Oral Answers to Questions

Philippa Whitford Excerpts

Tuesday 7th May 2019 Commons Chamber

[Stephen Hammond]

My hon. Friend is completely right. One would have hoped that all Members on both sides of the House celebrate the fact that the number of nurses and the number of doctors in the NHS are now higher than they have ever been in its 70-year history, and that the Government are backing that up with a commitment to invest £33.9 billion.

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

Cuts in lifetime and annual pension tax allowances are causing senior doctors to retire earlier and younger consultants to avoid working extra hours, as they can end up paying more in tax than they earn from the extra hours of work. What discussions has the Secretary of State had with the Chancellor about the fact that these recent changes are driving doctors from the profession and increasing workforce shortages?

[Stephen Hammond]

The hon. Lady raises a very important matter. The Government recognise the concerns that have been expressed by NHS doctors, and my right hon. Friend the Secretary of State is engaging in numerous conversations with the Chancellor. I am reluctant to give a running commentary on the nature of those internal discussions, but I can say that we hope to resolve the matter soon.

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[Matt Hancock]

I agree entirely and enthusiastically with my right hon. Friend. The need to improve services in the NHS just to bring them up to the best that is in the NHS is vital and urgent. We can lift the quality of care that all our constituents get simply by learning from the best. We have schemes such as the “getting it right first time” programme, which is brilliant at teaching hospitals how to do things the way the best hospitals do them, and we want to see more.

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

A recent report in the British Journal of Surgery demonstrates that the introduction of the Scottish patient safety programme resulted in a 36% drop in post-surgical deaths. Will the Secretary of State join me in congratulating all the surgeons, anaesthetists, theatre teams and ward staff who achieved this, and would he like to visit Scotland and see the programme in action?

[Matt Hancock]

I always love visiting Scotland and would love to come and see this programme in action; I have heard and read about it. In improving quality across the NHS, we need to improve the ability of the NHS to look everywhere—outside the NHS in England, as well as at other hospitals—to find and emulate best practice.

Social Media and Health

Philippa Whitford Excerpts

Tuesday 30th April 2019 Commons Chamber

[Matt Hancock]

Yes, my hon. Friend is absolutely right. In fact, the cumulative effect of posts on mental health, in particular eating disorders, came up in the discussion yesterday. We have to look at what the social media companies call the density of content—I think my hon. Friend put it rather better as the cumulative impact of lots of different posts. Social media companies’ algorithms are powerful enough to understand that and pick up on it. We need rules in place so that action can be taken when it is spotted by those algorithms.

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

I too welcome the statement, the two summits that have already been held and, in particular, the announcement of funding to Samaritans. However, the scale of the task is absolutely huge. The scale of the donation to Samaritans is actually quite small by comparison both with that and with the profits the companies make. They are expected to make profits of £50 billion just this year. It is important to talk about preventing the promotion of eating disorders, self-harm and suicide, and I welcome that approach.

As chair of the all-party group on vaccinations for all, I particularly welcome, in World Immunisation Week, the Secretary of State talking about anti-vaccination. As the shadow Secretary of State said, the drop in uptake is caused not just by online, but by complacency. People have forgotten that measles is a killer. It used to kill 2.5 million people a year across the world. We have seen an outbreak in Europe, where 82,000 cases have led to over 70 deaths. It is important that we tackle misinformation. It is also important that we make it easy for busy mothers to get their children vaccinated by having health visitors and district nurses who try to help. It is partly that that has allowed Scotland to keep the rate above 95%, but we, like everywhere else, are still seeing that rate drip down and fall by 0.5% or 1%.

On the online harms White Paper, I welcome the talk about a regulator. I hope it will actually be a regulator and that there will not be voluntary or self-regulation. I would like to know when it is actually going to happen. Like many other pieces of proposed legislation, it is still in the long grass and the situation is urgent.

[Matt Hancock]

The regulation of online harms will indeed be statutory. As I said, we are in the middle of a consultation on how, rather than whether, to put that in place. I am sure the hon. Lady will want to feed back, although I know her SNP colleagues in the Scottish Government in Edinburgh have been kept abreast of developments.

The hon. Lady raises complacency and financial resources. I will address both points. She is absolutely right that part of the problem is a complacency about some killer diseases, partly because we have hardly known them in this country for generations. As I said in my statement, measles is a horrible disease and a killer; it is deeply unpleasant. So, too, is rubella. Rubella might be hardly noticed by a pregnant woman. There might be a rash for three or four days which comes and goes, but the impact on the baby is permanent and very, very serious. On measles, rubella and other diseases, we have to be absolutely clear with the public about the consequences not only for their children but, even worse, for vulnerable children and adults who, maybe because they are immunosuppressed or very young, cannot have the vaccination. Their lives are directly threatened by a parent who chooses not to vaccinate. We need to be very clear and stark about that.

The hon. Lady mentions that the social media companies have contributed to Samaritans. That was Samaritans’ ask for this stage of putting together the organisation and experts it needs to provide clarity on the boundary of what is and is not acceptable in this space. I would, of course, be perfectly prepared to go and ask for more if more is needed. What is more, we are bringing forward a digital services tax. Historically, the global tax system has not worked well in taxing such companies fairly, because of the nature of how they make their money. We have worked for years to try to get a global consensus on how to tax them. We are now clear that we will bring forward the tax next year in the UK, regardless of whether we can get global consensus.

Access to Medical Cannabis

Philippa Whitford Excerpts

Monday 8th April 2019 Commons Chamber

[Matt Hancock]

Characteristically, my hon. Friend makes an excellent point. The clinicians consider that there is a much less evidence on THC, as opposed to CBD. I have therefore instructed the National Institute for Health Research to do the research. Doing the research will of course require some cases where the drugs can be legally tested. I had already put that in place, and I am telling the House about it today.

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

I am glad this urgent question has moved from the Home Office to Health, where it should be, but one has to ask why drugs are being seized when they are no longer illegal—that is what changed in November.

In medicine, we use many controlled drugs, such as heroin, morphine, ketamine and diazepam which have a street value, but that has never stopped them being used in medicine. The problem is that the way cannabis was treated for 50 years means we have had almost no research and almost no experience.

The problem is also that expectations were raised in November, as if every GP would be able simply to write a prescription, but a prescription for what? We have to have a pharmaceutical quality of drug so that we know exactly how much CBD and how much THC we would be prescribing. That is not yet generally available. It is important that we look, through the Government, to get that pharmaceutical grade licensed, with reliable formulations.

This issue is under inquiry in the Health Committee, and we have heard from patients who were advised to go to Holland to get drugs, costing them £30,000 per visit. That is unacceptable. The Government will have to stimulate research, and I am grateful that calls for research are going to go out. However, we need specialist centres in paediatric neurology for children with epilepsy, we need adult neurology for multiple sclerosis, and we need pain specialists for chronic pain.

These preparations are unlicensed; that means there has been no testing on their efficacy—whether they work—and on whether they are safe. That is quite scary for doctors, particularly as if it is an unlicensed drug, they have to sign a form to say that they accept personal liability. I can tell the House that that is quite intimidating, as I have done it myself. The Government need to push for centres of excellence to help to stimulate the research they say they are calling for. That is the only way we will get randomised controlled trials, and get the answers that will lead to these drugs being licensed, rather than our just having a temporary fix for now.

[Matt Hancock]

In an outbreak of cross-party unity, I agree entirely with the hon. Lady. The approach she has taken is incredibly sensible; it is also the one that has been recommended to me by my clinical advisers. We need to ensure that we take an evidence-based, pharmaceutical-grade approach to prescription. I will take away her idea about centres of excellence, because I entirely see the point there. In the case of most drugs, it is the pharmaceutical industry that pushes for, and pays for, the randomised controlled trials. In this case, because the industry is in a different shape for other reasons, it is we who are making this happen, and we are pushing it as fast as we can

Oral Answers to Questions

Philippa Whitford Excerpts

Tuesday 26th March 2019 Commons Chamber

[Jackie Doyle-Price]

My hon. Friend will know that this has to be reviewed independently, but the Secretary of State does have duties to consider inequalities in all his work.

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

I, too, wish to pay tribute to the hon. Member for Winchester (Steve Brine), who I sparred with many times in Westminster Hall. We might not have agreed on how to go about it, but he was clearly passionate about improving health.

The Secretary of State’s vision for NHS England includes video links to GPs, diagnostic phone apps and healthy people undergoing gene tests for a few hundred pounds. Considering his own experience of such a gene test, does he not recognise that this just increases access for the well-off, will drive demand in the system and will actually widen health inequalities?

[Jackie Doyle-Price]

I do not accept that at all. Apart from anything else, we are seeing younger generations be more technologically savvy. We are taking advantage of that technological innovation to spread good health prevention and to help people look after themselves.

[Mr Speaker]

I call Dr Philippa Whitford.

[Dr Whitford]

I wish to come in on Question 5, Mr Speaker.

[Mr Speaker]

I beg the hon. Lady’s pardon; I thought she wanted two questions on this. Maybe I was misinformed. Very well—she can have another question later.

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[Caroline Dinenage]

People on low incomes who do not qualify for an exemption may be eligible for either full or partial help with prescription charges through the NHS low-income scheme. In addition, for those who do not qualify for that, the prescription pre-payment certificate is available, under which everybody can get all the prescriptions they need for only £2 a week.

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

Of the 300,000 who have missed out on their prescriptions, a quarter have had a flare-up of their asthma and 13% have ended up in hospital. Does the Minister not accept that prescription charges simply are not cost-effective and should be abolished, as they have been in Scotland?

[Caroline Dinenage]

Almost 90% of prescription items dispensed in the community in England are free of charge. That includes medicines for the treatment of asthma. The fact is that people who, like me, suffer from asthma and need those prescriptions have to decide, as taxpayers—as the people funding our NHS—whether we would rather contribute to those prescriptions or see the underfunding we have seen in Scotland, where GPs have been underfunded by almost £660 million over the last four years. It is a case of priorities.

Healthcare (International Arrangements) Bill (Changed to Healthcare (European Economic Area and Switzerland Arrangements) Bill)

Philippa Whitford Excerpts

Ping Pong: House of Commons
Tuesday 26th March 2019 Commons Chamber

[Julie Cooper]

I think the objections raised by the Labour party in the past were based on the methodology used and the potential abuse of personal data, but we would fully support an efficient system to recover moneys owed to the UK.

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

When talking about the disparity in numbers—there are more than 3 million European citizens here and approximately 1.5 million UK citizens there—is it not the case that the majority of EU citizens here are working and paying taxes and therefore are not covered by this system but are covered by the tax they already pay?

[Julie Cooper]

The hon. Lady makes an important point. I was referring to the fact identified by the Public Accounts Committee in its concerns about collecting what is due, but I take her point that many people pay for their own health provision while in the UK.

My point further reinforces the rationale of restricting the scope of this Bill to the EEA and Switzerland, which will help to ensure the priority is to improve the recovery of healthcare costs, where they are due, before we even begin to think of entering into non-EEA agreements.

We, of course, welcome the Government’s decision to remove the Henry VIII powers from this Bill. We repeatedly return to that issue in this raft of Brexit legislation, and I hope now, and certainly in connection with this Bill, that the Government agree it can never be right to confer on any Minister the same powers as are conferred on Parliament.

I understand that the Minister has a big vision and wants to take this opportunity to extend the current arrangements and to present a Bill that allows the Government to enter into any number of new reciprocal health agreements with any and every nation of the world, should they so choose. There could be a time and a place for such legislation, but it is not now because time is so short. There is not time for Parliament to scrutinise such an extensive range of proposals properly for such wide-ranging powers.

Our noble Friends raised some very reasonable concerns on that point, and they are correct to note the comments of the Delegated Powers and Regulatory Reform Committee when it concluded that the Bill, in its original form, gave law-making powers that were too wide. Our noble Friends were right to give serious consideration to the Constitution Committee’s recommendation that the scope of the Bill should be limited to countries that participate in the existing EHIC scheme:

“While the exceptional circumstances of the UK’s departure from the European Union might justify legislation containing broader powers than would otherwise be constitutionally acceptable, this does not extend to giving effect to new policy unrelated to Brexit.”

Above all, we now have a Bill that does what was intended: to ensure the continuation of the current reciprocal healthcare arrangements with the nations of the EU and the EEA. Given that that is the Bill’s principal target, there is no need to give the Bill worldwide scope.

I am pleased to join the Minister in giving our full support to the amended Bill before us.

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[Kevin Foster]

As always, I thank my right hon. Friend for his incisive intervention. The Channel Islands might use our currency and, in many ways, fly our flag, but people forget they have a very different constitutional status and are not part of the European Union. For some visitors, it can be a surprise that there is not a reciprocal agreement. There is a reciprocal arrangement with Gibraltar, for example, and it makes eminent sense to try to have such an arrangement between the UK and the Channel Islands, not least given the strong cultural links and the fact that many families split their time between the mainland and the islands.

Looking across the Commonwealth more widely, it might make sense to have arrangements with countries such as Canada and Jamaica in the long run, based on the fact that they have comparable systems of healthcare provision. That is perhaps where the oft-cited example of the United States starts to fall apart, because it is one of the handful of modern, developed countries that do not have a guaranteed system of universal healthcare free at the point of need rather than a system based on insurance schemes for which people may pay.

It is welcome to have ambition, and the Bill is clear about where we are going. I have no problems with the Lords amendments, which are welcome, and I am happy to support them. I am conscious that we are looking to move the debate forward, but I wanted to get those thoughts on the record.

[Dr Whitford]

Obviously, the Bill itself is quite small. It does not extend or protect continuing reciprocal healthcare rights; it is simply an enabling Bill that gives the Secretary of State powers to try to do that. It enables him to pay for overseas treatment in the EEA and Switzerland. We have heard how the Lords removed the powers to extend that worldwide and increase the scope, as well as limiting some of the Henry VIII powers.

The Bill will allow the Secretary of State and his team to negotiate healthcare agreements with the EEA and Switzerland as a group through the EU system or, failing that, to make bilateral agreements. Unfortunately, that would mean having bilateral agreements with 31 countries, which would inevitably be more complex, more bureaucratic and more expensive.

Clause 4 allows data exchange, which most Members would recognise is absolutely critical not just for collecting payments or swapping money, but for accessing medical health records if someone goes for treatment in another country. It is important that that will be handled only by an authorised person who is part of a statutory body—a public body.

I welcome the new clause in Lords amendment 11, which says that the devolved Governments must be consulted, because it is the three devolved Governments who deliver healthcare in Wales, Northern Ireland and Scotland. It is critical that they are involved in any agreements.

This legislation is needed whether there is a deal or no deal. As came out of the points of order exchange earlier, the withdrawal agreement would extend through the transition period, but we have all seen how the last three years have melted away like snow off a dyke. The next 20 months will also disappear, so legislation is required for the long-term protection of those who already live in Europe and want to stay there, particularly those who have been there only a few years and do not have five years-worth of residency rights in the country they have chosen to settle in. After the Bill is passed, it is therefore important that the Government hope to negotiate the continuation of reciprocal healthcare.

The problem is that reciprocal healthcare is not a free-standing thing on its own; it is there simply to enable freedom of movement. People cannot exercise their freedom of movement rights if they simply cannot afford healthcare where they choose to live, work, love, settle or retire. We have had the right over the past few decades to retire and settle anywhere. People are well aware of my husband’s situation as a German citizen who lives here and has spent virtually all his adult life working in our health system. That was certainly his first concern after the Brexit vote, and I am sure it is a concern for all 5 million people who have either settled here from Europe or settled in Europe from the UK.

The problem is that, as the Government reject freedom of movement and talk merely about a mobility framework, any reciprocal arrangement is likely to be proportional to that mobility framework, as is described in the impact assessment. The Government are not offering visas of over a year for unskilled workers. They are demanding that people be high skilled, possibly that they earn more than £30,000 a year and that they are economically active and are contributors. Will pensioners still be able to retire elsewhere, since they are not necessarily contributors in a major sense and are certainly not necessarily economically active?

People highlight the difference between what the UK has to pay into the European system and what we get back from Europe. A lot of that difference is quite simply because of the number of UK pensioners who choose to retire to sunnier climes—who can blame them?—and the general lack of obsession with retiring to the drizzle and moving in the other direction. Living in Scotland, I can vouch for that. Who would choose to leave the south of France and come to live in the mist, fog and drizzle? That is why the number of European pensioners retiring to the UK is considerably smaller than the number of UK pensioners who retire to the south of Spain and the south of France. That is simple logic.

[Mr Dunne]

Would the hon. Lady account for the massive diaspora of Scots all around the world as a comment on the mist and greyness of Scotland’s location? Why does she think so many Scots live abroad?

[Dr Whitford]

The right hon. Gentleman probably would not like me to get into the clearances of the 17th and 18th centuries when people were burnt out of their villages and put on boats, or when people were transported for criminal activities. There are all sorts of reasons why Scots have ended up all over the world, and they are not all about the weather.

[Mr Charles Walker (Broxbourne) (Con)]

I just want to say to the hon. Lady that I adore Scotland. I just love the mist, the fog, the rain—it is what I call proper weather, and it is to be celebrated.

[Dr Whitford]

That is why I live there, right beside the sea, but that does not necessarily mean that somebody living in the vineyards of France will think, “You know what? The weather’s a bit boring here. I fancy somewhere with snow, sleet, hail and sunshine all in one day.”

It is a fact that the disparity is because of the number of pensioners. It is often described as if it is the EU somehow tricking the UK—it simply is not. We are obliged to pay for the pensioners from the UK who have settled in Europe. Indeed, we pay a fixed rate per head that is considerably lower than—just over half—what would be charged for a European citizen settling here.

[Jeremy Lefroy (Stafford) (Con)]

Does the hon. Lady agree that another reason for the disparity is that the NHS, in being free at the point of need, has not over the years been as geared up as other countries for recording the patient episodes of EU nationals and collecting that kind of data? Because it is not an insurance-based system but is free at the point of delivery, it does not necessarily have the mindset or the paperwork to think about healthcare in terms of money.

[Dr Whitford]

I totally agree that that is part of it. The Government have to consider, given the numbers involved, whether creating that entire administrative system will bring more money back in than is spent on administering it.

It is important to consider exactly how we will expect doctors and other health staff to demand to see someone’s settled status. Will it be based on a foreign sounding name, a skin colour or an accent? Will people have to produce an ID card if they were born here, they grew up here, they have never been anywhere else and their family are 20 generations English? That is the point: there is no ID card here. In other European countries, there is an ID card and it will show that UK citizens have whatever the equivalent of settled status is. I think doctors and others are anxious about the circumstances in which they should ask for proof of habitual residency.

We see that already in respect of universal credit. I have dealt with a German lady who has been settled here for 30 years and who was refused universal credit on the basis that she was not habitually resident. We are already seeing these things, and we do not want to see them around healthcare.



As we have heard, there are three main groups. The biggest group is the almost 200,000 pensioners using their S1 rights to register somewhere they have never paid tax—and yet they benefit as if they have. It is important that their rights continue, or they may end up having to come back home. They would cost more here than the Government are paying France or Spain to deliver their healthcare. It is important that they are not limited in some way, so that only people who do not have medical health risks are accepted, as happens with insurance. Ordinary pensioners who have exercised those rights would simply not be able to afford comprehensive private health insurance.

A lot of work is being done to protect those who have settled already, but what about the rest of us, who might fancy settling in the south of France or Spain? Will this be achievable by ordinary pensioners in the future?

Approximately 1,300 UK citizens use S2 forms for planned treatment, and the biggest number is the 250,000 claims a year that are made through the EHIC card, which allows people to travel or study all over the EU. As the hon. Member for Burnley (Julie Cooper) said, that includes people with expensive chronic conditions that require treatment such as dialysis three times a week. I defy any Member to find affordable health insurance that would cover such treatment. That is not a risk of healthcare, but planned healthcare, otherwise the trip simply cannot be made.

Health Inequalities

Philippa Whitford Excerpts

Wednesday 20th March 2019 Westminster Hall

[Lucy Allan]

I thank my hon. Friend for sharing his expertise in this area. My local council and health and wellbeing board have equally not been listened to on this issue. It is a Labour council, but it has tried extremely hard; if there was an opportunity to suggest otherwise, I would perhaps take it, but that is not the case. Both tried hard and have not been listened to. Most frustrating has been that the voice of local people has not been heard. Who do we expect to enforce this statutory duty? We cannot expect constituents to crowdfund a legal process because we want to hold CCGs to account.

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

Does the hon. Lady share my concerns on integrated care providers? Those should be statutory bodies and not in any way open to being private companies, which can hide behind commercial sensitivity, for exactly the reasons she says.

[Lucy Allan]

I thank the hon. Lady for her comment. There was an interesting debate on that issue on Monday night in the Chamber. This is an important issue, and I have a lot of sympathy with what she says.

On the injustice of unequal health outcomes, I said at the outset that that is of course not about spending more, and that poor health is not only about healthcare but is a much wider issue. However, if the NHS overlooks its statutory, constitutional and moral duty to properly consider health inequalities when making major spending decisions, the Secretary of State has a legal duty to act; he cannot just sit on his hands and say it is down to local clinicians. That response is all the more frustrating in my case because all six voting members of the Telford CCG voted against the transfer of resource from an area of deprivation and to an area of relative affluence, whereas all six voting members of the CCG in the more affluent Shrewsbury naturally voted for the funding resource to be transferred to their area.

In our case, Telford CCG was made to vote again until it came up with the right answer and allowed that transfer of funding. [Interruption.] That is very topical, yes. This whole issue reminds me exactly of Brexit. I wish I had not come on to that point; this should be a Brexit-free zone, for a change, so that we can all maintain our sanity. However, it is similar in the way that those in power have not been listening to the people. It is extremely important to note that, if we give that sort of funding to relatively affluent areas and take resource away from the most disadvantaged, we are doing something wrong. No Government could think that that was a good idea. I am grateful to the new Health Secretary, who came to Telford to visit our Princess Royal Hospital earlier this month and took the time to see for himself the fantastic work being done in the very areas that the management is seeking to close and to transfer 19 miles away to Shrewsbury hospital.

I would like to get something else off my chest, to further illustrate the problem of unequal health spending. Six months ago the Government gave the Shrewsbury and Telford Hospital Trust £3 million for winter pressures. The trust decided to spend all of it in Shrewsbury—all of it—despite there being no evidence that the decision reduced health inequalities between the areas that it serves and not even an indication that it had considered health inequalities when making that decision.

No Government could possibly condone transferring resources from an area of need to an area of greater affluence and better health outcomes. The Government have a legal responsibility to ensure that that does not happen. Everyone in this room will agree that NHS funding decisions must focus on the areas of greatest need, and where that is not happening, we cannot ignore it. The trust has been able to forge ahead with a plan that has never made sense to local people, that was roundly opposed by a consultation that took place, bizarrely, two years after the original decision was made, and despite MPs and councillors vocally pointing out the plan’s shortcomings and its failure to address health inequalities. The hospital trust and CCGs carried on regardless. It cannot be down to local people to enforce the Act. I can only conclude that decision-makers perhaps do not understand their duty to narrow health inequalities or—of more concern—that they do not understand the extent of the need, disadvantage and health inequality in the area they serve.

The flat-out refusal to even discuss the reconfiguration’s impact on health benefits and outcomes for the most disadvantaged has been extraordinary. I have written letter after letter for a considerably longer period than the consultation lasted and I have not received any answers. My trust treats the issue as if it was entirely irrelevant to its reconfiguration plan. If it is not able to show how its plans narrow health inequalities, it must think again.

I know that once the Secretary of State receives the relevant documentation from my local council, he will carefully consider whether to call in the Telford proposal for review by an independent reconfiguration panel. For that, I am most grateful. I hope the panel will look closely at the failure to address need and disadvantage and, on those grounds alone—there are many others—throw out the scheme. If the Government are committed to reducing health inequalities and not only focusing on better health for all, they need more than just warm words. I ask the Minister to remind hospital trusts and commissioners generally, and the Shrewsbury and Telford Hospital Trust and its commissioners specifically, to give due regard to their duty to demonstrate how their spending decisions narrow health inequalities.

In conclusion, I ask the Minister to keep focusing on this issue. It is so easy to lose sight of the reason we all came to this place, and it is too easy for the Department or the Minister to believe that health spending is allocated and targeted towards need, and that we do not have to look beyond the spreadsheet. We have to ensure that it is happening in practice on the ground. We cannot simply say that we have done our bit and that there is no need to look any further. Health inequalities are a shameful injustice of unequal lives and unequal life chances. I know that the Secretary State wants to ensure that no NHS decision-maker allocates funding in a way that exacerbates this injustice, whether in Telford or any other area.

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[Dr Philippa Whitford (Central Ayrshire) (SNP)]

Obviously, we are discussing the duty to reduce health inequalities, but as other hon. Member have mentioned, the increase in life expectancy is stalling and healthy life expectancy is falling. There is an exact linear correlation with deprivation. Women in poorer areas will have 26 years of poor health compared with 13 years for the least deprived. That all generates health pressures in the health service and in social care. Last year, the Scottish Government passed the Fairer Scotland Duty, which puts an obligation on all public bodies to work towards reducing inequality.

There are different aspects to this issue, including access to healthcare, which the hon. Member for Telford (Lucy Allan) talked about. In Scotland, we now spend £185 a head more on health and £113 a head more on social care than in England. That allows us to offer free personal care, which allows people the luxury of staying at home if they need the support mentioned by the hon. Member for St Ives (Derek Thomas).

A key issue of access to healthcare is free prescriptions. They are not available in England, other than for a very limited number of conditions, not including asthma. Asthma UK has conducted surveys showing that, at some point, half of all patients have not collected their prescription, and that three-quarters of asthma patients struggle to pay for their prescription. Of those who did not collect their prescriptions during that period, 13% were admitted to hospital. That is not cost effective.

The long-term plan talks about access to a digital GP, video access and healthy people being able to buy genomic testing. I am sorry, but all that will feed the inverse care law of increasing demand from the better-off instead of tackling unmet need among poorer people. Those are the people who do not attend appointments for screening, who live far away from services and who do not have access to decent healthcare.

On the public health and prevention side, obviously Scotland was the first to enact the smoking ban, followed by England. We have introduced minimum unit pricing to try to tackle alcohol, which is another one of the scourges. That policy has yet to be enacted here. I welcome the UK Government’s sugar tax, but I would like to see some action on advertising junk food to children before 9 pm. Scotland has also signed up to the World Health Organisation’s global action plan, which tries to improve physical activity and participation in sport, particularly among women, girls and the elderly.

It is particularly important to invest in children and we try to do that in Scotland through the Best Start grant, the Baby Box and the fact that our early years education is available to all children and does not just depend on parents’ circumstances or work pattern. If we do not invest in children, we inevitably end up spending more later to pick up the pieces.

As has been said, Professor Marmot highlighted in his report the fact that increasing poverty means increasing inequality. The welfare cuts, particularly the benefit freeze, have driven an increase in every group in poverty over the last number of years. Poverty in England is at 22%, it is 24% in Wales and it is down at 20% in Scotland. However, if we look at the disabled, pensioners and children, we see that they are particularly vulnerable. Child poverty was falling, but the Institute for Fiscal Studies says that it will climb by another 7% before 2022. In England, child poverty is now over 30%, in Wales it is 28% and in Scotland we had got it down to 21% but it has climbed to 24%. That is due to the impact of welfare cuts on families.

For the last several years in Infant mortality has risen England. That is a measure that we use to look at health on a worldwide basis in developing countries. The Scottish Government mitigate policies such as the bedroom tax, and they have measures such as the Scottish welfare fund, which is why we have the lowest levels of child, disabled and pensioner poverty. However, in all those classes poverty is still increasing and we are having to use £100 million a year on it.

The Government talk about tackling worklessness, but 70% of children have a working parent. What we have is the working poor. The International Monetary Fund says that a more equal society is a healthier society, which brings better economic growth, so what we need to do is promote the real living wage, to make work pay. We need to tackle poverty. It is the biggest driver of ill health, which means we need a “health in all policies” approach. The NHS alone cannot fix this problem.

--- Later in debate ---

[Jackie Doyle-Price]

We have a number of inter-ministerial groups looking at particular areas of inequality, such as rough sleeping and the first 1,001 days. The hon. Member for Central Ayrshire (Dr Whitford) spoke about the importance of early intervention; if we could get that right, that would be a real way of addressing inequality. My short answer to the question asked by the hon. Member for Oldham East and Saddleworth (Debbie Abrahams) is that we pick up public health in a number of ways, but my priorities are the first 1,001 days and particular pinch points where there are real inequalities. We will continue to look at those areas, not least because supporting those individuals is not just better for them, but makes financial sense. If we can tackle some of these issues earlier, not only do individuals live longer and healthier lives, but there is a reduced cost for the health system.

[Dr Whitford]

Many of us have spoken about the fact that poverty drives ill health. Can the Minister tell us whether any discussion is taking place between the Department and the Department for Work and Pensions about the impact of welfare changes over the past few years, and how to tackle them?

[Jackie Doyle-Price]

I have been in close consultation about that issue with the recently departed Minister of State for Disabled People, Health and Work, my hon. Friend the Member for Truro and Falmouth (Sarah Newton). She has really challenged the DWP to look after people who are vulnerable, and put in place safeguarding policies for them, so I confirm to the hon. Member for Central Ayrshire that that discussion is taking place.

My hon. Friend the Member for St Ives (Derek Thomas) raised the issue of dementia. Clearly, dementia has a big impact on the number of years in which people can enjoy a healthy life, and we must get that right. For that reason, we have introduced the ageing society grand challenge, which is focused on narrowing those inequalities. My hon. Friend is right that we must have better integration with social care; there have been a lot of moves towards better integration between local authorities and the NHS, and that must continue.

The hon. Member for Washington and Sunderland West (Mrs Hodgson) referred to public health cuts. We have tackled those through the NHS forward plan, and have said that this is an area in which we expect the NHS to focus and work collaboratively with local government, specifically highlighting health visitors and the wider public health agenda. My answer to the hon. Lady’s point is “watch this space”, but we recognise that we spend less if we spend wisely, which has to be about getting the system to work better.

[Derek Thomas]

rose—

[Dr Whitford]

rose—

[Jackie Doyle-Price]

I have limited time, and I would like to get through this.

We have made it clear that the long-term plan will be focused on reducing inequalities. The hon. Member for Strangford (Jim Shannon) mentioned people with learning disabilities and autism, and I can tell him that those people are a real priority for me. When we consider inequality, the life expectancy of people with those conditions is massively less than it ought to be, and we need to fix that. This year we expect all local health systems to set out how they will reduce health inequalities by 2023-24 and by 2028-29. Through that, we are targeting specific areas. NHS England will highlight areas in which it can do specialist commissioning. One example is people who are rough sleepers, who have low levels of life expectancy.

I absolutely agreed with what the right hon. Member for Rother Valley (Sir Kevin Barron) said about social prescribing. How we deliver health services depends not only on medicalised professions and clinical support; when tackling inequality, a lot of the wrap-around and de-medicalised support can deliver better health outcomes. I am very excited to hear about what is happening in Rotherham, so I might pay a visit next time I go to see my mum. That would be quite nice.

Turning to the specific points made by my hon. Friend the Member for Telford about her local trust and the impact on inequalities, she has clearly articulated the issues that she is concerned about. The decision is clearly a local one, but it is within the gift of the council to make an appeal to the Secretary of State, and I gather from my hon. Friend’s comments that that will happen. I obviously cannot prejudge the outcome of that case, but I assure her that when it arrives on the Secretary of State’s desk, he will consider it impartially. She has articulated the concerns from her constituents’ perspective extremely well.

I am under no illusion about the fact that tackling inequality requires commitment and leadership, energy and focus, and national and local accountability. Let us look at the plans that come from clinical commissioning groups later this year and interrogate them to make sure that they will tackle inequality. We will make sure that we stand fully behind them to ensure that they deliver.

Integrated Care Regulations

Philippa Whitford Excerpts

Monday 18th March 2019 Commons Chamber

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

As I have said in many debates, I totally support integration. That is the journey we have been on in Scotland for almost 20 years. We amalgamated some trusts after devolution, we got rid of hospital trusts in 2004 and we got rid of primary care trusts in 2009. We had the health side run by health boards, which are statutory bodies that carry out area health and social care planning for a population. The integration between health, which is free, and social care, which is means-tested, was passed in legislation and introduced in 2014.

I warn Members that that is much more difficult than integrating the NHS itself. The NHS in England has become really fragmented. It is important to put that back together before integrating it with social care. What integration stops is the arguments between acute care and social care about which purse the money comes out of to look after a particular patient, but there does have to be money in the purse to start with. In Scotland, we spend £163 a head more on health and £113 a head more on elderly social care. The money is needed to provide the service. Scotland is the one place in the United Kingdom where we provide free personal care, because we think it is cost-effective as a way of allowing people to stay at home.

The Minister says that these will be statutory bodies and that they are unlikely to be private companies. If that is what the Government believe, they should put it in legislation, because that removes any doubt or concern. The response to the consultation says that

“further requirements around financial controls, transparency and accountability will be developed before the ICP Contract is made available for use.”

When will that be? Will it be before contracts are put out? The transparency is critical. If any private companies are running ICPs, they will hide behind commercial sensitivity and will not be open to freedom of information. That would be unacceptable. What about their contracting, which is mentioned in this SI? Will section 75 be revoked so that we do not have a replay of what happened in Surrey, when commissioners tried to bring the new contract back to the NHS, were sued by Virgin for over £2 million and settled out of court?

If outsourcing continues, fragmentation rather than integration will continue. Will tariffs be abandoned because they reward admission to hospital, whereas the aim of this proposal is to support people at home? How will the components of an ICP between a main acute hospital, a small cottage hospital and social care or community services be funded? It may all sound very good if it is a gentleman’s agreement, but if one part of that system goes bankrupt because the financing system has not been changed, all bets will be off and all co-operation will disappear.

Social care is critical to this and Age UK says that well over 1 million people are not getting the social care that they need. It is necessary that the ICPs deliver prevention, early treatment, chronic disease management, acute care, mental health, social care and end of life. That is a lot of different players to bring together and it is important that the Government recognise that the Health and Social Care Act 2012 fragmented and blew apart the whole system. For integration to work, they need to admit that it failed, bring back proper legislation and put the system back together in a way that is wrapped around the patient, so that there is patient-centred, not budget-centred, care.

Human Medicines (Amendment) Regulations

Philippa Whitford Excerpts

Monday 18th March 2019 Commons Chamber

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

We are discussing changes to the Human Medicines Regulations 2012. I welcome the implementation of the falsified medicines directive, with its provisions on unique identifiers and anti-tampering devices. I also welcome the change to allow nasal naloxone to be used to deal with opioid overdose. But snuck in among those perfectly reasonable measures is the serious shortage protocol. That deals with prescription-only medicines and highlights what we face with Brexit coming in 11 days.

Forty-one million packets of drugs a month go from the UK to the EU, and 37 million are imported into the UK, including almost all insulin—the UK does not produce insulin to a large extent. There are many other drugs that the UK does not produce. We have previously and in this debate raised the issue of radioisotopes, although this clearly does not apply to that. There will also be problems with the supply chain of raw chemicals to produce drugs in the UK and with processes such as batch testing for UK exports into the EU, because the EU will not recognise batch testing not carried inside the EU. One of the key words missing from the withdrawal Act that was scattered throughout the Chequers deal, if we can call it that, is “frictionless”. Do a word search. It is not there. We have been discussing this matter in the context of no deal, but there will be issues regarding the supply chains in making drugs and moving drugs around even if the Government’s withdrawal agreement goes through.

Bizarrely, section 8 of the explanatory memorandum to the regulations claims:

“This instrument does not relate to withdrawal from the European Union.”

As we would say in Scotland, “Aye, right.” It continues that:

“if withdrawal from the European Union were a contributing factor to a serious shortage…a serious shortage protocol could be used”.

That is the thinnest fig leaf I have ever seen in my whole life.

The documents talk about the Minister or Ministers being able to add drugs to the serious shortage protocol list. Who is meant by “Ministers”? Is it the devolved Ministers in Edinburgh and Cardiff, or are we merely talking about all the junior Ministers and the Secretary of State here in Westminster? Health is devolved, and the use of drugs and the diseases dealt with vary across the UK. It is important that health is not pulled back away from devolution. I would like that to be clarified, particularly when the Minister suggests that this is not a short-term solution, but envisaged as a long-term solution for shortages.

I accept that shortages can arise, but normally they are few; normally it is possible to get access to information about what is causing them, making it easier to come up with solutions. However, as has been said, the review will take place only after a year, which is quite a long time for a protocol to be in place. It would be useful to send information on what replacements could be used to the GP or prescriber, rather than to the pharmacist. If it is known that there is a national shortage, why wait until the point of dispensing the drug? Tell GPs. Tell non-GP prescribers. Do not leave it to the last minute, when someone is in the pharmacy. That is the issue: the shortage protocol gives pharmacists the power to override the prescriber. Predominantly, that is a GP, but not necessarily.

I say to other Members that pharmacists can change the strength, but not the dose. If someone is on a 10 mg tablet and is used to taking one 10 mg tablet, they may be given two 5 mg tablets. That may seem innocuous, but an elderly, vulnerable or slightly confused patient who knows that they take one tablet every morning might end up taking half the dose they require. Even worse is if they are given a larger dose that they are meant to cut in half. That is much more complex. The number of tablets patients have to take could cause confusion.

The statutory instrument talks about quantity. At the moment, patients are usually given eight weeks of a prescription and pay a prescription charge. If they only get four weeks of their medication, will they get the second four weeks without paying another prescription charge or will prescription charges be doubled? That is not an issue in Scotland, but it is certainly an issue here in England.

[Alison Thewliss (Glasgow Central) (SNP)]

My hon. Friend is speaking very knowledgably about dosage. Many of my constituents are on methadone prescriptions. They need to get the correct amount of prescription or it can have very real consequences for relapse and how they are able to live their lives. Does she agree that protections need to be put in place for groups for whom removing the dose could have severe consequences?

[Dr Whitford]

It is critical that the patient’s dose is not changed or put in danger. The management of any condition is dose sensitive. We cannot go down to homeopathic doses of antibiotics or blood pressure medication—that would be crazy.

Pharmacists can give a different form, such as liquid, solid or capsule. Again, for some patients that will not be a problem; for others, it will. The hon. Member for Newton Abbot (Anne Marie Morris) mentioned generic drugs. Generally, NHS prescribers use generic drugs as the default to save money. However, I have had patients who had appalling side effects from the generic form of tamoxifen, but not from the non-generic brand. There always has to be a right for GPs to say, “In this case, I will use the brand.”

The most important bit of this statutory instrument is that it allows a change to a completely different drug. It may be a drug that is approved by a panel sitting somewhere in London with the colleges, who say that it is a reasonable replacement for the other drug, but that does not take into account the fact that patients are all individuals. I can tell you that they are all individuals.

Pharmacists are very knowledgeable—in Scotland, we have had community pharmacists for over a decade and they contribute massively—but they work to their own protocol, they work within limits and they do not have access to the patient’s notes. Therefore, they cannot see that the patient has been on a drug in the past and had terrible side effects. They will replace with a protocol drug, but what about the responsibility? Why is this happening right now?

It suggests to me that the Department of Health and Social Care is expecting massive shortages, to the point where the simple act of picking up the phone and saying to the GP, “I don’t have drug A. Would drug B be reasonable for Mrs Smith?”, is somehow impractical. I find that very worrying. It may be that Mrs Smith has had six drugs to control her blood pressure. Drug 2 and drug 5 caused her to faint or have blackouts, but the pharmacist does not know that.

Epileptics have been mentioned. The issue with epileptics is that any change can destabilise their epilepsy. They are therefore never prescribed by generic, but are prescribed by brand to avoid precisely that.

[Norman Lamb]

The hon. Lady makes a very good point. Does she agree that there is often an interaction between epilepsy drugs and other drugs that the patient may be on and that any interruption of that relationship may cause problems?

[Dr Whitford]

The right hon. Gentleman makes a very good point, and one that applies to many drugs. When we prescribe, we sit and look at the interactions. I would expect a pharmacist to look at that. They will have the patient’s full prescription and should, therefore, be able to look at interactions.

[Norman Lamb]

They do not have the patient’s records.

[Dr Whitford]

That is the key thing: they do not have the patient’s records and they do not know what problems a drug may have caused in the past.

This change could have a real impact on epileptics. It brings the danger of a fit, and the fit itself may be a threat to them. Obviously epileptics are exposed to sudden unexpected death in epilepsy and can suffer from trauma, depending on where they are when they take the fit. They can even lose their driving licence for a year because they have one fit. The social impact of that on epileptics is enormous.

It says in the explanatory notes that, because of that, epilepsy drugs and biological drugs would not be considered suitable for the protocol. However, it does not say that in the SI—they are not excluded. It is important that such people are protected.

[Lyn Brown (West Ham) (Lab)]

I have been listening closely to the hon. Lady. This is already happening. A friend of mine went to her chemist to pick up some drugs and the dosage was halved by the pharmacist, not by her doctor. She had enough drugs to keep her going until she went to the doctor again, who reinstated the original drug. I just think it is really scary at the moment; people do not understand why this is happening. It cannot be about Brexit, because it is happening now.

[Dr Whitford]

I am just coming on to that issue. I reiterate that it is the strength, rather than the dose, so I imagine the hon. Lady’s friend would be expected to take two smaller tablets, not to reduce her dose.

As I have said, the obvious thing would be to share the protocol with the prescribers, not to aim it at the pharmacists who are right at the end of the process.

Why is it that we are seeing the shortages now? Quite simply, there are two ways to stockpile: either by forcing increased production, which it is not necessarily within the gift of the Department or even the Secretary of State to do, or by setting aside some of the drugs within normal production. When I talk to my GP friends, they talk about a massive surge in shortages over the past nine months. That coincides almost exactly with the acceleration of stockpiling. My concern is that drugs are being set aside into the stockpile and that is causing shortages right now.

There should be publication of the list of drugs that are at risk of shortage, so that a GP can say, “For this lady or gentleman it is not that important, so if it is a shortage drug I won’t use it, but for this other patient I will have to use it.” Apparently, that is currently hidden behind commercial sensitivity.

It is important that a consultation and an impact assessment are carried out. I was shocked that the BMA was given a week to respond and the General Medical Council was not even consulted. This statutory instrument totally reverses medical and prescriber legal responsibility, so who is legally responsible? How do pharmacists feel about the fact that they might be held answerable for changing the drug, or will the Government underwrite that? I think that this has been appallingly handled and has been snuck in with no scrutiny and no debate.

The hon. Member for Leicester South (Jonathan Ashworth) talked about cost and time saving for GPs and, secondary to that, the impact on patient safety. If we look at the basis for the review in a year, it says that No. 1 will be the function of the market and that No. 2 will be the impact on patients, so again we see that patient safety is not being put at the heart of this. This proposal has not been properly thought through, particularly if it is envisaged as a long-term solution to drug shortages. No deal should now be off the table, as of last week. There should be time to look at this issue properly, consult properly and come up with something that will not endanger patients.

Draft Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 Draft Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Philippa Whitford Excerpts

Wednesday 6th March 2019 General Committees

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

It is a pleasure to serve under your chairmanship, Mr Robertson. I thank the hon. Member for Ellesmere Port and Neston and I echo many of his points. I certainly echo his points on the complexity and the short time that we have had to go through the draft regulations. I do not feel that it is sufficient scrutiny for something so technical and complex.

The three main groups affected will be the MHRA itself, the industry—both pharmaceutical and device producers and wholesalers and those who are involved in research and trials—and, thirdly, the NHS and the patients that it serves.

The MHRA will have to massively expand its organisation and its staff. It will have to take on people with skills that it does not currently require. As was mentioned by the shadow Minister, it will also have to develop systems to replace what the EMA has been doing. The EMA typifies one of the benefits that we get from the EU, because we will have to duplicate massive amounts of systems, and we are asking pharmaceutical companies to duplicate staff in the UK and the EU.

The immediate and urgent challenge the MHRA faces is grandfathering the central market authorisations, of which there are about 1,000 from 1995 to 2017. They are central authorisations, and only about a third are held in the UK. It will also have to transfer parallel import licences for similar drugs. The explanatory memorandum cites 21 days. How many of those licences exist? Is it remotely feasible to expect the MHRA to transfer them over within three weeks?

Data access will become more difficult, as this often involves looking at commercially sensitive data. As the UK will not be covered by the European Court of Justice in the future, many companies will be more wary, as they will be asking what their recourse to law will be if they feel that their data has been misused.

In the longer term, the MHRA will have to treble the number of new drug and new agent assessments to produce market authorisations for the UK. It will have to replace the pharmacovigilance work that the EMA does, both the major work and the regular reviews and updates. It will have to replace new data systems, because the UK will no longer have access to EudraVigilance data. That is the key loss—a loss of collaboration.

Although I have tried to raise it, one point that has been overlooked a lot in the past couple of years is the issue of quality control and batch release authorisation. The National Institute for Biological Standards and Control will be leaving the EU shared group of official control authorities on batch release, which means it is losing access to a collaborative network. It will have to ensure that all that work is replaced in the UK. That also means losing mutual recognition.

The MHRA will also have to license people. We heard that there will have to be marketing authority holders and qualified persons for pharmacovigilance for every single company here in the UK, as well as this new creation, the responsible person for import. What will their qualifications be? Exactly how will they be judged and licensed?

I recognise that it is a practical thing just to say that drugs that will be certified in the EU should be recognised in the UK, but this is not driven by our wanting to stay close to Europe; it is driven by the fact that the UK simply does not have enough qualified persons to do it any other way. That shows the threat. This is demanding a big increase in staff and skills, both for pharmaceutical industries and for the MHRA.

Under “Responsible Person”, the explanatory memorandum says that a licence holder must

“put in place an assurance system”.

Why is it not the Government putting in a single assurance system? Do they really want every drug company to come up with their own assurance system for licences?

MHRA funding has been based on the work that it has done for the European Medicines Agency in the past and on statutory fees. We are told that that will all be replaced through fees: more than £60,000 for a major assessment, more than £50,000 for a major pharmacovigilance assessment and smaller fees for some of the reviews and updates. When we hear so much about a Brexit dividend, why are the Government not looking at putting some funding into the MHRA, particularly in relation to set-up, but also in relation to maintaining these things?

For the pharmaceutical industry, the issue is duplication —having a legal marketing authority holder in the UK and a qualified person. It will mean the time involved in processing the grandfathering of marketing authorities. It will mean the costs of the additional fees, and as I said, those are substantial fees. It will mean a disincentive to launch medicines in the UK when a fee has to be paid to the EMA and then another fee has to be paid within the UK.

The aim is to negotiate bilateral recognition for batch-testing. How long will that take, and how many jobs are likely to go to the EU? What the paper that I am discussing focuses on is purely drugs being made available in the UK market. Although that is understandable, because it is about the MHRA, there is no talk about what support and help there will be for the industry. Forty-one million packets of drugs go to the EU, and the EU rules are that they need to be batch-tested within the EU. At the moment, 10% of batch-testing is UK only; three quarters is EU only; and only 13% of batch-testing is in both places. There is no talk about what support there will be for the industry. We risk losing those jobs, and the problem is that although those jobs might go first, other jobs tend to follow. Will a big, multinational drugs firm that is opening a new production unit in Europe pick the UK? The chances are that it will not, so the issue is future jobs as well.

Then we come to the NHS and patients. We hear, obviously, about costs for the NHS, because it will have more paperwork to do. There will be delays in accessing new drugs for patients; Australia and Canada have significant delays—sometimes as much as three years. That means that patients will lose access, and there will be an impact on future trials. Trials are always carried out on the best available versus the brand-new. If the UK is not able to deliver the best available drug to patients, it will not be able to take part in future trials.

The papers to which I am referring state that the UK Government will incentivise innovation in relation to rare diseases, but in fact the big step forward in the past 10 or 15 years was collaboration across a population of 500 million people. If we are talking about incredibly rare diseases, the bigger the population from which we recruit people to take part in the trials, the sooner we will find the answer.

As was mentioned, there is also the issue of leaving the falsified medicines directive and the safety packet measures therefore not being required in the UK. Similarly, it is stated that UK producers will not have to register, or to register their products, if they sell online. The worry about devices is that the sheer pressure of all this on the MHRA could lead to shortcuts and to rushing things through to try to keep up.

We have had multiple debates and discussions in the House about the impact of vaginal mesh. That was automatically passed on, because there was no recognition that the device was changing and that the operation to use the device was changing. Unless we have people with expertise looking at these devices, it will be very easy to think that they are exactly the same, but there might be substantial changes in how they work, the materials they are made of and how it is proposed that they will be used. Again, I come back to collaboration. Not sharing pharmacovigilance information through the EudraVigilance database is a real concern to patients in the EU and here.

On shortages, the documentation simply mentions that Ministers will have new powers if there are significant shortages after leaving the EU. I have raised the issue of the Human Medicines (Amendment) Regulations 2019, regarding the serious shortage protocol, which would allow a pharmacist to change a patient’s medication without consulting their GP. They do not have access to the patient’s medical records, only their prescription. A patient might have been on multiple drugs in the past to reach one that controls their condition. They will not remember all the drugs they were on over the years. They will not necessarily remember which drug caused them to have blackouts or other side effects. Those regulations were put through as a negative SI with no scrutiny and no debate. This measure proposes exactly the same powers.

When I came across the serious shortage protocol, I was shocked to find that there was no consultation with the General Medical Council, even though it would be a significant reversal of medical legal responsibility. I have concerns that in the future such moves on shortages will be simply rushed through, with insufficient cognisance taken of the impact they will have on patients. What other changes does the Minister envisage that Ministers will have powers to enact? Does she not recognise that doing things through the negative procedure does not allow for any scrutiny or debate, and does not allow us to protect our constituents?

[Jackie Doyle-Price]

I thank the hon. Members for Ellesmere Port and Neston and for Central Ayrshire for their probing questions. They have both made compelling arguments. I recognise their concerns about scrutiny, but we are where we are. The Government have to make provision for a no-deal scenario, even though we remain determined to leave the EU on 29 March with a deal. None the less, we need to put these statutory instruments in place to deal with the event that that does not happen. Both hon. Members asked probing questions, and I shall try to address all of them. I am sure I will miss some, but I promise to write to them both with full answers to the points they have raised.

Overall, there are concerns about the costs to businesses, patients and taxpayers, all of which need to be addressed. However, I should be up front about this. Clearly, there will be a cost to business. One reason why Margaret Thatcher was such a big believer in the single market was that a single-market regime would reduce costs to business. Therefore, unilaterally leaving the single market will increase costs. We need to be frank and honest about that. We also need to be frank and honest that some of those costs will be passed on to taxpayers and patients. That is a given, but it underlines why we are determined to leave with a deal and minimise any disruption, recognising that we want to make the best out of this scenario for Great Britain.

Some issues were also raised about resources and personnel in respect of the MHRA, which I will come on to. I appreciate that hon. Members feel that they have not had sufficient opportunity to scrutinise this. However, I can assure the Committee that the proposals have been taken forward by MHRA in full consultation with business with a desire to minimise disruption and additional cost, and with a full view to planning to ensure that MHRA is equipped to deal with it. Much of the machinery is in place, given MHRA’s role in being such a key player within the EMA.

As I mentioned in my opening remarks, the Government’s approach has been to minimise burdens on business while enabling the most robust action for the UK to protect public health. As I have said, I acknowledge that that will place costs on business. The hon. Member for Central Ayrshire explained the disproportionality of EMA costs with regard to what might be replicated with the MHRA. She is absolutely right about that. I can tell her that the fees have been developed based on existing processes. For example, the targeted assessment fee is based on the existing MHRA incoming mutual recognition fee. Furthermore, the MHRA regularly reviews its fee levels and will continue to do so. There is a commitment from the MHRA to review the overall system of fees to the industry following exit with no deal so that we can maintain that they are fair and proportionate to business.

[Dr Whitford]

Obviously, the MHRA uses a trading fund now and must basically wash its own face financially. Will the Government provide more direct funding to the MHRA or is it envisaged that all of the costs will still be recouped from fees?

[Jackie Doyle-Price]

On day one of exit under this scenario, the MHRA will, as the hon. Lady says, continue to wash its own face. As to what might materialise subsequently, that would be subject to further discussion. I would not rule out anything at this stage. We are trying to ensure that the business can continue as usual on 30 March if we leave without a deal, but—let us set this in stone—that is if that is the result on 30 March. If we end up in that scenario, we will of course want to make sure that we have got things working effectively. It is also true that we will have to see how relationships work in practice. We can already see that some market practices are preparing for a no deal; others are not. We have said what we are prepared to do to recognise what has happened and what is licensed and goes through the regulatory system in Europe. We are being quite open about accepting that.

The hon. Lady mentioned batch testing, for example. We cannot be sure the same will happen in Europe. We will have to monitor how that works out in practice before setting in stone what the future regulatory regime will be. I come back to my original point: this is for day one of exit to keep the show on the road.

[Dr Whitford]

The Minister talks about preparing for a no deal, but as the EMA does not have associate membership, most of what is being put in place will be required, deal or no deal.

[Jackie Doyle-Price]

That is right. As I have said, we are seeing that some parts of industry are preparing for that scenario on the basis that there will be no associate membership. Having left in that scenario, if we look broadly at how the MHRA discharges its functions and how it is funded, at this stage we are looking at it continuing as usual and washing its own face. The hon. Lady mentioned that we could use some of the Brexit dividend to meet the cost. All of that is completely wide open at this stage. This measure is really just to keep the show on the road.

We have put some expectations down in terms of review. Most of the commitments we have made are to review all of the operations within two years. As for any conclusions we reach, we will come back to Parliament to institute any change if that is what we wish to do, but that would be done very much in consultation with industry and in a transparent way, recognising that all Opposition Members are not entirely satisfied. Clearly, we will go back to business as usual when it comes to scrutiny of these matters. Again, I cannot say often enough that I do not want that eventuality to materialise. It is my determination that we leave with a deal.

There was a reference to the impact on SMEs. The MHRA is taking steps to ensure that the burden on them is minimised. It will look at things such as fee waivers for some products to encourage further research and innovation. Again, that recognises the real concern about that.

[Jackie Doyle-Price]

I trust the MHRA to manage its own finances and take a proportionate view as to what is an appropriate fee, because it has the day-to-day contact with businesses. Overall, it will still be expected to settle its budget on the basis of the fee income that it incurs. That still gives it the freedom to do that, if that is in the sector’s strategic interest.

We have responded to some of the representations made by business about the potential additional costs. One reason that we introduced the responsible person for import assurance procedure was to minimise, as effectively as possible, the burden on the trading of the wholesale sector. Again, that recognises that where things have been checked and have gone through an appropriate European regulatory procedure, we should be satisfied that that is good enough for us. I am confident that that pragmatic approach will be repeated as the MHRA takes the matter forward.

Several points were made about the MHRA’s ability to take on new roles. The UK already has substantial capacity and expertise to regulate and evaluate the safety of our medicines and medical devices. The MHRA has real expertise in many areas, including pharmaco- vigilance and clinical trials regulation, which provides benefits to patients across the EU. I am confident that the EU will want to retain access to that expertise. That also shows that the MHRA has the expertise and human resources to discharge those roles. It has 30 years of experience as a lead regulator, it has led on the registration of more than 3,500 medicines, and it is globally recognised for its expertise. None the less, it will manage the demands on its service and I have every confidence in its ability to do so.

The hon. Member for Ellesmere Port and Neston raised the issues of continued access to medicines and of reviewing the fees. The statutory instrument provides continuity for patients and businesses by providing for existing EU licences to be automatically converted into UK licences, which should give continued access to medicines and will be done at no cost to industry. It also puts in place a new licensing route that will allow the MHRA to accept the same information from companies that apply for an EMA licence and that will allow the UK to grant a licence in the same timeframe as one would be received today.

Effectively, we will follow and replicate what the EMA does. There has been much talk of the UK being rule takers and hon. Members might suggest that there is no change here. That recognises, however, that we are in a global marketplace for medicines and that we all want to have access to the best medicines. In practice, there is much shadowing and sharing of expertise in this area. That raises a question that we do not have time to debate this afternoon, but there is much to be gained from international co-operation in this area.

Obviously, we want to make sure that the UK remains an attractive market for new medicines and for innovation. As I said earlier, we will review the fees set out in the SI within two years to make sure that they remain competitive and fit for purpose, and that they deliver the objectives that we want to achieve through the regulatory system.

The hon. Gentleman laid down a challenge; he said that the regulations go beyond a simple technical implementation of the directives into UK law and raise new powers for the Secretary of State. Clearly, the regulations are made under section 8 of the European Union (Withdrawal) Act 2018, which gives Ministers powers, where appropriate, to take additional powers. However, the changes are the minimum necessary to maintain continuity while protecting the health of UK patients while we are outside the EU, although clearly there is concern about issues of supply, as the hon. Member for Central Ayrshire mentioned.

We do not anticipate needing to use the Henry VIII power. We are confident that the regime that we have set out will ensure continuity of supply. However, in the event that that did not happen, provision would be needed. The power is a safeguard to be used in the case of serious shortages. I would not choose to describe it as a Henry VIII power, but I recognise the right of Opposition Members to do so. It is limited to temporarily modifying the effects of the human medicines regulations, for a limited time or purpose. As has been mentioned, the statutory instrument would use the negative procedure, but it could obviously be annulled. However, it would be used only where existing processes had been exhausted.

The hon. Member for Ellesmere Port and Neston raised the question whether any particular medicines would be at risk, and also mentioned prices in that regard—a concern that I think the hon. Member for Central Ayrshire will share. Clearly the MHRA consulted on the issue, and that informed its analysis. Any potential increase in medicine prices will depend on the extent to which costs are passed on to the consumer; but we shall bear the matter in mind, with regard to future medicines price negotiations. It is something that we shall have to keep an eye on at this stage. It is difficult to quantify. None the less, we have made clear commitments to the public about what they can expect, and about ensuring a continuous supply of medicines, and we shall have to find ways to deliver on those commitments.

[Dr Whitford]

Is the Minister aware that the Royal College of Radiologists has now produced emergency guidance to nuclear medicine departments, simply because the UK Government did not, on the potential threat of shortage of radionuclides and radiopharmaceuticals, both for scanning and for cancer treatment?

[Jackie Doyle-Price]

I was not aware of that, but I encourage everyone to participate in the dialogue, because in such an event the whole system would need to be ready. I shall perhaps come back to the hon. Lady on that specific point because, although much of our no-deal preparation is happening within the confines of Whitehall, it is not all being shared publicly.

I emphasise that there have been massive conversations with industry, including those in the life sciences industry—and with charities—about the changes, to make sure that everyone is prepared.

[Dr Whitford]

The Minister says that preparation is happening in Whitehall that is not being shared with the public, but we are talking about the president of the Royal College of Radiologists. The people who actually deliver scans have not had any guidance from the Government. That is not scaremongering. They have to be ready for something that could happen in a few weeks. They are talking about delaying patients, planning light weeks, and when the molybdenum will arrive, because those things cannot be stockpiled. Why has there not been guidance to the NHS about how to prepare to deal with shortages of radionuclides?

[Jackie Doyle-Price]

My understanding is that those conversations have been taking place. However, the hon. Lady is right that the very nature of those products, which cannot be stockpiled, has brought complications. I fully expect the president to be involved in those conversations. I do not have that knowledge to hand now, but I will write to her afterwards, to give her some reassurance.

We had two waves of consultations on the draft instruments. For the last, in October, we issued a consultation that received 170 responses, through which we ended up with the proposals before us. Again, these are subject to further consultation with the industry.

It is obviously a priority for us to make sure that Britain remains a competitive location for life sciences companies, and we are committed to maintaining our renowned strength in science and research. Since the referendum, we have seen many signs of the industry’s continued confidence in the UK. In 2017, we received the highest level of life science investment in Europe, and were second globally only to the US. That illustrates the confidence in our regulatory system, which is why we are confident that the MHRA is well up to the task given to it by the draft statutory instruments.

The hon. Member for Ellesmere Port and Neston gave an impressive illustration of what he described as the confusion regarding the various dates at which parts of the draft regulations will come into effect and the complexity of some of the references within them, and he posed legitimate questions on how business would understand and prepare for them. However, as I say, we have produced detailed guidance to support everyone in interpreting the draft instruments, and the MHRA does not expect anyone to navigate this alone and will be there to give advice. That support is partly reflected in the length of time that businesses will have to prepare for and implement these measures. We will ensure that that dialogue continues.

The hon. Gentleman also raised questions about market access and legal accountability, and whether we will have sufficient people to discharge that role for the industry. We believe that those skills are already in place, bearing in mind that a lot of companies will already have to fulfil these functions with the EMA, particularly when exporting. We do not anticipate that this change will be disproportionately onerous on business. However, we have given the industry 21 months to implement that aspect. To make sure that only genuinely qualified people undertake that role, anyone who vouches for a medicine that is then potentially harmful to patients faces a maximum two years’ imprisonment. The sector has sufficient integrity to engage only properly qualified people; to do otherwise would be foolhardy.

Questions were asked about the degree to which UK consumers could be protected from false medicines. To reassure Committee members, the falsified medicines directive, implemented in 2013, will remain in UK law, even in the event of a no-deal exit. We will make sure that we continue to apply the same protections as before. We obviously want to retain a close working partnership with the EU on medicines regulation, and I think that we will be able to share expertise and information on such issues over and above any potential mutual recognition of regulations. We will all benefit from that information sharing. Issues were also raised about the wholesale sector. We will obviously continue to ensure that the MHRA keeps a good eye on that and makes sure that that regulatory regime is fit for purpose.

Turning to some of the comments about the devices, we will continue to recognise the CE mark on medical devices. It is also fair to say that the existing regulatory regime has perhaps been seen as rather liberal in its approach—the hon. Member for Central Ayrshire alluded to this when she referred to mesh—and it has been subject to some revision at EU level. Certainly, we want to follow what is happening with that review and consider whether there are any further improvements we would wish to make to that CE mark system.

To those colleagues who thought that leaving the EU might lead to a bonfire of regulation, I say that, clearly, when it comes to medical devices, some of which remain within the body for a length of time, we should not stint in our approach to the protection of patients. Patient safety should be the primary objective, notwithstanding the importance of maintaining a competitive marketplace. Patient safety is crucial.

There are estimated to be around 600,000 medical devices available on the EU market, many of which have not been produced in the UK or approved by UK-notified bodies. It would be quite a big undertaking for the MHRA to license those products, but we will increase our market surveillance by requiring all new devices being placed on the UK market to be registered with the MHRA after exit day by the manufacturer or a UK responsible person, in accordance with the transitional timetable. Our emphasis is patient safety first and foremost, while doing our best to improve access to the market. We will require, as the hon. Member for Ellesmere Port and Neston said, all overseas manufacturers to register those products here with the MHRA themselves.

We have also had some discussion about the RP-I. That is a new role; the hon. Gentleman asked how many will be required and where we will find them. We are giving the industry a two-year transition period, to give it the opportunity to register those persons with the MHRA, and it will depend on the number of wholesalers who intend to import products from the EEA. We are satisfied on the basis of the discussions we have had with the industry that that two-year implementation period is appropriate, and there has been consultation on exactly what sorts of skills those persons should have, with the intention that they should fill the regulatory gap caused by our removal from the EMA, but without putting undue burdens on the industry.

Exiting the European Union (Medicines)

Philippa Whitford Excerpts

Tuesday 19th February 2019 Commons Chamber

[Jackie Doyle-Price]

I appreciate the hon. Gentleman’s point. Perhaps I can reassure him by emphasising that the UK is committed to establishing a far-reaching science and innovation pact with the EU to facilitate the exchange of research and ideas, so we continue to maintain the competitiveness to which he refers.

In bringing forward these proposals, we have been determined to establish our pattern of regulation from outside the EU if need be, but as much as possible we wish to continue with business as usual. We will continue to engage with the sector to maintain competitiveness, because we fully appreciate the value of the life sciences sector to our economy.

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

Paragraphs 7.6 and 7.7 of the explanatory notes highlight that the EU makes information public and transparent. They talk about the MHRA doing that, but they do not mention that the MHRA would be publishing data within the upcoming EU system.

[Jackie Doyle-Price]

The regulations are determined to facilitate transfer with not only EU bodies, but internationally. We fully recognise that in bringing forward the regulations we are operating in an international landscape. The regulations are designed to facilitate that co-operation, as well as to establish the MHRA as the lead regulator. It is worth noting that, within the current system, the MHRA is the lead. In terms of the regulation we are transposing, rather less is coming to the MHRA given the existing ownership it has in this field.

--- Later in debate ---

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

As we all know, Europe is the biggest research network in the world—bigger than China and America; and the UK and, within the UK, Scotland have been major beneficiaries. As the shadow Health Minister mentioned, the EMA provides a single licensing system, and countries outside Europe that are not major economies, such as Canada and Australia, face a delay of six months to a year in accessing and licensing new drugs. The EMA is not just a licensing body, however; it also funds and promotes research, particularly into rare conditions and childhood diseases.

Europe created the comprehensive trial regulation system with the clinical trials directive in 2001 and the good clinical practice directive in 2005. As mentioned, however, in 2014 a new directive introduced the EU clinical trials information system and the new trials regulation system, which will be under the control of the EMA when it comes into force next year. The system will provide a single portal for sponsors to register, collaborate and analyse their work and will provide work spaces for authorities and a public site that will tell patients what trials are going on and what their benefits are. It will also contain the EudraVigilance database on medicinal products that are not yet licensed, which is critical during initial trials.

The MHRA will take on the full role of clinical trial regulation, including legislative functions currently carried out by EU bodies, which will obviously mean additional work and costs for the MHRA. I welcome the Government’s commitment to align closely with the new European regulations, but this is not the same as being part of a single collaborative system. I note that the UK Government plan to recognise sponsors in the EEA, since EEA states will be recognised as approved countries—this is one of the amendments made—to minimise upheaval, but that means there will not be any compulsion to have a legal representative or lead researcher here in the UK.

Clinical trials sponsors must report any suspected unexpected serious adverse reactions—SUSARs, as they are known—to the EU database. They can currently do that from the United Kingdom, in a straightforward fashion. Similarly, any SUSARs registered elsewhere in Europe are entered in the database, so that concerns are highlighted at the earliest point during trials. Many of us will remember safety trials carried out on human subjects that resulted in major damage. It is critical that the UK does not operate in a vacuum.

Before licensing, particularly in the early stages of safety, dosage or phase 1 trials, investigational medicinal products are used. Those products are unlicensed, and, as the Minister said, they must be certified by a qualified person based in the EEA. If they are made in the EEA or in a third country, that is critical. For IMPs made in a third country, the importer must have a manufacturing and importation authorisation, and must ensure that a qualified person certifies the products before supplying it.

Unfortunately, the regulations mean that bringing a drug into the UK for the purpose of a Europe-wide trial and exporting an IMP to Europe from a UK pharmaceutical firm will introduce bureaucracy. It is bizarre to claim that there will be no additional bureaucracy. The regulations merely describe the extra licences that will be required. The MHRA will publish data on UK trials, but there is no promise that they will also be posted on the EU trials information system.

Simply creating something separate will not replace our collaboration across Europe. We are seeing duplication, obstruction and expense. I am sorry to say that those are all the enemies of collaboration—and that defines the loss that is Brexit.

--- Later in debate ---

[Jackie Doyle-Price]

I thank all hon. Members who have participated in this debate, which has demonstrated how vital it is that we make sure the legislative underpinning of clinical trials continues safely, as the hon. Member for Washington and Sunderland West (Mrs Hodgson) outlined in her opening comments. That is by far our biggest priority: we need to continue business as usual, and to value our important pharmaceutical and life sciences sector and guarantee people’s safety.

I will try to address some of the points made today. The hon. Lady mentioned the clinical trials regulation and what it would mean in terms of adoption by the UK if it was implemented after March 2019. We expect the clinical trials regulation to be implemented in late 2020, and the MHRA, the National Institute for Health Research and the NHS have been working towards the implementation of that regulation since it was agreed in 2014. The withdrawal agreement Bill will give effect to the implementation period in domestic law and will allow EU regulations to continue to apply directly in the UK for this time-limited period. If the clinical trials regulation comes into force during the implementation period, as it is currently expected to, we would expect to apply that to the UK. If however we leave without a deal—this is why we have these regulations—the CTR will not be in force in the EU at that time so will not be incorporated into UK law on exit day; however, we intend to align, where possible, with the CTR without delay when it does come into force, subject of course to the usual parliamentary approvals. But that alignment will happen after 29 March 2019.

The two key elements of the regulation that are outside the UK’s control and that this instrument does not therefore cover are the use of the shared central IT portal, as mentioned by the hon. Member for Central Ayrshire (Dr Whitford), and participation in the single assessment model, both of which will require negotiated UK-EU agreement regarding UK involvement post-Brexit. This reiterates the wish expressed by the hon. Lady and shared by me that it would be far preferable if we can leave the EU with a deal. Sadly, experience tells us that these things always go to the wire, but let us hope we get a resolution sooner rather than later.

The hon. Lady also mentioned patient safety. Currently a sponsor can report a suspected unexpected serious adverse reaction—SUSAR—during the course of a clinical trial through the EU database. Similarly, all SUSARs originating outside the UK where the sponsor has an ongoing trial in the UK involving the same medical products currently must be entered on the EU database, and we will clearly need to find a way of entering that so we can share such information and have arrangements for holding it on the MHRA database.

[Dr Whitford]

Does that mean that that ability is not there if the UK leaves without a deal, for April of this year?

[Jackie Doyle-Price]

Being brutally honest with the hon. Lady, and perhaps more honest than some are in this debate, I do not think we can dictate terms to our EU partners; I think we can look forward to having constructive working arrangements with them and it is in all our interests to do so, but ultimately we would have to seek agreement about this. At this stage this SI can only really cover the things that are in the gift of this Government, and a lot will rest on good co-operation after the event, which again means it would be much more preferable to leave with a deal.