Care Bill [HL]

Lord Campbell-Savours Excerpts

Monday 10th June 2013 Lords Chamber

[Lord Hunt of Kings Heath]

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?

[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.

[Earl Howe]

No, that is not the case, because the LETB is only responsible for healthcare staff, not adult social care staff.

[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.

--- Later in debate ---

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.

[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.

--- Later in debate ---

[Lord Phillips of Sudbury]

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.

[Lord Campbell-Savours]

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?

--- Later in debate ---

[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.