Questions for Written Answers

Debate between Lord Willis of Knaresborough and Earl Howe

Monday 22nd February 2021 Lords Chamber

[Earl Howe (Con)]

My Lords, I am advised that an exception has been made in the case of the noble Lord, Lord Frost, to enable him to return to full duties in this House at an early date.

[Lord Willis of Knaresborough (LD) [V]]

My Lords, on 25 September last year I tabled a Question concerning deaths from Covid-19 in care homes. It was answered 131 days later, on 2 February. It revealed that in one six-week period some 11,155 elderly patients died, the equivalent of a small town such as Wetherby in Yorkshire. Was there a delay because the Government were not compiling statistics for care home deaths at the time, or was it a policy decision to delay publication of such a devastating policy failure? What assurance can the noble Earl give on ensuring rapid publication of data in future?

[Earl Howe (Con)]

My Lords, I have asked the Department of Health and Social Care specifically about very long-delayed Answers, which I agree are deeply regrettable. The number is coming down; I understand that there are only a handful. Often the reason for such a delay is either the practical difficulty of gathering data or the rapidity with which the policy environment is moving, precluding an accurate answer being formulated.

NHS: Clinical Negligence

Debate between Lord Willis of Knaresborough and Earl Howe

Tuesday 20th January 2015 Lords Chamber

[Earl Howe]

My Lords, we are looking at that proposal, but there are currently no plans to repeal that particular piece of legislation.

[Lord Willis of Knaresborough (LD)]

My Lords, following the passage of the Health and Social Care Act, there are now some 350 other qualified providers. Will my noble friend confirm that they all get support through the Department of Health for any clinical negligence claims? If that is so, how much was paid out in 2013? Further to the point made by the noble Lord, Lord Hunt, if a claim is made within the private sector or third sector, will such providers be prevented from providing that claim within their organisations if negligence was proven?

[Earl Howe]

My Lords, potentially, independent sector providers may elect to be members of the negligence scheme, although only in respect of their NHS services. Therefore, only NHS-related liabilities would be covered in those circumstances. It is a pay-as-you-go pooled scheme, and I do not therefore have the figure that my noble friend requested. If I can get the figure disaggregated for him, I would be happy to write. In answer to his last question, I take it that he is asking whether the provider would be allowed to continue treatment, having been found to be negligent or having admitted negligence. That decision would be clinically led, with the patient exercising choice in each individual case.

NHS: Five Year Forward View

Debate between Lord Willis of Knaresborough and Earl Howe

Monday 1st December 2014 Lords Chamber

[Lord Willis of Knaresborough (LD)]

I thank my noble friend for repeating the Statement. I echo the point that, while many of us on all sides of the House may have disagreed with some of the structural changes in the Health and Social Care Act, the last thing the health service wants is another structural reorganisation. The plan by the party opposite to scrap the Health and Social Care Act is a real worry to many professionals. I say to my noble friend that no matter how much money the Chancellor promised today, it will not be enough to meet the demands of a changing healthcare system, where we are seeing, year on year, because of the success of the NHS, people living longer and with lots of different comorbidities.

I have a concern about the Statement. I actually think that Simon Stevens’s report is an excellent report and one that should have united this House rather than dividing us. After all, his pedigree comes from working with the Labour Party on the early reforms in the last Parliament. What really worries me is that neither in Simon Stevens’s report, nor in the Statement, is there a mention of the other crucial element, which is the workforce. The workforce and, indeed, the work of Health Education England, is not even worth a mention in the Statement—yet it is the 500,000 nurses and the 1.4 million care workers who bind the health and care system together and who will deliver the integrated health and social care which all of us in this House want to see.

Will my noble friend make it clear today that no savings will be made by reducing Health Education England’s budget? Will he state clearly that there will be investment in the skills of our staff in order that Simon Stevens’s plan actually works and that we can make it a realisation rather than a hope?

[Earl Howe]

My noble friend is absolutely right. One of the critical elements of the Five Year Forward View is to ensure that we have the right number of staff with the right qualifications in the right places. While Health Education England is the body charged with ensuring that that happens, it is up to us in government to ensure that there is adequate funding to enable it to do that. I can assure my noble friend that Ministers are very clear that Health Education England should be fully supported to deliver the programme that it has mapped out for itself. That programme is an exciting one. It involves more doctors and nurses in training over the next few years. Our ambition is to see by 2020 an extra 10,000 people working in primary care, for example—and that is only one detail.

As a result of the Government’s reforms to the health service, we have been able to afford a large number of extra posts in front-line care, including doctors and nurses in both primary and secondary care. We have done that by reducing the number of administrators in the system—20,000 fewer than there were in 2010. My noble friend is right to draw attention to this issue; it is one that is very much in our focus.

Health: Patient Safety

Debate between Lord Willis of Knaresborough and Earl Howe

Tuesday 24th June 2014 Lords Chamber

[Earl Howe]

It was only recently that the Nursing and Midwifery Council revised the curriculum for the training of nurses. I am sure that the noble Lord will be pleased to know that that curriculum is broadly divided 50:50 into practical training and training in the classroom, which was the balance historically. I believe that nurse training is now set fair for the future. The noble Lord is right to raise concerns about Project 2000, which many people felt did not quite address the needs of nurse training. However, that programme is substantially different now from what it was in 2000.

[Lord Willis of Knaresborough (LD)]

My Lords, I am delighted to follow the arch-moderniser, the noble Lord, Lord Pearson. In the whole of my noble friend’s Statement, and indeed until the noble Lord raised his question, not a word was mentioned about the training of the staff who actually care for our patients. We have a situation in which, unless you are a medic, you are not entitled, even if you are a qualified nurse, to have resources spent on you in order to continually update your professional development. In terms of preceptorship, there are no resources; in terms of mentorship, there are little additional resources; and there is virtually no resource to train healthcare assistants. Will my noble friend agree that although the move to have 9,000 more nurses is incredibly welcome, we need to put training at the very heart of the safety agenda, because unless we train we will not get high-quality staff?

[Earl Howe]

I agree with my noble friend; it would be difficult to disagree with him. Training is essential if we are to have high-quality staff. That is why we have protected the training budget, which is now hosted by Health Education England, whose job it is to ensure not just that there are adequate numbers of each type of professional in the health service but that the quality of the training is as we would all wish. It is the task of the local education and training boards to assess the position at a local level and, informed by the NHS providers that are under their wing, to respond to the needs of those providers.

Healthcare Professions: Regulation

Debate between Lord Willis of Knaresborough and Earl Howe

Tuesday 10th June 2014 Lords Chamber

[Earl Howe]

No, my Lords. We understand the frustration felt by the regulators that this has not been taken forward yet, but other government priorities have had to take precedence. That is the reality that we must accept. As I have said, we are committed to legislating on this important issue when time allows. With that in mind, we are currently working hard in consultation with key partners, including the professional regulators and patient and professional representatives, on our response to the Law Commission’s work. The complexity of that exercise cannot be overemphasised.

[Lord Willis of Knaresborough (LD)]

Would my noble friend agree that, after the very challenging Bills that went through the House in the first two Sessions, this Bill would have support right across the Chamber, across both Houses and across all the professions in terms of patient safety? Would my noble friend also agree that this would be a wonderful opportunity for us to tackle the appalling situation whereby 1.3 million healthcare support workers are not regulated and do not have standards, and no one can judge fitness to practise? A draft Bill would at least give us an opportunity to frame that legislation.

[Earl Howe]

My Lords, as my noble friend will know, we have debated the regulation of healthcare assistants on a number of occasions. The Government’s view is well known. However, I agree with him that the content of the Law Commission’s draft Bill is welcome to many parties—indeed, the Government are keen to see it progress. Much of the proposed legislation is already law in one form or another. The review is about pulling together all the different bits of legislation, introducing consistency across the professional regulators where practicable, making sure legislation is fit for purpose and, importantly, introducing flexibility for the regulators to respond to changing situations.

National Health Service: Nursing Staff

Debate between Lord Willis of Knaresborough and Earl Howe

Monday 12th May 2014 Lords Chamber

[Earl Howe]

My Lords, as the noble Lord will be aware, finances in the NHS are tight. However, as I said earlier, there are now 5,100 more nurses on our wards than there were in May 2010. That must indicate that nursing is still an attractive profession for the brightest and the best of our young men and women.

[Lord Willis of Knaresborough (LD)]

My Lords, will my noble friend accept that nurses do not work in isolation and that in order to deliver the high-quality care and safety that the Government rightly demand, the whole of the caring workforce needs to be properly trained and properly educated? What steps are being taken to ensure that healthcare support workers in particular—there are more than a million of them—get the training that they deserve to give patients the care that they too deserve?

[Earl Howe]

My noble friend is right. He may be aware that last month Health Education England, Skills for Care and Skills for Health launched the pilot for the new care certificate, which is taking place across a range of health and social care settings. It will test a set of standards designed to help employers to assess not only workers’ skills, but also the knowledge, behaviours and values that are required to deliver compassionate and high-quality care. That pilot will continue throughout the summer and, subject to evaluation, it is planned to introduce the care certificate next March.

Regenerative Medicine: S&T Committee Report

Debate between Lord Willis of Knaresborough and Earl Howe

Thursday 13th March 2014 Lords Chamber

[The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)]

My Lords, first, I congratulate the noble Lord, Lord Patel, on securing this debate and congratulate the Select Committee on Science and Technology, chaired by the noble Lord, Lord Krebs, on its excellent work in highlighting the important issues associated with the development of the regenerative medicine sector in the UK. The Government welcome the committee’s report and recommendations and agree that it is very important that the translation and commercialisation of research in this area in the UK is enabled.

As noble Lords recognised, regenerative medicines have enormous potential to treat and cure diseases, including in areas where no cure yet exists, to improve the quality of people’s lives and generate significant economic benefits for the UK. The Government remain committed to developing this important field of medicine, which we recognise as one of the UK’s eight great technologies. As the noble Lord, Lord Patel, acknowledged, the UK, with its strong science base, research funding and regulatory frameworks, and access to patients provided by the NHS, retains a strong international position to support the successful commercial translation of regenerative medicines. That said, more can be done to support and enhance the development of regenerative medicines in the UK.

I am grateful to the committee for the recommendations that it made on ways in which this area of medical science can be better supported. The actions that the Government are taking are set out in detail in our response to the report, but I would like to take this opportunity to highlight a number of areas of important activity.

The Government are continuing to invest to support translational health research on regenerative medicines, and this remains a high priority. A number of noble Lords, including the noble Lord, Lord Patel, asked for some reassurance that the NHS was ready for regenerative medicine clinical trials. As he knows, the Department of Health’s National Institute for Health Research—the NIHR—funds infrastructure in the NHS for translational research in regenerative medicine, in particular, as my noble friend Lord Willis mentioned, through biomedical research centres and units. These are established in leading NHS and university partnerships to drive progress on innovation and translational research in biomedicine into NHS practice. In 2011, the Government announced £800 million of NIHR funding for five years from April 2012 for 11 biomedical research centres and 20 biomedical research units. As part of this, the NIHR is investing more than £9 million annually in research programmes within its BRCs and BRUs that involve significant cutting-edge translational research in regenerative medicine across a range of disease areas.

This approach is already bearing fruit. For example, scientists at the NIHR biomedical research centre at Guy’s and St Thomas’s, and King’s College London have, for the first time, identified the unique properties of two different types of skin cells, including those responsible for repairing skin wounds. This research could pave the way for new and effective treatments to repair injured skin and reduce the impact of ageing on skin.

In addition to these centres and units, the NIHR funds infrastructure for regenerative medicine studies through its clinical research facilities and the Clinical Research Network. The Government’s response to the committee’s report highlighted work to implement changes to the organisational structure of the Clinical Research Network to take effect from 1 April, and I can report that these changes are on target.

The noble Baroness, Lady Greenfield, in her highly informative speech, spoke about the development of regenerative medicines to treat neurodegenerative diseases, including dementia. The Government have established the new National Institute for Health Research Dementia Translational Research Collaboration to pull discoveries from basic science into real benefits for patients. This brings together resources within the NIHR biomedical research centres and units.

As part of the collaboration, the NIHR Queen’s Square Dementia Biomedical Research Unit recently held a workshop on the use of stem cells in dementia and other neurological diseases, without—as the noble Baroness emphasised—conflating very distinct conditions. In addition, the NIHR Clinical Research Network will be responsible for delivering clinical research studies across a full breadth of specialties, which will include dementia and neurodegenerative diseases. Studies in regenerative medicine will be supported within the relevant specialty.

Regenerative medicine research has also benefited from the Regenerative Medicine Platform, the Technology Strategy Board and the Biomedical Catalyst, which have made significant investments in this area. Furthermore, noting the committee’s observation that there are a large number of different research and development funders, I am pleased to report, particularly to my noble friend Lady Sharp, that a single, interactive research “funding portal” is in development. We anticipate that it will be rolled out this spring. This portal will support researchers across academia and industry to identify and access relevant funding opportunities. As noble Lords have suggested, there should be a clear pathway from development to delivery of regenerative medicines in the NHS. This will aid the growth of this sector so that effective regenerative medicines become readily available and provide benefits to patients.

The healthcare system in the UK has already been delivering regenerative medicines successfully for decades, as shown through stem cell or tissue transplantation and through medicines such as erythropoietin. As the noble Lord, Lord Patel, pointed out, it is important to remember the breadth of the therapies that fall under a regenerative medicine definition, ranging from well established bone marrow transplantation procedures through to those at early-stage research. Each regenerative medicine product that is developed will differ by its mode of action, cost and therapeutic application.

My noble friend Lord Selborne referred to some new therapies appearing over the horizon. For new innovative therapies we are implementing recommendations from the Innovation, Health and Wealth report to spread innovation quickly and at scale throughout the NHS to improve outcomes and quality for patients and the NHS. I recognise fully the concern of the noble Lord, Lord Hunt, about the pace of uptake in the NHS of NICE-approved medicines; it is a concern that I share.

NHS England’s Commissioning through Evaluation programme provides an opportunity to strengthen the information we have available to inform commissioning policy for procedures or treatments that show significant future promise, but for which the evidence base on clinical and cost-effectiveness is currently insufficient to support routine commissioning. This is particularly important for rarer or smaller-volume treatments, such as some regenerative medicine treatments, where randomised controlled research evidence may be less readily available. We have also asked NICE to develop multiple-technology appraisal guidance on autologous chondrocyte implantation, a regenerative medicine for repairing symptomatic articular cartilage defects of the knee.

As noble Lords mentioned, in order to develop an NHS pathway for regenerative medicines, we have established a Regenerative Medicine Expert Group, as recommended by the committee, to develop an NHS regenerative medicine delivery readiness strategy and action plan. We are pleased that Professor Sir Michael Rawlins has agreed to chair this group, which is of a multidisciplinary nature with all the key stakeholder groups represented within the membership, including NHS England, the National Institute for Health and Care Excellence, regulators, industry, researchers, patient representatives, NHS Blood and Transplant, the Scottish National Blood Transfusion Service, the Welsh Blood Service and the Cell Therapy Catapult.

The noble Lord, Lord Patel, asked about the group’s terms of reference. These can be found on its website, which is located on the Department of Health’s website. However, in essence, we have tasked the group with considering all the important elements of the pathway of regenerative medicines into the NHS, including licensing and regulation of a product, evaluation, commissioning and reimbursement, as well as practicalities such as manufacturing and distribution. I can tell the noble Lord that the group has been asked to report to the Secretary of State by the end of this calendar year, and its work is well under way. It will deliver an NHS regenerative medicine delivery readiness strategy and action plan.

I am sure that the noble Lord, Lord Turnberg, will be glad to know that as well as NHS delivery we have also tasked the Regenerative Medicine Expert Group with looking at the regulatory system for regenerative medicines. My noble friend Lord Selborne referred to this, as did my noble friend Lady Sharp and other noble Lords. The Government recognise, as did the committee, that regulation in this area may act to stifle innovation and thus that we should endeavour to simplify systems to provide support for those developing regenerative medicines to navigate regulatory pathways. With these aims in mind, the main regulatory bodies are working closely with one another to streamline the regulatory system and provide support to help guide applicants with regulatory submissions—for example, the Health Research Authority is undertaking work to streamline research approvals and has a new website to guide researchers. Also, we can look to the joint working of the MHRA and the Human Tissue Authority as a result of the McCracken report recommendation on the regulation of tissue for applications aimed at developing regenerative medicines. I hope that those initiatives will be of particular comfort to my noble friend Lord Willis.

I should like to emphasise to him, to my noble friend Lady Sharp and to the noble Lord, Lord Hunt, that the Government remain committed to streamlining research approvals.

[Lord Willis of Knaresborough]

Before my noble friend leaves that point, I asked specifically—as did the noble Lord, Lord Turnberg—when a decision will be made on the initiative of the Health Research Authority to bring together and streamline NHS approvals and local ethics approvals. The decision has been awaited since October.

[Earl Howe]

My noble friend anticipates some news that I was about to convey. He is right: the Health Research Authority is the organisation created to deliver the streamlining of research approvals. It has completed its feasibility study. The results demonstrated that NHS R&D assessments could be integrated with elements of the research ethics committee review into a single HRA assessment for the approval of all research in the NHS. Department of Health officials are scrutinising the business case submitted by the HRA as part of standard governance processes, and approval of the case is subject to the proposals demonstrating value for money. Consideration of the business case is well advanced and we would anticipate that this process will conclude shortly.

The noble Lords, Lord Patel, Lord Turnberg and Lord Hunt, asked me about support for manufacturing, in particular as regards large-scale trials. The Cell Therapy Catapult has recently completed its survey of regenerative medicine manufacturing capacity in the UK, and an appraisal of national capability is planned on an annual basis to keep abreast of the evolving needs of the area and to ensure that the UK remains globally competitive. The 2013 survey and analyses that the Cell Therapy Catapult compiled have been shared with stakeholders. The key findings of the survey, including a demand forecast, have been shared at various meetings in the UK, including at the Regenerative Medicine Expert Group, and at meetings of the advanced therapeutic products manufacturing community and will be published shortly. The survey output, along with analysis of demand, was used to make a proposal to BIS for further investment to fill the cell manufacturing gap and support late-stage clinical trials. The investment proposal is currently being assessed.

The noble Lord, Lord Patel, asked what action UKTI has taken to improve the chances of the UK being a location for the development and manufacture of regenerative medicine therapies. UKTI has consulted extensively with UK stakeholders and has developed a new UK regenerative medicine sector proposition, which was launched in December 2013 at the World Stem Cell Summit in San Diego. Training on the materials has been rolled out to a number of its overseas teams, with more training to follow in the coming months.

The noble Lord, Lord Hunt, made some criticism of the MHRA in the context of progress on adaptive licensing. This issue was also raised by the noble Lord, Lord Turnberg. The MHRA has been involved with a discussion group at the European Medicines Agency in developing guidance, case studies and draft calls for expressions of interest to go out this year. One has to remember that work on adaptive licensing must be conducted within the context of European law. We had hoped that this would be issued last year but there has been a delay, as the European Commission has wanted to be satisfied that proposals can be accommodated in the existing regulatory flexibilities. I can tell the noble Lord, Lord Hunt, that we continue to be actively involved in pushing the EMA in bringing this work forward, and I have been personally involved in overseeing that.

Distinct from the concept of adaptive licensing is the early access to medicines scheme. This is designed to enable earlier UK patient access to highly promising medicinal products before they are licensed. This is expected to be announced very soon. It will operate within the current regulatory structure, and is voluntary and non-statutory. The MHRA will provide a scientific opinion on promising new medicines that will treat, diagnose or prevent life-threatening or seriously debilitating conditions without adequate treatment options before the medicines are licensed. Further details will be announced in the near future.

My noble friend Lord Willis asked about NICE’s value-assessment process. NICE, in consultation with stakeholders, keeps its methodologies under review to ensure that they remain fit for purpose. Our priority is to make sure that we get the best possible results for all NHS patients with the resources that we have, which means using taxpayers’ money responsibly and getting good value for money. We have asked NICE to look at how drugs are assessed so that patients can get the treatments that they need at the best value for the NHS and so that the price that the NHS pays is more closely linked to the value that a medicine brings. NICE will carry out a full public consultation before implementing any changes. I would just add that NICE is a key member of the Regenerative Medicine Expert Group, which will look at and provide recommendations on the evaluation and commissioning of these novel medicines and their adoption in the NHS.

My noble friend Lord Selborne and the noble Lord, Lord Turnberg, referred to developments in Japan. We are aware of the Japanese plans, and the report on the approach is being considered by the expert group. As noble Lords have mentioned, the Japanese Government are exploring ways in which the regulatory process there might be changed to support earlier evaluation of the clinical effectiveness and adoption of regenerative medicines within their health system following evidence of safety. Earlier this year, a Department of Health official, along with Foreign Office officials, attended a conference in Japan where the plans were discussed. The details have yet to be worked out but a watching brief will be maintained with the contacts that were made. A report of the conference has been made available to the expert group for consideration.

The Government look forward to receiving the Regenerative Medicine Expert Group’s strategy and action plan. We anticipate that this will provide a platform to help ensure that the UK will be in the lead in realising the exciting medical and commercial potential of these cutting-edge treatments.

Health: Confidential Patient Information

Debate between Lord Willis of Knaresborough and Earl Howe

Thursday 23rd January 2014 Lords Chamber

[Earl Howe]

My Lords, everybody in the country has a right to object to their data being shared. Those objections will always be respected. A practical way had to be found to enable that process to happen, and we believe that it is not unreasonable to expect a patient to have a conversation with their GP. I will, however, take the noble Baroness’s suggestions on board and feed them in.

[Lord Willis of Knaresborough (LD)]

Does my noble friend agree that while patients can object to having their records sent, they cannot, in fact, legally prevent the GP sending those records to the central repository? It is at that point that the discussion as to whether those records should be sold on and used by pharmaceutical companies and others is important. Does he agree that it is important that companies carrying out research into new drugs and compounds can access patient records, because they are an important dataset for making sure that we have better healthcare for our people?

[Earl Howe]

My noble friend is correct. The UK has a unique advantage in being able to link patients’ data records for the purposes of research and for effective healthcare commissioning. It would be extremely concerning if European law prevented that. I believe and hope that patients will be encouraged that there will be no abuse of identifiable information. The controls around this are very strict and, in the main, only anonymised data are required for research purposes.

Professional Standards Authority

Debate between Lord Willis of Knaresborough and Earl Howe

Thursday 7th November 2013 Lords Chamber

[Earl Howe]

My Lords, I agree with the noble Baroness, and I pay tribute to her work as chair of the PSA. The benefits of accredited voluntary registration are clear. The point is to give the public, employers and commissioners choice to use people on a register that the authority has independently assessed and approved, and only those registers that the authority has accredited are allowed to use its kitemark.

[Lord Willis of Knaresborough (LD)]

My Lords, the 2013 annual report of the Professional Standards Authority states that its third strategic objective is to:

“Enhance public confidence in unregulated health and care occupations”.

How many voluntary registers of healthcare support workers are now registered with the standards authority, how many individual staff do they cover and how can the public get access to them? How long does the Minister expect it to take for all healthcare support workers to be registered, as the recent reports following the Mid Staffs inquiry suggested?

[Earl Howe]

My Lords, the Francis recommendations made no reference to voluntary registers for healthcare support workers. The broad position is that the PSA has not received any applications from organisations holding voluntary registers for healthcare support workers, and therefore no voluntary registers for healthcare support workers have been approved. As accredited registers are voluntary, I am afraid that the Government are not in a position to predict how long it will take for all healthcare support workers to be registered.

Care Bill [HL]

Debate between Lord Willis of Knaresborough and Earl Howe

Monday 21st October 2013 Lords Chamber

[Earl Howe]

My Lords, I hope that I can give noble Lords considerable reassurance on the Government’s position on these important issues. It is almost axiomatic that safe, high-quality care is dependent on people and that right-staffing, in terms of numbers and skills, is vital for good care. The importance of having the right staff with the right skills and in the right numbers is central to the delivery of high-quality care. Where staff are stretched because they are too few in number, corners will be cut, with inevitable adverse consequences for patient care. Equally, where staff do not have the right skills to carry out their tasks, the quality of care will suffer.

Patient safety is the first priority, and safe staffing levels really matter. The quality of care provided to patients is ultimately the responsibility of the leadership of provider organisations. It is their responsibility to ensure that they have the right staff with the right skills in the right place at the right time in order to provide high-quality care. In the final analysis, it is for hospitals themselves to decide how many nurses they employ, and they are the best placed to do that. Nursing leaders have been clear that hospitals should determine and publish staffing details and the evidence to show that staff numbers are right for the care needs of the patients that they look after.

Although local providers are best placed to do this based on local need, we expect them to look to authoritative guidance and evidence-based tools and learn from best practice to deliver cost-effective and safe care. We recognise that there is a need for national action to ensure that local organisations meet those expectations. As a result of the national nursing and midwifery strategy and vision published in 2012, Compassion in Practice, a considerable amount of work is going on across England to ensure that providers use evidence-based tools, using acuity and dependency measures to set staffing levels, and for boards to publish these staffing levels on a regular basis.

I want to explain what we are now doing to build on that work. First, the Chief Nursing Officer, supported by the National Quality Board, is developing guidance for the system, including a set of expectations, to support provider organisations in securing the appropriate staffing capacity and capability for nursing, midwifery and care. This guidance is being developed with the intention of ensuring safe patient care and that patient outcomes are not compromised. It will include expectations on transparency and publication of information on staffing.

This guidance is being developed jointly by the statutory organisations responsible for quality across the NHS, which are brought together as part of the National Quality Board and which include the Care Quality Commission, Monitor, the NHS Trust Development Authority and NHS England. It will be published next month. I can therefore only agree with the intention behind the amendment that providers need to be open and transparent about their staffing numbers. The positive news is that action is already in place to ensure that this happens.

[Lord Willis of Knaresborough]

What my noble friend has said is incredibly encouraging. However, before he leaves that point, could he take up the very important issue raised by the noble Lord, Lord Warner? This is not just about hospitals; it is also—particularly in my case—about care homes and other community settings. Will the regulations apply to all those settings, so that we get continuity throughout the system?

[Earl Howe]

My Lords, I am happy to come to that point. The short answer is that that is certainly our intention.

I turn to Amendment 159, about which I will be a little critical. We consider that requiring health or care service providers to,

“publish a report containing staffing levels based on evidence of safe staffing levels supported by acuity and dependency levels for each patient”,

is really not a viable alternative to what we are already putting in place and would not work in practice. It would be burdensome to implement in precisely that form and could detract from the ability of staff to deliver good clinical care.

I understand, of course, the thrust of the thought behind the first part of the amendment, which says that,

“the first duty that a health or care service provider must consider for any decision is patient safety”,

However, it carries the risk of unintended consequences. It could lead to other important factors, such as innovation and service improvement, not being given sufficient weight and providers becoming unduly risk averse. We need to reflect that any innovative treatment—which we want to encourage in the health service—carries some risk. That is always justified by benefits for the wider system. We do not want clinicians to become reluctant to take risks if this amendment were passed.

Also, we do not feel that specifying report requirements for provider boards is the role of the Secretary of State any more. Rather, the focus has to be to allow for local accountability and local decision-making. However, as I have said, we recognise that decision-making tools are needed and I agree with my noble friend Lord Willis about that. We are working with the CQC, NICE and others to ensure that providers have the evidence-based tools they need to make decisions to secure safe staffing levels. These decisions will then be subject to external scrutiny and challenge by commissioners, regulators and the public, and to inspection by the Chief Inspector of Hospitals.

However, at the end of the day we come back to the fundamental point, that it is the responsibility of individual providers to be accountable for staffing levels in their organisations. The existing registration requirements, which are enforced and monitored by the CQC, already recognise the importance of that. That is my response to Amendment 144. The requirements state that providers must take steps to ensure that at all times there are sufficient numbers of suitable staff to carry on the regulated activities that the organisation provides. Additionally, the Chief Inspector of Hospitals has also made it clear that appropriate staffing levels are part of the requirements of registration for the CQC.

In assessing whether a provider meets the registration requirement on staffing, the CQC refers to relevant guidance about staffing levels and skills mix published by professional councils and relevant expert and professional bodies. These include the Department of Health, Skills for Care, Skills for Health, the NHS and the Royal College of Nursing. Where a provider does not meet the staffing registration requirement, the CQC is able to use its enforcement powers to protect patients and service users from the risks of unsafe care associated with inadequate and/or poorly trained staff.

In its consultation document A New Start, published in June this year, the CQC stated that the focus of its new inspection methodology would be on five key domains. Are services safe, effective, caring, responsive to people’s needs, and well led? These domains will cut across all areas of activity, including levels of staffing and skill mix.

--- Later in debate ---

[Earl Howe]

My Lords, at this point it will be convenient to consider also Amendments 166, 167 and 168. We have previously had some valuable debates about the Health Research Authority’s role in promoting transparency in research. I thank the Joint Committee that scrutinised the draft Bill and the Science and Technology Select Committee in the other place for their reports, which have informed Amendments 166 and 167.

In previous stages of the Bill’s passage, the noble Lords, Lord Patel, Lord Turnberg, Lord Warner and Lord Winston, the noble Baroness, Lady Wheeler, and my noble friend Lord Phillips of Sudbury have made particularly valuable contributions to the debate on this issue, which I have listened to with considerable interest. The Government have also discussed the Health Research Authority’s role in promoting transparency with stakeholders and with the existing special health authority.

The life sciences industry plays a key role in the Government’s strategy for economic growth and makes a valuable contribution to both the health and wealth of our nation. The Government agree that there is a powerful case for increasing transparency in clinical trials. Ensuring that research is registered and published and that data, information and tissue are available where relevant will help to make the best use of research, thereby maximising the health benefits for patients and the public from research undertaken and thus maximising the return on our investment in research. Amendment 166 makes it explicit that the Health Research Authority’s objective of facilitating the conduct of safe and ethical research includes promoting transparency in research. Amendment 167 lists some of the ways in which the HRA must promote transparency.

The existing special health authority is already making great strides in promoting transparency in research. The Health Research Authority published an action plan in May 2013, which received widespread support from a range of stakeholders including researchers, research sponsors, funders, professional bodies, stakeholders and members of the public with an interest in transparent research. Since 30 September, registration of clinical trials in a publicly accessible database has been a condition of favourable ethical approval from a research ethics committee.

These amendments will ensure that the Health Research Authority continues to promote greater transparency in research when it becomes a non-departmental public body. By doing so, that authority will continue to reassure people who participate in research that research is not duplicated unnecessarily and that unnecessary risks and burdens continue to be avoided. As promoting transparency in research is specifically included within its objective under Amendment 166, the Government would expect that the annual report would cover the authority’s measures to meet this section of its objective. While there is more to be done in this area, including by research funders, I hope that I have been able to reassure noble Lords that great strides are being taken and will continue to be taken.

Amendment 165 clarifies that the Health Research Authority may delegate any of its functions to any of its committees, sub-committees, members or any other person. The amendment mirrors a similar amendment that we have already debated with respect to Health Education England in Schedule 5—it was Amendment 157.

Finally, I would like to explain briefly Amendment 168, which corrects an oversight in the drafting of the Bill. It ensures that an appropriate body under the Mental Capacity Act (Appropriate Body) (England) Regulations 2006 is a research ethics committee recognised or established by or on behalf of the Health Research Authority, rather than a research ethics committee recognised by the Secretary of State.

I thank noble Lords and others for the contributions that have informed the amendments on the HRA’s role in promoting transparency in research. I hope that they will be welcomed. I beg to move.

[Lord Willis of Knaresborough]

My Lords, first, I declare an interest as the chair of the Association of Medical Research Charities. The brief comments that I am about to make are an amalgam of those made with the Academy of Medical Sciences, Cancer Research UK and the Wellcome Trust. On behalf of all those organisations, I can say how much we welcome these amendments and the way in which the HRA has so quickly become embedded into the research psyche. The work that it is doing ensures that on each of the major obstacles—of which ethics was the first, particularly in local ethics committees, but going right through to the regulation that it is starting to streamline, particularly with the Human Tissue Authority—we are really seeing a march forward. Frankly, the progress that has been made has staggered me. I congratulate not only the chairman and chief executive of that organisation but the Minister himself.

NHS: EU Legislation

Debate between Lord Willis of Knaresborough and Earl Howe

Monday 21st October 2013 Lords Chamber

[Earl Howe]

My Lords, I stress that this is not a step to find a way to make doctors work longer. As I said a moment ago, it is clearly in nobody’s interest to go back to the days when doctors were constantly tired and worked excessive hours. However, when senior clinicians tell us, as they have, that the implementation of the directive is harming patient safety and doctors’ training, we have to take that seriously. That is why we want to take a closer look at how this directive is impacting on the ground.

[Lord Willis of Knaresborough (LD)]

My Lords, I welcome my noble friend’s very strong comment that the working time directive has huge benefits, as well as clearly having challenges. However, in terms of this review of surgeons’ training, will he also look at the fact that for at least two and a half days a week most of our theatres are absolutely empty, with no activity taking place? One of the big requirements is that there should be more activity in terms of elective surgery within our hospitals—which would itself help the whole training issue.

[Earl Howe]

My noble friend makes an extremely good point, which I shall ensure is not lost on the president of the Royal College of Surgeons as he conducts his review.

NHS: Out-of-Hours Services

Debate between Lord Willis of Knaresborough and Earl Howe

Monday 29th July 2013 Lords Chamber

[Earl Howe]

I apologise to the noble Baroness on two counts. NHS Direct is a separate, statutory organisation, which means that the management and controls of risk are the responsibility of the NHS Direct board.

[Lord Willis of Knaresborough]

My Lords, may I try to redress the balance? There is a real sense that very significant numbers of people calling the 111 service get a good service. On 9 June, I had reason to call 111 because I was having a heart attack. The response from 111 was excellent, in York. At the same time not only did the service call the paramedics but it had me in hospital within 25 minutes to an absolutely superb accident and emergency service. If York can do that in such an efficient and superb way, why cannot we guarantee that service throughout the country?

[Earl Howe]

I am sure that I speak for all of us in saying how pleased I am that the service worked so well in the noble Lord’s case. The answer to his broader question is that the service is working well in the vast bulk of the country. Unfortunately, in two particular areas we have seen problems, which are being gripped, and I am confident that NHS England has taken these issues forward with the seriousness that they deserve. I am assured that, even in the areas where problems have arisen, the service is good.

Care Bill [HL]

Debate between Lord Willis of Knaresborough and Earl Howe

Tuesday 4th June 2013 Lords Chamber

[Earl Howe]

I am grateful to the noble Baroness. I have to go a little further, so if I may I will cover her point in a moment.

Amendments 40 and 42 to 46, tabled by the noble Lord, Lord Hunt, and the noble Baroness Lady Wheeler, focus on the need for expertise on the local education and training board. Specifically they seek to change Clause 91(3) to require a LETB also to have as members persons who deliver education and training to healthcare workers, a registered nurse, persons with experience in staff groups that are not professionally registered, healthcare workers who receive education and training from within the area, patients and carers or their representatives, and a representative of the local health and well-being board.

I fully expect Health Education England and the LETBs to work closely with and seek advice from a range of key stakeholders, including those providing education and training, members of staff, patients and carers. That requirement is clearly set out in Clause 89. I appreciate the position of noble Lords but do not agree that we need to specify all these groups in the governance structure.

In establishing the LETBs, the Government are committed to driving up standards and the quality of education and training provided. I suggest that that can happen only if those directly involved in the provision of education and training are at the heart of the new system. By their very nature, local education and training boards will be representative of local healthcare providers, who play a critical role in educating and training our workforce. They are the health professionals who support and supervise clinical placements and training programmes across the country, providing professional leadership and support to students and trainees.

If we mandate a requirement for a nurse, others will ask why there is no requirement for a doctor, a dentist, an allied health professional or any of the many other professions. I completely agree that these professions, and the bodies that represent, regulate and support them, need to be closely engaged in the work of the LETBs, but it is not practical to require all of them to be members of the board. The Bill makes provision in Clause 91 for those involved in the provision of education and training, such as universities, to be eligible to sit on an LETB. We know from the 13 LETBs established by the HEE special health authority that all of them have a university representative on their boards, and many different health professionals are also represented on them.

HEE will appoint independent chairs of the LETBs. These will be people who are not directly involved in the delivery of health services, or education and training, in the geographical area. Having an independent chair will ensure that the local education and training board acts independently and in the interests of all healthcare providers represented.

To be appointed in the first place, local education and training boards will need to demonstrate to HEE that they have the right governance arrangements and the right mix of people on their boards with the necessary capacity and capability. In going through that process it will be for HEE to assess whether the local education and training board has the right mix of skills, knowledge and expertise with which to carry out its functions. However, as the intention is for local decisions on education and training to be made by the LETBs, it is important that we give them the flexibility to determine who sits on their boards.

To sum up the position, I can reassure noble Lords that LETBs are already developing strong partnership arrangements in their patch to engage with all education institutions involved in education provision in their area. The HEE special health authority has reinforced the importance of this in the appointment criteria that it set the LETBs, which have to be approved by the Secretary of State. These demand that LETBs demonstrate meaningful engagement and collaboration with many stakeholders with an interest in education and training, including students and trainees, and patients and carers. As a result, they are putting in place appropriate advisory and partnership arrangements to support the decision-making of the local education and training board.

[Lord Willis of Knaresborough]

Perhaps I may interrupt the Minister and come back to the important point made by the noble Baroness, Lady Wall. In responding the Minister has yet again constantly referred to what I would call professional organisations. There are nearly 1 million healthcare support workers in the care and the health sectors. Many are untrained. Most are unregulated and unregistered. The two organisations that are providing basic skills, Skills for Health and Skills for Care, were dreamt up within the department. They did not widely consult before they put their forward their proposals for training programmes. The Nursing and Midwifery Council was never asked about the standards for Skills for Health. Will the Minister say who will be consulted about training the people who do so much of our basic social and healthcare—those who are called healthcare support workers?

[Earl Howe]

I fully recognise the importance of the healthcare support worker sector. I can reassure my noble friend and the noble Baroness, Lady Wall, that Health Education England will be working closely with the sector skills councils, Skills for Health and Skills for Care. I note my noble friend’s scepticism about those bodies, but I do not share it. They have done a pretty fine piece of work and the fruits of it will be apparent over the coming months. HEE will need to do that if it is to perform its role as fully as it should to plan and shape the development of the entire workforce. If by some mischance it were to neglect that aspect of its work and not focus on improving training standards for the health and care support workforce, it would lead to a very unbalanced and unsatisfactory position. Therefore, we are very clear that this should be part of the remit of Health Education England. I hope that that is sufficient reassurance for noble Lords.

The noble Lord, Lord Hunt, asked about health and well-being boards being represented on LETBs. There is a clear commitment in Clause 93 for LETBs to consult health and well-being boards in the development of their plans.

My noble friend Lord Willis asked how Health Education England’s workforce planning will take into account new innovations. Workforce planning is a key focus for Health Education England. It is not about churning out the same old numbers but about working with service commissioners, service providers and other partners such as royal colleges to understand how the workforce needs to respond to service change. This means taking account of technological, pharmaceutical and other advances, and having a flexible workforce that is able to adapt to those innovations.

Care Bill [HL]

Debate between Lord Willis of Knaresborough and Earl Howe

Tuesday 4th June 2013 Lords Chamber

[Earl Howe]

It will certainly be open to the board of HEE to establish an advisory committee that specialises in unregulated professions. Although, again, I cannot make a firm commitment about that, the very fact that we are dealing with a workforce of substantial size on which the NHS crucially depends—I am now talking about healthcare support workers—means that it would be very surprising indeed if the board were not to have some form of specialist advisory service to inform its decisions.

[Lord Willis of Knaresborough]

Before we finish debating this group of amendments, will my noble friend reflect on what he has just said about regulation? One of the traps we fell into with the Health and Social Care Bill—I do not think that it was intentional, it just happened—was that so much was promised in regulation that it was not until we started discussing the regulations that we saw what we had not done in the Bill. Perhaps it would be helpful to produce draft regulations as we go along before Report, so that we know what we are including in the regulations.

[Earl Howe]

It may not surprise my noble friend to know that I asked my officials the self-same question, because I anticipated an appetite for draft regulations. I am, unfortunately, not in a position to make that promise, much as I would like to do so, because there may not be the necessary time available for the regulations to be drawn up in draft. However, I will take back the strength of my noble friend’s request and see whether there can be any reconsideration of that point.

Local Authorities (Public Health Functions and Entry to Premises by Local Healthwatch Representatives) Regulations 2012

Debate between Lord Willis of Knaresborough and Earl Howe

Thursday 7th February 2013 Grand Committee

[Lord Willis of Knaresborough]

Will the Minister state categorically that, in the event of a major public health incident within a local authority area, it will be the director of public health who has the lead responsibility in co-ordinating a response to that event?

[Earl Howe]

We expect that that will be the case but it will depend on the nature of the incident and how big a public health emergency we are dealing with. We might find, for example, that if it is an emergency that covers more than one local authority area, a particular director of public health will take responsibility on behalf of all the local authorities. We would expect Public Health England to be on the scene for any major incident and to advise, but the central point is that there has to be somebody with ultimate responsibility for what goes on on the ground. Clearly, who that person is will depend on how major or minor the incident is and the nature of that incident. It would be open to the director of public health to delegate certain functions but, again, we would expect the director of public health to retain an oversight role to make sure that functions were appropriately performed.

The noble Lord, Lord Collins, referred to the important area of prevention. He expressed concern about local authorities investing in prevention work. I was grateful to him for what he told me about the work currently being done in London on HIV prevention. The mandate to the NHS Commissioning Board does not specifically cover prevention, but local authorities will want to undertake prevention activity because this will improve the health and well-being of their population and reduce costs. Sexual health services are also a preventive activity in their own right—for example, the provision of contraception to prevent unplanned pregnancy and the testing and treatment for STIs to prevent onward transmission.

On HIV, one of the public health outcome indicators is to reduce late HIV diagnosis, and prevention activity can clearly play a crucial role in that. We are aware that in London, in particular, councils will be working together to review arrangements for pan-London HIV prevention work. The noble Lord may well be aware of the work going on to underpin the current pan-London HIV programme. The current programme comes to an end at the end of March and this has been known by all the providers and voluntary sector organisations for some time. Therefore, a needs assessment of pan-London HIV prevention was undertaken in 2011. London Councils and the mayor’s office are absolutely sighted on the need for effective HIV prevention in the capital and urgent discussions are under way about taking this forward from April.

HIV services will continue to be commissioned by the NHS. More generally, local authorities will be able to enter into cross-charging arrangements if they wish. In London, we introduced secondary legislation last year to allow the Greater London Authority to undertake public health activity in partnership with the boroughs, and that was obviously designed to facilitate co-operation across boundaries.

The noble Lord asked how we would ensure that HIV treatment was standardised across the country and whether we were intending to publicise HIV prevention. Local authorities will certainly be able to run awareness and information campaigns, and they will be funded to do so. HIV treatment will, as now, be commissioned by the NHS and be informed by the existing standards and guidance.

My noble friend mentioned the letter from my honourable friend Anna Soubry, which stated that there are no plans to do anything on the regulation of public health specialists at present. He sought reassurance on the regulation of public health specialists being in place by the end of next year. During the debate on the Health and Social Care Bill we made the commitment to regulate non-medical public health consultants after conducting a consultation. That remains the case. However, the process will take 12 to 18 months to complete and so, at this point, I am reluctant to commit to a particular date for implementation. I should be happy to follow up that comment in a letter to my noble friend.

He also raised the issue of the interface between Healthwatch England and services providers. Part 4 refers to the duty on services providers to allow entry to local Healthwatch rather than Healthwatch England. If local Healthwatch representatives observe anything that might be unsafe or poor care of any kind, they can report those matters directly to the Care Quality Commission to investigate. I hope that that addresses an issue also raised by the noble Lord, Lord Collins, because it is clearly very important for local Healthwatch not only to have a hotline to the CQC where necessary but to co-ordinate its work, where relevant, with that of the CQC—exactly as LINks do at the moment.

The noble Lord, Lord Collins, asked me about local Healthwatch in the context of the Francis report, published yesterday. All I can say at this point is that, as the Leader of the House said yesterday, my right honourable friend the Secretary of State will be considering all the recommendations in Robert Francis’s report in detail over the coming weeks. Clearly, we will need to reflect very carefully on the implications of his recommendations and we will be providing an initial response next month.

Finally, the noble Lord, Lord Collins, raised the issue of local Healthwatch being able to enter and view premises and, in doing so, access all areas in those premises—for example, areas being renovated, kitchens and so on. Local Healthwatch representatives will be able to access communal areas but there are restrictions based on the privacy of residents or patients and the need to respect that, and on intruding on the provision of care while it is being delivered. The enter-and-view powers are activities for the purposes of Section 221 and relate to service improvements. These regulations support local Healthwatch’s role in that respect.

On the issue of the reasonableness of local Healthwatch’s enter-and-view activities, the service provider’s view has to be one that is held reasonably; otherwise the provider would be acting unlawfully. Regulation 13 requires local Healthwatch, when on any premises, not to act in a way that would compromise “effective provision of care” or the,

“privacy and dignity of any person”.

These terms bear their ordinary meaning and, in our view, they are clear. They have worked well on the ground so far. They are, of course, based on the 2008 regulations and we are confident that they will serve the new system well.

I am aware that there are several matters of detail that I have not covered but I shall, as promised, look carefully once again in Hansard at all the questions posed by both noble Lords and write accordingly.

Care Services: Winterbourne View

Debate between Lord Willis of Knaresborough and Earl Howe

Monday 10th December 2012 Lords Chamber

[Earl Howe]

My Lords, the noble Baroness raises another important point. In this country we have a list that acts as a check on those who have abused or otherwise maltreated adults or children and have been dismissed on that basis, to ensure that the scenario that she has painted in which someone who has committed such an offence is re-employed cannot occur in practice. I am not sure that I recognise the situation that she outlined because the POVA system is designed to ensure that dangerous people are not employed to look after the vulnerable. However, I will gladly drop her a line in writing to set out what we propose in this area.

[Lord Willis of Knaresborough]

My Lords, I echo the comments around the House that this Statement is appropriate. The fact that it has support across the House demonstrates that there is unity in terms of tackling the issue. I spent a significant part of my professional life working with young people with severe behavioural issues. As the head of a school, I, together with my governors, would be held responsible for what happened to those young people—and rightly so. The weakness in the Statement is that it does not go far enough.

The Minister was right to make clear, and I am glad he did, that it was the management and the corporate owners of the home who were principally responsible, yet it was the staff who were prosecuted and jailed. I would like to hear what steps are going to be taken with the CPS to deal with corporate responsibility, and why that is not the priority here. Without it, frankly, a lot of the things that appear in this report will not have the necessary teeth.

I respectfully but fundamentally disagree with the noble Lord, Lord Pearson, on the training of nurses and other health workers. The more that we demand of staff in terms of their education and other opportunities, the better the staff we will ultimately get. However, I agree with him and with the noble Baroness, Lady Masham, that it cannot be right that the most vulnerable people in our society are looked after by people whom we cavalierly say do not require qualifications. How unacceptable is that in the 21st century? A voluntary register of an organisation that is disreputable is utterly and totally meaningless. We need a commitment on this from the Government. I agree that this will be over a period of time; it will not happen tomorrow. However, simply stating, as recommendation 15 does, that by 2013 there will be a voluntary register will not give parents and carers of these very vulnerable adults and young people the support and comfort that they need. I plead with the Minister to make the case in the department for mandatory registration, to ensure that there is appropriate regulation and that nobody works with these young people or adults who does not have appropriate qualifications and training.

[Earl Howe]

My Lords, I am very happy to recognise the excellent work done by my noble friend in the report that he published and submitted to the Royal College of Nursing, which we will debate later this week. He rightly drew attention to the responsibility that lies with leaders of organisations and boards of directors. They should be fully held to account for poor quality or for creating a culture in which neglect or abuse can happen. I completely agree with that. He was right to say that despite convictions for some front-line staff, Winterbourne View has revealed weaknesses in our ability to hold to account those who were higher up. Owners, boards of directors and senior managers must take responsibility for the quality and safety of their services.

We are determined to strengthen the accountability of boards of directors and managers, but we are not yet in a position to say exactly how that should be done. It is not as easy to define a legal route as it might first appear. It is perhaps easier to do so in the area of financial irresponsibility or negligence than it is where value judgments have to be made over the quality of care delivered to a group of individuals. However, I can tell my noble friend that this is one of the priorities that we have set ourselves. I listened with respect to his suggestions on the compulsory registration of care workers. I repeat what I have said in the past: the Government’s mind is not closed to this suggestion.

Health and Social Care Bill

Debate between Lord Willis of Knaresborough and Earl Howe

Monday 19th March 2012 Lords Chamber

[Earl Howe]

I think that the noble Lord asked me whether the board will be an advisory board or a board. Its function will be to provide advice. It will be a board, but the Secretary of State and the chief executive of PHE will look to the board for that robust challenge and advice that a public health service needs.

[Lord Willis of Knaresborough]

I am grateful to my honourable friend—I am sorry, I mean my noble friend; I keep calling him honourable, but I am sure he is as well—for that response to the noble Lord, Lord Turnberg. The issue is really quite fundamental. If what my noble friend has described is a purely advisory board, the board will not therefore be able to take any executive decisions about the nature of the research that it carries out; that will be totally dependent on the Secretary of State passing it down. Is that so? If so, how in fact will it interface with, for example, the new European programme, programme 8, in terms of European-wide research on public health?

[Earl Howe]

No, my Lords, my noble friend is not correct. It will be able to take decisions. What it will not be able to do is to bind the Secretary of State because, ultimately, if there is an issue of public health importance, it is the Secretary of State who must take responsibility for that. This said, Public Health England will of course be its own master as regards the research that it undertakes, and it will be operationally independent, as I emphasised earlier.

We will ensure the chair’s direct access to Ministers through regular and ad hoc meetings. The chair will have its own section in PHE’s annual report which it will draft personally and independently, and that report will also reflect the views of external agencies and individuals who have dealings with PHE. I hope that that gives my noble friend additional assurance about the independent voice that we want to see and hear.

My noble friend Lady Cumberlege asked me whether PHE will be able to give professional advice freely to the public. We expect it to do precisely that, in much the same way that the Chief Medical Officer already does. It will be good practice for PHE and the department to consult each other about communications on public health matters, but with a view to agreeing the content, not censoring it.

PHE data will be subject to the code of practice on official statistics, which severely restricts access to certain material by Ministers or officials before it is published. Within three years of PHE becoming operational we will undertake a review of its governance to ensure that it is entirely appropriate and effective.

My noble friend’s amendment also addresses the very significant issue of PHE’s capability to undertake research and to bid for external research funding—a matter to which the noble Lord, Lord Warner, devoted particular attention. This is something we have touched on in previous debates, and it is clearly vital to PHE’s long-term success. We will publish more information about how PHE’s research function will work, including its relationship with academic institutions, but I can assure noble Lords that it will be able to exercise all the necessary powers and duties of the Secretary of State in relation to research.

In particular, Clause 6 confers on the Secretary of State a duty to promote research relevant to the health service, which embraces public health services. Clause 11 specifies that the conduct of research is an appropriate step for him to take under his health protection duty. Clause 50 provides that charges may be made in respect of such steps. Clause 17(13) confirms the Secretary of State’s power to conduct, commission or assist research relating to health, which includes the power to apply for grants or other funding for the purpose of such research. In addition to the Bill’s provisions, the Secretary of State has power to generate additional income for the health service under Section 7 of the Health and Medicines Act 1988, which can be used by PHE to provide research services under contract. I can therefore reassure my noble friend and the noble Lord, Lord Warner, that existing legislation gives the Secretary of State, and therefore PHE, the freedom to bid for research funding and to tender for contracts.

The noble Lord, Lord Warner, asked about external partnerships and whether agencies that currently fund the HPA research will be able to fund PHE in the future. The answer is that we are not aware of any insurmountable obstacle to any of the HPA’s current partners choosing to fund PHE, although in some instances PHE may need to collaborate with an academic institution. Of course, we cannot guarantee that they will choose to. All we can do is ensure that PHE remains at least as attractive a partner for health protection research as the HPA has been. I can also say to the noble Lord, Lord Patel, that we will publish more information on this question quite soon, but we have no reason to believe, as I say, that academic institutions will be reluctant to go into partnership with PHE. In fact, the National Institute for Health Research has already announced that it will invite joint bids.

My noble friend’s amendment and the powerful way in which she has argued for its objectives—

Health and Social Care Bill

Debate between Lord Willis of Knaresborough and Earl Howe

Monday 27th February 2012 Lords Chamber

[Earl Howe]

My Lords, we had a very positive debate on the importance of research at an earlier stage of Report. I was grateful to the noble Baroness, Lady Morgan, for the support she expressed for the changes the Government have made to the Bill. I am more than happy to respond to these amendments this evening. I sympathise and agree with the noble Baroness’s championing of research in this Bill. She and my noble friend Lord Willis have been particularly vocal and well informed on this subject. Nevertheless, I am afraid I am reluctant to agree that the Bill needs yet more amendment. Having said that, I hope I can reassure the noble Baroness going forward.

On Amendment 60A, the duties on the Secretary of State, the board and CCGs to promote research and the powers to conduct research all apply to the health service in its widest sense. This encompasses both NHS and public health services under the 2006 Act. In relation to the board’s duty in new Section 13L, the duty to promote research on matters relevant to the health service already covers public health protection. Public health protection is a function of the Secretary of State under Section 2A of the 2006 Act and therefore part of the health service.

There are also other clauses in the Bill that focus specifically on research into health protection. Clause 10 lists research and other steps for advancing knowledge and understanding as examples of action that the Secretary of State may take under his wider duty in relation to protecting public health. Public health and health protection in particular will, of course, be predominantly the responsibility of Public Health England rather than the board. It is not therefore necessary for the board’s functions to cover such matters but there will, of course, be close working between them and there are powers under Clause 21 for the Secretary of State to arrange for other bodies, including the board, to undertake any of his public health functions if necessary.

Turning to Amendments 66AA and 67AA, we have had a number of debates about exactly what the board should give particular attention to in its annual business plan and its annual report. I would like to remind your Lordships that the board is already required to set out in these documents how it intends to exercise its functions including how it will meet the various duties placed on it under the Bill.

The Bill emphasises a very few key duties that the board must look at in particular in its business plan, annual report and performance assessments, and that CCGs must look at in their commissioning plans and annual reports. We feel that we have chosen the right duties in each instance. As to the board’s and CCGs’ annual reports, it is more important that they focus on the outcomes that have ultimately been achieved through the provision of services, rather than on the way in which those services are being delivered. On the whole, that is the distinction we have tried to draw.

My noble friend Lord Willis asked about Dame Sally Davies and her reporting lines. I am sure my noble friend will remember that I wrote to him on 17 November and briefly covered this point. In short, as he knows, the National Institute for Health Research is and will remain part of the Department of Health. Its budget is held centrally by the department. The Chief Medical Officer is and will remain responsible for the NIHR and its budget. In her capacity as Chief Scientific Adviser and head of the NIHR, she will report to Ministers and the Secretary of State, but she will be there to give advice to the NHS Commissioning Board if asked to do so on matters relating to research. Similarly, in her capacity as CMO, she reports directly to the Secretary of State, but will be there to provide advice to Public Health England. I hope that that is of help to my noble friend.

The noble Lord, Lord Turnberg, asked me how the local authority role in promoting research would be assisted and how that would manifest itself in practice. I should like to write a letter to him on that point because the planning on that is, if I can put it this way, work in progress and I hope that I will be able to tell the noble Lord a little more in writing in a few days’ time.

[Lord Willis of Knaresborough]

Before he sits down, will my noble friend tell the House whether he has made it clear in his remarks that the chief executive of the Commissioning Board will not have a direct relationship in terms of research, and will not have responsibility that will, in fact, be with the Chief Scientific Officer—the head of the NIMR? If that is the case, how on earth will the Commissioning Board have a relationship with the commissioning groups in terms of their duty to promote research?

[Earl Howe]

My noble friend is not correct. The board will have a duty to promote research, and we have debated that point. What it will not have is the budget for the National Institute for Health Research, which is held centrally. I think that noble Lords have welcomed that because it will mean that that budget is held separately from the board’s own budget. However, that does not absolve the NHS Commissioning Board from responsibility for promoting research. Indeed, it will do that and have responsibility in particular for ensuring that the health costs of research carried out in NHS establishments are covered under the various tariffs. That will be a major part of the board’s work.

I hope that I have reassured the noble Baroness sufficiently to enable her to withdraw her amendments, but I should of course be happy to talk to her outside the Chamber if there remain points that she would like to raise with me.

Health and Social Care Bill

Debate between Lord Willis of Knaresborough and Earl Howe

Wednesday 21st December 2011 Lords Chamber

[Earl Howe]

I shall be glad to attend to the noble Lord’s request.

[Lord Willis of Knaresborough]

Perhaps not quite in the spirit of Christmas, with regard to the important issue which the noble Baroness, Lady Thornton, raised and the noble Baroness, Lady Williams referred to, it is frankly not good enough to say that there will be a letter, which none of us will actually see apart from those particular people over the Christmas period. The major question which hangs over this House is whether the tribunal’s decision will be made available before the Report stage. Could the Minister give a real Christmas present to this House by saying that, whatever happens, the Report stage will not take place until that decision is available?

[Earl Howe]

I cannot give that undertaking, for the reasons that I will set out in the letter. The position—which I shall elaborate on when I write—is that the Information Commissioner has requested more time, and in light of that we have made representations to expedite the process as far as possible. However, the advice I have at the moment is that it is highly unlikely, if not impossible, that the judgment will be delivered before we are due to go into the Report stage of the Bill. This is something that we are dealing with at present, and if I can update my noble friend, as well as other noble Lords, when I write, I shall be happy to do that. I do not wish this to be a closed process. All noble Lords in this Committee who have taken part in these debates are very welcome to be copied in.

Health and Social Care Bill

Debate between Lord Willis of Knaresborough and Earl Howe

Wednesday 7th December 2011 Lords Chamber

[Earl Howe]

My Lords, the amendments in this group aim to create a Health Research Authority. My noble friend has explained the rationale for the authority very succinctly and I want to make it clear at the outset that I am on precisely the same page as him as to what he is seeking to achieve for health research. We announced in the Plan For Growth in the Budget in March that we would create a body to combine and streamline the approvals for health research, which are at present scattered across many organisations. We also said that wherever we can achieve this simplification without primary legislation, we will. We have already laid legislation to establish the Health Research Authority, which started its work on 1 December 2011 as a special health authority, as was reported in Monday’s Statement on our strategy for UK life sciences. In that form it will take on a number of key functions and I will come to those in a moment.

Looking ahead, as I mentioned earlier, we will be consulting on the future of the HFEA and the HTA. That consultation, as the noble Lord, Lord Beecham, has pointed out, has been delayed but we are still very much intent on launching it and hope to do so shortly. We look forward to stakeholders’ views on the option of passing the research-related functions of the HFEA to the HRA as proposed in the AMS report. In that regard, where primary legislation is required to consolidate functions, we intend to subject it to pre-legislative scrutiny during the next Session and to introduce it as soon as parliamentary time allows.

It may interest my noble friend to know that I am upbeat. I am advisedly upbeat and want to stress to him and other noble Lords that contrary to the apprehensions that have been expressed, the Health Research Authority will have substantive functions as a special health authority. It will combine and streamline approvals for health research through unification of functions and processes wherever that is possible without additional legislation and through co-ordination where it is not. I say to my noble friend without any hesitation that we can achieve a very high proportion of what we wish to achieve with the HRA in this form as a special health authority. It will bring together functions relating to research ethics committees currently performed by the Secretary of State, the National Patient Safety Agency and strategic health authorities. It will operate a single system for researchers to apply for approval to research ethics committees, NHS trusts, the Medicines and Healthcare products Regulatory Agency, the National Information Governance Board and the Administration of Radioactive Substances Advisory Committee.

By April 2013, it is intended also to bring in functions currently performed by the Secretary of State on the advice of the National Information Governance Board’s ethics and confidentiality committee. The Health Research Authority will also work closely with the bodies I have just mentioned, as well as the Care Quality Commission, the Human Fertilisation and Embryology Authority, the Human Tissue Authority and the National Institute for Health Research to co-ordinate relevant functions, processes and standards. That is why, despite my noble friend’s understandable desire to see an NDPB established as soon as possible, I suggest to him that for practical purposes, setting aside the HFEA issue for one moment, the amendment is unnecessary.

However, there is another reason why it would not be right to establish the agency in this Bill—it would not be for the good of research in this country. I say that for the following reasons: it would weaken parliamentary scrutiny by stopping Parliament being able to debate primary legislation on the functions of the agency because it would consign much of the detail to secondary legislation—I do not think that is something that in the past your Lordships’ House has been keen on. It would pre-empt public consultation; for example, on the future of the HTA and the HFEA, and in my view it would put haste ahead of getting it right by dealing with a complex issue without due discussion and consideration.

[Lord Willis of Knaresborough]

I am listening carefully to what my noble friend is saying. However, Amendment 258 would not compromise in any way the consultations which he has rightly promised on the HTA and the HFEA. The proposed new subsection (3)(a) in Amendment 258 refers to,

“the provision of ethics committee opinions and other approvals”.

It does not state what those other approvals are. Therefore, if the amendment were passed, the Minister could consult in a year’s time or in two years’ time and come to a decision without compromising those approvals.

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[Earl Howe]

I hear what my noble friend says but I cannot agree that his approach is the best for research in this country. Very real risks would accompany trying to shoehorn a very important and complex issue into this Bill in what I have to say to my noble friend is an inappropriate legislative form. The noble Lord, Lord Warner, asked about the view of the Academy of Medical Sciences on this matter. The last time that I spoke to staff at that body, which was not very long ago, they were dead set against my noble friend’s approach. They believe that the approach the Government are taking, which is a step-by-step approach, is exactly right. They recognise that the Special Health Authority can achieve a very great deal, we do not need to rush into primary legislation and we would do very much better to take our time over that process.

My noble friend mentioned the devolved Administrations. We have also directed the Health Research Authority to collaborate with the devolved Administrations in the exercise of its functions. We expect it to maintain effective communications with the UK health departments on the practical implications of implementing legislation, policy and guidance, building on the success of the national research ethics service at developing a single UK-wide system for research ethics committee review. Therefore, I do not regard that problem as at all insurmountable.

We agree with the intention behind Amendment 260C of improving the consistency and efficiency of reviews of the bodies carrying out research. We consider the National Institute for Health Research to be a more appropriate mechanism than the Health Research Authority for taking action to achieve outcome improvements, such as those called for in the Academy of Medical Sciences report. My noble friend may wish things were otherwise but noble Lords need to remember that NHS trusts are autonomous bodies. It is important that there is a clear division between the responsibilities accepted by them when planning and conducting research and the responsibilities of the body that regulates their practice. In this environment, the NIHR is in a strong position to support and influence them. The NIHR has already introduced mechanisms to achieve the effect of Amendment 260C through its co-ordinated system for gaining NHS permissions, its research support services framework of standard operating procedures and good practice guidance and its research passport scheme. It is also introducing benchmarks for NHS trusts’ performance in the initiation and delivery of research. NIHR funding will become conditional on meeting such benchmarks, so there is a direct incentive for NHS organisations to comply with those benchmarks.

As regards the Health Research Authority monitoring developments relating to activities within its remit, I thank my noble friend for raising the horizon-scanning point. I will gladly consider that further to see what can be done.

In sum, I do not see this amendment as appropriate. I appreciate that my noble friend intended it as a probing amendment, but I hope that I have set out clearly why I do not think that this would be the right way to go. Noble Lords can be relaxed that we are already embarked on a course which should deliver major improvements in all the areas where we want to see improvements as regards the clinical trials process in this country. As I say, I am optimistic that we are embarked on the road to the sunlit uplands in this sense. We will in due course—I hope that that will be sooner rather than later—come to a point where we can embody these things in primary legislation. However, I urge noble Lords to consider the need to take our time and to consider those matters very carefully.

[Lord Willis of Knaresborough]

My Lords, I thank the Minister, as always, for his courteous and passionate reply to this debate. He has used the words upbeat, relaxed and enthusiastic about the amendments and the aim behind them and I appreciate what he said. He made the point—and has made it often—that the Special Health Authority, which was set up on 1 December, will be able to take on, over a short period of time, many of the functions which I have outlined in Amendment 258. I would be grateful if the Minister would put in writing the timetable for delivering all those elements. It would be hugely advantageous to know just how they would fit and dovetail in.

My noble friend Lord Warner—well, he is a friend—commented on the views of the Wellcome Trust and the Academy of Medical Sciences; the Minister said that the Academy of Medical Sciences was against the Willis amendment. In fact, the last time that we met the Academy of Medical Sciences—the noble Lord, Lord Turnberg, and I were on the same platform with it about a month ago—the academy made it clear that, while it did not want to have any detail in the Bill because that would compromise the detailed discussions, it was happy to see the architecture in the Bill. This is something which the Wellcome Trust supported; in fact, I was helped by both the trust and the Academy of Medical Sciences in drafting these amendments. The Association of Medical Research Charities, which I chair, was also incredibly helpful. There are, perhaps, some crossed wires here.

On Amendment 260C, I hear what the Minister says about bringing those two issues together, particularly for the R&D functions of NHS trusts. I said that there is a real issue about autonomous organisations. Why has the NIHR not actually done it? If this is the biggest obstacle to getting clinical trials developed quickly in the UK, why has it not already forged those relationships, and what confidence do we have that it will be able to do so over the next year or so?

This has been a good debate and I am incredibly grateful to noble Lords throughout the House for their support for these amendments. I still believe that the proposals in Amendment 258 could be in the Bill but given the Minister’s assurances and his willingness to debate these issues further, I beg leave to withdraw the amendment.

Life Sciences

Debate between Lord Willis of Knaresborough and Earl Howe

Tuesday 6th December 2011 Lords Chamber

[Earl Howe]

The planning horizon for research, as my noble friend will know, has always been a long one. With the increasing cost of research, particularly in later stage clinical trials, companies end up making an extremely significant investment in order to bring one molecule to the market. What we seek to achieve for big pharma in this package of measures is a sense that we in the UK have, as it were, an unrivalled ecosystem that brings together business, researchers, clinicians and patients to translate discovery into clinical use for medical innovation within the NHS. What we want them to appreciate is that the UK provides an environment and infrastructure that supports pioneering researchers and clinicians to bring innovation to the market earlier and more easily so that this country becomes the location of choice for investment. I am thinking here particularly of our proposals for setting up academic health science networks that will span the NHS. That is our ambition. I am thinking of the early access scheme for medicines, which was mentioned in the Statement. We want to break down the regulatory barriers to speeding up clinical trials that have beset the industry. For all those reasons, I should like the industry to see this as facilitating a shorter time horizon. However, we cannot do anything to get around the essential safety and quality standards that the patient and the citizen rightly insist upon.

[Lord Willis of Knaresborough]

My Lords, I welcome the Statement from my noble friend. I realise that other noble Lords want to get in. I should like to ask a few brief questions. First, we have to recruit patients on to trials. It is interesting that there is a proposal automatically to opt patients in to trials—or at least have access to them. How will that be achieved? Will it be achieved through this Bill? Secondly, will the £180 million catalyst fund for the valley of death replace the Health Innovation Challenge Fund that currently operates between the Department of Health and the Wellcome Trust? If not, where will the £180 million come from?

[Earl Howe]

My Lords, I shall answer the second question first. The £180 million biomedical catalyst fund is a completely new fund for industry. Its object is to nurture innovative technologies from the academic or commercial sector through to companies with products or technology platforms in order to attract private equity. I shall probably need to write to my noble friend with further details of where the money is coming from. It is coming from the budget of BIS, rather than my own department, and it is therefore necessary for me to ask my colleagues in BIS precisely where the money emanates from. I am happy to let my noble friend know.

The proposal to which he referred is only a proposal. We are suggesting that the public should be asked whether the NHS constitution should be changed so that patients are aware that their data, as now, can be used in anonymised form for research. Our intention is to ask more patients whether they wish to be approached for research if that research is relevant to them. As the Statement made clear, we know that more than 70 per cent of the public wish to be informed if a piece of medical research is relevant to them. Patients are keen to be involved in this. It is important to have a public dialogue about the extent to which patients may be approached so that they may know in advance that there is a possibility of a project being relevant to them. We are formulating these proposals now and it will be some time before we issue the consultation. I shall make sure that I let my noble friend know as our proposals crystallise in this area.

I can, in fact, answer my noble friend’s earlier question as to whether the Health Innovation Challenge Fund is being replaced. No, it will continue.

Health and Social Care Bill

Debate between Lord Willis of Knaresborough and Earl Howe

Wednesday 9th November 2011 Lords Chamber

[Earl Howe]

I should be very glad to do so. The noble Lord may not be surprised to hear that, when I was being briefed for this Bill, I had to ask myself that very same question. The definition is there, but I think that it would be helpful if I set out the import of that phrase in its fullest sense.

I hope that I have said enough to encourage noble Lords not to press their amendments, but, in doing so, I reiterate my thanks to all noble Lords who have made such an excellent contribution to this debate.

[Lord Willis of Knaresborough]

My Lords, I thank the Minister for, as ever, a very courteous and thoughtful response to many of the issues which have been raised, in particular his response to Amendment 39 and his undertaking to reconsider “have regard to the need to”, which appears to be a little bit of clumsy draftsmanship that would be unworthy of the Minister himself.

The Minister raised a number of important issues, including that to which the noble Lord, Lord Warner, referred. We have now had a definition of “health service” which includes public health. That means that public health research could lie within some local authorities, because a significant amount of public health will be devolved to local authorities. While I was pleased to hear the Minister say today that those people moving from the National Health Service to local authorities for public health matters would retain National Health Service terms and conditions, the reality is that they will be working under a local authority aegis and that research would therefore be an issue for local authorities rather than Public Health England—or so I understand, but we will probe that later.

On protecting funding, I was particularly grateful for the way in which my noble friend the Minister responded to the idea of ring-fencing. He spoke not of ring-fencing, but said that there had been an increase in budget. It would have been good if he could have made that comment. However, he did say that NIHR would remain a stand-alone organisation. That was news to me; I thought that it was going to move into other organisations. Quite frankly, that is good news. It has a reputation which demonstrates that research is very important and we can track how it is used and when. I thank the Minister for that.

I apologise profusely to the noble Baroness, Lady Emerton, for indicating that “research” meant the work that is coming out of universities and being translated for use at the bedside. She was quite right to remind us that “research” for the purposes of this Bill was all research, and that what should underpin all public policy, in the NHS or anywhere else, is research which gives you evidence to inform policy decisions. I thank her for that rebuke.

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[Earl Howe]

My Lords, Amendment 41A, tabled by my noble friend Lord Willis, will require the Secretary of State to set up a system to ensure that research is conducted properly and ethically and that there are sanctions in place in cases of misconduct. Let me say straight away that I am in agreement with the intention of my noble friend in tabling this amendment; the proper conduct of research is very important, just as proper conduct is critical in clinical practice. All my noble friend’s comments on that theme were extremely pertinent.

Looking at the amendment as it is worded, I can assure my noble friend that there are already systems in place to ensure that research is conducted ethically. Research, as he knows, cannot proceed without ethics committee approval. I realise that this is a probing amendment, but equally, as it is worded, it overlooks an important element in the current system of accountability, because it would risk undermining the clear responsibility in research, as in clinical practice, that employers have for the conduct of their employees and that professional councils have in regulating their members. Both can impose sanctions on researchers if their conduct is found to be inappropriate. I do not see that it is the responsibility of the Secretary of State to impose sanctions on clinical professionals, and it should not be his responsibility to do so for researchers. In the future, the Health Research Authority will continue the good work of the National Research Ethics Service, working with others to prevent misconduct by ensuring that the ethics of research have independently reviewed by research ethics committees.

This evening, I am able to give a new commitment to my noble friend. I am happy to tell him that we intend to publish the draft clauses on research for pre-legislative scrutiny in the second Session of this Parliament. That scrutiny will enable my noble friend and other noble Lords to comment on the detail of our proposals for the Health Research Authority and, in turn, enable us to ensure that future legislation is fit for purpose. I hope my noble friend will welcome that pledge.

If I may, I will cover the question my noble friend asked me about the concordat in a letter to him following this debate. I hope I have reassured him that there are systems in place to ensure good conduct in research. Nevertheless, his points are well made and I shall reflect fully upon them. I can only say at the moment that the Health Research Authority intends to build on these systems. In the light of what I said, I hope my noble friend will feel able to withdraw his amendment.

[Lord Willis of Knaresborough]

I am grateful to my noble friend the Minister for that response. In view of it, I beg leave to withdraw the amendment.

Health and Social Care Bill

Debate between Lord Willis of Knaresborough and Earl Howe

Monday 7th November 2011 Lords Chamber

[Earl Howe]

My Lords, I have yet to hear from at least one of those consultants. Clearly it is for them to explain why they added their names. I am trying to explain to my noble friend that I see grave problems in accepting an amendment of this kind because in practice it is a non-issue, and because the idea that this is a matter for public policy is one that we should perhaps have a further conversation about. I am not convinced that my noble friend is introducing a matter that should go into statute. It is probably best if we defer further debate on this subject. I have listened carefully to my noble friend and other noble Lords who have spoken. I am happy to have a conversation with him after the Committee stage. I understand the issue that he has raised and I hope that he will accept that, but I see considerable difficulties in trying to frame an amendment in a way that will do precisely what he wants.

[Lord Willis of Knaresborough]

Could I help my noble friend? A sensible suggestion was made that this was more a role for Monitor than anything that should be in an amendment to the Bill. Would my noble friend agree that when this comes back, either later in Committee or on Report, we should look at whether Monitor should carry out the new duty, proposed in the Bill, to reduce inequalities? That might be a better way of moving forward.

[Earl Howe]

I shall be happy to look at that. Of course, Monitor has a role in making sure that a foundation trust adheres to the conditions of its authorisation, one of which is that its principal purpose will be to serve NHS patients. There could be mileage in that and I would be happy to look at it.

Health and Social Care Bill

Debate between Lord Willis of Knaresborough and Earl Howe

Tuesday 25th October 2011 Lords Chamber

[Earl Howe]

I will happily consider that between now and Report, as indeed I will consider all the points that have been powerfully made in this debate. I have quite a lot more to say in answer to various questions that have been raised, and I hope that I will be given the opportunity to do so.

The Government’s amendment, quite consciously, does not confer any new powers on the Secretary of State. It requires him to exercise his existing powers to provide an existing system. The duty means that he would have to intervene if the system was failing and ineffective. He has a range of powers, including the powers to provide or commission training under Section 63 of the 1968 Act, as referred to in subsection (2) of the Government’s amendment. However, the point is that future legislation may add further powers to those that the Secretary of State already has, and that is what I cannot pre-empt in my reply today.

[Lord Willis of Knaresborough]

My Lords, I am sorry to interrupt. I have listened carefully to the whole debate today and it seems that we are hampered by the fact that we do not know what is going to go into this new Bill or indeed when it is going to appear. The Minister has been consulting on this issue for nearly 18 months. Will he give the House a clear understanding that in the next Queen’s Speech there will be two Bills, one of which will deal with education and training while the other deals with research? Could he give the House that assurance so that we know what the timetable is for the delivery of these elements?

[Earl Howe]

I would like nothing more than to give that assurance but unfortunately I cannot, as I am not in a position to know what the Government’s programme in the next Session is going to be. I know that it is the hope and wish of many noble Lords that we will have a social care and health Bill.

[Lord Willis of Knaresborough]

This is important. I understand what the Minister is saying but at least he could have given us guidance that such Bills would have been in the next Queen’s Speech. If we are talking about another period of two years or more, we are looking at total confusion for that period of time in terms of the delivery of education, training and, later on, research. That cannot be what the Government want; it certainly cannot be what the Minister wants.

[Earl Howe]

My noble friend knows—very well, I hope—how important research is to Ministers in my department, how important education and training are and how important it is that we have a system for the provision of social care that commands the support of all parties. A Bill of that kind is something that we dearly wish to see coming to Parliament as soon as possible. However, he will understand that I am not in a position to give any undertaking about the next Session, much as I would love to be able to wave a wand and do so.

Perhaps I could be allowed to answer some of the questions that have been asked of me.

Multiple Sclerosis

Debate between Lord Willis of Knaresborough and Earl Howe

Thursday 13th October 2011 Lords Chamber

[Earl Howe]

My Lords, I take the noble Lord’s point. NICE is reviewing its clinical guideline. That is not due to be published until 2014. Although we strive to ensure that there is national guidance on the most commonly used medicines and treatments, there will always be instances where decisions have to be made locally. Under the NHS constitution, patients have the right to expect local decisions about the funding of medicines and treatments to be made rationally, following proper consideration of the evidence. We are emphasising to PCTs that they should do just that.

[Lord Willis of Knaresborough]

My Lords, one of the great problems—

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[Earl Howe]

My Lords, new and innovative treatments for MS are being developed in a number of countries. It is quite clear that any new treatment of this kind should be subject to the rigours of the regulatory system before it is made available to NHS patients. Many of them will not have been fully tested to ensure efficacy and safety, but we will of course examine every novel and innovative treatment that has the potential to benefit patients.

[Lord Willis of Knaresborough]

My Lords—

NHS: Clinical Excellence Awards

Debate between Lord Willis of Knaresborough and Earl Howe

Monday 27th June 2011 Lords Chamber

[Earl Howe]

My Lords, the pay structure for clinical commissioning groups is a separate issue from clinical excellence awards, which apply only to those holding a consultant’s contract in the NHS. To the extent that anyone holds a consultant’s contract in any of the clinical commissioning groups, they will be subject to whatever new scheme the DDRB recommends and the Government accept.

[Lord Willis of Knaresborough]

Would my noble friend accept that one of the real challenges is to make sure that people who are working in clinical practice have the opportunity to engage in research? Research salaries are significantly lower than clinicians’ salaries. What is the Minister doing to try to ensure that there is a seamless progression between research and clinical practice and between clinical practice and research?

[Earl Howe]

My Lords, those who hold honorary contracts, who are in general clinical academics, are well represented among those who are awarded clinical excellence awards. We are absolutely clear that that should continue as long as possible. We must incentivise those who do not spend the bulk of their day engaged in treating patients so that we ensure that we have a bank of academic excellence driving forward innovation in the NHS.

Health: Brittle Bone Society

Debate between Lord Willis of Knaresborough and Earl Howe

Monday 6th June 2011 Lords Chamber

[Earl Howe]

My Lords, I shall need a small tutorial from my noble friend on that condition, which is not mentioned in my brief, I fear.

[Lord Willis of Knaresborough]

My Lords, does my noble friend the Minister accept that the charitable sector is absolutely fundamental to medical research in this country, putting over £1.4 billion a year into research? The Brittle Bone Society is one of the charities that does exactly that. However, many of these charitable research organisations fear that the resources that go in through the charitable support fund may be lost at the end of this comprehensive spending period. Will my noble friend give an assurance that that fund will continue at current levels into the future so that the charitable sector in funding research can have the security of knowing that it will not have to find money simply to underpin the research facilities in our universities?

[Earl Howe]

My Lords, the voluntary sector investment programme has a confirmed budget of £25 million for 2011-12. That is the same as the budget allocated last year. I hope that that sends a strong message to commissioners about the role that the voluntary sector plays in health and care. We are sending a message to local authorities and PCTs that the voluntary sector should not shoulder a disproportionate share of any funding cuts that they may have to implement.

Public Bodies Bill [HL]

Debate between Lord Willis of Knaresborough and Earl Howe

Monday 9th May 2011 Lords Chamber

[Lord Willis of Knaresborough]

Does the Minister not understand the incredulity of many of us? This is a Bill that deals with getting rid of quangos, yet the Minister’s solution is to set up a quango to create time in order to set up a bona fide agency. Surely the Minister sees that by simply delaying the whole process until the agency is in place, everything can be transferred either to the CQC or to the new agency, all at once, without an interim body.

[Earl Howe]

I ask my noble friend to wait a few minutes; I hope I will tell him something that he will welcome.

I turn to the amendments. On Amendments 7 and 8 the issue is not so much the end point that they seek to achieve as the practical implications that they would carry if they were accepted. Let me set out what we plan to do. There will be a full public consultation on our proposals this summer. Alongside that, we will publish an impact assessment, which will include a view about the cost-effectiveness of options for transferring functions. I assure the House that the key comparison for the purposes of the assessment will be between our preferred option and the organisations’ own plans for rationalisation. I hope noble Lords will endorse the idea of a formal impact assessment as the vehicle for doing this. It is a process that, until now, has been accepted by Parliament for general legislative and policy changes. There does not seem to be any obvious reason why that should not be an appropriate way to proceed in this case.

In addition, as I have said previously, there will be a further consultation on the proposed regulations in due course before these are laid. Taken together, these three safeguards should be sufficient to meet the aspirations of noble Lords for achieving a robust evaluation. The approach that we propose on consultation and impact assessment will, I suggest, produce a result that is thorough, transparent, balanced and, therefore, fit for purpose. The amendments, taken literally, would have us go further by suggesting a formal process of independent assessment of cost-effectiveness. This would be neither necessary nor desirable. With the best will in the world, any such assessment would be costly to the public purse, highly subjective—as any assessment of cost-effectiveness is bound to be—and very difficult to measure definitively. Practically, it would get us no further forward than a standard impact assessment. In any issue of this kind, we need to take care that legislation does not set conditions that are impossible to meet. That is why I hope the assurances that I have given will be enough to persuade the noble Baroness not to press these amendments.

In turning to Amendment 9, I will address the question posed by my noble friend Lord Willis. The amendment seeks to ensure that no HFEA or HTA functions would be transferred using the powers in this Bill until the health research regulatory agency has been established. I fully appreciate the reasoning behind this. It very much accords with the Government’s wish to avoid a piecemeal approach to the transfer of functions. In my letter of 27 April to the noble Baroness, Lady Thornton, I said that,

“in principle our preference would be to consult on the draft secondary legislation during 2012 and to commence it after the primary legislation is place that will give the health research regulatory agency the necessary legal basis. In that way, transfer could take place as a single and clear exercise, and in a co-ordinated and least disruptive way”.

In the light of this amendment and the points made today in support of it, I am prepared to go further and give a firm commitment that, subject to the will and views of Parliament, the Government will proceed on the basis of transferring functions from the HFEA and HTA only once the research regulatory agency is established in legislation. I hope that this commitment will satisfy the House. There are problems with including the amendment in the Bill from a legal perspective. It is difficult to envisage how, within this Bill, we could describe with the necessary level of legal certainty the new research body that would need to be established. The detail of what a new regulator will look like and the functions it should hold is a matter for Parliament to debate and determine as and when the relevant legislation comes before it. To make provision for a future body in this Bill risks both describing it in a way that is not accurate, thus making the power to transfer functions redundant, and attempting to limit the discretion of Parliament in relation to future legislation.

The amendment also seeks to provide in this Bill that the research agency,

“must have a separate ethics committee to undertake … ethical consideration functions”

transferred to it from the HFEA and HTA. I fully appreciate the need for assurance that the research regulatory agency will have access to the relevant expertise to deal with the licensing of embryo research and any research-related functions that may transfer to it from the HTA. Therefore, I repeat the assurance that we have consistently given that expertise will follow function, and that we expect that the research agency will have access to expert peer reviewers and others in the relevant fields that are currently available to the HFEA and HTA. However, I suggest that the level of detail on matters such as expert committees is again more appropriate for consideration by Parliament in relation to any legislation that will seek to establish the research regulatory agency rather than attempting to include it prematurely in this Bill.

Although, for the reasons I have given, I cannot accept the amendment, as I indicated at the beginning of my remarks, I would like to believe that noble Lords who have spoken will not now be too far removed from the Government’s own position on these matters. In view of our developed approach to the transfer of functions and our clear intention to consult on our proposals in an open and transparent way, I hope that the noble Baroness will feel able to withdraw the amendment.

Public Bodies Bill [HL]

Debate between Lord Willis of Knaresborough and Earl Howe

Monday 28th March 2011 Lords Chamber

[Earl Howe]

My Lords, I do not think that I am chancing my arm by saying that that is my understanding of what the impact assessment ought to look like in that a typical impact assessment will have within it several alternatives so that it is possible to compare different options. I would be happy to come back to the noble and right reverend Lord with a definite answer on that but my understanding from previous impact assessments is that that kind of benchmarking ought to be possible.

The noble Baroness, Lady Thornton, has previously raised her concerns about where the ethical framework for any new arrangements will sit. Ethical safeguards, for example concerning the embryos and gametes that can be used in treatment, the need to consider the welfare of the child and the need for consent in respect of human tissue, are clearly enshrined in legislation in accordance with the wishes of Parliament. These safeguards will continue to remain firmly in place and will underpin the regulation of treatment and research as currently, by whoever is responsible for regulating. Where there are specific ethical issues surrounding new treatments, the department will consider how best to commission expert advice on an individual basis, as is currently being done for mitochondrial transfer, for example.

A number of noble Lords have shown interest in and support for the Government’s announcement last week, as part of the growth review, about streamlining research regulation and governance. The Government announced in the Plan for Growth on 23 March that they will create a health research regulatory agency to combine and streamline approvals for health research which are at present scattered across many organisations. As a first step, the Government will establish this year a special health authority with the National Research Ethics Service as its core. When established, the new agency will work closely with the Medicines and Healthcare Products Regulatory Agency to create a unified approval process and promote proportionate standards for compliance and inspection within a consistent national system of research governance.

This will reduce the regulatory burden on firms and improve the timeliness of decisions about clinical trials and hence the cost-effectiveness of their delivery in the UK, and has clear support from the Academy of Medical Sciences review of medical research regulation and governance.

In this context, it is important for me to remind the House of a key point. Here I refer particularly to the question posed by the noble and right reverend Lord, Lord Harries. The AMS report recognised at paragraph 9.5.1 that there are significant benefits in bringing all medical research regulation, including embryo research currently undertaken by the HFEA, within the remit of a single health research regulatory agency. Indeed, remarks made by Sir Michael Rawlins in the Guardian on 11 January firmly backed up that view. We agree with that proposition but again the consultation will invite views on it.

My noble friend Lord Willis expressed his fears about the Government adopting a piecemeal approach to reorganisation, as did some other noble Lords. I accept that our approach to the HFEA and the HTA may indeed seem rather complex. The powers of the Public Bodies Bill will enable us to transfer some of the functions of the HFEA and HTA to other bodies but they do not enable us to do everything that we have set out in the arm’s-length body review. In order to abolish the HFEA and HTA, or to transfer their research-related functions to any new research agency, we will require powers under future primary legislation.

It might help if I provided a rough outline of how and when we could take this forward. We intend publicly to consult on proposals to transfer all the HFEA and HTA functions to other bodies in the late summer of this year. During 2012-13, under the provisions of the Bill, we will prepare draft orders for formal consultation dealing with the transfer of functions, other than research functions. If appropriate, we would then be able to lay the orders before Parliament. This process would enable noble Lords and other interested parties to see, comment on and debate the proposals, as they progress.

Without the inclusion of these bodies in Schedule 5, we would have to provide for the transfer of their functions entirely within future primary legislation. I simply say again, particularly to the noble Lord, Lord Warner, that not including these bodies would significantly increase the risk that the underlying ethical provisions of the Human Fertilisation and Embryology Act and the Human Tissue Act were reopened for debate.

[Lord Willis of Knaresborough]

Would it not be possible to include a new clause in the Health and Social Care Bill to set up the new medical research agency and leave to consultation and secondary legislation the details that would follow? That would at least give certainty to that organisation and, with a new Bill in the second part of the Parliament, put it into the parliamentary timetable much earlier than envisaged.

[Earl Howe]

In theory, my noble friend makes a constructive suggestion. We have considered that option and, I am afraid, rejected it on the grounds that the Health and Social Care Bill is big enough as it is, and contains a substantial programme of modernisation. It would be possible to Christmas-tree that Bill almost ad infinitum, and we have decided that that would not be helpful. With the Health and Social Care Bill, we seek to focus on the modernisation agenda, pure and simple. I am sorry to disappoint my noble friend, who makes a perfectly sound point, but I am afraid that we are not going to do that.

As I made clear earlier, I confirm to my noble friend that the CQC will have staff transferred into it. The intention is that expertise in staff and advice will follow the functions. Unfortunately, we cannot be definite about exactly which functions will be transferred to the CQC or elsewhere until after the summer consultation. If, standing here, I were to say exactly how that would work, I would be pre-empting the results of that consultation. I agree on the desirability of having clarity and certainty, and our aim is that there should be more clarity and certainty for HFEA and HTA staff after the consultation.

The noble Baroness, Lady Warwick, asked a number of detailed questions about the effect of our proposals on bodies regulated by the HTA and the way that its functions are performed. The case that she put eloquently was an argument in favour of keeping the HTA’s functions together. I understand her point of view; however, I reassure her that we will consult on the option of keeping the HTA’s functions together. We will not consult simply on one model, let alone pre-empt the results of the consultation.

Human Fertilisation and Embryology: Regulation

Debate between Lord Willis of Knaresborough and Earl Howe

Wednesday 13th October 2010 Lords Chamber

[Earl Howe]

My Lords, I recognise the experience of the noble Baroness and I pay tribute to her time as chair of the HFEA. The review that we have conducted has been based on a close examination of the functions of every arm’s-length body. Whereas some 20 years ago it may have made sense to look at a single body for carrying out the functions undertaken by the HFEA, she will agree that the functions concerned are very different. Times have moved on and we think that there is a more logical way to parcel out those functions which does not dilute in the slightest the efficacy or the efficiency of the regulatory action.

[Lord Willis of Knaresborough]

My Lords, I beg to disagree with my noble friend. What remains the same, as the noble Baroness, Lady Warnock, said, is the fact that we must enshrine in legislation and through regulation the very special status of the embryo. Since 1991, the HFEA has carried out that function very effectively indeed and it has done so because it has the support of the British people. As regards bringing these regulations in house, will the Minister say why the public should have more confidence in him as the Minister than in an independent regulator?

[Earl Howe]

My Lords, I need to make it clear that our proposal is not to bring the regulation in house; it is to distribute the regulatory function between several different bodies. I also emphasise that there is absolutely no suggestion that we are changing the special status of the embryo. We have no plans to re-examine those parts of the legislation which recognise that status. We fully recognise the role which the HFEA has played in establishing the UK as a world leader in this area, but times change and so has the way in which we regulate the delivery of healthcare. That is the basis on which we have looked at this.