Baroness Wheeler
My Lords, we support the amendment. Our amendment on this issue relating to Health Education England’s national role in planning education and training for healthcare workers was considered last week. We were, in particular, keen to probe the role that LETBs will play in that important area.
The amendment would ensure that the annual reports of LETBs specify how they propose to support continuing professional development in that area. We strongly support that. The amendment specifies the medical professions, but it is applicable across the healthcare workforce. CPD is about ensuring that structured learning continues throughout one’s career, with clear objectives set and progress logged and regularly reviewed. CPD complements formal training and enables practitioners and other staff to acquire new knowledge and skills, as well as to maintain and improve their standards across all areas of their practice.
The HEE mandate has a small subsection on supporting the professional and personal development of the existing workforce, underlining the importance of HEE leadership and work with LETBs, but that aspect is far from being given the importance that it needs in the mandate—the point made by the noble Lord, Lord Ribeiro. There is of course emphasis elsewhere in the document on the workforce needing to be flexible and receptive to research and innovation, but CPD is wider than just keeping up to date and applies to values, behaviours and the ability to understand how one’s working role relates to the wider service, as we heard during our earlier debate on integration.
I could not see CPD addressed in any depth on the HEE website, although we join other noble Lords in welcoming the general, across-the-board progress that HEE has made in its new role so far. HEE recognises that providing leadership and ensuring greater transparency in the investment that employers make in their workforce and in supporting and championing multidisciplinary and professional CPD is a strategic priority. Does the Minister agree that HEE needs to step up and develop its CPD strategy as a major priority, and does he accept that the mandate needs better to reflect the importance of CPD?
The HEE website also mentions that it will be allocating a limited amount of central funding for LETBs to invest in CPD, particularly for staff employed at Agenda for Change bands 1 to 4 and equivalent staff employed as part of primary care teams in general practice, community pharmacy and other community-based employers.Does the Minister have any further information on how the Government expect HEE to take this forward with LETBs?
Last week I mentioned the recent member survey by the Royal College of Nursing on CPD, showing how varied the time allocated by NHS trusts is. It is worth going into the findings in a little more detail today. The survey found that in the past 12 months almost a third of respondents had received no CPD that was provided or paid for by their employer. By sector, just a third of respondents in the NHS received no training in the past 12 months, compared to just under a quarter of those working in the independent or voluntary sectors. Just over a third said that the amount of CPD provided had decreased in comparison to the previous year, while 45% said that it had stayed the same.
Interestingly, overall, members working in the NHS were more likely than those working in the independent and voluntary sectors to report that the amount of CPD undertaken had decreased. Obviously, CPD is a mix of both employer-supported and resourced training and personal development learning resourced by the individual, either in their own time or with their own money. However, the RCN survey shows a very worrying trend in the importance employers place on providing CPD. Can the Minister comment on this and on how the problem can be addressed in the future? Is he confident that HEE or LETBs will have the resources to address this problem?
Our earlier amendment was similar to the wording that the Government included in the original Bill but subsequently deleted. I am sure the Minister will explain his thinking behind this and, as the noble Lord, Lord Patel, fully expects, delight us all by announcing that he has decided to put the CPD wording back in.
The Parliamentary Under-Secretary of State, Department of Health (Earl Howe)
My Lords, I make no apology for repeating my firm belief that the staff working in our NHS and public health system are the health service’s most precious resource. We must do all we can to ensure that staff have and continue to have the right values, training and skills to deliver the very highest quality of care for patients.
Clause 93 requires local education and training boards to publish an education and training plan for each financial year. The education and training plan must set out the local education and training board’s proposed investment in its current and future workforce for the following year. Note the word “current” in this context. In developing an education and training plan, the Bill makes clear that a local education and training board must consult with and have regard to the local priorities of, among others, the NHS and health providers and the commissioners that it represents.
The noble Lord, Lord Patel, asked what level of funding is attached to CPD in the NHS. The answer is that investment in CPD is really a decision to be taken locally. As I indicated, local providers and commissioners are best placed to decide what ongoing professional development their staff need. It will be their job to feed that in to the LETB as the local education and training plan is developed. I have already spoken in reply to an earlier group of amendments about the importance of continuing professional development, and the leadership role that Health Education England and local education and training boards can play in supporting this.
The noble Lord, Lord Patel, and the noble Baroness, Lady Wheeler, asked what happened to the reference to CPD in the draft Bill. The answer is that we widened the description in Clause 84(6) so that the Bill states that:
“HEE may, with the consent of the Secretary of State, carry out other activities relating to … education and training for health care workers”.
This still very much includes CPD. I emphasise that we consider this to be an important part of the way HEE may exercise this power. The NHS constitution sets out that staff can expect employers to invest in their development, and that all healthcare providers must take this issue seriously. Employers have a clear responsibility to provide their staff with the support and personal development they need, as well as access to appropriate training to enable them to fulfil their duties. However, Health Education England will play a crucial role in providing leadership in supporting employers in this area. The mandate sets out that Health Education England will work with LETBs and healthcare providers and commissioners to ensure that professional and personal development continues beyond the end of formal training to enable staff to deliver safe and high-quality health and public health services, for now and in the future.
Lord Turnberg
I am sorry to interrupt again. I think the noble Earl said that we should leave it to the local providers to decide what or how much CPD individuals should have. We know, however, that at the moment local providers are very variable in how far they are willing to go along that route. The problem is that leaving it where it is certainly does not give any great confidence that CPD will be uniformly available in the service. Hence the amendment of the noble Lord, Lord Patel, which tries to give a little force and pressure to local providers so that they could indeed be sure that CPD was being provided. The noble Earl is full of good intentions, quite rightly, but we need a little more than that.
Earl Howe
I probably expressed the position less than well because I was seeking to indicate that CPD is inescapable. There are a whole host of reasons why providers and the LETBs cannot avoid a focus on continuing professional development. Equally, we do not want to prescribe any kind of ring-fenced budget for CPD, for the reasons we debated earlier: we are clear that we must leave it to LETBs to exercise autonomy in the way that they work out their local education and training plans. They will have to prioritise, inevitably, in certain cases and from year to year. It may be that they will have to make hard choices. The great thing about Health Education England is that, as a non-departmental public body separate from NHS England, it will have a dedicated budget which cannot be eroded by those who might wish to siphon money off to patient care, for example. I hope that, in that sense, the noble Lord, Lord Turnberg, can take some comfort. We are very clear that the prescription is there and that local providers cannot avoid addressing the needs of their employees for CPD, but at the same time we do not want to dictate to them how much to spend on this in any one year.
Lord Patel
My Lords, I thank the Minister for his reply. I have no doubt whatever that he speaks with conviction and is full of good intentions. However, the way in which he spoke makes me feel that he, too, has some doubt that local providers and employers will deliver on this. If LETBs do not have any duty even to collect information about continuing professional development, local providers may not take any notice of the issue; there will be that variability in their reactions to which the noble Lord, Lord Turnberg, referred. However, I have no doubt that the Minister and the department have the intention that this will be delivered. We will reflect on that. In the mean time, I beg leave to withdraw the amendment.
Lord Campbell-Savours
As a layman among all these very professional people, I raise a very simple point. Returning to the private care home paying workers something like £7 an hour, I presume that that care home, if it so wished, could use the LETB.
Lord Campbell-Savours
Perhaps that answers the question, but from the way in which the Bill is written I understood that it went wider than that and included care home staff. What about nursing homes? Nursing home workers are healthcare workers, are they not? I suppose that they are covered by both areas.
Earl Howe
My Lords, in so far as nursing homes are staffed by healthcare staff, those staff are certainly eligible to benefit from the education and training budget. Indeed, I should have clarified that in privately run care homes you might well find a nurse who is healthcare trained, and therefore is in a position to receive the benefit of the healthcare budget if they are an employee funded by the NHS.
Lord Campbell-Savours
Then let us take it to the next statement. What about the healthcare assistant working in a nursing home—in other words, in this particular sector, where I presume the LETB applies? Would that worker also be trainable under the system established under the Bill, or does that nursing home healthcare assistant also have access to other training facilities outside the provision being made here? In other words, does the employer have the option?
Earl Howe
My Lords, training can be delivered in a variety of ways. It can be delivered onsite and on the job within the healthcare or care setting. It can be delivered outside as part of a higher education course. Who funds that will depend on the status of the worker. If he or she is a healthcare worker, it is possible, as I said, that they are funded by the NHS. It is also possible that he or she is privately employed by the organisation concerned, and that organisation will therefore fund the course of education. So it depends. I suggest that in a care home it is more likely that the person would be designated as a care worker rather than a healthcare worker if they do not have a recognised qualification to their name. I do not think that there is any generic answer to the noble Lord’s question. I hope that I have been helpful in explaining the various situations that can arise.
Lord Hunt of Kings Heath
There are various definitions relating to LETBs. For instance, Clause 90(3) says:
“In carrying out its main function, an LETB must represent the interests of all the persons who provide health services in the area for which the LETB is appointed”.
However, the general interpretation on page 89 defines not “health services” but rather “the health service” as,
“the comprehensive health service in England continued under section 1(1) of the National Health Service Act 2006”.
My question is: does “health services” in Clause 90 equate to “the health service” in Clause 110, or is “health services” in Clause 90 a wider interpretation that embraces the argument of my noble friend Lord Campbell-Savours?
Earl Howe
It may be convenient for the Committee if I take together the questions of the noble Lords, Lord Campbell-Savours and Lord Hunt, because the noble Lord, Lord Hunt, asked me about the role of the independent sector in participating in training and indeed in funding it. Perhaps I may clarify that.
The Health and Social Care Act 2012 placed a duty on the Secretary of State to ensure an effective education and training system, as I mentioned earlier. The Act also placed a duty on commissioners of health services to ensure that providers support the Secretary of State in this duty when contracting with them. The Government have already put into place measures to deliver the Secretary of State’s education and training duty by amending the commissioning contracts and supporting regulations for the delivery of services, so they now require co-operation on education and training. This means that all providers of NHS services are expected to co-operate and, where appropriate, this co-operation will involve them providing education and training.
Lord Campbell-Savours
I have one final question. How can a person placing a relative in a care home know that the standard of care provided in that home by presumably trained healthcare assistants will be of a similar standard to that available under the arrangements proposed in the Bill for those who work directly in the healthcare sector of the National Health Service?
Earl Howe
The answer is twofold. First, the Care Quality Commission inspects every care home to a uniform standard. One of its duties is to ensure that the staff in a care home are sufficiently capable and trained to deliver care in the right way to the patients and service users who live there, taking into account the acuity of need of those people. Secondly, as the noble Lord may be aware, the Government have proposed that a system of star ratings should be reintroduced for both healthcare settings and adult social care settings. In that way the general public may have a much closer and more detailed sense of the quality of care provided in the care home, as assessed by the Care Quality Commission. Again, this is work in progress. The Care Quality Commission is working out its methodologies for delivering those star ratings, but if we get this right, I believe it will take us several steps forward in transparency of quality and the ability of members of the public to choose, in a much more meaningful way, the setting that they wish to see either themselves or their families benefiting from.
Lord Hunt of Kings Heath
My Lords, that has been extremely useful. The intervention of my noble friend Lord Campbell-Savours has been particularly useful. Reading Clause 86 (5) together with Clause 93 and the interpretation in Clause 110, it becomes clear that many nursing homes will receive some funding from the NHS in providing continuing healthcare for some residents. That seems to me to be very helpful indeed because, given that there is a great deal of concern about the quality of staff in nursing homes and the training of those staff, it gives local education and training boards a clear remit to concern themselves with the staff in a lot of nursing homes in their area. I hope that it will be possible for a message to be sent to Health Education England from this debate that, if it is looking at the most vulnerable areas in terms of vulnerable people, that ought to be where the priority should be. My noble friend has teased out a very important indicator of the way in which LETBs should work in future. I hope we will see in their plans that a major effort will be devoted to the staff in those homes.
On the more general question, I noted that the Minister had been urged to be cautious by various bodies in relation to whether there should be a levy on private sector providers. It is a bit rich of the Future Forum to worry about the third sector contribution since it is the Future Forum that has tried to open the door to a competitive market in the NHS. The third sector and Sir Stephen Bubb cannot have it all ways. If he wants to have a competitive market, as he seems to, then the third sector can jolly well make a contribution alongside the NHS. They cannot have it both ways.
Earl Howe
My Lords, I hear what the noble Lord has said on this. In practice, as he knows, most education and training take place in the public sector, but we expect Health Education England and the LETBs to seek advice from a range of stakeholders. Indeed, HEE has reinforced the importance of this in the appointment criteria that it has set for LETBs which state that they should demonstrate meaningful collaborative working relationships with stakeholders, including third and independent sector providers. This will help to establish stronger links with the independent sector so that it can deliver clinical placements and perhaps also postgraduate training programmes where appropriate.
“(A1) The HRA must appoint a committee for the purpose of giving advice—
(a) to the HRA in connection with the exercise of the HRA’s function under regulation 5(1)(a) of the Health Service (Control of Patient Information) Regulations 2002 (S.I. 2002/1438) (approval for processing confidential patient information);(b) to the Secretary of State in connection with the exercise of the Secretary of State’s functions under regulations 2, 3(4) and 5 of those Regulations (processing of confidential patient information).”
Earl Howe
My Lords, I beg to move Amendment 53, and at this point it will be convenient to consider government Amendments 54 to 57 as well.
The importance of balancing a person’s right to confidentiality with the benefits of using information to improve the current and future health and care of the population cannot be underestimated. The NHS constitution sets out a number of rights and commitments in this regard.
Section 251 of the NHS Act 2006 provides the Secretary of State with a power to make regulations that modify the common law obligations of confidentiality so as to allow researchers, public health staff and other medical practitioners to access information where there is no reasonably practicable way of obtaining consent to use such information for the purposes of medical research; that is, in the interest of improving patient care or in the public interest.
The Health Service (Control of Patient Information) Regulations 2002 made under Section 251 of the NHS Act make provision for public health surveillance and risk management, work associated with cancer registration and approvals for the processing of confidential patient information for medical purposes in certain circumstances, provided that the processing has been approved by the Secretary of State.
These amendments provide continuity for the functions of advising on the approval of processing of confidential patient information for medical purposes, other than direct patient care. These functions were previously carried out by the national information governance board and its ethics and confidentiality committee. The special health authority has been directed to undertake these functions since 1 April this year, and so the provisions would ensure continuity.
I turn to the detail of this group of amendments. The amendments would require the Health Research Authority to appoint an independent committee to provide advice on applications to process confidential patient information. The committee would advise on approvals to process confidential patient information for medical research purposes and for other medical purposes. As the Bill is currently drafted, the Health Research Authority would have the power to appoint such a committee under its proposed functions in Schedule 7 to the Bill, but this would be discretionary.
This group of amendments would ensure that such a committee is established and that it is independent. This is important to ensure that the arrangements that are currently in place will continue, maintaining public confidence in the decisions made. In the interests of consistency across the system, these amendments would require a single, independent committee to advise both the Health Research Authority itself on approval for medical research purposes, and the Secretary of State on all other approvals for medical purposes.
The Health Research Authority special health authority has established an independent committee, known as the Confidentiality Advisory Group, to advise the existing Health Research Authority and the Secretary of State on approvals. The provision of transparent, expert and independent advice to support approvals for processing of confidential patient information is vital. It protects and promotes the interests of the patient while facilitating the appropriate use of confidential patient information beyond direct patient care. It ensures that each application for approval is carefully considered and that there is consistent, expert advice to inform approval decisions.
I hope noble Lords will accept that these amendments will ensure that there continues to be independent advice on applications to process confidential patient information for medical purposes. I beg to move.
Lord Hunt of Kings Heath
My Lords, I am sure that the amendments will be welcome, and that access to confidential patient information needs to be accompanied by full safeguards for the protection of individual patient privacy. However, will the noble Earl also confirm the importance of access to this information for the purposes of legitimate research? Can he also confirm that by transferring these functions to the HRA, we can look forward to a more transparent, consistent and streamlined process in the future?
Earl Howe
My Lords, as I indicated, we have always needed to strike a balance—reflected in the 2002 regulations which the noble Lord brought forward in that year—between protecting the rights of the individual and ensuring that ethical approved research can take place using confidential patient data only where appropriate. I agree with the noble Lord that we should not place any undue barriers in the way of research, but there are clear rules around this which we need to honour and protect. We will be reaching a group of amendments around the issue of transparency, and if the noble Lord will allow it, I will reserve my remarks on that until we reach that group of amendments.
Lord Warner
Perhaps I may respond to my noble friend. I was arguing the case on behalf of the Joint Committee as much as anything else. The committee heard a lot of evidence on this, and across the parties, and across the Commons and the Lords, the conclusions were drawn up in its report to the Government.
I say to my noble friend that most of these clinical trials look at a product which is being tried for a particular purpose. If that product happens to fulfil some other purpose, a different set of issues arises. Seroxat was actually trialled as an anti-depressant, but it failed that test in so far as it was applied in a dangerous way to juveniles. The information about it failing that test was concealed from the public and the regulator. My wording might not be perfect but I am not arguing for my wording. I am trying to get the Government to engage with the issue so that they can find a wording that meets my concerns—and, I suspect, those of my noble friend Lord Turnberg—in the way that the Joint Committee proposed, to engage the HRA in ensuring proper transparency when there are downsides to research. That is in no way stopping a pharmaceutical company from using a drug or trialling a drug for a different set of purposes from that for which it was originally constructed.
Earl Howe
My Lords, I say straight away that I sympathise with the intention behind the noble Lords’ amendments. These two amendments seek to make an explicit statement about the Health Research Authority’s role in encouraging transparency in health and social care research findings and clinical trial results.
We are all keenly aware of how topical the issue of transparency in health research is. The House of Commons Science and Technology Select Committee is currently undertaking an inquiry into clinical trials. Last week I gave evidence to that committee along with my right honourable friend the Minister of State for Universities and Science. I look forward with interest to the committee’s report. As the noble Lord, Lord Turnberg, and the noble Baroness, Lady Wheeler, rightly pointed out, maintaining trust in research is crucial to its success, and the way in which we respond to the mounting calls for greater transparency has consequences for how the integrity of research conducted in this country is perceived not just on a national level but on the international stage.
However, in reaching answers to these pressing questions, we must be careful not to create perverse incentives that simply result in people choosing not to carry out research in the UK and invest elsewhere. Promoting transparency in research is a core part of facilitating the conduct of safe, ethical research. People enrol in trials because they want to contribute to medical knowledge and advances. In considering the ethics of research proposals, ethics committees have to be assured that any anticipated risks, burdens or intrusions will be minimised for the people taking part in research and will be justified by the expected benefits for participants, or for science and society. Knowing what research has already been undertaken or is under way and the results of that research is therefore essential in order to minimise risks and burdens by not repeating research that has already been conducted.
Here, I come to the answer to the question asked by the noble Lord, Lord Hunt, in debate on the previous group of amendments. Promoting transparency in research is inextricably part of facilitating the conduct of safe and ethical research, which is the Health Research Authority’s main objective in Clause 97(2)(b). As Dr Wisely, the Health Research Authority chief executive, said in evidence to the Joint Committee which scrutinised the draft Bill, promoting transparency is absolutely fundamental to protecting patients and the public in health research. As a special health authority, the Health Research Authority is already doing a number of things with regard to transparency in research. First, research ethics committees already consider an applicant’s proposals for the registration and publication of research, for dissemination of its findings, including to those who took part, and for making available any data or tissue collected as part of the research.
Secondly, since April 2013, the Health Research Authority has been undertaking checks of research ethics committee applicants’ end-of-study reports to see whether they registered and published research as they declared they would to the ethics committee. Thirdly, as noble Lords may be aware, the Health Research Authority recently published a position statement setting out its plans for promoting transparency in research. This statement has received widespread support from stakeholders, including the AllTrials campaign, the James Lind initiative, the Association of the British Pharmaceutical Industry and INVOLVE.
I turn specifically to Amendment 63, which would specify that one way in which the Health Research Authority, the bodies listed in Clause 98(1)—for example, the Human Tissue Authority—and the devolved Administrations would be able to fulfil their respective duties to co-operate would be through encouraging transparency in the reporting of clinical trials results. The intention behind these duties of co-operation is to encourage co-ordination and standardisation of practice so as to streamline regulation and remove duplication. The aim is that through these duties the people and bodies listed will work collaboratively with the Health Research Authority to create a unified approval process for research applications and to put in place consistent and proportionate standards for compliance and inspection. Streamlining the approval process for research will make initiating research faster for researchers, funders and sponsors, and ultimately enable people who use health and care services to benefit from research more quickly.
Noble Lords will be aware that clinical trials in this country are governed by EU law. The EU Commission’s current proposals for a new clinical trials regulation look likely to enshrine the principle of transparency in the rules governing clinical trials at every stage, including, as the current proposals set out, mandatory publication of clinical trials summaries, not only in their technical form but in a form that ordinary members of the public will understand. We believe that that is the right direction of travel.
Given the focus of these duties on streamlining the regulatory system that the HRA has, I hope that noble Lords understand why it is not necessary to make encouraging transparency in reporting clinical trials a fundamental part of co-ordinating and standardising the regulatory practices of the persons and bodies listed and the devolved authorities. I hope that noble Lords are reassured by the fact that promoting transparency is a core part of the Health Research Authority’s main objective in facilitating safe and ethical research.
The noble Baroness, Lady Wheeler, asked about discussions with the national advisory council on health improvement drugs. Perhaps I may write to her on that topic. I hope she will forgive me for not answering now.
The noble Lord, Lord Campbell-Savours, asked about the patient information leaflet that is now mandatory within packs of medicines. The risks that are set out typically on the patient information leaflets can be derived in several ways: first, from the original clinical trials data—the noble Lord is quite right about that—but also from any data that may have subsequently arisen from the reporting system that exists. Pharmacovigilance legislation, which came into force last year, now enables the Medicines and Health products Regulatory Authority to require pharmaceutical manufacturers to report safety and efficacy data where either concerns arise or where the evidence for a medicine was perhaps less than it might have been in the first instance. So transparency can be promoted in that sense as well. The noble Lord may already be aware that the MHRA regards its pharmacovigilance responsibilities extremely seriously.
Lord Campbell-Savours
Is the Minister therefore saying that, in the event that adverse effects arose during the course of the clinical trial, there is now a requirement that the risk factors, as set out in the leaflet to which he referred, will reflect those adverse effects?
Earl Howe
There is a requirement that the patient information leaflet should contain warnings about the possible adverse side-effects of the medicine. The noble Lord is quite right that data may well have arisen from the clinical trials, but also from the yellow card reporting system, as it is called, and any other data that emerge from across the world. The point is to ensure that the patient is properly informed. No medicine is risk-free. All medicines carry some kind of risk of a side-effect and one has to recognise that that is part and parcel of the benefit that we get from medicines. The benefit-risk equation has of course to be positive, but these things need to be kept under scrutiny.
Lord Campbell-Savours
The noble Earl said that it “may well reflect”, which is different from “shall reflect”.
Earl Howe
The MHRA, in granting a marketing authorisation to any medicine will have access to all the clinical trial data that the company has at its disposal. That is mandatory. Therefore, if the MHRA decides to issue a licence for a medicine, it will require that the full range of adverse effects is reflected in the patient information leaflet. The answer to the noble Lord’s question is yes, but he will not necessarily see a whole lot of technical data in the patient information leaflet. It will be translated into language that the ordinary patient can understand.
I believe that the Bill as drafted already gives the HRA a clear objective which requires it to take an active role in promoting transparency in research. I hope that I have given enough reassurance on these issues to all noble Lords to enable the proposers of Amendments 58 and 63 not to press them.
Lord Warner
My Lords, that was an interesting and rather complicated set of assurances from the noble Earl. I would like to consider it carefully and talk to my noble friend Lord Turnberg and the noble Lord, Lord Patel, before considering whether to go any further.
As an observation, if the EU directives are going in the direction of this amendment and there is a lot of concern to make sure that patients are left in no doubt that a full, frank publication of reports including the adverse consequences of that research is a prime consideration, I still cannot see why we cannot put something—whether my wording or something equivalent to my noble friend's wording—on the face of the Bill. I would like to think about that a little further and I certainly do not promise not to bring this issue back after talking to my noble friends. In the mean time, I beg leave to withdraw the amendment.