Committee (2nd Day) (Continued)
Clause 93 : Education and training plans
48: Clause 93, page 77, line 36, at end insert—
“(e) support the continuing professional development of medical professionals in its area.”
My Lords, one often feels during any legislation that by the time it finishes the Minister—in this case, the noble Earl—must wish that he had included in the Bill something that he had forgotten. This amendment is it and I hope that he will see it in that light, particularly as continuing professional development was a part of the original draft Care and Support Bill. However, it was taken out of this Bill and I wonder why. I am sure that the Minister knows why and will tell us. I feel that somehow the page got turned and it was left out, rather than being deliberately not included. None the less, I will make a case that it should be included because it is one part of education that should be part of HEE and LETBs.
The amendment requires the local education and training boards to set out in their education and training plans how they will support continuing professional development. The NHS constitution commits all employers supplying NHS-funded services to provide staff with personal development and access to appropriate training for their jobs. Continuing professional development is important for healthcare professionals to maintain and improve their professional skills. While you might go to medical school for five years and undertake postgraduate study to be a specialist or a GP for six or seven years or even longer, continuing professional development is for the rest of your professional life. For many specialties, without continuing professional development you cannot provide up-to-date care.
Continuing professional development is particularly important for those working in medicine but it is also important for all other clinicians. Doctors and nurses need constantly to update their skills and keep abreast of the latest developments. Good CPD is therefore vital for improving patient care and spreading innovation throughout the NHS.
Evidence of participation in CPD activities is a compulsory requirement for the revalidation of doctors in order to demonstrate continuous fitness to practice. In April 2013, the General Medical Council published the results of a study that aimed to assess the impact of CPD on doctors’ performance and patient and service outcomes. The study underlined the importance of CPD in maintaining competence and identified a lack of funding and a lack of allocated time as key barriers to undertaking CPD.
CPD used to be funded through the national multi-professional education and training budget—I remember because I used to be given an annual budget. If you did not spend it, initially you could not carry it over but latterly you could. Lots of other doctors did not take advantage of it, so those like me who did benefited even more. However, it is no longer funded in that way. Currently, the funding is tight and there is a risk that CPD funding for medicine and other clinicians will be cut at the expense of other areas. The Council of Deans of Health, for example, says that reductions in education and training budgets are most likely to impact on CPD compared with other areas of education and training.
I saw that as part of its strategic intent document, Health Education England recently announced that it would ensure greater investment in CPD for staff currently in post, but I feel that further clarification is needed about what this will mean in practice. It is presently unclear what level of funding is provided for CPD across the NHS. In their response to the Future Forum report on developing the NHS workforce in June 2011, the Government said that they would,
“explore ways to provide greater transparency about the overall level of investment across the [education and training] system, including for continuing professional development”.
I am sure that the Government are taking steps to make sure that this happens and I am keen to know what the noble Earl has to say.
At present CPD is a responsibility for healthcare providers, but there is no requirement in the Bill on HEE or LETBs to support this or to monitor how providers are supporting CPD. Again, the GMC-commissioned report, The Effectiveness of Continuing Professional Development, found that trusts varied from being “generous” to “not interested” in providing CPD opportunities for staff. While both Health Education England and the local education and training boards have a clear role to support training more broadly, it is unclear to me how they will currently support CPD for all clinicians as distinct from other types of training that apply to other healthcare workers. My amendment would therefore place a clear requirement on local education and training boards to set out how they would support CPD for clinical professions. I hope that the Minister will find in favour of it, particularly as I feel it is something that got left out, having been included in the original draft Care and Support Bill. I beg to move.
My Lords, following the disruption of medical education that followed on from the MTAS debacle in 2007, one of the outcomes, which was a positive one, was the development of schools of surgery—a concept that we took on from the anaesthetists. This required personnel from the Royal College of Surgeons and the deaneries to take responsibility for the delivery and planning of training and education. However, this was very much confined to trainees. There was no requirement to extend it to consultants in terms of CPD.
However, we all know that health education does not end with certification; it is a continuum that occurs throughout one’s career as a professional doctor. It is a requirement to keep up to date. It is a requirement by the GMC to ensure that one knows what is happening within the wider medical field. One of the problems for doctors is having the time to go away and attend courses to improve one’s CPD. The amendment of the noble Lord, Lord Patel, places an obligation on HEE and the LETBs to support CPD and, in doing so, to allow the release of NHS staff, as he quite rightly said, to attend courses and educational programmes. It is also important to provide consultants and medical personnel of all disciplines with the opportunity to work in the wider NHS. It has been one of the basic tenets of the NHS that contributions in the wider NHS benefit not only the NHS but the participants, who learn a lot more about its workings. That, too, can improve and enhance one’s continuing development.
In that context, I welcome the suggestion made today several times by speakers—certainly by the noble Lord, Lord Hunt of Kings Heath, in that he made reference to the Francis report. One thing that came out of the Francis report was a clear statement that he would recommend that the GMC and the royal colleges work together in providing visits to educational centres. That was stopped some time ago. I think that there is a real opportunity to reintroduce that and I hope that the Minister, in responding, will address that issue. Here again is an opportunity, because in the past lessons were learnt by consultants visiting hospitals and looking at the education provision.
The very presence of peer groups in a hospital often helps to raise standards. Therefore, not only would CPD provide another training opportunity for those who participate but it would improve local education provision. The quality assurance of the training it would provide would ensure that, in the long term, patients benefited from such visits. For that, if nothing else, I support the amendment of the noble Lord, Lord Patel. We need to include something on continuing professional development because the whole emphasis of HEE is very much on training and trainees and it has very little to do with those who continue right through to retirement.
My Lords, I, too, strongly support the amendment of the noble Lord, Lord Patel. Like him, I am concerned and rather surprised that there is no mention in the Bill about the need for trusts and other providers to support their staff in continuing professional development. We really cannot afford to have any staff working in front-line clinical services not keeping up to date when we know that clinical practice changes rapidly from month to month.
New tests, new diagnostic methods and new treatments are coming along fast and furious. Unless members of staff are given the time and facilities to keep abreast of all of those, we will get poorer and more out-of-date care. As the noble Lord, Lord Patel, said, it is unfortunately the case that when health budgets are stretched, as they almost always are, CPD budgets are the first to go. Time off to attend courses or to engage in appraisals disappears quickly, as everyone in the service is rushed off their feet.
It is in just those circumstances that a stand should be made. The amendment of the noble Lord, Lord Patel, makes it clear that the LETBs must include the need for employers to allow the time for CPD development of their staff. How else will doctors, for example, be able to comply with the mandatory requirement of the GMC to revalidate at regular intervals? We have struggled both long and hard to get revalidation mandated and we cannot afford to see it eroded now at the same time as the responsibility for funding CPD is falling to employers. LETBs must be given the teeth to insist that time and support for CPD are included in their educational contracts with trusts.
My Lords, I support the amendment but I also support what the noble Lord, Lord Patel, said, about CPD being extended to other healthcare professionals. One thing that has emerged as a barometer from the questionnaires is that, often, the culture of an organisation is affected by the fact that there has been no appraisal system and no continuing professional education built into the programme for other healthcare professionals—nurses, physiotherapists and radiographers. There is an important issue here: all staff delivering care need to have regular appraisals and regular updating of their continuing professional education.
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.
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.
My noble friend Lord Ribeiro asked whether we were considering peer-to-peer visits to educational centres. I think I will have to give him a somewhat generalised answer. As commissioners of education and training, both HEE and the LETBs will work with education providers, service providers and professional regulators to ensure that the education and training provided by education institutions continually improves and delivers programmes that are fit for purpose. I have no doubt that my noble friend’s suggestion will be considered in that context.
It is worth observing, as the noble Lord, Lord Turnberg, rightly pointed out, that the introduction of revalidation at the end of 2012 has placed an increased emphasis on doctors’ CPD activity as a means of demonstrating that they remain up to date and fit to practise throughout their careers.
I hope that the noble Lord, Lord Patel, will accept what I have said as at least some measure of reassurance, if not a full measure, that Health Education England and local education and training boards will work closely with healthcare providers to ensure that in planning education and training, there is adequate provision of continuing professional development of healthcare workers.
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.
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.
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.
Amendment 48 withdrawn.
Amendments 49 to 52 not moved.
Clauses 93 agreed.
Clause 94 agreed.
Clause 95 : Tariffs
Debate on whether Clause 95 should stand part of the Bill.
My Lords, we now come to the tariffs to be imposed in respect of education and training. Clause 95 establishes a tariff-based system for funding clinical education and training, whereby providers receive the same payment for the same activity. This is intended to enable a national approach to the funding of clinical payments and to provide for equality of treatment between different providers. What the clause does not do is to provide for equality of treatment between the public and private sectors. The noble Earl will be aware of Monitor’s fair playing field review that looked at a number of different activities and the impact on different providers, including public sector providers, private sector providers and the third sector. On education and training it remarked:
“Many stakeholders voiced concern that the private or charitable sectors are able to employ clinical staff without facing the cost of training them”.
It has been reported recently that surveys show an increase in the use of the private sector by the NHS in recent years and enforced marketisation. The Section 75 regulations are likely to increase that. The question that I put to the Minister is, if the NHS is developing much more into a mixed economy, what is the provision for the private sector to contribute to education and training?
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.
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.
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?
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.
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?
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.
Current funding arrangements for education and training are based on top-slicing NHS budgets. That is a simple and effective method of funding, but the contributions of individual providers are not transparent. Introducing a levy on providers to raise the central budget would be one way of improving transparency and ensuring that those who train are rewarded for doing so, while those who undertake less training than they receive the benefit from contribute to the training provided by others. A number of concerns about the practicalities associated with introducing a levy have been raised by stakeholders. Given the size of such a change and the range of views received, before we produce firm proposals for consultation we will undertake further work and consult widely on how such a levy could be designed and the possible impact it would have.
The noble Lord asked me whether “health services” in Clause 90 equate to the health service in general interpretation. Clause 86 (5) states:
“‘Health services’ means health services provided as part of the health service”.
The extent to which the independent sector will be participants in training or will fund training has yet to be determined. Consultation on the White Paper sought views on introducing a levy. Many respondents felt that the proposals should be developed slowly, with widespread consultation, to avoid any unintended consequences and that is the approach we are taking. The NHS Future Forum expressed particular concern about the impact of such a system on third sector and local authority employers, so my general answer is that this is something we are considering and I hope we will be able to bring forward some proposals shortly.
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?
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.
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.
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.
Clause 95 agreed.
Clause 96 agreed.
Schedule 7 : The Health Research Authority
53: Schedule 7, page 118, line 27, at beginning insert—
“(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).”
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.
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?
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.
Amendment 53 agreed.
Amendments 54 to 57
54: Schedule 7, page 118, line 27, after “appoint” insert “other”
55: Schedule 7, page 118, line 27, at end insert—
“(1A) The committee appointed under sub-paragraph (A1) must consist of persons who are not members or employees of the HRA.”
56: Schedule 7, page 118, line 28, leave out “A” and insert “Any other”
57: Schedule 7, page 118, line 28, leave out from “include” to end of line 29 and insert “such persons”
Amendments 54 to 57 agreed.
Schedule 7, as amended, agreed.
Clause 97 : The HRA's functions
58: Clause 97, page 80, line 35, at end insert “and the publication of its findings fairly and frankly”
My Lords, I suspect that the amendment has a similar purpose to Amendment 63, in the names of the noble Lords, Lord Turnberg and Lord Patel. The purpose is to ensure that in exercising its functions the HRA not only promotes the interests of research participants and those of the wider public in facilitating research but, in doing so, has to ensure that the publication of research findings takes place fairly and frankly. I tabled the amendment because there was concern in the Joint Select Committee, of which I was a member, about whether those responsible for conducting research were tempted on occasion to shield from public view the downside findings of a piece of research, for commercial or even professional, reputational reasons.
The Joint Committee’s discussions of that issue are set out in paragraphs 328 to 336 of its report to the Government. There was a lot of support in principle for greater transparency around research findings, and particularly clinical trials data, but there was some ambivalence in the discussions of witnesses in front of us, including the Minister, about prescribing this requirement in primary legislation. Tucked away in the discussion was a concern that this kind of approach would cause pharmaceutical companies to take clinical trials away from the UK. That was the implication, I think, of some of the remarks passed to the Joint Committee, which rightly in my view took a more robust view. In paragraph 335 of its report, it recommended that the Bill should be amended,
“so that promoting transparency in research and ensuring full publication of the results of research, consistently with preservation of patient confidentiality, becomes a statutory objective of the HRA”.
That is what my amendment aims to do.
My views on this issue have been shaped over time, but particularly by my experience as the Department of Health Minister responsible for the pharmaceutical industry and its regulation as well as for NHS R&D. In those roles, I did my bit to promote that industry and secure UK jobs in it, and I know the arguments about securing clinical trials. However, they have to be balanced with other considerations, when deliberate concealment of adverse research data has taken place. This is in nobody’s interests, including those of the company where it has taken place, because eventually it usually gets found out.
To illustrate my concerns, I want to detain the House a little longer with a brief account of what came up in my time as a Minister, when there was concealment. “Panorama” revealed, in 2003, what was happening with an anti-depressant called Seroxat, which was being given to about half a million people a year. Some of the people taking higher doses of the drug experienced suicidal feelings, and there were a number of cases of younger patients committing suicide. There was widespread concern among patient groups, and the MHRA had to launch a review, which included a small subset of younger patients under 18, for whom Seroxat was not licensed but for whom it was being prescribed by doctors. At that time, about 8,000 young people a year were being prescribed this drug, and the Committee on Safety of Medicines advised me that children taking this drug were more likely to self-harm or have suicidal thoughts. That finding was not then available to the regulators, but the public fuss caused by the media caused the company—and I want to mention it; it was GSK—to end up passing the information in its files to the regulators in the UK, Europe and the US. I took the view, in 2004, that there was a respectable case for prosecuting GSK, because it had failed to inform the MHRA in a timely fashion of the information on adverse reactions in juveniles.
The whole affair limped on after my time as a Minister and became the largest investigation of its kind. Over 1 million pages of evidence were scrutinised, with GSK challenging matters all the way. Matters were only concluded in March 2008 when the decision was taken not to prosecute GSK, which received a slap on the wrist. The then MHRA chief executive said in a press release:
“I remain concerned that GSK could and should have reported this information earlier than they did”.
This case—and there are others which I know of—illustrates why we should put in the Bill a clear requirement that research information is put into the public arena in a timely way when there is a downside as well as when there is an upside so that people can have a fuller picture of what is actually going on. If noble Lords want a fuller account of the Seroxat saga, they can find it in my book, A Suitable Case for Treatment, which is available in the Library. I beg to move.
My Lords, the point of Amendment 63, which is in my name, is the need for the HRA to emphasise transparency in the reporting of clinical trials because patients and the public must have confidence that research in which they have been involved will be used in the best way to spread the message for the good of other sufferers. They have to know that results, whether negative or positive, are published. As my noble friend Lord Warner has said, it is particularly important if they are negative, for at least two reasons. First, it is to stop the unnecessary, wasteful repetition of the research by others who are unaware that it has already been done. Equally important is to prevent a bias in reports towards research that shows only that a new drug works when other, unpublished, research shows that it does not. This is particularly important when we consider what is called meta-analysis, whereby an analysis is made of all relevant published reports, brought together to provide a large database on whether a drug works or does not. If only the positive results are reported, we have a biased result at the end, which could result in all sorts of problems.
Open access to research data provides researchers with a much better picture of their field than if research results are held too closely to the chest, perhaps by researchers jealous of their findings or by drug companies fearful of rivals gaining an advantage. It is heartening to know that GSK seems to have learnt the lesson: it is the first pharmaceutical company to lead the way in transparency. Members of the Association of Medical Research Charities make it a condition of their grants that results are published. We are pushing on an open door and we just need the HRA to have some capacity to ensure transparency in NHS research.
My Lords, I support Amendments 58 and 63. It is right for my noble friends Lord Warner and Lord Turnberg and the noble Lord, Lord Patel, to press the Government on this important issue. As we have heard, the Joint Committee proposed including the promotion of transparency in research and ensuring full publication of the results of research—consistent with the preservation of patient confidentiality—in the Bill and we strongly support this.
This is our first opportunity to welcome the establishment of the Health Research Authority as a statutory body and we do so wholeheartedly. We recognise the vital importance of research and innovation to the NHS, the very real progress that is being made in these areas and the scale and pace of change in medical science. The HRA’s objectives not only promote and protect the interests of patients and the public in health and social care research but ensure that it is ethical and safe research, which inspires the public confidence that my noble friend Lord Turnberg spoke about.
Alongside other bodies, the HRA has a key role in promoting transparency, and we acknowledge that its recent guidance on how it will undertake this role sets out important measures that will go some way towards underlining that it takes its duty seriously. These include: gaining approval from research ethics committees before clinical trials can go ahead; a new timescale for registrations; the commitment to work with research funders and sponsors to set the standards for the publication and dissemination of research outcomes; taking steps to facilitate further analysis of detailed data; and plans to look at how patient consent forms can be amended to provide early consent and understanding on how data will be used, as well as how the HRA will be informed of the outcome of study findings.
There is no doubt that the HRA is committed to working with others to overcome barriers to transparency and create a culture of openness. The amendment and Amendment 63, which provide for the publication of research findings “fairly and frankly” and transparency in the reporting of clinical trials, would enshrine the HRA’s commitment in statute, and ensure that clinical research benefits patients and that the findings are available for others to learn and benefit from. As we have heard from my noble friend Lord Turnberg, the advice of the Association of Medical Research Charities to its members to ensure that there is a requirement to publish in the terms and conditions of all their research awards has played an important role in providing greater transparency and would be reinforced by greater HRA authority in this matter.
Finally, like other noble Lords, I received a valuable briefing from the National Advisory Council to the Thalidomide Trust on the need for transparency and a change in the law for the disclosure of clinical and healthy volunteer trial data in relation to the drugs available on the market. The briefing states:
“Adverse effects caused by drugs that are designed to lead to a health improvement can be difficult to prove, and easy for the pharmaceutical companies to dismiss ... At the core of the problem is the fact that the safety assessments of a drug, undertaken in clinical trials done prior to the drug’s launch, remain hidden once the drug is on the market. A patient experiencing adverse effects therefore has no access to data that could be used to prove their claim … the onus is on patients to prove it was a drug that harmed them rather than the company that already holds that evidence”.
The Thalidomide Trust proposes changes to the informed consent form to allow sharing of anonymised data and making data from clinical trials available and accessible to the public once a drug has been released on the market. The trust acknowledges that this is a difficult issue. Have the Government had any discussions with the trust on this matter? I should be grateful if the noble Earl would comment on this, either today or in a written response.
My Lords, perhaps the noble Earl will tolerate a short intervention. I was for 30 years a trustee of the charity the Public Interest Research Centre. I think I am correct in saying that in the 1970s and 1980s it was the only independent charity carrying out extensive research on the matters under discussion here. I agree with every word said by the noble Lords, Lord Warner and Lord Turnberg, and the noble Baroness, Lady Wheeler. There is, to some extent, a disparity of arms between the huge pharmaceutical companies and the regulatory authorities. Frankly, I see no harm and some potential good in the amendments to try to rectify the balance of power and to avoid a repetition of the example given by the noble Lord, Lord Warner, which is extremely sobering but by no means unique. A number of instances that we confronted in the 1970s and 1980s mirrored that example, if not on quite the same scale.
My Lords, I want briefly to intervene with a thought to which the Minister may have a response. When you have medicines prescribed under the National Health Service—indeed, when you buy medicines—there is a leaflet inside the package setting out the need for the product and the circumstances in which it can be taken. However, there is also a section that deals with risk. I have often wondered whether that section on risk assessments, which lays down varying levels of risk, dependent on the incidence of conditions that might arise under use of the medicine, is based on the original clinical trials carried out by the manufacturer. If it is, it may well be that there is an argument for more frank information to be made available. If the element of risk is linked to the original research, it would obviously be very interesting to the wider public. I wonder whether the Minister might be able to help us there. Is there a connection?
My Lords, I entered the Chamber expecting to speak not to this amendment but, as the Minister may recognise, on the issue of human fertilisation. However, I am feeling drawn into the argument. I find it difficult to agree with my noble friends on this side of the House. The wording of the amendment would not really fulfil the laudable purpose set out by my noble friends. There are many examples where this information would be very important. The case of Seroxat is a fine example of where there was a real need to have better regulation of the negative results of a drug trial.
There are many examples where the negative effects of a drug trial may not be of relevance in the same sort of way. In the area of reproductive medicine, for example, clomiphene citrate was first given as a contraceptive. The surprise was that people got pregnant on it, so the drug was shelved as a contraceptive. A great deal later, however, a drug company suddenly recognised that it had something that might stimulate pregnancy in women who had been infertile. The problem is that a drug company sponsors, pays for and organises research, so to some extent it has a commercial value in that research. We have to strike a very careful balance between when there is an important commercial angle which requires proper legislation and, equally, when there is a chance for drug companies to do a good job—as they did eventually with clomiphene citrate when it was launched as one of the most successful drugs in my area of medicine.
With all due respect to my noble friend Lord Warner, that makes the wording of this amendment difficult. I do not think that frank and fair reporting of a drug trial would be sufficient to meet the needs of what he is arguing in this case.
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.
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.
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?
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.
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.
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.
Amendment 58 withdrawn.
House adjourned at 10.03 pm.