Oral Answers to Questions

Ivan Lewis Excerpts

Tuesday 23rd July 2019 Commons Chamber

[Stephen Hammond]

Adjustments are already being made in the funding formula for differences in costs related to rurality or location. Northumberland CCG will receive an extra £1.1 million in funding this year to provide emergency ambulance services in sparsely populated areas. By 2023-24, Northumberland CCG will receive £98.5 million more funding.

My hon. Friend has already spoken to me about Rothbury Community Hospital in her constituency, and I would be delighted to speak to her about it again.

[Mr Ivan Lewis (Bury South) (Ind)]

People in rural areas need more investment in social care services. I do not always agree with the Daily Mail, but is it not right when it says that we now need a national dementia fund and an all-party approach to defining the nature and funding of the social care system in this country? Successive Governments have failed in that respect, and older people, disabled people and their families are being let down as a consequence. When will we see some action?

NHS Procurement and Subcontractor Exclusion

Ivan Lewis Excerpts

Thursday 4th July 2019 Commons Chamber

[Mr Ivan Lewis (Bury South) (Ind)]

I requested this debate this afternoon not only to put right a wrong that has been done to a long-established business in my constituency, but to highlight wider issues about Government procurement policy, particularly in relation to the national health service. The Government rightly talk about delivering a Brexit that supports UK businesses, jobs and our standard of living. However, this sorry story illustrates how, even before Brexit, we are unable to create a level playing field for our companies, let alone back them up. In this case, the EU cannot be blamed for a lack of transparency or fair competition, or for the exclusion of a UK company from an NHS preferred supplier list.

Under NHS ProCure22, the Department of Health and Social Care appointed Kier as a tier 1 provider to decide who should be the preferred providers for floor covering in NHS facilities. In May 2018, without any competitive tendering or other transparent process, it was announced that three overseas companies would be on the preferred supplier list—two French companies, Tarkett and Gerflor, and a Swiss company, Forbo. James Halstead, a UK plc from my constituency with a 50-year track record of supplying NHS institutions was not on the list or even given the opportunity to tender or participate in dialogue with Kier.

Halstead is highly successful global business that we are proud of in Radcliffe, with a global turnover of £250 million and a UK turnover of £83 million. The NHS currently accounts for approximately 15% of that UK turnover. A significant proportion of that is now at risk, and there is the also potential reputational damage of being excluded from the list for unstated reasons. Many NHS organisations are understandably asking Halstead why it is not on the list. That would be bad enough in any circumstances, but things have been made worse by the recent track record of the three overseas companies.

In October 2017, the three companies were found guilty of price fixing over a 23-year period in France, and the French competition authority fined them a total of £302 million. They were found to have discussed minimum prices, price increases, sales policy and other sensitive information, such as their trading volumes. The French regulators discovered that the companies had also exchanged confidential, recent and detailed information on their sales volumes and commercial forecasts. That information was exchanged through the SFEC, a sectoral trade union in France, which was in charge of collecting the information and sharing it with manufacturers. It is surprising—some would stay staggering —that seven months later these same companies were given a monopoly as preferred suppliers for the NHS. In addition, it is worth noting that Tarkett pays no UK taxes whatsoever. To be clear, it is not breaking any laws in doing so, but that does not mean that there are no ethical and fairness issues.

I have several questions for the Minister, and if he is unable to answer them today, I would be grateful if he wrote to me in detail. What criteria did Kier use to draw up the preferred supplier list? In the absence of competitive tendering, what process did it use? Why were Halstead and other suppliers not included on the list or given the opportunity to put their case? What consideration was given to the probity of the three overseas companies in view of the sanctions imposed on them in France?

Will the Minister assure me—this is incredibly important—that Kier will be instructed to add Halstead, and any other appropriate company, to the list as a matter of urgency? Will the Minister initiate a review of all such NHS contractor lists with a view to identifying how many are drawn up without a competitive tendering or transparent process? Finally, will the Minister issue an instruction in due course that NHS staff and third parties, such as tier 1 providers, appointed on the NHS’s behalf to commission goods and services should have a duty to be proactive in encouraging UK companies to apply or bid, depending on the relevant process?

I believe that this case has wider implications for UK Government and NHS procurement policy than simply the effects on the business in my constituency. I want to make it clear that this is not about saying that, in an unlawful manner, the NHS or the Government should favour UK companies over foreign companies. That is not the case whatsoever, so officials should not try to deflect us away from the substantive issues here. The issue is that a UK company with a good track record, a history of financial probity, and quality goods and services should be on this list. It has never been sanctioned by any regulatory authority. In contrast, these three overseas companies were significantly sanctioned, less than a year before the NHS’s decision, for price fixing—basically operating a cartel in France—over a 23-year period.

Clearly this is not a matter of direct ministerial responsibility and, having been a Health Minister, I do not hold the Minister personally responsible for individual procurement and tendering decisions, but Ministers are responsible for policy and oversight in this area. There has either been incompetence by those charged with these responsibilities or, frankly, something stinks in Kier’s decision-making process in this case.

I would be incredibly grateful if the Minister responded to my substantive points, considered the wider implications for UK Government and NHS procurement and put right, as a matter of urgency, the wrong done to Halstead plc in my constituency.

--- Later in debate ---

[Stephen Hammond]

I want to speak about the overall process later in my speech. Having been to Nottingham to open the national procurement centre for the NHS last week, I am clear that we should have the best procurement processes in place to ensure that money from the public purse is spent wisely. That is even more important in the health service than it is in almost any other part of the public sector, because money spent wisely means better patient care, and that is key.

I hope that I will be able to prove to my hon. Friend and the hon. Gentleman that the problem with this contract was not with the framework itself, but with how one particular company chose to apply the criteria. I am not saying that the company necessarily applied the criteria inaccurately or wrongly, but it did not do so in a way that we would normally encourage.

[Mr Ivan Lewis]

I thank the Minister for the openness and frankness of his response so far. His last comment was very telling, because he acknowledged that in these circumstances, Kier perhaps did not behave in accordance with best practice or what would usually be expected, even if it did not do anything unlawful. If possible, I want clarity on whether the Minister or his officials have had, or will have, strong words with Kier about what the situation has exposed and the unfairness that has been applied to the company in my constituency. Will he or his officials have that conversation with Kier about what is expected of it, or have they done so already?

[Stephen Hammond]

To be absolutely clear, I was not suggesting that Kier had not necessarily followed best practice, and it certainly had not acted unlawfully. I was suggesting that, as I said a moment ago, we would encourage all the people who use the frameworks to ensure that there are opportunities for UK firms to be on those frameworks.

Let me try to answer directly some of the hon. Gentleman’s questions. He asked what criteria Kier used to draw up the supplier list. As I explained, in respect of how the framework is set up, the Department ensures that the principal supplier on the framework is there correctly, appropriately and legally. It is not for the Department to comment on the criteria that private sector organisations use to draw up their supplier lists. The Department sets out the expectation of the principal supply chain partners, and our expectation on them is to ensure that supply chains provide value-for-money, quality services for the public sector. Understandably, because of the nature of what is being procured, each supply chain partner will have its own processes and prequalification criteria.

The hon. Gentleman asked me directly what processes were used in the absence of competitive tendering. Again, it is not for the Department to comment directly on the specific processes, but I can confirm that each of the supply chain partners needs to follow its own internal policies, and those policies and procedures must align with the requirements of the framework.

The hon. Gentleman asked directly why Halstead and other suppliers that were not included on the list were not necessarily given the opportunity to put their case. The Department does not have visibility of which suppliers were given the opportunity to put their case; however, Halstead is now discussing that with the supply chain partners. As I said, Halstead has spoken to officials at my Department, and that communication goes back as far as March 2018. I understand that Halstead is now using that feedback and is bidding to form part of the supply chain. We give the undertaking that the application will be considered fairly and scored against the set criteria.

The hon. Gentleman asked me directly about what consideration was given to the probity of the three overseas companies, given that sanctions were imposed on them in France.

[Mr Lewis]

The Minister said that the application will be tested against the set criteria, but he cannot tell me what those criteria are. Is that a fair reflection of the situation?

[Stephen Hammond]

As I said earlier in my remarks, each principal supply chain partner must make sure that their internal policies and procedures align with the requirements of the framework, but it is not for the Department to tell each principal supply partner how to set out their criteria, nor the specific processes they should use. The hon. Gentleman rightly made the point that is my Department’s responsibility to ensure that the policy is correct. I hope he is hearing that my Department ensures that the right procedures and processes are in place and that the individual principal supply chain partner must choose the most appropriate one for the right framework it is on. I hope he will accept that.

I was just about to refer to the issue of the three overseas companies that were chosen and the sanctions that were imposed on them. As I said earlier, I am aware that the French authorities imposed the fine on the three companies at the end of 2017, but those convictions were imposed after the preferred supplier list was established. Clearly, the Department does not have sight of the contractual agreements between the supply chain partners and the suppliers. The supply chain partners are not within the scope of the Public Contract Regulations 2015.

The hon. Gentleman asked whether I could assure him that Kier would be instructed to add Halstead to the list as a matter of urgency. He will know, obviously, that it is not within my remit or my ability to instruct private sector organisations to engage with specific companies, but I can reassure him that Halstead is currently bidding as part of the refresh of the Kier supplier list and its application will, I know, be scored on the merit of the criteria set. I hope that that reassures him.

I want to turn briefly to how the Department supports and encourages small and medium-sized enterprises and subcontractors more generally. Clearly, we have been dealing with some very specific issues, and that underlines the complexity of the procurement landscape. The understanding of who exactly subcontractors are, and the work that they undertake, is, by its very nature, not well understood unless it is for a very major significant construction project. NHS organisations would usually expect the Crown Commercial Service or the regional procurement solution to identify and track the supply chain of the suppliers providing the goods, works or services. However, there is currently a limited understanding of the suppliers on locally negotiated contracts.

The Public Contract Regulations 2015 clearly allow public sector organisations to permit subcontracting within supply chains as long as the subcontractors meet the minimum standards set out, and the hon. Gentleman knows that I have just set those out. Where issues in subcontractor performance arise, the regulations also allow for the subcontractor to be excluded.

The Department’s SME action plan for 2019-20 highlights the actions that we are taking to make it easier for SMEs to work with the whole of the health supply system. The Department has a target of 23% of our direct and indirect spend with SMEs by the end of March 2022.

[Stephen Hammond]

I am happy to give my hon. Friend that assurance. It is absolutely the commitment of the Government to ensure that small and medium-sized enterprises are not excluded from any form of public sector procurement. I am pleased to say that the Department has published an action plan to that effect. I am actually the Minister in charge of ensuring that that action plan is implemented, and I am pleased to say that the Cabinet Office holds meetings of ministerial champions across Whitehall to ensure that, as a Government, we meet our targets.

[Mr Lewis]

May I ask the Minister about a really important point of clarification? Are Kier or similar organisations fulfilling that function required to publish the basis on which they make these decisions? The Minister has said that it is not for the Department to tell such organisations how to fulfil their responsibilities in drawing up these lists, but are those organisations required to publish, openly and transparently, the basis on which they make decisions about their preferred suppliers?

[Stephen Hammond]

What I can say to the hon. Gentleman—he has heard me say this twice, and I am happy to have a longer discussion with him outside this debate—is that there is a process in place whereby principal supply chain partners are on the framework. If they are on that framework, they have to ensure that their policies, procedures and the criteria they intend to use align with that framework. As private sector organisations that have been contracted by the public sector, they in turn have subcontractors, and they have to ensure that the processes they use to contract those subcontractors are compliant with the framework. I am happy to set that out in writing for the hon. Gentleman, if he would like me to. Clearly, the Department cannot and does not instruct principal supply partners to detail every aspect but, as I have said to him before, we have to be reassured that the processes and procedures they use are compliant with what we have set out in the framework.

This has been a fascinating debate because it gets to the heart of what we want to do. If we want to have a vibrant economy, we must have transparency regarding how companies contract for public sector contracts and the supply thereof. What the hon. Gentleman has rightly done on behalf of his constituents is to ensure that the Department is clear and has investigated that the processes and procedures being used were the correct ones, and that if, as he believes, his constituents were unfairly treated, the Department looks into the case. My officials have been in regular contact with Halstead since 2018 and I am pleased that it is now able to refresh its application for the subcontract list. I am also pleased to have had the chance briefly to set out the Government’s overall ambitions to ensure that all small and medium-sized enterprises are able to bid for Government contracts.

Question put and agreed to.

Health

Ivan Lewis Excerpts

Tuesday 14th May 2019 Commons Chamber

[Mr Ivan Lewis (Bury South) (Ind)]

The Secretary of State is right to say that the shadow Secretary of State is, indeed, a nice man, but he is far more than that. I pay tribute to the hon. Member for Leicester South (Jonathan Ashworth) for the tremendous work that he and the right hon. Member for Birmingham, Hodge Hill (Liam Byrne) have done on behalf of the children of alcoholics—they are making a tremendous difference.

I will focus on the impact of cuts to mental health services. At a time when there is a welcome all-party commitment to parity of esteem between mental health and physical health, there is an alarming gap between rhetoric and reality. Headline national figures too frequently do not reflect the experiences of people at the sharp end. It is widely acknowledged that mental health services were underfunded to start with, and the perpetual cuts we have seen have made matters worse.

A lethal cocktail of cuts to health and benefits has created a shameful epidemic of rough sleeping that is so evident in the towns and cities of our country. Specific Government funding, although welcome, is inadequate and no substitute for the savage cumulative cuts to mainstream services. It is paying for the damage caused by indiscriminate, disproportionate cuts.

I put on record our support for the tremendous leadership shown by the Mayor of Greater Manchester with his “a bed every night” initiative, but that will need considerably more investment from the Government if it is to achieve its noble objectives.

My “Talking About Mental Health” campaign in Bury South has attracted a lot of support from people with mental health issues and their families. It has illustrated a simple truth: one in four people experience mental health problems every year. The campaign is encouraging people to feel able to talk about their own experiences and is galvanising support to improve local services. Cuts have meant too often that people endure long waits for psychological therapy, and are unable to access appropriate in-patient and emergency services. Community support is scarce, and far from services being focused on prevention and early intervention, people can usually access services only in the event of a crisis. Relatives and carers are frequently left to struggle alone.

We have some excellent, innovative local voluntary services, such as the Creative Living Centre, Moodswings and The Friendship Circle, but they are underfunded and cannot be expected to meet the scale of the demand for support. A major concern is the state of child and adolescent mental health services. Although the Government’s pledge of an extra £1.4 billion to transform CAMHS in 2015 was welcome, work by YoungMinds has demonstrated that in the first year of extra funding only 36% of clinical commissioning groups that responded had increased their CAMHS spend by as much as that Government funding.

In my constituency, I am currently advocating on behalf of a number of local parents who have autistic children with mental health problems—I am sure other hon. Members have the same experience. These people are under unspeakable daily pressure, yet services consistently fail to meet their needs. In the light of it being Mental Health Awareness Week, I would like to read part of a blog written by my brave 19-year-old constituent Libby Bean, who describes the realities of living and coping with a mental health condition as follows:

“I found going to many psychologists that it just wasn’t working for me, I didn’t like the by the book exercises and help they would give me and treat my case like every other person as I believed it had to be adapted specifically for me. After several psychologists I tried this one amazing person that I had heard was great for anxiety. Me being me I said I’d try it because”—

it was just an opportunity—

“to get rid of my feelings of anxiety, I thought how this will be any different to what I have been through before, well I was wrong. This changed my life. They have helped me so much and have been the best support system.”

The point that I am making and that I think Libby is making is that health and local public service cuts are making it harder for people such as Libby to receive the tailored care and support that they need. A one-size-fits-all approach is always destined to fail; an issue as varied as mental health requires personalisation.

Supporting mental wellbeing should be at the heart of any responsible Government’s approach to building a better society. It requires health and local government leadership, and a joined-up, cross-government approach. It requires us to continue the tremendous progress that has been made in recent years in tackling stigma. It also requires the full engagement of employers in the public and private sectors. Parity of esteem and a shift to prevention and early intervention are noble objectives, but disproportionate cuts to local government and underfunding of the NHS mean that the reality is very different. Not only does this make vulnerable people even more vulnerable, but it corrodes trust in politicians and this place. I hope that the Secretary of State will give serious consideration in the future to ring-fencing funding for mental health, so that people at the sharp end genuinely see the benefits of extra funding that is announced at a national level.

[Several hon. Members rose—]

Mental Health Support: Young People

Ivan Lewis Excerpts

Tuesday 9th April 2019 Commons Chamber

[Ruth George (High Peak) (Lab)]

I applied for this debate because of the cases of young people struggling to receive mental health support in my constituency of High Peak and in the county of Derbyshire. However, since last week, when the debate was announced, hundreds of parents, support workers, teachers and young people themselves have contacted me from across the country with heartbreaking stories of young people suffering with little or no support.

Their families suffer, too: like the mum of an 11-year-old boy in my constituency who has been severely mentally ill since last September. He suffers from panic attacks and his mum says he hardly eats or sleeps. He is unable to leave the house. He is very depressed and anxious all the time, and has been destructive and suicidal on many occasions. Mental health services will not support him, in spite of a referral from the GP, because they will not do home visits for a boy who is too ill to leave the house.

There is the six-year-old who is at risk of being excluded from school due to his behaviour. He has suspected attention deficit hyperactivity disorder or autistic spectrum disorder, but 18 months after referral the family are still waiting. Without a diagnosis, he can get neither the health nor education support he so desperately needs. His mum is trying online courses in child behavioural psychology, but she cannot help him without a diagnosis to access the medication and/or therapy he needs. The stories are similar from around the country and I thank all the people who have contacted me on this issue.

[Mr Ivan Lewis (Bury South) (Ind)]

Does my hon. Friend agree that young people with autism who have mental health problems and their families have particular challenges in accessing appropriate services? Does she agree that Ministers need to look specifically at the needs of young people with autism who also have mental health problems? My experience in my constituency is that access to emergency support when there is a real crisis is often non-existent or inappropriate. There is then the question of transition for young people from being a teenager to being an adult. Does she agree that that needs a distinct approach?

[Ruth George]

I absolutely agree with my hon. Friend. There are so many areas of children’s mental health where support is needed, but with ASD a diagnosis is needed as well, which can delay the support they so desperately need.

--- Later in debate ---

[Jackie Doyle-Price]

That is not borne out by the figures from the Derby and Derbyshire clinical commissioning group, which show that 31% of children and young people with mental health needs were seen by NHS-funded mental health services. I come back to the point that it is not acceptable for children to be told that they are not yet ill enough to receive treatment, which is why we are investing in more provision. We expect at least an additional 345,000 children and young people aged nought to 25 to be able to access more direct support.

[Mr Ivan Lewis]

I have to say to the Minister that in this area there is a massive gap between the rhetoric and the reality on the frontline. I urge her to reconsider the whole concept of ring-fencing resources. When we have Cinderella services such as CAMHS, unless the Government decide to ring-fence that funding and insist that local commissioners give it to frontline services, they will never achieve the changes they are seeking.

[Jackie Doyle-Price]

In the past we have treated ring fences as a ceiling and set CCGs the clear objective that they need to increase investment in CAMHS by more than what we have been giving them. [Interruption.] However, acknowledging the hon. Member for Worsley and Eccles South (Barbara Keeley), we will look at what more control we can give, and NHS England is keeping a very close eye on how that money is being spent. As I said at the outset, I am not complacent about the challenges we face. I have to say that we are on it. Direction of travel is one thing, but we have to make sure that we are managing expectations and that we can deliver the services that people expect. That includes investment in the workforce to deliver on very clear expectations.

Pancreatic Cancer

Ivan Lewis Excerpts

Tuesday 2nd April 2019 Westminster Hall

[Nic Dakin (Scunthorpe) (Lab)]

I beg to move,

That this House has considered treatment for pancreatic cancer.

I pay tribute to the hon. Member for Winchester (Steve Brine), who was an outstanding Health Minister and who I am sure will continue to make significant contributions to the fight against cancer. I thank members of the all-party parliamentary group on pancreatic cancer and associated charities for their work, and people watching on the Parliament channel for their interest and support.

It is time to up our game on the diagnosis and treatment of pancreatic cancer. Full marks to campaigners such as Ali Stunt of Pancreatic Cancer Action, who was inspired after surviving the cancer herself to set up a charity that focuses on improving early diagnosis in particular. We need even more people like Ali, with her determination and passion, to ensure we can make a difference. Once diagnosed, there is an urgent need for access to faster treatment for people who have pancreatic cancer.

[Mr Ivan Lewis (Bury South) (Ind)]

I thank my hon. Friend for ensuring that this issue is brought to the attention of the House. Does he agree that, while there is a great emphasis on early identification of pancreatic cancer and we all share the concern that identification should come as early as possible, the speed of treatment is every bit as important? Does he agree that we have some way to go before we can be satisfied with that speed of treatment for most patients with pancreatic cancer in this country?

[Nic Dakin]

My hon. Friend is right: speed of treatment after diagnosis is an issue, and I will emphasise that in my speech.

Pancreatic cancer is the quickest-killing cancer: only one in four people survive a year and fewer than 7% of those affected in England will survive for five years or more. Those are appalling statistics, and they have not improved in this country in decades.

Human Medicines (Amendment) Regulations

Ivan Lewis Excerpts

Monday 18th March 2019 Commons Chamber

[Mr Ivan Lewis (Bury South) (Ind)]

I am glad we have had the opportunity to have this debate. Like other hon. Members, I want to focus on the impact these changes could have on those with epilepsy. I thank SUDEP Action, which the right hon. Member for North Norfolk (Norman Lamb) mentioned, for the work it has done to bring concerns about this issue to the fore. I also agree with many of the concerns my hon. Friend the Member for Leicester South (Jonathan Ashworth) expressed in his opening remarks.

The Secretary of State was unable to address bereaved families and clinicians at the recent summit held by SUDEP Action, but will he meet me, other hon. Members and representatives of SUDEP Action and talk directly to families about the concerns they have? If he could agree to do that, it would be very helpful.

Medicines shortages pose a serious risk to people with epilepsy. As hon. Members are aware, it is a high-risk condition, requiring complex, tailored care. As other hon. Members have said, many people with epilepsy are particularly vulnerable to changes to that care. I have recently met families, such as that of Rachel Shah, whose daughter Emily died aged 19 shortly after a non-specialist prescriber made an error with her medication. The family and the non-specialist were entirely unaware of the risks of sudden unexpected death in epilepsy, and the error was not noticed. That is quite shocking.

Studies show that people on existing medications are put at risk when those medicines are changed. Tried and tested systems mean that, when there is a medicines shortage, specialist prescribers with expertise and access to the full patient record are involved in any changes. There are known risk factors that can increase the risk of death among people with epilepsy. However, those can be carefully managed through open, positive relationships between clinicians and patients. Those clinicians have often had responsibility for the patients’ medication schedule, which has often been worked up with the patient over many years.

The serious shortage protocols, passed under the Human Medicines (Amendment) Regulations 2019 give pharmacists the right to supply a different quantity or pharmaceutical quality of medicine in the event of the country experiencing a serious shortage of prescription-only medicines. As other hon. Members have said, pharmacists are skilled professionals in medicines and medicines management, but they are not specialist prescribers. Nor are they specialists in assessing SUDEP or other epilepsy risks in individuals, and they do not have access to full patient records.

[Jackie Doyle-Price]

With your indulgence, Madam Deputy Speaker, I would just like to reassure the right hon. Member for North Norfolk (Norman Lamb) and the hon. Member for Bury South (Mr Lewis). We do not consider that treatment for epilepsy would be appropriately covered by a serious shortage protocol, for exactly the reasons that they have both outlined: this is specialist prescribing and very bespoke to the patient. In the event of a shortage of epilepsy drugs, the clear guidance would be for the pharmacist to refer the patient back to their prescriber. The shortage protocols will be very tightly defined, within given circumstances, as to what drug will be an appropriate alternative treatment; they are by no means meant to be very one size fits all.

[Mr Lewis]

I think the Minister for that reassurance. I think we will want to see that in writing. Having that clarity is incredibly important, so that when the guidance is published, the reassurance is there for people with epilepsy and their families. That is incredibly important.

We should remember that laws that sought to allow change in the prescription of epilepsy medications were rejected in 2010 after a public consultation that highlighted major patient safety concerns. MHRA guidance in 2017 included vital safeguards against switching medication for people with epilepsy. These issues have therefore been interrogated in the past.

A precautionary approach concerned with patient safety would include analysis and openness about the causes of medical shortages; include an impact and risk assessment; aim to avoid any risk of worsening medical shortages; follow good practice in the regulation of medical shortages; include training and communication arrangements for all affected; and include clear, robust and timely accountability to patients and the public for adverse events and avoidable deaths. Nurses and clinicians are currently unable to gain access to a number of medications. They need to know which are on the list of likely shortages, and whether all the possibilities of measures to prevent such shortages have been exhausted.

People with epilepsy are recognised to be a high-risk group in current legislation. They must be protected against shortages of any medications that they take—not just their epilepsy medication—by a requirement in the legislation, and in any accompanying guidance, for the involvement of a specialist prescriber at all times. To be fair, that is the assurance that the Minister sought to give this evening.

It is not good enough to say in the explanatory memorandum that protocols will not apply to certain epilepsy treatments for which a brand is required. Any change in the 2017 MHRA guidance on epilepsy medication should be avoided, although, if such a change is required owing to a serious shortage, it must follow public consultation with the involvement of the third sector and patients. I think that patient groups feel they have been excluded from the process thus far. I urge the Minister to agree—in the spirit in which she has engaged with the House this evening—to meet SUDEP Action along with me, and other Members, if the Secretary of State is not willing or does not have time to do so.

The Government should make publicly available the list of medications that are at risk of shortage. If people living with long-term health conditions, and their clinicians, know about serious shortages that may affect them, they should have opportunities to contribute to any consultations and debates. An early-warning system for prescribers is essential, but it must be extended to all specialist prescribers. Many are on the front line, trying to ensure continuity of medication for patients, and they will be able to provide the necessary reassurance for those patients if they are aware of potential shortages.

We should not forget the anxiety that this will cause among people who are already extremely vulnerable, and the fact that that anxiety could lead to further health problems. All who are involved in the chain need to be able—where appropriate—to offer the maximum clarity, information and reassurance. The Government should also publish an operational framework and guidance to ensure that there is good practice and medicine shortages can be managed safely. They should commit themselves to patient-centred and shared care decision-making.

Perhaps this is the most important point that has been made so far: it is still not clear where accountability lies in the event of an adverse event—worst of all, a death—when there has been a failure of continuity of supply lines. That issue has been highlighted by the Pharmacists’ Defence Association. Obviously the association is very concerned about the potential negative effect on pharmacists, but a greater concern relates to the potential impact on patients and families.

This legislation is not simply another complication caused by Brexit. It may present serious challenges for many years to come. It is first and foremost about patient safety, and in those circumstances, the Government need to take appropriate time and care when making their decisions.

Orkambi

Ivan Lewis Excerpts

Monday 4th February 2019 Commons Chamber

[The Parliamentary Under-Secretary of State for Health and Social Care (Steve Brine)]

It is a pleasure to see you in the Chair for the Adjournment debate, Mr Speaker. My hon. Friend the Member for North Herefordshire (Bill Wiggin) and all Members who have contributed to the debate, some of whom I recognise from previous debates, have spoken on behalf of constituents from the heart as usual, regardless of political persuasion, with one voice. That is good to hear. I had a school here this morning, and the students asked me what the biggest misconception about this place is. I said that we get on far more than we do not, even at the moment. If they tune in this evening, they might see that happen. Adjournment debates are always a good example of that, in my experience—and as Public Health Minister, I have significant experience of the Adjournment debate, as does my poor Parliamentary Private Secretary.

Everyone has been speaking without political bias and with one voice, and that voice wants patients to benefit from effective treatments for cystic fibrosis. So do I, and the Government wholeheartedly share that view. We have urged Vertex to accept the fair offer that NHS England has made to the company, which would guarantee immediate access for NHS patients to all Vertex’s cystic fibrosis treatments. I hope that the pleas we have heard from my hon. Friend and other Members once again this evening will go some way to persuade Vertex—I agree that it will be listening intently—to consider NHS England’s fair and best offer.

[Mr Ivan Lewis (Bury South) (Ind)]

rose—

[Ian Austin (Dudley North) (Lab)]

rose—

[Steve Brine]

I will give way once—and that is it—to the hon. Gentleman who rose first.

[Mr Lewis]

I thank the Minister for giving way, and I congratulate the hon. Member for North Herefordshire (Bill Wiggin) on securing this Adjournment debate. We have been debating this in this place for months, and the fact is that our constituents and patients still do not have access to Orkambi. May I say to the Minister that it is time that Ministers themselves took over these negotiations and responsibility for sitting face to face with and eyeballing the company so that our constituents get the justice they deserve? These negotiations between NHS England and the drug company have got us nowhere, despite the efforts of right hon. and hon. Members in this House. Will Ministers now directly get their hands dirty, roll up their sleeves, participate in these negotiations and bring this matter to a conclusion on behalf of our constituents?

[Steve Brine]

Okay, the hon. Gentleman has got his press release with his intervention. Perhaps I should go back on what I said at the start. All he has done is to take away time, on what is a very complex issue, from my trying to set out a response to my hon. Friend’s Adjournment debate.

My hon. Friend has called on the Government to consider making use of the legal provision in UK patent law of Crown use licensing to break, as he rightly puts it, the current “deadlock”. As the hon. Member for Bury South (Mr Lewis) said, in a reasonable part of his intervention, it is a deadlock and it has been going on for some time. I commend my hon. Friend’s efforts in raising this. Indeed, it is right that we consider every possibility. Every effort must be made to ensure that effective medicines are made widely available to cystic fibrosis patients. There is no doubt and no debate about that.

I can assure my hon. Friend that we, too, have considered this option. Indeed, I have received initial advice on Crown use licensing. While the use of these mechanisms is not our preference, we are looking at all options. Crown use licensing is complicated, and it would not represent a quick solution to ensuring patient access to Orkambi. My hon. Friend the Member for Newton Abbot (Anne Marie Morris) mentioned that in her intervention and, sadly, she is right.

The UK is one of a limited number of countries that actively protects the role of intellectual property in medicines development in international forums. We believe, however, that there is a balance to be struck between providing incentives to create and commercialise new medicines and ensuring that they remain affordable to the taxpayer—our constituents.

The 2019 voluntary scheme for branded medicines pricing and access, alongside the statutory scheme for branded medicines, are two mechanisms that are in place for ensuring branded medicines are affordable to the NHS. The 2019 scheme provides for flexible commercial arrangements between companies and NHS England—in other words, the customer in this scenario.

In theory, Crown use licensing could be utilised with respect to Orkambi. However, in the past Crown use has only really been intended or designed to deal with emergencies, where a particular patented product is not available in the UK at all. Crown use has not historically been intended to circumvent commercial agreements or to create a mechanism for the production of medicines at a lower price.

The relevant legislation on Crown use states that compensation would need to be provided to the original patent holder—in this case, Vertex, and that would stick in the throat of many of us—which would need to take into account any loss of profit from not being awarded a contract to supply the patented medicine. Unless an agreement could be reached with Vertex, it would be for a court to decide on an amount in this instance. This would of course need to be paid from the public purse. If a Crown use licence were issued, then there would be a subsequent, critical question about how the medicine would be produced and authorised as the usual licensing requirements would apply, with approval required by the Medicines and Healthcare Products Regulatory Agency.

Vertex has protections in the form of both data and marketing exclusivity for Orkambi, and it will continue to have these for a number of years. As such, unless another manufacturer conducted its own clinical trials, there are no realistic alternatives at this time to produce it and the NHS does not hold such a capacity. Using this route, it could take several—many—years before the drug was available on the market, and it would, in all likelihood, be very expensive for another manufacturer. The total length of time and cost of manufacturing and licensing—plus the compensation to the patent holder and a potential appeals process through the courts, which seems inevitable everywhere we turn these days—could be potentially significant.

We also do not know what impact Crown use would have on the other medicines that Vertex supplies to the NHS or the pipeline of products that it is developing. We should remember—and my hon. Friend reminded us of this in his opening speech—that around 50% of people with CF would benefit from Orkambi; in other words, 50% would not.

Crown use could have the effect of putting patients at a disadvantage, jeopardising access to future medicines and potentially setting a precedent of issuing further licences at very high cost.

Access to Orkambi

Ivan Lewis Excerpts

Tuesday 17th July 2018 Commons Chamber

[Mr Ivan Lewis (Bury South) (Ind)]

We are living in an era when public confidence in a mainstream political class is at an all-time low. Too often the public suspect that we choose the low ground when they yearn for us to build common cause in pursuit of the high ground. Tonight we have a chance, in a small way, to prove them wrong, by using this debate to show the relevance and humanity of Parliament in the cause of human dignity and human life. I pay tribute to colleagues here, especially the hon. Members for Dudley North (Ian Austin), for South Cambridgeshire (Heidi Allen), for Erith and Thamesmead (Teresa Pearce), for Bury North (James Frith) and for York Central (Rachael Maskell), the right hon. Member for Hemel Hempstead (Sir Mike Penning) and the hon. Member for Strangford (Jim Shannon), for championing this issue so passionately and effectively over a long period of time. I also want to place on record our appreciation for the tremendous work of organisations, including the Cystic Fibrosis Trust, which ensure that the voices of people with cystic fibrosis and their families are heard and heard loudly.

[Jim Shannon (Strangford) (DUP)]

I thank the hon. Gentleman for being so generous. The fact that so many Members have stayed behind tonight is an indication of the importance of the issue. It was my privilege to attend an event at Belfast City Hall this month, standing side by side with CF sufferers and their families calling for Orkambi to be made available. Does the hon. Gentleman agree that medication that is proven to improve the quality of life for CF sufferers must be made available regardless of postcode? The Department must again ask the National Institute for Health and Care Excellence to enter into negotiations with a pharmaceutical company to provide this drug and allow CF children to progress and CF adults to achieve a good quality of life. Once again, I congratulate him on bringing this issue to the House. It is very important.

[Mr Lewis]

I agree entirely with the hon. Gentleman. It is absolutely vital that we see an engagement process that leads to action. I will develop that argument as I make my contribution here this evening.

[Marion Fellows (Motherwell and Wishaw) (SNP)]

The hon. Gentleman mentioned many organisations. I wish to pay tribute to Scotland Parents CF Support Group, which has been very generous in helping me to understand and bring this matter to people’s notice. This is a UK-wide issue. I know that we are discussing NHS England, but this is also an issue in Scotland. Hopefully, if we can get those in England to get this drug, it will have a domino effect in Scotland, thereby saving and improving the lives of people with CF.

[Mr Lewis]

I think that, in this context, we can all unite behind the concept that we want a resolution that is UK-wide if at all possible. Clearly, that would require different organisations to be involved, but if we can set a precedent here, we could make rapid progress, and that can only help all parts of the United Kingdom. May I make some progress, and then I will give way to other hon. Members?

All of us who have the privilege of serving in this House are mothers or fathers, brothers or sisters, grandparents, uncles or aunts, godparents, friends or neighbours. It could very easily be one of our family members or friends who is diagnosed with cystic fibrosis at birth and who struggles with a life of perpetual illness, frequent hospitalisation and a daily multitude of drugs. Worse still, they could be living with the fear of premature death at an age when many young people are getting married, starting a family or taking their career to a new level.

I ask hon. Members to imagine that their family member or friend was denied access to a drug that could improve their quality of life and prolong their life for many years—a drug that was readily available in 12 other countries. No one in this Chamber today would accept no for an answer, or remain silent as the NHS and a major drugs company traded increasingly public blows as to who is to blame for unnecessary suffering and potential loss of life. If the situation is not good enough for our loved ones, it should not be good enough for anybody else’s.

I first became aware of Orkambi when a young constituent from Prestwich attended my constituency surgery with her mother. Many Members will have met constituents in a similar situation. Alex Darkin is 10 years old and suffers from cystic fibrosis. She is a remarkable girl, whose courage and positivity are truly inspirational. Alex started this year with 80% lung function—a number that scared her mother, Emma, because Alex’s lung function was over 100% a few months previously. These days, Emma would give anything to see the number 80 again. Alex’s lung function continues to drop and is now around the 54% to 56% mark.

Alex has physio and takes a large amount of medication just to manage her condition. She brought all that medication to my surgery and I found myself looking at a young person who has to go through the routine of taking that medication every day; that, in itself, is a massive challenge. Alex has intravenous antibiotics every three months, and her daily life is inevitably dominated by her drug and physiotherapy regime. Very sadly, she now has irreparable lung damage. A consultant recently advised that doctors are running out of options with regard to medication, and explained that if Alex were a year older her parents would be able to apply for Orkambi on compassionate grounds, as her lung function had deteriorated more than 25% in less than three months. Emma and Alex contacted me because they could not afford to wait another year to get this drug on compassionate grounds. Surely a truly compassionate society would ensure that this drug was available to all who needed it.

[Sir Mike Penning (Hemel Hempstead) (Con)]

I congratulate the hon. Gentleman on securing this debate. I think that we all tried to get this debate, which is why we are all here. One of the reasons I said to Mr Speaker earlier that I was not happy was that I wanted us to get on to this debate. We have all heard stories in our constituencies, as I am sure you have, Madam Deputy Speaker. As a country of this wealth, we should be ashamed. People in countries with nowhere near the wealth of this country have been given these drugs to improve their quality of life. We are here to right that shame.

[Mr Lewis]

The right hon. Gentleman speaks for everybody present this evening and probably many who are not.

There is inevitably sadness, but there should be real anger because this situation is causing human misery to many people who have enough challenges in their lives without not being able to resolve this situation. It would not be right for any of us to pretend that these decisions are easy. NICE does a good job in very challenging circumstances, on the whole. In no way should we or do we seek to undermine its work.

[Anne Marie Morris (Newton Abbot) (Con)]

The hon. Gentleman is being very generous in giving way. As he is reflecting on NICE and its process, does he agree that there should be a change in the way it measures or calculates quality of life when it comes to rare rather than ultra-rare diseases? If the condition was classed as ultra-rare, we may well have got the go-ahead.

[Mr Lewis]

I think that most people would accept that now is the time for a review of the criteria that are applied and the processes that are undertaken. Any organisation needs to be continually improving. We do not condemn NICE. In fact, we acknowledge that it has got many difficult decisions right, but it has also got some wrong. Time and again, the reason that it has got those decisions wrong—arguably—is that the criteria it is applying and the criteria it has been given by the Department of Health are out of date and flawed. I think we would all want to see a review of NICE’s remit and the way in which it carries out its work over a reasonable period of time. It would be helpful if the Minister would respond to that point when he concludes the debate.

[Rachael Maskell (York Central) (Lab/Co-op)]

My hon. Friend is making a very important speech. As I know from being a physio who worked with cystic fibrosis patients, when making an assessment of the cost of treating cystic fibrosis, we must look at the social cost, the economic cost and the immense cost of keeping somebody alive. Does he agree that Orkambi would be a solution to that, let alone addressing the human cost?

[Mr Lewis]

I entirely agree—my hon. Friend makes absolutely the right point. When there is an incomplete assessment in looking at value for money versus outcomes, that will lead to flawed decisions that are incredibly difficult to justify. We have a mismatch between the basis on which NICE is expected to make these decisions and appropriate processes. Instead of everybody hinting, “Yes, of course there’s a need to review NICE—of course that would be a good thing”, we would like to hear from the Minister a timescale as part of the response to the specific issue of Orkambi in terms of NICE’s roles and responsibilities.

[Heidi Allen (South Cambridgeshire) (Con)]

Now is an opportunity because we have a new Secretary of State. I have already contacted him about this issue. The way that NICE is making its decisions is affecting not only drugs like Orkambi but an awful lot of drugs that people in our constituencies desperately need. Does the hon. Gentleman agree that now is absolutely the right time to grasp this situation on Orkambi and challenge NICE about its decision-making criteria? Let us change the way it is looking at the value of quality of life and do that urgently, using Orkambi as a starting point.

[Mr Lewis]

I entirely agree. It is always very important, when a new Minister begins a role, that they have a very clear sense of a positive agenda on which they want to achieve change. This will be a very appropriate issue for the new Secretary of State to adopt and to drive forward.

[Bambos Charalambous (Enfield, Southgate) (Lab)]

Orkambi would not be suitable for my constituent Holly, who is eight years old, but other drugs that have been manufactured would be more suitable for her. Does my hon. Friend agree that if NICE had more flexibility in looking at pipeline deals, that would help many more people such as my constituent Holly?

[Mr Lewis]

Of course I agree entirely. It must be very frustrating for Holly and her family to find themselves in this situation. There really is no excuse for delaying the beginning of a review. Members know full well how long these reviews can take, so let us get on with it. I think we are united in a belief that this is absolutely essential as part of the lessons that we need to learn from this situation.

[Paul Girvan (South Antrim) (DUP)]

The hon. Gentleman alluded to having spoken to families of people who were on a large cocktail of drugs and the costs associated with that. Let us not say that it is just down to costs; I appreciate that NICE might well be using the wrong process. This cocktail of drugs adds up to a significant cost, and there can be a dramatic saving if they can come off some of those drugs, as well as losing the side-effects that come with them.

[Mr Lewis]

I agree entirely. We sometimes spend vast amounts of public money reacting to a problem, and the rhetoric is all about prevention and early intervention, but we end up doing the opposite. This is a very good example of that.

[James Frith (Bury North) (Lab)]

rose—

[Mr Lewis]

I will give way to my hon. Friend and then I have to make progress.

[James Frith]

I congratulate my hon. Friend on securing this debate. Does he agree that there is a human cost to this gridlock for cystic fibrosis sufferers, who are victims of this disease and this disagreement? Frankly, NHS England should get in a room with Vertex and they should stay in there until they come out with an agreement to end this gridlock, so that cystic fibrosis sufferers do not see this debate just as yet another conversation but as delivering change and transformation of their lives.

[Mr Lewis]

My hon. Friend clearly wants to finish my speech off for me. Of course, he is absolutely right to make that point. The most important thing to see from this debate is action, not words. I will go on to talk about what those actions should be.

[Lady Hermon (North Down) (Ind)]

Will the hon. Gentleman give way?

[Mr Lewis]

I am going to make progress, if I may, but I will perhaps give way once more later on.

[Ian Austin (Dudley North) (Lab)]

Will my hon. Friend give way now, before he continues?

[Mr Lewis]

I will—my hon. Friend certainly deserves it.

[Ian Austin]

I am very grateful. This is a really frustrating process, and the Government have to find a way of bringing it to a conclusion. I agree that NHS England and Vertex have to get back into negotiations, which should not stop until this is resolved. Does my hon. Friend agree that it might be an idea for the Secretary of State to get Sir Simon Stevens and Jeff Leiden, the chief executive of Vertex, in a room—

[Ian Austin]

The right hon. Gentleman could lock the door, but first he has to get them in there so that negotiations resume and are not concluded until they resolve this issue, because it really does have to be sorted out.

On that point, does my hon. Friend agree that it was worrying to read the word “final” in NHS England’s response to Vertex yesterday? It cannot be final. I really hope the Minister is listening to this. [Interruption.] The word “final” was in there. [Interruption.] Well, he is the Minister. The word “final” cannot be used until it is finally resolved. That is when it will be final.

[Mr Lewis]

I agree entirely with my hon. Friend, and I will develop his argument as I continue my speech.

A quote from Emma, Alex’s mum, sums up many of the frustrations of the constituents represented here today. She says, very movingly:

“Alex has a real love for life and all she wants to do is live a long and happy live without having to fight to breathe.”

That powerful statement says it all.

Since March, when we last debated this issue, NHS England and Vertex have met on four occasions. I welcome the fact that, during those negotiations, NHS England accepted the principle of a funding agreement that supports a portfolio approach to current and future drugs. That is undoubtedly a step forward and a positive response to the contributions parliamentarians made in the initial debate, but it is clear that these negotiations have not produced an agreement that is acceptable to both parties. Indeed, the public recrimination suggests that the negotiations had all but broken down. It remains to be seen whether NHS England’s written offer, made on the eve of this debate, is a basis for progress, but the early indications are not encouraging.

It would be inappropriate for anyone to make judgments about the validity of either party’s case without having full access to the information, which remains confidential for reasons of commercial sensitivity. I know I speak for all parliamentarians when I express concern about the fact that, as my hon. Friend the Member for Dudley North said, NHS England described its offer as “final”. It could lead to a stalemate that once again lets down patients and their families. To be clear, I respect the need for an objective process that delivers appropriate medication and value for money for the taxpayer. If NICE did not exist, it would have to be invented, but—this point has been made time and again tonight—the shortcomings of the current assessment processes are well documented. That is why NHS England’s involvement in this instance is to be welcomed.

Equally, Vertex has the right to seek financial remuneration at a level that maintains its viability and supports the development of the company. Sadly, I am unconvinced that more of the same will lead to an agreement that will enable Orkambi and successor drugs to be made available to people with cystic fibrosis. Consequently—my hon. Friend the Member for Bury North suggested this—I urge the Secretary of State for Health and Social Care to facilitate an urgent meeting with the chief executive officers of NHS England and Vertex. In that meeting, they should seek to resolve any outstanding differences, and agree a rapid timescale for the roll-out of Orkambi across the country and an approach for other relevant drugs. People with cystic fibrosis have been waiting far too long.

[Lady Hermon]

The hon. Gentleman is well aware that health is a devolved matter in Northern Ireland, but we do not have a Health Minister because we have not had a functioning Assembly for 18 months. Will he join me in urging the Minister to liaise with the permanent secretary in the Department of Health in Northern Ireland to reassure the many cystic fibrosis suffers and their families, who are desperately anxious, that we have a drug available? The health service must enter into final discussions to reach the outcome we all want.

[Mr Lewis]

I agree entirely. The absence of a functioning Executive is a source of continued regret to those of us how care passionately about Northern Ireland. Progress has been made, but there is now a stalemate. It is incredibly important that, in the absence of an Executive, Ministers ensure that any solution that is reached also benefits people with cystic fibrosis in Northern Ireland.

The UK Government need to commit to a proactive role to help secure a deal as soon as possible that will ensure access to these new treatments. They must fulfil their own stated ambition for NHS patients to be

“among the first in the world to get life-changing treatments.”

Vertex, the pharmaceutical company, must be fair and responsible with pricing to ensure that a deal on access to new treatments can be agreed—and agreed rapidly. The Government must consider looking towards the future pipeline of treatments for cystic fibrosis to ensure that a robust and fair system is in place for appraising high-cost new medicines to avoid similar issues about access to medicines with other companies and drugs in the future. The time for words is over; on behalf of our constituents, tonight we demand action.

--- Later in debate ---

[Steve Brine]

I said I would not give way, and I will not do so.

I thought the hon. Member for Bury South made a good point when he said if NICE did not exist, we would have to invent it. I agree. Indeed, NICE has been able to recommend a number of drugs for patients with rare diseases through its technology appraisal process, including pirfenidone for pulmonary fibrosis and mifamurtide—why they cannot produce easier names, I will never know—for a rare form of bone cancer, to name but two.

I know that it is distressing, to put it mildly, for patients and their families, as well as campaigners, when NICE is not able to recommend a treatment. Unfortunately, there will continue to be occasions when NICE is not able to a recommend one for routine use on the NHS. As we know, NICE has not so far been able to recommend the use of Orkambi for treating CF, because the benefits were not sufficient to justify its considerable cost. At list price, the cost per quality-adjusted life year of Orkambi is many times higher than the upper end of the threshold used by NICE in deciding whether to recommend a treatment. NICE does not stick rigidly to a cost per QALY threshold, and it applies plenty of flexibility in deciding whether to recommend treatments where the decision is a borderline one. However, it must be stressed that the cost per QALY is not an arbitrary measure, but a tool to assess what the impact would be on other NHS patients if the NHS were to spend money on a particular treatment.

I want to talk about the discussions with Vertex. As Members know, NHS England has been in intensive discussions with Vertex to encourage it to lower the cost of Orkambi to a level that would allow NHS England to fund its use without adversely impacting other patients. I and the Under-Secretary of State Health, Lord O’Shaughnessy, who sits in the other place—he leads on this area for us—have been keeping an extremely close eye on these discussion, as I promised the House in the Westminster Hall debate I would do. As Members will remember, we wrote to Vertex in April, urging it to commit to pricing that is responsible and proportionate. I have the personal assurance from NHS England that it is committed to seeking a way forward in these negotiations, and I think it has shown flexibility.

Sadly—I am not ratcheting up the rhetoric or name-calling, as this is just fact—Vertex has been unwilling to price responsibly thus far, which has, as we have heard today, meant that patients have missed out on two years of treatment. Vertex claims that it has made the NHS

“the best offer in the world”—

but it has yet to substantiate that claim. I would challenge Vertex to waive confidentiality—which it can do: I cannot—so that we can all see, in the interests of transparency, the kind of prices it is trying to charge the NHS and, as a result, our constituents.

As mentioned this evening by the hon. Member for Bury South, NHS England wrote to Vertex yesterday to set out a proposed five-year deal with an option to extend, which provides the potential for Vertex to secure revenues from the NHS in the region of £500 million over the next five years. NHS England has made the content of this proposal public, to give patients and taxpayers the opportunity to make a judgment about the fairness of this offer. The proposed deal, if accepted, would guarantee immediate and expanded access, as clinically appropriate, to the two licensed medicines, Orkambi and Kalydeco—as was said earlier, Orkambi is not the only show in town. It would also provide immediate access for Symdeco from the date it is licensed for use in the UK, which is expected in coming weeks.

If Vertex is not willing to accept the deal, it must return to discussions with NICE and go through that process. Let me be clear that I truly hope it does not come to that, but until Vertex adjusts its prices, NICE will not be able to recommend the drug’s use. I repeat that we have put a figure on the table. The ball is in Vertex’s court. It has made a preliminary response today, saying that it is good to see that NHS England is negotiating. NHS England has been negotiating throughout. It is not Ministers who are negotiating on this.

[Mr Ivan Lewis]

rose—

[Steve Brine]

I will break my rule and give way to the hon. Gentleman who secured the debate.

[Mr Lewis]

That is kind of the Minister and I thank him for his serious response to the debate.

We said the last time we met that we did not want Ministers to keep an eye on the issue: we wanted Ministers to be actively engaged in it. The Minister gave us an assurance that his colleague would be actively engaged, not keeping an eye on it. Today, we repeat that we do not want NHS England and the drug company left in a room alone to work this out, otherwise we will be back here in six months’ time. We expect the Secretary of State to be in the room with the chief executive of NHS England and the drug company to bang heads together and come up with a satisfactory conclusion. Will the Minister respond directly to that point and give us an assurance that there will be political involvement and engagement in the negotiations, because we have waited for too long?

[Steve Brine]

When I say “keeping an eye”, I do not mean it like keeping an eye on the football scores on a Saturday afternoon. It is just my turn of phrase. Ministers are keeping very close tabs on this and making sure that NHS England is in no doubt that we want it to come to a conclusion with Vertex. But it takes two to tango, as we are seeing in another negotiation right now. We need Vertex to tango. The ball is in its court, and it is time to return it.

I stand by what I said at the last debate: it is vital that we go through the right process here. There is a process. I do not think for one minute that the Opposition are suggesting that if they were in government, Ministers would be making these decisions like Roman emperors, as that would be totally wrong. It is an important principle that the NHS must ensure that healthcare services get the best value for patients, and that is the approach NHS England is rightly taking.

NHS England has proven that it can strike innovative deals, working with the life sciences sector to make treatments available for patients, while securing fair value for taxpayers—our constituents. That includes hundreds of patients with multiple sclerosis who now benefit from a treatment called cladribine and the use of pertuzumab for breast cancer. It is important for me to be clear with hon. Members that Ministers should not make a decision on behalf of NHS England, which has the clinical expertise and the powers to purchase medicines.

I put it on record again that I urge Vertex to accept the proposal presented by NHS England, or it will only make those living with cystic fibrosis suffer. Yes, of course there are discussions among the new ministerial team. I spoke to the new Secretary of State just this evening in the Lobby. He is taking an incredibly close interest in this issue, less than a week into the job, and I pay tribute to him for that. I ask Vertex to recognise NHS England’s flexible approach. It would represent the largest ever financial commitment of its type in the 70-year history of the NHS. I certainly hope that they can reach a deal. Many, including in my own Winchester constituency, are counting on them.

Question put and agreed to.

Learning Disabilities Mortality Review

Ivan Lewis Excerpts

Tuesday 8th May 2018 Commons Chamber

[Caroline Dinenage]

The CQC conducted an inquiry into this issue in 2016 and has a responsibility to check local healthcare provision to ensure it is up to speed. When local trusts start publishing their learning from deaths data from June, the CQC will be able to inspect them on how they bring the data forward and to judge them on that information.

[Mr Ivan Lewis (Bury South) (Ind)]

Societies and Governments should be judged by how they treat the most vulnerable. As well as avoidable deaths of people with learning disability, we have savage cuts to services across the country, so they have no constructive positive activities to participate in, and we have a complete dearth of employment opportunities now for people with learning disabilities. I started my working life 36 years ago working with people with learning disabilities, and we made tremendous progress over a 20-year period. It is a source of tremendous sadness that we have gone backwards in the last 10 years in the support that such people and their families are receiving. It is shameful. We need a cross-Government approach and we need action, not strategies.

[Caroline Dinenage]

It is sad that the hon. Gentleman has sought to politicise this issue. It is nothing to do with funding cuts or cost-saving measures. We have actually invested more money into this programme. We are the first Government in the world to publish a learning from deaths programme so that healthcare trusts are held accountable and have to publish their data on people who die unnecessarily in their care. Making short-sighted party political points is therefore very unfair and does not get to the heart of the issue, which is about supporting people with learning disabilities and making sure that their health outcomes are the same as those of the population as a whole.

 Orkambi and Cystic Fibrosis

Ivan Lewis Excerpts

Monday 19th March 2018 Westminster Hall

[Mr Ivan Lewis (Bury South) (Ind)]

It is always good to see you in the Chair, Sir Roger.

I congratulate the hon. Member for Sutton and Cheam (Paul Scully) not only on securing this important debate but on his excellent opening contribution. I also pay tribute to my hon. Friend the Member for Dudley North (Ian Austin) for his work on this issue over a long period. Most of all, like other hon. Members, I thank the Cystic Fibrosis Trust—families up and down the country have come together in such a passionate and effective way to ensure that this House takes this life-and-death issue as seriously as it needs to be taken.

At the outset I want to acknowledge that it is entirely right that we have in place a system to determine objectively the effectiveness and relative value for money of new drugs. That is a policy area in which we should seek maximum consensus across the political divide in the national interest and in the long-term interests of patients and their carers. NICE does a difficult job in very challenging circumstances, and in no way should we or do we seek to undermine its work. However, any system of that nature can get it wrong or delay decisions when there is no time to waste, whether through pressure of work, changing evidence or, on occasion, a lack of nimbleness and flexibility. Sometimes pharma companies seek unreasonable commercial arrangements that have to be challenged—I am not saying that that is so in this case, but it is important for us to understand that that happens and that we always have a responsibility to ensure that we get fair value for money.

The present system truly has insufficient flexibility to take account of the true benefits of a portfolio approach. As other hon. Members have said—we can judge this from their contributions today—we may be politicians, but we are also citizens, whose human instincts are to speak up for people with life-threatening and life-limiting conditions. In any such debate, we should ask the question, what support would we expect if a member of our family or close personal friend were denied life-enhancing or saving treatment? We would not want to listen to arguments for why that was simply not possible.

I first became aware of Orkambi as an issue when a young constituent and her mother came to my constituency surgery. Alex is 10 years old and suffers from cystic fibrosis. She is a remarkable girl, whose courage and positivity are truly inspirational—that would apply to many of the young people we are here to talk about today. However, this case is perhaps a graphic example of what can happen very quickly. Alex started this year with 80% lung function, a number that at the time, understandably, scared her mother, Emma, because a few months previously it was at more than 100%. Now, Emma would give anything to see the number 80 again. Alex’s lung function continues to drop and is now at around the 54% to 56% mark.

Alex has physio and takes a large amount of medication just to manage the condition, including intravenous antibiotics every three months. Similar to what other hon. Members have rightly described, her daily life is inevitably dominated by her drug and physio regime. That is a quality-of-life issue on a day-to-day basis, as well as a health issue. Sadly, Alex now has irreparable lung damage. Recently, Alex’s consultant advised that they are running out of options with regard to the medication, explaining that had Alex been a year older—this demonstrates how random some of the decisions can be—her parents would be able to apply for Orkambi on compassionate grounds, because her lung function had deteriorated by more than 25% in less than three months. Compassionate use in the UK is used only when a patient is extremely ill, however, and NICE is not scheduled to look at Orkambi again until July 2019. But we now know that early use enables better management of the condition and reduces further complications. Emma and Alex contacted me because they cannot afford to wait another year to get the drug on compassionate grounds.

I say to the Minister and others that we talk a lot about the centrality of prevention and early intervention but in reality, when we make decisions such as this one, we do the opposite, and when public services face the kind of financial pressures that they face these days—whether that is local government services or the NHS—they resort to fulfilling core functions, statutory functions. In the real world, it is almost nonsense to talk about a shift to prevention and early intervention. This is an example of where that is crucial, in a very direct way.

Emma is understandably frustrated. Her daughter has spent her entire life fighting to stay well, and now she has to fight for a drug that could help her to feel better. For Alex, as I said, Orkambi would mean a slowing in the decline of her lung function, giving her control of her condition and a better quality of life. As Emma, her mum, movingly said:

“Alex has a real love for life and all she wants to do is live a long and happy life without having to fight to breathe.”

I would say this about disabled children and their families more generally. I coined a phrase: why do we have to constantly fight the system when we should have a right to have a system that is on our side. I have been involved in working with disabled people for about 35 or 40 years, and I am sad to say that that is the reality for most families with disabled children today. It has been the reality under successive Governments, although we tried to improve investment. We certainly made progress on stigma and in recognising that disabled children should have the right to fulfil their potential and to be treated like any other child, for example, but the constant battle every single day—when, frankly, people have enough to cope with, whether as a child or as a family—is something we should all reflect on.

Along with other hon. Members, I strongly support the call for NHS England to engage in a meaningful dialogue with the drug company and to reach a fair settlement. Having sat in the Minister’s place, I can predict that officials will say, and this is not a criticism of the officials, that we should stay out of this; that it is not a matter for Ministers; that there should not be political interference; that we have a robust system that exists and is in place; and that we should let that system run its course. Ministers may end up allowing human emotion or politics and pressure from hon. Members to influence them to make decisions that are not always consistent with what the Department wants them to make. I say to the Minister that that is nonsense. Ministers have a duty to intervene in circumstances such as this, to be a facilitator and a convener, and to bring those parties round the table and say that it is not acceptable for this situation to remain unresolved for much longer.

My hon. Friend the Member for Bury North (James Frith) said that we do not want to be back here in six months’ time, having a debate such as this one in exactly the same circumstances. Many countries around the world have reached a different conclusion and have made a different decision. Obviously, they believe that this drug makes a massive difference from a health and quality of life point of view, and that it is economically effective. I ask the Minister to please use his convening powers, his accountability to Parliament, and the desires and the will of parliamentarians as expressed today, to apply immediate pressure to the relevant parties.

--- Later in debate ---

[The Parliamentary Under-Secretary of State for Health (Steve Brine)]

It is a pleasure to serve under your chairmanship, and that of Mr Evans, Sir Roger. May I be the final speaker to thank my hon. Friend the Member for Sutton and Cheam (Paul Scully), who has done his job as a member of the Petitions Committee in introducing the debate on the petition today. As the hon. Member for Washington and Sunderland West (Mrs Hodgson) said, the number of Back-Bench MPs who have spoken is 22. My Parliamentary Private Secretary reckons that we have had 60 Members through the Chamber in the past three hours. Of course that is only just over 9% of MPs, but, as we all know, having been to many Westminster Hall debates between us, that is a lot of MPs in one debate. That did not even include the hon. Member for Strangford (Jim Shannon)—I am worried for him. As we know, so many MPs attending the debate suggests a great deal of interest in the subject, and the way everyone spoke was excellent. Perhaps I may mention that the speech of the hon. Member for Motherwell and Wishaw (Marion Fellows) cannot have been an easy one to make, and she delivered it with grace.

With more than 115,000 signatures—my goodness—the petition shows what huge public support there is for tackling this terrible disease. The passionate way in which hon. Members across the board have spoken on behalf of their constituents is testament to that support. I want to make a special mention of the “Bury brothers”, who represent the 202 people in the Bury constituencies who signed the petition: the hon. Members for Bury North (James Frith) and for Bury South (Mr Lewis) both spoke well and in a sensible and balanced way. I can only assume that the hon. Member for Bury South, from what he said, must be a former Health Minister. Am I right?

[Mr Lewis]

indicated assent.

[Steve Brine]

I thank 163 of my own constituents who signed the petition and who have been in touch with me, and one who has been to my constituency surgery. I may be the Health Minister responding to the debate, but I am also a constituency MP and a parent of two young children.

I pay tribute to the Cystic Fibrosis Trust, which does a tremendous job on behalf of all our constituents. I know we are not meant to address the Gallery. I will not do so, but if I did I would thank those who have made the trip in the snow and ice, probably not all from SW1, to come to Westminster today. It is a credit to them that they have made time to do that.

I recognise the progress that Vertex has made to date in its mission—I believe it is a mission—to discover ultimately a cure for cystic fibrosis, and recognise the treatments that it brings to the market. I know Vertex understands the importance of the UK market, and NHS England as a customer, to its future and to that mission.

This petition is calling on the British Government—that would be me—

“to call for a resolution to ongoing negotiations between Vertex Pharmaceuticals, NHS England and NICE as a matter of the utmost urgency. It is essential that a fair and sustainable agreement is found.”

I am here today to do exactly that. It is not a difficult call to agree to. The negotiations must remain constructive and be undertaken with the utmost urgency, for all the reasons we have heard—I will not repeat them all—or, as my hon. Friend the Member for Mid Dorset and North Poole (Michael Tomlinson) said, people living with cystic fibrosis will suffer.

It seems to me that the main ask I have heard from pretty much every hon. Member speaking today is, “Get involved.” I am not the Minister directly responsible. That falls to Lord O’Shaughnessy, the Parliamentary Under-Secretary who sits in the other place, but I can say on his behalf and on mine that we are involved, and you can bet your life that we will continue to be involved. I do not think I can be clearer.