Cystic Fibrosis Drugs: Orkambi

Sharon Hodgson Excerpts

Monday 10th June 2019 Westminster Hall

[Mrs Sharon Hodgson (Washington and Sunderland West) (Lab)]

It is a pleasure to serve under your chairmanship, Mr Hanson, in this very important debate. I thank the hon. Member for Sutton and Cheam (Paul Scully) for opening this debate on behalf of the Petitions Committee and for his excellent opening speech, in which he took many interventions. I thank all hon. Members for their passionate contributions. I counted more than a dozen speeches by Back Benchers, but I lost count, because I was distracted by the mouse that joined us. Given that it has been such a busy day in the main Chamber, this debate has shown how important this issue is to the House, as well as to all our constituents who have signed this important e-petition.

Access to drugs for patients with cystic fibrosis is an issue that is incredibly important to us all. I congratulate, in particular, my hon. Friends the Members for Bristol East (Kerry McCarthy) and for Jarrow (Mr Hepburn), and the hon. Member for Dudley North (Ian Austin) on their tireless campaigning on this issue, along with patients, campaigners and charities, such as the Cystic Fibrosis Trust. I commend the trust for its expert briefings and support to patients and their families over many years.

Finally, I thank the 108,144 people who signed this e-petition, 310 of whom live in my constituency. As has been said, we debated a similar e-petition in March 2018, and there have already been five parliamentary debates about access to such medicines. I hoped, as others did, that by now cystic fibrosis patients would have access to the drugs that they need and deserve. Unfortunately, that has not been the case.

Just over a year ago, on 16 May 2018, in response to a question from my hon. Friend the Member for Erith and Thamesmead (Teresa Pearce), the Prime Minister called for a “speedy resolution” to the crisis. However, the only speedy thing has been the deterioration of the health of cystic fibrosis sufferers while they wait for a resolution of the crisis.

More than 10,000 people in the UK live with cystic fibrosis, and it is thought that around 50% of CF patients could benefit from Orkambi; that is more than 5,000 people. Although that is a lot of people, in NHS terms it is a small cohort. And yet Orkambi is still not available to patients, despite being licensed for use in the UK since 2015.

The UK is currently a world leader in cystic fibrosis outcomes, but that is changing. People with cystic fibrosis are physically sicker than they would be if these medicines were available to them. NHS England continues to make offers to Vertex, including the largest ever financial commitment in its 70-year existence, but that was rejected. Since then, an even better offer has been made, but again Vertex has been unwilling to accept it.

I know that that is frustrating for patients and their families, who have waited years for access to these life-saving drugs. We are all frustrated on their behalf. As my hon. Friend the Member for Colne Valley (Thelma Walker) Valley mentioned, in March it was reported in the news that nearly 8,000 packs of Orkambi had been destroyed because they were past their sell-by date. That would have particularly stung patients and their families. Those drugs were valued by Vertex at £104,000 per patient per year. With my limited maths skills, I reckon that means that more than £60 million of drugs were destroyed by Vertex—drugs that could have been given to patients.

It is an outrage that Vertex would destroy so many packs of a life-saving drug while in a cost dispute with NHS England. So many patients could have benefited from those drugs. It was spiteful of Vertex to watch those drugs go out of date so they would have to be destroyed. In the midst of all that, Vertex reported a 40% rise in its revenues, with net income doubling in the previous quarter. I am sure I am not alone in feeling shocked and angry at that.

By refusing to play fair with NHS England, Vertex is holding lives at ransom, and patients and their families are the ones left suffering. Therefore, I was not surprised by the feature on “Newsnight” last week about parents and families establishing a cystic fibrosis buyers’ club to buy the generic drug Lucaftor from Argentina. The stress and frustration that families face because of Vertex mean that they now feel they have no other option but to take matters into their own hands.

[Laura Smith]

It is great to hear my hon. Friend’s response. It seems perverse to me that the interests of big pharmaceutical companies can hold such enormous sway in this country, to the extent that cystic fibrosis sufferers can be left without their treatment—treatment that has the potential to prolong their lives significantly.

[Mrs Hodgson]

I agree with my hon. Friend. I hope that the Minister will have some ideas about how this drug company can be held to account and not be allowed to continue in this way. I hope the Minister agrees that the situation should never have been allowed to get to this stage.

Lucaftor has the same active ingredients as Orkambi, and the Argentinian pharmaceutical company Gador is offering a price of £23,000 per patient per year, which drops to £18,000 if patients and their families can get together a group of more than 500 patients to purchase Lucaftor as a collective. That is significantly lower than the £104,000 Vertex wants for Orkambi. I say “want” deliberately—it is not the cost, but what Vertex wants. Of course, for many patients in the UK, Lucaftor will still be way too expensive to access, so it is not a feasible alternative at all. That is why NHS England and Vertex need to come to a conclusion that puts cystic fibrosis patients first, and ensures that they have access to the life-saving drugs they need and deserve.

[Kerry McCarthy]

I thank my hon. Friend for all her support on this issue. I agree that the issue with the Argentinian solution is that in a buyers’ club where people have to pay privately, the drugs will still be out of reach for many people. However, the fact that Gador is offering this drug for so much less than Vertex is charging for a similar product means that the NHS could, if it decided to trial the drug, buy it for 4,000 patients who would benefit from Orkambi. Therefore, no one would have to pay for it privately. The NHS could fund it, but at much less than Vertex is asking for. I ask the Minister: why is that not the solution?

[Mrs Hodgson]

I was going to come on to that, but if a point is worth making once, it is worth making twice. I will make it to the Minister as well, so she will have plenty of time to think about it.

As we all agree, patients and their families should not be put in the position—as some are—of having to pay thousands of pounds for their treatment. Family income should not determine who lives and who dies. That is why the NHS was founded—so that all could have access to the same excellent treatment, regardless of means. That was true 70 years ago when the NHS was formed, and it is still true today.

As the hon. Member for Sutton and Cheam pointed out, our NHS is there for us all and should not be held to ransom by a pharmaceutical company, but neither should access be denied because of unfit processes and systems in the NHS. Over the years, as a shadow public health Minister, I have met many patient groups, including those with cystic fibrosis, who are missing out on life-changing medicines because their condition is not rare enough and is therefore not deemed by NICE to be cost-effective. We need an appraisal process that is fit for purpose and that will capture rare diseases such as cystic fibrosis effectively.

Without drugs such as Orkambi, patients and their families are being harmed physically and psychologically. Every day without the drugs that patients need makes their condition worse and threatens their lives. What steps will the Minister take to ensure that patients with rare diseases have access to the medicines that they need and deserve? It is about access not just to Orkambi, but to other precision medications such as Symkevi and the next generation of cystic fibrosis drugs that could help patients who are suffering.

Vertex recently announced the headline results for its fourth cystic fibrosis medicine, a triple combination therapy that could radically transform the lives of nine in 10 people who live with cystic fibrosis in the UK, delivering unprecedented improvements in acute lung health. That is amazing news, but patients fear that they will never be able to access this ground-breaking drug. I urge Vertex to put patients first and consider the real-life impact of this cost dispute on patients and their families.

Vertex and NHS England must come to an agreement urgently, because patients have already waited far too long. If an arrangement cannot be made soon, will the Minister personally step in and pursue the alternatives that my hon. Friend the Member for Bristol East mentioned, such as a Crown use licence or a clinical trial? Cystic fibrosis patients need urgent access now to the drug that they have been denied for three years. It is time the Government considered all alternatives.

--- Later in debate ---

[Seema Kennedy]

I thank the hon. Gentleman for his intervention. As my hon. Friend the Member for Sutton and Cheam said in his opening speech, which was very well made, we recognise the importance of British pharmaceutical companies and that companies invest hugely in developing new drugs. However, as the other examples of drugs for rare diseases that I have given show, it is possible to go through the NICE appraisal process and reach an agreement with NHS England. As one hon. Member who is no longer in their place said, this is an offer for a long-term agreement.

Vertex is an outlier, and I would like to put that on the record.

[Mrs Hodgson]

Will the Minister give way on that point?

[Seema Kennedy]

Yes, and I hope that I will be able to remember the hon. Lady’s question.

[Mrs Hodgson]

At this point I should clarify, for the benefit of the campaigners who I have spoken to about the Crown use licensing option, that it is not an immediate solution from their point of view; I understand that it would take at least a couple of years. If an agreement can be reached, there would be an immediate outcome. That is why the campaign is called Orkambi Now; it is about trying to get the drug now. Although the Crown use licensing option would be an option to consider if nothing else can be found, it would not give the sufferers and their families the drugs as quickly as we would like.

[Seema Kennedy]

As always, the shadow Minister makes an excellent point. Crown use licensing is not something that any Government would consider lightly. It is very rarely used in health. It has probably not been used—my officials will correct me if I am wrong—since the 1970s.

The ideal thing is to get a deal, and deals have been done with other pharmaceutical companies; that is the point I want to make. As I have said, Vertex is an outlier in this regard, but that does not mean that I do not have an obligation to look at other options. I will do that.

Health

Sharon Hodgson Excerpts

Tuesday 14th May 2019 Commons Chamber

[Mrs Sharon Hodgson (Washington and Sunderland West) (Lab)]

I am happy to be closing an excellent debate on public health in what is, as we have heard, Mental Health Awareness Week. I thank those who have contributed to the debate: the hon. Members for Fareham (Suella Braverman) and for Bury South (Mr Lewis); the right hon. Member for Chipping Barnet (Theresa Villiers); my hon. Friend the Member for Wolverhampton South West (Eleanor Smith); the hon. Members for Chichester (Gillian Keegan), for Westmorland and Lonsdale (Tim Farron) and for Taunton Deane (Rebecca Pow); my hon. Friend the Member for Birmingham, Edgbaston (Preet Kaur Gill); the hon. Member for Lewes (Maria Caulfield); my hon. Friend the Member for Rotherham (Sarah Champion); the hon. Member for St Ives (Derek Thomas); and my hon. Friend the Member for Stockton South (Dr Williams), whose speech was absolutely excellent and is the only one I am going to highlight—[Interruption.] Yes, there is a little bit of favouritism. I also thank the hon. Member for Redditch (Rachel Maclean), my hon. Friend the Member for Oldham West and Royton (Jim McMahon), the hon. Member for Chelmsford (Vicky Ford), and my hon. Friends the Members for Swansea West (Geraint Davies), for Heywood and Middleton (Liz McInnes), for York Central (Rachael Maskell) and for Bethnal Green and Bow (Rushanara Ali). There were a lot of excellent speeches in among all those.

It has been a passionate debate—with good reason—and I am pleased to see so many Members who are as passionate about public health as I am. Let us be clear: it is not talking down the fabulous work that our NHS does day in, day out, or the amazing doctors, nurses, radiographers, clinicians, porters, catering staff, cleaners—indeed all NHS workers—to say that the health of our nation is at risk because of this Government’s callous and careless cuts to public health services. The public health grant is expected to see a £700 million real-terms reduction from its 2014-15 level. That includes £85 million in the current financial year, at a time when the Government are peddling the phrase “prevention is better than cure”. That phrase means nothing without adequate funding for our public health services.

I therefore ask the Minister, since prevention is a priority for this Government, whether she will commit today to reversing years of public health budget cuts. Public health spending is just a tiny proportion of the overall spend on health in England. It was just 2.8% in 2018-19, and that figure is falling year on year. Because of that, the Association of Directors of Public Health says that reductions in services are now “inevitable”— and that is a direct quote. This is at a time when services are needed more than ever, as we have heard.

Gonorrhoea and syphilis rates are on the rise, rates of smoking among pregnant women have risen for the first time on record, Victorian diseases—scarlet fever, whooping cough, malnutrition and gout—have seen a 52% upturn since 2010, and there has been an increase of more than 3,000 hospital admissions per year: that is all on this Government’s watch. This Government are making our country ill. Local authorities were given the responsibility for public health in 2013, rightly so in my opinion, but without sustainable funding they have buckled under the pressure of austerity. Their ability to maintain and improve the health outcomes of local residents has been jeopardised. Last year, for the first time in over a century, increases in life expectancy stalled, and in some parts of the UK they have even decreased, as we have heard.

The life expectancy gap between women in the most deprived and least deprived areas is 7.4 years. The healthy life expectancy gap between men in the most deprived and least deprived areas is almost two decades. Yes, you heard me right, Mr Speaker—I said two decades. That is 20 years of difference in healthy life. There is a persistent north-south divide in life expectancy and healthy life expectancy, with people residing in southern regions of England on average living longer and with fewer years in poor health than those living further north. As someone from the north, as Members can probably tell, that particularly concerns me.

The Northern Health Science Alliance, or NHSA, set out why that is so important in its “Health for Wealth” report, published last year. I recommend that every Member reads it. Productivity is worse in the north, because health is worse in the north. Improving health in the north of England would therefore lead to substantial economic gains. What will the Minister do to address these regional health inequalities? Obviously, I agree with the notion that prevention is better than cure, but I do not share the Government’s belief that prevention is possible without sustainable funding. If we are to reduce the ever-growing pressure on our NHS, we should therefore be investing in our public health services to ensure that everyone has the opportunity to live a healthy life—[Interruption.] I am pleased that we have been joined by the Secretary of State, and I shall have to try to repeat some of my best lines for him.

Analysis by the British Medical Association shows a continued trend of decreased funding, despite hospital admissions in which obesity, smoking, and alcohol was a factor increasing over a similar time period.

We have an obesity crisis in this country. The UK has one of the worst childhood obesity rates in Europe, but the Government’s childhood obesity plans have failed to seriously tackle this crisis, and with consultations still ongoing we have yet to see any material action by the Government. The UK spends about £6 billion a year on the medical costs of conditions related to being overweight or obese, and a further £10 billion on diabetes, but less than £638 million on obesity prevention programmes. Will the Minister commit to correcting that funding imbalance today?

Smoking remains the No. 1 cause of death in England, yet Action on Smoking and Health, ASH, found that in England from 2014-15 to 2017-18 local authority spending on tobacco control, including stop smoking services, fell by 30%. Furthermore, an annual survey conducted by ASH, commissioned by Cancer Research UK, found that, in 2018, 30 local authorities had no budget for tobacco control activity outside of stop smoking services. Although smoking costs the NHS an estimated £2.5 billion, NICE estimates that for every £1 invested in stop smoking services, £2.37 will be saved on treating smoking-related disease and lost productivity. Will the Minister therefore justify the Government’s reasoning for not investing in stop smoking services?

Alcohol is the leading risk factor for ill health, early mortality and disability among people aged 15 to 49. Even though hospital admissions associated with alcohol have nearly doubled since 2006-07, and have risen tenfold when obesity is also a factor, the budgets for alcohol and obesity services have been cut by more than 10% over the past three years. Does the Minister agree that if there is a need funding should follow? Will she ensure that public health services are funded sufficiently?

Demands on sexual health services have also increased. At a time when sexually transmitted infections such as gonorrhoea and syphilis are on the rise, the Government have cut funding for sexual health services by £55.7 million since 2013-14. I welcome the Government’s commitment to end HIV infections in England by 2030, but that progress risks being undone by those cuts. Sexual health services are essential if we are to end new HIV transmissions in the UK, but clinics report that they have to turn people away because of cuts to services. Does the Minister agree with the assessment by the Terrence Higgins Trust? [Interruption.] If the Minister’s two colleagues will allow her to listen to what I am saying, the trust said that

“sexual health services are at crisis point”.

The Secretary of State may shake his head as much as he likes, but that is not me saying that—it is the Terrence Higgins Trust.

Finally, I would like to state my disappointment and frustration at the fact that there is no future funding settlement for the local authority public health grant after 2019-20. The Minister will know all too well that time is ticking by, so will she set out the Government’s plans for a funding settlement post 2020? We need a settlement that will ensure that people can access the public health services they need so that they can live healthier and longer lives. I hope that after this debate the Minister will see how important that is to our constituencies and local authorities, which are responsible for this area of work. That is why the Opposition are calling on the Government to publish impact assessments on public health spending cuts and stalling life expectancy. I look forward to the Minister’s response. This is only her second or third time at the Dispatch Box—it is the first time we have faced each other across the Dispatch Box—and she is still finding her feet, but she will be keen to make her mark. Now is her chance. I urge her to publish those impact assessments, then do the right thing: properly fund public health now, because people’s lives really do depend on it.

Draft Food and Feed Hygiene and Safety (Miscellaneous Amendments) (EU Exit) Regulations 2019

Sharon Hodgson Excerpts

Monday 13th May 2019 General Committees

[Mrs Sharon Hodgson (Washington and Sunderland West) (Lab)]

It is an honour to serve under your chairmanship this afternoon, Mr Robertson. I want to start by officially welcoming the Minister to her new role. It is the first opportunity I have had to do that and the first time we have faced each other in a debate. I am sure it will not be the last. I look forward to shadowing her and no doubt opposing her when I need to, but I hope that we can work together on all things public health, as I did with her predecessor, to ensure the better health of everyone in the country, regardless of where they live, how much they earn or who they are.

Earlier this year, as we approached the 29 March Brexit deadline, some of us would be in in this room, or one very like it, regularly as SIs were rushed through in haste. As has been said, the Minister’s predecessor and I debated 15 SIs relating to food safety in a matter of weeks. For many reasons I am pleased that we were able to secure a Brexit extension, but in this case I am particularly happy because if we had left on 29 March, some of the minor deficiencies that we are discussing today could have turned major very quickly.

The regulations have not previously been addressed in Brexit preparations, so it is good that we have time to discuss them now. They also deal with recent changes to EU law, which could not have been addressed in earlier instruments. As the Minister said, public safety is paramount. That is why any future changes to regulatory controls after the UK leaves the EU should provide the same, or hopefully an improved, level of consumer protection.

Any changes as a result of the regulations must be effectively communicated to the affected agencies in a timely manner. Will the Minister please tell the Committee whether she has had any further communication with those agencies since March? I am sure that they are awaiting further information from the Government about Brexit, and their business is no doubt hanging in the balance in the meantime. As this is a matter of public safety, changes must be communicated clearly and in a timely manner to ensure that the industry can be in line with current legislation. Will the Minister give assurances that that will not affect the safety or quality of foods available in the UK, now and in the future?

As we have heard, the SI relates to trichinella, which is a pork nematode worm parasite. I am sure that none of us had ever heard about it before, and hope never to need to do so again, or to deal with its effect. The SI also relates to the transitional provisions for official laboratories. The retained EU law regarding specific official controls that apply to trichinella in meat and trichinella testing requirements may not be fully enforceable until the specific inoperabilities are addressed by the SI. Is the Minister confident that the legislation sufficiently addresses the inoperabilities regarding the testing requirements for trichinella, and when does she think that they will be fully enforceable, on passing the SI?

The instrument states that facilities approved by EU member states would in future no longer be automatically approved for food imported from the UK. Does the Minister know what impact that will have on supply and businesses? How long will the process be to approve facilities for food imported from the UK, and will a list of approved facilities be available? The instrument also includes provisions to set minimum charging rates for hygiene controls for fishery products by amending the Fishery Products (Official Controls Charges) (England) Regulations 2007. Will the Minister outline what the charges will be and what impact any new set rates could have?

The explanatory memorandum for the SI states that functions currently undertaken by the European Commission in adopting some implementing regulations rendering applicable the controls on imported food will in future be the responsibility of the Secretary of State. Can the Minister provide information on how decisions on those controls will be decided and managed? What will the arrangements be for collecting data monitoring the effectiveness of the regulations and regularly reporting the findings? What bodies will be able to scrutinise performance and delivery, and what assessment has been made of their capacity to take on that work, as my hon. Friend the Member for Wallasey mentioned?

Finally, what conversations has the Minister had with devolved nations regarding the SI? We do not know for sure exactly when we will leave the EU, but it is best to be prepared, especially when dealing with parasites such as this little worm. That is why the Opposition do not oppose the regulations, but rather express some concerns that I hope the Minister can address.

Pre-eclampsia

Sharon Hodgson Excerpts

Thursday 9th May 2019 Westminster Hall

[Mrs Sharon Hodgson (Washington and Sunderland West) (Lab)]

It is a pleasure to serve under your chairmanship again, Mr Hollobone. I am sure that happened just earlier this week or maybe it was last week; maybe it is every week.

I thank the hon. Member for North Ayrshire and Arran (Patricia Gibson) for securing this important debate, just ahead of World Pre-Eclampsia Day on 22 May, and for her heartfelt, thoughtful and passionate speech. She is so brave, as has already been said, to do this. I know, and she knows, how hard it is to speak in a debate about something as personal and hurtful as the loss of a baby; nothing can ever be harder. I have the honour of being vice-chair, along with the hon. Lady, of the all-party parliamentary group on baby loss, which we set up. All the Members who set up the group have had the awful experience of baby loss, which makes it such a powerful all-party group. We all take the work it does very seriously and have had some small achievements, thanks to the Government listening to the voices from the group.

Some changes are being made and implemented across the country because of it. I am proud that we are able to use our own tragic experiences of loss to campaign for better care, treatment and diagnosis for future parents, so that hopefully they do not ever have to go through anything like the experience that the hon. Lady has been through. Let us hope that the debate today, which, as the hon. Lady said, is the first debate of its kind, will lead to some future changes that will ensure that even fewer people will have to go through that experience. I was so very sorry to hear the details of the hon. Lady’s own personal experience of pre-eclampsia. I knew that was how she had lost her son, but not the detail. I thank her for sharing her story with us and I am sure that Kenneth would have been very proud of his mum.

I also thank the hon. Members for Paisley and Renfrewshire North (Gavin Newlands) and for Glasgow East (David Linden) for their excellent speeches, and I join everyone in saying how disappointing it is that there are not more Members attending this important debate. Perhaps the debate about acquired brain injury, taking place in the Chamber, has drawn a bigger crowd of available Members. Nevertheless, what we have lacked in quantity we have certainly made up for in quality; this has been an excellent debate so far, and we have yet to hear from the Minister.

As we have heard, pre-eclampsia affects around 6% of pregnancies; that means 1,000 babies a year are stillborn due to this awful condition. That is not good enough; it has to be and it can be reduced, as we have heard. The last triennial audit of maternal deaths in the UK reported that of the 22 deaths from pre-eclampsia, 14 were avoidable. Again, that number can be reduced. Because the symptoms of pre-eclampsia are so similar to the general symptoms of pregnancy, they are often missed and that can be fatal. That is why we are here today: to raise awareness and ensure change.

Women with diabetes, high blood pressure, kidney disease and a body mass index of over 35 are more likely to develop pre-eclampsia. Many instances of these conditions can be prevented with a healthy lifestyle. As the Shadow Minister for Public Health, I cannot miss any opportunity to mention prevention and the cuts to health services of £800 million between 2015 and 2021 under this Government. If public health budgets, which fund services such as obesity services, had not been slashed so vigorously by the Government, the number of women with these conditions would be reduced. Even so, where cases have not been prevented, these women should still be a priority for midwives and healthcare professionals, and offered the tests that exist for pre-eclampsia, and support throughout their pregnancy. The same goes for women with lupus, women over the age of 40, women expecting multiple babies and women who have had pre-eclampsia before.

If we target the women most at risk of developing pre-eclampsia, we can detect the condition early and prevent fatalities. Finding at-risk women is now much easier as tests are available, as we have heard, that can predict with nearly 100% accuracy which mothers are at risk of pre-eclampsia, but unfortunately the tests are not being used to their advantage. The test that is currently the only NICE-approved clinically available diagnostic test for pre-eclampsia in the UK has seen uptake in only a handful of trusts so far, meaning that very few women in the UK have access to those life-saving tests. Will the Minister write to NHS trusts urging them to take up those tests, and advising them of the clinical guidance to do so?

Those tests can improve patient safety through accurate diagnosis upon the suspicion of pre-eclampsia, reduce the number of unnecessary admissions of suspected pre-eclampsia and reduce the direct costs to the system from the array of in-patient monitoring tests that are undertaken on the woman and her foetus. They will also relieve the stress and anxiety felt by expectant mothers that their symptoms are pre-eclampsia. We still do not know the root cause of pre-eclampsia. Does the Minister have any plans to fund research into the causes of pre-eclampsia so that more cases can be prevented each year?

Expectant mothers must also be made aware of pre-eclampsia and the signs and symptoms to look out for. I can remember being told about this terrible condition and every time my legs swelled or I had a urine test I would worry that I would get it. Maybe I was more informed or just a worrier, but I probably did not know enough about pre-eclampsia then. I might have been worrying needlessly; information is always a good thing. The knowledge will also fuel patient-led demand for testing and will, again, help to prevent deaths.

I hope the Minister will be able to assure us that the Department will look at this important issue further in the future, so that no more families have to go through the pain and suffering of losing a child to pre-eclampsia that we have heard about today.

Oral Answers to Questions

Sharon Hodgson Excerpts

Tuesday 7th May 2019 Commons Chamber

[Matt Hancock]

Yes. My hon. Friend raises another important area where progress is being made on the ability for people to get access to drugs that could help them. We now have a medicinal cannabis programme in place, as we discussed in this Chamber a couple of weeks ago, so that those with acute conditions and with clinical support for using medicinal cannabis can get it. We are also working as rapidly as we reasonably can to normalise the ability to use medicinal cannabis within the NHS.

[Mrs Sharon Hodgson (Washington and Sunderland West) (Lab)]

Kuvan, Orkambi and Spinraza—these are just three life-changing drugs to which thousands of patients are being denied access on the NHS. Patients have waited far too long for the drugs they desperately need, and for some, as we have heard, it is a matter of life and death. Does the Secretary of State agree that the NICE appraisal process for rare diseases is just not fit for purpose?

[Matt Hancock]

I do agree it is important that NICE constantly tries to get those decisions made objectively, robustly and as fast as possible. There is cross-party support, and I hope continuing cross-party support, for these judgments being made independently so that they are taken not by Ministers but by clinicians. We can all agree that this has to be done as quickly and as efficiently as possible.

Healthcare: East Midlands

Sharon Hodgson Excerpts

Tuesday 30th April 2019 Westminster Hall

[Mrs Sharon Hodgson (Washington and Sunderland West) (Lab)]

It is a pleasure to serve under your chairmanship, Mr Hollobone. I thank my hon. Friend the Member for Lincoln (Karen Lee) for securing this important debate. She is a passionate advocate for the NHS in her area and made a passionate speech. I also thank the other hon. Members who spoke—the hon. Members for Bosworth (David Tredinnick) and for Sleaford and North Hykeham (Dr Johnson), my hon. Friend the Member for High Peak (Ruth George) and, of course, the hon. Member for Strangford (Jim Shannon), who has just left the Chamber—for their excellent speeches and interventions.

Although I am pleased to respond on behalf of Labour, it is with sadness that Members come here time and again to explain the impact on their constituents of the crisis in the NHS. Sadly, as we have heard, standards are slipping across the board. It was a mild winter, but despite the thankfully lower levels of flu and vomiting virus, we saw the worst performance against the four-hour A&E target since records began. [Interruption.] If the Minister cares to—

[The Minister for Health (Stephen Hammond)]

It was an improvement on last year, so it was not the worst.

[Mrs Hodgson]

Oh, right—it was the second-worst, then. Anyway, bed occupancy also rose to 95.2% this winter, well above the 85% deemed to be safe, and patients are waiting almost 4% longer in A&Es than they were two years ago. In Nottingham they are waiting 14% longer than in 2017, and in Leicester they are waiting almost 4% longer than two years ago. East Midlands Ambulance Service NHS Trust has missed its targets for responding to patients in life-threatening situations. We have heard countless stories today that demonstrate how the crisis happening in our NHS both locally and nationally is real.

It is clear that the Tories’ plans for NHS funding fall short of what is needed. The autumn Budget announcement of a cash injection for health services excluded public health budgets, training and capital, which means an increase of just 3% for health services when we have a childhood obesity crisis, cuts to sexual health and addiction services, workforce shortages and a backlog of nearly £6 billion in repairs. It is not even enough to wipe out hospital deficits.

Nottingham University Hospitals NHS Trust alone predicted a deficit of more than £40 million by the end of the financial year, and it has declared 15 black alerts since December. How will the Government’s settlement help trusts like that become more sustainable? Where is the funding to guarantee sustainable health services in the face of ever-increasing demand from a complex and changing demographic? For example, in the east midlands, the number of preventable deaths from liver disease has increased by 37%. Obesity is also a growing problem, 66% of the population being overweight. People in the east midlands are more likely to have had a depressive episode than those in the rest of the country—3.9% compared with 2.2%. In 2013-15, the average life expectancy at birth across the east midlands was 79.3 years for males and 82.9 years for females, both of which are significantly below the national average. There is also considerable variation in preventable mortality from the major causes of death across the east midlands local authorities, with an urban-rural divide. The urban areas of Nottingham, Leicester and Derby have significantly lower life expectancy than the average for England.

Money is, of course, only one of the issues surrounding the crisis in the NHS. There is a staff recruitment and retention issue, too. NHS figures show that there are 100,000 vacancies across the health service, including 31,000 across the midlands and the east of England. Therefore, 9.3% of posts in the midlands and the east—about one in 11—are unfilled.

Constituents will also be worried about the integration of services in the east midlands. In recent years, councils have distanced themselves from sustainability and transformation plans and the integrated care systems in some areas, due to a lack of democratic accountability and scrutiny from stakeholders, including concerns over cuts and privatisation. Nottinghamshire’s ICS is an interesting case: the city council suspended its membership for six months last year for those very reasons, rejoining only in April 2019 after assurances were given to improve accountability and shared decision-making processes. I am sure that Members will be keen to hear from the Minister how democratic accountability and transparency is being improved in such cases.

Residents will also be concerned about the number of community hospitals that have closed or are under threat of closure. Residents of Bakewell and Bolsover have to travel to Chesterfield or Derby for their appointments, after their hospitals closed. The loss of those community hospitals impacts on rural areas of the east midlands, isolating people further because not only will they have to travel further to appointments, but so will any visitors, so patients are suffering.

The Government have spent nine years running down the NHS, imposing the biggest funding squeeze in its history, with swingeing cuts to public health services, and social care has been slashed by £7 billion since 2010. As we have heard, the NHS is clearly buckling under the pressure as a result, and standards of care continue to plummet. I would appreciate assurances from the Minister about how the Government will get a grip on the situation in the east midlands and across the country as a whole, to reverse the extremely worrying statistics and tackle the issues we have heard about.

Draft Food Additives, Flavourings, Enzymes and Extraction Solvents (amendment etc.) (EU Exit) Regulations 2019

Sharon Hodgson Excerpts

Monday 1st April 2019 General Committees

[Mrs Sharon Hodgson (Washington and Sunderland West) (Lab)]

It is a pleasure to see you in the Chair, Sir Roger. We are very happy that you joined us by stepping in for your colleague. I thank the Minister for introducing the statutory instrument and summarising its provisions after it was withdrawn two weeks ago. I welcome him to his position, although I am not sure if it is permanent. I know he was already a Health Minister, but by taking on the public health brief, he will know he has big shoes to fill. His predecessor and colleague, the hon. Member for Winchester, who resigned from his ministerial position last week, was a formidable and accomplished Minister who I had a lot of respect for, and I wish him well.

Things are constantly changing and developing with Brexit, as we know. I would like to express once again my severe regret that almost three years since the referendum, the Government have failed to significantly prepare or lay sufficient Brexit legislation before the House in a timely manner. As I am sure the Whip especially will know, we have been very busy of late, and we have missed the 29 March deadline. Unless the Government can compromise on a way forward and secure support from across the House today or very soon, we are heading towards no deal on 12 April. In that scenario, this legislation will be vital. I hope that this week—I have been saying this for many weeks now—will be the week we achieve a good deal with the EU that will protect jobs, workers’ rights, our environment and, most importantly, our economy.

This SI was due to be debated two weeks ago, but was withdrawn from the Order Paper at the last minute. Can the Minister please illuminate and explain why that was? So far, an explanatory memorandum has accompanied all the statutory instruments that we have debated, apart from this one. Is that because the explanatory memorandum for the original draft still applies, or because the Government have omitted to provide one? I would be grateful if he could explain the reason for the delay and set out the differences between the two versions of the SI.

Throughout the debates on SIs, I have raised concerns about the time available to scrutinise them. This SI perfectly highlights my point that without a clear summary being available to the Opposition of what the SI is designed to achieve and what consultations the Government have undertaken, it is almost impossible to scrutinise the legislation properly in the given timeframe. There has been a lack of time to scrutinise properly the Food Standards Agency SIs that the Government have brought to the House and crucial details have been omitted from them, which industry representatives have raised concerns about, too. Now that the leaving date has changed, what conversations has the Minister’s Department had with the industry about what these SIs will mean for their businesses and day-to-day working, and has the Department provided more information and reassurance to them?

Food improvement agents are used in or on food for a technological purpose during its production or storage. They are also used to improve the taste, texture and appearance of food. Examples include artificial sweeteners, preservatives and flavourings. The majority of us will come into contact with food improvement agents daily. However, the Minister must appreciate that, for medical reasons, not everyone is able to consume food improvement agents. The relevant legislation provides specific labelling requirements for certain food products sold to consumers. An example would be mandatory warnings on products containing aspartame, as it is a source of phenylalanine, which could be detrimental to those suffering from PKU—phenylketonuria. Any reduction in standards for food labelling and mandatory warnings on products could be dangerous for people with dietary requirements. What may seem unnecessary to people who do not have those dietary requirements will be vital to those who do. What assurance can the Minister give that this legislation will not put PKU patients, in particular, in danger? I am particularly concerned that it could make the PKU diet even more difficult to maintain if warnings are removed from food labelling.

This SI will revoke for the whole of the UK a regulation that established a programme for the re-evaluation of approved food additives, as it is not thought appropriate or necessary to retain that legislation for the UK. Will the Minister elaborate on why that is? The SI goes on to say that there are other mechanisms by which new and emerging scientific data must be brought to the attention of decision makers by applicants. Will he please tell the Committee what those mechanisms are? The former Minister wrote to me about this SI, saying:

“I would like to reassure you that the UK will continue to monitor scientific evaluations and outputs from international assessment bodies such as EFSA and The Joint FAO/WHO Expert Committee on Food Additives…to ensure that we remain alert to emerging scientific analyses.”

Has this Minister made any assessment of how long it would take to update regulations in the event of any new scientific analysis? What will happen if our European neighbours decide that a food additive is unsafe? Will we follow the lead of our neighbours? How will those decisions be made? Under these changes, if an application is made for a new additive to be introduced, will that be made public, and if not, why not? What will be the arrangements for collecting data, monitoring the effectiveness of the regulations and regularly reporting?

The Food Standards Agency will take on a lot of responsibility in this area after Brexit. Is the Minister confident that the agency is prepared and properly resourced to take on that extra burden? The health and safety of the public is paramount in all this, and I hope he ensures that safeguards are in place so that food containing any food improvement agents that are found to be harmful is quickly removed from the market. I look forward to his response.

Oral Answers to Questions

Sharon Hodgson Excerpts

Tuesday 26th March 2019 Commons Chamber

[Jackie Doyle-Price]

The hon. Lady makes some excellent points and highlights those areas of the community where take-up is much lower. We need to be more imaginative about how we promote the need for screening, and in that regard I am very pleased to see the work of Jo’s Trust, and also that of the Eve Appeal to raise awareness. We can all do our bit, and I would encourage everyone to spread the word about the need to get screened.

[Mrs Sharon Hodgson (Washington and Sunderland West) (Lab)]

I, too, want to start by paying tribute to my hon. Friend the Member for Ellesmere Port and Neston (Justin Madders)—he is a big loss to the Front Bench—and also to the Minister I used to shadow, the hon. Member for Winchester (Steve Brine). Credit where it is due: I know cancer charities and campaigners are all tweeting their regret, because the hon. Gentleman was, and hopefully will remain, a true ally of that cause.

Cervical cancer is the most common cancer in women. Smear tests can prevent 75% of cervical cancers from developing, but one in four women do not attend their smear tests and screening is now at a 21-year low. This was not helped by the failure of the outsourced screening to Capita, which failed to write to 48,000 women in six months. What are the Government going to do to ensure that women and girls know what happens at a smear test, what it is for and why it is so important?

[Jackie Doyle-Price]

As the hon. Lady will know, we have brought that service back in-house, but we should leave no stone unturned in relation to thinking more imaginatively about how we spread the word about the need for screening. I should like to pay tribute to those celebrities who have tweeted pictures of themselves going for their smear tests, because it is only by normalising it and ensuring that everyone realises that it is something they should do that we are going to encourage take-up.

NICE Appraisals: Rare Diseases Treatments

Sharon Hodgson Excerpts

Thursday 21st March 2019 Commons Chamber

[Mrs Sharon Hodgson (Washington and Sunderland West) (Lab)]

It is a real pleasure to take part in this very important debate. I start by thanking my hon. Friends the Members for Blaydon (Liz Twist) and for North Tyneside (Mary Glindon). We are part of the north-east massive, so I am very pleased to be joining them in this debate today. I thank them for their very passionate and heartfelt contributions. I should also mention, as part of the north-east massive—it goes without saying—my hon. Friend the Member for South Shields (Mrs Lewell-Buck). I thank all other hon. Members who spoke for their excellent contributions. They know who they are and I do not need to name them. They were all fantastic.

Throughout the debate we have heard of the heartbreak experienced by patients and their families when they are unable to access life-saving drugs on the NHS. We have heard of their determination to continue fighting to access those drugs, whether by writing to their MP or even by protesting in Parliament square. I was happy to join my hon. Friend the Member for Bristol East (Kerry McCarthy) there just two weeks ago for the Cystic Fibrosis Trust rally, where people were calling, “Orkambi now!”—they were so loud that we could hear them over the crowds chanting, “No Brexit!” or whatever the shout was at the time.

We must hear patients’ voices in this debate, as it is they and their families who are affected the most by the appraisal process, which is not fit for purpose. The Minister has heard about the real-life experiences of patients throughout this debate, and I am sure that he will continue to listen to them afterwards. I know that he is also in regular communication with patients. In my role as shadow Public Health Minister, I regularly meet patient groups and campaigners, so I know just how important access to these life-saving drugs is to them.

As a constituency MP, I recently met young Riley and his mum Michelle. Riley has phenylketonuria—PKU—and needs Kuvan. He is now 11 and at secondary school. He just wants to blend in with his mates and to be able to go on those first excursions out to the Metrocentre, and perhaps to get something unhealthy to eat from a takeaway, but obviously he cannot do any of that. I asked him about his life and how he felt not having access to Kuvan. He said that it was not fair and that it made him mad. Well, I agree with Riley.

It can take years to get the right diagnosis for a rare disease, so once patients get the diagnosis they are excited and feel that there has been a breakthrough, because they think that they will finally get the treatment they need and deserve. Instead, as we have heard today, they are back at the beginning of the fight, because the life-saving drugs that do exist are not available to them on the NHS. It is one hurdle after another for patients with rare diseases. That is why the Opposition strongly believe that patients should have fast access to the most effective new drugs and treatments. I am therefore pleased to support the motion.

As we have heard, a rare disease is generally considered to be one that affects fewer than five people in 10,000. According to the 2013 UK strategy for rare diseases, it is estimated that in the UK more than 3 million people will suffer from a rare disease at some point in their life. All those patients must have access to the drugs and treatments that they need. However, they are being failed by the NICE appraisal process, which is just not fit for purpose when it comes to assessing the suitability of drugs and treatments for rare diseases.

Patients with rare diseases are squeezed in the middle of two appraisal routes: the highly specialised technology evaluation programme and the single technology appraisal route. The HST evaluation programme is selected for most non-cancer rare disease medicines and is designed for evaluating medicines of that nature, with small patient populations. However, the HST evaluation programme currently lacks the capacity or capability to effectively appraise all new licensed orphan medicines. Since the HST evaluation programme was established in 2013, it has published guidance on eight medicines, which is much fewer than the 45 orphan medicines for non-cancer indications that have been licensed in the same period.

The STA route is designed to appraise treatments for more common conditions and those with existing treatments. This route is poorly suited to considering rare disease medicines, which tend to have small patient populations, a limited evidence base and benefits beyond direct health benefits—something the appraisal process just does not take into account. Some rare diseases are not rare enough for the STA route, and only a handful of medicines are being approved by the HST route. Yes, it is complicated, but it is clear that neither route is working for patients with rare diseases, so patients are missing out on crucial medicines.

Kuvan was licensed in 2008 to treat PKU patients, but it is still not available to patients in England. Orkambi was appraised by NICE in 2016 through STA, but was recommended for use. Three years later, as we have heard, people with cystic fibrosis still have no access to it. That has caused physical and psychological harm to patients and their families. Every day without the drugs that they need makes their condition worse. We must have an appraisal process that captures rare diseases effectively.

Medicines to treat rare diseases are often found to be cost-ineffective, which is why they are not approved for routine commissioning. However, establishing value for money is not straightforward, especially when population groups are small. It does not sit comfortably with me—or, I am sure, with any of us—that cost-effectiveness is prioritised above clinical need, or, as we have heard, the lives of children. Manufacturers want to make a reasonable return on their investment, although some of the figures are huge, but I do not think that that should be a priority. Manufacturers must not hold NICE or NHS England to ransom for their own financial gain.

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

Or the Government.

[Mrs Hodgson]

Exactly.

Behind profit forecasts are thousands of people and families who need access to life-saving drugs, and they simply cannot wait any longer. We must not put businesses before patients. Because of the NICE appraisal process, patients and their families are being left in an awful limbo. The processes can be long-winded, confusing and difficult to navigate. Some medicines can undergo multiple assessments while others are not assessed at all, and that creates an unpredictable and unattractive system. As a result, patients are left in the dark about when, or if, they will have access to innovative treatments for their conditions.

When a drug is being appraised, patients live in hope that this time it will be approved for use by NICE—as in Maryam’s case, which was described so powerfully by my hon. Friend the Member for West Ham (Lyn Brown)—but they are almost always left to feel disappointed and helpless. Patients and their families must be involved in the processes, and the processes must be transparent.

The wait for access to drugs is excruciating, especially when the drug is available in nearby countries, or even—as we have heard—in Scotland. Spinraza is available to patients in Scotland, but not to those in England. My hon. Friend the Member for West Ham spoke passionately on behalf of her constituents and their seven-month-old baby Maryam. This sounds blunt, but she is dying, because she has been denied access to medication that could extend and enhance her life.

The pain and anguish that the parents of a critically ill child must feel when they are told that there is medicine available that will help but it is not available for their child are unimaginable. Knowing that if your child lived a few hundred miles away, in Scotland or perhaps somewhere in Europe, the drug would be available is heartbreaking and infuriating. Patients in England should not be left behind. We should be working to find ways to get these medicines to the patients who need them, on the NHS.

I hope that the Minister will consider the motion seriously, for the sake of patients with rare diseases and their families. They cannot be left behind any longer: they must have access to these life-saving drugs now.

Health Inequalities

Sharon Hodgson Excerpts

Wednesday 20th March 2019 Westminster Hall

[Mrs Sharon Hodgson (Washington and Sunderland West) (Lab)]

It is a pleasure to serve under your chairmanship today, Mr Hollobone.

This has been an excellent debate, and I start by thanking the hon. Member for Telford (Lucy Allan) for securing it and for her excellent contribution. Sadly, many areas across the UK face similar issues to those affecting Telford, as we have heard. As we know, our NHS was built for everyone. The original leaflet explaining the NHS to households across the country read:

“Everyone—rich or poor, man, woman or child—can use it or any part of it.”

Seventy years on, we cannot forget that ethos, which is why this debate is so important. I also thank all other hon. Members for their contributions to the debate. Due to time, I will not name them all.

Health inequalities are avoidable, but they still persist so clearly, both nationally and locally, within our communities, as we have heard. It cannot be right that in England men and women from the most disadvantaged 10% of areas on average now die 9.3 and 7.3 years respectively sooner than those in the 10% least disadvantaged areas. And those living in the most deprived areas not only die much earlier than those living in the most affluent areas but they also live much longer in bad health. For example, between 2014 and 2016 women in the most deprived areas could expect to live for 51.8 healthy life years, meaning that their remaining 27 years would be spent in bad health. That is compared, for instance, to women in the least deprived areas, who could expect to live for 70.7 healthy life years, with only 15.5 years in bad health.

It has to be said that there is also a persistent north-south divide in both life expectancy and healthy life expectancy, with people in the southern regions of England on average living longer and with fewer years in poor health than those living further north. For example, 2015-17 figures show that men and women in the north-east—my region—have the lowest life expectancy at birth in England, at 77.9 years and 81.6 years respectively. That is compared to the south-east, where men can expect to live for 80.6 years and women for 84 years.

However, health inequalities also exist within local authorities. For example, the longest life expectancy in the country is in the richest borough, Kensington and Chelsea; I am not surprised. Nevertheless, the most disadvantaged people in that London borough can expect to live for 14 years less than their most advantaged counterparts. Such a stark difference is completely unacceptable.

Also, children living in poverty are more likely to die before the age of one, become overweight, have tooth decay or even die in an accident. Parents living in poverty are also more likely to smoke, experience mental health difficulties, be a young parent, be a lone parent, experience domestic violence and other negative outcomes, all of which also increase adverse childhood experience risk factors that impact children’s health, too.

So, after a century of decline the number of deaths in childhood in the UK has risen for two consecutive years, with the highest mortality rates evident in the poorest communities. Life expectancy in the UK had always increased slightly, year on year, for over a century, largely due to improvements in nutrition, hygiene, housing and control of infectious diseases. However, it seems that that is not happening any more.

What are we going to do? Labour is committed to a new health inequalities target, to improve life expectancy, mortality rates and children’s health. The target would be independently assessed, and as the hon. Member for Telford called for, the Health and Social Care Secretary would be held accountable to Parliament and would produce an annual health inequalities report.

The four biggest risk factors that affect health—smoking, excessive alcohol consumption, poor diet and lack of exercise—also affect the poorest in our communities. Public health services support those people. However, there have been public health cuts to the tune of £800 million between 2015 and 2021, and local authorities have been put in untenable positions, where they have to make difficult decisions.

I believe that the Government already have a moral duty to ensure that health inequalities are reduced, but unfortunately they have not taken that duty seriously enough, so I would like the Minister not only to set out her commitment to reducing health inequalities but to lay out details of how the Government will reduce them, and I urge her once again to reverse the cuts to public health budgets.

[Mr Philip Hollobone (in the Chair)]

If the Minister concluded by 5.28 pm, that would allow Lucy Allan time at the end of the debate to sum up.