Barts Health NHS Trust
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The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, I will now repeat in the form of a Statement an Answer to an Urgent Question tabled in another place and given by my honourable friend the Minister for Public Health on the subject of Barts Health NHS Trust. The Statement is as follows:
“The NHS Trust Development Authority announced on Tuesday 17 March that Barts Health would be placed into special measures. This followed a report by the Care Quality Commission that rated services at the Barts Health site at Whipps Cross as ‘inadequate’. As a result of this decision, the trust will receive a package of tailored support to help it to rapidly make the necessary improvements for patients. This will include the appointment of an improvement director and the opportunity to partner with a high-performing trust.
The Chief Inspector of Hospitals has highlighted the scale of the challenge ahead and this is an opportunity to ensure that the trust has the extra support it needs to meet this challenge. Barts Health has already announced that it has begun to strengthen management arrangements at Whipps Cross, in response to concerns raised by the CQC.
We make no apology that, under the new rigorous inspection regime led by the Chief Inspector of Hospitals, if a hospital is not performing as it should, the public will be told. If a hospital is providing inadequate care and we do not have confidence in the ability of its leadership to make the required improvements without intensive support, it will be put into special measures. It will remain in special measures until it is able it to reach the quality standards that patients rightly expect.
While the trust is in special measures, it will receive increased support and intensive oversight to help it address its specific failings. This process is publicly transparent so that patients and the public can see and track for themselves, online through the NHS Choices website, the progress that their trusts are making. Any changes or additional support required for the trust leadership are put in place early on in the improvement process, as has already taken place at Barts Health.
The expectation is that an NHS trust or foundation trust will be reinspected by the CQC within 12 months of being placed in special measures. It is the job of the Chief Inspector of Hospitals to recommend when a trust is ready to exit special measures. The NHS Trust Development Authority or Monitor will then formally decide to take the trust out of special measures when they consider that the trust is able to sustain the quality of care at the level that patients expect.
A total of 21 trusts have been put into special measures over the past 20 months as a result of this new approach to poor care. Six trusts have exited the regime and there has been progress at nearly all the others. The willingness to recognise poor care has been critical in starting a journey to improvement and we make no apology for upholding the high standards of care that are rightly expected of the NHS”.
My Lords, that concludes the Statement.
Lord Hunt of Kings Heath (Lab)
My Lords, I am sure that the House is grateful to the noble Earl, Lord Howe, for repeating that. It is a worrying report about the largest trust in England, which is directly managed by his department through the NHS Trust Development Authority. Why have these problems been allowed to get worse over the past two years? Does he agree that the report has identified that the root cause of the problem was the reorganisation of the trust in 2013? Can he say why Ministers overruled the Co-operation and Competition Panel, which advised against the proposed merger and warned of the adverse consequences for patients?
Earl Howe
The decision to create Barts Health was taken following a report that analysed the options open to the department at that time. As the noble Lord knows, there was, effectively, a merger of several trusts to create Barts Health. The advice received by the Secretary of State at the time was that none of the three trusts subject to the merger with Barts was sustainable as a stand-alone organisation. The appraisal of the options identified the three-way merger as the most beneficial and strategic solution for the system as a whole, taking into account a wide range of clinical, financial and government issues.
Baroness Finlay of Llandaff (CB)
My Lords, in looking at the non-viability, I have been concerned that the PFI deals that Barts Health is saddled with amount to £115 million a year. I wonder whether the other trusts that went into special measures have also had this albatross of PFI deals around their necks that has pulled them down over the years. Why have the Government been unable to address the problem of the burden of previous PFI deals?
Earl Howe
Early on in the Government’s term of office, we analysed all the trusts that were subject to PFI liabilities. The worst affected trusts were singled out to be given ongoing financial support by the Department of Health. Barts has a very large PFI debt of about £1 billion, and I have asked whether it is considered that this in itself has proved to be a deciding factor in the trust’s financial stresses. The advice I have been given is that it is not seen as a particular cause of the difficulties now being experienced.
Baroness Donaghy (Lab)
My Lords, I want to ask a question about a trade union representative who was dismissed from the authority two years ago for raising some of these very issues. She was a member of UNISON, and I declare an interest as a former member. I wonder whether, in working closely with trade unions, a better step would be to look after the interests of all the staff and to be not afraid to listen to some of the difficulties. The authority fought that case tooth and nail. She won at an employment tribunal but did not get reinstatement. Can the Minister give us a reassurance that in future there will be a more constructive relationship with the trade unions?
Earl Howe
My Lords, I cannot disagree with the philosophy expounded by the noble Baroness. It is very important that not just the trade unions but members of staff generally feel involved and have a sense of ownership of the organisation for which they work. I hope it is of some reassurance to the noble Baroness that staff and health partners will be fully involved in the development and implementation of the improvement programme and that a staff representative will be a member of a new improvement board at Whipps Cross.
Baroness Masham of Ilton (CB)
My Lords, it was stated in the press that there had been bullying at Whipps Cross and that people had been denied food and fluid for far too long. What is being done about those people who bullied patients?
Earl Howe
The noble Baroness is right. The CQC found that there was a culture of bullying at Whipps Cross. They had concerns about whether enough was being done to encourage a culture of openness and transparency—something on which, as she knows, we place great emphasis in the light of the report on Mid Staffordshire NHS Foundation Trust. I can only say to the noble Baroness that this is one of the issues that will be top of the list for the new improvement director at Whipps Cross.
Baroness Manzoor (LD)
My Lords, the culture within the NHS appears to be changing, and not for the better. Is the Department of Health looking at that, as well as at the issue of PFI across the NHS, and is it doing so not in a piecemeal fashion whereby things are identified only when they go wrong?
Earl Howe
It is precisely because we have wanted to confront the issue across the NHS that so much has been done following the report of Sir Robert Francis into Mid Staffordshire NHS Foundation Trust. All the recommendations flowing from that report should resonate with every part of the NHS. The recent work done by Sir Robert on whistleblowing can be put into the same category. There are lessons and messages for the NHS as a whole, and I believe that progress is being made, as it needs to be in particular quarters.
Lord Campbell-Savours (Lab)
My Lords, I declare an interest as a financial sponsor of research into cancer at St Bartholomew’s Hospital in central London. Can we be given an assurance that the work done at St Bartholomew’s is in no way under criticism in the Statement made by the Minister?
Earl Howe
The Statement related to Whipps Cross specifically, but the Trust Development Authority took the decision to place the entire trust into special measures. That was a slightly unusual step to take but I think that it reflected the concern that it felt about the management of the trust generally. However, the TDA also singled out some areas at Barts for particular praise. It is important to stress that patients will receive the good care that they have known about at Barts in the future.
Proxy Purchasing of Tobacco, Nicotine Products etc. (Fixed Penalty Amount) Regulations 2015
Earl Howe Excerpts(10 years, 11 months ago)
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False or Misleading Information (Specified Care Providers and Specified Information) Regulations 2015
Earl Howe Excerpts(10 years, 11 months ago)
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The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, before I go into the detail of the regulations, I will briefly set out the background for why this offence was set in statute and why the regulations are required.
The report of the Francis inquiry into the events at Mid Staffordshire NHS Foundation Trust made clear the need for clear and reliable information about the quality of care and organisational performance. The inquiry found that inaccurate statistics about mortality rates obscure the true picture of care and can allow poor care to continue unchecked. The creation of a culture of openness and honesty is vital in improving care in the NHS and in empowering staff to challenge poor care where and when it occurs, and this Government have taken great strides to ensure that this is the case.
The provision of accurate information is central to the safe functioning of the NHS. It provides the intelligence on which commissioners and regulators form judgments about the quality of care. Where that information is wrong, it can result in delays in taking action to protect patients and service users. Deliberately falsifying such information is a serious matter that can frustrate attempts to provide safe care for patients and service users.
Care providers, which are directly responsible for the standard of services, have a clear responsibility to ensure that the information they supply is accurate and gives a true picture of the standards of care that they provide. The Care Act 2014 put in place a new criminal offence that will apply to care providers that supply, publish or otherwise make available false or misleading information. The offence will apply to the misreporting of information that is required to comply with a legal obligation. I wish to emphasise that last point: this offence applies only to providers of care, not regulators or commissioners of care.
Where a provider is found to have committed the offence, which could be as a result of deliberately supplying false or misleading information or as a result of neglect, the provider can be fined by the courts. In addition, the courts can require the provider to take action to address the failings which led to the offence occurring and make publicly known the action it is taking.
The FOMI offence can also apply to senior individuals within a care provider but only when the care provider has been found guilty of the offence. Senior individuals can also be found guilty of the offence where they have consented or connived in the publication or submission of false or misleading information, or have been sufficiently neglectful in their duties to allow false or misleading information to be published. An individual found guilty of the offence could face imprisonment of up to two years, a fine or both.
Of course, misreporting of information can be the result of genuine error and it is essential that such mistakes do not result in a criminal conviction. The Care Act 2014 therefore allows for a defence against the offence where a care provider is able to demonstrate that it took all reasonable steps and exercised due diligence to avoid the misreporting of information.
The primary legislation contains a regulation-making power that allows the types of care providers and the types of information to which the offence applies to be specified in regulations. The regulations before the Committee specify that the offence will apply to NHS trusts in England, NHS foundation trusts and other persons who provide health services from a non-NHS hospital,
“pursuant to arrangements made with a public body”.
For clarification, this means that the offence can apply to independent providers delivering services under an NHS contract, but only if they are also required to submit or publish the information included in the regulations.
The information to which the FOMI offence applies is focused on the issues raised by Robert Francis, such as mortality figures, and is supplied by providers of NHS secondary care. This is a short list, but one that represents a significant quantity of data provided by the NHS and forms the foundation of the information used to assess NHS performance.
The regulations include other key information supplied by providers of NHS secondary care, including cancer waiting times, maternity data sets, many of the core commissioning data sets and NHS quality accounts. The latter is an important inclusion, as Sir Robert Francis specifically recommended that:
“It should be a criminal offence for a director to sign a declaration of belief that the contents of a quality account are true if it contains a misstatement of fact concerning an item of prescribed information which he/she does not have reason to believe is true at the time of making the declaration”.
All the information listed in the regulations is that which providers are or will be required to publish or submit because of a statutory or other legal obligation. This is a requirement of the primary legislation of the Care Act 2014 and an important part of the legislation for a few reasons.
First, it means that a provider cannot opt out of submitting or publishing information just because it wants to circumvent the false or misleading information offence. Secondly, as this is information that is already required to be published or submitted, we are not requiring providers of NHS secondary care services to undertake any additional work—only that they should ensure the information they provide is accurate and not misleading. Finally, providers of NHS secondary care services publish or submit on a voluntary basis a great deal of information which is incredibly valuable to improving the delivery of services and developing a greater understanding of the nation’s health. We do not want to dissuade providers from submitting or publishing such information, which is why the offence cannot be applied to information of that type.
In summary, the offence will apply only to the providers listed in the regulations and only where the offence occurs in relation to the provision or publication of the information listed. When the Department of Health consulted on the regulations in 2014, it was noted that the application of the offence was quite complicated. We have addressed this concern through guidance on the application of the FOMI offence which sets out how this law works.
The FOMI offence puts in place an important new sanction against providers of NHS-funded secondary care that mislead others about the performance of their services. As this offence is new, the regulations have been developed to focus the application of the offence so that it covers important data sets and data that can be robustly interrogated to determine if a provider has committed the offence. Designing the regulations this way will enable us to better understand how the offence operates in practice and allow us to make changes to the regulations in a targeted way in the future. I hope that noble Lords will support this rationale and will therefore agree to these regulations being commended to the House. I beg to move.
Lord Hunt of Kings Heath (Lab)
My Lords, I am very grateful to the noble Earl for introducing these important regulations, which the Opposition are very happy to support. It is clearly unacceptable for anyone or any organisation in the NHS to knowingly publish false or misleading information. We are fully behind the Government on this. The noble Earl will probably remember that during the passage of the Care Act we tried to strengthen the clause that the regulations emanate from by tabling an amendment which would have made it an offence to withhold information with the intention to mislead or misdirect. That was not accepted by the Government.
I come back to the point that the Minister ended with. He emphasised that this applies only to NHS trusts, foundation trusts and those providing services. He will know from our discussions on the Bill that we wanted to expand this to cover other organisations, including local authorities and clinical commissioning groups. I would be grateful if he could respond on why the Government still think this should be confined to those who provide services.
I put to him that the Francis report into Mid Staffordshire, and indeed the more recent report by Bill Kirkup looking at the very worrying incidents that happened in Morecambe Bay, do not just put responsibility for what happened at the door of the providers, though I fully accept that in the end the board of the Mid Staffordshire NHS Foundation Trust and the board of the trust that ran Morecambe Bay must take primary responsibility. However, a number of other organisations were listed—organisations that would not be defined as providers. There are circumstances in which clinical commissioning groups, or part of NHS England, ought to be covered by the same rules and law because one depends on honesty and openness throughout the system. I would be interested in the Minister’s comments on that.
This is part of wishing to develop a culture of openness and transparency. People in the health service are very cynical about these proposals because they do not see the same transparency and openness and, to be frank, honesty emanating from the Minister’s own department. If my noble friend Lord Brooke were here, he would remind the Minister about the lack of publication of the interim risk register. I point to the report by the noble Lord, Lord Rose, on management capacity. It is one thing to have a legal provision, but it is another to ensure that everyone in the system actually operates according to the spirit of what the Government intend. I myself believe that that should apply as much to the Minister’s department and NHS England as it does to the providers in the health service.
Earl Howe
My Lords, I am grateful to the noble Lord for his support for these regulations. He returned us to an issue that we debated during the passage of the Care Act: the question of why this offence is restricted to providers and does not extend further to either NHS or local authority commissioners. We took the view that, in determining the scope of the offence, the focus should be on information that is closest to patient care, where inaccurate statements can allow poor and dangerous care to continue. This type of information is required by law from providers of NHS secondary care, such as hospital trusts, and to be frank we have not yet identified information that would warrant extending this offence to commissioners or other providers of information. The scope of the offence is therefore determined by the information to which it applies.
The noble Lord referred to the need for openness throughout and across the system. I agree with him, of course, and I contend that over the past five years this Government have done more than any other to promote transparency in the health service and indeed from the department itself. The particular case of the risk register is one that we have debated on a number of occasions. He may recall that while the decision was taken by the Cabinet not to publish the transition risk register, nevertheless I laid before the House the essential elements contained within the register to enable noble Lords to understand the broad content of the risks that the transition addressed. The approach to risk registers in general is one that was taken under the previous Administration in a number of departments.
The report prepared by the noble Lord, Lord Rose, on NHS leadership is being looked at in the light of NHS England’s five-year review. The five-year review was published during the time that the noble Lord, Lord Rose, was preparing his report and the possibility of extending the report to take account of the review is being considered. We look forward to seeing the conclusions of the report once it is ready.
Health Care and Associated Professions (Knowledge of English) Order 2015
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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.
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.
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.
NHS: Cancer Drugs Fund
Earl Howe Excerpts(10 years, 11 months ago)
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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.