NHS: Shortage of GPs and Nurses

Baroness Blackwood of North Oxford Excerpts

Wednesday 8th May 2019 Lords Chamber

[Lord Clark of Windermere (Lab)]

My Lords, I beg leave to ask a Question of which I have given private notice.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Blackwood of North Oxford) (Con)]

My Lords, the Government recognise the pressure on the NHS workforce. The forthcoming NHS people plan will set out how we will attract more people into training and keep the workforce that we have in the NHS. In 2018, Health Education England recruited a record 3,473 junior doctors into GP specialty training—a 10% increase since 2017. Demand for nursing courses is strong: the latest data, published this February, showed a 4.5% increase in the number of applicants compared with 2018.

[Lord Clark of Windermere]

My Lords, I thank the Minister for her Answer and acknowledge her long-term commitment to the National Health Service. I shall not just swap statistics with her—that is easy—but I wish the Government would not keep repeating basic statistics. She talked about an increase in the number of GPs, but we have the lowest number of GPs for more than 50 years, with patients on occasion having to wait seven weeks for an appointment. We know that there is a 40,000 shortage in the number of nurses and that, according to the interim report that the Government have received and despite all their efforts, that figure could increase to 68,500. That report states that shortages in nursing are the single biggest and most urgent problem. Instead of playing around, will the Government seriously address the drastic situation that our NHS is in? We truly survive because of the efforts of the staff.

[Baroness Blackwood of North Oxford]

I thank the noble Lord for his Question and I echo his sentiments exactly in thanking GPs, nurses and all of our NHS workforce. Probably every noble Lord in this Chamber has a personal story of owing the NHS for personal service, as we do as a nation. That is exactly why the Government have put in a serious plan to address the challenges within the workforce. First, within the long-term plan we identified an increase in funding that is higher within general practice and community care than the wider increase in funding of £4.5 billion. Secondly, we have recruited the highest number of GP trainees ever. This is not swapping statistics, this is identifying the fact that we are being successful in recruiting into a challenging specialty. Thirdly, we are opening brand new medical schools to ensure that we have the capacity to increase training, while recognising that it takes time to grow a doctor. Fourthly, we are putting in place incentive programmes to make sure that the job is more attractive, so that we can retain those individuals.

Within the new general practice contract framework we have put funding in place for up to 20,000 more support and technical staff working in GP practices in order to relieve the pressure within that job. This will help bring down delays in getting appointments and make sure that the job is more attractive in itself. When it comes to nursing, we have put in place a pipeline, with new nursing associates and the new nursing degree apprenticeship, and we see this starting to pay off. So there is an improving picture, but there is still some way to go. We are making sure that we put in place a serious plan and we are determined to deliver on it.

[Baroness Walmsley (LD)]

My Lords, the Nuffield Trust has noted that there are fewer GPs per head in poorer areas than in wealthier areas. Health inequalities in this country are being made worse by some of the political decisions of this Government. Can the Minister say what steps the Government are taking to ensure that everyone has equal access to a GP, whatever their income and wherever they live?

--- Later in debate ---

[Baroness Blackwood of North Oxford]

The noble Baroness is right that driving out variation within the NHS is one of the key commitments of the long-term plan: it can be seen as a priority throughout every commitment within it. One of the ways in which we intend to do this is through the new undergraduate medical school places; the expansion in medical schools has been targeted specifically to address that. Those medical schools will be placed in key areas—Sunderland, Lancashire, Chelmsford, Lincoln and Canterbury—to ensure that we recruit doctors from right across the nation. That is something that I think she will welcome.

[Baroness Finlay of Llandaff (CB)]

My Lords, I declare an interest as the author of Medical Generalism, a report for the Royal College of General Practitioners some years ago. Do the Government recognise that while their moves to increase supply are admirable and welcomed by everyone, the problem is retaining staff? We have an increasing number of medical and nursing staff who, for reasons to do with taxation, their pensions and their revalidation processes, find that it is just not worth their while to carry on with the onward, uphill struggle to carry on providing services. I recently met some who have dropped off the medical register simply because the revalidation processes were just too cumbersome for them. These are good clinicians, whose skills are now being lost. Their skills are also being lost from the pool of people to teach the next generation of doctors coming through the system. These pressures are now having a knock-on effect in emergency departments, where waiting lists are going up inexorably, and we know that that is being reflected in the four-hour waiting targets. Talking to staff in emergency departments, they are routinely seeing situations that used to be unusually busy.

[Baroness Blackwood of North Oxford]

I thank the noble Baroness, who is very expert in this area. She is absolutely right that there is no point in our bringing new trainees into the system if we do not retain the expertise and the teaching quality within the system. We can be very proud of the quality we have within the system, which is why we have put in a number of programmes to address this. We have put in a targeted, enhanced recruitment stream to attract doctors into parts of the country where there have been consistent shortages. We have put a broad offer of support for GPs to remain within the NHS, including GP Career Plus, the GP Retention Scheme, the Local GP Retention Fund and the national GP Induction and Refresher Scheme. We have also put in place a number of schemes for nurses, including a scheme that will attract nurses into specific, targeted areas, such as mental health, learning disabilities and district nursing, where we believe we should make the career more attractive. We recognise that there is more to do, and in areas such as pensions, which the noble Baroness rightly raised, we are taking that issue up with the BMA and the Treasury.

[Lord O’Shaughnessy (Con)]

My Lords, the increased numbers of staff coming through GP and nurse training are of course incredibly welcome but the truth is that we have a problem now, which is that we need more doctors and nurses practising today. One way to do that is to look around the world to recruit people, but another way is to make sure that we make the most of the resources we have through technology. Can my noble friend tell the House what the department is doing to enable us to use technological solutions to improve the efficiency of the GPs who are practising today?

[Baroness Blackwood of North Oxford]

My noble friend is absolutely right, and he has his own expertise in this area. I am pleased to be able to report that we have had an increase in recruitment of nurses and NHS workers from abroad. Compared with June 2016, we have over 5,200 more EU health and care staff working in the NHS, and we have had a 126% increase in the number of non-EU NHS workers, which shows the attractiveness of working within the NHS. But he is also right that we need to make sure that those who work in the NHS have access to the most innovative and effective tools possible, which is why, particularly within GP practice, we are launching the GP IT Futures programme. That will provide GPs with the best tools possible so that we can make their job more efficient while also allowing them to provide the best-quality care to patients.

[Baroness Thornton (Lab)]

My Lords, I think I need to declare an interest as a member of a CCG; I spend some of my time surrounded by GPs, who are utterly wonderful, and who tell me that morale is not good. The problem is that a lot of GPs are leaving because they are completely fed up with the way that they have been treated by the NHS. That has to be taken account of by the noble Baroness, Lady Harding, as part of her work in bringing forward the plan, and I know it will be.

I am afraid that it does not say much about the current lack of a workforce strategy that we are having to trawl the world to get GPs and nurses to come and work in the UK. I know that other Members of your Lordships’ House have been worried that we are taking nurses, GPs and doctors from countries where they are very much needed. Will the Minister address how to deal with the morale of GPs, as well as the ethics of the UK recruiting nurses and doctors from countries where they are needed?

[Baroness Blackwood of North Oxford]

I slightly question the premise of the noble Baroness’s question, given that I am the daughter of an English doctor and a South African nurse. This has always happened in the NHS, and it is an absolutely acceptable process. Recruitments go back and forth between nations, and that has always been the case.

To move on to the noble Baroness’s question about morale in the NHS, particularly within general practice, it is essential that that is addressed, and she is right that GPs are the bedrock of the NHS now and in the future. That is why we have announced in the long-term plan not only that we are investing an extra £4.5 billion in primary and community care, which is at a faster rate than the rest of investment within the NHS, but the new contract to develop partnerships to provide greater certainty for GPs to plan ahead and to give them the extra 20,000 support workers who can make the job within GP practice more effective and sustainable. That is also why we have announced the GP IT Futures programme to give them the tools that they need to deliver more effective services and to deliver better-quality care, and why we have announced targeted and enhanced recruitment schemes to support and retain GPs within practices, not only in hard-to-reach areas but within the pipeline. That demonstrates that the Government are completely committed to general practice and will retain that commitment as long as we are able to do so.

Atrial Fibrillation

Baroness Blackwood of North Oxford Excerpts

Tuesday 7th May 2019 Lords Chamber

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Blackwood of North Oxford) (Con)]

My Lords, I thank my noble friend Lord Black for giving us all this opportunity to discuss what is not just an important issue but one that must be of incredible importance to him personally, and for sharing his story to date. As noble Lords are aware, and as we have discussed, although briefly, AF is a common heart rhythm disorder associated with debilitating consequences including heart failure, stroke, poor mental health—which we have not yet discussed—reduced quality of life, and death.

As my noble friend rightly said and others repeated, anticoagulation is an effective therapy for managing people with AF who are at risk of stroke. It can reduce the risk of stroke by up to 66%. AF increases the likelihood of stroke by five times; on average, there are 40 AF-related strokes every day in England. As my noble friend rightly indicated, PHE has been working alongside key partners to increase the proportion of patients with AF offered appropriate treatment from 74% to 89% by 2021. I will come on to the questions asked about surveillance and data.

My noble friend and other noble Lords are absolutely right that, although we have made progress on treatment, regional variation remains in the detection of AF and appropriate treatment. For that reason, a national programme was established in 2017 by NHS England and Public Health England to tackle the issue of AF-related strokes. Through this work, the 15 academic health science networks across England made it a priority to “detect, protect and perfect”—that is quite challenging to say in one sentence—AF services.

In response to questions from my noble friend Lord Black and the noble Viscount, Lord Craigavon, regarding the importance of accurately monitoring progress, a number of quality and outcomes frameworks—QOFs—measure the diagnosis and management of patients with AF. I am pleased that, based on the captured data, we can say accurately that progress has been made and that, as of last year, 84% of people with AF were appropriately managed with anticoagulation treatment; however, as the noble Viscount said, those people are only those who have been identified. It has therefore been agreed that the ambition for optimally managing AF should be increased to 90%; there is clinical consensus that this revised ambition is appropriate and achievable.

As the noble Baroness, Lady Wheeler, rightly identified, there is a role for technology to aid self-management and prevention. That is why, in July 2015, AliveCor’s KardiaMobile ECG mobile heart monitor, which allows individuals to detect, monitor and manage heart arrhythmia, joined the NHS Innovation Accelerator. Currently, 33 NHS organisations, including GP practices and acute trusts in all 15 academic health science networks, now use it with the aim to reduce the prevalence gap in AF to ensure that more people are treated appropriately to prevent AF-related strokes.

As has been mentioned, The NHS Long Term Plan, published in January 2019, sets out the ambition to prevent 150,000 heart attacks, strokes and dementia cases over the next 10 years. It includes commitments to developing and implementing an AF patient optimisation demonstrator programme, helping to case-find and optimise treatment for people with known cardiovascular disease. That is important because it will include practice pharmacists being trained in shared decision-making skills to utilise when having conversations with patients about their treatment options, which answers some of the questions asked by the noble Lord, Lord Rennard. It will also give health professionals the opportunity to work together with patients to decide on a patient’s treatment and care. SDM has been shown to improve patient experience and increase adherence to medication—a crucial issue raised by the noble Viscount, Lord Craigavon.

Clinical pharmacists, anticoagulant nurses or other appropriately qualified clinical staff will also carry out case-finding in GP records to find people with untreated AF as part of this programme, which is an encouraging part of the commitment made in the long-term plan. The programme launched on 7 May was developed in collaboration with Public Health England, the British Heart Foundation, the academic health science networks and NHS RightCare, as mentioned by the noble Baroness, Lady Wheeler. Through the programme, NHS England will invest £9 million over 18 months to case-find patients in GP records who have been diagnosed with AF but are not receiving optimal treatment. Twenty-three CCGs across England have already begun implementing the programme.

Of course, stroke prevention and treatment is a priority for the NHS. NHSE has been working closely with the Stroke Association to develop a national stroke programme to be delivered within the timeframe of the long-term plan. As the noble Baroness knows, the implementation plan will be published shortly. The programme will build on the successes of the Department of Health’s national stroke strategy and look at how to improve stroke care across the whole pathway, addressing the challenges of prevention—in this case, secondary prevention—service reconfiguration, optimising rehabilitation services, workforce development and transformative data. NHS England has engaged with cross-sector partners to support Health Education England in the development of workforce modelling for strokes. Health Education England is also looking carefully at the various components of the proposed stroke pathway and undertaking workforce modelling to articulate which workforce will be required; that will be engaged in the discussions on the spending review, as we have discussed previously in Questions. It has worked with arm’s-length bodies, charities, professional associations and academics to ensure that the required workforce is achievable over the period of the long-term plan.

The long-term plan also outlines commitments to improving vital stroke rehabilitation services. The recently established Stroke Programme Delivery Board also aims to place a strong focus on rehabilitation. Campaigns to increase awareness of stroke onset have been in place since 2009; of course, that is essential because early response is vital in avoiding disability. Public Health England has run the “Act FAST” national campaign, of which I know your Lordships will be aware. It has helped to reduce the amount of time between someone having a stroke and arriving at hospital, helping those eligible for thrombolysis and thrombectomy to access treatment in a timely way. As a result, 5,365 fewer people have become disabled due to stroke since 2009—an outcome we can all be pleased about.

I will answer some of the questions asked by the noble Baroness, Lady Wheeler, and the noble Lord, Lord Rennard, regarding regional variation. Quality of care varies greatly depending on geographic location, the day of the week and even the time of day that a patient is admitted. The NHS is working with providers to share best practice through initiatives such as that mentioned by the noble Baroness: the RightCare programme, which sets out optimal pathways for the care of stroke patients and AF patients through the collection of data in the Sentinel Stroke National Audit Programme.

My noble friend Lord Black, the noble Viscount, Lord Craigavon, and the noble Lord, Lord Rennard, all rightly linked surveillance, training and optimal treatment. CVDprevent will be the national primary care audit tool, and has been referred to by a number of noble Lords. It will automatically extract routinely held GP data covering the diagnosis and management of six high-risk conditions that cause stroke, heart attack and dementia. It will be implemented from March 2020, in response to a question asked by the noble Baroness, Lady Wheeler. The outputs will include regular national data extraction for a professionally led national audit programme which will be limited to routinely recorded primary care data. They will require no input from GPs. Analysis and reporting will identify achievement, gaps, variations, opportunity and treatment. They will also support systematic quality improvements to reduce health inequalities, a point mentioned by a number of noble Lords. They aim to improve outcomes for individuals and populations.

I also point to the primary care networks, which will be required to deliver a set of seven national service specifications. Five will start in April 2020: structured medication reviews, enhanced health in care homes, anticipatory care with community services, personalised care, and supporting early cancer diagnosis. The remaining two, which will start by 2021, comprise cardiovascular disease case finding and locally agreed action to tackle inequalities. All these will go towards answering the questions that have been raised in the debate.

I am conscious there were some questions that I have not been able to answer, and I will be happy to write on those. I hope that I have demonstrated in my response the NHS’s commitment to improving outcomes not only for people living with AF in this country but for the many more who are at risk of suffering from stroke. I cannot think of a more fitting way to close this debate than by repeating the excellent point from the CVD report referred to by the noble Viscount, Lord Craigavon: the return on investment of getting this right will be measured not just in a better quality of life for patients, important though that is, but in lives saved and life-changing disabilities averted. That is something which we must all work together to achieve.

Antimicrobial Resistance

Baroness Blackwood of North Oxford Excerpts

Thursday 2nd May 2019 Lords Chamber

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Blackwood of North Oxford) (Con)]

My Lords, I thank my noble friend Lord Lansley for securing a very important debate which has been filled with expertise and wisdom from all sides. I am grateful to him for saying that, if he could, he would have chosen to make this a “take note with approval” debate, which is not always the case when debating a government strategy.

My noble friend is right that antimicrobial resistance is one of the most pressing global challenges that we face in this century. Unchecked AMR threatens the achievement of many of the sustainable development goals, including those affecting health, food security, trade and labour supply. The World Bank estimates that an additional 28 million people could be forced into extreme poverty by 2050 through shortfalls in economic output unless resistance is contained.

In recognition of the threat of AMR, we published the strategy in 2013 and, as my noble friend has rightly said, we can count many significant achievements over the five years since. I pay tribute to him for the role he played in developing it before he moved on. We have seen unprecedented levels of research investment and collaboration, with £350 million having been invested since 2014. We have also reduced antibiotic use in humans by 7.3%, as he noted, and as the noble Lord, Lord Trees, who is an expert in this area, rightly pointed out, sales of antibiotics for use in animals have reduced by 40%. However, the noble Baroness, Lady Masham, said that this is of value only alongside the development of comprehensive surveillance systems, which we have also been putting in place.

Finally, resources and campaigns have been delivered for front-line staff. As the noble Baronesses, Lady Redfern and Lady Walmsley, said, they have an essential role to play in changing the culture and communicating with the public. I would like to point to a particular tool which has been developed, known as “Treat Antibiotics Responsibly Guidance, Education and Tools”. It turns into a fantastic acronym—TARGET—which I know the noble Baroness, Lady Thornton, will like. It is a toolkit of evidence-based resources to help clinicians and commissioners in England to reduce inappropriate antibiotic prescribing. Some 99% of CCGs promote this to their GP practices. I hope that responds to the question raised by the noble Baroness.

However, we must be up front about the scale of the challenge that AMR presents here at home, let alone in developing countries. As has been noted in the debate, resistance continues to increase. Between 2013 and 2017, we saw a 35% increase in resistant infections in humans here in the UK. Just as my noble friend says, this is a dynamic problem that requires a dynamic response. However, I would like to reassure the noble Baroness, Lady Masham, on her questions about Candida auris. It can establish itself within the hospital environment and be difficult to control, but currently the NHS has no persistent outbreaks. It is an uncommon fungus in the UK and our surveillance shows a low risk to patients in healthcare settings. No multi-drug resistant strains have been identified and there have been no deaths in NHS hospitals.

In order to respond to the dynamic challenge we face, the Government have recognised that no single five-year plan could deal with it, so we have set out our vision for a world in which AMR is contained and controlled by 2040 and we will continue to play our part in tackling the global problem of AMR by modelling best practice at home. Further, by supporting progress internationally through strong action to prevent infection generally, we will contain the emergence and spread of resistance. Alongside this vision we have published a five-year AMR national action plan which sets challenging five-year ambitions that will begin to fulfil the vision.

I would like to reassure the noble Baroness, Lady Thornton, on the question she raised regarding the workforce. Unlike the NHS Five Year Forward View, the NHS Long Term Plan commits to implementing the AMR national action plan which sets out to assess current and future workforce needs for strong infection prevention and control as well as antimicrobial stewardship. This should ensure that we develop the correct workforce targets. This is reassuring in terms of hoping we can achieve the priorities we have set out in the plan.

Our new plan includes a strengthened focus on infection prevention and control, renewing our commitment to halve levels of healthcare-associated Gram-negative bloodstream infections by 2023-24. It includes a world-first target to reduce the actual numbers of resistant infections, with an aim to reduce them by 10% by 2025. We will go further on our previous ambition to reduce antimicrobial prescribing, reducing it by a further 15% by 2024, strengthening stewardship programmes and raising public awareness, while ensuring rapid and timely treatment with antibiotics where it is essential to save lives. Through greater interoperability of data, we will develop real-time, patient-level prescribing and resistance data to inform antibiotic treatment, optimise life-saving treatments for serious infections and help develop new interventions to reduce AMR.

The noble Baronesses, Lady Masham and Lady Walmsley, are absolutely right that better use of diagnostic testing is essential. However, we found many challenges in this area over the last five-year period with the previous plan. We believe that, through data linkage work, by 2024 we will know which diagnostic tools and tests have been used in support of every prescription for antibiotics and will be able to target improvement. There is also further research work going on, which I will come back to.

The noble Baronesses, Lady Greengross and Lady Walmsley, and the noble Lord, Lord Trees, raised the important issue of vaccines for humans and animals, which play a key role in tackling AMR. One of the nine ambitions for change set out in our 2040 vision is to minimise infections in humans and animals. Optimising the use of effective vaccines will be critical in achieving this ambition. The national action plan includes commitments to stimulate more research into and promote broader access to vaccines. One of the ways in which we are doing this and supporting the development of the uptake of vaccines in lower and middle-income countries is through the Global AMR Innovation Fund and the UK vaccine network, as well as through our significant contributions to Gavi, the Vaccine Alliance and, more recently, through CEPI, the Coalition for Epidemic Preparedness Innovations—which, we understand, is having a significant impact on the pipeline.

My noble friend Lord Crathorne raised the question of the use of antibiotics as growth promoters. He was rather put right by the noble Lord, Lord Trees, but I will just repeat for the sake of certainty that since 2006 antibiotics for use as growth promoters have been banned in the UK and Europe, and they will continue to be.

This brings me on to a point raised by the noble Baronesses, Lady Miller and Lady Thornton, and a point of clarification on the response to Kerry McCarthy. The Government have confirmed their intention to implement their restrictions on the preventative use of antibiotics in line with EU legislation, but this will require a consultation with all interested stakeholders following the usual processes when amending domestic legislation. I hope that is a reassuring clarification. If noble Lords would like to follow up in writing, I shall be happy to respond on that.

I will respond to a follow-up point that also came from the noble Baroness, Lady Miller, and the noble Lord, Lord Trees, regarding trade agreements and AMR. I assure the House that any future trade agreements must work for consumers, farmers and businesses in the UK, and we will not water down our standards on food safety, animal welfare or environmental protection as part of any future trade deal. I hope that is a reassuring response.

I hope the noble Lord will forgive me, but following the debate I shall raise his point regarding AMR funding associated with the Agriculture Bill with the Minister and return to him.

I will now move on to the question regarding research and treatment development. Building on our research co-ordination and collaboration, we must continue to invest in research and to support the development of new, alternative treatments, vaccines and diagnostics. As noted by noble Lords from across the House, this is clearly essential if we are to make progress on the aims we have set out in what is rightly an ambitious plan.

Significantly, as my noble friends Lord Lansley and Lord Crathorne point out, the plan includes a commitment to lead the way in testing solutions that address the failure of companies to invest in the development of new antimicrobials. We are the first country in the world to announce that we will test new models that pay companies for antibiotics based primarily on a health technology assessment of their value to the NHS as opposed to the volumes that are used. This is an exciting and important step and we must fight hard to push it forward.

The noble Baroness, Lady Walmsley, asked about timelines. NICE and NHS England are leading on this complex work and a core team of experts and specialists are already in place. There is no delay in pushing forward this work. We anticipate it will take 18 months to two years to complete. The current NICE appraisal processes take about 49 to 60 weeks but this project requires a bespoke process to deal with the complexity of considering the full dimensions and value for antimicrobials. I look forward to reporting back to the House as the project continues.

We are sharing our learning with other countries and encouraging them to do the same or similar. I hope that we can push for this to be raised in international fora, as it is only when these kinds of pilots happen on a global scale that we can hope to see real progress. We hope that the data generated from this work will help other countries to think about how they value these precious drugs and how we can work with the industry to overcome market failure.

A number of noble Lords raised the question of a global fund. We have made some initial progress with the Global AMR Innovation Fund, GAMRIF, which has been set up. We are pushing at every opportunity to improve collaboration and to get support for it. However, it is a challenging picture and I hope to be able to report more progress in coming months.

On co-ordination, the national action plan was co-developed across government departments, agencies, the health family and the devolved Administrations, with an input from a wide range of stakeholders. We intend to continue in that vein as it is the only way in which we will make effective progress. The UK has played a lead role in strengthening international co-operation to tackle AMR, not least in securing the UN declaration at the General Assembly in 2016.

I pay particular tribute to the noble Lord, Lord O’Neill, for his ground-breaking early work and expertise in this area. I join others around the House who have paid tribute and expressed gratitude to Dame Sally Davies in advance of October. She has been a driving force on the global stage on this agenda. I have no doubt that, whatever happens in the autumn, her leadership will continue from Cambridge and beyond. It will be of tremendous value to the United Kingdom and everywhere else that she goes.

Whether it is getting it right with new antimicrobials and getting them through the pipeline or it is supporting the development and testing of rapid point-of-care diagnostics, the Government are clear that we want to improve the whole system. I am pleased to update the House: today I announced a new and expanded accelerated access collaborative to serve as an umbrella organisation for UK health and innovation. The new AAC will work with patients and the system to pull through the best and most cost-effective innovations, to get them to clinicians and patients faster than ever before. This includes the use of digital tools and health tech alongside the best new medicines. From new diagnostic tools to better identify people who need treatment, to improved ways of monitoring usage to ensure that patients complete treatment courses, together these innovations will help to address the growing threat of AMR.

I hope that with this information I have covered the points raised by noble Lords today. We can be proud of the work that we have done in the UK to secure AMR on the global agenda, not only as a health issue but as a “one health” issue with an enormous social and economic impact. We have invested to turn declarations into concrete actions and to support countries to develop their capacity to tackle AMR, improve global surveillance and undertake vital research and development. Through this plan we are setting out our challenge to ourselves and to other countries to continue life-preserving work to preserve antimicrobials for future generations.

In closing, I do not think that I can do better than to follow my noble friend in quoting from the IACG report to the Secretary-General:

“The challenges of AMR are complex … but they are not insurmountable”.


We should take courage from this, but should remember that our success will depend on the urgency with which we drive forward this response and the continued success in securing international collaboration. I believe that together we can achieve that.

NHS Funding: Mental Health Services

Baroness Blackwood of North Oxford Excerpts

Wednesday 1st May 2019 Lords Chamber

[Baroness Thornton (Lab)]

With his consent, I beg leave to ask the Question standing on the Order Paper in the name of my noble friend Lord Bradley. Noble Lords will know why he cannot be with us today, and the House will wish to know how much he and his family appreciate the sympathy that has been expressed.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Blackwood of North Oxford) (Con)]

My Lords, NHS England and NHS Improvement have set out their commitment to increase mental health spending by at least £2.3 billion in real terms between 2018-19 and 2023-24. In five years, this will represent over 10% of NHS England’s additional settlement. More details of how the long-term plan will be resourced will appear in the implementation framework, which is due to be published soon.

[Baroness Thornton]

I thank the noble Baroness for that Answer. Given that mental health illnesses account for 28% of the burden of illness in the NHS but receive only 13% of its funding, I find her Answer very confusing. Can she be more precise? This is not just about the number of staff required but about how much will be required to achieve parity of esteem and over what period.

[Baroness Blackwood of North Oxford]

I thank the noble Baroness, Lady Thornton, for her question on behalf of the noble Lord, Lord Bradley. I am sure that the whole House will want to join me in sending him and his family our support at this difficult time.

The noble Baroness has asked a very important question. The mental health budget will increase by £2.3 billion by 2023-24, growing faster than the wider budget. We are using transparency to drive improvements. The mental health dashboard shows that last year, for the first time, all CCGs met the mental health investment standard, which is an encouraging sign. This builds on the work done in the five-year forward view, which delivered real improvements for patients. It delivered £247 million for liaison psychiatry, £290 million for perinatal services and £400 million for crisis resolution and home treatment teams. However, we will not rest there. The long-term plan will deliver much more for patients, including 345,000 more children and young patients to receive specialist support services. This is the ambition that we have and the ambition that we will deliver.

[The Earl of Listowel (CB)]

My Lords, I welcome the additional money and note my interest as a trustee of a mental health service for adolescents. Can the Minister assure me that highly experienced clinicians will be retained to provide vital supervision for the new people coming in at the front line—for instance, in schools? Is she concerned that there is a 1% decline in the trend for the number of child and adolescent psychiatrists, for example? Is it not crucial that we have highly experienced clinicians to supervise the new people whom the Government have in development?

[Baroness Blackwood of North Oxford]

The noble Earl is absolutely right that it is essential not only that we recruit new psychiatrists and mental health specialists to support the ambitions of the long-term plan—we have set out an ambitious plan to do so, intending to recruit 8,000 new specialists—but that we retain those within the system, who are doing an outstanding job in difficult circumstances. NHS Improvement is working with mental health trusts across the country to give them the tools that they need to do so, and I am encouraged by the progress that they have made so far.

[Baroness Tyler of Enfield (LD)]

My Lords, to help ensure that the money allocated for mental health services is indeed spent on improved mental health care and not diverted to other areas of NHS activity, will the Minister say what plans the Government have to introduce a strengthened mental health investment standard for children alongside the existing mental health standard, which focuses primarily on adults, and with meaningful sanctions imposed on CCGs that fail to meet the standard without a valid reason?

[Baroness Blackwood of North Oxford]

As usual, the noble Baroness’s expertise shines through in her question. She is right that we must ensure that the money allocated to children and young people’s mental health gets to exactly where it is intended. The dashboard is extremely valuable in tracking through the effectiveness of the funding priorities in this manner. We will be holding to account CCGs and mental health trusts in ensuring that the money allocated to trusts is spent on exactly what it is intended to be spent on.

[Baroness Redfern (Con)]

My Lords, can the Minister tell us what part of the ring-fenced mental health budget will be allocated to recruiting appropriately trained probation staff for the 39% of offenders who have mental health issues and ensuring they receive access to effective support?

[Baroness Blackwood of North Oxford]

I shall have to write to my noble friend in order to answer her question with the best accuracy possible. However, my understanding is that the ring-fenced funding will be spent on health professionals rather than probation professionals. One of the most effective measures introduced under the five-year forward view, which has delivered very effective outcomes, has been liaison services. I shall investigate the point that she has raised and come back to deliver the response that she deserves.

[Baroness Pitkeathley (Lab)]

My Lords, does the Minister agree that continuity is what is important here? That means continuity of care and of services across the NHS, social care and family support. In the absence of any coherent plan for social care, which is needed by mental health patients almost as much as medical care, have we any hope of achieving this continuity? And if the Minister could say anything about the Green Paper, I am sure the House would be delighted.

[Baroness Blackwood of North Oxford]

The noble Baroness is right to identify the need for continuity of care and the fact that community care is essential to ensuring good mental health outcomes. That is exactly why the focus in the long-term plan is on ensuring prevention and early intervention and on targeting the support of liaison services—for example, support for mental health training in the context of schools as well as for liaison services in policing and other areas. She is right that we must endeavour to deliver on the social care Green Paper. It is imminent, and I look forward to the debates in this House when it is produced.

National Institute for Health and Care Excellence (Miscellaneous Amendments) Regulations 2018

Baroness Blackwood of North Oxford Excerpts

Wednesday 1st May 2019 Lords Chamber

[Baroness Thornton (Lab)]

I thank my noble friend for bringing this matter to the Floor of the House and for leading this short discussion. I too have many questions for the Minister but many of the questions that I would have asked have already been asked by my noble friend and the noble Baroness, Lady Jolly. It seems that our concerns are very similar. I agree with the noble Baroness, Lady Jolly, that when I read through the notes accompanying this regulation, it seemed puzzling that the consultation had produced a majority against this process, and I too was not completely convinced by the Government’s justification. That must lead to something which we can probably call cuts and wanting to save money. To want to save money with an organisation which is so integral to our NHS infrastructure and so important to ensuring the efficacy and cost benefit of and access to medicines and procedures is not a sensible way to proceed.

Some of my other questions centre around a concern about the impact that these charges will have on the jewel in the crown that is the UK-based science industry, particularly at a time when there is already such uncertainty with the dual impact of Brexit and these charges. It seems that the additional costs for a market may diminish the UK’s attractiveness for life science businesses, which has already been mentioned, and may also mean that NHS patients get access to new therapies later than those in other countries across Europe, which my noble friend also alluded to. Has there been an assessment of the impact of these charges on the UK bioindustry and its attractiveness to the international life science community, and of the UK as a location to research, develop and launch innovative medicines?

What will be the impact on patients? The UK BioIndustry Association has stated its concerns that the charges for technology appraisals could either prohibit or delay patient access to medicines in England. This could result in inequalities across the UK, as medicines may be available in Wales and Scotland, where charges for technology appraisals have not been introduced, before receiving approval for use on the NHS in England. That might disproportionately affect patients with very rare conditions, and therefore might also undermine the UK rare disease strategy to ensure equity of access across all four nations of the UK. Have the Government considered not only the financial impact but the potential impact on patient health? Do the Government have a strategy in place to mitigate delays in patient access to medicines that may come from these charges?

I join the noble Baroness, Lady Jolly, in asking whether there will be a review of the impact of this proposal, when that will take place, and when we will learn about the impact of this proposal on NICE and the NHS infrastructure. That will be important. We need to review this, because I fear that it may be a wrong decision.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Blackwood of North Oxford) (Con)]

I thank all noble Lords who have contributed and congratulate the noble Lord, Lord Hunt, on securing this debate. It is an important subject and it is right that we take time to consider it. I know that he takes a keen interest in NICE’s work from his previous role as the first Minister with responsibility for NICE, and it is a privilege to have taken on his mantle some years later.

This year marks a significant milestone for NICE, as it celebrates its 20th anniversary, during which time it has transformed the way in which decisions are made in the health and care system. I echo the comments made by the noble Baroness, Lady Thornton, who referred to NICE as a jewel in the crown of the UK life sciences ecosystem. She is absolutely right that we must ensure that we not only protect it but promote its success. Since its inception, NICE has played a vital role, not only in securing maximum value from health spending but in ensuring that patients are able to benefit from rapid access to effective new drugs and other treatments. The noble Lord, Lord Hunt, hit the nail on the head when he said that that balancing act in the health system is so challenging.

Of course, the NHS is required to fund the treatments recommended through NICE’s technology appraisals and HST evaluation programmes, so that they can be provided if a patient’s doctor says that they are clinically appropriate for the patient. Over the past 20 years, more than 80% of NICE’s recommendations have supported use of the technology assessed, meaning that many thousands of patients have benefited from rapid access to effective new treatments. A less-frequently reported statistic is that 75% of HST applications have also gone through, which is encouraging.

Recent IQVIA research has just been published which showed that, despite some of the frustrations we have with update and access—which is something we are working hard on—the UK is in fact one of the fastest countries in Europe to get products through its regulatory system. We can be very proud of that, and must protect it.

I know that your Lordships will agree not only that it is extremely important that we have a system such as NICE in place to ensure the NHS spends its money in the most effective way possible, but also that it is critical that NICE operates on a sustainable footing so that it continues to be responsive to developments in the life sciences sector, to which noble Lords all referred.

To date, as has been mentioned, NICE’s TA and HST programmes have been funded through government resources but, as is common with government bodies, it is right that NICE considers how to operate to the utmost efficiency, and that those who stand to benefit from services contribute.

This is standard procedure and a standard model for many organisations and ALBs such as NICE. It is standard for the MHRA, the HTA, the CQC and for HTAs in other countries, so we are not operating an unusual procedure here, as the noble Lord, Lord Hunt, mentioned. I was grateful for his support for the charging model.

However, recognising the need for sustainability must be balanced with the imperative to encourage innovation, and the Government and NICE believe that the most appropriate and sustainable model for NICE’s TA programmes in future is for it to levy a proportionate charge on companies that benefit directly from its recommendations. This goes right back to a recommendation of the triennial review of NICE in 2015, so long-term work has been going on in this area. Recognising the importance of getting it right, the Government consulted on the draft regulations. That consultation has been referred to by noble Lords. At that point, as part of those proposals, the Government proposed the 25% discount for small companies. The consultation also sought views on a proposal to enable NICE to recruit appeal panel members engaged in the provision of healthcare in the health services across the UK instead of just England. This has not been mentioned and I know is widely supported, but I just wanted to point out that fact, which we are very pleased about.

As was raised by the noble Baronesses, Lady Thornton and Lady Jolly, there were 78 responses to the consultation, around half of which represented views from the life sciences industry, including pharma companies, industry representatives, consultancies and medtech companies. Other responses came from patient groups, NHS organisations and individuals. Although, as has been said, the majority of respondents—62%—disagreed with the specifics of the proposal to charge companies for making recommendations, the analysis showed that just over half of respondents agreed that life sciences companies should contribute to the cost of developing NICE recommendations, which is why further work was done to develop the charging proposal but refine it.

Respondents also supported, by 59%, a mechanism for reducing the impact on small companies, but felt that the proposed 25% discount did not go far enough. Other more specific concerns were raised about the potential impact on patient access to new treatments, in particular for rare diseases, the impact on NICE’s independence, and the analysis contained in the impact assessment.

The SLSC also picked up on issues in its report, and I will address some of those in response to points raised by the noble Baronesses, Lady Thornton and Lady Jolly. The Government considered the issues raised in the consultation very carefully and carried out further analysis to feed into the final impact assessment. We concluded that it was appropriate to make two main changes to the policy in light of the consultation responses. These particularly dealt with concerns about the design of the charging with respect to SMEs. I know that noble Lords are well aware of those concerns.

There is an increased discount for small companies of 75%, to minimise barriers to the participation of small companies wishing to bring forward new products. I realise that many feel that that did not go far enough but, to address that concern, it also included the new power to enable the Secretary of State to direct NICE in specific cases to calculate charges on what it considers to be the appropriate commercial basis. This provides more flexibility for amending charges, should that be required in future, subject to consultation with stakeholders. For example, we may see different types of innovation, including devices or digital products going through TA programmes, and this provides flexibility for the Secretary of State to direct NICE to propose charges at a level appropriate to those markets. I think that responds to the point raised by the noble Lord, Lord Hunt.

Social Media and Health

Baroness Blackwood of North Oxford Excerpts

Tuesday 30th April 2019 Lords Chamber

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Blackwood of North Oxford) (Con)]

My Lords, with the leave of the House I shall now repeat a Statement made today by my right honourable friend the Secretary of State for the Department of Health and Social Care, Matt Hancock. The Statement is as follows:

“Mr Speaker, I would like to update the House on yesterday’s social media summit and the progress we have made to tackle online harms to health. We called this summit to bring together principal social media companies, including Facebook, Instagram, Twitter, Pinterest and Google, as well as Samaritans and the eating disorder charity, BEAT. Along with the Education Secretary and the Minister for Suicide Prevention, this was the second such meeting I have held on how we can protect people, particularly children, from online content that promotes eating disorders, self-harm and suicide, as well as on how we address the growing problem of anti-vaccination misinformation.

Social media companies have a duty of care for people on their sites. Just because they are global does not mean that they can be irresponsible. We have been resolute that we will act to keep the internet safe, especially for children. I am grateful to the companies for their engagement. We have all seen and heard about tragic cases of vulnerable children turning to self-harm, even taking their own lives, after accessing graphic images online promoting, even encouraging, suicide and self-harm. In the same way, we know that online content on eating disorders can be extremely harmful to vulnerable children and young adults. I have met the parents of children brought up in loving homes who had no idea of the dangers their child was being exposed to on their smartphone or tablet while they were supposed to be safe at home. We all know parents whose children have been affected. For all of us, this is very close to home. We must do everything we can to keep our children safe online.

I am pleased to inform the House that, as a result of yesterday’s summit, leading global social media companies have agreed to work with experts from Samaritans to speed up the identification and removal of suicide and self-harm content, and create greater protections online. Not only will they financially support Samaritans in its work but, crucially, Samaritans suicide prevention experts will determine harmful and dangerous content. The social media platforms committed to either remove it or prevent others seeing it, and help vulnerable people to get the positive support they need. The mainstream media already have well-established codes of practice and training to remove material that promotes suicide and self-harm. In my experience of the British media, they act with great responsibility. It is time that social media companies do the same.

This partnership marks, for the first time globally, a collective commitment to act, build knowledge through research and insights, and implement real changes that will ultimately save lives. Social media companies also gave us an update on the actions they have already taken. Following the first summit in February, Instagram now has a global policy of removing all graphic self-harm imagery. Other sites have also taken action but there is much more to do and much more content to remove.

Importantly, the commitments that companies made at yesterday’s summit are what Samaritans asked for and are a positive step forward. The progress we have made so far shows that we can effect positive change, but I know that this House feels strongly that just because these companies are global does not mean that we cannot determine society’s rules and expectations. We are prepared to act on this. My right honourable friends the Home Secretary and the Culture Secretary recently published the online harms White Paper, which sets out the proposed regulatory framework for addressing online harms. It sets out a new statutory duty of care to require companies to take more responsibility for the safety of their users and tackle harm caused by content or activity on their services.

Compliance with this duty of care will be overseen and enforced by an independent regulator, which will be responsible for producing codes of practice that will explain what companies need to do to fulfil their duty and the robust action they need to take to remove illegal or harmful content. The White Paper also proposes sharing of information, research and best practice to improve the understanding of harmful content across the industry.

The summit also allowed us to discuss how we can work together to tackle another online danger: the spread of anti-vaccination misinformation. Since Edward Jenner’s discovery, vaccination has saved hundreds of millions of lives around the world. There are few innovations that have reduced human misery so much. After clean water, vaccination has prevented more deaths and disease than anything else in human history. The science is settled: vaccination saves lives. It not only protects your children, it protects other vulnerable people who cannot do anything about it themselves. Failure to vaccinate puts their lives at risk. The rise of social media now makes it easier to spread lies about vaccination, so there is a special responsibility on the social media companies to act.

Coverage for the measles, mumps and rubella vaccine in England decreased for the fourth year in a row last year to 91%, and there was a steep rise in confirmed measles cases from 259 to 966. We forget that measles is a horrible disease. We have one of the most comprehensive vaccination programmes in Europe. The well-documented problems in America and on the continent are worse than here, but we are determined to get ahead of this problem because there are real and devastating consequences for people from the failure to vaccinate. Our action to promote vaccines is not limited to removing anti-vaccination misinformation. We are promoting the objective facts about the importance of vaccination. We are increasing funding to primary care to improve access, and our prevention Green Paper will set out further actions.

Social media can be a great force for good and can help us to promote positive messages, but it is the responsibility of us all that this new technology, with all its great potential and power, be moulded to the benefit of society. We will not duck this challenge. I commend the Statement to the House”.

My Lords, that concludes the Statement.

--- Later in debate ---

[Baroness Jolly (LD)]

My Lords, I too thank the Minister for repeating the Statement. I am sure nobody in your Lordships’ House doubts the benefits, as well as the dangers, of social media. As the noble Baroness, Lady Thornton, has just stated, the tech giants really need to recognise their responsibilities by taking action now to remove material that could damage the vulnerable.

I would like to link the Statement with the NHS Long Term Plan. In it, there is a commitment to increase spending on children’s and adult mental health services. What figure will this amount to? How much of it does the department anticipate will be earmarked for technology? Where will it be directed? Who will receive the money? What does the department expect the NHS to do to support this move? What criteria will govern its use?

Vaccination uptake is clearly a current issue. How does the department anticipate that social media can help and not hinder the uptake of these life-saving shots?

[Baroness Blackwood of North Oxford]

I thank the noble Baronesses, Lady Thornton and Lady Jolly, for their questions. They are right: the Health Secretary has taken a personal interest in this issue and is determined to drive this policy forward, not only through the work of my honourable friend the Minister for Suicide Prevention but through the prevention Green Paper mentioned in the Statement. He will ensure that he keeps a personal eye on this issue.

I turn first to the question raised about the social media company Instagram saying that it has a global policy of removing graphic self-harm images—other sites also say that they have taken action—so that if you search today you cannot find such images, although on top searches you can find them through accounts in other places. It is recognised that there is much more to do and more content to remove. That was one reason why the Secretary of State convened these summits. A more coherent approach to this work is needed. While I recognise that the noble Baroness feels it is obvious what self-harm content is, the approach that has been taken as an outcome of the summit is encouraging. It has led to the strategic partnership, which will ensure that the policy that has come forward from the social media companies will now lead to effective implementation. Such companies will be held to account, not only through the strategic partnership but through the outcomes of the online harms White Paper. There will be not only a duty of care but a regulator associated with it. Those combined strategies are encouraging.

The noble Baroness asked about the unintended impact. This is where the second set of proposals to have come out of the summit is extremely important. As well as developing industry-wide standards on identifying harmful suicide and self-harm content and agreeing robust responses to it, it will lead to a clearer understanding of what is harmful content. It will also lead to better training for mediators to respond to it and to support vulnerable users, which I think is exactly the point she was after.

On the important questions about public health spending in response to anti-vax campaigners and ensuring that we have a robust vaccination programme, the noble Baroness is right that vaccination programmes rest on the basis of strong public health support. We have a £3 billion ring-fenced public health spend every year and we must ensure that that goes forward. It will be a key part of the public health bid in the spending review and part of the Green Paper that is to be published. I know she will look forward to holding me to account on the effectiveness of that Green Paper.

The noble Baroness, Lady Jolly, raised an important question about the effectiveness and benefits of social media. We do not think that compulsory vaccination at the moment is an evidence-based policy. The Health Secretary has said that nothing is off the table and this is the right response given the serious concerns of other countries. At the moment, in the UK, we operate a system of informed consent. This is the right thing to do, given our high uptake. There is no immediate plan to change it and we strongly encourage families to take up vaccinations when offered.

One of the ways in which we spread information about the effectiveness of vaccines, and shall continue to do so, is through our online accounts at nhs.uk, which are highly trusted. In the UK the public attitude to and confidence in vaccination is monitored through a series of annual surveys, including Public Health England’s annual attitudinal survey, which show high levels of trust in health professionals and the NHS. The public trust the NHS as a source of advice and that is why our digital media output, through the NHS, our social media outlets and nhs.uk, is a crucial way of encouraging and maintaining trust in vaccinations. We shall continue to drive it forward.

[Lord Lansley (Con)]

My Lords, my noble friend referred to the discussion with the social media companies about vaccination, but the Statement did not refer to any specific commitments on their part or even acceptance of a responsibility in relation to disinformation about vaccination. Does my noble friend agree that it is important to understand why immunisation rates and vaccination coverage have dipped? I was Secretary of State when we reached the highest level of, I think, 94% for MMR following a period from 2007, bringing it up from 80%. It has not dipped back to those levels, but we need to understand why this has happened. If it is about disinformation on social media, what have the companies said about this up to this point?

[Baroness Blackwood of North Oxford]

The social media companies accept that they have a responsibility to deal with anti-vaccination misinformation, harmful information relating to eating disorders and general health-related misinformation that can be found online. The Health Secretary has been clear with social media companies that they are expected to address these harms. The Department of Health looks forward to working with them on it. My noble friend is right when he says that our levels of vaccination are extremely high compared to other countries’, but we must not be complacent and must ensure that we not only maintain the current vaccination rates but drive them further and do not tolerate any further permeation of the pernicious anti-vaccination messaging which is starting to leak out online.

[Lord Scriven (LD)]

My Lords, the approach being taken is welcome, but in itself probably will not be enough. We cannot ban and regulate everything that goes on on the internet. For example, a blogger who may have nothing to do with health may have 80,000 to 100,000 followers and may blog about a health issue, and that becomes fact. What is needed in the modern world is alternative narratives; that is what is seen on social media. Rather than just using statutory websites and web pages, what is the NHS doing to adopt a much smarter, blogging/lifestyling approach—involving those who influence young people and who use these media outlets—and to use effective alternative narratives that work, rather than just putting all its eggs in the banning approach basket?

[Baroness Blackwood of North Oxford]

I do not have access to the statistics now, but I know that a lot of research has gone into assessing the amount of peer-to-peer support young people access online from medical charities and other charities via social media routes, or other online routes such as blogs or influencers who engage very effectively with various different medical charities. There is some very encouraging evidence that social media can be used in this way to direct people to the help and support they need, if it is used effectively. As the noble Lord says, we must be very careful not to throw the baby out with the bathwater and must produce alternative narratives to direct young people and vulnerable people to access the support they need in the most effective way. This is done very effectively by many organisations. It is a matter of making sure that, wherever possible, young people and vulnerable people are protected as much as possible from harms that they really should not be exposed to.

[Lord Brooke of Alverthorpe (Lab)]

I am grateful for the Statement. I want to address the social media aspect rather than vaccination. We have a paper from DCMS on social media—the online harms White Paper. The Minister mentioned coherence; I am finding the situation increasingly incoherent, and I will be raising this topic later. Who is giving a lead in this area? The Statement said:

“This partnership marks, for the first time globally, a collective commitment to act, build knowledge through research and insights, and implement real changes that will ultimately save lives”.


It also said that there was a second summit, but DCMS and the Home Office were not involved. The Education Secretary has been attending those meetings. Are more meetings planned? What agenda will be pursued at those meetings? Which departments will be involved? Who is going to take the lead?

[Baroness Blackwood of North Oxford]

The noble Lord asks a number of questions, but I think the nub of the issue is to ensure coherence across government in approaching an important and complex policy issue. He is right, in that the correct approach is to ensure effective implementation of our significant policy commitments in the online harms White Paper and in the outcomes from this summit. Of course, DCMS and the Home Office have been engaged in different policy proposals, development and engagement, and they will continue to be so. The Department of Health and the Department for Education have been leading on this in relation to the mental health Green Paper because of the policy specialisms around vaccinations, suicide and harm and the effect on young people. That work started some time ago so it makes sense for the department to continue, but it will be working hand in glove with the online harms White Paper. I am sure that that discussion will continue in the next debate this afternoon.

NHS Mandate

Baroness Blackwood of North Oxford Excerpts

Thursday 25th April 2019 Lords Chamber

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Blackwood of North Oxford) (Con)]

My Lords, with the leave of the House, I shall now repeat in the form of a Statement the Answer given to an Urgent Question in another place. The Statement is as follows:

“I am grateful for the opportunity to set out the Government’s approach to setting a mandate for NHS England for 2019-20. The Government’s annual mandate to NHS England for 2019-20 will, for the first time, be a joint document with the annual NHS Improvement remit letter, signalling the importance of these two arm’s-length bodies working increasingly closely to maximise their collective impact.

It will set one-year transitional objectives to allow the NHS time to plan to implement the long-term plan it has developed to allow it to meet the needs of patients, families and staff as it heads towards its 80th anniversary, as well as continuing to set expectations on planning for EU exit. We are committed to the NHS and are funding its long-term plan to ensure it is fit for the future for patients, their families and NHS staff. The accountability framework sets the expectations that will make the plan a reality as we look ahead to the 80th birthday of the NHS.

The Government have continued to prioritise funding the NHS with a five-year budget settlement for the NHS announced in summer 2018, which will see its budget rise by £33.9 billion a year in cash terms by 2023-24. The funding settlement and implementation of the NHS long-term plan are not affected in any way by the short delay in publication of the accountability framework. We are all engaged to ensure that the accountability framework is published and laid as soon as possible. I and my ministerial colleagues and officials are working closely with NHS England and Healthwatch, as statutory consultees, to ensure accountability, improvement and progress to deliver world-class care for patients”.

[Baroness Thornton (Lab)]

My Lords, I thank the Minister for repeating the Answer to the Urgent Question asked by my honourable friend Jonathan Ashworth in the Commons earlier today. Why was it necessary to ask that question at all? I hope the Minister may be slightly embarrassed by the lack of courtesy in not informing Parliament of the delay in laying the mandate for NHS England before Parliament in a timely fashion. That is the first time that has happened since the Health and Social Care Act 2012 came into operation. She must also recognise that this is a very important matter. The Secretary of State appears to have ignored the statutory obligation which was much debated and discussed in your Lordships’ House before that Act was passed. Your Lordships placed huge importance on the mandate and the fact that this was how the NHS would be held to account.

Why was this deadline missed? The answer—that the NHS was busy doing the plan and such things—is not adequate. This is about accountability to Parliament. We need to discuss why targets in last year’s mandate have not been met. This is a serious omission for the mandate because it sets the objectives that the Government expect NHS England to achieve, as well as its budget. I absolutely accept that the Government are committed to the budget and the plan, but they do need to address, with some apology, the lack of accountability that this omission means.

[Baroness Blackwood of North Oxford]

I thank the noble Baroness for her question. I refer to the comments by Simon Stevens in the PAC yesterday, when he laid out how he sees the situation for the NHS:

“We have an agreed direction in the long-term plan … We have the budget set for the next year, and we have the NHS annual planning process … wrapped up. 2019-20 is … a transition year into stepping into the new five-year long-term plan”.


As the noble Baroness knows, planning guidance for 2019-20 was updated in January when the long-term plan was published. For all practical purposes, this document sets the decision-making for local NHS decision-makers during this year. The national implementation programme for the long-term plan, which will set the longer-term milestones for delivery of the plan until 2023-24, will be published at the end of this year. The mandate and its accountability framework is an important accountability mechanism and strategy document for the NHS. It is taking longer partly because of the close working of NHSE and NHSI and the transitional nature of this year.

It is important that this document does come out, for the purposes of strategy and accountability, but it is most important that it is got right. That is why it is taking slightly longer. I look forward to the debate this House will have when it is published. I am sure that the noble Baroness will hold us to account in the usual manner.

[Baroness Walmsley (LD)]

My Lords, I am very sorry that the Minister has been forced to give such an innocuous Answer on such a very important issue. We are awaiting not only the mandate but the workforce plan, and we have long awaited the social care Green Paper. Is the department still busy recruiting around the world to replace positions that are being vacated by staff from the EU—who are either going home or not coming here in the first place—or is there some other reason? I would have been much more reassured if the Answer had told us that the department is discussing with other departments across government the social determinants of health and how addressing those will help make the NHS much more sustainable in the near future. Can the Minister rescue this innocuous Answer by assuring the House that those discussions are taking place?

[Baroness Blackwood of North Oxford]

The noble Baroness is absolutely right that there is cross-departmental relevance to both the social care Green Paper and the workforce strategy. She will know that the long-term plan and the forthcoming Green Paper on social care have been developed in tandem. A number of reforms were already set out in the long-term plan, including the enhanced health and care homes model, which will of course involve MHCLG; the comprehensive model for personalised care, which will involve the personalised health budgets; and of course local health and care plans, which will simplify healthcare systems. We are looking forward to the Green Paper being published in full and I am sure that she will want to hold me to account on that in this Chamber. I look forward to that moment with great anticipation.

Of course, the workforce plan and HEE’s budget are also a matter for cross-departmental debate, as is the spending review, which is another reason why a lot of work is going into this. Again, it is important that this work is done to get it exactly right. The principles on which that work must be done are to consider multi-year funding plans for clinical training places based on the workforce requirements of the NHS going forward.

[Lord Low of Dalston (CB)]

My Lords, I want to raise not the timeliness of the mandate but its content. The noble Baroness will be aware of the problems of undercapacity in eye care services—which were documented by the report entitled See the Light: Improving Capacity in NHS Eye Care in England, produced by the All-Party Parliamentary Group on Eye Health and Visual Impairment, of which I am co-chair—and that undercapacity is putting the sight of patients at risk. The first recommendation of that report, addressed to the Secretary of State for Health and Social Care, was that eye health should be specifically included in the Government’s mandate for the NHS, to ensure that it is accorded a higher priority than it appears to enjoy at the moment. Will the Minister give me an assurance that this recommendation will be fully addressed when the new NHS mandate is finally published?

[Baroness Blackwood of North Oxford]

I thank the noble Lord for his question. I can tell him that, while the accountability framework has not yet been published, it has been decided that it will be a high-level framework that will set two objectives: to ensure the effective delivery of the NHS long-term plan, and to support the Government in managing the effects of EU exit on health and care. Of course, the long-term plan includes improvements to a number of services and this will be followed by the national implementation programme for the long-term plan, which will have milestones for delivery of that plan up to 2023-24. I hope he will be reassured that eye health is included in that. If he would like to follow up specific points with me regarding the concerns his group has raised, I would be very happy to meet him later.

[Baroness Masham of Ilton (CB)]

My Lords, can the Minister give an assurance that people who want to do so can come to work in the UK and be paid less than £30,000? Otherwise, this will stop many people coming: care homes and people who are disabled and living in their own homes cannot afford £30,000.

--- Later in debate ---

[Baroness Blackwood of North Oxford]

The noble Baroness raises a very important point. This, of course, will not be part of the accountability framework but it is a very important question of concern for Higher Education England and the workforce strategy which is going forward. It has been a question of close discussion and debate between the Department of Health and Social Care and the Home Office and will continue to be so.

[Baroness Emerton (CB)]

The 2014 Act stated clearly that we were looking for safe staffing. The cry at the moment is an urgent plea for a safe staffing formula that will satisfy the needs of the whole population. As far as I can see, five years after the law was passed, we are now looking at another two or three years. We are really in a situation in which safe staffing is the top priority.

[Baroness Blackwood of North Oxford]

I thank the noble Baroness for her question. As I have said, the Government set out six principles underpinning the long-term plan to meet the expectations that the NHS has for the future. One of those principles is to ensure that the NHS is building the workforce that we need for the future, so that we have the right numbers and the right types of doctors, nurses and other expert professionals, with more of them being trained here in the UK. As part of the spending review period, we will be working to understand how we can get the funding necessary to recruit and train new staff as part of the HEE process for the workforce strategy.

Mental Capacity (Amendment) Bill [HL]

Baroness Blackwood of North Oxford Excerpts

Ping Pong (Hansard): House of Lords
Wednesday 24th April 2019 Lords Chamber

Moved by

[Baroness Blackwood of North Oxford]

That this House do not insist on its Amendment 1B proposed in lieu of Commons Amendment 1, to which the Commons have disagreed, and do agree with the Commons in their Amendment 1C in lieu.

1C: After Clause 3, page 3, line 28, at end insert the following new Clause—
“Deprivation of liberty: code of practice
(1) Section 42 of the Mental Capacity Act 2005 (codes of practice) is amended as follows.
(2) After subsection (1) insert—
“(1A) Guidance about what kinds of arrangements for enabling the care or treatment of a person fall within paragraph 2(1)(b) of Schedule AA1 must be included in the code, or one of the codes, issued under subsection (1).”
(3) After subsection (2) insert—
“(2A) Before the end of each review period the Lord Chancellor must—
(a) review each code for the guidance of persons exercising functions under Schedule AA1, and
(b) lay a report of the review before Parliament.
But this does not affect the Lord Chancellor’s functions under subsection (2).
(2B) A review period is—
(a) in relation to the first review, the period of 3 years beginning with the day on which this subsection comes into force, and
(b) in relation to subsequent reviews, each period of 5 years beginning with the day on which the report of the previous review was laid before Parliament.”
(4) In subsection (3) after “preparation” insert “, review”.”

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[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Blackwood of North Oxford) (Con)]

My Lords, today we have an opportunity to pass legislation which will reform a broken and bureaucratic DoLS system which is leaving thousands without safeguards and bring forward a new system which will deliver protections to those who are not currently receiving them. Before I talk about amendments from the other place, I take the opportunity to thank noble Lords for the contributions they have made throughout this process. The noble Baronesses, Lady Thornton and Lady Jolly, have provided important scrutiny from the Opposition and Liberal Democrat Front Benches. The noble Baroness, Lady Finlay, has brought great insight from her role as chair of the National Mental Capacity Forum. The noble Baronesses, Lady Tyler and Lady Murphy, have brought the important issue of clarifying the meaning of a deprivation of liberty to the fore, and the noble Baronesses, Lady Hollins and Lady Watkins, have done excellent work to highlight the importance of providing a person with information about their authorisation and relevant rights.

The Bill has dealt with a number of legal issues and to this end our discussion has benefited from contributions from the noble and learned Lords, Lord Brown, Lord Hope and Lord Woolf, and my noble and learned friend Lord Mackay. Our debates have also benefited from contributions from my noble friends Lady Browning and Lady Barran, the noble Baronesses, Lady Meacher and Lady Barker, and the noble Lords, Lord Hunt, Lord Touhig and Lord Cashman. Finally, I thank my noble friend Lady Stedman-Scott for her excellent support and to my predecessor and noble friend Lord O’Shaughnessy, who marshalled the Bill through its earlier stages most ably, of course. Through the work of noble Lords, the Bill has been improved to address potential conflicts of interest in the new system and to ensure that protections for those in independent hospitals are now strengthened. After the work of the noble Baroness, Lady Finlay, and others in highlighting this, we have clarified the ability of families and care staff to whistleblow. The Bill has also benefited from the hard work of many outside this Chamber and from the careful scrutiny of the Joint Committee on Human Rights.

Today, we turn to the Commons amendments, which were tabled as alternatives to the amendments put forward by this House. The Government listened carefully to the concerns of noble Lords and reflected these in our amendments. Amendment 1C prescribes that the code of practice must contain guidance on what kinds of arrangements amount to a deprivation of liberty. There is also a duty to review any parts of the code that give guidance to persons exercising functions under the liberty protection safeguards and to lay a report of the review before Parliament, initially after three years of the subsection coming into force and then every five years after the date on which a report is laid before Parliament.

The meaning of a deprivation of liberty will remain as defined under Article 5 of the European Convention on Human Rights, as it is under Section 64(5) of the Mental Capacity Act. I know that noble Lords and other stakeholders had hoped that we could provide further clarification on the meaning of a deprivation of liberty in statute; we have had many debates about that. The Government had hoped to do so as well. We agreed with the Joint Committee on Human Rights that a definition could help bring greater certainty to people and professionals; to this end, we explored providing a statutory clarification over several months, working with colleagues across government and across the sector.

However, we established that the only way we could do this was to take an exclusionary approach and define a deprivation of liberty as having the same meaning as in Article 5 of the convention, then setting out what does not constitute a deprivation of liberty. This House made it clear that it was uncomfortable with an exclusionary approach to defining a deprivation of liberty. The Government have listened carefully to the views of Peers, MPs and other stakeholders, and decided not to insist on our original amendment. However, the Government were not able to accept the amendment tabled by the noble Baroness, Lady Tyler. It risked falling out of line with case law and would mean having two different definitions in place, which would bring confusion to a sector that needs clarity.

I assure noble Lords that the Government are still committed to providing clarification regarding the meaning of a deprivation of liberty for both people and practitioners. Amendment 1C makes it clear that the code of practice must lay out in clear terms, and provide detail of, when a deprivation of liberty is and is not occurring; this guidance will reflect existing case law, including the Ferreira decision, which addresses the provision of life-sustaining treatment. We will set out the meaning of a deprivation of liberty in a positive framing and in a way that is clear for people and practitioners. We will also include case studies in the code to help illustrate this.

The amendment also brings in a duty to review any parts of the code that give guidance to anyone exercising functions under LPS. This includes laying a report of the review before Parliament. As I said, initially, there must be a review within three years of the subsection coming into force to ensure that it is working as intended. Following that, there must be a review every five years after the date on which a report is laid before Parliament. This will mean that the meaning of a deprivation of liberty will be considered regularly and remain up to date with evolving case law. The review will not be limited to the definition but will include all the guidance relating to the liberty protection safeguards contained in the code of practice. By regularly reviewing the code in this way, we will ensure that there is up-to-date guidance for people and practitioners, which will support the successful operation of the liberty protection safeguards system.

Amendments 25B and 25C state that after authorising arrangements, the responsible body must, without delay, arrange for a copy of the authorisation record to be given or sent. If the responsible body has not done this within 72 hours of the arrangements being authorised, it must review and record why not. The Government recognise the importance of providing people with information. We amended the Bill in the other place to clarify that people should be informed of their rights under the liberty protection safeguards process and provided with a copy of their authorisation record.

Building on this, the noble Baroness, Lady Watkins, tabled an amendment in this place specifying that a record must be kept if the authorisation record is not provided immediately, and that if the authorisation record is not provided to the person within 72 hours, a review must be conducted. The Government agree that it is important to make sure that the authorisation record is provided quickly; however, there were some issues with Amendment 25A, which we have addressed in our amendments. For example, we have made it clear in our amendments that the new duty falls on the responsible body. This is important as it means that the duty to arrange for the authorisation record to be provided to the person and their representatives can now be enforced.

The government amendments reflect the aims of the Lords amendment. Noble Lords will notice a small difference in that we do not require it to be recorded if an authorisation record has not been provided immediately. The reason for this is simple: our priority is ensuring that the person and their representatives receive the authorisation record. If there is an opportunity for the responsible body to send the authorisation record within 72 hours, they should be doing so rather than recording why they have not sent it. Providing information, including the authorisation record, is important to ensure that people are able to exercise their rights. Noble Lords have made clear their view that there should be a contingency provision to ensure that the responsible body makes arrangements in a timely manner to provide the authorisation record. The Government have listened and this amendment reflects that.

By passing these final amendments today we will bring to a close the parliamentary stages of the Bill. When the Government introduced it last year we committed to reforming the process so that it is less burdensome for people, carers, families and local authorities. That is what the Bill will deliver. On Royal Assent, the Bill will become an Act and will introduce a new targeted and streamlined system that will allow people to access protections quicker. This is vital when we have more than 125,000 people in the backlog not receiving protections and over 45,000 people who have been waiting for more than a year. I ask the House for its support and I thank all Members who have helped to deliver the Bill we have today. I beg to move.

--- Later in debate ---

[Baroness Thornton (Lab)]

My Lords, it is always a good moment when we get to this point in any legislation. It is also an opportunity for us to look at where we started in July. In July, my Chief Whip spoke to me about a really small, uncontroversial Bill that would amend the Mental Capacity Act. I am not criticising him, because that is what he had been told. The idea was that we would have the Second Reading quickly before the Summer Recess and then move straight into Committee immediately after it and get through the Bill quite quickly. It is a great testament to this House that we recognised quite quickly that it might be a small Bill but it was certainly not uncontroversial. As I said when we moved into Committee, the noble Baronesses, Lady Jolly and Lady Barker, and I were sending each other messages about this Bill when we were all poolside in different parts of Europe because we realised that we needed to understand it much better.

I do not accept the criticism that we have failed. I think we started off with a flawed Bill and that we have improved it. In a few years’ time I think we will almost certainly return to this subject, because by then we will have discovered things that have not worked out and that need to be reviewed and possibly changed. We need to thank both Ministers for listening, hearing and working to change the Bill. I particularly thank my fellow Peers for working so co-operatively and with such great expertise. It is always a pleasure when we do that and we are always at our most effective when we do so, and I have been very happy that various Members of the House have taken the lead on various issues throughout the passage of the Bill. The Minister named everybody, so I shall not do so again, but they know who they are and it has been a pleasure to work with them.

We should be pleased that we have successfully tackled what, as far as we were concerned, were certain huge issues, many of which have been mentioned by the noble Baroness, Lady Barker. They included care home managers’ powers, conflicts of interest, private hospitals, the definition of deprivation of liberty and the information provided. We should be proud that those issues have been tackled. I particularly thank the noble Lord, Lord O’Shaughnessy. I have not often been called a juggernaut but on Report he suggested that I was. I think he was expressing the opinion that in my remarks I was representing the views of the whole House and that we were definitely coming for him, as it were.

If we are to learn some lessons from this, one is possibly that the Bill team took a little while to gear up to what happens in the House of Lords and how we approach things. We talk to the stakeholders—we have a continuous dialogue with them—and that is the next group that I would like to thank. I thank all the stakeholders who came to endless meetings with us to make sure that we did our job properly, although some of them still have some major concerns.

I say to the House that what matters is what happens next. First, it seems likely that within the next year or so we will have another mental health Bill, so it is quite possible that some of the issues that we have been concerned about will re-emerge and be discussed during that process. Secondly, we will have the regulations and the code of practice. I would like to be assured that the consultation, which might not have been quite as good as it should have been at the beginning of this whole process, will absolutely inform the code of practice and the regulations that follow the implementation of this legislation.

I do not wish to threaten the Minister but, after the past eight or nine months, there is a body of commitment and passion over this issue that will certainly be watching and be interested in what happens next and will have something to say about it. Therefore, in a spirit of positiveness, we hope that we will be able to help with the next stages but we will certainly be watching them to make sure that the gains that we have made are reflected in the code of practice and the regulations.

Finally, I very much thank the Minister, who came in in the middle of the Bill. This is the second Bill that she has had to pick up and run with in your Lordships’ House. She has done it with great dignity and intelligence, and it has been a pleasure to work with her.

[Baroness Blackwood of North Oxford]

I thank noble Lords for an important moment in the passage of the Bill. I assure them that they will never have to threaten me to get me to listen to important points regarding the progression of legislation of this import. I identify myself with the comments of the noble Baroness, Lady Tyler. This is indeed a pragmatic solution to the very challenging problem of getting the right solution.

I also echo the comments of the noble Baroness, Lady Finlay, who said that this has been a bumpy ride, but it is a major decision to deprive someone of their liberty, so it is right that there has been very detailed scrutiny of the legislation. When someone is deprived of their liberty we have to ensure that it is always necessary and proportionate and, wherever possible, consistent with their wishes and feelings. I agree with her that the advocacy provisions in this Bill are stronger than in the DoLS legislation, and that it will provide greater responsiveness and flexibility than previous legislation. We can be proud as a House to have delivered that.

I am sorry to hear the concerns raised by the noble Baroness, Lady Murphy. As we proceed through the next stages of engagement over the code of practice, I hope that we shall be able to prove her wrong, in the most positive sense. We have put in place very strong measures for whistleblowing thanks to the contribution of the noble Baroness, Lady Watkins; thanks also to her work, we have strengthened the provisions for information. We have also to nail down the questions around the definition, of course, but I think it right that this is not on the face of the Bill for all the reasons that we have debated at great length in this Chamber. I will not rehearse them now but will try to answer some of the questions that I was asked.

The first is about when the code of practice will be published. Obviously, as the noble Baroness, Lady Finlay, pointed out, the department is collaborating very closely with the sector in the preparation of the code; that is already happening. We are working with many organisations and individuals. The drafting will be considered by expert reference groups and people with lived experiences, to ensure that we get the most practical and workable code of practice. The department has already convened a working group involving a wide range of stakeholders. We expect to have output from the working group by this summer. After Royal Assent, I will place a letter in the Commons Library as requested; this will contain timescales for the code of practice, including when a draft code will be published for consultation. I hope that is reassuring.

As I have said, the statutory guidance will include a suite of case studies which will demonstrate how the definition applies in different settings and scenarios. It will provide clarity and aid to practitioners. We are collaborating to ensure that it can provide clarity and lack of ambiguity and can be a real help to those using it. As the noble Baroness, Lady Tyler, said, we have made a commitment that it will provide detail about when deprivation of liberty does and does not occur. It will reflect existing case law, including the Ferreira decision, and it will set out the meaning of a deprivation of liberty in a positive framing; this should be reassuring. On the question of a review, the code can be updated at any point. This will ensure that it can reflect changes in legislation practice or case law—that is, the entire code, not just the definition. I hope that is reassuring.

I would like to respond also to some of the points made by the noble Baroness, Lady Barker. She is absolutely right regarding the questions of resourcing, the backlog and training. We are very alive to this. A further impact assessment will be done following Royal Assent and we will work with stakeholders collaboratively to take on board feedback from previous iterations. We will also ensure that the Government will provide guidance ahead of implementation. That will include steps that can be taken to help reduce the backlog.

However, we will not stop there. The Government are committed to supporting training ahead of the new system coming into force and are working with Skills for Care, Health Education England and Social Work England to deliver that. Ahead of day one, we will work with local and national networks and the Welsh DoLS network, in partnership with the LGA and ADASS, to reduce the existing backlog. Work is under way for that. Cared-for persons who have existing DoLS authorisation on day one will remain under that authorisation until it expires, after which a new application will be needed to try to manage the volume of work that will be undertaken. I hope this is reassuring. To respond to the point raised by the noble Baroness, Lady Finlay, I can assure her categorically that the code of practice will be statutory.

I hope that all this is reassuring; I think this is a great step forward and I commend the Bill to the House.

Motion A agreed.

Moved by

[Baroness Blackwood of North Oxford]

That this House do not insist on its Amendment 25A to Commons Amendment 25, to which the Commons have disagreed, and do agree with the Commons in their Amendments 25B and 25C to Commons Amendment 25 in lieu.

25B: Line 2, leave out from “(1)” to “to” in line 3 and insert “After authorising arrangements the responsible body must, without delay, arrange for a copy of the authorisation record to be given or sent”

Access to Medicinal Cannabis

Baroness Blackwood of North Oxford Excerpts

Tuesday 9th April 2019 Lords Chamber

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Blackwood of North Oxford) (Con)]

My Lords, with permission, I shall now repeat the response to an Urgent Question on medicinal cannabis originally made by the Secretary of State for Health and Social Care:

“First, Mr Speaker, my sympathies go out to the patients and their families who are desperately seeking to alleviate their symptoms with medicinal cannabis. We are working hard to make the right approach. The law was changed on 1 November last year and it is now legal for doctors on the specialist register of the General Medical Council to prescribe cannabis-based products for medicinal use in the United Kingdom.

Whether to prescribe must remain a clinical decision to be made with patients and their families, taking into account the best available international clinical evidence and the circumstances of each individual patient. Indeed, there have already been prescriptions written for the products that the family attempted to bring into the country, and these have been supplied to patients. Without clinical authorisation, it is of course not possible to import controlled drugs, which is why the drugs were seized by Border Force on Saturday. However, we have made available the opportunity for a second opinion and the products have been held and not destroyed, as would usually be the case.

In relation to childhood epilepsy, the British Paediatric Neurology Association has issued interim guidance. NHS England and the Chief Medical Officer have made it clear that cannabis-based products can be prescribed for medicinal use in appropriate cases, but it must be for doctors to make clinical decisions in the best interests of patients. It is they who have the skill and the training to balance the risks and the benefits of any proposed treatment, including cannabis-based products, and to make a decision with patients and their families on whether or not to prescribe.

To date, research has centred on two major cannabinoids: THC and CBD. There is evidence that CBD may be beneficial in the treatment of intractable epilepsy, and over 80 children have already been supplied with CBD products in the UK on the basis of a specialist doctor’s prescription. I entirely understand how important this issue is to patients, and I have met and listened to the families and know just how frustrated they are. Therefore, after meeting the parents, I have taken the following actions.

First, I have asked NHS England to rapidly initiate a process evaluation to address any barriers to clinically appropriate prescribing. Secondly, to provide the evidence base and to get medicinal cannabis to patients in need, I have asked the National Institute for Health Research and the industry to take action to produce that evidence in a form that will support decisions about public funding. The NIHR has issued two calls for research proposals on medicinal cannabis, and I look forward to responses to those consultations. This is in addition to the training package being developed by Health Education England to provide every support to clinicians to enable them to make the best decisions with their patients.

This is a very difficult area, with some heart-rending cases. I look forward to working with all Members of this House to ensure that patients get the best possible care”.

[Lord Kennedy of Southwark (Lab Co-op)]

My Lords, I thank the Minister for repeating the Answer given in the other place by the Secretary of State to the right honourable Member for Hemel Hempstead. While we are not talking only about children, children having up to 300 seizures a day must leave their parents distraught and desperate. The Government must act much more hastily to ensure people who can benefit from medical cannabis have the means to get access to it on prescription. Can the Minister set out for the House the timescale for the process evaluation announced by the Secretary of State yesterday? This issue has been going on for far too long and needs resolving finally in the next few days.

[Baroness Blackwood of North Oxford]

I thank the noble Lord for his question. The Secretary of State has asked NHS England to act with the utmost urgency and to bring responses forward quickly. I note that this comes in addition to the HEE training model and the NHS England and BSA system to monitor prescriptions for cannabis products. We expect results from that data this month, so we expect more action imminently.

[Baroness Walmsley (LD)]

My Lords, I thank the Minister for the action she is taking. I have some specific questions about what she said. Can she confirm that the second opinion she mentioned will come from a doctor with an appropriate understanding of the safety and effectiveness of these drugs, and that it will be available to all patients in the same situation? Secondly, she mentioned the British Paediatric Neurology Association’s interim clinical guidance, which was made very much as a snap judgment straight after the rescheduling last November; in effect, it just said, “No, no, no”. Can the Minister encourage the BPNA to consider further the massive amount of evidence from abroad and produce more considered guidance? Thirdly, she mentioned the 80 prescriptions for CBD medicines, but that does not strike me as making much progress, because you can get CBD legally on the internet; the only advantage of such prescriptions is getting the drug for free. The issue concerns medicines containing THC, which are the ones that patients desperately need. Finally, the Minister will probably find that trusts are stopping doctors who would like to prescribe these medicines from doing so. Getting the NICE guidance a lot sooner than next autumn would probably encourage trusts to allow their employees to do so. Can she encourage NICE to hurry up, please?

[Baroness Blackwood of North Oxford]

I thank the noble Baroness for her question, and I know that she has campaigned on this issue for some time. NHS England has clarified that clinical guidance does not remove or replace the clinical discretion of the prescriber to act. I know that the process review will look at the impact of clinical guidance, which will hopefully be helpful. We will also look at the role of second opinions. I hope that that has answered some of the noble Baroness’s questions; she made a number of points, and I will write to her on the rest.

[Lord Hunt of Kings Heath (Lab)]

My Lords, I want to come back to the point about NICE made by the noble Baroness, Lady Walmsley. My understanding is that, at the moment, the evidence on which doctors can base a decision to prescribe these medicines is very limited. Clearly, relying on the NICE guidance is one way through. My problem is that, if we look at another area such as cataract operations, we see that despite NICE guidance many patients are now being denied treatment that has absolutely proven to be effective. My concern is that the Government seem to be trying to find a way round the evidence relating to these medicines when, up and down the country, patients are being denied interventions that we know will be successful and that can help thousands of people. Can the Minister comment on that?

[Baroness Blackwood of North Oxford]

The noble Lord is right that it is important that guidance is provided. The point of bringing the guidance forward is to look at the most up-to-date evidence available across the country. The challenge with medicinal cannabis is that the evidence base is developing. Currently, more than 100 clinical trials are ongoing worldwide. We are bringing the NICE guidance forward in the autumn to take all that clinical evidence into account in the most up-to-date guidance, so that patients can benefit and clinicians can have more confidence in prescribing. The NIHR call for clinical trials has been brought forward so that the evidence base can be strengthened even further as we go forward because, in the long term, the only way for us to move from an unlicensed prescribing route, which is where we are now, to a licensed route is through clinical trials and a greater evidence base. That is what the Government are keen to encourage.

[Baroness Finlay of Llandaff (CB)]

Do the Government recognise that, whenever patients take part in a clinical trial, there will also be some patients who access the medication outside that trial? Are the Government establishing a confidential database to monitor the outcomes of every child who is prescribed a cannabinoid to look at its efficacy and any harms reported, so that we can get a cross-population database of the effects that could then feed into the evidence-accruing processes? It may be that a royal college such as the Royal College of Paediatrics and Child Health would be able to assist the Government by providing a confidential haven for such clinical data to be collected.

--- Later in debate ---

[Baroness Blackwood of North Oxford]

I thank the noble Baroness for her comments, and I know that she is expert in this area. Proposals for an observational trial and the collection of observational data have been put forward. I think that the concern is that, at the moment, there is a lack of confidence in the data. What is needed is the highest quality clinical data because, while a large amount of observational data for medicinal cannabis is available, data at the level of randomised controlled trials is required so that there is confidence not only among clinicians to prescribe but also for the funding system to fund within the NHS. At this point, it is that level of data which needs to be gathered, and that is why the NIHR is bringing forward public funding for it and why the Government are encouraging the industry to fund such trials as you would expect in any other area of the pharmaceutical industry.

[Baroness Hussein-Ece (LD)]

My Lords, I declare an interest in that my grandson has intractable epilepsy, so we have been through the whole process, and I have some understanding and experience of this issue. He has recently been prescribed Epidiolex after a long struggle for him to be allowed to use it. Over the past few months, we have seen some incredible benefits from it. Does the Minister accept that rather unfair barriers have been put in place as regards access to this drug for children? I have heard of other cases where the British Paediatric Neurology Association, which she has mentioned, has said that Epidiolex, which is manufactured without THC, could be used for the treatment of childhood epilepsy as long as all other treatment avenues have been explored, including brain surgery and VNS. My grandson has had this treatment, where a device is attached to the spinal cord. These are incredibly invasive, dangerous and risky procedures. Surely it would be better to allow Epidiolex to be tried out rather than insisting on other routes? One mother told me that they are insisting that her child has brain surgery first. That cannot be right.

[Baroness Blackwood of North Oxford]

I thank the noble Baroness for her comments and for setting out her personal experience. She obviously has expertise in this area which few of us in the Chamber can claim. The reason NHS England has put forward is that individual clinical expertise relating to an individual patient is of the utmost importance, even where the guidance might seem to contradict that judgment. That is why in the autumn we will be bringing forward NICE guidance that will look at the most up-to-date evidence which should, we hope, be of assistance. It is also why we are bringing forward the NICE process review in order to understand what barriers may be in place and to encourage clinically appropriate prescribing and try to assist with cases such as these.

[Baroness Warwick of Undercliffe (Lab)]

My Lords, what Mrs Emma Appleby has done—and I praise her courage—is to show that, whatever relaxation there appears to have been or modification, which we all thought was likely to produce some positive results, in fact that really is not happening. People are being denied medication, with incredibly debilitating results. I have an interest in this because I have a young family member with stage 4 terminal brain cancer. He suffers from sickness as a result of chemotherapy which nothing else is able to help. He has been refused cannabis. The consultant will not prescribe it because he feels that there is not enough information from the Department for Health and Social Care for him to feel that he is justified in doing so and he does not know what the implications might be. I understand from another consultant that the BMA is in fact advising medical professionals not to prescribe it. What is the alternative for desperate relatives? Is it to buy cannabis off the streets not knowing what the quality is and facing the prospect of a criminal conviction? Speed is of the essence here, certainly for my family member. I hope that the Minister can say a little more about the way in which this is likely to progress and the speed with which it will do so.

[Baroness Blackwood of North Oxford]

I thank the noble Baroness for her question and for describing her personal experience. I emphasise that we must allow clinical decision-making in this. We have tried to encourage more experience in the system by putting out guidance through NICE based on the latest evidence, by providing Health Education England with the opportunity to bring forward training to share the best quality experience, and by putting through the process review so we can bring down any inappropriate barriers in the system. I hope that encourages the noble Baroness.

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

Baroness Blackwood of North Oxford Excerpts

Tuesday 9th April 2019 Lords Chamber

Moved by

[Baroness Blackwood of North Oxford]

That the draft Regulations laid before the House on 20 March be approved.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Blackwood of North Oxford) (Con)]

My Lords, I thank noble Lords for their consideration of these regulations. The Government’s priority is to ensure that the high standards of food safety and consumer protection we enjoy in this country are maintained when the UK leaves the European Union. This instrument forms part of our preparations for a functioning statute book on exit.

Food additives, flavourings, enzymes and extraction solvents are important substances referred to collectively as “food improvement agents” which are used in a wide variety of everyday foods. These substances perform technological functions in or on food during its production or storage. Examples include preservatives, which are highly effective in protecting consumers from dangerous pathogens and help to provide a decent shelf life of products for consumers. Other substances are used to improve the taste, texture, and appearance of food. Common examples are artificial sweeteners, emulsifiers and flavourings added to food where they are considered necessary.

This instrument is made under the powers in the European Union (Withdrawal) Act 2018 to make the minimum necessary amendments to retained legislation that governs the use of food improvement agents and corrects deficiencies in those regulations. I wish to make clear that no policy changes are being made through this instrument, and neither is there any intention to do so at the present time. The instrument was due to be debated on Tuesday 19 March alongside four other instruments on regulated products in food. Minor drafting errors were identified which have now been rectified.

Currently, the European Commission holds a range of powers and functions under the EU legislation to enable new substances to come on to the market, to amend current conditions of use and purity criteria and to remove substances from the permitted lists. This instrument transfers these powers from the Commission to Ministers in England, Scotland, Wales and the devolved authority in Northern Ireland. It also transfers responsibility for risk assessment from the European Food Safety Authority, EFSA, to the UK “food safety authority”. This will be the Food Standards Agency in England, Wales and Northern Ireland and Food Standards Scotland in Scotland, which have a close working relationship.

Risk assessment and the oversight of food safety controls will be essential to ensure that food remains safe, whether imported or produced in the UK. The Food Standards Agency and Food Standards Scotland are responsible for protecting public health in relation to food and will continue to be independent science and evidence-based government departments. These functions will be delivered through the increased risk assessment capacity that has already been put in place. This instrument will ensure that the controls contained in 11 retained regulations governing food improvement agents continue to function effectively after exit day. All existing food improvement agents permitted for use in the UK prior to exit day will continue to be permitted immediately after exit and all conditions and requirements attached to their use will be preserved. There will be no change in how food businesses are regulated or managed.

These regulations will ensure a robust system of controls that will also underpin UK businesses’ ability to trade both domestically and internationally. This will ensure continuity and clarity for UK food businesses and those exporting their food products to the UK, while maintaining existing levels of public health protection and food safety. There are no changes to the authorisation process for new substances, except that the roles of the European Commission and EFSA will be replaced by the relevant UK entities. To support industry with these changes, the Food Standards Agency intends to publish detailed guidance on the UK authorisation processes. Scientific data requirements in support of applications will remain the same, so the same package of data can be submitted to the UK and the EU, avoiding any unnecessary additional burden.

It is also important to note that the devolved Administrations have provided their consent for these instruments. Furthermore, we have engaged positively with the devolved Administrations throughout the development of these instruments. This ongoing engagement has been warmly welcomed. A full public consultation indicated support for the proposed approach to retained EU law for food and feed safety and hygiene. These instruments therefore constitute a necessary measure to ensure the continuation of effective food safety and public health controls. I beg to move.

[Baroness Wheeler (Lab)]

I thank the Minister for introducing these important regulations dealing with food improvement agents such as preservatives, anti-oxidants, flavourings, enzymes and extraction solvents. As the Minister explained, this is the second version of the regulations, which have been re-presented to comply with requirements in drafting, elucidation and compliance with proper legislative practice identified by the Joint Committee on Statutory Instruments, which led to their hasty withdrawal and subsequent reissue. The Ministers, both today and in the Commons, described the faults in the original draft as minor, but it is important to underline for the record that the committee made some important stipulations now contained in the draft which are welcome because they assist with the clarity needed to ensure compatibility with other related regulations.

We recognise that this and the related SIs considered so far are necessary to ensure we retain the high-level principles underpinning the day-to-day functioning of the UK’s food safety legal framework. Ensuring continuity for business and public health bodies is in the vital interests of the public. However, in discussions across the range of food safety-related SIs from either the Department of Health or Defra, we have repeatedly raised our concerns about the UK’s preparedness for additional responsibilities in terms of resources and staffing levels in the Food Standards Agency, Food Standards Scotland and the related bodies that are to assume wide-ranging responsibilities from the EU after Brexit.

Let us remember that, between 2010 and 2017, the FSA saw its budget cut by 26%—nearly £30 million—leaving it resourced, in its own words,

“just to provide a basic statutory service”,

without contingency funds and with service delivery likely to be seriously compromised if any further cuts take place. Can the Minister explain how she envisages that an organisation that has been run down in this way so as to be able to carry out just its statutory obligations will, in the short or medium term after Brexit, be able to ratchet up to assume the key responsibilities currently undertaken by the European Food Safety Authority?

We have been told by the Government that both the FSA and the FSS will deliver the widened responsibility for protecting public health in relation to food through,

“an increased risk assessment capacity”,—[Official Report, Commons, Fifth Delegated Legislation Committee, 1/4/19; col. 5.]

and that additional staff are being recruited to deliver risk assessment and risk management functions from day one of Brexit. Can the Minister tell the House how many additional staff have been recruited, when they started work and what roles they are currently undertaking? What additional funds are being provided to the FSA and FSS to meet these costs, and what transitional management funding is being provided to support their taking on new and wider functions?

We are also concerned about the key issues raised by local authorities during the consultation with stakeholders on the SI, on how extra responsibilities they are taking on will be resourced—particularly if further responsibilities are identified in the course of ongoing negotiations. These so far remain unanswered by the Government. We know just how cash strapped local authorities are, so will the Minister confirm that the additional costs will be on a full cost recovery basis and that any additional financial burden that arises through ongoing negotiations will be funded, especially in the event of a no-deal Brexit?

The Explanatory Memorandum for the SI, in paragraph 2.7, expresses the Government’s confidence—which the Minister also expressed this afternoon—that,

“These changes will ensure that the retained legislation remains operable and enforceable within the UK regulatory framework without compromising existing levels of public health protection and food safety”.


Paragraph 2.9 reassures consumers that,

“existing levels of public health protection and food safety are being maintained”.

It is difficult to see how such supreme confidence can be justified in the light of the scale and extent of the changes that will take place in the food industry and related key industries. Can the Minister advise what steps have been taken on a cross-departmental basis to monitor implementation of the new structures, particularly in the transitional phase?

On the key EFSA re-evaluation programme of approved food additives, can the Minister please explain in more detail why the EU regulation is being revoked and it is not thought necessary to retain this important legislation for the UK? Why is a UK-wide re-evaluation programme not needed? While the EU regulation placing a duty on producers or users of a food additive to immediately notify the UK of any new scientific or technological information that may affect the safety assessment of a food additive is being retained, is the Minister confident that the UK will have sufficient safeguards and expertise in the FSA and FSS to ensure that food additives on the UK’s authorised list are kept under review on an ongoing basis? How will we ensure that we continue to keep up to date with and implement recommendations from international assessment bodies such as EFSA and the Joint FAO/World Health Organization Expert Committee on Food Additives?

The Explanatory Memorandum, at paragraph 12, states that the impact of the SI on business, charities or voluntary organisations is “minimal” and does not impact on the day-to-day workload of the small and micro-businesses that make up over 90% of the food industry sector. We are told that only one-off familiarisation costs resulting from the legislative changes are involved; and there is no impact assessment, because the SI has been assessed by the FSA as being below the de minimis threshold expenditure requiring an assessment to be produced. Again, the scale and extent of the proposed change makes these statements seem somewhat complacent. Can the Minister assure the House that the situation will be kept under close review so that swift action can be taken if the burden of introducing and maintaining the new arrangements leads to unsustainable costs for small businesses or voluntary organisations?

Finally, on the consultation exercise undertaken by the FSA on the EU law for food and feed and hygiene, the Minister in the Commons was quick to reassure my honourable friend Sharon Hodgson that the food industry had been fully consulted and understands the minimal impact the changes will have and “is satisfied”. Also, that of the 50 responses received,

“some 82% supported the Government’s approach”.—[Official Report, Commons, Fifth Delegated Legislation Committee, 1/4/19; col. 9.]

However, the Explanatory Memorandum, at paragraph 10.2, says that of the respondents,

“82% supported or did not agree with the proposed approach being outlined by the Food Standards Agency”.

Can the Minister clarify this? What actions are being taken to ensure that stakeholders’ concerns expressed in the consultation that changes will be clearly communicated with urgency and sufficient lead-in times are addressed?

--- Later in debate ---

[Lord Deben (Con)]

My Lords, are we not very lucky that they managed to put off the date as long as this, otherwise this SI would not have come before us? I just wonder how many SIs are hidden behind this one that would not have been passed in time. It seems pretty remarkable that we are talking today—after the date that the Prime Minister promised that on any basis whatever we were going to leave—and are dealing with this very important matter. It just draws attention to the absolute barminess of the whole process. To be doing this after what we did earlier in the week seems remarkable.

I do not envy my noble friend who has to defend this. When she says there are no changes, there is, of course, a fundamental change in that every small business in Britain that is exporting to the rest of Europe has to get itself passed by both the British and the rest of Europe. Although my noble friend rightly said that she did not believe this will stop people importing things, it could easily stop people exporting things. Indeed, the whole Brexit operation is designed to shoot the exporter in the foot and to enable the importer to have unrestricted access.

My first question is whether my noble friend can conceive of any circumstance in which the British would have different rules from the rest of the European Union on, for example, cocktail cherries. I hope the House has seen that there is a specific reference to cocktail cherries in this SI. I do not know why cocktail cherries should have this applied to them; it would be difficult to eat enough of them to be severely damaged in any way other than what always happens if you eat too much fruit. The issue is this: can we imagine circumstances in which we had a different regime from the rest of Europe?

What we are proceeding to do today is decide that the UK will test and check everything and do it again—or perhaps not. Perhaps what we are really going to do is say, “We accept everything that the rest of Europe says but we’re not going to have any part in it at all”. Is this not the fundamental issue about the whole Brexit concept—that the only way Brexit would work would be on the basis that we did everything that we do today but we did not have a say in it? I know this is very unfair on my noble friend but it seems important to me that we do not let any of these SIs go past without reminding your Lordships and the public of the fundamental lunacy of this whole policy.

That brings me to the cost and resources. The FSA has been starved of resources; the cuts have been significant. Yet the public are increasingly interested in food safety, and there is a good reason for that. We have lived through a whole lifetime in which food has fallen in price but we are now in a world in which food will be rising in price, by the very nature of the emerging middle classes throughout the world and the fact that resources right across the board are less and less available. In these circumstances, because there is more money to be made by fraud, we are likely to have more of it. The FSA is going to have a great deal more to do even without this additional work being placed upon its shoulders.

It is important for my noble friend to reassure the House that the full costs, both to local authorities and to the FSA, will in fact be provided by the Government. This is another example of the mathematics of Brexit never having been properly explained, because none of this came into the arguments about how much we were going to save by leaving the EU. We still need to have that fundamental reassurance. It is not unreasonable to ask the Minister to give us examples of when our independent FSA is going to make different decisions from the rest of Europe and, if so, how that would deal with the import/export problem to which I have adverted.

No doubt we will have to pass this—and are we not lucky that we have an opportunity to do so?—but, frankly, it is yet another example of the sheer waste of time that we are all involved in due to this Alice in Wonderland position in which we seriously think that a nation 22 miles off the coast of the rest of Europe is actually going to have a different safety arrangement for food products that are, and have to be, freely traded within the EU.

[Baroness Blackwood of North Oxford]

I thank noble Lords for this fascinating debate. I want to be the first to wish the noble Baroness, Lady Walmsley, a happy birthday, and I thank the noble Lord, Lord Deben, for disclosing to the House his passion for cocktail cherries.

Our approach to EU exit when it comes to the FSA is underpinned by three principles. The FSA has been working hard to ensure that UK food remains safe and is what it says it is; that the high standard of food and feed safety and consumer protection we enjoy in this country is maintained when the UK leaves the EU; and that from day one a robust and effective regulatory regime will be in place, meaning that business can continue as normal.

As has been debated, this instrument was subject to parliamentary scrutiny through the affirmative procedure and requires affirmative approval. It needed redrafting and I would like to go into some detail on that, given that the issue was raised by the noble Baroness, Lady Wheeler. Some drafting errors were identified. I have been advised that they were minor. They mainly related to drafting style, rather than content. That is why the instrument was withdrawn. The errors have been rectified and the amended draft was brought back today. They related to an error in Regulation 16(b), where an obligation to inform the authority—the FSA or the FSS—of the receipt of an application for a product to be included in the list of products authorised for smoke flavourings was not included. That has been addressed. The FSA felt that the changes were minor, including a correction to remove a quotation mark at the end of a definition, which had been overlooked.

It was also said that the draft required elucidation relating to the requirement for definitions of appropriate authority and the authority prescribed for certain regulations. The FSA felt that this was not necessary as definitions are inserted by other draft EU exit regulations, but this has been actioned to make sure that it is absolutely as it should be. A final comment was about the failure to comply with proper legislative practice. This related to whether some text should be presented as a footnote instead. Again, the FSA considered that this was not required when originally drafting the instrument, as it replicated how the text was presented in the European Union (Withdrawal) Act 2018. However, the comment was taken on board and the amendment has now been made. I hope that clarifies what the amendments were.

I turn to the questions raised by the noble Baronesses, Lady Walmsley and Lady Wheeler, about the FSA’s preparedness and about funding, which was also raised by my noble friend Lord Deben. Extra funding—£14 million last year and £16 million this year—has been allocated to the FSA to help it prepare for the additional requirements it will have to take on board. This has enabled it to put in place some additional risk assessment tools and risk management experts and to replace some EFSA procedures on which it previously relied. It is important to understand that the FSA has always had a robust risk assessment system in place and has always undertaken evidence-based risk management decisions for the future of food and feed safety issues. It has now built into its capacity the ability to provide robust risk assessment and management advice post exit, using the additional funding provided. That is why we have been able to provide reassurance as these SIs have gone forward, and this has been taken into account as we have prepared for negotiations going into the implementation period, whether in a deal or no-deal scenario.

Obviously, we are considering what kind of relationship we will have with EFSA and what the situation will be regarding the RASFF. At this point, no decision has been made about our future relationship with EFSA, because it will be subject to forthcoming UK-EU negotiations. However, departments have undertaken an analysis to understand the impact that withdrawal from the EU will have on our relationship with EFSA and the EU agencies. This is why the FSA has ensured it has robust risk assessments in place, no matter what the scenario may be. However, it is our preference to have a close relationship with EFSA and access to the RASFF. That is the ideal scenario, which we will be working towards.

The noble Baroness and my noble friend Lord Deben raised the consultation with industry. It is important to point out that this was a thorough six-week consultation, undertaken by the FSA, which took place in September and October last year. Late responses were also taken into account. There was significant support for the approach the FSA has now taken with the SIs. That is why we are confident that the industry and stakeholders will be able to take on board the approach taken in this and other SIs, which have been fully debated in the House. That approach has also involved the devolved Administrations, and the FSA will continue to have close working relationships with the Administrations in Scotland, Wales and Northern Ireland as we go forward. That is why we are confident that, in practice, it will be possible to make arrangements and operate a framework for food and feed safety regulations across the UK, whatever exit scenario we have.

The noble Baroness, Lady Walmsley, asked about contingency arrangements should there be changes in regulation within the EU. If noble Lords support these regulations they will be on course to come into force this week. But if there is a short delay to food law they will not be fully operable, amendments to authorised products could not be made and urgent action might be required on unsafe food. The Food Safety Act and already corrected retained EU law would then continue to provide food safety protection for consumers, and enforcement action could be taken against the placing of unsafe food on the market. I hope that reassures the noble Baroness on that point.

I thank noble Lords for their consideration of these regulations, and I hope I have answered their questions. As I said, the Government’s priority is to ensure that the high standards of food safety and consumer protection we enjoy in this country are maintained when the UK leaves the European Union. This instrument performs an important part of our preparations for a functioning statute book on exit. Food additives, flavourings, enzymes and extraction solvents are important parts of substances referred to as “food improvement agents”. We must ensure we have the correct protections in place to protect public health after exit. This instrument makes no change to public policy—pace my noble friend Lord Deben—and I hope noble Lords will therefore accept it as it stands.

Motion agreed.