Medical Act 1983 (Amendment) (Knowledge of English) Order 2014
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The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, this Government recognise that overseas doctors make a valuable contribution to the NHS, and we are keen to ensure that highly skilled professionals do not face unnecessary barriers. However, it is vital that all doctors practising in the UK have the necessary English language skills in order properly to care for and communicate with patients.
Due to the legislation that governs the regulation of doctors, the General Medical Council is not able to apply language controls to applicants from the EU as a pre-condition to registration as a medical practitioner. This is of great concern to the Government and to the General Medical Council, as it raises a clear risk to patient safety.
The same restrictions in law do not apply to international applicants from outside the EU. Therefore, the General Medical Council is able to require all international applicants to provide evidence of their English language capability—for example, by taking an English language test—before being registered and given a licence to practise in the UK.
We have worked with the General Medical Council to identify a system of language controls which provides greater patient safety while being compliant with European law. We believe that the proposed legislative changes contained in the draft order will achieve this outcome. The draft order gives the General Medical Council appropriate powers to ensure that only those doctors who have the necessary knowledge of English to do their jobs safely and competently are able to practise medicine in the UK.
The draft order makes changes to the Medical Act 1983 to do two things: first, to give the General Medical Council the power to refuse a licence to practise in circumstances where a medical practitioner from within the EU is unable to demonstrate the necessary knowledge of English; and, secondly, to create a new fitness-to-practise category of impairment relating to language competence. This will strengthen the General Medical Council’s ability to take fitness-to-practise action where concerns are identified.
The licensing amendments will enable the General Medical Council to require evidence of English language capability as part of the licensing process where language concerns have been identified during the registration process. This is compliant with EU law, which sets out under the mutual recognition of professional qualifications directive that a professional’s qualifications must be recognised by the host member state before any language checks can take place.
The order makes amendments to Section 29G of the Medical Act 1983 which will require the General Medical Council to publish guidance setting out the evidence, information or documents which a medical practitioner must provide to demonstrate that they have the necessary knowledge of English. Any person who is refused a licence to practise on the grounds that they have failed to demonstrate they have the necessary knowledge of English will have a right to appeal.
The process for determining whether a person has the necessary knowledge of English will be set out in the General Medical Council (Licence to Practise and Revalidation) Regulations, which will be amended by the GMC in due course to enable the policy to be implemented.
With regard to the fitness-to-practise amendments, a new category of impairment relating to English language capability will be created. This will allow the General Medical Council to request that a doctor undertake an assessment of their knowledge of English during a fitness-to-practise investigation where concerns have been raised, which it is currently unable to do. These changes will strengthen the General Medical Council’s ability to take fitness-to-practise action where concerns about language competence are identified in relation to doctors already practising in the UK.
The proposed amendments to the Medical Act 1983 are designed to complement and further strengthen the existing language controls imposed through the responsible officer regulations, performer list regulations and checks undertaken by employers at a local level. These amendments will enable the General Medical Council to carry out proportionate language checks where there is cause for concern, and ensure that all doctors practising in the UK have the necessary knowledge of English to do their jobs well and reduce the risk to patient safety. I commend this order to the Committee, and beg to move.
Lord Walton of Detchant (CB)
My Lords, I cannot say how welcome this order is. Forty-three years ago I was elected dean of the medical school of the University of Newcastle. By virtue of that election, I was immediately appointed to the General Medical Council. I became a member of its education committee and three years later I became the chairman of that committee. By virtue of being chairman of the education committee of the GMC, I was then appointed, under the new arrangements for the European Union, to the Advisory Committee on Medical Training, which met twice a year in Brussels and was required to make recommendations on basic medical education, specialist medical education and the mutual recognition of qualifications.
That was an interesting experience. Under the treaty of Rome, the first directive derived from that treaty said—I am not quoting exactly but the meaning is clear—that in the movement of doctors across the European Union there should be mutual recognition of qualifications and registration should be granted, but that it should be up to the host country to see to it that the incoming doctor had such ability to communicate with patients to make him or her safe to practise. That seemed to give us at the GMC full authority to embark upon establishing a language test.
At that time, for historical reasons, some doctors from outside the European Union—from Commonwealth countries such as Australia, New Zealand, the West Indies and many others—had enabled the General Medical Council to inspect their examinations and qualifications so they were automatically granted full registration under the Medical Act. But doctors from many other countries who had not had that ability to have inspections were required to apply for temporary registration if they wished to come to the UK, and they had to take a test set by the Professional and Linguistic Assessments Board, which established tests of not only clinical and academic competence but language capability. That was the so-called PLAB test.
It is important to make the point that the rights of doctors graduating in any other member country of the European Union applied only to those who had graduated in those countries but who were also nationals of EU member states. For instance, if a doctor from a country outside the European Union graduated from, say, Heidelberg, they were not entitled under that treaty to come to the UK and had to go through the same procedure as a doctor from India, Pakistan or other parts of the world.
Indeed, there was one such doctor, an Iranian, who qualified in medicine in Heidelberg. He applied for registration with the General Medical Council and was turned down. He took the GMC to a judicial review. Of course, he lost because he did not qualify. The result of this was that I was interviewed by Special Branch because he had made serious threats against my person, including threats of violence. However, we will leave that alone for a moment.
The point I wish to make is that it is so important that we have this language test. We at the GMC, having read what the directive said, tried to impose a language test on incoming doctors from the European Union, but we were threatened with being taken to the European Court because we were told very clearly by our lawyers and by the lawyers from Europe that this was contrary to the treaty of Rome. We tried again 10 years later when I became president of the General Medical Council, again with a total lack of success. All we were able to do then was to persuade the employing authorities in the UK, through the Department of Health, that they could impose a language test as a condition of employment. Regrettably, that agreement with the Department of Health was never properly or widely fulfilled across the UK, so a language test as a condition of employment for European doctors was not widely employed. Our attempts at that time were lost.
The great thing about this order is, first, that it makes it clear that the GMC can properly design and employ a test of the language ability of an incoming doctor from the EC as a condition of registration. Secondly, the responsible officer can make certain that any doctor coming up for revalidation speaks English adequately. Finally, when any doctor who is already a specialist from the EC or is working either in general practice or in a specialist grade and is brought before the GMC on the question of fitness to practise, the fitness-to-practise procedures can take note of the doctor’s ability to speak English. These are extremely welcome developments. Perhaps I am wrong about the condition of registration but the GMC, I think, is hoping that that is the effect of this order. Perhaps the Minister can clarify it for us. The whole process set out in this paper is extremely welcome and long awaited.
Earl Howe
My Lords, I am very grateful for the welcome that this order has received from all noble Lords who have spoken. Perhaps I may begin by making clear one critically important point relating to the order prompted by a comment made by the noble Lord, Lord Walton. It is important to understand that the English language test is not a condition of registration. If a language test is required of a doctor, it would be a condition for that doctor receiving a licence to practise. Registration is granted on a full basis and language is assessed after registration.
The noble Lord, Lord Turnberg, questioned the quality of the training of specialists who come from other EU countries and asked what was being done to assure the safety of those doctors. If the specialism of a doctor is listed as a specialism under the directive then he or she will be required to comply with the minimum training standards set out in the directive. However, I will seek the advice of the GMC on this matter and will write to the noble Lord accordingly. A similar point was made by the noble Lord, Lord Kakkar, around the competency of EU doctors. I am sure he will know that it is not possible for the GMC to assess the competency of an EU doctor on registration. However, the council could assess an EU doctor’s competency in fitness-to-practise proceedings if questions are raised about the competence of that practitioner.
The noble Baroness, Lady Finlay, asked who would bear the cost of the fitness-to-practise case where there were language concerns. I can confirm that a doctor will not be required to pay for his or her own assessment in fitness-to-practise cases. The GMC has confirmed that it will bear this cost. She made the point, rightly emphasised by a number of noble Lords, including my noble friend Lady Brinton, that good communication skills are about more than just language competence. The issue is one that falls squarely to the GMC and we look to the council to ensure that it is addressed in guidance. If communication skills result in deficient professional performance, that matter could certainly be considered as part of a fitness-to-practise issue.
The noble Baroness spoke with her customary experience about the International English Language Test. On 25 February, the GMC announced a change in the score it requires in the English language test. As she pointed out, this is a test that many international medical graduates currently use to demonstrate their knowledge of English when they apply to join the register. Currently, IMG applicants must achieve a minimum score of seven out of nine in each of the four elements, and an overall score of seven. From the middle of June 2014, doctors will have to achieve a higher overall score of 7.5. They will continue to have to achieve scores of at least seven in each of the four domains. The new requirements for IELTS will be the same for all those applying to join the register. This move follows research commissioned by the GMC which suggested that the level should be enhanced. Moreover, IELTS will be one of the pieces of evidence that European doctors can use to demonstrate that they have the necessary knowledge of English.
My noble friend Lord Bridgeman asked about the extent to which the principle behind this order will be extended to other medical professionals, including nurses. The Government believe that in order to maximise patient safety, nurses coming to work in the NHS should not be able to work unless they have the necessary knowledge of English to perform their job well. Departmental officials are having ongoing detailed discussions with the NMC to seek to establish a system that will enable them to carry out proportionate language checks which are in line with EU law. I cannot give him further detail at this point but I can assure him that this matter is very definitely under scrutiny.
It must also be remembered that registration with the Nursing and Midwifery Council does not guarantee employment in the UK. Individual organisations are responsible for ensuring that the people they employ have the necessary skills for the post for which they are applying. EU legislation does not prevent the employer from assuring themselves that the nurse being recruited is competent, safe to practise, has up to date and contemporary knowledge, and has the necessary language and communication skills.
The noble Lord, Lord Hunt, raised the concern that the test for language competence should not be abused, and asked what safeguards the GMC was proposing in this area. As I mentioned, the GMC will be issuing guidance to provide absolute transparency of what evidence and documents are needed to demonstrate the necessary language competence. That should provide not only the necessary clarity for all applicants but also minimum scope for the kind of abuse that he referred to. It is for the GMC as the independent regulator of medical practitioners in the UK to decide the necessary knowledge of English to practise safely in the UK. As regards the guidance, in its recent consultation it suggested that where there is a cause for concern, similar evidence may be required to what is currently required for IMG doctors—for example, the required score in the academic version of IELTS or that the doctor has a primary medical qualification taught and examined in English. But, of course, in making that determination, the GMC will need to be mindful of EU law and ensure that such requirements are necessary and proportionate in view of the job to be performed.
The noble Lord, Lord Hunt, also asked whether the language requirements will be in any sense new. Systematic language checking is not permitted under the new directive. Any testing, as I mentioned, must be proportionate, and we anticipate that the new directive is likely to come into force in January 2016.
As regards the noble Lord’s other question, about the quality of language tuition where a doctor has been found to be deficient—and he asked whether the GMC will be signposting such doctors to good language schools—I have no doubt that this is an issue that the GMC will consider. However, it is ultimately an issue for it.
I hope that I have succeeded in answering most if not all of noble Lords’ questions. If I have not I will of course write. I conclude by thanking noble Lords for their very constructive and helpful comments.
Health: Multiple Sclerosis Nurses
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The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
It is the responsibility of commissioners and local providers to ensure that services have the staff they need to deliver high-quality care for people with multiple sclerosis. Listening to and learning from patients to improve care is a top priority for the Government. We are committed to putting patients at the centre of services. Commissioners are under a legal duty to involve patients and the public in the commissioning of services.
Lord Dubs (Lab)
My Lords, that is a bit disappointing. Does the Minister agree that MS nurses provide an invaluable service for patients as regards treatment, advice and access to services? Does he further agree that MS nurses can save costs elsewhere in the health service because they can reduce the pressure on GPs and on hospital admissions? Would it not be sensible for the Minister to say positively, “We need to ensure that every patient with MS should have an MS nurse to provide help and support”?
Earl Howe
My Lords, I agree with the noble Lord, Lord Dubs; there is no doubt that MS specialist nurses provide support that is extremely valuable for MS patients and their carers. They help to manage relapses and give advice, they act as a gateway into counselling and physiotherapy, and they help to minimise hospital admissions and reduce the need for consultant appointments. I do not disagree with the noble Lord at all. However, it is worth reminding ourselves that NICE guidelines on multiple sclerosis set out that after diagnosis, patients should be,
“put in touch with … a skilled nurse or other support worker”.
We expect those who work in the NHS to take account of NICE guidance.
Baroness Brinton (LD)
My Lords, given the Minister’s last response, is it not extremely worrying that currently 25 multiple sclerosis nursing posts are under threat of redundancy—about 10% of all MS nurses? Shifting back to generalist nursing care would be a waste of an extremely valuable resource in both health and economic terms, as has been outlined. What is being done to encourage hospitals to maintain this vital service, which can save clinical and out-patient costs, too?
Earl Howe
I have already mentioned the NICE guidelines, which we expect NHS professionals to take account of. In that context it is worth saying that the guidelines are due to be updated later this year, and patients and patient groups will have the opportunity to feed into that. However, in the end it is up to local healthcare organisations, with their knowledge of the needs of their local populations, to determine the workforce required to deliver safe and effective patient care within their available resources.
Baroness Pitkeathley (Lab)
My Lords, given what the Minister has said about the variations, can he explain a bit more about the tremendous regional variations in the numbers of patients who have access to an MS nurse, because this causes great confusion to patients and their families? For example, I understand that in the east of England there are 220 patients per MS nurse, whereas in the north-west there are as many as 650.
Earl Howe
I am aware of those variations. Making the NHS more responsive to the needs of people with long-term conditions such as MS is a key government priority. We have committed to it in the NHS mandate, the NHS constitution and the outcomes framework. Strategic clinical networks have a key role to play in providing expertise and guidance and to smooth out the variations that the noble Baroness mentions. She may be aware that NHS England has appointed David Bateman as the first national clinical director for neurological conditions, whose job it will be to look at the very issues that she has raised.
Baroness Gardner of Parkes (Con)
My Lords, I declare an interest as I have a daughter with multiple sclerosis. I think that I mentioned this some time ago, but is my noble friend aware that the Chelsea & Westminster Hospital waited years to get an MS nurse but had her for only a short time before she was poached by the Royal Free? Then no replacement MS nurse was even considered; the next vacancy on the list was considered and, as far as I know, the MS nurse has still not been replaced. Is there some problem? Is there a shortage of MS nurses? How was one so easily poached from one hospital by another? Is it a case of no one really wanting to spend the money on that and wanting to treat it is as a general thing, comparing it to all other jobs in a hospital? Can anything be done about that?
Earl Howe
My Lords, something can be done. First, patient groups can speak up and can speak to commissioners. As I said in my original Answer, we are committed to putting patients right at the centre of services, which means giving them a voice in the services that are commissioned. I am not aware of the situation in the Chelsea & Westminster Hospital, but my noble friend may like to know that there are now more than 3,300 more nurses working on NHS hospital wards than there were in 2010. That is a positive trend.
Lord Turnberg (Lab)
My Lords, is this not part of a wider problem, in that we have seen a marked reduction over the past few years in specialised nurses working in the community, where they can do so much to help keep patients safe and out of hospital? Should we not be seeing joint funding between the local authorities and the CCGs to fill this gap, which is looming all the time?
Earl Howe
Yes, my Lords, that is why we are creating the Better Care Fund, with £3.8 billion worth of shared money between the NHS and social care, starting in 2015, to make care seamless for the patient, whether it is NHS or social care. That fund has scope to do exactly what the noble Lord wishes to achieve.
Lord Wigley (PC)
My Lords, does the Minister appreciate the cross-border issues that sometimes arise between north-east Wales and north-west England, where multiple sclerosis patients may get some primary treatment in England but the level of support services, such as nurses, may be different over the border? Can he ensure that there is discussion on this between his department and the National Assembly in Cardiff to ensure that people do not miss out for that reason?
Lord Monks (Lab)
My Lords, will the Minister comment on the remarks made to me by an MS sufferer I know very well that MS is a Cinderella service in the NHS and does not get its fair share of resources? Does the Minister agree with those remarks?
Earl Howe
I think that has been true. We are very clear that neurology and, for that matter, specialised neurology, should assume a higher priority than it does. That is why it is so welcome that Dr David Bateman has been appointed as the first national clinical director, which I believe will raise the profile of all neurological conditions. However, the status of NICE guidelines and the quality standard that is coming down the track, which NICE will produce in a year or two, will also help to raise the standing of this very serious condition.
Health: Midwives
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The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, the Department of Health has been working closely with Independent Midwives UK, which represents self-employed sole-practitioner midwives, to explore possible options to secure insurance for its members. Independent Midwives UK has presented a business plan to the department seeking government funding, which has been carefully assessed. As any solution must be applicable across the UK, discussions have also taken place with the UK devolved Administrations. A decision regarding Independent Midwives UK’s proposal is imminent.
Baroness Cumberlege (Con)
My Lords, I thank my noble friend for that Answer and declare my interests as listed in the register. It has occurred to me that the first person to see your Lordships in the nude is a midwife. Midwives are very special people, and independent midwives are equally so. It is a travesty that independent midwives will not be able to practise if they cannot get clinical indemnity. As my noble friend said, Independent Midwives UK has worked very closely with the department but, unfortunately, there is still a gap of £1 million, the initial pot required to get midwives clinical indemnity. Will my noble friend work very hard to ensure that he and his colleagues fund that £1 million? I have to say that, in the context of the NHS budget, which is £110 billion, it is simply short change.
Earl Howe
My Lords, I hesitate to correct my noble friend but Independent Midwives UK submitted a business proposal to the department which would require the Government to provide a £10 million grant to support the inception of an insurance scheme for its members to provide full maternity care. We have considered two options, either of which would deliver that result. The creation of any government scheme specifically for Independent Midwives UK would effectively position the Government as the underwriter of the independent sector. That is something that we have hitherto found difficult to consider.
Lord Hunt of Kings Heath (Lab)
My Lords, I refer noble Lords to my health interests. It sounds to me as though the Government are perhaps going to come up with a positive outcome. Why have independent midwives been excluded from the NHS Litigation Authority’s clinical negligence scheme for trusts? Would that not be a very straightforward way of allowing independent midwives to continue and to be regulated? Clearly, one of the big issues at stake is that, without cover, it is likely that they will not receive proper registration in the future.
Baroness Manzoor (LD)
My Lords, the Royal College of Midwives says that there is a shortage of 4,800 midwives —a welcome drop from the 6,000 in recent times. However, this shortage and the shortage of obstetricians are resulting in variations in maternity services and in standards of care among trusts. What is the Government’s strategy to address these concerns?
Earl Howe
My Lords, the Government are committed to improving the choice of place of birth for women, continuity of care for mothers and the experience of care that they have. There are now 1,800 more full-time equivalent midwives than in May 2010 and there is a record number—in excess of 5,000—in training at the moment. The most recent data from November last year show that the number of midwives has increased at twice the rate of the number of births—by more than 6% since May 2010. We know that we need more midwives in the service but they are coming down the pipeline.
The Earl of Listowel (CB)
My Lords, is the Minister aware of the Australian research which suggests that the NHS could save £300 per birth if it adopted the one-to-one midwifery model? Might he consider how to encourage clinical commissioning groups and health and well-being boards to commission caseload midwifery? This has proved very effective in reducing the number of episiotomies and in encouraging, for instance, breastfeeding.
Earl Howe
My Lords, I am very interested to hear what the noble Earl says about the Australian experience. The mandate that the Government issued to NHS England, published in November 2012, states that women should receive better care during pregnancy and have a named midwife responsible for ensuring personalised, one-to-one care throughout pregnancy and childbirth, as well as postnatally. As part of that, we want NHS England to work with partner organisations to ensure that women are able to make informed and safe choices about where to have their baby. However, it is probably too soon to commit to a ratio of one midwife to one expectant mother.
Baroness Gardner of Parkes (Con)
My Lords, I am sure we all support the position of the midwives, but I would like to bring up the financial aspect again. Last week, we had a debate on how people would manage to finance their care in care homes and I mentioned that there are many difficulties, including the fact that no one will now give bridging finance for anything. I understand that all the midwives are asking for is contingency support to enable them eventually to run this as an independent scheme. They simply need the finance to get it off the ground. If that is the case, I remind the Minister of all the difficulties involved in raising funding for anything.
Baroness Wall of New Barnet (Lab)
My Lords, following on from the question from the noble Earl on the Cross Benches, I am sure that the Minister is aware that most trusts—this is certainly the case in the maternity unit at Barnet hospital—now have a community midwife at the birth, and that midwife follows the mother home and stays there for as long as the mother needs support. Therefore, there is one-to-one care from a midwife, not necessarily during the delivery but certainly in the care that the mother receives when she goes home.
Earl Howe
I am very glad to hear about that. It is certainly the aspiration that every trust should have. It is important for me to point out that we are talking here about a very small number of independent self-employed sole practitioners representing less than 0.5% of the 32,000 registered midwives in England. That is the context of this debate.
Young People: Suicide
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The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, I am very grateful to the noble and right reverend Lord, Lord Eames, for raising this important issue, and for the valuable contribution made by all speakers today. The Government take the issue of suicide very seriously, and are working hard to reduce the number of people who take their own lives.
The suicide rate among teenagers is below that in the general population and has remained steady over the past few years. However, we know that this group is vulnerable to suicidal feelings, as has been made abundantly clear in this debate. The risk is greater when they have mental health problems or a behavioural disorder, misuse substances or alcohol or have experienced family breakdown, mental health problems or suicide in the family. However, any suicide is one too many.
Suicide is devastating for loved ones left behind, and it is especially tragic when the victim is a child or young person. That is why children and young people have an important place in our 2012 publication, Preventing Suicide in England: A Cross-Government Outcomes Strategy to Save Lives. The report identified those groups of children and young people who are thought to be particularly vulnerable, including looked-after children, care leavers, children and young people in the youth justice system and gay and lesbian young people.
The noble and right reverend Lord mentioned funding. This strategy is backed by £1.5 million of funding for research. One of the funded projects will be exploring the use of the internet in relation to suicidal behaviour and identifying priorities for prevention. I assure noble Lords that the Government are committed to continue working with the internet industry in the UK to keep people safe online and to promote access to positive support for all suicidal people, including children and young people.
Education is also key. A number of noble Lords have mentioned bullying, including my noble friend Lord Black. The Government have sent a very clear message to schools that all forms of bullying are totally unacceptable and should not be tolerated. The Department for Education is in the process of reviewing behavioural guidance, which will be made available to all teachers.
The new national curriculum will see children aged five to 16 taught about internet safety in a sensible, age-appropriate way, a really important step to help children and young people to understand some of the issues. Furthermore, the major internet service providers are working on a parental awareness campaign, due to launch in the spring. This aims to raise parents’ awareness of, and ability to effectively use, the filters that they provide, and to provide parents with information about how to keep their children safe online.
We have also been clear that social media sites need to take responsibility for inappropriate content that is made available on their sites, which includes images of self-harm and suicide. We expect social media companies to respond quickly to incidents of abusive behaviour and inappropriate content on their networks. This includes having easy-to-use reporting tools, robust processes in place to respond promptly when abuse is reported and, where appropriate, suspending or terminating the accounts of those who do not comply with the acceptable-use policies. The Minister for Culture, Communications and the Creative Industries met with a number of leading social media companies to discuss what more might be done to protect young people when they are online, and we will continue to discuss this and work with the social media companies.
It is good to report that the industry has already worked on positive initiatives in this area. I want to echo the tribute paid by my noble friend Lady Buscombe to the excellent collaborative work that Facebook and Google have done with the Samaritans’ mental health strategy. The Samaritans have been facilitating a call to action for suicide prevention in England. More than 50 national organisations have signed this call for action, committing to work together so that fewer lives are lost to suicide and to support those who are bereaved or affected by suicide. My noble friend prompted me on the issue of the promised round table. I reiterate to her that free-to-caller access to the excellent Samaritans service would be an important step forward. Work to set up that meeting is in hand, and a date will be fixed shortly.
The Samaritans have also been instrumental in developing media guidelines for the reporting of suicide. Those guidelines are aimed not only at journalists reporting suicide but also at authors and producers of television and film dramas. Research tells us that reports of suicide can lead to copycat suicides. I am sure that all noble Lords will agree that it is important that any media reporting should be sensitive.
The noble and right reverend Lord, Lord Eames, mentioned stigma. The Government are very pleased to be supporting Time to Change, a campaign to end stigma and discrimination faced by people, including children and young people, with mental health problems. It is clear, thankfully, that attitudes towards mental illness are improving in the general public, with the latest national surveys showing continuing improvement. Any incidence of self-harm, however, must always be taken seriously. In all cases of self-harm, all noble Lords will agree that it is important for health professionals and others to intervene early, before it is too late.
Last month my right honourable friend the Deputy Prime Minister, with the Minister of State for Care and Support, launched the mental health action plan. Of the 25 actions, one relates to our commitments to change the way frontline services respond to self-harm and to ensure that no one experiencing a mental health crisis should ever be turned away from services.
I now turn to what the Government are doing to protect vulnerable young people in custody, an issue raised by my noble friend Lady Linklater and the noble Lord, Lord Ramsbotham. It is very sad that three young people in custody took their own lives in 2011 and 2012. My right honourable friend the Secretary of State for Justice has established a working group to learn from these tragic deaths. The group has identified and disseminated the key learning points from the deaths, highlighting common themes and actions to be taken to prevent further deaths of children and young people. Additionally, a review of the assessment, care in custody and teamwork procedures for young people is being undertaken. I shall convey to my colleagues in the Ministry of Justice the points made so powerfully by the noble Lord, Lord Ramsbotham.
The Government strongly support the recommendations in the report of the Children’s and Young People’s Health Outcomes Forum and the Chief Medical Officer’s report, Prevention Pays—Our Children Deserve Better. We are working with key partners to consider options for taking this important work forward, to look at the prevalence of mental health conditions in children and young people. The Government are very keen that all professionals who work with children and young people have access to information about mental health. I am delighted to tell my noble friend Lady Bottomley and the noble Lord, Lord Ramsbotham, that my honourable friend the Minister for Care and Support is launching an interactive e-learning tool for children and young people’s mental health on 25 March. This is aimed at health professionals—teachers, social workers and others—who are not necessarily mental health specialists and who work with children and young people. I want to pay tribute to the consortium of organisations headed by the Royal College of Paediatrics and Child Health for developing this exciting tool.
The mental health services for children and young people are very much in the Government’s sights. Between 2011 and 2015 we will be investing £54 million in children and young people’s improving access to psychological therapies, the CYP IAPT programme. This will give children and young people improved access to the best-evidenced mental health care.
My noble friend Lady Buscombe referred to the problem faced by children when they had a long distance to travel. Our aim must of course be to support children and young people with mental health problems near to where they live. Admission to hospital should be a last resort for a young person, quite clearly. We recognise the difficulty if people are treated away from home but the decision, inevitably, will depend on what facilities are available locally and the clinical needs of the individual.
The noble and right reverend Lord, Lord Eames, rightly pointed out that a multifaceted approach is needed. We completely support and agree with the need for such an approach. The role of the voluntary sector here is key and I pay tribute to the excellent work that is being done by the third sector—for example, by PAPYRUS, an organisation mentioned by the noble and right reverend Lord, and by CALM, which supports families who are concerned about suicide or have been bereaved by it.
My noble friend Lady Linklater and others raised the vexed topic of self-harm, which should always be taken seriously. Child and adolescent mental health services are there to support children and young people who self-harm. There is evidence that self-harm is a symptom of stress and mental illness. Clinical care must always focus on these causes and on coping strategies rather than on the self-harm itself. In 2004, NICE published clinical guidance on the management of self-harm which covers the care that people who self-harm can expect to receive.
Finally, as we have debated frequently in this House, the Government are working towards parity of esteem between physical and mental health. We have been clear that there must be equal priority between mental and physical health services. One of the 24 objectives in the mandate to NHS England is to put mental health on a par with physical health and to close the health gap between people with mental health problems and the population as a whole. We expect the NHS to bear this in mind when taking decisions about how to spend NHS money on services for local people, including young people.
NHS: NICE-appraised Medicines
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Lord Hunt of Kings Heath (Lab)
My Lords, I beg leave to ask the Question standing in my name on the Order Paper and I refer noble Lords to my health interests.
The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, patients have a right to drugs and treatments that have been approved by the National Institute for Health and Care Excellence that their doctor decides are appropriate for them. There can be many reasons for variation in use but we are determined to tackle unjustified variation where it exists.
Lord Hunt of Kings Heath
My Lords, I am grateful to the noble Earl for that response. Does he agree that one of the conclusions of the report is that there can be a tenfold variation in the take-up of innovative new medicines that have been approved under the NICE technology appraisal programme? Given that it is a legal requirement for clinical commissioning groups to fund those treatments, as I understand it, what sanctions can be taken against commissioning groups which do not fund those treatments? What can patients do in each area if they are refused such treatments? Is there a process of appeal that they can take their concerns to?
Earl Howe
My Lords, there is a process of appeal. Patients can go to their clinical commissioning group or, indeed, to NHS England and ask for the matter to be specially looked at. However, it is important to understand what these figures are and what they are not. They are not intended to be, and do not claim to be, a statement of whether certain drugs are being underprescribed or overprescribed in a particular area. One has to drill down into the reasons. In fact, when one does that, for most of the groups of medicines where it was possible to compare observed and predicted use, the report shows that use has increased over time, and we are introducing additional tools to allow the NHS to get to the heart of the reasons for variations in local areas.
Lord Walton of Detchant (CB)
My Lords, can the Minister say what consideration the Government are giving to the availability of the highly expensive so-called orphan and ultra-orphan drugs that are now coming on stream, which are effectively treating many rare diseases?
Earl Howe
My Lords, this important class of drugs will be subject to a special evaluation process by the National Institute for Health and Care Excellence. That methodology has been worked through and over the coming months we will see NICE evaluating orphan medicines and medicines for highly specialised conditions to inform clinicians in the NHS and, where appropriate, provide a funding direction for those drugs.
Baroness Brinton (LD)
My Lords, perhaps I may follow on from the Minister’s answer to the noble Lord, Lord Hunt, on clinical commissioning groups. The previous year’s report on appraised medicines provided a very helpful algorithm of biologics for rheumatoid arthritis. Will NICE and other organisations involved in these specialist medicines follow a similar algorithm to make it even clearer to CCGs where they should not step out of line but must follow clinicians’ advice?
Earl Howe
It is important to distinguish between a technology appraisal, where, if favourable, there is a clear funding direction for the NHS—in other words, it must fund the drug if the doctor thinks that it is appropriate for the patient—and a clinical guideline, where NICE issues best practice advice for the NHS. There is no funding direction attached to that. However, clinicians are expected to take account of NICE guidelines in everything that they do.
Lord Kakkar (CB)
My Lords, I declare my interest as chairman-elect of University College London Partners, one of the designated academic health science partnerships. Is the noble Earl content that the funding arrangements to be put in place by NHS England for the 15 designated academic health science networks are appropriate and will ensure that they can discharge their substantial obligations under their licence agreement, including the adoption of NICE guidance among the populations for which they are responsible?
Earl Howe
The noble Lord asks a very important question. It is slightly wide of the Question on the Order Paper, which relates to a particular set of statistics. However, I can tell him that I am broadly satisfied with the level of funding for AHSNs, and NHS England has given its commitment to maintain its support for them going forward.
Lord Campbell-Savours (Lab)
If the appeal is to NHS England or the commissioning groups, does that mean that they have the right to overrule the decision that has been taken by NICE?
Earl Howe
My Lords, patients have a right under the NHS constitution to access clinically appropriate drugs and treatments recommended by NICE technology appraisals. That is a legal right. If a prescriber has failed to adhere to that, a clinical commissioning group is bound to find in the patient’s favour. However, there are clearly individual circumstances for each case that need to be looked at. The key is that the patient is entitled to expect a transparent and fair process where the reasons for a decision are published.
Lord Alton of Liverpool (CB)
Given that the noble Earl has just referred to the Question of the noble Lord, Lord Hunt, about access to new, innovative medicines, will he undertake to look at material which I have sent to him today from the Toronto-based mesothelioma research institute, which has developed new, innovative treatments for mesothelioma victims and may hold hope for some of the 2,200 who die of that horrific disease in this country every year?
Lord Aberdare (CB)
My Lords, is the noble Earl aware that a new treatment has recently been licensed for advanced pancreatic cancer, offering the greatest improvement in survival of any such treatment in 17 years? Does he share my concern that it needs to be made available to sufferers from the disease as urgently as possible via the Cancer Drugs Fund while awaiting NICE approval?
Earl Howe
My Lords, drugs which have not yet been assessed or approved by NICE are eligible for use under the Cancer Drugs Fund. I am pleased to say that the Government have made a total of £1 billion available under that fund and 44,000 patients have been treated under it. I appreciate the noble Lord bringing that particular drug to my attention and I undertake to look at it.
Baroness Masham of Ilton (CB)
My Lords, does the Minister realise the frustration that some clinicians have when there is a drug that gives a better quality of life to patients but they cannot give it to them?
Earl Howe
My Lords, if a drug is licensed in this country, it is open to a clinician to prescribe it as long as their clinical commissioning group will fund it. There are local funding policies for drugs. I understand the noble Baroness’s point, but when a drug is assessed by NICE, it can be assessed for quality-of-life properties—that element will have been included in the assessment. Indeed, that is the reason why we have the process that NICE goes through.
NHS: General Practitioners
Earl Howe Excerpts(10 years, 8 months ago)
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Lord Hunt of Kings Heath (Lab)
My Lords, I beg leave to ask the Question standing in my name on the Order Paper, and refer noble Lords to my health interests in the register.
The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, the GP patient survey showed that the vast majority of patients are satisfied with their GP and rated their experience of making an appointment as good. To improve access further we have announced a £50 million fund to support GP practices in improving services and access for their patients. We have also reduced the quality and outcomes framework, the QOF, by more than a third. This will free up space for GPs to provide more personalised care. In addition, by March 2015, all practices will have the facilities to offer online appointment booking and repeat prescription services, increasing ease of access to GP services.
Lord Hunt of Kings Heath
My Lords, the noble Earl will know that the analysis by the Royal College of General Practitioners at the weekend showed, according to its work, that 10% of patients were finding it difficult to find an appointment with their general practitioner. Can the noble Earl tell the House what the Government are going to do about that? Does he agree that as hospitals are now moving to full seven-day working, the accessibility of primary care must be improved?
Earl Howe
I do agree with the noble Lord’s final comment in particular. We know that GPs are hard pressed. GP consultation rates have risen by 40% since 1995. We therefore need to take several steps to address that. One is in the medium to longer term: we need more GPs, and we have tasked Health Education England to ensure that at least 50% of medical students move to the GP specialty. In the immediate term, there are the measures that I mentioned relating to the GP contract and the £50 million fund, both of which are designed to make the use of GPs’ time a lot more productive than it is at present.
Lord Forsyth of Drumlean (Con)
Can my noble friend tell me whether the previous Labour Government’s negotiation of the GP contract, which resulted in GPs being less available but being considerably better paid, may have something to do with the difficulties that we are now experiencing?
Earl Howe
My Lords, the resources that have been devoted to GP practice and primary care have gone up by a third in real terms since 2002. A lot of that was due to the revised GP contract. Unfortunately, that contract also allowed GP practices to opt out of out-of-hours care which, over time, has meant that patients have found it more difficult to access their GPs at evenings and weekends.
Baroness Meacher (CB)
My Lords, very much respecting the point about out-of-hours care, I am aware of a number of practices that are finding it extremely difficult now to recruit GPs. Will the Minister undertake a review of the impact of the now falling GP pay on recruitment and therefore on the capacity of patients to obtain appointments?
Earl Howe
The noble Baroness raises a very important issue. I can tell her that the department and Health Education England have commissioned an in-depth review of the GP workforce looking towards a more sustainable solution for the longer term. The final report will be published in the summer. The preliminary report suggests that increasing the supply of practice nurses and greater collaboration with specialists may help to improve effective workforce supply.
Baroness Wall of New Barnet (Lab)
I follow on from the question of my noble friend Lord Hunt and the Minister’s acknowledgement that the effectiveness of primary care needs to be improved. I agree with what the Minister said about the improvement in some GP services, but still many individuals come to A&E at all times, whether the surgery is open or otherwise, which makes things very difficult. For instance, Barnet Hospital received 117 ambulances yesterday, which made it extremely difficult to deal with people who had walked in, who probably could have had their treatment somewhere else.
Earl Howe
The noble Baroness is quite right. The NHS is seeing an extra 1 million patients in A&E compared to three years ago. Despite the additional workload, it is generally coping very well although we know that departments are under strain. This is not just about A&E, as the noble Baroness will be aware, but about how the NHS works as a whole: how it works with other areas, such as social care, and how it deals with an ageing population and more people with long-term conditions. Dealing with all that means looking at the underlying causes, and that work is going on at the moment in NHS England.
Lord McColl of Dulwich (Con)
Does the Minister agree that it was very unfortunate indeed that certain politicians, who shall remain nameless, said to the general practitioners: “We know what you’re doing. You should have been working but you were on the golf course and, from now on, we’re going to pay you only for what you do”? The general practitioners thought this was a rather good idea, because it resulted in a substantial pay rise.
Earl Howe
My Lords, there is no doubt that the general practitioners bit the Government of the day’s hand off, 10 years ago, and they had every reason to do so with the money that was being offered to them. However, while a feature of that contract was the quality and outcomes framework, which was a good idea in itself, it has resulted in a lot of box-ticking for GPs and it is that element which we have drastically reduced in the contract for next year. That will be helpful in freeing up GPs’ time.
Baroness Manzoor (LD)
My Lords, I am fortunate that I am registered with an excellent GP practice which is well run, accessible and innovative. Over the last 30 years, I have seen significant improvements, and not only in the range of services that the practice provides. Who is responsible for ensuring that GPs are learning from other GPs the excellent practices which are available across the country?
Earl Howe
My Lords, there is a variety of means to ensure that GPs have continuous professional development. It is partly up to Health Education England to see that that happens and that there is peer-to-peer learning and review. Clinical commissioning groups also have an interest in ensuring that the quality of service provided by every member practice is of an equally high standard.
Care: Financial Services Industry
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The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, I begin by thanking the noble Lord, Lord Lipsey, for raising this very important issue. I thank equally all speakers for their contributions to the debate. The noble Lord, Lord Lipsey, and I have conversed many times of late on the Floor of the House about the provisions of the Care Bill, so I am in no doubt that he is very well acquainted—perhaps more than most of your Lordships—with the recommendations of the Dilnot commission on the funding of care and support. However, for the benefit of others who may not have been following as closely, I will take a moment or two to refresh our memories.
The commission found that the current system is simply unsustainable and not fit for purpose. We need to ensure that we have a system that is sustainable and that people do not face catastrophic care costs. This is what the reforms we are introducing will do. The commission defined a new model for funding care and support—a new partnership between the individual and the state. It suggested that where individuals can afford to contribute they should do so but that it was simply not fair to expect people to spend their lifetime savings meeting the cost of their care. To address this current imbalance we are putting in place a cap on care costs, as recommended by the commission, to provide people with an insurance against catastrophic costs and the fear and worry that these can bring. We are also extending the means test and, as a result, we will be giving 35,000 more people means-tested support with their care costs immediately when the system comes in.
These are all ways that the state will be providing additional protection. However, we must remember that what the commission described was a partnership, and there are at least two sides to every partnership. It recommended that where they can afford to do so, individuals should also contribute. It is just as important, perhaps even more so, to make sure that we are providing individuals with the support they need to meet their contribution. We as government are providing flexibility through the introduction of the universal deferred payment scheme and additional support through the new Clause 4 duty on local authorities to provide financial information and advice. I shall say more about that in a moment.
We cannot, however, do this alone. The financial services sector needs to provide some support, too. The noble Lord, Lord Lipsey, recommended Ministers to go away and think about a postponement of the deferred payment scheme. I am sure he would agree with me that the deferred payment agreements perform a very important function and are one of the ways in which people can pay for their care more flexibly. Local authorities, as he is aware, already offer deferred payments. That gives me grounds for believing, and indeed having confidence in believing, that they have the ability to implement the universal scheme in April of next year. Given the fundamental function that these deferred payment agreements will fulfil, I am very hesitant, if not reluctant, to consider delaying the universal scheme. However, I will convey the noble Lord’s views to my honourable friend Norman Lamb.
I should like to address the precise question placed before me by the noble Lord, Lord Lipsey. He asked what plans the Government have for the role of the financial services industry in funding care provision in the light of the Dilnot commission reforms. My straight answer to that question would need to be that we have no direct plans because the industry is independent of government and, as such, we have no control over what it does. We cannot compel it to play any role, however much we might like to. I cannot say what plans we have, but I can tell the noble Lord about the joint work that we have been doing with the industry, our shared ambitions and our commitment to continue this joint working—a commitment, incidentally, reinforced by the briefing issued by the ABI ahead of this debate.
In March 2013, the Department of Health invited companies from the financial services industry to conduct a review of financial products to fund care—the opportunities that the Care Bill would provide and the barriers that needed to be overcome for it to flourish. The review reports were published on 21 January this year, alongside a joint statement of intent between industry and government, where we both committed to working together on this agenda. The industry-led review told us that the introduction of the Care Bill reforms would largely give us the right conditions for a market of care products to emerge. I do not think we should overlook the importance of that finding. Further, the reports confirmed that industry saw itself as able to play an important role in helping people to plan for their care and support needs—again, a sentiment reinforced by the ABI in its briefing yesterday.
However, that does not mean that our job is done. We need to be realistic about what we might expect, and when. More work needs to be done and there are some barriers to overcome if we are to see this market take off. Again, I have no need to familiarise the noble Lord, Lord Lipsey, with some of those barriers. Indeed, he has spoken of them in the debate. Public awareness of how care is funded is woefully low. We need to build an understanding, a greater awareness of how the system works and the need for people to plan and prepare for future care needs—something that the Government have already committed to do. My noble friend Lady Brinton asked how demand for financial products could be stimulated. We need to make sure that there is good information and advice to support and enable people to make well informed decisions about the types of care they want to receive and how they can pay for it—something that we will ensure happens through the new information and advice duty on local authorities.
To be successful, an awareness campaign needs to be delivered in partnership—national and local government working alongside the wider care sector. We are already working with partners to develop the right approach. I can tell the noble Baroness, Lady Greengross, that we have already embarked on a joint programme with local government to implement the care and support reforms and that awareness raising will be an important part of this. The department will co-ordinate the messages to ensure that a simple, coherent campaign can be delivered nationally and locally. We are engaging with the voluntary sector, care providers and the financial services industry to make sure that we can all play an effective part in communicating these reforms. The noble Baroness, Lady Greengross, emphasised the need for stability in the sector in the way these reforms are implemented. If we combine our efforts and maintain cross-party support for these reforms—which I hope and believe we can—we can ensure that this happens.
We want to see products developed and in that process we need to consider whether this could be aided by regulatory change, which was also mentioned by the noble Lord, Lord Lipsey. The department has already opened up the lines of communication between industry, the Treasury and the Financial Conduct Authority to explore this issue further.
As to being realistic about what we should expect, I want to be clear that I do not expect a big bang moment where financial services companies across the country release hundreds of new products. I want to see a sustainable market develop, with products which are designed to meet the demands of customers. These developments will be incremental and are likely to take some time. That is emphasised in the ABI report, which states that it will take a much longer period of time before younger people are encouraged to purchase care products. It also identifies products that could be adapted and brought to market in the short term. It suggests that the first step, the quick wins, would be to adapt existing products such as pension annuities, health insurance and, as my noble friend Lady Gardner said, equity release, to name but a few. The recent announcements made in January by a number of leading firms confirm that the industry is beginning to develop its offer for the market. That is a positive development.
The noble Baroness, Lady Greengross, and the noble Lord, Lord Hunt, asked about the timetable for the guidance. We will consult on the draft regulations and guidance for the April 2015 reforms in the spring of this year. We intend to consult on the draft regulations and guidance for the April 2016 reforms—that is, the cap on care costs—in the autumn of this year. We have committed to do this to make sure that they get the scrutiny they require and to give local authorities enough lead-in time properly to prepare for implementation.
My noble friend Lady Brinton asked how people could obtain information and advice about the adequacy of the products they were being offered. There is a separation of roles here. It should be the role of government to raise the levels of awareness of how care funding works and encourage people to plan and prepare—I have already talked about that—but it should not be for government to recommend or give a gold seal to any financial product. Advice is regulated precisely because whether something works or is appropriate is down to individual circumstances. That is why the noble Lord, Lord Lipsey, emphasised the point around the expertise of SOLLA representatives, for example.
The noble Baroness, Lady Greengross, suggested that the eligibility criteria for deferred payments should be national. Eligibility criteria for deferred payments will be in national regulations to ensure that there is protection for those people who face having to sell their homes in their lifetime to pay for care—that is the minimum offer. Local authorities, however, will have discretion to be more generous than the minimum offer, and we will consult on all the draft regulations and guidance that are to come in next year, as I have mentioned, in the spring of this year.
The noble Lord, Lord Hunt, returned us to the issue of the cap on care costs and suggested that, in reality, people would find themselves paying more. I would not seek to argue with the points that he and the noble Lord, Lord Lipsey, made. It is a difficult issue. We want to extend state support for social care to tens of thousands of people who get little or nothing under the current system and the Care Bill establishes a legal framework to enable this. We would like to be able to set a lower cap, which may well be possible in the future, but we also need to live within the broader economic constraints on public spending that we currently face. It is a matter of finding that balance at the current time. We have committed to reviewing this question every five years to ensure that we continue to get that balance right.
I am optimistic that the financial services industry will step up to the plate and play a role in helping people to plan for their care costs. We will encourage it to do so. Our continuing work with the industry is a key pillar in our efforts to support individuals in the new partnership recommended by the Dilnot commission. There is still a long way to travel but the first stirrings of growth are beginning to show.
NHS: Patient Data
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Lord Turnberg (Lab)
My Lords, I beg leave to ask the Question standing in my name on the Order Paper. In doing so, I declare my interest as scientific adviser to the Association of Medical Research Charities.
The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, NHS England’s care.data programme takes forward the ambitions set out in the Government’s information strategy for health and care in England, The Power of Information, published in 2012, in particular elements of chapter 5 of the strategy. The Department of Health strongly supports NHS England’s decision to do more engagement work before data collection takes place. This is a vital programme which will bring real benefits to patients.
Lord Turnberg
My Lords, I am grateful to the noble Earl for his response. Few people doubt that there are enormous benefits to be gained from patient data, both for the care and treatment of patients at the moment and for research into treatment for future patients. However, does the noble Earl agree that NHS England has been remarkably unsuccessful so far in communicating both the benefits and the safeguards to confidentiality? Does he further agree that it is vital that NHS England uses the next six months, which is the delay, to develop some robust and convincing methods of communicating with the public?
Earl Howe
I entirely agree with the noble Lord. This is a vital programme which will bring real benefits to patients. It has major potential benefits for research and public health. It commands generally wide stakeholder support. However, there is no doubt that concerns over how this has been explained to patients have been raised and those concerns need to be addressed. I agree that the next six months will be crucial in pursuing that aim but it is essential that this programme commands public support.
Lord Kakkar (CB)
My Lords, I declare an interest as professor of surgery at University College London. What assessment have Her Majesty’s Government made of the proposed European data protection regulation which, if passed, has the potential to impact seriously on our national strategies with regard to health informatics and biomedical research?
Earl Howe
My Lords, we take that concern extremely seriously. The draft text that has been published by the so-called LIBE committee would, if enacted, pose serious obstacles for our research effort in this country. We are taking every opportunity and using every effort to persuade both the Parliament and the European Commission that the original text is the one we should go with. That work is on-going and the Ministry of Justice is leading on it.
Lord Cormack
Will my noble friend assure the House that the leaflet which was recently sent out, and which was far from satisfactory, will be replaced by something that really communicates what people need to know?
Earl Howe
My Lords, I am aware of concerns around the leaflet. Many people have said that they have not received it, which is clearly a concern. NHS England, which is leading on the development of the programme, will consider how to ensure that it engages fully with stakeholders and the public over the coming weeks and months and respond to the concerns that have been raised. The Government will also be engaging with stakeholders to see what we can do from a broader perspective.
Lord Hunt of Kings Heath (Lab)
My Lords, I refer noble Lords to my health interests. Is not one of the problems that if a patient wants to opt out of the system they have to go to or communicate with their general practitioner? I am sure the noble Earl will have seen the report at the weekend from the Royal College of General Practitioners that GPs are sometimes rather difficult to find. Would it not give the public more confidence if they could opt out in a straightforward way rather than have to go to see their GP and then depend on the GP to enact that in practice?
Earl Howe
My Lords, I cannot agree with that. The GP surgery is where the records are kept and would seem to be the natural place for patients to go. They do not have to make an appointment to do that. If they are concerned, they can write a letter or send an e-mail to the GP practice and then have a conversation later if they would like to. I do not think this is a difficult process.
Baroness Brinton (LD)
My Lords, it is clearly illegal for pseudonymised data to be worked back and then aggregated with other available data. Can the Minister assure the House that the Government will consider increasing the penalties for infringing personal data, including prison sentences for serious breaches and a ban on the offenders and their organisations accessing any data for up to 10 years? This is because current organisations are often not taking seriously breach-of- data fines.
Earl Howe
My Lords, I have seen quite a lot of comment on this aspect of the issue in the press. At present, the Information Commissioner’s Office already has the power to impose a fine under Section 55A of the Data Protection Act and the current penalty is up to £500,000, which is quite a severe penalty. To amend that would require changing the Data Protection Act and, at the moment, the Government have no plans to do that.
Lord Walton of Detchant
My Lords, does the Minister accept that all appropriate steps are being taken to protect the anonymity of these data? In the light of that, is it not more important to the future of medicine in this country that the availability of this massive database should be taken advantage of in relation to medical research, which will in turn have the undoubted effect of giving huge potential for improvement in patient care?
Earl Howe
The noble Lord is absolutely correct. It is worth pointing out that the vast majority of medical research in this country relies on fully anonymised data. It does not require patient-identifiable data. An organisation making an application for information that is identifiable would be allowed to do so only if it had obtained patient consent or had been granted legal approval to do so, either by the Secretary of State or the Health Research Authority, or where there is a public health emergency of some kind.
Drug Companies: Medical Trials
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Lord Kennedy of Southwark
To ask Her Majesty’s Government what action they intend to take in respect of drug companies that withhold the results of medical trials.
The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, companies are legally required through the marketing authorisation application process to provide the relevant regulatory authority with all information for evaluation of a medicine. This includes clinical trial results which are both favourable and unfavourable. The Medicines and Healthcare products Regulatory Agency has powers to take action where particulars supporting an application are incorrect or where the company has failed to inform authorities of new information that would influence the evaluation of the benefits and risks of the product.
Lord Kennedy of Southwark (Lab)
My Lords, the number 1 risk on the Government’s national risk assessment for civil emergencies, ahead of both coastal flooding and a major terrorist incident, is that of pandemic influenza. Is the noble Lord concerned that Tamiflu, which is supplied for use in a flu epidemic, may not be as effective as was once thought? Is he concerned that many large-scale trials of Tamiflu have not been publicly reported?
Earl Howe
My Lords, during the course of last year, the Government gave detailed evidence to the Science and Technology Committee on the issue of data provision in respect of clinical trials. The committee made a number of helpful recommendations on the removal of barriers to transparency. In our formal response, we set out how we would work to achieve the aims of greater transparency. In the light of that response, the Government are looking into the recommendations of the PAC report on the stockpiling of Tamiflu and access to clinical trials data, published in January. We will give our formal response to the report next month.
Baroness Brinton (LD)
My Lords, evidence shows that the chances of a complete trial being published are roughly 50%. The recent EU clinical trials draft directive will require all trials to be registered before they start, and full results to be published within a year. However, the regulation will be applicable only to trials starting from this year. How do the Government plan to ensure that pharmaceutical companies will release medical records for drugs that were launched before 2014?
Earl Howe
My noble friend raises a topical question. The industry’s trade body, the Association of the British Pharmaceutical Industry made clear, in its code of practice in 2012, that companies are obliged to publish all clinical trial results within a year of marketing authorisation and publicly register new clinical trials within 21 days of the first patient being enrolled. That, of course, is a forward-looking exhortation, but we are encouraged by the fact that the industry is taking an increasingly responsible view in this area by publishing data voluntarily, as demonstrated by companies such as GSK, AstraZeneca and Johnson & Johnson. We want to encourage more companies to do the same.
Lord Walton of Detchant (CB)
The noble Earl has made very clear the legal background to the present situation. He is fully aware that if a drug that has been fully tested and shown to be highly effective, and NICE has recommended that it should be prescribed to patients, the authorities have the legal responsibility to prescribe it. If, on the other hand, NICE has been given evidence to indicate that a particular remedy is ineffective as a result of negative clinical trials, is it equally incumbent on health authorities to recommend that that drug should not be prescribed?
Lord Mawhinney (Con)
I compliment my noble friend on the full and comprehensive Answer that he gave to the Question, and on the reassurance that it contained. Do he and his colleagues think that perhaps the issue here is not the legal framework but the issue of transparency and ease of access to information? If they think that that has some merit, would they be willing to consider having a simplified summary of the legal position on the department’s website for easy access for those who are interested?
Earl Howe
I absolutely agree with my noble friend. The Government are committed to transparency in the area of clinical trials. Transparency is important for patients, the public, researchers and the NHS, and it can be achieved through ensuring trial registration and outcome publication, as well as making data available through the appropriate channels. I think that the new EU regulation will be extremely helpful in promoting transparency, and the availability of summaries of all trials and clinical study reports will be a part of that regulation. However, I take my noble friend’s point about a simple guide for the public and I will gladly consider it.
Lord West of Spithead (Lab)
My Lords, will the Minister confirm that the work put in hand by the previous Government to ensure that we had the capacity to produce sufficient quantities of drugs to counteract various types of bird flu, once it had been identified, has now been completed and that we are in a position to be able to do that?
Lord Hunt of Kings Heath (Lab)
My Lords, I come back to the question raised by the noble Baroness, Lady Brinton. Once a medicine goes off patent it can, through generic production, remain available to members of the public for many years. The evidence seems to be that trials that give a favourable verdict are twice as likely to be published as trials giving unfavourable results. Could the noble Earl focus a little more on whether the industry can be encouraged to produce evidence around those trials in relation to current medicines as well as future ones? I also refer noble Lords to my health interest in the register.
Earl Howe
My Lords, it is important to point out that the MHRA does not have evidence that there is systematic or large-scale withholding of data. However, it has investigated cases in the past where clinical trials and safety data were not properly reported. The Government believe that the proposals included in the new EU clinical trials regulation will, as I said, contribute to greater transparency in the area of clinical trials. It must be remembered that any company infringing even the current rules can lay itself open to some very severe penalties.
Health: Meningitis B Vaccine
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Lord Turnberg
To ask Her Majesty’s Government whether they plan to introduce a vaccine for meningitis B in children.
The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, the Joint Committee on Vaccination and Immunisation, the independent expert committee that advises the Government on immunisation matters, has not yet made a final recommendation about the use of the meningococcal B vaccine, Bexsero. The JCVI is due to report in March 2014, having reviewed additional evidence at its meeting earlier this month. We will respond to any JCVI recommendation as quickly as possible.
Lord Turnberg (Lab)
My Lords, I am grateful to the Minister for that response. Meningococcus B causes a very nasty form of meningitis. It affects about 1,000 cases a year, mostly in children. It kills about one in 10 and causes severe and lasting disability in one in three. It is no wonder that it is a parent’s worst nightmare. Yet the safe and licensed vaccine that can prevent most cases was turned down by the JCVI after what seems to have been rather a doubtful cost-benefit analysis. Will the Minister make sure that when the JCVI comes to look at it again, as it is doing, it uses a more relevant discount value for the quantity and quality of a child’s life; and that once the Government have received the committee’s advice, they will make a rapid decision to make the vaccine available?
Earl Howe
I can give the noble Lord an assurance on the latter point. We will take a decision as rapidly as we can once we receive the JCVI advice. I appreciate that the JCVI’s interim position statement will have been disappointing to many people. I know the noble Lord recognises that it is important that decisions about the introduction of new vaccines into the national immunisation programme take account of evidence of their effectiveness, safety and cost-effectiveness compared to other healthcare interventions. We need to wait and see what the JCVI’s final advice is. I am aware that it is looking at the cost-effectiveness methodology that is used for vaccines of this type.
Lord Avebury (LD)
My Lords, do the options now being developed by Public Health England at the request of the Government include a population-based evaluation of the meningitis B vaccination, taking into account the discounted lifetime cost to the public sector of supporting children who are disabled by the disease? Will my noble friend also explain why the Department of Health assumed that the carriage effects achieved with meningitis C do not read across to this variant of the disease?
Earl Howe
I can tell my noble friend that the JCVI has been considering both those issues: first, the possible need for a population-based evaluation of the MenB vaccine to address uncertainties in its effectiveness; and, secondly, what the possible effect of the MenB vaccine on the carriage of meningitis B bacteria might be. I say again that we need to wait for the JCVI’s final statement of advice to get clarity on either of those issues.
Lord Hunt of Kings Heath (Lab)
My Lords, of course I understand that we need to await the outcome of the Joint Committee’s further deliberations. However, following up the Question asked by my noble friend, if the committee sticks to the view that a vaccine would have a huge impact on an estimated 1,000 young people every year but still considers that that is not cost-effective, surely it calls into question the methodology that it is using. Will the noble Earl say a little more about how the Government can ensure that this methodology is put under full scrutiny?
Earl Howe
Last October, in recognition of concerns about the methodology currently used for assessing cost-effectiveness of vaccines, the JCVI agreed that a working group should be formed to consider two issues: first, how the impact of vaccination programmes to prevent rare diseases of high severity should be best assessed; and, secondly, whether there were aspects of cost-effectiveness in relation specifically to children that should be addressed. It is a complex issue both economically and, indeed, ethically. We should not expect a report from that group, once it has been established, until next year at the earliest.
Lord Patel (CB)
My Lords, the vaccines that my friend, the noble Lord, Lord Turnberg—he is a friend, at least as regards medical matters—talked about are developed through a new kind of science, which does not involve the use of eggs or any other animal material, and therefore is not only more effective but produces fewer side-effects, particularly in children. The vaccine that we are talking about is for a particular type of meningitis. The new vaccine may not be considered as cost-effective as a conventional vaccine. However, if you take into account clinical side-effects, the new vaccine may be considered cost-effective, so a different kind of assessment must be carried out that is based not just on conventional cost-effectiveness.
Baroness Masham of Ilton (CB)
My Lords, how do we compare with other European countries in giving children this vaccine?
The Earl of Listowel (CB)
My Lords, will the Minister assure the House that, if this vaccine is accepted, the infrastructure will be in place to enable it to be administered swiftly to as many children as possible? Are health professionals trained and ready to administer the vaccine, if it is decided to accept it?