Health and Social Care (Safety and Quality) Bill
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Lord Turnberg (Lab)
My Lords, I hope your Lordships will allow me just one minute. I do not intend to oppose this Bill, but in Committee I expressed some concerns about the possible unintended consequences of Clause 1. In fact, I have withdrawn an amendment I had intended to move that would have tried to mitigate some of these consequences by pointing to a rather better way of avoiding harm to patients by proper education, training and supervision within hospitals and care homes which would lead to a continuing, progressive reduction in harm but without stifling innovation. I withdrew my amendment because I was told that I would cause the Bill to fall and I have no intention of doing that. But I do hope, at least, that the noble Earl will be able to offer some reassurances on the points that I have raised.
The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, I understand concerns that noble Lords have raised about the Bill potentially stifling innovation and openness. I assure noble Lords that this is in no way the intention of the Bill. Indeed, the Bill does not place any requirements on providers of healthcare and adult social care registered with the Care Quality Commission. This is achieved through regulations and the associated guidance issued by the CQC. My officials have been in contact with the Chief Inspector of Hospitals, who would be very happy to meet noble Lords to discuss the content of the guidance to ensure that the CQC’s approach to inspection supports continuing reductions in avoidable harm, innovation and supervision and training of staff.
General Medical Council (Fitness to Practise and Over-arching Objective) and the Professional Standards Authority for Health and Social Care (References to Court) Order 2015
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Earl Howe
That the Grand Committee do consider the General Medical Council (Fitness to Practise and Over-arching Objective) and the Professional Standards Authority for Health and Social Care (References to Court) Order 2015.
Relevant documents: 24th Report from the Joint Committee on Statutory Instruments, 26th Report from the Secondary Legislation Scrutiny Committee
The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, I beg to move the first Motion standing in my name on the Order Paper.
This Section 60 order will amend the Medical Act 1983 to establish the Medical Practitioners Tribunal Service, the MPTS, in statute and make other reforms to the General Medical Council’s fitness to practise procedures. Reforming the way that the GMC adjudicates on cases where a doctor’s fitness to practise has been called into question has been a long-term policy objective for both the Department of Health and the GMC, following the decision not to proceed with the establishment of the Office of the Health Professions Adjudicator, the OHPA, in 2011.
The introduction of these amendments will strengthen and modernise the GMC powers and systems, enabling it to carry out its fitness to practise adjudication functions more effectively. They will place the MPTS on a statutory footing and enable the GMC to make amendments to its fitness to practise rules to further modernise the procedures which govern how fitness to practise cases are handled.
These reforms will increase the separation between the investigation of fitness to practise cases and adjudicating on what should happen in each case to enhance public and professional confidence in the system of medical regulation. They will modernise the MPTS’s adjudication function, including strengthening the case management arrangements, by introducing enforceable case management directions. These include costs for unreasonable behaviour, introducing the ability to hold reviews on the papers where the parties agree, and introducing a duty to use rule-making powers in order to pursue the objective that cases be dealt with fairly and justly, similar to the courts’ Civil Procedure Rules.
The MPTS will be subject to accountability hearings held by the parliamentary Health Committee in Westminster, ensuring transparency and public debate in relation to the way that it discharges its statutory functions. The MPTS will also be required to lay its annual reports and accounts before the UK Parliament, and it is also held to account by the Professional Standards Authority, the PSA, via its annual performance review.
This order will address a number of patient safety issues, including strengthening the power of the registrar to require the disclosure of information from a doctor, to refer a doctor to the MPTS for decisions as to whether to impose conditions in relation to registration or to suspend that doctor in the event of non-compliance.
The GMC currently operates a rule which enables it not to proceed with an investigation if the matters relating to the allegation are more than five years old, unless it is deemed to be in the public interest to do so, and is in the “exceptional circumstance” of the case. The Government are using the opportunity of the order to remove the “exceptional circumstance” element. That is because a developing body of case law demonstrates that the additional test of having to prove that a case has an exceptional circumstance has prevented cases from being taken forward, even when it was considered in the public interest to do so. By expressly setting this out in statute, we are ensuring that an investigation can be taken forward, regardless of the amount of time that has passed, without having to prove exceptional circumstances. That will mean that the GMC will be able to investigate an allegation no matter what the circumstances or how much time has passed, if it feels that it is in the public interest to do so. That can only strengthen public protection and reduce risk to patient safety.
The order will bolster the objectives of the GMC in relation to its fitness to practise functions expressly to take account of the need to promote and maintain public confidence in the profession and the need to uphold proper professional standards and conduct, in addition to protecting the health, safety and well-being of the public. However, maintaining public confidence must only be considered as being relevant in pursuit of the protection of the public. Its inclusion in the overarching objective will help to ensure that it is given due weight in all fitness to practise cases.
The proposed overarching objectives will include the term well-being, as this term encompasses those aspects of a professional’s role that may have an impact on individual patients—not directly impact on their health or safety, but nevertheless affect them in a manner which is relevant to the health professional’s clinical care. Dignity, compassion and respect are all important in delivering care, and it would not be right to disregard them. The inclusion of the term well-being ensures that the well-being of a patient under the care of a health professional is not disregarded as a standard for regulatory action. The Law Commission’s report states that well-being has already been incorporated, without difficulty, into the main duties or objectives of regulators, and it feels strongly that, within that context, the term cannot be misinterpreted.
Increased separation will make it explicitly clear that the GMC has the role of investigating and presenting evidence in fitness to practise cases, but it will be for the MPTS to constitute tribunals to adjudicate on whether a doctor’s fitness to practise is impaired. With the greater separation between investigation and adjudication introduced through the order, the Government believe that it would be appropriate for the GMC also to have a right to appeal decisions made by the MPTS in cases where it believes that a decision does not protect the public. That will provide a transparent mechanism for decisions to be challenged in those instances where the GMC has concerns about a decision made by a medical practitioner tribunal.
The proposals also change the grounds on which the Professional Standards Authority can make a referral to the higher courts. That will enable the PSA to make a reference if it believes that a decision is insufficient to maintain public protection, which involves protecting the health, safety and well-being of the public, maintaining public confidence in the profession and maintaining proper professional standards and conduct. The order will ensure that the PSA can take action where it considers it appropriate in the interest of public protection, guaranteeing its right to intervene and take over an appeal where the GMC has withdrawn. The proposed GMC right of appeal would be in line with these revised grounds.
The Department of Health undertook a UK-wide consultation on making changes to the way that the GMC makes decisions about doctors’ fitness to practise. The consultation received 81 responses from a range of respondents, including medical and legal professionals, healthcare recruitment organisations, regulatory bodies and members of the public. The responses demonstrated strong support for the principle of enhancing the separation between the GMC’s role in investigating fitness to practise concerns and its role in adjudicating on whether those concerns amount to impaired fitness to practise.
A significant proportion of respondents—52%—felt that creating an entirely independent body like the former Office of the Health Professions Adjudicator, rather than establishing the MPTS as a statutory committee of the GMC, was a preferable approach. However, this group included an organised group of 39 co-ordinated and near-identical responses, which the department had to consider as individual responses. The department’s original decision not to proceed with OHPA was taken in 2011 and endorsed and implemented by Parliament in the Health and Social Care Act 2012. The Government’s proposed approach remains that we should enhance and protect the independence of decision-making at fitness to practise panel hearings, to secure public protection and the confidence of doctors and patients. However, the department believes that the same benefit as establishing a separate body can be achieved without the expense by retaining the adjudication function within the GMC and increasing the separation between its investigation and adjudication functions. Taking into account the group of respondents who wanted greater separation, as well as those who supported the statutory committee model, there was significant support for the principle of greater separation. We consider that establishing the MPTS as a statutory committee of the GMC is the right means of achieving this. The majority of consultation respondents did not agree that the GMC should have a right of appeal to challenge MPTS decisions. However, this again included the group of 39 co-ordinated responses, although they did not give reasons.
The policy intention, once separation of functions has been achieved, is to enable the GMC—the organisation that is best placed to challenge a tribunal decision about a doctor’s fitness to practise, having already acted in the prosecution role before the tribunal—to be better able to make such a challenge, given its closer knowledge of the case. These proposals to strengthen and modernise the GMC’s fitness to practice process will make the system more efficient and effective, benefiting patients, practitioners and the health service. They will result in improved public protection and an increase in public confidence in the GMC. I commend the order to the Committee.
Baroness Finlay of Llandaff (CB)
My Lords, I am grateful to the Minister for the way he introduced this legislation. We debated much of the content and wording of it previously in discussions on the Health and Social Care (Safety and Quality) Bill. I do not intend to go over that ground again. I simply ask the Minister whether I am correct in believing that the guidance relating to this legislation is to be produced by the GMC, not the Department of Health, and whether the Department of Health will be able to have some kind of scrutiny role over the way that guidance is worded. As I have outlined before, there is concern among the profession—I declare my interest as a licensed practitioner, as well as a registered practitioner—that the term “well-being” could be viewed as being much wider. The public confidence issue is one where there remains concern—I am sure there will be concern—about trial by media and what is in the public domain that might influence the thinking of a panel.
Earl Howe
My Lords, I shall endeavour to answer the questions that noble Lords have asked but first I endorse the comments made by the noble Lord, Lord Hunt, about the GMC, in which we in the department have great confidence. It is a well led organisation and has approached this whole exercise in a very responsible way. The background to this order is of course, as the noble Lord stated, that we do not have— much as we wish we did—a consolidated Bill building on the Law Commission’s work. In the absence of parliamentary time for a Bill, we are therefore working within the limitations of existing legislation and using Section 60 orders. Let me reassure the Committee that we are very much committed to taking forward a Bill in this important area when parliamentary time allows.
The various Section 60 orders being taken forward are driven by the need to address a small number of areas which we view as priorities. They both deal with the priorities of government such as English-language concerns, which will be debated later this afternoon, and address some immediate issues that have hampered the regulators from being able to fulfil their basic function of protecting the public. I therefore welcome the fact that the noble Lord, Lord Hunt, is willing to give the order a fair wind.
The noble Lord, Lord Hunt, asked about the possibility that the inclusion of the objective of promoting and maintaining public confidence in the medical profession could in some circumstances be used in a vexatious way, perhaps at a personal level or in the media’s response to what has happened—a so-called trial by media. If the actions of a doctor appear likely to reduce confidence in the medical profession and influence the decision of individuals as to whether to seek medical help at all, it may be right to take action. However, panels and tribunals will be asked to reach their own objective judgment as to whether particular acts or omissions would affect public confidence if no action were taken. A subjective view, uncritically influenced by public opinion or the media, would be an unacceptable basis for a decision. The question of whether GMC staff will be able to sit on the MPTS was raised. The answer is no, they will not. The noble Baroness, Lady Finlay, asked about the guidance. The GMC is consulting on its rules, and the department, I can assure her, will work closely with the GMC in drafting the guidance.
The noble Lord, Lord Hunt, asked about the issue of legal support for a medical practitioner tribunal. The MPTS will be best placed to assess what kind of legal support a tribunal will need and therefore what criteria legal assessors should meet. It is important that medical practitioner tribunals have appropriate support to make decisions based on strong legal knowledge. Where the MPTS has appointed a legally qualified case manager to also act as a chair of a medical practitioner tribunal, the MPTS may consider that there is not also a need for a separate legal assessor.
The noble Lord, Lord Patel, asked about the right of appeal for the GMC. As I explained, the order would enable the GMC to appeal decisions made by the MPTS in cases where it believes that the decision does not protect the public. Currently a respondent doctor has a right of appeal against panel determinations, although the GMC has no such right. Once greater separation is introduced through this order, the Government believe that it would be appropriate for the GMC to also have a right of appeal. This will reflect and underline the separation of investigation and adjudication. It will also provide a transparent mechanism for challenging decisions where the GMC, as a party to the proceedings, disagrees with a decision made by a medical practitioner tribunal. I hope that that explanation is helpful.
Baroness Finlay of Llandaff
I would like to briefly return to the issue of guidance. I was not completely convinced by the noble Earl’s reply. Does he agree with me that there is a danger for a doctor, when there has been a lot of media coverage of the accusation—whatever that is—that the panel hearing the case may have been subject to a barrage by the media, which can be compared to baying hounds, and it can be very difficult for the doctor who is before the panel to be confident of a fair and balanced hearing?
For that reason the guidance becomes critical. It is incredibly stressful for a doctor to be reported to the GMC. The rates of suicide and mental health problems among such doctors are extremely high—higher, in any case, than the baseline population in normal circumstances, but there have been some notable cases of suicide. Does the Minister agree with me that the guidance for panels, particularly about the way they receive reports through the media, will be really important in ensuring that it is a balanced and fair hearing and not excessively influenced by press reports?
Earl Howe
I completely understand the point that the noble Baroness has made. I hope that I can reassure her that the GMC is mindful of that issue. It would be the last organisation to wish for anything other than a fair and just approach to every fitness to practise case. I suggest that one of the safeguards here is that the legal representative and the legal assessor would advise the MPT on what is acceptable in law and proceed on that basis, so the tribunal would be governed by legal considerations and the guidance will make that clear. However, if I can add to those remarks in writing after this debate, I will be very happy to do so.
Health Care and Associated Professions (Knowledge of English) Order 2015
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The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, the Government recognise that overseas healthcare professionals make a valuable contribution to our NHS, and we are keen to ensure that highly skilled professionals do not face unnecessary barriers to working in our health service. However, it is vital that all healthcare professionals practising in the UK have the necessary English language skills to properly communicate with and care for patients and members of the public. The department has consulted on proposals to introduce language controls for nurses, midwives, dentists, dental care professionals, pharmacists and pharmacy technicians, and the vast majority of respondents to the consultation—99%—were supportive of the proposals.
We have worked with the Nursing and Midwifery Council, the General Dental Council, the General Pharmaceutical Council and the Pharmaceutical Society of Northern Ireland to identify a system of language controls for EU nurses, midwives, dentists, dental care professionals, pharmacists and pharmacy technicians which provides greater safety for patients and members of the public. The draft order gives those regulatory bodies the powers to apply proportionate language controls so that only healthcare professionals who have the necessary knowledge of the English language are able to practise in the UK, together with an assurance that they can do their jobs in a safe and competent manner.
The draft order sets out to amend the Nursing and Midwifery Order 2001, the Dentists Act 1984, the Pharmacy Order 2010 and the Pharmacy (Northern Ireland) Order 1976 to strengthen the regulatory body’s powers to introduce proportionate language controls and to require EU applicants to provide evidence of their knowledge of the English language following recognition of their professional qualification—but before registration and admission on to the register. We also propose corresponding amendments to the fitness to practise powers of the NMC, GDC, GPhC and PSNI, so that they can initiate fitness to practise proceedings in cases where a healthcare professional’s knowledge of the English language may pose a serious risk to patient safety.
A new category of impairment relating to English language capability will be created. It will allow the regulatory body to request that a professional undertakes an assessment of their knowledge of the English language during a fitness to practise investigation where concerns have been raised—something that they are currently unable to do. Those changes will strengthen the regulatory body’s ability to take fitness to practise action where concerns about language competence are identified in relation to healthcare professionals already practising in the UK.
Our overall approach is compliant with EU law which clarifies, under recent changes to the mutual recognition of professional qualifications directive, the ability of national authorities to carry out language controls on European applicants where the profession has patient safety implications. Any language controls must be fair and proportionate. For example, there cannot be automatic testing for all European applicants, and any controls cannot take place until the applicant’s qualification has been recognised by the regulatory body.
The order makes amendments to the relevant legislation which will require the regulatory body to publish guidance setting out the evidence, information or documents which a healthcare professional must provide to demonstrate that they have the necessary knowledge of the English language in order to practise their profession. Any person who is refused admission on to the register on the grounds that they have failed to demonstrate 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 relevant regulatory body’s rules or regulations, which we anticipate will be amended and implemented before the end of the year.
These changes are a major step forward for quality of care and patient safety, and build on the language checks already in place for the registration of healthcare professionals coming to work in the UK from outside the EU. They further build on the amendments made last year, which provided the General Medical Council with the powers to introduce a strengthened system of language controls for doctors from within the EU.
Since the GMC’s legislation was changed in June last year, the GMC has required 1,956 doctors from Europe to provide evidence of their knowledge of English when applying for first registration and a licence to practise. Of these, to date 429 doctors have been registered without a licence to practise medicine in the UK due to insufficient evidence of language competence. This evidence shows that these proposals are essential to ensure patient protection and uphold the standards of care delivered. I commend the order to the Committee.
Lord Hunt of Kings Heath (Lab)
My Lords, I thank the noble Earl for explaining the order. Clearly, we support the order because we want to protect patients from the risk of avoidable harm.
My own view is that language testing of healthcare professionals from outside Europe is now entirely adequate as a result of last year’s measures—which, again, the Opposition supported. However, we accept that there may be a—one hopes—small number of European professionals whose knowledge of English is not at a level that we might reasonably expect, and indeed an even smaller number of UK nationals who do not possess the requisite knowledge of English and where there are concerns.
I wonder whether the Minister can spell out one or two things in relation to how this is going to be done. I note—the noble Earl said it and it is repeated at paragraph 7.5 of the Explanatory Memorandum—that:
“Any language controls must be fair and proportionate, for example, there cannot be automatic testing for all European applicants and any controls must not take place until the applicant’s qualification has been recognised by the regulatory body”.
Paragraph 7.10 cautions that, in relation to the requirements that can be imposed as to English language controls, the bodies concerned,
“must first request and consider any available evidence before requiring a test”.
Can the Minister explain a little further how it is expected that employing authorities will go about that?
I also want to ask the noble Earl about the implementation of the power to implement fitness to practise proceedings. I noted from the Explanatory Memorandum that there is currently provision for most of the relevant regulatory bodies to commission an assessment of performance where fitness to practise allegations have been made. I was not sure about the purpose of the extension in this order, given that the Explanatory Memorandum notes that there is already provision for most of the relevant regulatory bodies to do this.
I would like to ask the Minister about support and guidance for individual employers. This comes back to my first question about how you make the assessment that a test should be undertaken. I should have thought that human resources professionals within NHS organisations would need some careful advice and guidance on this—first, because this may be a sensitive area, and, secondly, because some consistency throughout the NHS would be appropriate.
Finally, there is the question of vexatious complaints, which we discussed in relation to the previous order. Clearly, we have to balance the public interest with that of the appropriate interest of medical professionals. We know that there are cases in which medical professionals have been subjected to complaints that have turned out to be unsubstantiated. Clearly there are political sensitivities around the ability of European immigrants to speak English; I refer the noble Earl back to our previous debate and the points raised by the noble Baroness, Lady Finlay. I want to be clear that the Government understand that, while this is undoubtedly the right measure for patient safety and the protection of the public interest, we have to have regard to ensuring that doctors and other professionals are dealt with fairly under these provisions.
Earl Howe
My Lords, I am grateful to the noble Lord for his support of the order. The first point for me to make about what might trigger a language test is that European healthcare professionals currently provide a range of supporting information to accompany their application for registration and admission to the register. It is during that process that if a regulatory body had cause for concern, such as a poorly written application form, it would write to the individual to seek further evidence of English language competence. It is important to restate that the individual would still have their qualification recognised, but would not be admitted to the register until the body was satisfied that they met all the requirements for registration.
The draft order requires the regulatory bodies to publish guidance on the evidence to be provided by a healthcare professional where there is cause for concern about their English language capability. However, the regulatory body, as the independent regulator of the relevant healthcare professionals in the UK, will have the power to decide what the necessary knowledge of English is to practise safely in the UK. All the regulators subject to this order are in the process of developing this guidance. In recent discussions they suggested that, where there is a cause for concern, the evidence required could be the required score in the academic version of IELTS—the International English Language Testing System—or that the healthcare professional has a primary qualification taught and examined in English. In making that determination, the regulatory body will need to be mindful of EU law and ensure that such requirements are necessary and proportionate in view of their scope of practice.
As regards vexatious complaints, responses to the department’s public consultation highlighted the potential serious risk to patient safety posed by a professional practising without adequate English language skills. As I explained, these proposals would allow the regulatory bodies to take pre-emptive fitness to practise action, even if no actual harm has yet occurred, to maintain public protection. We accept that this could lead to a rise in the number of referrals but we are confident that if these are triaged correctly, any discriminatory or vexatious complaints can be identified early on and dealt with appropriately by the regulatory bodies affected by the order. The regulatory bodies will also be responsible for communicating the changes effectively to employers, which may be best placed to deal with issues at a local level. As I mentioned, there is a right to appeal if a person is refused admission on to the register, or is subject to fitness to practise proceedings and then found to be impaired on the grounds of defective English.
The noble Lord asked how we would ensure that the controls were fair and proportionate. Guidance will be published by the regulator on the evidence accepted on initial application for registration. If that has not been supplied, an individual will be sent a letter of recognition requesting further evidence. If it is not supplied at that point, a test will be requested.
The introduction of language controls at national level should not have the effect of requiring individual professionals to undertake the same English language test twice: once at national and once at local level. We agree that that would be disproportionate. However, it must be remembered that the regulatory bodies’ roles as the national regulators of the healthcare professionals affected by the order will be to ensure that all professionals have the minimum English language capability required to work as a practitioner. It will still be for the employer to assure themselves that the applicant has the necessary English language skills for a specific role, which may require more sophisticated language skills. I hope that that is helpful.
NHS: Cancer Drugs Fund
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Lord Hunt of Kings Heath
To ask Her Majesty’s Government why the public are not allowed to appeal against a decision to remove certain drugs from the Cancer Drugs Fund list of approved drugs.
The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, NHS England’s appeal process for the national cancer drugs fund list centres on whether due process is followed with regard to decisions to add or remove drugs from that list. NHS England considers that third parties not involved in the application process, including patients, would not be in a position to make a judgment about whether due process had been followed.
Lord Hunt of Kings Heath (Lab)
My Lords, the cancer drugs fund was set up as a way of getting round NICE’s refusal to approve the use of a number of drugs by NHS patients. Would the noble Earl concede that NHS England has, essentially, set up a new rationing tool to exclude patients from drugs which had originally been agreed through the cancer drugs fund? Last Thursday, NHS England listed 19 drugs no longer available. Although the noble Earl said that the process is around the procedure used, does he not agree that in the end this impacts directly on patients who can no longer get those 19 drugs? Why should not patients be involved in an appeal process? How does the mantra “No decision about me without me”, which the Government have set for the NHS, fit the lack of patient involvement in these decisions?
Earl Howe
The noble Lord is right that NHS England has just gone through a reprioritisation process. There are three important things to observe in that process. NHS England has assured the department that no patient whose treatment is currently being funded through the fund will have funding withdrawn, as long as it is clinically appropriate that they continue to receive that treatment. In addition, no drug will be removed from the fund where it is the only therapy for that condition. Clinicians will still be able to apply for individual patients to receive a drug not on the national list on an exceptional basis. We have seen through experience that many of those applications succeed.
Lord Walton of Detchant (CB)
Would the Minister accept that NICE is faced with an extremely difficult problem in continually having to consider the efficacy and affordability of new cancer drugs as they emerge in a National Health Service under financial constraint? Would he also accept that another major problem is emerging in relation to the orphan and ultra-orphan drugs now coming on stream for the treatment of rare diseases, which are equally deserving in many respects? How does he feel that the next Government—however they are constituted—will be able to consider this increasingly serious problem?
Earl Howe
My Lords, the noble Lord is right that there is a particular issue around the appraisal of new cancer drugs. That is why NHS England, the Department of Health, cancer charities, NICE and the Ethical Medicines Industry Group, as well as the ABPI, are working together currently as part of a new working party tasked with finding the best way to get new cancer drugs appraised and commissioned for patients. A number of proposals have been looked at to reach an integrated process between NHS England and NICE which results in clear and final decisions on baseline commissioning of chemotherapy drugs.
Baroness Brinton (LD)
My Lords, given the good news that the Minister just gave us about the working group looking at the future of some of these complex drugs, and the whole policy about “No decision about me without me”, would it not be sensible to have patients’ advocates, such as Prostate Cancer UK, able both to present and to appeal the case for a drug? It seems bizarre that this is the one area where there is no input of anybody other than the committee making the decision.
Earl Howe
I differ slightly from my noble friend on this point. I think that the key determinant for the reprioritisation process has to be clinical input, and that is indeed what happened. It is necessary to have as objective a process as possible when looking at how to reprioritise a cash-limited fund of this kind.
Lord Hunt of Kings Heath
My Lords, if I could come back to the noble Earl, the NICE processes make sure that patients are involved in every stage of the process. I do not understand why there is a difference between the NICE process, which is incredibly thorough and well regarded internationally, and this hurried rationing tool used by NHS England, which is more about its own budgetary problems than an effective solution to these issues.
Earl Howe
My Lords, I do not agree about the hurried rationing tool, as the noble Lord puts it. The tool used by NHS England is one that has been tried and tested, and accepted and shared with the pharmaceutical industry. The point here, as I said in my original reply, is that there is due process here. NHS England believes that any patient group or third party not involved intimately with that due process would not be in a position to make a judgment about whether the process had been followed correctly.
Local Audit and Accountability Act 2014 (Special Trustees) Amendment Regulations 2015
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Standardised Packaging of Tobacco Products Regulations 2015
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The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, these regulations propose to introduce standardised packaging for tobacco products, which I believe to be an important public health measure. I pay tribute to all the noble Lords who campaigned for the introduction of these regulations—in particular the noble Baroness, Lady Finlay, the noble Lord, Lord Faulkner, and my noble friends Lady Tyler and Lord McColl, who all pressed for it during the passage of the Children and Families Bill in 2014.
Tobacco use remains one of our most significant public health challenges. Smoking places an enormous strain on the NHS, and is a significant driver of health inequalities. More people die from lung cancer in the UK than any other form of cancer and almost nine in 10 of all lung cancers are caused by smoking. For this reason, the Government have prioritised action to reduce smoking rates, which is why we published the tobacco control plan for England in early 2011.
We have looked carefully at the evidence and it shows that introducing standardised packaging is highly likely to bring important public health benefits, primarily by reducing the appeal and attractiveness of tobacco packs, especially to children and young people, and improving the salience of health warnings on packets. Packaging and branding are promotional tools used to attract consumers. Since the ban on advertising tobacco products in the UK, packaging has become a key avenue for the promotion of tobacco, and it is notable that one tobacco company referred to tobacco packaging as its “mobile billboard”. Opponents of standardised packaging claim that there is no evidence that it will bring about a reduction in smoking prevalence or the resulting health benefits. In fact, Sir Cyril Chantler, who reviewed the evidence, concludes that,
“it points in a single direction”,
and that there is no,
“convincing evidence pointing the other way”.
Let me first outline what the regulations propose, before discussing the wider issues. The Children and Families Act 2014 gives the Secretary of State powers to regulate the retail packaging of tobacco products. In November 2013, Health Ministers commissioned Sir Cyril Chantler, the eminent paediatrician and medical researcher, to undertake an independent review into whether standardised packaging would be likely to have an effect on public health, in particular in relation to children. Sir Cyril’s thorough and well considered report, published in April 2014, concluded that standardised packaging would be highly likely to have a positive impact on public health.
On the publication of the review, my honourable friend Jane Ellison, Public Health Minister, announced that the Government were minded to proceed with standardised packaging, subject to a final consultation. There has been extensive engagement and consultation with the public and stakeholders on this proposal, including two public consultations—one in 2012 and a further consultation in 2014. The Department of Health has carefully considered all responses to both these public consultations and the wider points that they raise.
These regulations propose to standardise the retail packaging of all cigarettes and hand-rolling tobacco. Cigars and pipe tobacco are not currently covered by the regulations. The regulations specify mandatory colours for those parts of the packaging that are not taken up by health warnings or duty marks. The outside of packs will have to be a uniform dull brown and the insides plain white. The brand name of the product may appear but must be in grey with a fixed size and typeface. This means, in effect, that no branding will be allowed except for the brand name. The regulations also specify that individual cigarettes must be plain white with a cork effect or white tip, but will allow the brand name to be printed in small text. An illustration of what a standardised cigarette packet could look like has been published, which noble Lords may wish to see.
The draft regulations will also implement certain packaging-related requirements from the European tobacco products directive that was agreed last year, such as the shape, material and minimum content of packs. The remainder of the tobacco products directive will then be implemented through separate regulations, which the Department of Health will be consulting on shortly. Standardised packaging would be a UK-wide measure. Public health is a devolved matter but Scotland, Wales and Northern Ireland have provided the necessary consent for the regulations to extend to their Administrations.
Looking wider than the UK, there is international momentum towards introducing standardised packaging. Although the only country to have implemented standardised packaging is Australia, many other countries are taking positive steps towards legislating, including Ireland, France, Norway, New Zealand and Turkey. The Australian Government were clear when introducing the measure that they expected the benefits of standardised packaging to be “generational” and come in the longer term. The Cancer Council Victoria has recently reviewed the available Australian evidence and data so far, and concluded:
“Prevalence of smoking in Australia fell dramatically between 2010 and 2013”,
and that,
“plain packaging is likely to continue to contribute along with Australia’s other tobacco control policies to further reducing the prevalence of smoking in Australia”.
There have been some suggestions that standardised packaging may lead to growth in the illicit tobacco market. I want to reassure noble Lords that this issue has been considered carefully across government. HMRC leads on reducing the size of the illicit tobacco market and has undertaken a detailed assessment of the potential impact of standardised packaging on the illicit trade of tobacco, which was published and put into the Library in February. The HMRC report concluded:
“We have seen no evidence to suggest the introduction of standardised packaging will have a significant impact on the overall size of the illicit market”.
Some also have concerns that this will be the start of a slippery slope towards standardised packaging for other products, such as unhealthy foods or alcohol. I want to be absolutely clear that the Government have no intention to extend standardised packaging to any product other than tobacco. Tobacco has been treated uniquely in regulatory terms before, as it is a uniquely harmful consumer good. All smoking is addictive and harmful to health, and half of all regular smokers are eventually killed by smoking-related illness. This is not true for other consumer products.
I understand that some noble Lords will, rightly, have concerns with regard to the potential legal implications of introducing standardised packaging. Let me be clear that thorough consideration has been given to such concerns. We know that the tobacco industry is likely to challenge this measure should the regulations be made, as it has with other tobacco control legislation. Threats of legal action have already been made by tobacco companies. However, we believe that these regulations are a proportionate and justified response to a major public health challenge, and will be defensible in the courts. We cannot let the vested interests of the tobacco industry control the public health agenda, and we will defend public health legislation from legal action.
Smoking remains a critical public health concern. Smoking is an addiction, largely taken up in childhood and adolescence. The choice to smoke is not like other choices and is often not made as an adult decision. Research included in the Chantler review shows that around 600 children between the ages of 11 and 15 start smoking every day in the UK. It is crucial that we do all we can to reduce that number. We also need to do all that we can to assist those already addicted to quit; and I believe that standardised packaging will contribute to doing so. The introduction of standardised packaging is likely to deliver important public health benefits and, as part of a comprehensive tobacco control strategy, will bring us a step closer to a smoke-free generation. I beg to move.
Lord Hunt of Kings Heath
My Lords, I sense that the House is ready to come to a view on this very interesting matter, and I am looking forward to the response of the noble Earl, Lord Howe. I should start by declaring my interest as president of the Royal Society for Public Health.
Not surprisingly, noble Lords will know that I support the regulations, for which the Labour Party campaigned vigorously. The noble Lord, Lord Stoddart, is right that they come on the back of a successful amendment in your Lordships’ House to ban smoking in cars when children are present. Like the noble Earl, I pay tribute to the noble Lord, Lord Faulkner, the noble Baronesses, Lady Tyler and Lady Finlay, and the noble Lord, Lord McColl, for their outstanding work on this issue in your Lordships’ House.
I have some questions to put to the noble Earl, Lord Howe, in relation to the effectiveness of the measure, following the debate. That is the fair test that we need when reaching a decision. First, can the noble Earl confirm that opinion polls have shown very strong support among the public for this policy? Does he agree with me that, if we look back at the measure we passed in relation to smoking in cars with children present, again the public showed enormous support for the action that was being taken? It is not as if we have an authoritarian measure, imposing a sort of public-health view on the public; what we have here is a sensible measure that the great majority of people in this country support.
I turn now to the evidence. I listened with care to the comments of the noble Lord, Lord Naseby. Does the noble Earl stand by the evidence contained in the impact assessment published with the Explanatory Memorandum? Is it his view that, far from what the noble Lord, Lord Naseby, said, the evidence is clear about the Australian experience so far? Industry leaders have talked about market decline in Australia. On a point made by the noble Lord, Lord Walton, I refer to Sir Cyril Chantler. He may not be a marketing expert, but, goodness me, he is a man of enormous reputation in his ability to sift evidence, so can the noble Earl confirm that Sir Cyril Chantler took a highly dispassionate view on this issue? He made himself available to people on all issues. It is not an emotional report; it is a dispassionate, weighing up of the evidence.
On the issue of illicit trade, can the noble Earl confirm that the HMRC concluded that standardised packaging is not likely to have a significant effect on that? In answer to the point raised about the paragraph in the assessment, is his reading of it that, on balance, it is “very unlikely” to have an impact on illicit trade? The words, “very unlikely” mean that obviously there is a small percentage chance that it might not. That is my reading of that paragraph. Will he confirm that I am right about that?
As for the view of the noble Viscount, Lord Falkland, that because it is legal we should therefore not place any controls around it, I fail to understand the argument. Driving is legal, but we do not recoil from setting speed limits. There is general support for seat belts. Is that not the same issue? It is a legal activity, but we are right to place constraints on it to safeguard people from its worst effects.
On whether the packaging industry will be hit by the change to plain packaging, can the Minister confirm that cigarette packaging accounts for less than 5% of all packaging cartons manufactured in the UK—and, of course, packs will still be required in future? Perhaps he can then address points made about questions asked in the other place that were not answered. There is a question about the process and timetable to be followed once the regulations, if accepted by your Lordships’ House, are put in place.
The question of enforcement was raised today. I understand that several local authorities have advocated the need to ensure that trading standards officers are equipped and trained to implement the measure. That is clearly important, and perhaps the Minister can say something about the programme by which the Government intend to help local authorities once the regulations come into law.
My view is that the noble Earl, Lord Howe, in his speech today, in the regulations, in the Explanatory Memorandum and in the impact assessment has made a very powerful case for why the regulations should be passed. I sincerely hope that the House will listen to that and pass the regulations.
Earl Howe
My Lords, this has been a very powerfully argued debate. I am grateful to those noble Lords who have welcomed the regulations for the many supportive points that they have made. I also thank my noble friend Lord Naseby for setting out his objections and concerns with his customary clarity and courtesy. Several noble Lords have already done part of my job for me in responding to my noble friend’s critique, but I believe it to be incumbent on me to address directly all the matters that he raised, as well as the questions posed by other speakers.
I turn to the issue of the illicit trade and the evidence from Australia. Contrary to what the tobacco industry would have people believe, the evidence from Australia does not show an increase in the illicit market in that country following the introduction of plain packaging. There have been a number of criticisms of the tobacco-funded reports on that issue. It is therefore useful to consider the data provided from official Australian government sources. Official data from Australia on the use of illicit tobacco show a drop in those aged 14 years and over currently smoking illicit tobacco following the introduction of plain packaging. From 6% using illicit tobacco in 2007, the figure dropped to 5% in 2010 and then to under 4% in 2013—after plain packaging had been introduced.
A study published in BMJ Open analysed data from smokers before, during and one year after the introduction of plain packaging in Australia. The proportion of smokers reporting current use of illicit tobacco did not change significantly after plain packaging was introduced. I assure the House that the Government have looked very carefully at the potential impact on the illicit market. Tackling tobacco smuggling is a government priority. I can tell the noble Lord, Lord McFall, in particular, that, due to the fantastic work of HMRC and others, there has been a long-term decline in the tax gap for tobacco products over the past decade. The potential impact of standardised packaging on the illicit trade was considered extensively by HMRC, Sir Cyril Chantler, the Select Committee’s inquiry on smuggling, the Trading Standards Institute and RUSI. They all concluded that standardised packaging will not have a significant impact on the illicit market. HMRC has undertaken a detailed assessment of the potential impact of standardised packaging on the illicit market, which is the most comprehensive and reliable information available. Its assessment is that:
“We have seen no evidence to suggest the introduction of standardised packaging will have a significant impact on the overall size of the illicit market or prompt a step-change in the activity of organised crime groups.”
The Trading Standards Institute, which has extensive experience of tackling illicit tobacco at retail level, said in its consultation response that it,
“is aware that the tobacco industry regularly argues against standardised packaging for the reason that it will inevitably lead to an increase in the illicit tobacco trade. The Institute does not regard this as a valid argument”.
My noble friend referred to the system known as Codentify. That system is a voluntary security feature developed and controlled by the tobacco industry. We know that HMRC is starting to make use of the system to assist in identifying illicit tobacco. We are working across government to ensure that anti-counterfeit systems that are useful to HMRC and other enforcement agencies now and in the future can continue to feature on standardised packs. That will require such anti-counterfeit systems to be put on to a statutory footing.
My noble friend suggested that the prevalence of smoking had increased in Australia and that standardised packaging had not helped. Australian government figures show that smoking prevalence is in fact at an all-time low since the implementation of standardised packaging, with a 15% drop between 2010 and 2013. This change is likely to be attributable to the cumulative effects of a range of policies, including standardised packaging.
My noble friend also referred to the study by Kaul and Wolf apparently showing that smoking had increased among teenagers. The Kaul and Wolf report was funded and its release was closely directed by Philip Morris International, part of the tobacco industry. It was based on a specific survey of population smoking that is not intended to provide reliable estimates of smoking among teenagers, and the sample size was very small. It also compared figures immediately before and after implementation, and the effects of standardised packaging are more likely to be gradual. It is not a reliable study, we suggest, from which to draw any conclusions.
My noble friend Lord Blencathra urged the Government to wait for more evidence from Australia. He may like to know that studies in Australia have found that smokers buying standardised packets reported being more likely to prioritise quitting than smokers using fully branded packs. Calls to quit lines have increased. Smoking has decreased in outdoor cafes and fewer packs are being displayed on tables.
What has happened to tobacco sales in Australia? There have been suggestions that sales have gone up. Sales of tobacco can be measured in many different ways—sales by manufacturers to wholesalers, wholesalers to retailers or by retailers to consumers. Different pictures of sales emerge depending on the source of the data and the timeframe. In fact, official government data from Australia suggest that a continuing decline in per capita consumption of tobacco products has taken place. Commonwealth Treasury figures show that excise and customs clearances of tobacco declined by 3.4% in 2012-13, and that is generally regarded as the most reliable indicator of population sales.
I turn now to the print industry and my noble friend’s complaint that more time should be given to the print industry to enable a proper lead-in period. Standardised packaging is not a policy that has been sprung on the print industry. It has been under discussion since 2008 and two public consultations have been held on the subject, as I mentioned earlier. The regulations would come into force in May 2016, which provides the print industry with a lead time of over a year. I confirm to my noble friend Lady Tyler that the regulations will be implemented at the same time as the European directive is transposed in May 2016, so the industry does not have to undergo two changes to its manufacturing process.
The previous changes to tobacco packaging, such as the requirement for picture warnings in 2008, showed that a 12-month period in which to sell through old stock is appropriate and that stock sells through more quickly than one year. In answer to my noble friends Lord Naseby and Lord Blencathra, it is not true to say that standardised packaging will make it easier to copy packs and therefore make things easier for counterfeiters. Standardised packaging would remain complex to counterfeit. The packs will continue to feature large and complicated to reproduce picture health warnings and will retain all the security features currently on packs, including covert anti-counterfeit marks. The European Union directive includes provisions on the printing of labels. As I said, we have given very careful and measured consideration to that. We believe that the synchronised introduction of the provisions in the directive with the coming into force of these regulations is a sensible course.
Mention was made of intellectual property issues. As I said earlier, we have given very careful and measured consideration to all legal aspects of the policy, and this includes intellectual property aspects. These regulations regulate the use of tobacco branding, which includes trade marks. I emphasise that we regard tobacco as a unique consumer product in this context because it is a uniquely harmful consumer product. For the record, we do not consider that these regulations breach intellectual property laws or our international obligations in relation to trade marks.
I listened with care to my noble friend Lord Geddes, who argued from experience of his National Service that plain packs would not deter smoking. He referred to “Blue Liner” cigarettes, which I was interested to hear about. However, there are several key differences with regard to our proposals. First, the regulations we are considering mandate health warnings, which did not appear on “Blue Liner” cigarettes. Secondly, there is the colour of the packaging. Our regulations take into consideration the extensive market research the Australian Government undertook to determine the most effective designs for standardised packaging. Of the eight different colours tested during the research, dark brown packaging was the least appealing and thought to contain cigarettes most harmful to health. After carefully considering the research, our regulations adopt the same dull brown colour as the packs required in Australia.
The noble Viscount, Lord Falkland, referred to the possibility of unintended consequences. We believe very firmly that the benefits of these regulations far outweigh any of the unintended consequences that might come from introducing standardised packaging. In some cases, we are not convinced that certain predicted unintended consequences are anything more than scare stories. The department has run two consultations on standardised packaging, which contributed to our understanding of all the relevant factors in making our decision.
My noble friend Lord Blencathra queried the Explanatory Memorandum. I think he might have been referring to the impact assessment, which was rated green by the Regulatory Policy Committee, meaning that it is fit for purpose.
The noble Lord, Lord Hunt, asked about public support for standardised packaging. Multiple surveys have shown that the public support it. A YouGov poll in spring last year, with a representative sample of 10,000 people, found that 64% of adults in England supported standardised packaging while 11% opposed it. Even among smokers, more people were in support of or neutral towards standardised packaging than opposed it. After the implementation of standardised packs in Australia, support for the policy increased from 28% to 49% among smokers. Survey data from Australia show that more smokers approve of the policy than oppose it.
The noble Lord, Lord Stoddart, made a point that I have heard him make powerfully before—that alcohol is, in fact, the most addictive and harmful drug, not tobacco. I just say to him, as mentioned in my speech, that all smoking is addictive and harmful to health, and half of regular smokers are eventually killed by smoking-related illness. That is simply not true of other consumer products such as alcohol. Tobacco is being treated uniquely in regulatory terms because it is a uniquely harmful consumer good. All smoking is addictive and harmful to health. Therefore, to be absolutely clear, we see the introduction of standardised packaging as a unique approach to tackling smoking and its appalling effect on public health. It fits within a comprehensive tobacco control policy.
We are proud that smoking rates are the lowest ever recorded in this country, and my noble friend Lord Naseby was right to point that out. However, we cannot rest on our laurels. In other parts of the world we have seen that if Governments take their foot off the pedal with tobacco control, smoking rates can go up. For the good of public health, we want to continue our policy action to see smoking rates continue to fall, which is why I once again commend these regulations to the House.
Lord Naseby
My Lords, I should like, first, to thank my noble friend on the Front Bench for addressing the four points that I raised and were vital to be addressed. I shall comment on only two short matters because I sense that the House wants to move on.
My first comment is on youth smoking, which a number of Members raised. One may dispute this or not, but the facts are that the Australian Institute of Health and Welfare has stated that youth smoking rates have not declined as a result of standard packaging; in fact, they are at a seven-year high. Secondly, there is the matter of illicit tobacco consumption, which is the issue that worries me most. One has only to go round a building site in the United Kingdom today. I recently did so and checked a bit. Illicit tobacco is being offered on many building sites in this country; it is costing the Revenue and genuine companies a great deal. Not only that, when we look at Australia specifically, which we have done this evening, we see that by mid-2014 in that country illicit tobacco consumption stood at an unprecedented 14.7% of the market—25% higher than it had been in 2012. Whatever anyone says, as far as the industry is concerned—after all, it knows exactly how many cigarettes are produced and sold—that is a crucial area, and a crucial area of public health. Unless someone does something about that, we may well find increasing numbers of counterfeit cigarettes imported into this country. That will have an effect on public health because they kill even quicker than the genuine ones do.
I am grateful to all those who have taken part. I particularly thank my noble friends who have supported me this evening. Some home truths have been spelt out by the noble Lord, Lord Stoddart, the noble Viscount, Lord Falkland, the noble Earl, Lord Erroll, and a number of other colleagues who have supported me. The key issue, however, is a little wider than the tobacco industry, because what this Motion does, if it goes through—I imagine that it may well do so—is totally to undermine intellectual property rights, which are the very foundation of our modern capitalism. Intellectual property rights are fundamental to every business and defend a company from rogue competition—wherever it may come from—and, in my view, from totally misguided Governments on occasion.
I have to decide whether to divide the House. I take note of the fact that in another place nearly 25% of that Chamber voted against the Motion. I sense this evening that about 25% are against this Motion and I thank that 25% for the support they have given me. Nevertheless, it does not seem to me to be terribly productive for us all to march through the Lobbies and for me to get only 25% of the vote, or thereabouts, so with the leave of the House I will withdraw my amendment.
Health: Deprivation of Liberty Safeguards
Earl Howe Excerpts(10 years, 1 month ago)
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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 Baroness, Lady Finlay, for raising this important issue for debate and for her authoritative speech, alongside those of the noble and learned Lord, Lord Hope, and the noble Lord, Lord Bradley. I also very much appreciated the contributions from the noble Baroness, Lady Hollins, and my noble friend Lord Howard of Lympne.
Since the Supreme Court judgment in the case of Cheshire West on 19 March 2014, social care and NHS providers have been working hard to understand the implications for their service users and to plan a response that prioritises the well-being of all the individuals for whom they care. I pay tribute to their efforts and the efforts of the local authority teams responsible for assessing and authorising any deprivation of liberty.
The phrase “deprivation of liberty” arouses a lot of emotion, some of it unhelpful. It can feel intimidating, perhaps even stigmatising. The phrase derives from the European Convention on Human Rights, which stipulates that, when an individual is subject to a deprivation of liberty, they must be provided with legal safeguards and a legal route of appeal. In England, for those who lack capacity in hospitals and care homes, this is provided by the system known as the deprivation of liberty safeguards, or DoLS. Despite the negative connotations of the phrase, a deprivation of liberty can be entirely appropriate, if it is in the best interests of the individual concerned and an appropriate and proportionate approach to providing necessary care and treatment. An example would be a dementia sufferer who requires 24-hour care and who would be prevented from leaving a care home because he does not know where he is going, does not know how to safely cross a busy road and who has a history of endangering himself when he does leave. This could be an entirely appropriate deprivation of liberty.
The noble Baroness referred to the Supreme Court judgment, as did noble Lords. The judgment clarified the test for a deprivation of liberty. There are three parts: first, that the individual lacks capacity to consent to the arrangements for their care; secondly, that they are under continuous control and supervision; and, thirdly, that they are not free to leave. Many have welcomed the Supreme Court judgment for emphasising the universal nature of human rights. As for the scope of the judgment, about which the noble Baroness asked me, I hope that she will excuse me for not attempting to interpret case law here and now. However, she may be interested to know that, by the end of this month, the Law Society, commissioned by the department, will publish extensive guidance on the matter.
How we regard those who lack capacity is a cultural challenge. A Select Committee of this House recognised that the health and care system, and society at large, have a way to go to implement the Mental Capacity Act, of which DoLS are part. It noted the tendency of the health system to act in a paternalistic fashion—that of “doctor knows best”. Of course, all health and care professionals want what is best for the service user, but this does not mean that health and care settings can be exempted from the legal safeguards that all of us are entitled to and which ensure that our human rights are protected.
Let us be clear on another point as well: DoLS do not cause a deprivation of liberty. The deprivation of liberty results from the nature of the care and treatment package. As I indicated, the restrictions on freedom of movement and choice that constitute a “deprivation of liberty” may be entirely justifiable and necessary. DoLS exist to ensure that this is the case—in other words, to assess the individual’s situation and ensure that the deprivation of liberty really is necessary—and, if not, to instigate the steps to ensure the person is provided with more freedom. Therefore, DoLS, despite the sometimes negative attention, are positive things that promote the equal human rights of the individual.
The key question, then, is this: are the current deprivation of liberty safeguards the best they can be? Do they allow the individual’s human rights to be protected, but, at the same time, can they be implemented at a population level so that all individuals have their rights protected? As has been mentioned, following the Supreme Court judgment there has been a great surge in DoLS applications: 90,000 in the nine months following the judgment. This represents a tenfold increase. Many local authorities are struggling to process these; there is a significant backlog of applications. It seems clear to the Government that the current DoLS system was designed when deprivation of liberty was seen to be a fairly rare occurrence. The law—perhaps even society—has now moved on.
The Government believe that the DoLS system may not be the best way to provide safeguards at a population level. That is why we have secured the services of the Law Commission to fundamentally review the legislation and propose a new system that covers care homes, hospitals and community settings. This summer, the Law Commission will produce a detailed public consultation paper on future options.
Meanwhile, the Government have been taking steps to assist providers. We have instigated more frequent data collection to monitor better the impact of the Supreme Court judgment. We have issued guidance notes to reassure and to inform. We have significantly cut the number of standard forms associated with making a DoLS application from 32 to 13. We have commissioned extensive guidance as to what now constitutes a deprivation of liberty, which will be published within the next two weeks.
The noble and learned Lord, Lord Hope, and the noble Lord, Lord Bradley, referred at some length to the backlog of applications. We are aware of this. ADASS has produced some helpful guidance that assists local authorities to prioritise the applications for those most at risk. The reduction in the number of forms will also reduce the administrative burden, allowing applications to be processed more quickly. However, the backlog is concerning as it indicates that some people may not be benefiting from the safeguards. We are working more closely with local government and are closely monitoring the situation.
There is a positive element here: because of a clarification by the Supreme Court, tens of thousands of vulnerable individuals are having their care scrutinised. There is work to be done in responding to the judgment, but as I have said, we will work closely with local authorities to get the safeguards provided to as many as possible. I can tell the noble Lord, Lord Bradley, and the noble Baroness, Lady Finlay, that the Department of Health has provided local authorities with £35 million in 2014-15 for their MCA/DoLS responsibilities.
The Government, together with the Care Quality Commission and the Association of Directors of Adult Social Services, have stressed over the last year the importance of a proportionate response to the Supreme Court judgment that puts the individual’s best interests first. DoLS will become a paperwork exercise only if it is applied as a blanket measure—for example, assessing all individuals in a ward together and not considering each patient’s individual circumstances. If providers can demonstrate that they have an understanding of the Supreme Court judgment, that they have policies and procedures in place to ensure that restrictive care practices are minimised, and that they are doing their very best to make DoLS applications where appropriate, then we do not expect that they will be unfairly penalised.
The noble Baroness, Lady Finlay, asks whether decisions are properly scrutinised and whether advocates or relatives are asked to feed in to those decisions. Government officials are in regular contact with those working on the front line. So far, it seems that assessors are keeping to the ethos of the Mental Capacity Act—namely, they are not treating this simply as paperwork. The DoLS forms were subject to consultation with a range of practitioners. We are still taking on board comments on the forms and we welcome suggestions for improvement.
The noble Baroness, together with the noble Baroness, Lady Hollins, referred to the difficulty posed by delayed discharges. The Government have recently done a lot of work to speed up appropriate discharges from hospital settings. It is hard to be conclusive about the impact of DoLS here, but it is reasonable to assert that in some cases a DoLS application could help discharges, identifying, as it may, a least restrictive option outside of hospital.
The noble Baroness, Lady Finlay, asked about consent—whether it had to be in writing and the timeliness of the consent. It is important that any wishes that the person made known when they had capacity are considered when decisions are made at a later date when they may lack capacity. This would apply, however those wishes were expressed. However, having something in writing means that the wishes are clear and not second or third hand, and therefore that form of consent may hold more weight. In terms of timeliness, any medical professional should always give consideration to whether a statement of wishes or an advance decision reflects the person’s current wishes or feelings. As these may have changed over time and/or in the light of a change of circumstances, it is important that family members and carers are consulted on the current validity of such decisions.
The noble and learned Lord, Lord Hope, referred to long-term placements as compared to restrictions imposed on a temporary basis. It is an important principle that any deprivation of liberty authorisation must be for the shortest time needed to achieve the desired outcome. Currently, we have essentially a one-size-fits-all model for DoLS. However, the Law Commission will be considering whether a more flexible model might be better.
The noble and learned Lord, Lord Hope, and my noble friend Lord Howard questioned whether there might be changes to the law that we could make more quickly to help alleviate the pressure on the system pending the Law Commission report. I know that some partners have called for rapid legal changes. One example is increasing the time for which hospitals can authorise a deprivation of liberty—that is, instead of the current seven days, perhaps 14 or 21 days. Another suggestion that I have heard is to change the requirement for local authorities to process applications within 21 days by extending that period. Although I sympathise with local authorities and hospitals because of the pressures they are under, the counterargument that I know many others make is that, with something as important as fundamental human rights, government should not weaken the safeguards. My own belief is that the changes proposed should be considered in the round with the wider changes that the Law Commission is currently considering so that we do not inadvertently cause negative or unhelpful side-effects.
The noble Baroness, Lady Finlay, questioned whether there should be a test case—and, if so, who should do it and where the funding should come from. In terms of a test case to take to the Supreme Court, the Government are not yet minded to force this issue. The majority of partners that officials have spoken to support the Cheshire West judgment. We understand that the implications are many and that they vary by settings. As such, the Government have provided, where possible, guidance on specific settings, such as those that the noble Baroness, Lady Finlay, referred to relating to hospices. That guidance has, I think, been very well received.
I understand the noble Baroness’s concern about the implications of the judgment for different settings, particularly those where the fewest number of DoLS applications have traditionally come from. She has, as we all acknowledge, considerable expertise in this area and I would be grateful and pleased to facilitate a meeting with the officials leading this work if she would find that useful—and, indeed, with the Law Commission team looking at future legislation. It is vital to have the support of medical professionals for any future system to replace the current DoLS system.
I have not addressed all the points made by noble Lords this evening. If I am able to add to the comments that I have made, I would be happy to do so in writing. Suffice it to say, for now, that the Supreme Court judgment has challenged us to think about how we regard the most vulnerable members of society. The ultimate test is for those of us fortunate to have full capacity to put ourselves in the place of those who do not. If we were prevented from leaving a hospital ward—if we could exercise no choice over our day-to-day activities, over whom we met and when we met them—I wonder how we would feel. I suspect that we would expect at the very least to have a legal route of redress. Those who lack capacity deserve and are entitled to exactly the same. The challenge now is to deliver these rights in a busy and pressurised health and care system upon which demand continues to rise.
NHS: Health and Social Care Act 2012
Earl Howe Excerpts(10 years, 1 month ago)
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The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, the Act created the architecture within which NHS England’s innovation, health and wealth strategy is being implemented. As part of this, the innovation scorecard shows a real improvement in the uptake of certain NICE-approved innovations. The NICE implementation collaborative has also resulted in increased national spend on key technologies. The department and NHS England have commissioned an independent evaluation of innovation, health and wealth, which is expected to be completed by winter 2017.
Lord Wills (Lab)
I am grateful to the noble Earl for that Answer, but does he recognise that there is a significant gap between those fine words and what is actually happening on the ground? To take the case of giant cell arteritis, for example, 2,000 to 3,000 people go blind needlessly as a result of it. I hope the House will indulge me for a few seconds if I set out this important example. The condition is easily treatable. Professor Dasgupta, in Southend, has pioneered a fast-track pathway for diagnosis and treatment which has reduced the numbers of people going blind by two-thirds. Rolled out nationally, that would save thousands of people every year from going blind. It would save them and their families needless misery and suffering and would save the taxpayer hundreds of millions of pounds every year.
In January, Sir Bruce Keogh, the medical director of NHS England, wrote to me and said that this “represents a new way of doing things which is better and costs no more. We must learn from such innovative examples”. Is the Minister aware of what has happened since he wrote to me? Thousands of people have gone blind—
Lord Wills
Noble Lords opposite ought to listen to this; the people who suffer most from this are elderly and it is very much in their own interests to listen. Nothing has been done to roll out this innovative pathway. Can the Minister not accept that having a few guidelines is simply not good enough? Can he not accept that since the Health and Social Care Act came in, there has been no good example of good practice in this area?
Earl Howe
My Lords, I recognise the noble Lord’s close interest in this important topic. We recognise that early diagnosis and treatment of giant cell arteritis is extremely important to preventing sight loss. I am aware of the interest in the Southend GCA pathway developed by Professor Dasgupta. I recently raised the issue of the pathway with NHS England and understand Sir Bruce Keogh will be writing to the noble Lord very shortly about this. As he may be aware, the Royal College of Physicians has produced a best practice guideline on the diagnosis and management of GCA, which Professor Dasgupta has helped to develop. That is good progress and provides a very good framework for disease assessment, immediate treatment and urgent referral.
Lord Hunt of Kings Heath (Lab)
My Lords, the noble Earl has been answering health Questions for nearly five years now with courtesy and skill. How does he feel, as possibly the sole apologist, other than Mr Andrew Lansley, for the Health and Social Care Act 2012? What is his response to the independent King’s Fund, which described the Act, which the noble Earl piloted through this House with great skill, as having an impact that was both “damaging and distracting”? Is that not the real answer to my noble friend? The reason he has identified a problem and a shambolic decision by NHS England is that we have a shambolic organisation, which this Government are responsible for.
Earl Howe
If I had to single out two or three things from that Act which have been of enormous and incomparable benefit, one would be the enhancement and promotion of clinical leadership within the system, which has happened as a result of the creation of clinical commissioning groups. The second is the creation of Public Health England and the transformation of public health delivery in this country. The third is the separation of elected politicians from the running of the health service, which has enabled the NHS to free itself up to look at innovation in a more creative way
Baroness Greengross (CB)
My Lords, does the noble Earl not agree that if specialist secondary clinicians worked a more significant part of their time in primary settings in the community, this would be a welcome innovation across the country?
Lord Brooke of Alverthorpe (Lab)
My Lords, it would be churlish not to accept the noble Earl’s remarks that there have been some changes which have been beneficial. But does he not agree that the public at large recognise that overall there have been many downsides? Many of those downsides have been hidden and continue to be hidden by politicians, who refuse to release the risk register that was drawn up prior to that Act going through.
Earl Howe
My Lords, we are back to that one. As the noble Lord knows, the strategic risk register for the department is something that we are entitled to keep confidential, as all Governments have done. The Cabinet took the decision that the transition risk register should remain confidential because of the principle of the need to preserve private space for civil servants when advising Ministers.
The Countess of Mar (CB)
My Lords, some months ago I led a debate on the lack of clinical governance between health and social care. I was promised a meeting with the noble Earl by the noble Baroness, Lady Jolly. One of the big problems is the fact that there is no governance framework between health and social care, and as a result a lot of people are falling into a black hole. Can the noble Earl say when that meeting will take place?
Baroness Corston (Lab)
My Lords, does the Minister accept that one of the—I hope unintended—consequences of the Health and Social Care Act has been the disastrous effect on the recruitment of GPs, the number of people going into the GP profession and the number of people leaving the profession or who have said that they will be retiring early? It was described to me recently as an impending car crash.
Earl Howe
My Lords, I think we all recognise that general practice is under unprecedented pressure but I would not attribute that to the 2012 Act; I would attribute it to the unprecedented rise in demand from patients. The NHS across the piece is busier than ever before and naturally that has an effect on morale. We are, however, taking steps to promote recruitment into general practice and to reduce the day-to-day burdens that are imposed on general practitioners.
Health Service Commissioner for England (Complaint Handling) Bill
Earl Howe Excerpts(10 years, 2 months ago)
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The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, I very much welcome the debate on this important Bill. I thank my right honourable friend in another place, David Davis, and the noble Baroness, Lady Finlay, for their stewardship of the Bill, which makes the health service ombudsman more accountable to people taking their complaints to her and, more generally, to Parliament. A productive debate was had in the other place, with support for the Bill from all sides. Speaking for the Government, I hope that we can get the Bill on to the statute book as soon as possible, although I understand that parliamentary time is limited.
The Government very much support the principles that lie behind the Bill. It is a good Bill, and an important one. We are committed to continuing to improve the way in which complaints are handled across the health and social care systems and are actively encouraging the NHS to be more open and receptive to complaints. We remain committed to putting patients first.
Rightly, our focus on giving patients a stronger voice, coupled with reviews such as those by Sir Robert Francis QC and Ann Clwyd MP with Professor Tricia Hart, have raised people’s awareness of their right to complain. If someone is dissatisfied with the NHS services that they have received, it must be right for them to expect that their complaint will be investigated efficiently and effectively. The health service ombudsman investigates, and makes final adjudications on, complaints that individuals have been treated unfairly or have received poor service from the NHS in England. She is the second, independent stage of the NHS complaints arrangements, being independent of both government and the NHS, accountable directly to Parliament. An efficient ombudsman service is therefore vital if we are to deliver the effective complaints service to which NHS patients are entitled.
In response to the noble Baroness, Lady Hayter, and the noble Lord, Lord Hunt, who asked about the prospects for having a more unified and integrated ombudsman service, I would add that the Cabinet Office is reviewing the way in which the public services ombudsmen currently operate. We take complaints about the public services, including the NHS, very seriously. We consider that there is a continuing need to improve the handling of these complaints—in particular, to use information obtained from them to improve service delivery. As part of that work, we have been looking at reform of the public services ombudsmen. Noble Lords will be aware that Robert Gordon, a former director-general in the Scottish Government, has been asked to undertake this review, and the Cabinet Office is hoping to go out to consultation on reform before the end of this Parliament.
Dame Julie Mellor, the Parliamentary and Health Service Ombudsman, has transformed the way her office works. The noble Baroness, Lady Finlay, was absolutely right about that. The circumstances have been challenging, but she has done a good job. There is more openness and transparency in how the office works. The number of complaints investigated by her office has recently greatly increased, and we expect a further rise to be recorded in her 2014-15 annual report. Complaints are generally efficiently reviewed and assessed in a timely manner.
However, certain cases suggest that the ombudsman might benefit from legislative reinforcement in the difficult task of working towards further improvement. The noble Baroness has made reference to the Sam Morrish case. I shall not repeat what she has said; suffice it to say that the family’s experience of the NHS fell well below, and tragically below, an acceptable standard and, unfortunately, so, too, did their experience of taking their complaint to the health service ombudsman. Dame Julie rightly apologised to Mr and Mrs Morrish. In answer to the noble Lord, Lord Hunt, I think lessons have been learnt from that case. At the very least, I hope that the health service ombudsman would consider carefully and learn from the Morecambe Bay report where appropriate. It is not possible for me to say more than that; as noble Lords are aware, the ombudsman is independent of government, and it would not be proper for me to do so.
It is still true to say that any unnecessary delay in investigating cases adds to the distress of those involved. NHS complaints often raise personal or sensitive issues. It is important to respond to the person making the complaint as quickly as possible. Reducing unnecessary delay in completing the investigation of a case will reduce the distress of those involved. However, where there are considerable delays of more than 12 months, even if seemingly unavoidable, it is surely right for individual complainants to be told why an investigation has taken so long to conclude. We also think it right for Parliament to be informed, in the ombudsman’s annual report, of how many complainants are kept waiting longer than 12 months for their case to be concluded and, equally importantly, the action being taken to reduce that number.
In summary, this Bill will improve the accountability of the Health Service Commissioner for England to people making a complaint, and to Parliament. The Government fully support these aims, and we fully support the Bill.
Health and Social Care (Safety and Quality) Bill
Earl Howe Excerpts(10 years, 2 months ago)
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The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, I shall first address a concern that several noble Lords have flagged up most prominently: that the regulations are not sufficiently clear that the duties that we are talking about here are duties on providers rather than individuals. The regulations apply to registered persons. Schedule 1 to the Interpretation Act 1978 makes it clear that in legislation “person” includes not only natural persons but legal persons, such as companies. Under the Health and Social Care Act 2008, the registered persons are providers, not individual members of staff.
The noble Lord, Lord Hunt, asked why the clause does not list the bodies covered by the Bill. The clause amends Section 20 of the Health and Social Care Act 2008. It is the 2008 Act which sets out who the regulations apply to. They apply to registered persons who, under the Act, are the providers, not individual staff, as I said. He also asked whether almost all providers would be likely to be in breach of the regulations for one reason or another. The clause amends the Secretary of State’s regulation-making powers. It would not by itself impose requirements on providers. Those requirements will be as laid down in the fundamental standards regulations, to which I shall come in a moment. On the specific example that the noble Lord gave, where a surgeon did not engage meaningfully with the WHO checklist prior to an operation, my answer is that that would be a disciplinary issue for the employer and/or the professional regulator, if it became known.
Lord Hunt of Kings Heath
That is an extremely helpful answer, but will it be made absolutely clear to employers in the guidelines to be issued alongside the regulations that they have not only a right to take disciplinary action but a duty to do so? If that is set from the centre, that will give a lot of authority to boards, which they sometimes feel that they do not have at the moment.
Earl Howe
That is a very important point, which I shall be happy to take away.
Amendment 1, tabled by the noble Lords, Lord Turnberg and Lord Warner, would replace the reference to “no avoidable harm” with “take steps to reduce” avoidable harm. I accept that in some settings regulated by the CQC, including the NHS, that phrase may better reflect the scale of what can be achieved. However, regulation by the CQC is not just about the NHS. In the case of some health and adult social care services, I believe that it is reasonable to strive to eradicate all avoidable harm. It is for that reason that I prefer the current wording. Yes, it is more ambitious, but its ambition contains an incentive to strive towards a continuous reduction of avoidable harm across all settings regulated by the CQC.
The amendment would also result in requirements on providers to monitor the steps they take to reduce avoidable harm and to train staff in the reduction of avoidable harm. That is clearly desirable, but I must question whether it needs to be a duty set out in primary legislation. The training of staff in reducing avoidable harm is important, and Section 20(3)(d) of the Health and Social Care Act 2008 already expressly provides for regulations to include requirements on the training of staff.
The fundamental standards regulations, to which I referred a minute ago, which were passed by this House in November and come into force in April, already meet the test of the Bill, and no change to regulations is required. The fundamental standards require that care and treatment is provided in a safe way for service users. They give the CQC power to take action against providers where a failure to take steps to provide care in a safe way results in avoidable harm.
The regulations are breached not whenever avoidable harm occurs, but where there has been a significant failure effectively to manage the risks of harm. They are clear that that involves assessing the risks and taking steps to mitigate them. They ensure that staff have the right skills and qualifications, that premises and equipment are safe and that medicines are properly managed. They also require providers to have systems in place to assess, monitor and improve the quality and safety of services.
Noble Lords have cautioned that the clause might lead to staff taking a risk-averse approach. The noble Lord, Lord Hunt, expressed the concern that it could encourage staff to lose sight of the patient and instead focus on covering up mistakes. I firmly believe that the reverse is the case. What it does is to underpin our efforts to strive for the very thing so strongly advocated by the noble Lord, Lord Turnberg: an open reporting culture where identifying errors helps organisations to improve the safety of care. Where providers take the steps to manage the risk to safety, front-line staff can focus on the needs of patients and service users, content in the knowledge that the environment in which they work promotes safety and quality.
Our debate up to now has perhaps given the erroneous impression that the fundamental standards are just about the systems and processes. They are not. They focus on the outcomes of care and treatment. The new regulations, which come into force in less than three weeks, place patients and service users at the heart of service provision. They require that treatment and care meet the needs of service users and reflect their preferences. They prohibit providers from providing care without consent. They also put in place a new duty of candour that requires providers to inform service users where there have been failings in their care.
In those ways, patients and service users are central to the fundamental standards. Clause 1 rightly ensures that safety and the reduction of avoidable harm will always be the foundation of the regulatory system operated by the CQC.
I turn to Amendment 4, in the name of the noble Baroness, Lady Finlay. I am confident that all noble Lords share the same objective as that of Clause 1, which is to place patient safety at the heart of the delivery of services. The Committee will be aware of the importance that the Government place on improving safety. The recent report of the Morecambe Bay investigation has re-emphasised that that is the right approach. Moving towards the reduction of avoidable harm requires action across the health and social care system.
I agree with those who say that the main way to reduce avoidable harm is through changes in culture. None the less, there is also a role for legislation. The role of the law in this area is straightforward: it can define minimum acceptable standards and introduce ways to protect patients who are put at risk when those standards are not met. It provides a safety net that protects people from harm.
I stress that the regulations issued under Section 20 of the Health and Social Care Act 2008, which Clause 1 amends, apply to registered providers of health and adult social care in England. There are two important points here. First, the regulations do not apply to individual members of staff but to the providers of care. In that respect, they offer protection to staff as well as to patients and service users. Secondly, the scope of the regulations is not restricted to the health service but applies also to adult social care. In that respect, the scope of the clause is broader than that of the noble Baroness’s amendment. For that reason, I prefer the current wording, which offers the same protection to patients and service users wherever they receive care, not just in the NHS.
The noble Baroness asked whether the clause applies to all care organisations, including those in the voluntary sector. All providers of regulated activities must register with the CQC and meet the registration requirements, including voluntary sector and independent sector providers. She also asked whether the regulations will be consulted on and subject to affirmative resolution. The answer to both questions is yes, but having said that, the fundamental standards regulations are consistent with the objective of Clause 1. Those regulations were consulted on and were subject to affirmative resolution. Any future regulations amending or replacing those regulations would also be consulted on and, unless the changes are minor, would be subject to affirmative resolution.
Lord Warner
Can the Minister clarify something for me, because I am increasingly puzzled? He keeps talking about the fundamental regulations which are coming into force in three weeks’ time being consistent with Clause 1. If they are consistent with Clause 1 as they are framed, why do we need Clause 1?
Earl Howe
What Clause 1 does is to amend the provision whereby the Secretary of State may require the CQC to have safety as its prime objective to one where it must have that requirement as its prime objective. That is what Clause 1 essentially does, so there is a good reason for having the Bill alongside the regulations.
Lord Warner
I am sorry but this is quite a key point. If the Minister is right and those regulations were drafted in accordance with the law as it stood before this Bill, they presumably make the same requirement. The Minister is saying that they meet the requirements of the Bill. I still cannot reconcile why you need to change the law, particularly if we are now into “may” and “must” territory, which always delights your Lordships’ House. I am obviously being very dim but I still cannot understand why you need to change the law—the primary legislation—but do not then need to revisit the regulations which were made under other primary legislation. I thought I saw the Minister proceeding, uncharacteristically, with a degree of caution on this. There is an issue here on which, so far, the Government have not given me a particularly convincing explanation.
Earl Howe
I am very sorry that I have not given that explanation clearly enough. The point was well drawn out at Second Reading by my noble friend Lord Ribeiro that what Clause 1 essentially does is to bring patient safety absolutely to the fore in the context of the CQC’s work. That is entirely consistent with the approach that we took in the fundamental standards regulations which, as the noble Lord knows, flowed out of the work done by Sir Robert Francis QC in his report on Mid Staffordshire. If I can be clearer to the noble Lord before the conclusion of this debate, I will be glad to do so but I find it difficult to say more than I already have on this.
The noble Lord, Lord Turnberg, asked about the CQC’s guidance. Its guidance on the new fundamental standards has been consulted on. The CQC has a range of actions that it can take when a provider does not meet the fundamental standards, ranging from a warning notice to cancelling registration. The CQC’s enforcement policy is clear that any action that it takes will be proportionate to the risks to patients and that its most serious sanctions will be used only in response to the most serious service failings.
Lord Elton (Con)
My Lords, would another way of addressing the concerns of the noble Lord, Lord Warner, be to say that Clause 1 removes from the Secretary of State a discretion to produce regulations which are not as satisfactory as the current ones are?
Lord Turnberg
My Lords, I listened extremely carefully to what the noble Earl has just said and I am grateful to him for clarifying what a registered person is—I think that it is the word “person” that gets very personal here. I remain somewhat concerned about whether legislation to stop avoidable harm is a feasible proposition.
Lord Ribeiro
No. The heading “harm-free care” will be changed to “reducing harm in care”.
Earl Howe
My Lords, before the noble Lord, Lord Turnberg, decides what to do with his amendment, I shall reinforce the explanation I gave earlier in answer to the noble Lord, Lord Warner. This clause removes the Secretary of State’s discretion around whether the requirements for registration with the Care Quality Commission should cover the safety of care. That is the approach at the moment, but the impact of the change we are making is to embed current policy and practice. As my noble friend Lord Ribeiro has helpfully explained, without this change a future Secretary of State could in theory decide not to include patient safety requirements in future regulations. The Bill ties the hands of future Secretaries of State on this important matter. It would require a change to primary legislation to alter that. That has substantive significance as well as presentational significance.
Lord Hunt of Kings Heath
My Lords, this has been an interesting debate. I thought that the noble Baroness, Lady Finlay, raised some important points in relation to the definition of “best interests”. Because she referred to a number of identification streams within the health service, I ought to declare my interest as president of GS1 UK, the barcode association. Barcoding is, of course, another indicator that can be used.
I recently had an interesting discussion in Solihull with people who are helping the integration board that is aiming to bring health and social care together to provide integrated services. It was interesting to get an insight from a company that is helping the statutory providers to do this by confronting situations in which individuals are provided with services from a number of different statutory agencies but where there is, seemingly, no co-ordination at all between them. One often gets professionals arriving at the same time but not communicating with each other. This is partly due to the problem over information systems.
I should like to ask whether the noble Earl considers that the passage of the Bill will help the integration of that information, provided that the public have confidence in the process under which information is shared. There is clearly a balance to be drawn between the benefit of information sharing between statutory bodies in terms of integrating provision, alongside the safeguards necessary to the public. One should be in no doubt that this is quite a tension. Yesterday, the parliamentary Intelligence and Security Committee published a report on the holding of information by the security services. Reading it gives some cause for concern, in many cases, about the amount of information available about individuals. Although, as I understand it, the committee report says that that information is often never referred to or used, it none the less could be. The whole issue regarding the integrity of confidential information is important. On the other hand, we know that we have considerable failures in service because there is no sharing of information. The point that the noble Baroness raised about what we mean by “best interests” and the issue of how we can ensure public confidence is extremely important.
I support the amendment in the name of the noble Baroness, Lady Hollins, which offers an opportunity to debate the importance of including people’s communication needs in the information shared between health and care professionals. I have received helpful briefing from Mencap, the RNIB, the National Autistic Society and Sense. It has become abundantly clear that failure to understand the best way in which to talk to individuals can result in misunderstandings, misdiagnosis and, ultimately, poor care. Accessible and easy-to-read information, perhaps with pictures, to which the noble Baroness, Lady Hollins, referred, and the presence of family, advocates or interpreters, can make the difference between diagnosis and misdiagnosis.
It would be very helpful if the noble Earl could clarify that the communication needs of disabled people and the reasonable adjustments that they might need will be an important part of the health information that should be shared between professionals. I certainly hope that he is willing to place on record that guidance associated with the Bill will reflect this and that it will reach the relevant professionals.
Earl Howe
My Lords, let me turn first to Amendment 5. I understand the noble Baroness’s concern that there should be no confusion over the “best interests” wording in the Bill and the more technical and prescribed “best interests” checklist test in the Mental Capacity Act 2005. The key point for me to emphasise straightaway is that in this Bill the phrase “best interests” is ascribed its ordinary meaning: the consideration of a range of factors, including the wishes of the individual. Nothing in the Bill detracts from patient autonomy or the importance of supportive partnership working between clinicians and patients. This is in marked contrast to the “best interests” test checklist found in the Mental Capacity Act, which the noble Baroness was instrumental in shaping. In that Act, which concerns individuals who lack capacity, the term is not defined. A checklist of considerations helps professionals to determine what a patient’s best interests are.
The information-sharing provisions of the Bill respond to concerns expressed by the National Data Guardian. Dame Fiona Caldicott, in her 2013 review of information sharing, identified a risk-averse culture and concluded that the duty to share information for a person’s own direct care should be considered as equally important as the duty of confidentiality. I quote from her review:
“Health and social care professionals should have the confidence to share information in the best interests of their patients”.
These provisions seek to establish that sentiment in law.
The presence of the phrase “best interests” in this Bill ensures that it complies with the central principle of the Data Protection Act and the Caldicott review: to share information only where necessary and relevant. The term “best interests” is used elsewhere in primary legislation, including in the Human Fertilisation and Embryology Act 1990 and Section 38 of the Medical Act 1983. It was also used more recently in the Charities Act 2011, the Legal Services Act 2007, and in the Pensions Schemes Act 2015, which received Royal Assent last week—all are without reference to the checklist in Section 4 of the Mental Capacity Act. It is a term used across a wide-ranging legislative landscape with its ordinary meaning.
The “best interests” test in this Bill is no different from that in the pensions Act or the Legal Services Act. It requires a professional to apply a common-sense approach. I appreciate the noble Baroness’s concern that the use of the word “best” could herald a return to a “doctor knows best” kind of paternalism and to disempowering patients in the process. I sincerely hope that I can convince her that this is neither the intent nor the effect of this Bill. I am sure that the whole House will agree that the focus of information sharing should be on the needs of the individual, rather than defensive, risk-adverse behaviour of the type we have sometimes seen in the past.
I can confirm that the Department of Health will provide guidance to support the interpretation of these new duties. This will include a clarification that the term “best interests” is ascribed its ordinary meaning. The Government will also amend the Explanatory Notes to that effect.
Lord Hunt of Kings Heath
My Lords, that was a very helpful response. May I just ask the noble Earl whether explicit examples will be given in the guidance? The issue of professional defensiveness is very important. He will know that, out in the field, people often have a different view about data protection. Sometimes it gets in the way of sensible, professional working together. I urge that the guidance should be as practical as possible and that it should be aimed at field workers, rather than just the organisations they work for. Let us take as examples care workers, health service workers, health visitors and nurses, in regard to whom it is clearly in an individual’s best interests that information is shared about visits, and that sometimes responsibilities are shared, and that they are not inhibited because of some myth about their inability to share information.
Earl Howe
The noble Lord makes some very good points. The duty to share information will, we trust, ensure consistency in the sense that it will make it clear when the duty to share applies. It is clear that there is a real commitment throughout health and adult social care to overcome the cultural barriers that Dame Fiona referred to. For example, the sharing of information for the purposes of an individual’s direct care is already required as part of the professional duties of health and care professionals, and sharing for direct care purposes can be undertaken in accordance with the common-law duty of care.
The department is already working with its national partners to offer practical support to local provider and commissioner organisations on information governance and sharing. For example, the department is partner to the Information Governance Alliance, a group of national health and care organisations which has been established to provide a single authoritative source of guidance and support on information sharing. I confirm to the noble Lord that the guidance will include specific examples and will be prepared in consultation with our key stakeholders.
Turning to Amendment 6, the NHS number helps to ensure that an individual’s health and adult social care history is readily accessible when they move along their care pathway. This will improve safety and the experience of care. The adoption of the use of the NHS number as a consistent identifier has been a long-standing government objective.
It may help if I explain a little about the purpose and use of the NHS number. An individual does not need to know their NHS number to get treatment. Conversely, having an NHS number does not imply entitlement to the free use of all NHS services. The NHS number helps to confirm the identity of patients and link health records. There are some electronically based services for which an NHS number is essential and from which a patient who objects to the number being shared may not be able to benefit—for example, as the noble Baroness said, screening programmes, choose and book referrals, and electronic prescriptions in primary care. In these instances, the implications of objecting may be serious, which underlines why the decision to opt out should always be considered carefully and discussed with professionals.
That said, there is an important principle at stake here. The Government are committed to empowering the individual. In the future, it will increasingly be the citizen who determines who has access to their data, with care professionals respecting their preferences. For that reason, the Bill provides that if an individual objects, or is considered likely to object, then no duty to share information will arise under these new provisions. I hope that that is a useful explanation for the noble Baroness.
I am pleased to reassure her also that the Bill will not have any effect on the existing systems to protect victims of abuse. The Care Act 2014 sets out clear duties on adult safeguarding. Under the Act, local authorities must make inquiries, or cause others to do so, if they reasonably suspect that an adult who has needs for care and support is, or is at risk of, being abused or neglected.
Statutory guidance will provide that the early sharing of information is key to providing an effective response where there are emerging concerns. Where an adult has refused to consent to information being disclosed, practitioners must consider whether there is an overriding public interest that would justify information sharing.
There are equally robust mechanisms in place to protect children. The Department for Education has produced statutory guidance entitled Working Together to Safeguard Children, which clearly sets out that professionals should share information with local authority children’s social care where they believe that a child is at risk of abuse or neglect. It states:
“Fears about sharing information cannot be allowed to stand in the way of the need to promote the welfare and protect the safety of children”.
Existing guidance on information sharing for practitioners and managers states that if a child is suffering or is likely to suffer significant harm, professionals should share information even if consent is refused or withdrawn. The interests of the child are paramount.
I agree wholeheartedly with the sentiment behind the amendment in the name of the noble Baroness, Lady Hollins. It is critical that an individual’s communication needs are identified and shared appropriately with those responsible for providing and commissioning care and services. This Bill requires the sharing of information where this information is,
“likely to facilitate the provision to the individual of health services or adult social care in England, and … in the individual’s best interests”.
An individual’s particular communication needs would be a good example of such information. This will be made clear in guidance.
The concerns that the amendment seeks to address reflect those Mencap has recently raised with the Department of Health. I am pleased to say that my officials have had constructive discussions with Mencap and we welcome its offer to help shape the guidance. Mencap welcomes the Bill as it has the potential not only to improve information sharing between health and social care, especially for people with a learning disability, but also has, in its words, the potential to “save lives”. I would add that, provided the patient or his or her attorney have consented to its inclusion, any information from a GP record that can be coded can be included on a summary care record. Work is already under way to expand the summary care record inclusion data set to include specific communication needs items.
Lord Ribeiro
My Lords, I thank the Minister for clarifying the issues around the consistent identifier. It is interesting that the use of the consistent identifier and the sharing of information was welcomed at Second Reading by the noble Lords, Lord Turnberg, Lord Willis of Knaresborough and Lord Hunt of Kings Heath. The noble Lord, Lord Hunt, confirmed that the Opposition were very supportive of sharing a patient’s information, which, as he said, was,
“clearly in the best interests of their patients”.—[Official Report, 6/2/15; col. 961.]
That slides me very easily and comfortably into Amendment 5 and the question of best interests, which, again, has been addressed. I must confess that I have always used, and continue to use, the term “best interest” without assuming that this can be used only about those without mental capacity, as defined by the Mental Capacity Act 2005. It is my understanding that in these clauses the phrase “best interests” assumes its general meaning and provides a relevant person with a duty to act in the individual’s best interest when providing information for direct patient care. That is my understanding of the term.
As regards Amendment 6, patient control and choice about how their information is used is the subject of wider government policy. I believe that what needs to be done in that respect has already been illustrated. It is about empowerment of the individual and giving them control over their own information. I also welcome the intervention of the noble Baroness, Lady Hollins, in highlighting a key piece of information in patient care. Her description of a patient who died after surgery for want of the right word when asked a question—the patient answered incorrectly, which led to a fatal outcome—was truly revealing. In my experience, it is critical that if an individual has particular communication needs, those who provide care or treatment should know about them beforehand.
I am confident that the requirements to share information in support of direct care in the Bill already encompass communication needs. The Minister commented that Mencap has sought reassurances that health professionals should become more aware of the ways in which people can communicate their health and care needs. I am sure that, from his statement earlier, work on this will take place to ensure that those concerns are met. With those comments, I hope the noble Baroness will be happy to withdraw her amendment.
Lord Hunt of Kings Heath
My Lords, I am not sure about the noble Lord’s latter point. I think my noble friend has done us a great service in raising this issue. Since we are talking about unique personal identifiers again, perhaps I may first remind the House of my presidency of the bar-coding association, GS1.
As a resident of Birmingham, I thank my noble friend for his work as the Children’s Commissioner, which has been invaluable. Your Lordships will have a great opportunity to discuss these matters further on Monday night after we debate standardised packaging of cigarettes, because I have a Motion to Take Note on the Birmingham electoral order, which changes the electoral cycle in Birmingham following the work of the three commissions and the Permanent Secretary at the DCLG.
On the substantive point, my noble friend raised the case of Victoria Climbié, on which I well remember making the Statement to this House a long time ago now. What was so striking in that report was that she went through, I think, at least eight or nine public agencies. If any one of them had talked to another, it is likely that she would still be alive today. It was a shocking report, because there were so many failures by so many different organisations. Although, inevitably, the local authority always tends to be the focus of concern, neither the health service nor the police covered themselves in glory. I am not really in a position to commit the Opposition in exactly the way that my noble friend wants, but if the noble Earl would like to institute some urgent cross-party discussions with my noble friend, we would certainly be very happy to take part.
Earl Howe
My Lords, to start with a given, I am sure I speak for the whole Committee when I say that we are all committed to taking whatever steps are necessary to protect children from abuse and neglect. Clauses 2 and 3 are, as they stand, based on long-standing policy intentions. They have real buy-in and support from those who will need to deliver them.
As regards children’s social care and wider children’s services, the difficulty with proceeding without delay in the direction that the noble Lord, Lord Warner, is advocating is that we do not yet have robust evidence on the impact of the potential burdens and risks of an extension of these duties. Moving to the use of a common identifier for the education and children’s social care sector would represent a substantial change. In the discussions that I have had on this, I have been persuaded that it is only right that we fully understand and assess the impact before considering legislation.
However, I can give the noble Lord, Lord Warner, some hopeful news. I am pleased to inform him that the Department for Education has committed to undertake an evidence-gathering exercise to understand fully the impact of adopting a consistent identifier for these types of provision. That exercise is expected to report before the end of the year. I hope the noble Lord will understand that we would not want to pre-empt the outcome of that or make decisions now on behalf of Ministers in the next Government, who will wish to consider the evidence once it is available.
The amendment would also have the effect of creating a power to extend Clauses 2 and 3 to other public bodies where there was evidence that this would benefit the health and well-being or protection of children. I recognise and welcome the sentiment and reasoning behind the desire to extend the information-sharing duty under this Bill to encompass child protection issues. As I have already assured the noble Baroness, Lady Finlay, there are clear requirements on professionals to share information to protect children. I hope that reassurance is helpful.
Lord Elton
In fact, Reg Wells-Pestell, not Goronwy Roberts, was the Minister. I want to get that right for anyone who is old enough to remember and reads Hansard.
Lord Hunt of Kings Heath
My Lords, some very important points have been raised by the noble Baroness, Lady Finlay, and my noble friend Lady Pitkeathley. My regret is that we are dealing with these regulatory matters in this Bill. A number of statutory instruments will also come through your Lordships’ House, one from the GMC, in the next few days.
We had a Law Commission draft Bill which should have been a fifth Session Bill and would have enabled your Lordships to look at the statutory regulation provisions in the round. However, because of the Government’s decision not to proceed with that Bill, not even in pre-legislative scrutiny, we now have to look at this matter in a piecemeal way. It is wholly unsatisfactory. I am very sorry that we are having to deal with these issues in this way without enough time to focus on them properly. I am worried about Clause 5; I think that we are going to let it through without understanding its implications. We would be very grateful for anything that the noble Earl can do to clear this up.
Earl Howe
My Lords, I very much hope that I can allay the concerns of both noble Baronesses and the noble Lord. In its report, the Law Commission recommended a consistent main objective for professional regulators and the PSA around patient safety. It also recommended two subsidiary objectives: maintaining confidence in the profession and proper professional standards and conduct. The Law Commission’s report describes this proposal as restating the existing legislative position that public protection is the regulators’ main objective. The Government’s view is that public protection is sufficiently important that it should be expressly adopted in the legislation.
The noble Baroness, Lady Pitkeathley, asked whether public confidence might conflict with public health, safety and well-being. In the example of the Professional Standards Authority identifying a poorly performing regulator, it is clear that the interests of public protection and public health, safety and well-being would require the PSA to take action. In this example, any argument that the objective of promoting and maintaining public confidence in the professions would require the PSA to conceal poor performance would clearly run counter to public protection. The objective of promoting and maintaining public confidence in the professions does not mean that the PSA or the regulatory bodies should be promoting the reputation of the professions generally. Rather, it is about taking action where there is a risk that confidence in the profession as a whole is undermined to the extent that it may deter people from seeking the treatment or care that they need and impact on public protection. This example highlights the fact that while the objectives are all linked to public protection, in practice they may not always necessarily be relevant, or relevant to the same extent in particular cases. It is not a case of one objective overriding another or preventing it being considered but ensuring that they are pursued only where they are relevant to public protection.
The Bill does not prioritise or weight one element of public protection over another. It is for the PSA to determine how it applies those elements in carrying out its functions in relation to the regulators and considering the issues of the case. My view is that health, safety and well-being will always be relevant to public protection when the PSA is carrying out its functions in relation to the regulators. It will be for the PSA to determine how to apply the objectives appropriately.
The noble Baroness asked whether the objective to promote and maintain public confidence might inadvertently lead the regulators to be less transparent in highlighting bad practice. Equally, that might lead to regulatory committees and panels punishing professionals who do not pose any threat to the public. If the actions of a doctor appear likely to reduce confidence in the medical profession and influence the decision of individuals as to whether to seek medical help at all, it may be right to take action. However, panels and committees will be asked to reach their own objective judgment as to whether particular acts or omissions would affect public confidence if no action were taken. A subjective view, uncritically influenced by public opinion or the media, would be an unacceptable basis for a decision.
Turning to the term “well-being”, the BMA has raised concerns with my ministerial colleague Dr Dan Poulter about how it would be interpreted by fitness to practise panels and committees. Well-being has been a long-standing and established feature of the legislation for three of the regulators. It encompasses those aspects of a professional’s role that may have an impact on individual patients but not directly impact on their health or safety. Dignity, compassion and respect are all important in delivering care, and it would not be right to disregard them.
It will be for the regulators to formulate and issue guidance for fitness to practise panels on interpreting and applying the objectives in practice, including the term well-being. The legislation makes clear that those objectives are considered only under the umbrella of public protection.
My officials will draw the regulators’ attention to those concerns should the overarching objective become law. That is in order to inform any guidance that will be needed to implement both this Bill and the secondary legislation for the GMC.
The noble Baroness, Lady Finlay, also asked about how we view the definition of “public” in the Bill. It of course includes patients and service users, as well as other parts of the collective public. I hope that that reassures the noble Baroness that the objectives in relation to well-being and public confidence will not be pursued outside the regulators’ objective to protect the public.
Lord Ribeiro
In following the Minister, perhaps I may deal, first, with “well-being”. At paragraph 3.20, the Law Commission’s report states:
“We disagree with the criticism of ‘well-being’. This term has already been incorporated without difficulty into the main duties or objectives of many of the regulators”.
Within that context, it feels strongly that that term cannot be misinterpreted.
The Bill introduces consistent objectives for the PSA and the regulators based on the proposals of the Law Commission’s review last year. Most of the professional regulators have some form of main objective. Although they are not consistently expressed they are generally to protect, promote and maintain the health and safety of the public. It is the health aspect with which the noble Baroness, Lady Pitkeathley, was particularly concerned at Second Reading. I think that that concern has been allayed today.
It is clear that public protection—by “public” I of course include patients—is sufficiently important that it should be adopted expressly in legislation. Defining public protection in terms of these three elements to be pursued by the regulators and the PSA as their overarching objective enables public protection to be considered in its fullest sense. That should give comfort and reassurance to the noble Baronesses who have spoken. With that, I hope that the noble Baroness will agree to withdraw the amendment.