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
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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, 9 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
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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
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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.
Health and Social Care (Safety and Quality) Bill
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Baroness Masham of Ilton (CB)
I agree that there should be a culture of openness, honesty and transparency. When things go wrong, most people say, “I don’t want this to happen to anyone else”. There should be lessons learnt from mistakes, not cover-ups. This should be made as clear as possible.
Lord Hunt of Kings Heath (Lab)
My Lords, as noble Lords know, the Opposition support the Bill. However, issues have been raised which I hope the noble Earl, Lord Howe, will help to clarify.
I should like to pick up my noble friend’s point about whether this issue is raised at institutional or individual level. It looks as though the Bill focuses on individuals. Will the noble Earl confirm that it is his view that responsibility ultimately lies with the corporate boards which are responsible for the activities taking place in the National Health Service? If that is so, why does the Bill not list those bodies which it covers so that it would be clear who should take corporate responsibility?
Secondly, I take the noble Earl back to the Statement he made last week about Morecambe Bay. It was very telling when he talked about the concerns raised by Dr Bill Kirkup about the lack of a culture of openness and transparency. He said that,
“this report makes clear that there is a long way to go. It seems medical notes were destroyed and mistakes covered up at Morecambe Bay, quite possibly because of a defensive culture where the individuals involved thought they would lose their jobs if they were discovered to have been responsible for a death. However, within sensible professional boundaries, no one should lose their job for an honest mistake made with the best of intentions. The only cardinal offence is not to report that mistake openly so that the correct lessons can be learnt”.—[Official Report, 3/3/15; col. 160.]
Will the noble Earl say very clearly that that point, which I agree with, is not in conflict with the Bill, and in particular with Clause 1? It is very important—the last thing we want to do is discourage people from being open about mistakes. We do not want that to be an unintended consequence of the Bill.
The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, I shall first address a concern that several noble Lords have flagged up most prominently: that the regulations are not sufficiently clear that the duties that we are talking about here are duties on providers rather than individuals. The regulations apply to registered persons. Schedule 1 to the Interpretation Act 1978 makes it clear that in legislation “person” includes not only natural persons but legal persons, such as companies. Under the Health and Social Care Act 2008, the registered persons are providers, not individual members of staff.
The noble Lord, Lord Hunt, asked why the clause does not list the bodies covered by the Bill. The clause amends Section 20 of the Health and Social Care Act 2008. It is the 2008 Act which sets out who the regulations apply to. They apply to registered persons who, under the Act, are the providers, not individual staff, as I said. He also asked whether almost all providers would be likely to be in breach of the regulations for one reason or another. The clause amends the Secretary of State’s regulation-making powers. It would not by itself impose requirements on providers. Those requirements will be as laid down in the fundamental standards regulations, to which I shall come in a moment. On the specific example that the noble Lord gave, where a surgeon did not engage meaningfully with the WHO checklist prior to an operation, my answer is that that would be a disciplinary issue for the employer and/or the professional regulator, if it became known.
Lord Hunt of Kings Heath
That is an extremely helpful answer, but will it be made absolutely clear to employers in the guidelines to be issued alongside the regulations that they have not only a right to take disciplinary action but a duty to do so? If that is set from the centre, that will give a lot of authority to boards, which they sometimes feel that they do not have at the moment.
Earl Howe
That is a very important point, which I shall be happy to take away.
Amendment 1, tabled by the noble Lords, Lord Turnberg and Lord Warner, would replace the reference to “no avoidable harm” with “take steps to reduce” avoidable harm. I accept that in some settings regulated by the CQC, including the NHS, that phrase may better reflect the scale of what can be achieved. However, regulation by the CQC is not just about the NHS. In the case of some health and adult social care services, I believe that it is reasonable to strive to eradicate all avoidable harm. It is for that reason that I prefer the current wording. Yes, it is more ambitious, but its ambition contains an incentive to strive towards a continuous reduction of avoidable harm across all settings regulated by the CQC.
The amendment would also result in requirements on providers to monitor the steps they take to reduce avoidable harm and to train staff in the reduction of avoidable harm. That is clearly desirable, but I must question whether it needs to be a duty set out in primary legislation. The training of staff in reducing avoidable harm is important, and Section 20(3)(d) of the Health and Social Care Act 2008 already expressly provides for regulations to include requirements on the training of staff.
The fundamental standards regulations, to which I referred a minute ago, which were passed by this House in November and come into force in April, already meet the test of the Bill, and no change to regulations is required. The fundamental standards require that care and treatment is provided in a safe way for service users. They give the CQC power to take action against providers where a failure to take steps to provide care in a safe way results in avoidable harm.
The regulations are breached not whenever avoidable harm occurs, but where there has been a significant failure effectively to manage the risks of harm. They are clear that that involves assessing the risks and taking steps to mitigate them. They ensure that staff have the right skills and qualifications, that premises and equipment are safe and that medicines are properly managed. They also require providers to have systems in place to assess, monitor and improve the quality and safety of services.
Noble Lords have cautioned that the clause might lead to staff taking a risk-averse approach. The noble Lord, Lord Hunt, expressed the concern that it could encourage staff to lose sight of the patient and instead focus on covering up mistakes. I firmly believe that the reverse is the case. What it does is to underpin our efforts to strive for the very thing so strongly advocated by the noble Lord, Lord Turnberg: an open reporting culture where identifying errors helps organisations to improve the safety of care. Where providers take the steps to manage the risk to safety, front-line staff can focus on the needs of patients and service users, content in the knowledge that the environment in which they work promotes safety and quality.
Our debate up to now has perhaps given the erroneous impression that the fundamental standards are just about the systems and processes. They are not. They focus on the outcomes of care and treatment. The new regulations, which come into force in less than three weeks, place patients and service users at the heart of service provision. They require that treatment and care meet the needs of service users and reflect their preferences. They prohibit providers from providing care without consent. They also put in place a new duty of candour that requires providers to inform service users where there have been failings in their care.
In those ways, patients and service users are central to the fundamental standards. Clause 1 rightly ensures that safety and the reduction of avoidable harm will always be the foundation of the regulatory system operated by the CQC.
I turn to Amendment 4, in the name of the noble Baroness, Lady Finlay. I am confident that all noble Lords share the same objective as that of Clause 1, which is to place patient safety at the heart of the delivery of services. The Committee will be aware of the importance that the Government place on improving safety. The recent report of the Morecambe Bay investigation has re-emphasised that that is the right approach. Moving towards the reduction of avoidable harm requires action across the health and social care system.
I agree with those who say that the main way to reduce avoidable harm is through changes in culture. None the less, there is also a role for legislation. The role of the law in this area is straightforward: it can define minimum acceptable standards and introduce ways to protect patients who are put at risk when those standards are not met. It provides a safety net that protects people from harm.
I stress that the regulations issued under Section 20 of the Health and Social Care Act 2008, which Clause 1 amends, apply to registered providers of health and adult social care in England. There are two important points here. First, the regulations do not apply to individual members of staff but to the providers of care. In that respect, they offer protection to staff as well as to patients and service users. Secondly, the scope of the regulations is not restricted to the health service but applies also to adult social care. In that respect, the scope of the clause is broader than that of the noble Baroness’s amendment. For that reason, I prefer the current wording, which offers the same protection to patients and service users wherever they receive care, not just in the NHS.
The noble Baroness asked whether the clause applies to all care organisations, including those in the voluntary sector. All providers of regulated activities must register with the CQC and meet the registration requirements, including voluntary sector and independent sector providers. She also asked whether the regulations will be consulted on and subject to affirmative resolution. The answer to both questions is yes, but having said that, the fundamental standards regulations are consistent with the objective of Clause 1. Those regulations were consulted on and were subject to affirmative resolution. Any future regulations amending or replacing those regulations would also be consulted on and, unless the changes are minor, would be subject to affirmative resolution.
Lord Turnberg
My Lords, I listened extremely carefully to what the noble Earl has just said and I am grateful to him for clarifying what a registered person is—I think that it is the word “person” that gets very personal here. I remain somewhat concerned about whether legislation to stop avoidable harm is a feasible proposition.
Lord Hunt of Kings Heath
Perhaps I may say to my noble friend that I think that the noble Lord, Lord Ribeiro, should wind up first and then he should come back.
Lord Ribeiro (Con)
My Lords, I thank the noble Lord for that intervention, and I thank my noble friend the Minister for his succinct answers in respect of Clause 1 and the four amendments that have been tabled. Before I respond to the amendments in the names of the noble Lords, Lord Turnberg and Lord Warner, and the noble Baroness, Lady Finlay, I would point out that I have heard reference in the Chamber again today to zero harm. Clause 1 is not about zero harm but rather about reducing harm. It is very important that we make that clear right at the beginning as well as right at the end.
The noble Lords, Lord Turnberg and Lord Warner, do not object in their amendments to placing a clear duty on the Secretary of State, as defined in the Bill, and they recognise that the clause places an obligation on the Secretary of State to include steps to reduce avoidable harm in the requirements for registration with the CQC. However, they argue against including the term “no avoidable harm” and would prefer it to be replaced by “reducible harm”. We will get there. It is important to note that it is the providers of health and adult social care services in England that are required to register with the CQC, not individual members of staff. Again, the concerns that the noble Lord, Lord Turnberg, expressed at the beginning were about the perception that this obligation would fall to individual practitioners or health and care workers. It does not. It is very much defined as being on those who are registered with the CQC. That cannot be clarified enough. I think that my noble friend the Minister made that point.
At Second Reading, the noble Lord, Lord Willis of Knaresborough—he is unfortunately not here today, but has been supportive of the Bill—and I attempted to blow away the myth of zero harm, which implies something negative that will impact adversely on healthcare professionals when something goes wrong. The fundamental standards, which have been referred to, become law on 1 April. They will not be changed by the Bill, which places a duty on providers to ensure that safe systems are in place for the care of patients. It is about putting safe systems into place, just as in the airline industry you need safe systems in place to ensure that disasters do not occur.
Clause 1 is in no way critical of the new fundamental standards, which meet the demands of the clause. As the noble Lord, Lord Warner, said, NHS providers have sought assurances on this point, and I think they have been given. In their report, they also asked how the Government will avoid the clause creating a clinical culture with staff fearful of taking controlled risks and reporting mistakes. I think that education and training of the workforce will be used to ensure that that does not happen.
The noble Lord, Lord Warner, was also concerned about some aspects of Clause 1 and the effect that the Bill will have on the Secretary of State’s position. The Bill removes the Secretary of State’s discretion in determining whether the legal minimum standards for providers of health and adult social care cover the requirement to move towards no avoidable harm. This is so central to the quality and safety of services that it is right that there is no possibility of future Secretaries of State electing not to cover this area in the registration requirements. That is one of the principal reasons why it is important to have Clause 1 in the Bill and not just rely on the fundamental standards.
I mentioned training and education. The noble Lord, Lord Turnberg, expressed his considerable concerns about the culture, fear and frustration that the Bill will create, rather than openness and willingness. I will address his Amendments 2 and 3 by referring to the Department of Health’s response to the Francis report in its document Culture Change in the NHS, which recognises the importance of health education and safety. The Berwick advisory group has been mentioned a lot during our discussions, along with the health foundation. The Berwick review recommended that,
“all healthcare professionals receive initial and ongoing education on the principles and practices of patient safety, on measurement of quality and patient safety, and on skills for engaging patients actively”.
Health Education England’s commission on education and training for patient safety, chaired by Sir Norman Williams, a past president of the Royal College of Surgeons, and Sir Keith Pearson, the current president of NHS England, set out proposals for enhancing safety training for all health and care professionals covering four themes: how to raise concerns about patient safety; human factors, which are increasingly important for patient safety, particularly in surgery; mandatory training to improve patient safety; and service improvement for patient-centred outcome and patient safety.
The noble Baroness, Lady Finlay, expressed concern that the Bill might stifle the reporting of errors. Berwick recommended a number of measures to ensure the effective reporting of serious incidents and prompt action in response. Many such measures, such as the new national patient safety alerting system, are already in place, and 17 alerts have been issued in the past year. I believe that the learning and training tools are in place, and NHS England is working with the Health Foundation to implement Berwick’s recommendations. Where a provider takes the necessary steps to mitigate the safety risks, this will allow front-line staff to focus on the treatment and care needs of patients and service users. Far too often we have heard it said that practitioners are looking up to managers rather than looking down at their patients. This Bill, if implemented, will provide them with the knowledge and comfort that safety systems are in place and that, if they fail, it will be the provider who stands accused, not the professional. I hope that that will give some reassurance to the noble Lord, Lord Turnberg.
I was heartened to see the heading of Amendment 4, which was tabled by the noble Baroness, Lady Finlay. Although I do not agree with the substance of the amendment, it does make the point that “reducing harm in care” is what this Bill is about. Many speakers in our earlier debate, including my noble friend the Minister, referred to reducing avoidable harm. The noble Lord, Lord Hunt, also talked about the checklist. At Second Reading, in response to the point about checklists, I said that colleges and speciality associations totally support the proposal. As the Minister pointed out, the checklists are mandatory and disciplinary action will be taken if they are not followed.
Lord Hunt of Kings Heath
Does the noble Lord agree that there is a problem at the moment in that organisations feel somewhat inhibited in taking action against consultants? There are two things—the checklist itself, and then the consultant’s approach and attitude to the checklist. It would be very helpful to have support from the Royal College of Surgeons and other bodies alongside that of the Government to put a bit of backbone into the boards of organisations.
Lord Hunt of Kings Heath
My Lords, this has been an interesting debate. I thought that the noble Baroness, Lady Finlay, raised some important points in relation to the definition of “best interests”. Because she referred to a number of identification streams within the health service, I ought to declare my interest as president of GS1 UK, the barcode association. Barcoding is, of course, another indicator that can be used.
I recently had an interesting discussion in Solihull with people who are helping the integration board that is aiming to bring health and social care together to provide integrated services. It was interesting to get an insight from a company that is helping the statutory providers to do this by confronting situations in which individuals are provided with services from a number of different statutory agencies but where there is, seemingly, no co-ordination at all between them. One often gets professionals arriving at the same time but not communicating with each other. This is partly due to the problem over information systems.
I should like to ask whether the noble Earl considers that the passage of the Bill will help the integration of that information, provided that the public have confidence in the process under which information is shared. There is clearly a balance to be drawn between the benefit of information sharing between statutory bodies in terms of integrating provision, alongside the safeguards necessary to the public. One should be in no doubt that this is quite a tension. Yesterday, the parliamentary Intelligence and Security Committee published a report on the holding of information by the security services. Reading it gives some cause for concern, in many cases, about the amount of information available about individuals. Although, as I understand it, the committee report says that that information is often never referred to or used, it none the less could be. The whole issue regarding the integrity of confidential information is important. On the other hand, we know that we have considerable failures in service because there is no sharing of information. The point that the noble Baroness raised about what we mean by “best interests” and the issue of how we can ensure public confidence is extremely important.
I support the amendment in the name of the noble Baroness, Lady Hollins, which offers an opportunity to debate the importance of including people’s communication needs in the information shared between health and care professionals. I have received helpful briefing from Mencap, the RNIB, the National Autistic Society and Sense. It has become abundantly clear that failure to understand the best way in which to talk to individuals can result in misunderstandings, misdiagnosis and, ultimately, poor care. Accessible and easy-to-read information, perhaps with pictures, to which the noble Baroness, Lady Hollins, referred, and the presence of family, advocates or interpreters, can make the difference between diagnosis and misdiagnosis.
It would be very helpful if the noble Earl could clarify that the communication needs of disabled people and the reasonable adjustments that they might need will be an important part of the health information that should be shared between professionals. I certainly hope that he is willing to place on record that guidance associated with the Bill will reflect this and that it will reach the relevant professionals.
Earl Howe
My Lords, let me turn first to Amendment 5. I understand the noble Baroness’s concern that there should be no confusion over the “best interests” wording in the Bill and the more technical and prescribed “best interests” checklist test in the Mental Capacity Act 2005. The key point for me to emphasise straightaway is that in this Bill the phrase “best interests” is ascribed its ordinary meaning: the consideration of a range of factors, including the wishes of the individual. Nothing in the Bill detracts from patient autonomy or the importance of supportive partnership working between clinicians and patients. This is in marked contrast to the “best interests” test checklist found in the Mental Capacity Act, which the noble Baroness was instrumental in shaping. In that Act, which concerns individuals who lack capacity, the term is not defined. A checklist of considerations helps professionals to determine what a patient’s best interests are.
The information-sharing provisions of the Bill respond to concerns expressed by the National Data Guardian. Dame Fiona Caldicott, in her 2013 review of information sharing, identified a risk-averse culture and concluded that the duty to share information for a person’s own direct care should be considered as equally important as the duty of confidentiality. I quote from her review:
“Health and social care professionals should have the confidence to share information in the best interests of their patients”.
These provisions seek to establish that sentiment in law.
The presence of the phrase “best interests” in this Bill ensures that it complies with the central principle of the Data Protection Act and the Caldicott review: to share information only where necessary and relevant. The term “best interests” is used elsewhere in primary legislation, including in the Human Fertilisation and Embryology Act 1990 and Section 38 of the Medical Act 1983. It was also used more recently in the Charities Act 2011, the Legal Services Act 2007, and in the Pensions Schemes Act 2015, which received Royal Assent last week—all are without reference to the checklist in Section 4 of the Mental Capacity Act. It is a term used across a wide-ranging legislative landscape with its ordinary meaning.
The “best interests” test in this Bill is no different from that in the pensions Act or the Legal Services Act. It requires a professional to apply a common-sense approach. I appreciate the noble Baroness’s concern that the use of the word “best” could herald a return to a “doctor knows best” kind of paternalism and to disempowering patients in the process. I sincerely hope that I can convince her that this is neither the intent nor the effect of this Bill. I am sure that the whole House will agree that the focus of information sharing should be on the needs of the individual, rather than defensive, risk-adverse behaviour of the type we have sometimes seen in the past.
I can confirm that the Department of Health will provide guidance to support the interpretation of these new duties. This will include a clarification that the term “best interests” is ascribed its ordinary meaning. The Government will also amend the Explanatory Notes to that effect.
Lord Hunt of Kings Heath
My Lords, that was a very helpful response. May I just ask the noble Earl whether explicit examples will be given in the guidance? The issue of professional defensiveness is very important. He will know that, out in the field, people often have a different view about data protection. Sometimes it gets in the way of sensible, professional working together. I urge that the guidance should be as practical as possible and that it should be aimed at field workers, rather than just the organisations they work for. Let us take as examples care workers, health service workers, health visitors and nurses, in regard to whom it is clearly in an individual’s best interests that information is shared about visits, and that sometimes responsibilities are shared, and that they are not inhibited because of some myth about their inability to share information.
Lord Elton
My Lords, given the undertaking that we are not going to divide on this, I am tempted on to my feet to remind your Lordships that, although we have talked about the Climbié case, this goes back to the case of Maria Colwell in 1975, when Lord Goronwy-Roberts, the Labour Minister for Health in this House, was successful in beginning the setting up of at-risk registers. That was a long time ago and yet we still have not solved the issue of the breakdown of information sharing between agencies, voluntary and otherwise. I encourage my noble friend to leave a note on his desk, to which we all hope he will return after the election, reminding himself to get on with this.
Lord Hunt of Kings Heath
My Lords, I am not sure about the noble Lord’s latter point. I think my noble friend has done us a great service in raising this issue. Since we are talking about unique personal identifiers again, perhaps I may first remind the House of my presidency of the bar-coding association, GS1.
As a resident of Birmingham, I thank my noble friend for his work as the Children’s Commissioner, which has been invaluable. Your Lordships will have a great opportunity to discuss these matters further on Monday night after we debate standardised packaging of cigarettes, because I have a Motion to Take Note on the Birmingham electoral order, which changes the electoral cycle in Birmingham following the work of the three commissions and the Permanent Secretary at the DCLG.
On the substantive point, my noble friend raised the case of Victoria Climbié, on which I well remember making the Statement to this House a long time ago now. What was so striking in that report was that she went through, I think, at least eight or nine public agencies. If any one of them had talked to another, it is likely that she would still be alive today. It was a shocking report, because there were so many failures by so many different organisations. Although, inevitably, the local authority always tends to be the focus of concern, neither the health service nor the police covered themselves in glory. I am not really in a position to commit the Opposition in exactly the way that my noble friend wants, but if the noble Earl would like to institute some urgent cross-party discussions with my noble friend, we would certainly be very happy to take part.
Earl Howe
My Lords, to start with a given, I am sure I speak for the whole Committee when I say that we are all committed to taking whatever steps are necessary to protect children from abuse and neglect. Clauses 2 and 3 are, as they stand, based on long-standing policy intentions. They have real buy-in and support from those who will need to deliver them.
As regards children’s social care and wider children’s services, the difficulty with proceeding without delay in the direction that the noble Lord, Lord Warner, is advocating is that we do not yet have robust evidence on the impact of the potential burdens and risks of an extension of these duties. Moving to the use of a common identifier for the education and children’s social care sector would represent a substantial change. In the discussions that I have had on this, I have been persuaded that it is only right that we fully understand and assess the impact before considering legislation.
However, I can give the noble Lord, Lord Warner, some hopeful news. I am pleased to inform him that the Department for Education has committed to undertake an evidence-gathering exercise to understand fully the impact of adopting a consistent identifier for these types of provision. That exercise is expected to report before the end of the year. I hope the noble Lord will understand that we would not want to pre-empt the outcome of that or make decisions now on behalf of Ministers in the next Government, who will wish to consider the evidence once it is available.
The amendment would also have the effect of creating a power to extend Clauses 2 and 3 to other public bodies where there was evidence that this would benefit the health and well-being or protection of children. I recognise and welcome the sentiment and reasoning behind the desire to extend the information-sharing duty under this Bill to encompass child protection issues. As I have already assured the noble Baroness, Lady Finlay, there are clear requirements on professionals to share information to protect children. I hope that reassurance is helpful.
Baroness Pitkeathley (Lab)
My Lords, I thank the noble Baroness, Lady Finlay, for tabling these amendments to Clause 5 and for her characteristically clear introduction. As noble Lords may remember from Second Reading, I too have concerns about Clause 5 in my role as chair of the Professional Standards Authority. I said then that there had been a misunderstanding of the role of the authority and that I was afraid that the Bill would make our objectives unclear and narrow the scope of our work. I was also concerned lest the Bill would in any way make it less clear that the primary and overarching role of the Professional Standards Authority is public protection. The Minister said then that his officials were happy to continue discussions, and I am pleased to say that there have been helpful conversations and meetings with the noble Lord promoting the Bill, the Minister and his officials. I am grateful for the care and attention that have been given to our concerns.
None the less, I take the opportunity that the noble Baroness’s amendment gives me to ask the Minister again to clarify that the Professional Standards Authority will never be required to prioritise the objective of promoting public confidence in the professions over its primary purpose of protecting and promoting the health, safety and well-being of patients, service users and other members of the public. In other words, could there ever be circumstances in which public confidence might conflict with public health, safety and well-being? Such circumstances might be where the authority identified a poorly performing regulator. If the Minister could give me this clarification, it would help the authority address any arguments that might in future be raised that it should conceal a regulator’s poor performance or otherwise prioritise the objective in new paragraph (b) over that in new paragraph (a).
The confusion about the hierarchy between the objectives in new paragraphs (a) and (b) may have arisen because of the conflation of the PSA’s role with that of the regulators which it oversees. It may have arisen also because Clause 5 does not follow the Law Commission’s recommendation, which proposed a clear main objective for the authority followed by two general objectives. Although the Minister has acknowledged the role of the authority as an overseer of the regulators, it would be helpful if he could provide an assurance that under Clause 5 the main and primary aim and focus of the authority will continue to be to promote the health, safety and well-being of patients, service users and other members of the public.
Lord Hunt of Kings Heath
My Lords, some very important points have been raised by the noble Baroness, Lady Finlay, and my noble friend Lady Pitkeathley. My regret is that we are dealing with these regulatory matters in this Bill. A number of statutory instruments will also come through your Lordships’ House, one from the GMC, in the next few days.
We had a Law Commission draft Bill which should have been a fifth Session Bill and would have enabled your Lordships to look at the statutory regulation provisions in the round. However, because of the Government’s decision not to proceed with that Bill, not even in pre-legislative scrutiny, we now have to look at this matter in a piecemeal way. It is wholly unsatisfactory. I am very sorry that we are having to deal with these issues in this way without enough time to focus on them properly. I am worried about Clause 5; I think that we are going to let it through without understanding its implications. We would be very grateful for anything that the noble Earl can do to clear this up.
Earl Howe
My Lords, I very much hope that I can allay the concerns of both noble Baronesses and the noble Lord. In its report, the Law Commission recommended a consistent main objective for professional regulators and the PSA around patient safety. It also recommended two subsidiary objectives: maintaining confidence in the profession and proper professional standards and conduct. The Law Commission’s report describes this proposal as restating the existing legislative position that public protection is the regulators’ main objective. The Government’s view is that public protection is sufficiently important that it should be expressly adopted in the legislation.
The noble Baroness, Lady Pitkeathley, asked whether public confidence might conflict with public health, safety and well-being. In the example of the Professional Standards Authority identifying a poorly performing regulator, it is clear that the interests of public protection and public health, safety and well-being would require the PSA to take action. In this example, any argument that the objective of promoting and maintaining public confidence in the professions would require the PSA to conceal poor performance would clearly run counter to public protection. The objective of promoting and maintaining public confidence in the professions does not mean that the PSA or the regulatory bodies should be promoting the reputation of the professions generally. Rather, it is about taking action where there is a risk that confidence in the profession as a whole is undermined to the extent that it may deter people from seeking the treatment or care that they need and impact on public protection. This example highlights the fact that while the objectives are all linked to public protection, in practice they may not always necessarily be relevant, or relevant to the same extent in particular cases. It is not a case of one objective overriding another or preventing it being considered but ensuring that they are pursued only where they are relevant to public protection.
The Bill does not prioritise or weight one element of public protection over another. It is for the PSA to determine how it applies those elements in carrying out its functions in relation to the regulators and considering the issues of the case. My view is that health, safety and well-being will always be relevant to public protection when the PSA is carrying out its functions in relation to the regulators. It will be for the PSA to determine how to apply the objectives appropriately.
The noble Baroness asked whether the objective to promote and maintain public confidence might inadvertently lead the regulators to be less transparent in highlighting bad practice. Equally, that might lead to regulatory committees and panels punishing professionals who do not pose any threat to the public. If the actions of a doctor appear likely to reduce confidence in the medical profession and influence the decision of individuals as to whether to seek medical help at all, it may be right to take action. However, panels and committees will be asked to reach their own objective judgment as to whether particular acts or omissions would affect public confidence if no action were taken. A subjective view, uncritically influenced by public opinion or the media, would be an unacceptable basis for a decision.
Turning to the term “well-being”, the BMA has raised concerns with my ministerial colleague Dr Dan Poulter about how it would be interpreted by fitness to practise panels and committees. Well-being has been a long-standing and established feature of the legislation for three of the regulators. It encompasses those aspects of a professional’s role that may have an impact on individual patients but not directly impact on their health or safety. Dignity, compassion and respect are all important in delivering care, and it would not be right to disregard them.
It will be for the regulators to formulate and issue guidance for fitness to practise panels on interpreting and applying the objectives in practice, including the term well-being. The legislation makes clear that those objectives are considered only under the umbrella of public protection.
My officials will draw the regulators’ attention to those concerns should the overarching objective become law. That is in order to inform any guidance that will be needed to implement both this Bill and the secondary legislation for the GMC.
The noble Baroness, Lady Finlay, also asked about how we view the definition of “public” in the Bill. It of course includes patients and service users, as well as other parts of the collective public. I hope that that reassures the noble Baroness that the objectives in relation to well-being and public confidence will not be pursued outside the regulators’ objective to protect the public.