in schedule 1 to the 1961 UN convention, which has made it extremely difficult to research its medicinal benefits. The irony is that we have had medicines derived from opiates for an extremely long time—they are standard medical products—yet medicines derived from cannabis were put beyond the bounds of research.

GW Pharmaceuticals owes its leadership in this area to a licence issued by Lord Boateng, when he was the Minister responsible for drugs policy in the late 1990s, that allowed it in exceptional circumstances to conduct research into medical cannabis. That decision was followed by £1 billion of investment in GW Pharmaceuticals. I want the Minister to understand that it is not only GW Pharmaceuticals but a number of billion-dollar companies in North America, particularly in Canada but also in the United States, that are now investing in this area. There is a tidal wave of investor money coming into the medical cannabis business and, to an extent, the recreational cannabis business—obviously we must focus on the former. We need to ask ourselves why so many people are choosing to invest so much money in the potential of this product.

When the hon. Member for Manchester, Withington and I became co-chairs of the all-party parliamentary group for drug policy reform, our third co-chair Baroness Meacher—I pay tribute to the work that she has done to reform this area—emphasised the need to focus our efforts on securing a legal change on medicinal cannabis. In 2016, the all-party parliamentary group commissioned a report from Professor Mike Barnes—we have already heard about his research in this debate—to identify which conditions medicines derived from cannabis had been established to a medical standard to help treat.

By 2016, it was already established globally, to the highest possible medical standards, that such medicines could be used to help treat epilepsy in children and spasticity associated with MS and that they could be used as an antiemetic for those undergoing chemotherapy. However, I want to emphasise that their potential application is very much wider. The problem is that the scientific research base is in its infancy, because we put in place stupid regulations that were driven by the racism of 1950s American law enforcement, which is why cannabis was listed in schedule 1 to the 1961 convention.

The Minister will know that the National Institute for Health and Care Excellence guidelines will focus on four indications: chronic pain, multiple sclerosis, treatment-resistant epilepsy, and nausea and vomiting due to chemotherapy. However, there is substantial evidence—enough to excite investors around the world to invest billions of dollars in the potential of this medicine—that cannabis or cannabinoids will be effective in improving chronic pain in adults, chemotherapy-induced nausea, short-term sleep outcomes in individuals with deep sleep disturbance, clinician-measured spasticity symptoms associated with MS, symptoms of Tourette’s syndrome, anxiety symptoms in individuals with social anxiety disorders and symptoms of post-traumatic stress disorder. I hope that the Minister will understand that, if we can advance the science satisfactorily in relation to anxiety and depression, this is of potentially vast application.

We have to understand the range of interests arrayed against the development of medicines in this area. We should consider how policy has been developed in both North America and Germany, and indeed here, because the development has come not from the medical profession or the pharmaceutical industry but from outside. In the United States, those states that have approved the use of medical cannabis usually started the process through a referendum that then imposed the answer on the state’s legislature. Twelve of the 25 states that have medical cannabis have now moved on and established a market for cannabis for recreational adult use. An important development is that Canada, which has had medical cannabis for some time, last year introduced a market for legally supplied cannabis for recreational adult use.

I quite understand the political need, reflected in the establishment of the all-party parliamentary group on medical cannabis under prescription by my right hon. Friend the Member for Hemel Hempstead and the hon. Member for Gower, to differentiate between medicinal and recreational adult use. We must of course focus on the medicine first. There is a separate discussion to be had about the important criminal justice, societal and public health benefits that would come from being able to protect the public and children by having a legally supplied and properly regulated and licensed market. What has been absent from the wider political debate about this to date is a proper consideration of evidence. We are 50 years behind on the potential benefit to the public because we have been unable to get the evidence, and that is a result of the policy imposed through the 1961 convention.

I want to draw attention to one potential application relating to chronic pain. The United States is now coping with an opioid epidemic. Last year, 63,000 Americans died of an opiate overdose that started in the doctor’s surgery. These were not junkies on the streets; they were people who went to their doctor to get treated for chronic pain. Many of them were prescribed OxyContin, courtesy of Purdue Pharma, in circumstances that are now subject to a class action. When the state of Arizona held a referendum on legalising cannabis, the result was on a knife edge and it was not clear which side would win. I am advised that right at the end of the campaign a substantial slug of money was put in to achieve a no vote. Nobody knew at the time where the money had come from, but my understanding is that it actually came from a business associated with the rehabilitation of opiate addicts, which is truly shocking. To prevent cannabis-based medicines having an opportunity to replace the much more dangerous opiate-based medicines, which have contributed to this terrible level of dependency on a medicine that is profoundly dangerous if taken incorrectly, cannabis had to be kept out of the business.

What I want to say to the Minister is that I am anxious for the Department of Health and Social Care, in taking this issue forward, to clearly understand where all the interests are here, and, if one begins to roll this forward in the years to come with regard to the potential application, to understand what opportunities there are for the United Kingdom as a provider of medicine from cannabis. GW Pharma ought to be reinforced by other companies supplying pharmaceutical grade cannabis-derived medicinal products to people. If the conditions I listed earlier are anything to go by, this will be a multibillion dollar-industry, particularly if we can get a decent slug of the global market.

This is not just about the economic effect, however. This is about the opportunity costs of people continuing to be prescribed opiates when they could be prescribed a cannabis-based medicine. It is about the opportunity costs of people self-medicating with alcohol to deal with the aches and pains of old age, rather than understanding the benefits they could get from cannabis. We are now at the stage—the Minister will have seen the report about people who have a medical condition for which they have a diagnosis who now cannot get medical cannabis—where people are now growing their own. In certain circumstances, they are being arrested for growing their own medicine. Our policy is in a mess. It will need real drive from Ministers to get a grip of all the regulators and the medical, pharmaceutical and patient interests to keep pushing for sensible reform.

I ask the Minister and her team to look around the world at the jurisdictions leading on this issue. Look at what is happening in North America, particularly Canada and New York state, and in Germany. Germany has moved pretty rapidly following a legal action by two cannabis growers producing their own medicine. The German state lost that legal action and it now enables them to grow their own cannabis for medicine, saying that what these people need is pharmaceutical grade medicine from cannabis. Two years on, I think 80,000 prescriptions have been written in Germany for people to get medicine from cannabis. We can move relatively quickly if we have the will.

If we do not have the will, we will see the continuing misery of families with epileptic children who are chronically ill. It is quite right that End Our Pain and the all-party group have focused on those families, led so brilliantly by the Deacon family, with Alfie, and Charlotte Caldwell, with her son Billy. They are the ones who have pushed this over the line. No politician can turn around to mothers and families in circumstances where they have obtained treatment with medicine derived from cannabis and faced up to the cruelty, on their return to the United Kingdom, of that medicine being taken away from them. Billy Caldwell’s case was the one that drove the Home Secretary over the line, issuing a special licence and beginning the process of reform in this area.

I cannot find anyone in this House who does not accept the principle that if we can have medicine from the opium poppy then surely we can have medicine from a cannabis plant. Find me evidence of someone who has died of a cannabis overdose. I am told there is not any. Of course, people have died in certain circumstances relating to mental conditions associated with very heavy use, particularly by young people, of the kind of dreadful stuff sold on our streets by the criminal supply chain. But we have chosen, by the laws we have passed, to put that business in the hands of criminals who are selling the strongest and most dangerous stuff to our children. Trading Standards is not going around measuring it or checking that consumers are over the age of 18 when they purchase it. That is why it is easier for our kids to get this dangerous form of cannabis than alcohol.

We need to get to grips with an awful lot of reform in this area, but the public benefit from the United Kingdom pushing on with the science and supporting research could be huge. We in this House must remain engaged, and Ministers must really push and lead on this. My fellow co-chair of the all-party group on drug policy reform, the hon. Member for Manchester, Withington, made a very important point. There will have to be a bespoke arrangement to regulate and license the system. There is an endocannabinoid system in all animals. That is not taught at medical school. That is not currently part of standard medical training or assessment, but it would appear to be a reason why this stuff works at a common sense level. It is why, among all the people we represent, there is the knowledge that this stuff does work. That is why hundreds of thousands of people are using it to self-medicate for the conditions from which they suffer. We have to bring those people into the legal framework, so they can access the medicines that will make their lives very much easier. Many of the diseases and conditions likely to be treated by medicinal cannabis are the diseases of ageing. It would be infinitely better if people can use a safe medicine such as cannabis, rather than dangerous medicines such as opiates or legal alcohol.

I ask the Minister to push her colleagues to ensure that we do not simply follow down a pharmaceutical path that just assesses medicine as a molecule with a particular individual effect on a particular individual condition. That will not work in respect of medicines derived from cannabis. We have heard the reasons: the complexity of a plant-based medicine that has many thousands of different variants once one starts spinning them out. There should not be a choice between randomised control trials and observational trials. We need to do both. The opportunity for the United Kingdom and the people we represent—both economically in terms of a highly successful business and in improving public health and reducing the danger of opiate use and so on—is there for us to grasp. That is why investors have got it. They understand the opportunities for innovation and investment with real money in this area.

I urge my hon. Friend the Minister, now that the policy lead is in her Department and not the Home Office, to get the rest of the licensing arrangements off the Home Office and get them into a state where we advance public health, advance the economic interests of the United Kingdom and make a huge difference to public health in the UK, making people safer and healthier, and, ultimately, providing much greater value for money than the alternative treatments that people are using at the moment.

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[John Howell]

I accept that point. In cases of children who need cannabis oil, I am aware of it being crowdfunded, which can be a valuable way of proceeding, but it seems a complete nonsense in a country that is proud of its NHS that people should have to go into the public arena to crowdfund a drug.

I have some questions about this short list that the GMC maintains of doctors who can prescribe medical cannabis. How accessible are these doctors, and what is the waiting time to see one? These are practical barriers to people getting the drugs they need.

A young girl in my constituency—her name is not important—has intractable epilepsy and there is a great hope that medicinal cannabis would improve the quality of her life. Many women who suffer the sort of pain and discomfort she suffers during her menstrual cycle take birth control pills, which eases the pain considerably, but she cannot do that because it reduces the efficacy of her epilepsy medication and leads to a radical increase in the number of serious fits. For Hannah—that is her name—her epilepsy is life-threatening, as she is in a high-risk group of epilepsy sufferers who could experience sudden unexpected death in epilepsy syndrome, and we ought to think about how we can make it easier for her to obtain these drugs and so make her life easier. I mention that because to make these points we need to bring this debate back to examples of real constituents.

My second point is that raised by my hon. Friend the Member for Lichfield (Michael Fabricant) about the availability of guidance and training. In respect of both, there is a great lack of information, and it is not just us who lack information; so does the medical profession. We should do all we can to increase doctors’ knowledge and awareness so that, among other things, we can broaden out that list and GPs and family doctors can have the information they need to make decisions. I have no problem with this being a clinical decision rather than a political decision.

[Crispin Blunt]

We are where we are only because a politician, when faced with the inhuman cruelty of taking away from two children medicine obtained overseas when they returned to the UK, in the end refused to do so and issued a special licence. If this medicine is outside the scope of conventional medicine and the conventional assessment of molecular-based medicines, something will have to give if we are to get the benefit.

[John Howell]

I agree with my hon. Friend. The in-principle decision has been taken and the practical decisions now have to be taken by clinicians who are willing and fully trained to prescribe. The press releases and parliamentary answers are full of talk about finding the limit to the use of cannabis as a medicine. I listened to an exchange—I cannot remember who it was with—on its use to treat pancreatic cancer. From memory, I think the Minister gave a rather mealy-mouthed response. We need to think about extending the limits to other diseases.

In conclusion, I go back to where I started and congratulate my right hon. Friend the Member for Hemel Hempstead on securing this debate, but the matter will not rest here. I do not think this will be the last time we have this debate. I hope we see some progress soon.

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[Tonia Antoniazzi]

I do agree. It just does not make sense, which is infuriating, because I like to apply sense and logic to most situations, and the current situation is not logical.

Not being able to access medical cannabis leads people such as Chris and the parents of children with epilepsy to consider alternative ways of accessing cannabis, which—as has already been pointed out—is fuelling a dangerous online trade in which, for all we know, they could be buying anything. That is dangerous and wrong. Clinicians to whom I have spoken often ask parents what they have given their children in addition to over-the-counter drugs. Access to CBD alone has great health benefits that are not recognised by many in the medical profession. The right hon. Member for Hemel Hempstead has referred to its being described as homeopathy. When I say that one of my interests lies in medical cannabis, there will always be someone—even a politician—who will make the pun about wacky baccy, and it is really not appropriate. ‘

There seems to be a theoretical concern about the exposure of children to THC, but that is about recreational use; it is not about medical cannabis. Discussions about the legalisation of cannabis for recreational use and about the rescheduling of cannabis for medical use under prescription must not be conflated in the House. Let me put the position into perspective. The law changed because of one boy, Alfie Dingley, and the campaign spearheaded by his mum, the fantastic Hannah Deacon, who is in the Visitors’ Gallery today.

[Crispin Blunt]

And Billy Caldwell.

[Tonia Antoniazzi]

And Billy Caldwell, yes.

Alfie’s life has been transformed. He has been seizure-free for as long as 300 days, riding a bike and riding a horse. Hannah continues to campaign for parents who cannot gain access to medical cannabis for their children, who need the same treatment for their intractable epilepsy. The fact is that although the law has changed, the rules on access to medical cannabis are even more stringent as a result. Under the guidance provided by the British Paediatric Neurology Association, Alfie would not be eligible for his prescription, which beggars belief. The Government were aware that they were opening the floodgates by providing access for Alfie, but the push-back from certain areas of the medical profession is what is preventing any advance. We have seen that with a number of patients, and it is extremely unfair.

The medical cannabis that is being prescribed is in line with manufacturing practice, which means that it meets European standards. However, these products will have to be subjected to trials that could take three to four years, which is not acceptable to the families with whom we work at End Our Pain. It is not acceptable to the parents of Bailey Williams, who are also in the Gallery. They cannot wait any longer. They did use a CBD, and I think that they are still using it, but it is not working; it has worn off. That is why they need the THC.

These products are available, and they need to be made available to everyone now. There is currently a two-tier system. There are those who have access to medical cannabis because they have the funding, and those who do not because it is not available on the NHS. We must change that.

[Crispin Blunt]

I pay tribute to the hon. Lady for the work she is doing. The situation is worse than that, however: we are driving a number of people into the hands of a criminal supply chain so that they can obtain their medicine, and that cannot be right.

[Tonia Antoniazzi]

I entirely agree, and I am very concerned about it. We have heard in the House this evening that people are growing their own cannabis, and there is a growing trade. There is an online family of people who are helping each other to obtain the most THC possible from different combinations of different plants. It is a complete industry. Why are the Government not getting a grip, and providing a proper, GMP-standard, pharmaceutical product for people?

I also want to talk about the cost, which is extraordinary. Has the Minister or anybody in her office done a cost-analysis? Alfie Dingley’s case provides a classic example: how much has he saved the NHS by not having emergency medication and not using the ambulance service to go into hospital? It seems nonsensical that we are not going down this road.

I want to talk about a couple of my constituents. Only a few weeks ago I had a visit from the parents of a 14-year-old son. My son is 14 too, so their situation struck a chord with me. Their son has intractable epilepsy. Mum has given up her job to look after him—he has a very efficient system around him. He benefits from a ketogenic diet and the next available medicine is Epidiolex. Epidiolex does not contain THC but she wants her child to be on a trial, and the trial is limited. A mum should not come to me begging for her son to be on a trial, but when I spoke to her about medical cannabis with THC she was reluctant to engage because of a fear of breaking the law and of not following the system properly. All our families are following a system. They are at the end of the road in terms of what medicine they can be given, so I want them to be given medical cannabis with THC as soon as we can.

NHS England is drafting terms of reference, and as co-chair of the APPG I appreciate its efforts. These children must have access, however; they must not be waiting three or four years. I urge NHS England to work collaboratively with the devolved nations because we need our children in Scotland, Wales and Northern Ireland to have the same benefits.

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[Seema Kennedy]

I thank the hon. Gentleman for his comments. Prescription is in the hands of the clinician. Whether the prescription is paid for is ruled on locally and I will talk about that later.

I would like to tell my right hon. Friend the Member for Hemel Hempstead that a report, including any recommendations, is expected shortly. We will carefully consider any further action we might take to improve access in the light of that report and the clinical guidelines that are due to be issued by NICE. Members are rightly frustrated with the slow pace, because of the distressing cases and because of examples they have seen from abroad. NICE guidelines have been expedited. They would normally take two years to produce, but these guidelines will come out in half that time, this autumn.

Members have said that patient expectations are not being met and that clinicians are taking an overly cautious approach. With new medicines, we need a strong evidence base. That base is still in development, partly because of the historical overhang.

[Crispin Blunt]

Will the Minister give way?

[Seema Kennedy]

I was about to refer to my hon. Friend, but I will let him speak for himself.

[Crispin Blunt]

The Minister was probably going to pick up the point I made about the assessment of the risk-reward ratio. Humanity has goodness knows how many thousands of years of use of this plant, and it may need a different risk-reward assessment base from the classic medical variety. Sitting in the background for all the people who regulate our medicines is thalidomide and their anxiety about what might happen. We might need a different framework for this.

[Seema Kennedy]

My hon. Friend raises an interesting point, as he always does. The normal NHS medicines governance systems apply, and they are being used to support good clinical practice and safe and effective prescribing, but we could of course do more to educate and support the health profession.

I want to pick up another point raised by my hon. Friend the Member for Henley, about who does the prescribing of these medicines. These are not frontline medicines, and it is right that specialists who have detailed knowledge of all the treatments available for these particularly difficult cases are the ones who should be responsible for prescribing. Cannabis-based products would not normally be considered until a patient was at the stage in their treatment pathway when they were under the treatment of a specialist.

On education, Health Education England has been commissioned to develop an online training package. The aim of the package is to familiarise those working in the health sector with the change in the law and provide straightforward information about the products and what is known about their mechanisms of action. It will support and underpin the knowledge and understanding gained by specialists as experience in prescribing these products grows.

NICE Appraisals: Rare Diseases Treatments

Crispin Blunt Excerpts

Thursday 21st March 2019 Commons Chamber

[Crispin Blunt (Reigate) (Con)]

I am delighted to support the motion standing in the names of the hon. Members for Blaydon (Liz Twist) and for North Tyneside (Mary Glindon). This is a life-changing issue for thousands of our fellow citizens who simply do not have time on their side. A number of my constituents, including the parents of my young constituents battling with cystic fibrosis, have brought to my attention the weaknesses in the current NICE appraisal model. I look forward to reinforcing the arguments of the hon. Member for Blaydon with some details that they have provided.

NICE’s appraisal model has led to a horrendous block on life-changing cystic fibrosis drugs being made available to those young people. Vertex’s three approved medicines and investigational triple regimen may be able to treat the underlying cause of cystic fibrosis for up to 90% of patients. There is currently no cure for cystic fibrosis, and half of people with the disease will die before they are 31. I recommend that my hon. Friend the Minister instructs NICE to review its current single technology appraisal, which is used to appraise inherited rare diseases, in order to come to a solution that can work best for all parties. The current model, which specifically affects Vertex drugs such as Orkambi, is fundamentally flawed. It directly affects the lives of not only my young constituents suffering from cystic fibrosis, but those with spinal muscular atrophy, Batten disease and PKU, to name but a few.

NICE’s single technology appraisal has been used for the past 20 years, and although it served as an important new way to assess the cost-effectiveness of new treatments, it has failed to keep pace with advances in science. No model should be biased towards favouring specific medicines, but there remains an unwillingness to accept that new precision medicines that treat the underlying cause of disease and have the potential to extend life are fundamentally different from the medicines that existed when NICE’s processes were first developed. The idea of working on an innovative new model for appraising rare diseases is also supported by the Genetic Alliance.

When performing a single technology appraisal, NICE applies the same methodology and cost-effectiveness criteria regardless of whether it is appraising a single-use medicine for an acute condition or a lifetime medicine for an inherited, progressive, incurable, life-limiting disease. The current evaluation process turns on the incremental cost-efficiency ratio, measured in quality-adjusted life years. With acute conditions resulting from shorter-term treatment, the ICER is moderated even if the drug is very costly. Conversely, with chronic and lifelong conditions, the drug must be taken every day for life, and the cost of lifelong treatment prevents downward moderation of the ICER. That means that, when evaluating medicines that extend life, those that treat conditions from which patients would die within a short period are favoured over those that would extend life far into the future.

That unfairness is doubly compounded by the fact that, when computing the number of quality-adjusted life years attributable to a treatment, NICE usually applies a “discount rate” of 3.5% per annum, based on the Treasury’s Green Book, on both the costs and health effects of the medicine by reference to how far into the future those life years will be added to the patient’s life. In essence, the longer a patient lives, the more expensive they are to the system and the higher the cost per quality-adjusted life year.

Let me give an example. If a treatment were projected to extend the life expectancy of a six-year-old cystic fibrosis patient from 47 to 57 years, the “present value” of those additional 10 years would be less than two once they were discounted. By comparison, an oncological orphan medicinal product may add five life years, starting immediately, to a patient’s life expectancy, so discounting would reduce those five years to 4.66 for the purpose of calculating quality-adjusted life years. That approach cruelly fails to account for the fact that every year of additional survival, regardless of whether it is gained in the short or the long term, will be valued equally in the mind of a cystic fibrosis patient and his or her family.

To add insult to injury, NICE currently does not take into account the fact that when medicines lose their market exclusivity after patent expiry, their cost to the NHS falls dramatically, typically by 80% to 90%. It is unrealistic to assume that a medicine would remain at its currently listed price over the entire model horizon, particularly when that can be upwards of 40 years. There is no reason why NICE could not model the effect of a post-patent expiry price reduction by reference to available evidence from the pharmaceutical market. That is yet another example of NICE’s discrimination against treatments for chronic and incurable conditions in favour of those for acute conditions.

Finally, while NICE recognises that medicines for very rare diseases—ultra-orphan medicines—need a higher threshold and more discretion in the way in which they are appraised, it does not allow cystic fibrosis medicines to be judged against that threshold. That is because, although cystic fibrosis is a rare disease globally, its prevalence in England is such that NICE insists that it is appraised via the conventional approach.

Vertex is not the only manufacturer of precision medicines for rare diseases to experience challenges with NICE. Both the Bioindustry Association and the Association of the British Pharmaceutical Industry have, on behalf of their members, repeatedly highlighted the need for NICE to be reformed, to

“take a broad view of the value of new treatments and innovations to the health service”,

and to incorporate a wider range of factors and flexibilities, beyond the standard cost per quality-adjusted life year gained. It is right for us to ensure that NICE processes are modern and up to date with the evolution of precision medicines.

My constituent Sharon Cranfield is a bit disappointed with a letter sent to the Minister by the Chairman of the Health Committee, outlining the conclusions of the Committee’s public hearing on 8 March. She says that the points that I had raised on her behalf

“appear not to have been considered and the findings of the Committee seem to lie with continuing to defend the NICE model that has been used for the last 20 years and an unwillingness to accept that they need to be re-evaluated to reflect the current and near term developments in precision medicines.”

I understand that the Committee may have advisers who were associated with the setting up of NICE. I think that Ministers, NICE, and everyone who is engaged in this should look forward to a model that will actually work for the people whom we represent.

NICE must re-evaluate the way in which it values rare disease medicines. I sincerely hope that following today’s debate, it will do more to achieve alignment on value, evidence and price for the sake of patients, and will address, once and for all, the limitations of the current NICE STA process for diseases such as cystic fibrosis. That would also benefit all the other patients who already suffer enough after being diagnosed with a rare disease.

 Orkambi and Cystic Fibrosis

Crispin Blunt Excerpts

Monday 19th March 2018 Westminster Hall

[Crispin Blunt (Reigate) (Con)]

I join colleagues in congratulating my hon. Friend the Member for Sutton and Cheam (Paul Scully) and the hon. Member for Dudley North (Ian Austin) on promoting this cause and on drawing parliamentary attention to it in an extraordinary way in this debate. I have a constituent, Sharon Cranfield, whose 16-year-old daughter, Jessica, has cystic fibrosis. This is about the grassroots and all those people who are affected. She is but one of those who have done an amazing job in promoting this petition and in campaigning for access to Orkambi for the 3,000-plus people who could benefit from it in England.

Last summer, Jessica was given access to Orkambi on a compassionate use scheme for those with the lowest lung function, and her quality of life has been transformed. The medicine reduces the mucus that builds up in the lungs, causing infection and damage. She is already benefiting from fewer exacerbations, which, before the treatment with Orkambi, caused hospitalisations about four times a year for up to a month at a time, taking her out of school. Judging by stories such as Jessica’s and the growing body of evidence that shows that the medicine is working effectively to keep children and young adults what cystic fibrosis out of hospital, there is a clearly a very strong case for making it available on the NHS.

Although many other countries have moved to reimburse this medicine in their healthcare systems, in the UK Orkambi remains unfunded more than two years since it received its European licence. The UK is falling behind our OECD peers in terms of speed of adoption, overall uptake, and expenditure on the newest medicines, and it is becoming increasingly apparent that the ways in which NICE assesses the cost-effectiveness of medicines are outdated and insufficiently flexible for precision medicines for rare diseases with relatively small patient populations, such as Orkambi.

[Bob Stewart]

On my good friend’s excellent point, I wonder how much it costs to put a child in hospital for a month. I am pretty sure it is not far off £100,000.

[Crispin Blunt]

My hon. Friend leads me to my next point. How do we wish to value better and longer life for those with cystic fibrosis? How do we wish to value the savings to the NHS of reducing the 9,500 hospital admissions and the 100,000-plus hospital bed days a year? How do we wish to value the societal and economic benefits of helping young people grow up to play a fuller part in their education and employment, and the benefits to their families and care givers? How do we wish to value and reward the risk and innovation that goes into researching and developing breakthrough medicines?

NICE applies rigid health economics methodologies through its standard technology appraisal, which is designed not for rare diseases and specialised services but for primary care medicines that treat large populations with well-known diseases. Are we content for NICE to apply a threshold for valuing life that has not changed since it was established in 1999, even though healthcare inflation has almost tripled what we spend on healthcare?

My right hon. Friend the Member for Chingford and Woodford Green (Mr Duncan Smith) referred to social impact bonds and payment by results. I do not envy those who have to make those evaluations, such as the Minister and NICE. The costs fall on NICE and the health service budget, and the benefits are often felt elsewhere, not least in patients’ quality of life. Our society and the Government have to become more sophisticated about early investment. We must be able to measure the savings that come from having fewer hospital admissions and from the greater contribution to society that people who suffer cystic fibrosis will make if we improve their quality of life and reduce the degradation of their lungs.

Does the Minister accept that, although NICE has a specific evaluation process for highly specialised technologies for ultra-rare diseases, it is missing a framework for other rare diseases and precision medicines that treat sub-groups of rare diseases? He will no doubt point to initiatives such as the accelerated access review and the sector deal for the life sciences industry. I welcome those schemes in so far as they aim to address some of the access challenges, but they count for little if there is not a willingness to find innovative and flexible approaches to introducing innovation in the NHS. If we get this right, the UK has huge opportunities better to serve NHS patients and attract industry investment in clinical trials.

Vertex, the manufacturer of Orkambi, recently proposed a portfolio arrangement to NHS England, as we have heard from many colleagues, whereby all its current and future cystic fibrosis medicines could be made available to eligible patients at a fixed cost to the NHS, irrespective of the number of patients treated. Vertex wants to work with NHS England and NICE to put a long-term arrangement in place, as it has already done in Ireland. As the company introduces new medicines and line extensions, patients will get rapid access to the most suitable products for them upon regulatory approval, and the NHS will have budget certainty. Vertex expects to develop therapies that will treat 90% of cystic fibrosis patients within seven years.

In the light of the company’s proposal and the strength of feeling expressed in the petition and by colleagues in this debate, will the Minister look at mandating NHS England and NICE to prioritise discussions with Vertex to find an innovative and sustainable funding solution? It gives me hope that the offer that Vertex found unacceptable last Friday included a possible portfolio approach. It failed simply because NICE was not prepared to increase the resources it already pays for existing drugs, not including Orkambi. That plainly meant that the offer could only be unacceptable to Vertex, given that it is proposing new treatments that are going to treat 10 times as many patients as are being treated by the drugs currently available.

This is urgent. As my constituent, Sharon Cranfield, said to me:

“Each day of delay is additional delay of ‘irreversible lung damage’”

for those with treatable cystic fibrosis.

Organ Donation (Deemed Consent) Bill

Crispin Blunt Excerpts

2nd reading: House of Commons
Friday 23rd February 2018 Commons Chamber

[Mr Robinson]

I am grateful to my hon. Friend. It was his Bill that sparked my personal interest, and I pay great tribute to the work he did in preparing that Bill, which we have adopted almost in its entirety. He will be pleased to know that we are hopeful that his Bill—from the beginning, as it were—will now find its way alongside my own on to the statute book; I know that will give him great pleasure. What he says about that individual case is certainly true. The positive news from a cautious assessment from the NHS is that, provided the opt-out system—the quintessential starting point for all these forward projections—is introduced and backed up with the necessary limited revenue and capital spending, up to 500 lives a year could be saved by deemed consent.

[Crispin Blunt (Reigate) (Con)]

I am delighted to appear as one of the supporters of the hon. Gentleman’s Bill, and am very pleased to have my name on it. I hope he will be able to look at just one thing in Committee: the issue of deemed consent involving people who lose capacity towards the end of their lives. I hope there will be more clarity in Committee to enable people who have made the decision that they want to make their organs available to do so, when just their brain is no longer of much use to anybody else and they do not have the capacity. I hope the Bill will be clear about such circumstances when people lose capacity towards the end of their lives but when the rest of the body can still be of use to others.

[Mr Robinson]

I thank the hon. Gentleman for his intervention and the fact that he agreed to be a supporter of the Bill—his name appears on the face of the Bill, he will be pleased to note. He raises an area of great concern, but it is something we will have to deal with in Committee; I am sure he will agree that it is not for Second Reading, so I will not go further into it now.

Drug Addiction

Crispin Blunt Excerpts

Wednesday 22nd November 2017 Westminster Hall

[Crispin Blunt (Reigate) (Con)]

It is a pleasure to serve under your chairmanship, Mr Gapes. It is long overdue. It is also a pleasure to follow the right hon. Member for North Norfolk (Norman Lamb). I congratulate him on his speech. I agree with his analysis entirely. I also congratulate my hon. Friend the Member for South Thanet (Craig Mackinlay) on raising this issue. He is right to point out the dramatic risk of fentanyl-associated harm that is perhaps coming our way following what is happening in the United States.

Any examination of the global evidence shows that the costs my hon. Friend pointed to, financial and human, are infinitely higher than they should be owing to the global policy of prohibition and criminalisation of drugs since the 1961 UN single convention on narcotic drugs, which has been an unmitigated global public policy disaster. He rightly drew attention to the dangers of drug-driving and his concern at the increasing number of road deaths caused by drug-driving, as in the United States. That will require strong enforcement action to catch, warn and punish offenders, in the same way as drink-driving here in the UK has met with effective policing and societal attitude changes.

[Jim Shannon (Strangford) (DUP)]

Will the hon. Gentleman give way?

[Crispin Blunt]

Forgive me; I am short of time.

I come to this debate from the criminal justice perspective, having seen for myself as Minister for Prisons and Criminal Justice the time and costs incurred by the police, courts, prisons and probation service in managing the effects of drug-related crime. My hon. Friend the Member for South Thanet also drew attention to the problems of cannabis, particularly street cannabis, which, with its high levels of tetrahydrocannabinol, or THC, is more potent and liable to cause schizophrenia in long-term users.

However, those looking to use cannabis recreationally often have little to choose from and have no idea what their cannabis, acquired on the street from drug dealers, has in it. Legalisation and regulation would allow consumers to access less harmful forms of cannabis with lower levels of THC and higher levels of cannabidiol, or CBD, giving the desired high, in just the same way as drug users of tobacco and alcohol can be assured of the regulated quality and provenance of their products, together with the health warnings and all the necessary restrictions on advertising and sales that a properly regulated market can deliver.

Licensing and regulation proportionate to the risks of each type of drug and signposting users to services when they get into trouble would be the right place for public policy if we followed the evidence of what works. At a stroke it would deliver the massive good of eliminating the huge costs associated with criminal possession and supply. By permitting a legal but regulated market, we would decouple hundreds of millions of consumers around the world—millions in the UK alone—from funding and facilitating a world of criminality.

Just as prohibition in 1920s America provided a financial basis for organised crime to flourish in American cities, so our policy of prohibition has gifted an industry worth half a trillion dollars a year to serious and organised criminals producing and supplying untested substances. Their interest is hardly the health of their consumers, but far more to produce the addiction that will sustain a vastly lucrative business model.

Alongside the addiction, we then have to deal with the awful consequences of drug market violence as gangs and dealers vie for control of the trade, quite apart from the enormous amount of the lower-level criminality of burglary and other acquisitive crimes as addicts seek to fund their addiction. As well as keeping criminals, many of them young people, out of drug supply, licensing and regulation allows us to tackle the health-related harms associated with drugs and drug addiction that my hon. Friend was right to draw attention to. Criminalisation means that users are hidden from health practitioners, and there is a lack of guidance about how to find and access services. Taxation of sales by licensed retailers would pay for better prevention, treatment and public health education, available at the point of purchase—a dispensing pharmacist, for instance.

Colorado has raised half a billion dollars in state taxes and fees since it licensed recreational cannabis in 2014. The right hon. Member for North Norfolk referred to the the Home Office evaluation of its own drug strategy, which states:

“There is, in general, a lack of robust evidence as to whether capture and punishment serves as a deterrent for drug use”.

If we translate that out of bureaucratese, that means we know current policy does not work. Since we have been fighting the war on drugs for more than half a century, it might now be an idea to examine the evidence. So I say to my hon. Friend the Member for South Thanet, instead of doubling down on a failing policy and demanding yet more higher sentences for particular parts of the supply chain—in the example he gave, the failing policy has led to the highest level of opioid drug deaths since records began—we should learn from decriminalisation and public health approaches in other countries.

In Portugal, for example, where the possession of small amounts of drugs has been decriminalised since 2001, a step well short of licensing and regulation, usage rates are among the lowest in Europe, and drug-related pathologies, such as blood-borne viruses and deaths due to misuse, have decreased dramatically. Compare the drug mortality rate of 5.8 per million in Portugal with Scotland, where it is 247 per million. The Portuguese state offers treatment programmes without dragging users through the criminal justice system, where it becomes harder to manage addiction and abuse. I can tell my hon. Friend, drawing on knowledge of the effort to establish drug-free wings in prisons, that it is not easy to do. I accept that it is a perfectly sound policy objective, but do not think for a minute that there is a magic wand to deliver a part of the prison system that will be proof against drugs getting in.

In the criminal justice system, as I can testify from my own experience, it is hard to manage addiction and abuse. The reshaping of our drugs policies should be informed by the growing body of evidence that will come in from the legalisation of cannabis sales in several US states and, from next July, in Canada. We will be able to learn, too, from the Netherlands, Switzerland, Germany and others with drug consumption rooms, an example of the kind of regulation we could deliver around heroin consumption in supervised, safer environments where, as the right hon. Member for North Norfolk said, no one has ever died of an overdose. So we must listen to the Global Commission on Drug Policy, which seeks a balanced, evidence-based approach. The UK could have a royal commission to make evidence-based policy recommendations free of politicians’ trite response, “Drugs are bad; they must be banned.” That can give us a route to reframing the debate on drugs and finding evidence-based policy approaches that will truly reduce the costs of addiction, both financial and human.

[Mike Gapes (in the Chair)]

Two hon. Members have indicated a wish to speak and I should like both to get in, but if they are to do so each needs to speak for no more than four and a half minutes.