Penrose Inquiry
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Lord Hunt of Kings Heath (Lab)
My Lords, I thank the noble Earl for repeating that Answer. Clearly the Penrose report is a detailed factual account of what happened, and I pay tribute to Lord Penrose for the work that he and his team have completed.
I noted the noble Earl’s comments this afternoon that we have the initial response, but that the full response is to be left to the next Government. It is clear that the report needs very careful reading in order to come to a substantive view. Certainly, as a Minister, I dealt with this issue in my time at the Department of Health—I see the noble Lord, Lord Fowler, and other former Ministers here—and Dr David Owen has on a number of occasions drawn attention to some issues about the way this was handled by the Department of Health. On the face of it, does the noble Earl think that at the very least this warrants some discussion about whether his own department needs to establish some kind of view on the Penrose report?
Lord Penrose made a single recommendation: that all people in Scotland who had a blood transfusion before 1991 should be tested for hepatitis C. Again, is that to be left to the substantive response after the election, or can he give an initial view on the implications of that recommendation for people affected in England?
The noble Earl referred to relief. Can he say anything about the Skipton Fund payments and progress made on that fund since its establishment in 2004, and about decisions that I believe were made by the Government in January 2011 with regard to payments to the estates of people who died prior to the announcement of the scheme in August 2003?
One of the stark conclusions from reading the report is about what could be described as the paternalistic view taken by doctors on information to be given to patients. He says that the expert evidence available to the inquiry indicated the withholding of information from patients on the absence of treatment for the condition, which from a contemporary ethical perspective was not acceptable. Does the noble Earl agree with that, and does he consider that circumstances have moved on such that today such information would not be withheld?
Earl Howe
My Lords, I am grateful to the noble Lord, Lord Hunt, for his comments and questions. There is no doubt that Lord Penrose has done a very thorough job in examining the facts. It is worth understanding that he has considered the evidence from England as well as Scotland.
I pay tribute to those who showed tremendous courage in telling the inquiry about the impact of infection on their lives and the lives of their families. The report has systematically examined the facts and set them out. As well as other inquires, such as the Archer inquiry, with which the noble Lord is familiar, this report has now given us a detailed account of what happened, which is extremely valuable. I agree that there will be a need to reach a formal view on Penrose’s conclusions once my department and the next Government have had an opportunity properly to consider the conclusions that he reached.
As for Lord Penrose’s recommendation to offer a hepatitis C test to everyone who had a blood transfusion before 1991, the department conducted a look-back exercise in 1995 to try to identify everyone who might have received infected blood prior to 1991. We will consider whether anything more can be done on this in England, although obviously Lord Penrose’s recommendation relates specifically to the Scottish Government taking steps along these lines. We have already done an exercise to identify anyone who could have been affected, and we will consider whether anything more should be done on this.
The noble Lord asked about the Skipton Fund, which, as noble Lords will remember, is there to make non-discretionary payments to patients infected with hepatitis C. To date, over 5,100 individuals in the UK have received the stage one payment and around 1,500 have received a stage two lump sum in the UK, with around 700 receiving annual payments in the UK.
Public Contracts Regulations 2015
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Lord Hunt of Kings Heath
That this House regrets that the Public Contracts Regulations 2015 laid before the House on 5 February are being implemented with unseemly haste, will cause confusion as to which procurement regime is to be used for integrated health and care contracts, and do not implement the assurances given by Ministers to Parliament during the passage of the Health and Social Care Act 2012 that NHS commissioners would be free to commission services in the way they consider in the best interests of NHS patients. (SI 2015/102)
Lord Hunt of Kings Heath (Lab)
My Lords, I say at once that I welcome certain aspects of the regulations we will debate tonight, specifically the help for social enterprises. However, I am concerned about their potential impact on the NHS, the enforced tendering of services that will entail and the potential confusion between two different sets of procurement regimes for the health and social care sector.
These regulations implement the main public sector procurement directive agreed by the EU in 2014 but also introduce a number of UK-specific changes intended to open up public procurement, including for small businesses. The directive replaces the old system of type A and type B services, and the new light-touch regime will apply to health and social services—formerly Part B services.
Contracts in the category will fall under the new rules if they are valued at above €750,000. Above the threshold, commissioners will have to publicise in advance their intention to award contracts and announce the contract award decision after it has been made. This regime will sit alongside the healthcare-specific requirements in the NHS (Procurement, Patient Choice and Competition) Regulations 2013 and Section 75 of the 2012 Act, which we debated in your Lordships’ House on 24 April 2013. I am sure that the noble Earl will recall that lively debate.
The introduction of this new regime has been delayed for NHS-funded healthcare services until April 2016 to allow commissioners time to adapt. The Government have argued that this is necessary because of the need to ensure that commissioners and other key stakeholders are fully prepared. The Government have stressed that other contracting authorities, such as local authorities, are not subject to these additional domestic regulations and therefore need to follow the new rules for the light-touch regime as soon as they come into force. However, the Government have also been forced to acknowledge that there are concerns about the scope for potential confusion as a result of the existence of two regimes side by side for another 12 months.
The Opposition have sought two different legal opinions, both of which advised that these new regulations could force the tendering of NHS health and social care services to go beyond the requirements of the Section 75 regulations under the 2012 Act. Practically all health services will be above the €750,000 threshold. This would escalate the level of service tendering and privatisation of health and social care services as well as wasting vast amounts of money on pointless tendering procedures when the money would be far better spent delivering services for NHS patients.
At best, the new procurement regulations are confused and unclear. NHS services have an additional year because the new regulations do not come into force for health services until April 2016, whereas they came into force on 26 February 2015 for all other areas. Council social care services have to comply with these new regulations immediately so, in effect, two procurement systems will be operating for health and care until 2016. There will undoubtedly be confusion over the definition of some services, to do with whether they are strictly social care or include elements of healthcare as well, and therefore whether they are subject to these regulations and there is a requirement for them to be advertised and tendered. The advice we have—I think experience in the last three years shows that this will be the case—is that CCGs will understandably err on the side of caution to avoid legal challenge and therefore advertise or tender services in case the new regulations are found to apply to them.
What happens if an NHS body wishes to commission a contract that includes elements of clinical healthcare and social care? This will not be completely unknown, given the effort that we all support towards trying to integrate health and social care. The question arises: which regime will the NHS body have to follow? Will it not be driven to split out these elements in two separate contracts to comply with two separate legal requirements? What about the potential for legal challenge? Would it not drive a wedge between joined-up commissioning of health and social care?
The regulations also fail to take advantage of many of the flexibilities in the 2014 directive that could have exempted the NHS from having to run pointless tenders. They also fail to incorporate the flexibilities in the directive that would have allowed NHS bodies to decide not to tender when there are wider strategic interests that mean a comprehensive local health service must continue to be provided by a key NHS provider.
These missed opportunities reflect the Government’s political imperative to turn the NHS into a market and pave the way for private sector operators to deliver more NHS services. The imposition of market mechanisms when they are not needed, and the failure to allow CCGs flexibility to decide when tendering is the right approach for patients, will create wholly unnecessary additional cost and uncertainty at a time when NHS bodies should be focused on meeting the needs of an ageing population and improving services.
We are already seeing the impact because many CCGs undoubtedly believe that there is no alternative to full-scale tender. A vast amount of resources is being consumed, with no benefit to patients. The evidence is clear. Commissioner spending on private providers has increased from £4.1 billion in 2009-10 to £6.3 billion in 2013-14. The proportion by value of community health services provided by private sector providers has increased from 12% in 2010-11 to 18% in 2012-13. Private provider spending on mental health services increased by 12% between 2010-11 and 2012-13. Overall, the Department of Health’s annual accounts suggest that some £10 billion of the total NHS budget of £113 billion is spent on care from non-NHS providers.
Some large contracts have attracted particular attention and concern. For example, in Staffordshire, CCGs are seeking bids for a 10-year contract worth £1.2 billion for cancer and end-of-life care, which is potentially likely to significantly involve private sector providers. Then there is the Bedfordshire case. The Bedfordshire CCG awarded a five-year contract to Circle as prime provider, assuming a total risk for musculoskeletal services worth £120 million. A local NHS provider has subsequently refused to sign the contract under which it would provide some of those services because it would see a referral drop of 30%, thereby putting at risk its trauma services, which are cross-subsidised by musculoskeletal services. There are other examples of bizarre decisions being made by clinical commissioning groups because they feel that they must put services out to tender, and by doing so they seem to have no analysis of what that would mean for the viability of the whole health service system.
A recent study by the British Medical Journal found that one-third of contracts to provide clinical services awarded in the year from 2013 were secured by private providers. A study by the NHS Support Federation found that, of 80 contracts awarded, 54 went to non-NHS providers. We have also seen what I can describe only as a ludicrous intervention by the competition authorities in sensible service changes in Dorset and then Bristol.
I am sure that the noble Earl will want me to refer to the recent King’s Fund study, which concluded that any benefits from competition,
“can be outweighed by costs and difficulties of competitive process”.
As the study says, it is also clear that CCGs remain very uncertain about procurement and tendering rules. They are spending a lot of money on legal advice. A lot of that legal advice is very risk-averse, which is why so many services are being put out to tender.
Lord Hunt of Kings Heath
My Lords, I thank the noble Earl for his response. He said that the imperative of the Government to introduce the regulations early is because of the economic benefits. Let me say at once that I have always accepted that there are some benefits in these regulations. I particularly welcome the social enterprises provisions, but my concern remains, rather like that of the right reverend Prelate, that the introduction of the regulations applying to care services now as far as local government is concerned, along with the existence of NHS regulations, will cause a great deal of confusion.
I also think that the noble Earl is underestimating the confusion out there in the health service about which services should be tendered and which should not. I do not believe that clinical commissioning groups accept the kind of view that he is putting forward. They are getting legal advice that actually makes them very risk averse. The noble Earl said that the requirement to advertise does not mean that people have to tender, but once you advertise you are inevitably on a route towards tendering.
Finally, on Staffordshire, my issue is that essentially the CCGs are outsourcing commissioning decisions which they as the statutory bodies ought to be taking for 10 years, and they are failing to engage with the public. They will not appear at public meetings to defend the position. The noble Earl will know from MPs in Staffordshire that there is a lot of concern about this, and if a Labour Government are elected we will certainly want to call in on what is happening.
Before I beg leave to withdraw the Motion, perhaps I may say to the noble Earl that he has been the Minister for Health in this Chamber for five years, and on behalf of my noble friend Lady Thornton and myself I would like to thank him for the courteous way in which he has responded to our many debates. I particularly thank him for the way he has agreed to meet a number of small charities over those five years on issues that I have raised. That is very much appreciated. I should also say that we have enjoyed working with the noble Baroness, Lady Jolly, as well.
Barts Health NHS Trust
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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.
False or Misleading Information (Specified Care Providers and Specified Information) Regulations 2015
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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.
Nicotine Inhaling Products (Age of Sale and Proxy Purchasing) Regulations 2015
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Baroness Finlay of Llandaff (CB)
My Lords, I thank the noble Earl for introducing these regulations and welcome the way in which they have been drafted. Clearly, a great deal of care was taken in the drafting, and they seem eminently sensible.
It is most reassuring to know that the Association of Convenience Stores welcomes these regulations and the clarity that they provide. It says:
“We support strong enforcement against proxy purchasing of tobacco. We need to see these properly enforced, something that is lacking with the same powers that are in place for alcohol proxy purchasing”,
and that the penalty for proxy purchasing on e-cigarettes puts everything consistently in line. Indeed, it has welcomed the age restriction.
I was glad, too, to hear the reference to the Welsh study because it was the data from Wales that really began to make me personally concerned about these products. There is evidence of increased use among under-18s. I know some people will say that data from ASH are biased, but ASH has been fairly neutral in its view on electronic cigarettes because of the way that they have helped people quit ordinary tobacco cigarettes. It has found that the number of 11 to 18 year-olds who have tried an electronic cigarette increased from 5% in 2013 to 8% in 2014, although it did put the caveat around those figures that the use is closely linked with smoking behaviour.
One piece of research which is really important to have on the record is the work from Counotte and colleagues, published in Developmental Cognitive Neuroscience in 2011, which found that,
“nicotine exposure during adolescence can disrupt brain development bearing long-term consequences on executive cognitive function in adulthood”.
These are new products, with high levels of nicotine in them. We know that the propensity for the developing brain in the age group up until 25 years to develop addictions of all sorts, right across the board, and addictive behaviour is greater than in the older brain. There is a concern that exposure in the young leads to a much greater propensity to develop nicotine addiction.
I have been concerned at the way that these products are marketed, especially to the young, and about their appeal almost as a fashion accessory. When I have looked at those shops which specialise in selling these products, they have made me feel as if I was probably a bit too old to go and buy one. They seem to be marketed very much to a young, vibrant population, which I find alarming. If they are shown to be as addictive as they might be, this will create a long-term market for them in the future.
I have been to several meetings about electronic cigarettes, including one held here in your Lordships’ House at which I was concerned at the almost aggressive way in which vaping was being pursued by some people present, which set alarm bells ringing a bit in my head over the process. These regulations are proportionate, timely and welcomed by those who have the responsibility for selling these products. I am glad that they appear to have universal support.
Lord Hunt of Kings Heath (Lab)
My Lords, I welcome both sets of regulations. The Opposition fully support them. Like the noble Baroness, Lady Finlay, I was very impressed by the evidence from the Association of Convenience Stores and its support for the regulations. It is very persuasive in relation to the introduction of a minimum age of sale and I commend the ACS for the responsible briefing that we were sent ahead of these regulations.
The noble Earl referred to the research, such as the Welsh data and the evidence we have received from ASH, and mentioned the CMO’s concerns. Essentially, although one can certainly see that these products can have a beneficial health impact for many adult smokers, there is this issue about whether children go to smoking through these e-products. Is the noble Earl satisfied that enough research is being undertaken at the moment, either through the traditional research areas such as the MRC and Wellcome or perhaps through Public Health England? I do not know if he has information about this, but clearly it would be good to know that his department is keeping a continuing watchful eye to ensure that enough research is being done. Particularly relating to children, there is enough uncertainty around to make us want to ensure that there is ongoing research on this.
I have another question for the Minister, raised by the evidence that ASH submitted to his department when it was consulting on the regulations. ASH says that there is real confusion about the relative risks of electronic cigarettes compared to smoking, not just among the general public but among health professionals. It quotes from newspaper articles saying that smokers have been given advice by medical people and have had the impression that it is nicotine rather than tobacco smoke that is harmful. ASH quotes a study presented at the UK National Smoking Cessation Conference; it was some years ago so the profession may be more up to date now, but in one study presented at the conference a substantial proportion of GPs incorrectly asserted that nicotine in cigarettes caused CVD, strokes and lung cancer.
The point that ASH makes is that at the same time as regulations are introduced, the Department of Health should promote better understanding of the relative harm of electronic cigarettes and other nicotine products, including those authorised as medicine and their potential benefit to smokers. I understand that with regard to children there are areas where we are uncertain, but there are areas where we are more certain as well. I would be interested to know whether any advice or guidance accompanying the regulations is to be given to medical practitioners in particular.
I welcome the proxy purchasing offence, which is something that we very much support. The Minister quoted cases of young smokers having their cigarettes bought for them by another person, and outlawing this will help to crack down on it and send a wider public message that this is wrong. The other point comes back to the issue raised by the ACS regarding the e-cigarette issue: introducing the offence will give greater power to responsible shopkeepers not to serve people who they know, or strongly suspect, are going to pass cigarettes on to children. Overall, we are glad to see these regulations and to support them.
Earl Howe
My Lords, I welcome the support that the noble Baroness, Lady Finlay, and the noble Lord, Lord Hunt, have given to these regulations. I shall respond to the questions and points that they have raised. The study mentioned by the noble Baroness, Lady Finlay, was referenced in our consultation document. It was an important study, showing the impact of nicotine on the adolescent brain, and it influenced us considerably in informing the policy.
E-cigarettes are not risk-free. We do not know enough about the long-term health effects of adults using them, let alone children. There have as yet been no long-term studies to examine whether e-cigarettes serve as a gateway to tobacco use. Therefore, we cannot be certain at this stage whether there is a gateway effect from the use of e-cigarettes into tobacco smoking. Further research is needed to answer the question definitively. However, we know that nicotine is highly addictive, and we wish to protect children from the risk of nicotine addiction and the impact that nicotine can have on the developing adolescent brain.
The noble Baroness expressed a fear, which I share, about the aggressive marketing of these products. It is worth noting that the revised European tobacco products directive, which will apply from 20 May next year, includes a ban on advertising e-cigarettes, with a cross-border dimension—that is, advertising through television, radio, newspapers, magazines and sponsorship of sports events.
On the point made by the noble Lord, Lord Hunt, about what are sometimes seen as mixed messages around e-cigarettes, there is no doubt that, looked at in a certain context, e-cigarettes could be seen to have a role in enabling smokers to quit where they have tried other methods and not succeeded. We recognise that e-cigarettes are used by some smokers in that way. That is why the Government are working towards a regulatory framework that ensures that these devices meet basic standards of safety, quality and efficacy. We are clear that e-cigarettes must be accompanied by sufficient information to enable users to make informed choices.
The noble Lord asked about research. I agree that these matters must be kept under the policy spotlight going forward. The National Institute for Health Research recently commissioned a large, randomised control trial to examine the efficacy of e-cigarettes compared with conventional nicotine replacement therapy when used within UK stop smoking services. That research study is inevitably quite long-term. It is envisaged that the project will end in 2018, but the NIHR is confident that it will improve our current understanding considerably.
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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Lord Patel (CB)
My Lords, I rise briefly to support the order. I declare an interest that, maybe for a short while only, I am a licensed practitioner and a registered practitioner, and the rules of the GMC may not be sufficient for me to revalidate.
However, the issue to which I want to refer is the separation of the functions, of which I approve—we have discussed that many times—but for the fact that the GMC can appeal against the decision made by the MPTS. Its role becomes that of an adjudicator as well. I would like the noble Earl to clarify that. I know that in the consultation process there were the same number of responses—39, as mentioned by the noble Earl.
Another issue that we have discussed before is that these changes are welcome, but there are other changes that the Law Commission identified in its report, published in April 2014, on the regulation of health and social care professionals Bill. The Government indicated that they would bring in legislation to deal with all the issues. This is obviously a piecemeal measure taken out of that Bill, so the noble Earl may want to comment on that.
Lord Hunt of Kings Heath (Lab)
My Lords, I, too, thank the noble Earl for introducing the order. I shall say at once that the Opposition support it. Like the noble Lord, Lord Patel, we are disappointed that it is yet another Section 60 order being considered in Committee. We should have had the Law Commission Bill, either in pre-legislative scrutiny or in its substantive form. It is disappointing that we are having to deal with these various professional regulation bodies in such a piecemeal fashion.
That said, on the question of the overarching objective, we very much support that and the three pursuits set out in Article 21(1B),
“to protect, promote and maintain the health, safety and well-being of the public … to promote and maintain public confidence in the medical profession, and … to promote and maintain proper professional standards and conduct for members of that profession”.
I want to pick up the point raised by the noble Baroness, Lady Finlay, and the British Medical Association. I suppose it is an issue of proportionality. In its report, the Law Commission expressed concern about examples given, suggesting that regulators were inappropriately imposing moral judgments in essentially private matters under the guise of maintaining confidence. The BMA has raised the issue of whether the order might end up punishing doctors who pose no threat to the health and safety of the public, on the basis that failure to do so might incur the public’s disapproval. The Law Commission has urged regulators to look carefully at regulatory interventions that do not take some colour from the need to protect the public.
This is a very important point. I have been very impressed with the GMC and the way in which it has improved its procedures and processes—and certainly with its current leadership. However, there are other regulators, perhaps not so much in the health sector, which clearly lack confidence and which are very much influenced by the flow and ebb of media comment and potential political interventions. I think that we have to be very careful about regulators which, in a sense, lose confidence in their own ability to make common sense judgments, and then have knee-jerk reactions in the face of media storms. I hope that the noble Earl will agree that that is not the intention in the case of the health regulators, and like me, he will express confidence, particularly in the GMC to apply common sense judgments in response to the points raised by the noble Baroness, Lady Finlay.
I now come to the question of the Medical Practitioners Tribunal Service. The Minister referred to the fact that the consultation demonstrated strong support for enhancing the GMC’s investigative and adjudication roles, but that 52% of respondents took the view that creating an entirely independent body would be preferable, with only 27% supporting the proposal to put the MPTS on a statutory footing.
We must refer in particular to the evidence of the Professional Standards Authority. It,
“did not agree that the proposals to establish the MPTS as a statutory committee of the GMC would achieve the aim”,
of appropriate separation of function. It commented that,
“former and current members of GMC staff should be excluded from sitting on medical practitioner tribunals or interim orders tribunals … The PSA also asked about the ability of the GMC to make rules delegating functions from the MPTS committee to ‘officers of the Council’”,
and it,
“referred to the fact that case managers will be paid by the GMC, but case managers will be performing a statutory office”.
The PSA was obviously concerned that because those managers were paid by the GMC, they might come under undue influence. As the Explanatory Memorandum points out, the PSA,
“conducts annual performance reviews of each of the health and care professional regulatory bodies”.
I would like the noble Earl to explain why the views of the PSA, above all others, were ignored in relation to this issue.
To pick up the point raised by the noble Baroness, Lady Finlay, about guidance, again, the Explanatory Memorandum says that:
“The Department does not intend to publish any guidance in respect of”,
this statutory instrument but that the GMC,
“will publish guidance as appropriate”.
Is the Minister in a position to respond to the noble Baroness about what kind of guidance will actually be produced?
However, overall I believe that the GMC has made great strides in recent years. It deserves to be supported for what it is doing. I accept that this will speed up processes to protect the public and provide more and better information about doctors on the register. It will improve doctors’ education and training and increase efficiency, and on that basis we are very glad to support the order.
Health Care and Associated Professions (Knowledge of English) Order 2015
Lord Hunt of Kings Heath Excerpts(10 years, 9 months ago)
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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: Health and Social Care Act 2012
Lord Hunt of Kings Heath Excerpts(10 years, 10 months ago)
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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
NHS: Cancer Drugs Fund
Lord Hunt of Kings Heath Excerpts(10 years, 10 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.
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.
Standardised Packaging of Tobacco Products Regulations 2015
Lord Hunt of Kings Heath Excerpts(10 years, 10 months ago)
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Lord Jopling (Con)
My Lords, I do not want to trump the ace of the noble Baroness, Lady Tonge, when she said that she gave up smoking in 1974 but, in 1950, at the end of my first year at university, I became very ill. I spent 12 weeks in hospital with a chest complaint—the doctors thought that it was tuberculosis, but mercifully it was not. At the end of it, the surgeon came to me—he was the professor of thoracic surgery at Newcastle, George Mason; the noble Lord, Lord Walton, will remember him. He said to me, “I think you’re going to be all right but, tell me, do you smoke?”. I said yes. He said, “Well, you shouldn’t”. I said, “Oh, come on. My father’s been talking to you”. He said, “No, I haven’t talked to your father, but one of our students in the University at Newcastle”—it was Dr Strang, who again I think the noble Lord will recall—“has just written a thesis where he has claimed to find a connection between smoking and lung cancer. I’ve scanned it and I haven’t properly been through it, but I found it very compelling. You’ve done the first year of a science degree. You will understand not all of it but most of it, and I’ll give it to you”. The following day there arrived on my bed in the hospital the thesis by this young student. I read it and I was so horrified that I have never smoked a cigarette from that day to this—I was smoking about 25 a day at that time. Ever since then, I have taken a great interest in the connection between smoking and lung cancer. I heard what the noble Lord, Lord Walton, said about the horrors of tobacco, which I thoroughly support. All the time since, I have listened to the arguments one way or another, as we have listened to the arguments here today.
I come back to what the noble Lord, Lord Faulkner of Worcester, said earlier about the publicity of the tobacco industry. I remember so well through the 1960s and 1970s, when I was in the other place, what I can only call the wicked advertisements, publicity and PR of the tobacco industry. I think the connection between smoking and lung cancer became clear in the 1950s, yet in the 1960s and 1970s the tobacco industry still tried to pretend that there was no danger whatever. That really was wicked.
I have not, I confess, examined the arguments about packaging this time but I listened to the arguments tonight. Bearing in mind the negative start I made—I admit it—when looking at the publicity of the tobacco industry, it seems that this is an experiment well worth trying. For that reason, I most strongly support the Government’s line tonight.
Lord Stoddart of Swindon (Ind Lab)
I have been very patient. Let me first declare my interest: I am a member of the Lords and Commons Cigar Club. Although I am a non-smoker, they tolerate me. I suppose I am an associate member rather than a full one.
The more I have listened to this debate—and I have listened to the whole of it—the more I feel that it should have been about a Bill to abolish tobacco. It has not really been about packaging but about the evils of tobacco and the tobacco companies. The attack on the tobacco companies by the noble Lord, Lord Faulkner, was one of the best I have ever heard him make. No doubt they will take note of what he said. However, the noble Viscount, Lord Falkland, was right. If we believe that tobacco is so dangerous—the noble Lord, Lord Walton, had no doubts about how dangerous it is—we should bring forward a Bill to ban tobacco as a dangerous drug. So long as that is not done, all this talk about tobacco is sheer hypocrisy. The Government are hypocritical about it because they do not want to lose the money that it gives to the Exchequer. They are trying to get rid of tobacco smoking but they will not come out and say so in the open. They will do it by stealth. This order is one of stealth.
I have been in this House since 1983 and in that time have spent some 25 years talking about tobacco and restrictions on it. Indeed, I remember that during the last Government I sat in a committee on the same side as the Minister, who then opposed the—what was it called?—ban on tobacco display. We were on the same side at that particular time, as he will recall. That went through but, of course, it has not yet been fully implemented. It does not come fully into law until April. Before we have the display ban, we now have the plain packaging ban. It would be useful if we could implement previous legislation before we start bringing forward more legislation. Does the House not think that that is sensible? The Government obviously do not think that it is.
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.