Health Bill

Public Bill Committee, 20 December 2005.

Health Bill - Standing Committee E

Health Bill

Eric Illsley (Labour, Barnsley Central)

For the benefit of members of the Committee, I must say that we are late starting this morning because of a security alert in part of the Palace. I have one or two announcements to make. Our sitting hours today will be from now until no later than 11.25 am and this afternoon from 2 pm until an adjournment is agreed.

The printers have wrongly retained the starring next to four amendments on the paper. None of the amendments before us is ineligible for selection on the basis of starring. We will now resume our proceedings at clause 13.

Clause 13 - Code of practice relating to health care associated infections

Steve Webb (Liberal Democrat, Northavon)

I beg to move amendment No. 100, in clause 13, page 8, line 43, leave out from second ‘infection’ to end of line 4 on page 9 and insert

‘which arises as a result of healthcare interventions, either in patients undergoing these interventions or in health care workers involved in these interventions.’.

Good morning, Mr. Illsley. I hope that we can now make fast progress because there is a lot to cover in the remaining six sittings, and we may not reach some issues if we do not do so. I shall try to be as brief as possible.

Amendment No. 100 relates to worries expressed by the Royal College of Nursing about the definition of heath care-acquired infections. I an interested in the basis for the definition under the Bill because it seems slightly at variance with that used by the Health Protection Agency, which states:

“Healthcare-associated infections are those that arise as a result of healthcare interventions, either in patients undergoing these interventions or in healthcare workers involved in these interventions. A wide variety of organisms can be transmitted in healthcare settings, causing in turn a wide range of different diseases.”

David Kidney (Labour, Stafford)

Did the hon. Gentleman say that we had six sittings left? I keep looking at the motion and thinking that there are four, including this one.

Steve Webb (Liberal Democrat, Northavon)

It is wishful thinking. The hon. Gentleman is right. There are four sittings left, so what I said was only a 50 per cent. exaggeration.

Anyway, back to health care-acquired infections. There are two definitions, one used by the HPA and one used in the Bill. Will the Minister explain why the definition is as it is in the Bill? The RCN says that we need first to understand what infections would be transmitted or spread anyway and what infections relate to health care actions. It is fair to say that members of the Committee do not want to exaggerate. We do not want to sensationalise. We do not want people saying, as they say to me sometimes, “I don’t want to go into hospital because I’ll catch something.” We do not want people to be so afraid of, or so concerned about, the national health service that they think it is bug-infested and do not want to go near it. There must be a sense of perspective and proportion.

The amendment would make the distinction between, for example, an infection brought into hospital by a patient, which becomes observed only in hospital, and an infection that is associated with a health care action. That is a relatively simple distinction, but has the Department assessed the extent to which infections that are identified on NHS premises are the cause of health care actions and the extent to which they are methicillin-resistant Staphylococcus aureus or something else that has been brought in and identified during a person’s course of treatment, but is not a health care-associated infection because the person already had it? I am not talking about health care action such as a dirty ward but about an infection that was brought into the hospital. The statistics for such infections are aggregate. No distinction is made in respect of the original source.

Andrew Murrison (Conservative, Westbury)

Has the hon. Gentleman observed the suggestion that people should be screened pre and post-admission? Does he agree that that might solve the conundrum? I suspect that the Minister will say that she does not have the information that the hon. Gentleman seeks. My suggestion would supply the information.

Steve Webb (Liberal Democrat, Northavon)

Superficially, pre-admission screening is attractive. We have discussed that briefly in Committee, at which time the Minister said that the cost-effectiveness of the screening processes had not been demonstrated. I am open to the suggestion. The private sector can take such action more often because it is dealing with planned admissions and elective surgery, whereas the NHS is, to some extent, the victim of having to take anyone who turns up at its door. If such action can be proved to be clinically effective and cost-effective, I shall be open to the suggestion. It would help the point that I am making.

Why is the definition in the Bill different from that used by health bodies? Can we distinguish between infections acquired as a result of health care intervention and those that are identified in a heath care setting? Can the Government give some assessment of the balance between those two sources of risk?

Andrew Murrison (Conservative, Westbury)

It is a great pleasure to serve under your chairmanship once again, Mr. Illsley.

The hon. Member for Northavon (Steve Webb) said that he hoped we could rattle through the remaining parts of the Bill. I also hope that we shall make some progress because, as he said, at the moment we are in danger of not reaching some of its important bits. Not to reach them would be a great pity, would it not?

If I may leap to the Government’s defence, amendment No. 100 seems somewhat redundant. As I read it—shortly, the Minister will be able to clarify her intentions—the Bill covers the eventuality to which the hon. Gentleman referred. Occupational health is important and the issue of the transfer of organisms from patients to practitioners, health care workers and people in general in hospital settings is important for two reasons: first, because those people may become ill and secondly because they may unwittingly transfer bugs to other people—patients or otherwise.

I understand the hon. Gentleman’s intentions. They are good ones, although, as I said, my reading of the Bill is that it covers the eventualities to which he referred; shortly, the Minister will clarify. Furthermore, the guidance notes are very good and comprehensive, although perhaps I shall regret saying that. They are helpful and assist us in this matter.

The hon. Gentleman did not mention some of the more catastrophic infections that face our health service. Last week, I raised the issue of viral hemorrhagic fever. It is important fully to appreciate the risks that people working in the health service face as a result of their occupation; perhaps we have neglected that. As we face an increasing threat from more exotic, but nevertheless devastating, infections, it seems appropriate that we should bend our minds towards how we might protect those who work in the health services in processes that are very difficult to control. In the context of occupational health, such infections create unusual circumstances for which there are no procedures. Each one of them is unique, and that means that risk is maximised.

The hon. Gentleman has, perhaps unwittingly, done us a service in prompting us to think not just of patients in the context of hospital-acquired infections but of those who work in the health service. For that we should be grateful. I hope that in a minute the Minister will say that she appreciates the hon. Gentleman’s intentions, but that his concerns are covered in the Bill—and, if not there, in the guidance notes.

Jane Kennedy (Labour, Liverpool, Wavertree)

I am tempted to say that I could not have put it better myself. I shall speak very briefly. It is worth saying that the definition is simple and straightforward. Health care-associated infections are those acquired in connection with health care; that definition is much broader than that of a hospital-acquired infection.

However, I acknowledge the concerns raised by the RCN and I understand the reason for the nature of the amendment. We acknowledge that the burden of health care-associated infections has been mainly on hospitals, where more serious infections are seen and where it is estimated that at any one time 9 per cent. of all in-patients have acquired an infection while in hospital. We are also interested in screening; I do not want to dismiss the concept out of hand. We are testing different methods of screening to ascertain whether there are ways to screen for MRSA, for example, in a cost-effective way that will produce results and reduce the risk of passing on the infection in hospital.

The amendment tabled by the hon. Member for Northavon would restrict the definition to the detriment of patient safety. For example, it would exclude infections caused by environmental factors as opposed to actual clinical procedure. Examples of environmental factors are inadequate ventilation or decontamination failures in the hospital. It would restrict the scope of the code to infections that are caused by health care interventions. As the objective of the code is to require an NHS body to carry out a risk analysis and develop systems to protect patients, staff and visitors by minimising the risk of health care-associated infections, the amendment would not benefit the Bill. I hope that the hon. Member for Northavon accepts that explanation.

Steve Webb (Liberal Democrat, Northavon)

I am grateful to the Minister for that response, but it raises a question. If the Health Protection Agency uses a narrower definition, similar to the one in the amendment, but the Bill proposes a broader definition, should she go back to the agency and suggest that its activities be broadened in scope because they are unnecessarily narrow? That is an interesting question.

I notice that the Minister did not offer an answer to my question about the Government evidence on the distinction between infections acquired in the health care setting and those brought in. That is an important distinction to make, because if we want effective measures to be in place to tackle infections, we need to know where they are coming from. It is interesting that the Government appear not to know, or certainly the Minister did not tell us, what the balance is on those two fronts. However, we have had a useful discussion to kick off the debate and I shall not press the point. As I said, I am grateful to the Minister for her response. I beg to ask leave to withdraw the amendment.

Andrew Murrison (Conservative, Westbury)

We have had quite an extensive debate on the clause and it would perhaps be wrong of me to repeat what has been said. Thursday’s debate was certainly an enlivening experience for me, and we covered a great deal of ground. However, I would like to put a few points to the Minister before we take a decision on clause 13.

The crux of the matter is the code, which is a bit of a mixed bag. It is a rather non-specific document; it has a lot of generalities, many of which we covered on Thursday. The question is to what extent the code adds anything to our fight against the range of infections that we are considering. We are left with the view that, as drafted, it does not do so. We hope that when the definitive document is produced in the fullness of time, it will be a little more helpful to those on the ground who are expected to carry forward the fight against hospital-acquired infections. The early draft, as I said fairly unequivocally on Thursday, does not give us a great deal of hope that that will be the case.

In debating the clause, we have proposed a number of amendments that would materially have assisted thed¤Government in producing legislation to help our fightd¤against hospital-acquired infections. The Government, having politely listened to our suggestions, declined to recommend them to the Committee, as is their prerogative, but we may well have to return to at least some of them later. I hope that when we eventually get the legislation and, subsequently, the code, it will lay out precisely what people should be doing to tackle hospital-acquired infections and that they will have something that will be useful to them and give them a sense of direction.

When I talk to health care professionals about the issue, they tend to say to me, “The Government appear to be devolving the responsibilities to us, but there seems to be little in the way of concrete guidance.” We have suggested that there should be a manual of hospital-acquired infection control. If the Minister does not want to lay all this down in the code of practice that emanates from the legislation, she should at least give some consideration to a definitive text, so that best practice throughout the health service can be pulled together. Such a document would of course have to be updated regularly, because this is a changing science, but it would be useful for people to refer to. Of course it would not have any statutory force; it would have force only as a text. As things stand at the moment, if there is a case against an individual or a hospital, standard works can be cited in defence or otherwise. The document would merely have that kind of strength, but it seems appropriate to produce such a volume to give guidance to people who are carrying on the fight against hospital-acquired infections.

We are concerned about the recording of data. The Government are, rightly, recording hospital-acquired infection data—MRSA data, specifically—by hospital, by institution. That is very good, but for data to be useful, they must be broken down to an appropriate level. Given the nature of large hospitals, data apportioned according to hospital may not prove that helpful. We all know that our constituents will give us mixed reports on hospitals. They may tell us that the cardiology or dermatology department is spotless, but that paediatrics is dreadful. We know from evidence that has been collected that cleanliness in hospitals can be a mixed bag. Therefore a hospital cannot be considered as a whole.

It would be expedient to break down data according to the department, ward, or unit in order to control hospital-acquired infections. Indeed, for reasons that I discussed on Thursday, we should break them down even further under certain circumstances, especially in areas in which we know there to be a risk of health care-associated infection. For example, if we attribute certain infections to an individual practitioner, one can identify and deal with specific problems. Data that are collected from a ward or department raises the question of what on earth we should do about those that are above or below average. We must decide why exactly that ward or department is an outlier. That can be done by ensuring that it is clean. If it is dirtier than the norm, one can deal with that.

We must be cleverer than that, however. I suspect that the cause of many infections is the practices of an individual. Indeed, the prevention of many infections will be as a result of an individual’s good practice. The problem can be dealt with only by collecting individual-level data. We can learn from cases in which a particular individual is performing better. By doing that, we can improve best practice.

Referring again to our proposed manual of hospital-acquired infection control, to which the Minister might wish to give some thought at some point, it would be a manual of best practice.

Steve Webb (Liberal Democrat, Northavon)

I am following the hon. Gentleman’s argument with interest, but I am a bit puzzled at the notion of individual-level reporting. Many health care professionals are involved in the care of any given patient. If one nurse has practised bad infection control, should everyone who has come into contact with or served the patient a meal be listed, or even blacklisted?

Andrew Murrison (Conservative, Westbury)

No, I am not saying that at all. That is an entirely predictable question from the Liberal Democrats. On Thursday, I gave the hon. Gentleman an example from my practice related to urinary tract infections. In such high-risk procedures, it is appropriate to determine why one individual produces better results than another. The hon. Gentleman furrows his brow, but he has been around for the past year or so when Ministers have presented those data in league tables. He must know what I mean.

A critical outcome is where someone contracts a urinary tract infection. That can be devastating. It is important that we know which individuals are performing well and which are performing less well. Collected data may show a high level of infection in a department in which many high-risk procedures are carried out. We are then left asking ourselves why there is that high level of infection. It prompts the question, “Who is responsible for this and what are we going to do about it?”

There is no point in collecting data for the sake of it unless those data will be put to some use. In order to do that, one must know who is involved with those data-collecting procedures. The hon. Gentleman may have a better suggestion, but I cannot think of a better way than recording data at an individual level to deal with problems or, as I have taken some pains to explain, to identify particularly good practice. That information is needed if we are to drive up standards.

I suggest to the hon. Gentleman that the worst possible thing would be to gather data that is largely useless. If data is to be gathered, it should be the right data, containing sufficient detail. That is the crux of what I am saying to the hon. Gentleman. It would be highly redundant to collect such material in respect of every clinical department; manifestly, that would be a gross waste of resources. However, in areas which are known to be high-risk, where in the general run of things there will probably be a fair number of hospital-acquired infections, it would be helpful to be more specific about the sort of data that is gathered.

Steve Webb (Liberal Democrat, Northavon)

Perhaps in a spirit of consensus the hon. Gentleman and I can find some common ground. I agree with him that statistical information at trust level is insufficiently disaggregated, but I struggle with the notion of ascribing things to an individual, whether the hon. Gentleman means a consultant or another individual. For example, if bad nursing practice is the cause of an infection, there is a danger that an individual consultant may, wholly unfairly, get “bad figured” and be at the bottom of a league table. Surely, we should identify where within a trust there is a problem and have a look at what is going on in the entire system, rather than just trying to tabulate and ascribe problems to named individuals. Departments and wards should be considered as a whole; it is the individual concept that I have trouble with.

Andrew Murrison (Conservative, Westbury)

I understand precisely where the hon. Gentleman is coming from. To judge from his earlier amendment, he has been discussing the matter with the organisations that represent individuals. He does not want individuals to be blamed or a blame culture to emerge, and I agree with that. However, it is individuals who provide health care, within teams, of course, but at the end of the day, individuals manage patients and, generally speaking, they do it extremely well.

We are discussing hospital-acquired and health care-associated infections and health care is provided by individuals. If there are problems or if there is good practice it is down to individuals, not to amorphous teams. I thought that I had made it clear that it would be redundant to undertake the kind of exercise suggested in, for example, a dermatology out-patients department; it would not be a very good use of resources. But in urology, the potential for health care-associated infections is quite high and it is individuals who do catheterisations, as I said at our last sitting. If there is a problem, it is down to the individual carrying it out.

Steve Webb (Liberal Democrat, Northavon)

The right individual.

Andrew Murrison (Conservative, Westbury)

Of course, but I am not exactly sure what the hon. Gentleman thinks I am suggesting. I am certainly not proposing a witch hunt against persons; I am trying to impress on him, but he does not seem to grasp, that infections are because individuals do not comply with best practice. That is precisely the problem that I am trying to get round.

The hon. Gentleman, in a way that is typical of his party, is keen on showering us with warm words; I suspect that he roundly approves the code of practice, which is full of words but has very few teeth. My constituents and those of the hon. Gentleman—we share a major hospital—are concerned about what is being done to address the infection that they or their nearest and dearest may contract when they are admitted to hospital. We need to identify where there are problems and take action to sort them out. That is not the witch hunt that the hon. Member for Northavon fears; it is identifying those who are not complying with best practice and re-briefing and retraining them.

I certainly accept that whole systems often need to be looked at, and that is why we must gather departmental data. However, I underscore the fact that, in my experience, it is a departmental, rather than a whole hospital, issue. I am sure that the hon. Gentleman will find common ground with me from his experience of the Royal United hospital, Bath. At the end of the day, it is individuals who deal with patients and individuals who implement best practice. Some of them may do less well, and when that is the case, there is obviously potential for health care-associated infection. That is my point. He may, on reflection, agree with me; if not, I suggest that he contacts the chief executive of the RUH, asks for an in-detail tour of the hospital, and views some of the high-risk procedures. He might then more fully understand what I am trying to get at. I think that we have exhausted this line of debate, so unless the hon. Gentleman wants to intervene on me to explore my thoughts further, I shall move on.

My hon. Friend the Member for Mid-Bedfordshire (Mrs. Dorries) is delayed, but I agree with the purpose behind her amendments. She described the difficulty with laundry in certain areas. I elaborated on that from my personal experience of 20 years of practice. I was fairly frank in my admission that during my time as a junior hospital doctor, hygiene standards were not what one might expect. I hope that things have greatly improved—indeed, from my observation, I think that they probably have. Certainly, the subject of hygiene in general is better covered than it was 20 years ago. I am sure that those now training in medicine, nursing and other health care professions are briefed quite well on their responsibilities to maintain hygiene and cleanliness.

However, my hon. Friend’s reference to her nursing colleague, who had spilled the previous evening’s dinner down her dress, was graphic. Many of our constituents are concerned about the cleanliness and presentation of health care staff, so my hon. Friend’s remarks were well made. On hospital laundry, it is important that the Minister understands that if uniforms are to be adequately laundered, we need some sort of central provision. It is simply inadequate to expect individuals to take care of that; they are busy people with demanding careers who lead frantic lives. With the best will in the world, and although we wish it otherwise, laundering often tends to get neglected.

If we live in the real world, as I hope that we do, it is important to investigate how we can help individuals to ensure that their uniforms are up to an acceptable standard of cleanliness. The Minister might say, “Ah, there’s another Conservative spending commitment,” but the fact is that health care-acquired infection—

Eric Illsley (Labour, Barnsley Central)

Order. I apologise for interrupting the hon. Gentleman, but both hon. Members who have spoken this morning made reference to the fact that we are in the ninth of 12 sittings, and we need to make progress. We Chairmen have been generous in allowing a clause stand part debate on this clause, which has already been extensively debated in discussing amendments to it. We are less than a quarter of the way through the Bill, so I strongly recommend that Members make their speeches a little more concise.

Andrew Murrison (Conservative, Westbury)

I am extremely grateful for that advice, Mr. Illsley. Your colleague generously allowed a discursive debate on Thursday, and I promise not to test your patience too much. However, we are addressing important issues; this is an important part of the Bill. Health care-associated infections exercise many of our constituents, and we need to explore the subject comprehensively—thus the extent of my remarks. However, I am coming towards the end of them.

I hope that, even at this late stage, the Minister will consider giving some beef to the clause. If she is not minded so to do, which seems to be a real possibility, I hope that when she draws up her definitive code, it will be more helpful than the document that she has produced in draft for us. That document is full of warm words, and I accept that it has good bits, but it needs to be specific if it is to do anything to tackle health care-associated infections.

David Kidney (Labour, Stafford)

The hon. Member for Westbury (Dr.d¤Murrison) was right to question the nature and the point of surveillance. Does my right hon. Friend the Minister intend, in due course, to use the clause to impose a more comprehensive system of surveillance in the national health service for health care-associated infections, and if so, is she satisfied that the clause is sufficiently widely drawn to enable her to do that?

I have been assisted in thinking this issue through by postnote 247 of July 2005 from the Parliamentary Office of Science and Technology, headed “Infection control in healthcare settings”. The current mandatory surveillance started in 2001 when the Department made mandatory the surveillance of methicillin-resistant Staphylococcus aureus blood infections. In 2003, we also made mandatory the surveillance of glycopeptide-resistant enterococci, and in 2004 we made mandatory the surveillance of clostridium difficile. I hope that I have pronounced those conditions correctly.

Many hospitals also continue to use the nosocomial infection national surveillance scheme—NINSS—which was established by the last Conservative Government in 1996. NINSS is a voluntary scheme, using standard surveillance methods in hospitals in England to provide information on all health care-associated infections. However, there is still no national mandatory surveillance scheme for all infections. The different surveillance schemes that exist do not present comparable data. Also, a lack of information technology in some trusts means that surveillance sometimes cannot be carried out. Therefore, the overall extent of health care-associated infections remains difficult to gauge. The Public Accounts Committee has looked into the matter twice, and has recommended that there should be a national surveillance scheme, perhaps building on NINSS, and that it should be mandatory. In response to that, the Department has commissioned a national survey of all infections that is due to report in 2006.

Problems associated with the diagnosis of these infections can also compound issues associated with the surveillance of them:

“when a patient’s sample is sent for diagnosis, different laboratories use different methods for detecting HCAIs. This means that what might be reported as an HCAI by one laboratory might not be reported as such by another. Experts are calling for regulation to be introduced, recommending the use of certain tests over others.”

Does the clause allow the Minister, when the survey is completed in 2006, to say that a more robust national mandatory system of surveillance can be brought in, and that, under the code, it can be enforced by the Department? According to my reading of the clause, that will be possible because it addresses itself to all English NHS bodies—to any body that carries out surveillance for the Department. Proposed new section 47A(5) states that the code may

“operate by reference to provisions of other documents”.

Therefore, if the Minister has introduced a new scheme for surveillance, that could be referred to in the code, and thus be taken into account. Is my right hon. Friend the Minister satisfied that if that is what she intends to do in the future, the clause will allow her to do that?

Jane Kennedy (Labour, Liverpool, Wavertree)

We have had a thoughtful clause stand part debate. In response to my hon. Friend the Member for Stafford (Mr. Kidney), I tell him that the clause does not need beefing up. It is beefy enough, and will do what the Government want to do about surveillance at this time. The way we are taking it forward will allow flexibility, so that if we decide to go down the route that he mentioned, we will be able to do so.

The clause is the cornerstone of the Bill’s health care-associated infections provisions. It adds three important new sections to part 2 of the Health and Social Care (Community Health and Standards) Act 2003, chapter 2 of which is concerned with, among other things, the quality and standards in NHS health care. The power to issue a code of practice on the prevention and control of health care-associated infections involving the NHS is extremely important.

While my hon. Friend the Member for Stafford, the hon. Member for Westbury and others have urged us to consider the surveillance of all infections, we must resist the temptation to do that just because we could. We must not overburden the health service with an overly bureaucratic structure that is not necessary for the purposes of patient safety.

On the point that the hon. Member for Westbury raised about a manual, as a result of some research we concluded that professionals did not want a manual as such. We have set up a web-based national resource for infection control. As with all things in the health service, it has an acronym, which is NRIC. It is a simple way to access all the infection control advice and guidance that is available to the health service.

Andrew Murrison (Conservative, Westbury)

I assume that the electronic version will be reliant on NHS IT. Will the Minister confirm that its roll-out will not be adversely affected by the chaos relating to Connecting for Health?

Jane Kennedy (Labour, Liverpool, Wavertree)

I do not recognise the description “chaos” in relation to the Connecting For Health programme. I undertake to ensure that the website is a robust one, which will be the useful tool that we intend it to be for health service professionals.

We are beginning to break down the MRSA data that we are getting by clinical department. More detailed analysis can be done at hospital level, but for the purpose of improving patient care locally it would not be appropriate for us to require the health service to provide the information nationally, given our current IT systems.

The code will bring together the best practice that has been developed in tackling health care-associated infections. Through the statutory nature that we are giving it, we will ensure that best practice becomes embedded at all levels of the NHS. The clause places a duty on everybody to observe the provisions of the code as part of their duty of quality in health care under the Health and Social Care (Community Health and Standards) Act 2003.

In our debates last week and in this morning’s one, much consideration has been given to the central part of the health care-acquired infections measures in the Bill.

Andrew Lansley (Conservative, South Cambridgeshire)

The Minister seems to have contrasted the position of the current requirements on mandatory surveillance, as illustrated during the debate, with the proposition that every infection should be the subject of mandatory surveillance.

There are significant areas of infection. The Government have started the process of mandatory surveillance of orthopaedic surgical site infections. It would be possible, and probably not onerous for the NHS, but helpful for it, for surgical site infections to be the subject of mandatory surveillance. I believe that my hon. Friend the Member for Mid-Bedfordshire raised this point. Will the Minister undertake to consider whether to extend the mandatory surveillance at least that far?

Jane Kennedy (Labour, Liverpool, Wavertree)

I am always willing to listen to sensible proposals. I am currently content that the mandatory requirements are all that is necessary. However, I am willing to examine the points that have been raised, including those made by the hon. Gentleman, and take them into consideration. Although the consultation period has ended, over the Christmas break I shall consider what has been said about the code today and last week, to see whether improvements can be made to it. I am grateful to all the members of the Committee for the contributions that they have made.

Andrew Lansley (Conservative, South Cambridgeshire)

We will expect an e-mail on Christmas day.

Jane Kennedy (Labour, Liverpool, Wavertree)

E-mails on Christmas day may not be on my agenda. I hope that the Committee will give clause 13 a fair wind.

Clause 14 - Code of practice: effects on existing functions of Commission for Healthcare Audit and Inspection

Andrew Murrison (Conservative, Westbury)

Clause 14 is an innocuous clause, but it is nevertheless important. I should therefore be grateful if the Minister answered a few questions on it, before we signify that we are content.

The clause essentially deals with the role of the Commission for Healthcare Audit and Inspection in respect of the code of practice. In that context, we must refer back to the Health and Social Care (Community Health and Standards) Act 2003, with which many of us are very familiar. Some of us spent many hours considering it in the same way as we are considering this Bill.

Clause 14 sets out the effects of the code of practice on the existing functions of the CHAI; those effects are quite marked. What extra resources will be allocated to the Healthcare Commission in relation to those functions? That is an important matter, and will incur an opportunity cost. The Healthcare Commission is spread reasonably thinly as it is, and works very hard. If it is to be given more responsibilities, the resources necessary to discharge those responsibilities need to be found from somewhere. It would therefore be good to know what assessment the Minister has made of the costs and where the resources to meet those costs will be found.

The 2003 Act requires the Healthcare Commission to conduct an annual review of each NHS body. It must publish the criteria that it has devised, and those must be approved by the Secretary of State in accordance with the Act. The criteria must reflect standards set up by the Secretary of State in accordance with clause 46 of the Act.

On Thursday, I moved a raft of amendments to give teeth to the code of practice; those amendments were discussed during our debate on clause 13. In comparing the Bill before us with the 2003 Act, I am delighted to see that those amendments may yet see the light of day, because it is for the Minister to set standards from which the Healthcare Commission will devise the criteria against which it will judge NHS bodies when it inspects and reports on them. Those standards will presumably be things such as minimum cleanliness standards, infection control, nurse requirements, and minimum standards for the cleaning of bed spaces, each of which were the subject of amendments that I and my hon. Friends tabled as part of the debate on clause 13.

The purpose of my contribution to the clause stand part debate is to ask the Minister whether my view of that matter is correct, and whether many of the concerns that I raised as part of our debate on clause 13 may be addressed via a circuitous route. I am, of course, disappointed that those matters will not form part of the code. However, I am pleased to hear that the Minister will spend her Christmas break deliberating on the code, and perhaps coming up with suggestions on how it might be improved, which she will send us electronically over the public holiday. That is very good, but I may be able to save her a little time and effort. It seems to me that she already has the power to set the standards that the Healthcare Commission will use to determine its criteria. The Bill hands the commission responsibility for judging NHS bodies on their cleanliness and their provision for addressing health care-associated infection, so all may be well. It would be good to hear the Minister’s views on that thesis; does she think that there is any truth in it?

Basically, what I am suggesting to the Minister is that if the 2003 Act and the Health Bill are taken together, the concerns that I outlined in debate on clause 13 may be addressed. The fact that the Minister is to set standards may sort out the issues that I raised in speaking to my amendments to that clause. I should be grateful if the Minister commented on that.

Jane Kennedy (Labour, Liverpool, Wavertree)

We will come shortly to the new power to issue improvement notices that we will give the Healthcare Commission. The clause gives the commission the duty to take account of the code, precisely as the hon. Gentleman suggests, when conducting any review or investigation of health care under the powers of the Health and Social Care (Community Health and Standards) Act 2003.

Observance of the good practice set out in the code will clearly be critical to achieving a real improvement in infection prevention and control. If NHS bodies are trying and failing to achieve what the code requires of them, it is essential that that is known, and the body that will know it is the Healthcare Commission. When failings occur, it can inform the trust and—we will discuss this shortly—where necessary, the Secretary of State.

The clause requires the Healthcare Commission to take into account observance of the code when awarding performance ratings for NHS bodies. That puts infection prevention and control at the heart of this important measure. The power to advise the Secretary of State is a sensible and necessary measure. It ensures that the Healthcare Commission will review the observance of the code at the front line; it can use its knowledge of how the code of practice is being observed to advise on how the code itself can be improved. The power will provide an additional mechanism to help bring about improvements in the code and, through that, improvement in the quality of infection prevention and control.

I am assured by the Healthcare Commission that it will be able to make reviewing the observance of the code part of the assessment process that it already conducts. That means that the additional burden on the commission about which the hon. Gentleman is concerned should be kept to a minimum. He will have seen that the regulatory impact assessment that accompanies the Bill included a broad estimate based on information supplied by the Healthcare Commission. As with all publicly funded bodies, the Healthcare Commission is under a duty to perform its functions as efficiently as possible. I am satisfied that it has the resources that it needs to undertake the extra work that we are asking it to do, although we expect that costs will initially be at the higher end of the range given in the regulatory impact assessment.

Obviously, it will take time for the best practice outlined in the code to become firmly embedded throughout the NHS. There will be early costs, but they will be minimal. I am confident that the Healthcare Commission has the resources that it needs. On that basis, I hope that the Committee will agree that clause 14 should stand part of the Bill.

Clause 15 - Code of practice: improvement notices

Steve Webb (Liberal Democrat, Northavon)

I beg to move amendment No. 103, in clause 15, page 11, line 30, at end insert

‘and

(d)specify what sanctions will be applied if the healthcare body fails to comply with the improvement notice.’.

As the Minister hinted, clause 15 deals with the issuance of improvement notices where problems are identified. Amendment No. 103 is intended to probe what sanctions would be imposed if a health care institution failed effectively to tackle health care-acquired infections.

There have been various noises from the Government about the nature of the sanctions. At one stage, it was suggested that there might be criminal sanctions—legal action—against people at the top of hospital boards, but that seems to have gone. It would interesting to hear the Minister clarify the basis on which the Government rejected that suggestion. I am sceptical about whether it would have been a good idea.

I want to draw the Committee’s attention to remarks made by the chief medical officer, who said as recently as December 2003 that, despite all the guidance that had been issued to the NHS, there had been little improvement in tackling health care-acquired infections. The chief medical officer lists a number of aspects of the problem, one of which is that

“evidence-based countermeasures of known effectiveness are not being implemented consistently or rigorously in the majority of hospitals.”

People understand that such things are serious. We have heard the figure of 5,000 fatalities a year mentioned, although I gather that that is out-of-date and based on overseas information. Perhaps the Minister will confirm her latest estimates. Perhaps effective things can be done, but are being done only sporadically, not systematically; the point of a code of practice and an improvement notice is to try to tackle that problem. However, we all respond best to incentives. Our amendment says that the improvement notice ought to contain some indication of what will happen if the notice is not acted on.

On reading the Bill, and linking it to the Health and Social Care (Community Health and Standards) Act 2003, I found some indication of what might happen and what the ultimate sanctions would be, but I hope that the Minister can flesh that out in a number of respects. What time line does she anticipate between an infection problem arising in one department, for example, and the Healthcare Commission picking it up and giving the trust some time to do something about it before getting into the formalities of improvement notices?

When is the improvement notice issued, and how long does the Minister envisage the trust being given to sort things out? Will she just give us an indication? The worry is that I cannot see any indication of the time scales about which we are talking. Clearly, these things need to be tackled urgently, if people are dying because of failures of process. It is important that there is some indication, not merely of how long it will take, but what will happen if things are not done by a certain deadline.

The concept of a sanction is not ours; it came from the Secretary of State, who said in the debate in the House on 24 May 2005 that the Bill

“will establish a statutory code of practice, improved inspection arrangements and”—

this is the critical bit—

“as a last resort, appropriate sanctions in the both the NHS and the independent sector”. [Official Report, 24 May 2005; Vol. 434, c. 574.]

Unless our amendment is agreed, it is not clear whether those improvement notices will be explicit about the sanctions. They may say, “We expect certain things to be done”, but it is not clear whether they will say, “by a certain time” or, simply, “they must be done”.

We have talked about eventually sacking the board, or bringing somebody else in. There is talk in the guidance notes of possibly bringing in the infection control manager from another trust. We are interested in getting the infection sorted out, which has to be the priority. As the hon. Member for Westbury said, we are interested not in a blame culture, but in effective action. I am concerned that hospitals and trusts are under so much pressure from central Government, with a panoply of targets, benchmarks and league tables, and all the rest of it.

Those of us who are under pressure often react to the one who shouts the loudest. If the infection control improvement notice is not up front and explicit about sanctions, perhaps some of the other pressures will be more powerful. For example, if there is a conflict between targets on waiting times and infection, and an infection control manager says “Shut the ward; it’s the only way to deal with things”, will the trust weigh the relative penalty for failure on either front and work out which is the most serious? If the improvement notice has no indication of a clear sanction, and the trust is unafraid of the consequences of not dealing with it compared with the implications of going down in the legal table or facing a penalty for not meeting another Government target, they might not make infection control the priority, which we believe is vital.

I have one other observation: I get a sense that part of the sanction mechanism is almost naming and shaming; it is about reputation, perhaps gained or lost formally through the league tables. I presume that I will know if my local trust is served with an infection control improvement notice, and perhaps the Minister will confirm that it will be made public. There are arguments on both sides of that debate. Perhaps merely the fact that people’s professional colleagues, patients and, I suppose in the NHS these days, business units know what is going on will, in itself, be an incentive, but there needs to be more than that.

I hope that the Minister will confirm that the stick as well as the carrot will be used. She must tell us the time scale for the implementation of the enforcement and improvement notices and ensure that because of how they are implemented trusts will take them very seriously.

Andrew Murrison (Conservative, Westbury)

The issue of sanctions is fascinating, because they can mean so many things. In the professional sense, success or otherwise in achieving an outcome is sanction enough, as we all want the approval of our peers. In Parliament, for example, if do not have a good reputation we feel unhappy about it, and the same applies to health care professionals. We like to think that our peers appreciate what we do and recognise that we achieve good results. That, generally speaking, is the driver in the NHS. The problem with sanctions is that that driver is not sufficiently recognised.

Hospital-acquired infections have traditionally been seen as the responsibility of someone else, as supplementary to the main thrust of what a hospital does, which is carrying out successful hip replacements, for example, and ensuring that people admitted to a coronary care ward are well when they leave hospital. We need to ensure that that aspect of health care is at the heart of what the NHS and other health care providers do.

To give credit where it is due, the professions have begun to address the issue. I therefore hope that sanctions per se will not be such a big issue in future; the true sanction is that driven by the professions themselves, and it is related to the esteem or otherwise in which individuals within those professions hold one another.

I hope the Minister will comment on the difference in how the private and not-for-profit sectors in health care are dealt with in relation to the NHS. In a previous sitting, the hon. Member for Northavon, contrasting the sanctions that may apply to the two sectors, seemed to misunderstand the level of sanction and the penalties that may apply to the private sector—those bits of our health care system which lie outwith the NHS. If I got that wrong the hon. Gentleman will correct me. In truth, the sanctions that apply to the private sector are potentially very severe indeed because they are quasi-commercial, or commercial, in the sense that the HealthCare Commission could deliver an unfavourable report which could lead to contracts being removed. There are jobs involved, staff have mortgages to pay and so on, and their minds are heavily focused on the issue.

It does not happen in quite the same way in the NHS. In accordance with the 2003 Act, when a management problem is identified in the NHS, the individuals concerned are usually moved on, or moved sideways. We can all think of examples from our own constituencies where that appears to have happened. The level of sanction is not quite the same.

Nevertheless, what will be of concern to those at the front line, be they managers or health care professionals, is how they will appear to their peers. That, together with the altruism that goes with being a member of a health care profession and the desire to do good or, in the context of medicine and allied professions, at least to do no harm, is what will drive this matter. We need a recognition that that, rather than heavy-handed sanctions per se, is what tends to drive standards, particularly in the NHS.

I hope that the Minister will assure us that she would not be tempted to apply financial sanctions. We would have difficulty with that because we take the view that if there is a problem, removing resource is the worst thing that can be done. Part of the problem might be the need to use resource to improve things. The Liberal Democrats have tabled a later amendment that touches on this matter and I believe that the crux of it has to do with financial penalties that may apply, in the hope that any improvement might be funded centrally. To that extent, we would have similar sorts of concerns.

The notion that, having identified a problem, we need to fine the institution seems to be wholly inappropriate and a bit of a paradox. We want to rely on the powers that the Secretary of State already has under the 2003 Act to effect managerial change where that is necessary. We hope that there might be a bit more bite to that in the Minister’s handling of this serious aspect of health care in this country.

Jane Kennedy (Labour, Liverpool, Wavertree)

For the avoidance of any doubt in the minds of members of the Committee, I declined the invitation to communicate electronically with them, either on Christmas day or on any day during the Christmas break. I undertake to read the Hansard record of our conversations, so long as my private office can get the box to me before the ferry departs on my last working day.

The Healthcare Commission has a key role in assessing the NHS and encouraging it to improve its performance. We have agreed that. In light of that supportive role, proposed new section 53A(4) would provide a power for the commission to recommend means to remedy the situation when an NHS body is failing. It is for the Secretary of State—and Monitor, in the case of foundation trusts—to consider what sanctions should be imposed, if necessary, where an NHS body has failed to comply with an improvement notice.

The improvement notice is a new and important power for the Healthcare Commission, one which will provide it with an interesting way of interacting with the organisations that it is inspecting. Special measures might include anything that the Secretary of State, or Monitor, thinks necessary to put things right as quickly as possible. That will be the focus of the effort. As we have discussed, such measures may include practical assistance or organisation support. For example, as the explanatory notes mention, the Secretary of State could enlist the help of the director of infection prevention and control from an NHS trust that has successfully implemented the code. That individual could advise a trust that is failing about how their trust put the code into practice and how the code could work.

Andrew Lansley (Conservative, South Cambridgeshire)

I am getting a bit confused. Perhaps the Minister will help me to clarify matters. My understanding is that improvement notices may be served in circumstances where there is not a significant failing under the terms of the 2003 Act, which would give rise to a report to the Secretary of State or to the monitor as appropriate. The Minister seems to be describing special measures taken under an improvement notice, but that clearly does not apply. Improvement notices specify remedies; significant failings lead to special measures of an interventional kind by the Secretary of State or the monitor.

Jane Kennedy (Labour, Liverpool, Wavertree)

That is right. I am sorry if I confused the hon. Gentleman. By describing the special measures, I was seeking only to go through some of the suggestions made by members of the Committee. It was asked why there are no criminal sanctions, for example. We discussed that briefly last Thursday, if I remember rightly. The Government have considered criminal measures or criminal sanctions, and I have thought about that carefully, but after listening to people on one or two visits that I made and after considering the response to consultation, we concluded that such measures would be inappropriate for two principal reasons.

First, our current powers of intervention are more effective as a tool than the threat of prosecution in the courts would be. I described last week how difficult it would be, in the case of total system failure, to narrow things down to a single individual or group of individuals, but we will—the Healthcare Commission will be part of this—look to see how seriously the organisation is taking the whole issue, and there will be an individual at board level who is responsible for overseeing the code’s implementation.

The second reason has already been touched on: there is a real risk that the use of criminal sanctions would discourage open reporting of errors and incidents. I want there to be a culture in the health service that encourages openness and reporting, not only of incidents of hospital-acquired infection but of all adverse incidents in hospitals, so that we can learn lessons from them without fear of unjust persecution of individuals.

On the question of what happens in respect of private sector care homes, the hon. Member for Westbury is right. Onerous sanctions already apply to those operating as a private organisation. They have to register in the first instance if they are providing care through a nursing home or a care home, and with registration comes the implied threat to the business. We will introduce a code that exactly mirrors the code of practice for the health service and that will apply to the private and independent sector.

Although I have not spoken for long, I hope that I have addressed the issues and concerns that have been raised.

Mr. Lansleyrose—

Jane Kennedy (Labour, Liverpool, Wavertree)

I was about to make one last point on financial sanctions.

Andrew Lansley (Conservative, South Cambridgeshire)

I do not think that this point is necessarily about financial sanctions. I understand, I think, how the measure works, but there is something that I do not understand. Circumstances are envisaged in proposed new section 53B(8) of the 2003 Act, in line 28 on page 13 of the Bill, in which the Healthcare Commission believes that the improvement notice has not been complied with, but it is not required to make a report to the Secretary of State or the monitor because the failings are not significant. What sanctions could apply in circumstances in which the Healthcare Commission has reached that view and it cannot use the sanctions under the 2003 Act?

Jane Kennedy (Labour, Liverpool, Wavertree)

If the Healthcare Commission has come to the view that there is a failure but not of the serious kind, it can reflect that in its annual report on the body that it is inspecting. I expect that, once the measure beds in, there will be a regular dialogue almost between the inspectors and those being inspected and an increasing awareness of the areas of risk in the organisation, so that steps are being taken and there is awareness of the steps that need to be taken. The Healthcare Commission will be able to see fairly quickly and clearly whether those steps are being taken in order to improve, year on year, the performance of the institution.

Andrew Lansley (Conservative, South Cambridgeshire)

I understand that, but what is contemplated in paragraph (d) in line 31? It appears to suggest that an improvement notice may not be complied with and that it may be concluded by the Healthcare Commission that the failing is not a significant failing which gives rise to sanctions using the powers of the 2003 Act set out in section 53(2) of the Act, but

“(whether or not paragraph (c) applies)”—

whether or not it has made a report to the Secretary of State—it should set out

any action which it proposes to take”.

What does action mean in that context?

Jane Kennedy (Labour, Liverpool, Wavertree)

I am trying not to be too prescriptive because I expect that it will very much depend on the circumstances at the time. The Healthcare Commission will be able to point the organisation that is failing, although not critically, to best practice that might not be being applied. The hon. Gentleman asks what will happen if the organisation fails or refuses to take that action. That will depend on the circumstances. The Healthcare Commission has wide discretion as to what it can recommend, but if it does not take action it will always be open to the Secretary of State to take action if he or she feels that there are sufficient grounds to do so.

Andrew Lansley (Conservative, South Cambridgeshire)

I am grateful to the Minister. The explanatory notes make it clear that action in this context could mean the further supply of information, such as more monitoring by the Healthcare Commission. I want to be explicit about this, as it may be okay. Do we have to rely on the fact that if any failure to comply with improvement notices becomes serious and is therefore the subject of a report to the Secretary of State or is to be monitored, if it is a significant failure under section 53(2) of the 2003 Act, the sanctions can apply and there can be direct intervention? Is it contemplated that any sanctions should be applied on the basis of a failure to comply with the improvement notice, save for information-gathering, scrutiny and further recommendations?

Jane Kennedy (Labour, Liverpool, Wavertree)

I am sorry if we are making heavy weather of this. The hon. Gentleman is absolutely right, but I shall not be so prescriptive as to say, at this point, what the commission can or cannot do. If it comes across some failings in an investigation or annual inspection, it has a duty to draw those failures to the attention of the organisation and to ensure that the organisation complies. Let us not get too bogged down in this. The hon. Gentleman is right. I do not expect specific sanctions to be taken in the event of a less serious failing, but I expect that the whole process will bring about an improvement, year by year, in the way in which hospitals and NHS health care bodies conduct their business in relation to the prevention of serious infections.

On financial sanctions, the hon. Member for Westbury can rest assured that we do not think it appropriate to introduce new financial sanctions, precisely for the reason that he gave: it would remove resources from patient care, which would defeat the object.

With that, I hope that I have answered the concerns raised by the hon. Member for Northavon when he moved the amendment. The amendment would not help the Bill, and I hope that the hon. Gentleman will not press it; if he does I will ask my colleagues to resist it.

Steve Webb (Liberal Democrat, Northavon)

I am sure that I have just heard an explanation as to why I should press the amendment, to be honest. I asked the Minister several questions and did not get many answers. I got an answer on criminal sanctions, for which I am grateful. I did not, however, get any answers to my questions on the time scale and process. I reassure the hon. Member for Westbury that we did not have financial sanctions in mind when we drafted the amendment; it does not say “financial”, it simply says “sanctions”.

Jane Kennedy (Labour, Liverpool, Wavertree)

I apologise to the hon. Gentleman; he did ask about time scales. Again, there is no prescription on that issue. I do not expect that health service bodies will not take seriously representations that the Healthcare Commission might make following specific or annual inspections. It will be very much up to the commission to determine the time frame of an improvement notice.

Steve Webb (Liberal Democrat, Northavon)

I am grateful for that. I simply wonder about the teeth of the provision, given that the commission existed then and the chief medical officer said as recently as two years ago that the evidence-based measures, which we know work, were not being implemented consistently or rigorously.

I admit that the debate on sanctions has been very helpful, but I am more confused than I was at the beginning about the code of practice and improvement notices. My understanding of the system is that the Healthcare Commission carries out an annual assessment, tells the Secretary of State if it spots something going wrong with the code of practice, and says that something must be done and that special measures must be taken urgently.

I hope that the Minister will correct me if I am wrong. Will she confirm that we are talking here about an improvement notice as a sort of second order? It is almost like saying that something is a bit wrong but not so seriously wrong that we need to do anything very urgently. It is fairly wrong so it is fairly urgent, and we should probably do something about it. I find that strange. It is saying, in effect, that there are breaches of the parts of the code that relate to infection control, but that they do not matter very much. We will give trusts until, say, the next inspection to sort out those breaches. I understand that there can be both big breaches and small breaches, but it worries me that we are communicating the message that minor breaches are okay so long as the trusts get around to sorting them out eventually. All parts of a statutory code should be taken very seriously. The attitude should not be, “Oh well, we had an infection.”

I used to be a shadow spokesman on work and pensions—the Minister’s old Department. Year after year, its accounts were not signed off. That became normal. The attitude was, “Oh well, they think our numbers don’t add up. They are a load of tosh, but what the heck, because there is no penalty, no problem, and no sanction.” My worry is that if we regard second order problems with the code as routine, do not tell the Secretary of State but simply ask the trusts to do something about them, and do the same the next year if we report that there may be another problem, the improvement notices will fall into disrepute after a while because they have no teeth. The only time they will have teeth is when the commission goes to the Secretary of State. I am more worried at this stage of the debate than I was at the start of it.

I have not heard a compelling argument against accepting the amendment, but in the interests of getting through the rest of the Bill, I beg to ask leave to withdraw the amendment.

Steve Webb (Liberal Democrat, Northavon)

I beg to move amendment No. 102, in page 11, line 43, at end insert—

‘(6A)When the Secretary of State is notified with a failing in connection with the code under section 47A he shall be responsible for the provision of resources necessary for the failing body to comply with the terms of the improvement notice.’.

As Conservative Members said, what happens if a problem is identified and the answer involves significant expenditure of resources, but the trust, or other body, is not in a position to deal with it? An obvious point to make at the outset is that we do not believe that effective infection control is primarily a financial issue or that not a lot of money is needed to ensure, for example, that people wash their hands properly. One can envisage circumstances, however, in which the answer to the infection problem is more substantial and may require the building of isolation facilities or other structural reform in a hospital. In those circumstances, it would be very unfair simply to issue an improvement notice, or even to have special measures to provide that the Secretary of State is informed but not to provide the trust with the wherewithal to deal with the problem.

Given the statutory duty on trusts to reach break even and the substantial minority of trusts that are in significant financial difficulty, how will such trusts be able to deal with a serious infection control problem that requires capital investment? If part of the problem is old, crumbling buildings and the only way in which to tackle the root of the problem is to bring in the bulldozers or build an isolation unit, and the trust says, “We have a £2 million deficit to clear by March, we simply cannot begin to do this,” how can the trust be expected to do it?

When there is a failing in the code under section 47A, our amendment would put a duty on the Secretary of State to ensure that the necessary resources are available to the failing body. The hon. Member for Westbury was right: the wording of the amendment seems to imply that the resources would come from Whitehall and would be centralist. To be honest, we do not mind who provides the resources; we want to place a duty on the Secretary of State to ensure that the resources are available. Whether they come from health authorities, primary care trusts or whoever, we do not mind.

Our preference is for a decentralised approach. However, if the Secretary of State brings in a code of practice and a notice about the big financial implications of breaching that code of practice, she cannot wash her hands of the consequences. It is not enough to say, “You must do better, you must sort this problem out,” while leaving the trust in no financial position to do so.

Andrew Murrison (Conservative, Westbury)

Would the amendment apply only to NHS bodies, or would it also include those parts of our health care system that lie outwith the NHS? If not, does not the hon. Gentleman accept that there might be a problem with what may be described as a level playing field?

Steve Webb (Liberal Democrat, Northavon)

I shall give the hon. Gentleman an instinctive response. As the amendment is drafted, it would appear to imply that, as he suggests, a failing body could mean one outside the NHS—a non-NHS provider. That was not my intention. If the private sector decides to supply services to the NHS, it should include in its financial planning the finances necessary to provide effective infection control procedures. My point is that the NHS and its finances are the responsibility of the Secretary of State, and it would be wrong of her to say that action with potentially substantial revenue and/or capital implications must be taken to tackle an infection without ensuring that the trust that had failed had the money it needed to do the job.

I shall not deviate on to the financial state of the NHS. Deficits are an increasing problem and they tend to be heavily focused, so where they happen, they are quite big. A significant minority of trusts have most of the deficit. If the bodies in substantial deficit were also the failing bodies referred to in the clause, it would be unreasonable to expect them to sort out the problem without the Secretary of State ensuring that they had the resources to do so. That is the purpose of our amendment.

Andrew Murrison (Conservative, Westbury)

Amendment No. 102 is interesting. I am pleased that in response to amendment No. 103, the Minister was able to assure me that financial penalties would not be imposed on trusts. However, amendment No. 102 would take the next step, providing money to trusts shown to be failing in respect of the matters under discussion. The amendment is fraught with difficulty, and I raised one difficulty with the hon. Gentleman on intervention. For that reason alone, we could not possibly support the amendment. It is flawed, and he was good enough to admit that.

The amendment would incentivise failure. In the same way in which we should be reluctant to support the levying of financial penalties on trusts that have been shown to have a problem, for the reasons that the Minister so eloquently discussed in her reassurance, we should not be minded to support this incentivising of failure either. At the last general election we listed ways in which trusts might improve their cleanliness, their hospital hygiene record and their record with health care-associated infections. That, rather than the hon. Gentleman’s suggested measures, seems the appropriate way to proceed.

I think that what he is talking about involves, often, large capital investment in trusts. That might, of course, introduce all sorts of perverse incentives. If the approach were to be fair, I suppose one could say, it would have to involve institutions outwith the NHS, and there would definitely be a commercial incentive, in certain circumstances, not to do things, in the expectation that the Secretary of State would be likely to come up with the readies to invest in real estate or whatever, to bring things up to spec. That would cause far more problems than it would solve. For those reasons, the amendment does not have our support.

Steve Webb (Liberal Democrat, Northavon)

The phrase “incentivising failure” is interesting, because in all sorts of areas of public life we spend money where there are problems. I suppose that that could be called incentivising failure, but that is what happens. We tackle problems, in some cases, by spending money on them. If the hon. Gentleman does not think that that is the answer, how would he tackle it? If a trust in his constituency was millions of pounds in deficit, and had an improvement notice served on it for tackling infection control, and its representative said to him in his surgery, “We haven’t the money to deal with the problem,” what would his answer be?

Andrew Murrison (Conservative, Westbury)

I am not sure that things are quite as black and white as that; I really do not think that they are. I should be interested to know precisely what elements of capital funding the hon. Gentleman is thinking of. It seems to me that reasonably small-scale stuff would be involved. I make no apologies for the term “incentivising failure”. The whole drift of our thinking about health services—and, to be fair, that of the Government, I believe—is a degree of independence and taking charge. The hon. Gentleman seems to be saying that his party would not be inclined to do that, and that it wants central control. That is precisely what the proposal would mean.

If the organisations in question would be looking to central Government for a bung of money to sort out their problem, that would be central control. That is part of the problem with hospital-acquired infections. The culture of targets has driven a great deal of that. The one cannot be divorced from the other. We either go for the kind of approach that the hon. Gentleman suggests—an entirely centrist approach to health care—or we adopt a devolved approach. Our view is that a devolved approach, with independence given locally, is far more likely to drive up standards across the board than the centrist approach that the Liberal Democrats favour.

I was on the point of sitting down when I took the hon. Gentleman’s intervention; now I am definitely going to sit down.

Jane Kennedy (Labour, Liverpool, Wavertree)

Before I respond to the amendment, those who are listening very closely to what is said—particularly by the Minister—have asked me to clarify something. I got carried away with my rhetoric and said that the code that will apply to the independent sector will be identical to the code that applies to NHS bodies. It will, in fact, be similar but not identical. I am pleased to take the first opportunity to make that clear.

Andrew Murrison (Conservative, Westbury)

I am not clear on that. It sounded to me like an important point. The Minister, for clarity, has said that the code will be different for the NHS and for the parts of health care that lie outwith the NHS. Is that correct, or have I got it completely wrong?

Jane Kennedy (Labour, Liverpool, Wavertree)

The codes will be very close, but not identical, simply because of the different structures within which the different sectors operate. However, in all essential elements—the standards with which people will be expected to comply—they will be the same. I hope that that helps.

Andrew Murrison (Conservative, Westbury)

This is important. I take the Minister’s reassurances about the level playing field, but she talks about structures, and I wonder if she could be more expansive about what problems, in respect of the differences between the two sectors, will require such a subtle change in the code.

Jane Kennedy (Labour, Liverpool, Wavertree)

In order to clarify the matter, I undertake to write to the hon. Gentleman and to circulate copies to the Committee.

I disagree with the hon. Member for Northavon, and find myself in a lot of agreement with the hon. Member for Westbury. It is important to be clear about the intention of the new code of practice. It will bring together existing guidance and good practice—things that NHS bodies should already be doing. Therefore, there is no question of its imposing significant new requirements or financial burdens ond¤trusts—certainly when it is first published. Furthermore, so far as future changes are concerned, there must be an expectation that NHS bodies, to which the code will apply, will want to keep up with good practice and to use the resources that are available to them. There cannot be an expectation that NHS bodies have to be individually funded every time there is a development in best practice. NHS bodies have a duty to improve the quality of the health care that they provide, whether that occurs as the result of a change in this code or due to wider changes in the field of health care dictated by improvements in good practice. We cannot say that that duty will be contingent on specific funding for every last improvement.

Steve Webb (Liberal Democrat, Northavon)

And that, obviously, is not what we are considering. We are talking about something specific to a failing body which might, for example, be peculiar to the history of the site and require specific intervention. It might be disproportionate to the body’s budget, it might be urgent or, in the context of a deficit, there might be no other money available to deal with it. Of course, general improvements that apply across the NHS do not need specific funding. That is not what we are talking about here.

Jane Kennedy (Labour, Liverpool, Wavertree)

But if a price tag came with failure, the effect of the amendment would be to provide trusts with a perverse incentive to fail to comply with the code of practice. That would mean that the new legislation, as amended, would actively encourage trusts to take inadequate action to protect patients against health care-associated infections. It would actively increase the very risks to patient safety that the measures are designed to reduce. It is hard to imagine that that is the desired outcome of the amendment, but that is the effect that we believe it would have. For that reason, I hope that the Committee will resist the amendment should it be pressed to a vote.

Steve Webb (Liberal Democrat, Northavon)

I must admit that I am shocked by the complacent response that we have just heard. Neither the Minister nor the hon. Member for Westbury has answered the question. We know that there are trusts that are in deficit—that is not in dispute—and we know that tackling infection control in a specific case could be expensive, could involve capital works and could need to be done urgently. However, we have not had an answer from the Government or the Conservatives as to how they would tackle such a situation. We have just been told that it is a devolved matter. The wishful thinking in both camps appears to be that those involved should just sort it out. I find that profoundly disappointing.

Under the terms of our amendment, the Secretary of State would have a duty not to write a cheque every time that trusts came asking but to ensure that they had the money that they needed. If the Government believed that the normal funding was adequate to cover routine infection control, the clause would not be necessary. It is clearly meant to apply to exceptional circumstances, and we have had no answer as to what would happen in such circumstances.

I find the argument about incentivising failure bizarre. The hon. Member for Westbury is, rightly, fond of telling us about the commitment of his professional colleagues, but here he seems to be implying that they would deliberately rig the system; they would respond to the financial incentives in the clause by deliberately failing. One can only assume that that is what he meant by his intervention. I have a higher opinion of his colleagues than he does.

Andrew Murrison (Conservative, Westbury)

The hon. Gentleman talks about my colleagues. I am, of course, referring to NHS bodies. There is a difference between the two, and I tried to tease that out in my earlier comments. However, by way of example, let us take an operating suite that is a little tired, and an organisation that feels that, in the event of an annual inspection by the Healthcare Commission, it might receive adverse comment resulting in a bung of money from central Government. Alternatively, it might decide to spend money on it from its own resources. Say the hon. Gentleman is a member of a trust board, faced with a string of priorities—he talks of NHS trusts in deficit, and they have long lists of things that they have to do. Where in that list of priorities will that matter be pegged? I suspect that it will be pegged relatively low down, in the expectation that the commission will come in and deliver an adverse report, which might have been expected in any case, and that what would result would be a bung of money. That is, of course, an extreme example, but it illustrates the point that I am trying to make, and that the hon. Gentleman is trying to misconstrue.

Steve Webb (Liberal Democrat, Northavon)

What we are saying in our amendment is that the Secretary of State should have a duty to ensure that the trust or failing body has sufficient resources. In the example that the hon. Gentleman gave, it is clear that the trust had sufficient resources, but spent them in some other way. That would not be acceptable; it would not be an eligibility criterion for the sort of assistance that we are discussing.

The hon. Gentleman failed to deal with the point that, throughout the public services, we spend money to put things right when they are going wrong. The idea that that is a perverse incentive to failure is absurd, because the alternative to spending money to put things right is not to spend money to put them right, which would be a far worse position. With some regret, I will withdraw the amendment, in the interests of having time to scrutinise more of the Bill. I feel that the Government have not given us straight answers on how a trust in deficit, facing those sorts of problems, which need substantial investment, is expected to deal with such a situation. I beg to ask leave to withdraw the amendment.

Andrew Murrison (Conservative, Westbury)

We have had a fascinating debate on the clause. I must confess that when I was looking through the remainder of the Bill after the provisions concerning smoking and the earlier clauses in part 2, I thought that we would rattle through it without too much controversy. However, this clause has sparked a certain level of controversy and an interesting debate.

I think that, between us, my hon. Friend the Member for South Cambridgeshire (Mr. Lansley), the Minister and I managed to thrash out what would happen in the event of the Healthcare Commission identifying a problem in respect of health care-associated infections, the difference between an improvement notice and a report, and their significance. I understand that in such a case an improvement notice would be served, and the sanction for not complying with that would be a report, which, in turn, if there was something called “significant failings”, would result in something that is defined in the 2003 Act as “special measures”.

I am still not clear what significant failings or special measures are, but I understand that they may have to do with some sort of sanction. I am not clear what the Minister’s understanding of that process is. I know that we are cantering along at this point in our consideration of the Bill, in the hope of reaching important bits later on, but it would be helpful if the Minister could give us her reflections on what she understands by “significant failings” and “special measures” and on what might be appropriate sanctions in the event that a report has to be made by the Healthcare Commission to the Secretary of State or to the regulator.

Section 52 of the 2003 Act allows for the commission to conduct overarching reviews of particular aspects of health care, such as hospital-acquired infections. If it did so in respect of that area, what would it do if it found a problem? It would seem inappropriate for it to deliver an improvement notice under those circumstances. I assume that some sort of report would be issued to the Secretary of State. It would be useful to know what action the Minister would take under those circumstances. We have had the Act for two years and I imagine that those sorts of situations, or something approaching them, may have arisen, and the Minister may therefore have some precedent on which to base her plan of action.

I focus specifically on hospital-acquired infection, because I cannot think of any area more worthy of the commission’s attention, if only because of the popular concern that has been expressed on that particular area of health care and, in some sections, the doubt that it has cast on the excellence of our system among the more hysterical elements of the press and therefore in sectors of the population. We have to reflect that. I cannot think of a better topic for the commission to seize for an overarching review than health care-associated infections. In the event that it were to carry out such a review, which it might be advised to do, if it found a problem it would presumably deliver a report to the Secretary of State. What action the Minister would take on receipt of such a report is uncertain.

Subsection (3)(c) leaves open the time allowed for the discharge of improvement notices. Clearly the Minister feels that that is reasonable, or it would not be in the Bill, but I find it a challenging concept. Most improvement notices that I am aware of have some sort of time limit; they are not left open. It would be useful if the Minister could discuss the time frame that she is considering. Will it be 12 months? That would, of course, be the normal periodicity of a commission inspection. Would the deadline be tighter than that? I hope, in the context of health care-associated infections, we would consider challenging time frames in which to deliver the improvements that are the subject of such a notice.

Jane Kennedy (Labour, Liverpool, Wavertree)

The clause gives the Healthcare Commission the new tool of the improvement notice. A notice may be issued when, following a review or investigation, the commission is of the view that the body is failing to observe the code in any material respect and an improvement notice is the most appropriate way to remedy that.

I thought that it was clear from the explanatory notes that the improvement notice will set out particulars of the failure and give the body a period of time in which to address the situation. I will not prescribe what that period will be. The commission may also include practical advice on how the body can remedy the failure. The improvement notice gives the body an opportunity to solve the problem itself, perhaps with the help of advice from the commission.

At the end of the period specified in the improvement notice the commission will conduct a review and send a report to the Secretary of State or monitor, as well as to the relevant strategic health authority if the body reviewed is a primary care trust or an NHS trust. That will ensure that any performance management role can be fulfilled in an appropriate manner.

If the commission is of the view that the NHS body has complied with the improvement notice and is fully observing the relevant provisions, that will be reported and the process will end there. If the commission is of the view that there are major outstanding issues that constitute a significant failing, that also will be reported to the Secretary of State or to the monitor, who could take the special measures that we have discussed. I have already described what the special measures could be and I will not offer any further prescription.

We will not define “significant failing” it in the Bill, but it will be one that seems significant enough to be drawn to the attention of the Secretary of State or monitor. It could include a failure to observe the code, but, taking all the relevant factors into account, it should be a failing that might, if it were not remedied, cause a risk to patient safety. In informing its opinion on whether the failings are significant the commission will have to take the overall situation into account, including the body’s failure to comply with the improvement notice and the reasons behind that.

If, following the review, there are outstanding issues that the commission does not consider to be significant failings, it will report that, together with its reasons. It will also report in all cases on any work it intends to do with the NHS body to rectify the remaining failings. As I have said before, and repeat now to try to be helpful, special measures in the event of a significant failing may include anything that the Secretary of State or monitor thinks necessary to put things right.

This discussion has been useful, and I hope that the Committee will give clause 15 a fair wind. It introduces a significant new measure that the Healthcare Commission can use. Perhaps it will interest the Committee to note that improvement notices are not new. Under section 81 of the 2003 Act, the Commission for Social Care Inspection already has powers to issue improvement notices for local authority failings, although those powers are different. The Healthcare Commission strongly welcomes the new power. I shall be interested to see how it is used, how the policy develops and whether we should consider using it as well.

Clause 16 - Accountable officers and their responsibilities as to controlled drugs

Andrew Murrison (Conservative, Westbury)

I beg to move amendment No. 11, in clause 16, page 14, line 6, after ‘regulations’, insert

‘having consulted with representative bodies’.

We are really rattling through the Bill now. We are at part 3 already—who would have thought it? Let us make sure that we keep up the momentum. I hope that the Minister will give lots of satisfactory responses to our amendment; that would expedite the process.

Amendment No. 11 is simple; it has to do with consulting representative bodies before provision is made to require designated bodies to nominate or appoint persons who have prescribed responsibilities on controlled drugs. I hope, Mr. Illsley, that we will have a stand part debate on clause 16—not this morning, I suspect, but at some point. I shall therefore be brisk and to the point now, although there is a great deal to cover.

Controlled drugs are important. The issue stems from Dame Janet Smith’s report on the Shipman tragedies, and it is important and appropriate that we should reflect on it and give it due place in our deliberations. If we are fortunate enough to have a clause stand part debate, Mr. Illsley, I will make no apology for being a little expansive, although I shall not be so this morning.

The amendment has to do with the representations that we have had from what one might call representative bodies, in particular the Royal Pharmaceutical Society of Great Britain, whose nose has been put somewhat out of joint by those who drafted the Bill. The society does not appear to have featured at all well, despite its having been given to understand that it would continue to have a fairly prominent role in the inspection of the regime for controlled drugs.

We can accept that that regime is unsatisfactory as it stands. It is a sort of polyglot arrangement of inspections that is clearly not fit for purpose. Broadly speaking, we welcome the element of the Bill under discussion, stemming, as it does, from Dame Janet’s inquiry. Of course, the Bill does not include that inquiry’s precise recommendations, but it is reflective of them and we are broadly happy with that.

However, it is a pity that we appear to have missed an opportunity to include in the Bill reference to those representative bodies, and not just because they are representative of particular interest groups. The Royal Pharmaceutical Society, specifically, is already involved in regulating the system that we have. The society is expert and contains people who have been doing such things for many years. It is a pity that its expertise has not been recognised and that it is not included in the Bill. I am sure that other bodies have also not been included. Any regulations that may be made under this clause would be improved through consultation with the bodies that I have described. That is the purpose of amendment No. 11.

Jane Kennedy (Labour, Liverpool, Wavertree)

I hope that I can quickly reassure the hon. Gentleman that we have not in any way excluded those who might be regarded as key stakeholders from being involved and consulted. We accept their involvement.

It is of the utmost importance that we ensure that representative bodies’ views are heard, and that we listen to them. For that reason, policy development of the Government’s action programme on controlled drugs, “Safer management of controlled drugs: The Government’s response to the Fourth Report of the Shipman Inquiry”, was overseen by an advisory group of key stakeholders, which included the Healthcare Commission, the Commission for Social Care Inspection, the Royal Pharmaceutical Society of Great Britain, the police, the Home Office, strategic health authorities, primary care trusts, patient groups and professional representative bodies.

Therefore a broad group has been assisting the Department of Health. That group helped to produce draft guidance for public consultation on strengthened governance arrangements for controlled drugs. That draft guidance sets out most of the detail that will be included in regulations. That consultation has now closed, and a final version of the guidance is being produced. The results of the consultation will inform the writing of the regulations. We shall also consult informally with key stakeholders on the detail of the regulations.

The amendment would require consultation with key stakeholders to be included in the Bill. A consultation with the representative bodies on the regulations would also be required, and that would delay implementation of the provisions and duplicate the consultation on the draft guidance on the new arrangements. For that reason, I hope that the hon. Gentleman will not press the amendment to a vote.

Andrew Murrison (Conservative, Westbury)

The Minister has given me some reassurance that the input of those bodies has at least been requested. Therefore I beg to ask leave to withdraw the amendment.

Health Bill - Standing Committee E

Clause 16 - Accountable officers and their responsibilities as to controlled drugs

Andrew Murrison (Conservative, Westbury)

I beg to move amendment No. 10, in clause 16, page 14, line 7, leave out ‘or appoint’.

This is a simple amendment, like all the best amendments. It is to do with a tautology; I am quizzing the Minister on the difference between “nominate” and “appoint”. Words are used sparingly in legislation, and I suspect that there is a clear legalistic difference between those two, but I would be grateful if she could clarify it for me.

Why should the individual be appointed? In the spirit of trying to reduce the number of people appointed to management positions in health services, it would seem entirely appropriate to nominate a suitable person who is adequately trained to do what is required. To make a new appointment would be contrary to the spirit of what Conservative Members are trying to achieve—and, I hope, to the Minister’s general direction of travel. We are trying to reduce the number of people employed in management capacities.

It is with those two strands of thought in mind that I tabled the amendment. First, we ask the Minister to clarify why we need both “nominate” and “appoint” in the Bill; secondly, we want to determine whether her intention is that the accountable officer of each responsible body should be a new appointee or somebody who is given the task in addition to those that they have already.

Jane Kennedy (Labour, Liverpool, Wavertree)

We do not like the amendment because it would remove the option of the organisation deciding how to meet the requirements. The regulations will specify the requisite seniority of the accountable officer; they will probably have to be at board level. Other likely requirements will be that they have relevant clinical knowledge and are remote from the day-to-day dispensing of controlled drugs.

It is just within the bounds of possibility that very small trusts may not have someone who is clinically qualified and senior enough, yet sufficiently removed from the day-to-day dispensing of controlled drugs, to fulfil those requirements. On those occasions, we expect that they may possibly have to consider appointing somebody. In most cases, however, I expect that someone working for the trust will be nominated to fulfil that role.

Andrew Murrison (Conservative, Westbury)

I am a little concerned about the Minister’s statement; if she is suggesting that small trusts may not have the expertise and therefore will have to appoint somebody officially, that would underscore my concern. The trick would surely be to find where that expertise exists in a neighbouring trust and to acquire those skills by buying them in. That would be better than appointing an individual to perform that function in a small trust where, presumably, the work load would be rather less.

Jane Kennedy (Labour, Liverpool, Wavertree)

And, indeed, if we allow the trust flexibility, so that it has a range of options open to it, including that of bringing in someone at the necessary level with capacity, that would be the best position. The hon. Gentleman’s amendment would restrict that flexibility unnecessarily.

By and large, we expect that someone already working for the health care organisation will become the appointed officer, but there is facility under the Bill for two organisations to have a joint appointment. While meeting the requirements of our response to the Shipman inquiry, we want to allow as large a degree of flexibility as possible, so that health organisations can respond in an appropriate way locally. I appreciate that this is a probing amendment, and I hope that I have been able to reassure the hon. Gentleman so that he feels able to withdraw it.

Andrew Murrison (Conservative, Westbury)

I am very grateful to the Minister for her assurances on those points. It is a probing amendment, and she has told me pretty much what I wanted to hear. In the spirit of Christmas, I beg to ask leave to withdraw the amendment.

Andrew Murrison (Conservative, Westbury)

I beg to move amendment No. 12, in clause 16, page 14, line 13, after second ‘is’, insert ‘(a)’.

Eric Illsley (Labour, Barnsley Central)

With this it will be convenient to discuss amendment No. 13, in clause 16, page 14, line 14, at end insert—

‘(b)should not routinely be involved in the prescription or handling of controlled drugs;

(c)be a senior member of staff; and

(d)be in receipt of appropriate training.’.

Andrew Murrison (Conservative, Westbury)

These two amendments are linked. The purpose of amendment No. 12 is purely to allow amendment No. 13. The function of amendment No. 13 is to establish some parameters for accountable officers. They will be powerful individuals; they will be given a significant role in the controlling of controlled drugs, and we should set some margins within which they must act.

Accountable officers should be senior. That is covered later in the Bill; it is suggested that they should report to a trust board member. I suggest that they should be a senior trust board member—not a non-executive director, but someone with executive responsibilities. It is appropriate for us to make it clear at this juncture that we want a senior individual to be given these functions. They should not be junior in the organisation, because these are important powers, and we all know what kinds of situation arise in organisations: there is the potential for a junior person—somebody without much experience or clout—to be influenced in a particular direction by more senior staff or parts of the organisation. In the context of the powers and responsibilities we are addressing, we should avoid situations in which somebody who is relatively inexperienced—or even young—could be subject to persuasion by senior individuals or by parts of the organisation that they are looking into. I am sure that the Minister will agree that these powers should be given to somebody who is clearly senior within the organisation. That is the purpose of proposed new paragraph (c).

The person will clearly have to

“be in receipt of appropriate training.”

We covered that issue when we discussed enforcement under part 1; we agreed that those who are tasked with enforcement need to be appropriately trained. As with part 1, it is likely that many of those who are given powers as accountable officers will be new to the game; this will be a new aspect of their work, and they will not previously have been familiar with the subject. Although some might have had dealings with controlled drugs in the course of their duties, others will not. Given the importance of this role, it is vital that they are given training. The Minister will say that that is covered later in the Bill, but, once again, my thesis is that this is so important that it needs to be stated at the beginning of part 3. There must be appropriate training.

It is also appropriate that the accountable officer should not be involved first-hand in the prescription or handling of controlled drugs. If the person were nominated, it means that the individual would be working within the body in some other capacity, such as a practitioner who could be dealing with prescription-only medicines and controlled drugs. Under those circumstances—although I hesitate to use the term because it is a little crude—we could have a “poacher turned gamekeeper situation” that might turn difficult if the individual had to look at his part of the system or his own practice. It could cause conflict that would be wholly undesirable.

Although it is desirable that individuals who are the accountable officers have an understanding of controlled drugs and have had some background with them in their professional lives, it is undesirable that they should be involved with them in a front-line way for the duration of their appointment under part 3 of the Bill. That is the crux of amendments Nos. 12 and 13. I hope that the Minister will give them a fair wind.

Jane Kennedy (Labour, Liverpool, Wavertree)

There is not a lot in the amendments with which I disagree, except that they should not be accepted. The issue of who should be an accountable officer has been the subject of public consultation on the guidelines that relate to the new inspection and monitoring arrangements. It is likely that the regulations will specify the seniority of the accountable officer as being probably at board level. Other likely requirements are that they should have relevant clinical knowledge and be remote from the day-to-day dispensing of controlled drugs.

I agree with the intention underpinning the amendments that we need to ensure that the accountable officer fulfils certain requirements. However, I believe strongly that requirements are best put in regulations or guidance. Occasionally, it may not be appropriate or possible for an organisation to have an accountable officer who meets all the relevant qualifications. For example, the amendment suggests that the individual officer

“should not routinely be involved in the prescription or handling of controlled drugs”.

We could hold a whole debate about the definition of “routinely”. To use a specific example, in some small ambulance trusts, all senior members of staff handle controlled drugs on occasions. Making it clear that the requirements of such an organisation should meet such provisions would genuinely be better dealt with under regulations or guidance rather than being enshrined in the Bill. I hope that the hon. Gentleman will accept that and withdraw the amendment.

Andrew Murrison (Conservative, Westbury)

The Minister has given me some reassurance. We shall return to the matter later in our proceedings. Perhaps then will be the time for a more expansive discussion about whether the Bill is adequate in such important respects. I am glad that she shares my worry, as expressed by the two amendments. With that in mind, I beg to ask leave to withdraw the amendment.

Andrew Murrison (Conservative, Westbury)

I beg to move amendment No. 14, in clause 16, page 15, line 46, leave out subsection (10).

The amendment was tabled for two reasons. First, I am not too sure what the subsection means and, by suggesting its deletion, I hope I shall receive clarification from the Minister. Secondly, if I had a little glimmer of light at the end of my tunnel of ignorance, it was that I perceived that subsection (10) allows the specifics of the clause to be nullified to an extent and replaced by a generality to which it refers. If that were the case, we would be unhappy for the reasons that we have outlined in previous sittings. We want more specifics in the Bill and a reduction in its capacity to allow the Secretary of State for Health at some future date to do pretty well what she likes under regulation. The amendment wants clarification from the Minister of the meaning of subsection (10) and, if it means what I think that it means, to clip the wings of the Secretary of State when making regulations in the future and taking to herself yet more powers under the Bill.

Jane Kennedy (Labour, Liverpool, Wavertree)

The amendment would limit the issues on which regulations relating to the accountable officer could be made to the detailed issues mentioned in subsections (5) and (7), as the hon. Gentleman said. Those two subsections deal with several topics, such as the conditions that anyone nominated or appointed as the accountable officer should meet and the main issues on which regulations relating to the accountable officer will be needed. They also deal with the requirements that the accountable officer should fulfil and the monitoring and inspection responsibilities that they should have.

As the accountable officer role develops and new organisational structures come into being, new issues may arise, which it might be helpful to clarify in regulations. We therefore wish to keep the broad regulation-making power in subsection (1), although I suspect that the hon. Gentleman will not like that answer—Oppositions generally do not. However, Governments generally use such powers, although sparingly, and I do not recall using them very often. I hope that he accepts that the power is justified in this case and that he will not press the amendment.

Andrew Murrison (Conservative, Westbury)

The Minister is absolutely right: I do not like the answer very much. I am relieved, however, that her explanation accords with my own, so my understanding of the clause was correct, which is a good thing. Clearly, I am not happy that the provisions give the Secretary of State more powers. As the Minister rightly said, Oppositions are generally reluctant to give Ministers powers unless they are absolutely necessary. The powers before us seem to have an anticipatory function: the Minister is saying that although we cannot foresee the circumstances in which they will be necessary, they might be necessary in the future, and that is why we have subsection (10).

All that leads me to think that we should oppose the provisions but, looking around the Room, I am not sure that we would get very far. Nevertheless, I hope that I have made it clear that we are not particularly happy with them. With that in mind and with a heavy heart and with great reluctance, I beg to ask leave to withdraw the amendment.

George Young (Conservative, North West Hampshire)

I want to press the Minister briefly on subsection (5)(g). As well as making provision for an accountable officer, the clause creates

“offences punishable on summary conviction by a fine”.

If we are going to set up a new organisation with new responsibilities, I quite understand that we shall need to underpin it with some sanctions. However, if an offence is committed—the accountable officer discovers, say, that consistently inadequate records are kept about drugs—and it is sufficiently serious to be taken further, who will bring the case? Will it be the accountable officer, who will be appointed under clause 16, or the relevant authority, which will have appointed the accountable officer? Will they have to get hold of the police or the Crown Prosecution Service to prosecute? Who will take the provisions in subsection (5)(g) forward?

Jane Kennedy (Labour, Liverpool, Wavertree)

The accountable officer will supervise the management of controlled drugs in the trust. There will be a requirement to share the data—that will be done on an anonymised basis so that patients’ details are not shared—with organisations such as the police. If practices of a criminal nature came to light, I anticipate that they would be dealt with by the appropriate authority. If it became clear as a result of monitoring the controlled drugs that there was, for example, a lack of training or a lack of understanding about protocols, one would expect that to be dealt with differently by the professional bodies responsible for the development of such protocols. I hope that that assures the right hon. Gentleman.

George Young (Conservative, North West Hampshire)

So the police will be the ones to prosecute, if they want to, under the provision in paragraph (g)?

Jane Kennedy (Labour, Liverpool, Wavertree)

Yes, in most cases. I have nothing further to add, and I hope that the Committee will give the clause a fair wind.

Andrew Murrison (Conservative, Westbury)

As I said before lunch, the clause is extremely important, as it contains the first part of the Government’s plans following their report, “Safer management of controlled drugs”, which was their response to Dame Janet Smith’s fourth Shipman inquiry report. It is appropriate that we reflect briefly on Dame Janet’s recommendations, because we must decide whether they have been adequately reflected in the legislation that the Government want the House to accept.

Dame Janet made four recommendations in four main areas. She recommended an integrated multi-professional inspectorate to manage controlled drugs and to replace the current rather amorphous system of regulation made under other legislation. That is manifestly not what is proposed in clause 16 and subsequent clauses in part 3. The Minister must explain why that is, given Dame Janet’s clear proposals.

I make no particular judgment about whether Dame Janet’s model or the Minister’s is the most appropriate, although there are benefits to both. However, it would be useful if the Minister could say to want extent she has considered Dame Janet’s first recommendation, and why she has sought to follow a different route that has at its heart the appointment of accountable officers at local level rather than an overarching inspectorate.

Several overarching health care bodies have been established in this country in recent years, and an inspectorate of the sort that I describe would have fitted into that structure reasonably well. Some of us may therefore be a little surprised that Ministers have not pursued that line. It is pretty fundamental, and it is important that the Minister explains why she has taken the route that she has taken and not embarked on the direction of travel that Dame Janet believed to be appropriate.

Dame Janet also believed that we needed to strengthen our audit trail of controlled drugs, which is absolutely right. I am hopeful that we will cover some of these matters in depth in our discussions on part 3. Our consideration of them will be complex, but vital if we are to prevent the tragedies such as those caused by Harold Shipman’s actions. It is vital to have an adequate audit trail and a system that is as foolproof as possible to ensure that there are no more such tragedies. We must also accept, however, that what happened under Shipman was the result of criminal activity, and that it might happen again under another devious, cunning and intelligent individual. Our job in Committee is to minimise the chances of it happening again.

Dame Janet also covered the need for better information to be given to patients. That is important, but clause 16 and successive clauses are remarkable for the absence of that element. They contain a passing reference to it, but nothing gives me any great confidence that Ministers have adequately explored that recommendation, which was in one of only four main areas on which Dame Janet passed judgment.

The fourth area that Dame Janet considered was the restriction of GPs’ prescription rights over controlled drugs, and prohibiting GPs from prescribing such drugs to themselves, to their families and beyond normal clinical practice. I hope that the audit trail will allow the accountable officer to deal with that. Again, it is important to appoint persons of sufficient seniority. For instance, one could foresee a well known senior GP—perhaps someone whom the accountable officer had worked with or even for—putting some pressure on him and trying to persuade him that what he was doing was part of his normal clinical practice.

Some leeway will be needed, because not all practitioners are the same; we have different ways of treating the same condition. Nevertheless, it is important that adequate scrutiny should be given to an individual’s clinical practice. For example, it would be remarkable for a dermatologist prescribing in the normal manner to prescribe courses of treatment with large amounts of diamorphine, the drug illicitly obtained by Harold Shipman. It is important that we pay particular attention to the audit so as to ensure that an individual’s prescriptions are appropriate for his area of practice.

The fifth inquiry is about the complaints mechanism and safeguarding patients. In truth, the two are closely linked. Some of the recommendations in the fifth report deal with what we are discussing today.

We need to reflect on what has already happened. When considering the proposals for accountable officers, around which all the rest revolves, it is important to note what has been achieved so far. When we come to assess whether the Bill has had any impact, we will need to establish where our starting point was. Our starting point has nothing to do with the conviction of Dr. Harold Shipman. It is now.

At this juncture, I ought to declare my interest as a doctor and a subscriber to the General Medical Council. It is not that my membership makes me particularly well disposed towards the GMC; it costs me a considerable sum every year to be a member in order that I can regulate myself. However, it is important to note the work that the GMC has done. It is customary to be anti-establishment about the organisation, but the poor old GMC has had a pretty rough ride in the media in recent years. None the less, it has worked terribly hard to improve its image and the image of the medical profession—but, more importantly, it is trying to ensure that acts such as those committed by Shipman do not happen again. When we come to pat ourselves on the back, saying that the Minister has done a terribly good job with clause 16 and the other provisions that relate to the control of controlled drugs, we need to understand what has already happened. The fact is that the GMC has reduced substantially the likelihood of a Dr. Harold Shipman happening again.

We ought to think in terms of revalidation and the fact that doctors will have to requalify every five years, or re-establish their credentials as practitioners. That is new, and for many, particularly occasional practitioners such as myself, it will be quite onerous. Nevertheless, I hope that we can weed out those in the profession who are what I might charitably call vulnerable so that we can protect patients.

We have seen a shift towards larger practices. Dr. Harold Shipman practised largely on his own. With particular exceptions, the general direction today is away from such small practices—and for good reason, because the ability to compare and contrast practices is limited if one is a sole practitioner. That is not to denigrate in any way the excellent and admirable work that single-handed practitioners do, often in isolated and remote areas, nor is it in any way to condone the Minister’s general direction of travel towards mega-practices, which I abhor. Nevertheless, very small practices, particularly single-handed practices, have their problems in areas such as this where there is self-regulation and partners must compare what is going on and in that way to improve safety. These matters are changing all the time. We have the Healthcare Commission with all its powers and, surely to goodness, that wonderful body, which is doing great work, will look at this area of practice and other important areas such as health care, acquired infections and associated infections, which clearly involve patient safety.

We have local systems of clinical governance, and this is an important point to get across in the context of accountable officers. Clinical governance was not spoken of in a meaningful way 10 years ago. If we used the term at all it was simply a throwaway line, but it now has a very specific meaning. I welcome the appointment of accountable officers because that will improve clinical governance and the level of oversight of practices, and thereby improve patient safety. It is part of a larger issue involving clinical governance to ensure that what we do is safe and reasonable and all the while driving up standards.

The point of mentioning that is to establish that while clause 16 and others will be helpful by and large—we will certainly not oppose it but hope to offer suggestions to the Minister—we already have a benchmark, which was established after Shipman. I hope that even if we took the do-nothing option, the chances of something awful like Shipman ever happening again would be very much reduced because of the way in which the professions regulate themselves. I think our constituents, the patients of the NHS, should be pleased and relieved that things have changed substantially since Shipman. Let us hope so.

Accountable officers will be given considerable powers, so we must be jealous of those powers, as we have been with Ministers. We have covered both of those matters during our discussion.

I should be grateful if the Minister could clarify an area of confusion. There seems to be a conflict between subsection (2) and subsection (5)(e), which refer to who can be called an accountable officer. One seems to establish that the person in question should be called an accountable officer, which is a change because they were to be called proper officers, which sounds rather Victorian. I think I prefer “accountable officer”. However, subsection (5)(e) is a bit Alice in Wonderland, and allows the person to be called whatever they want to be called or whatever their responsible body wants them to be called. I am a little confused, but I am sure that that is because of my lack of understanding rather than any fault in the drafting of the Bill. Some clarification for simple souls like me would be helpful.

Subsection (5)(g) has been questioned by my right hon. Friend the Member for North-West Hampshire (Sir George Young) and I will leave it at that. However, I would like to refer to the safe disposal of controlled drugs because that has not been given as a specific function of the accountable officer. That strikes me as rather strange because controlled drugs do not just go from prescription pad to patient. They hang around. There is a supply chain before their use; after their use, when they have ceased to be useful or wanted, they still exist and need to be disposed of. There is no comment about the destiny of those medicines and how they will be handled. Shipman hoovered up those drugs—that was part of what he was about. He removed diamorphine from the homes of those who had died and stored it up. That lay at the heart of that terrible set of tragedies, in which more than 200 people ended up losing their lives. It seems strange that we should not have given any thought to what might happen to redundant controlled drugs—how they are to be safely disposed of and the role that the accountable officer might have in that.

Does the responsibility of the accountable officer or the body for which he works end when the prescription is made or discharged? Perhaps it does, although that does not seem helpful, particularly in the context of what led to Dame Janet’s report. It would be useful if the Minister said how we might address the specific issue of what to do with the redundant controlled drugs that are left after a person has ceased to need them.

We have not heard anything about the security of the supply chain in the context of controlled drugs. We do not know anything about controlled veterinary drugs. I am not an expert, but I rather suspect that the diamorphine used for veterinary purposes is similar to that used for human purposes. If that is the case, one can see the potential for abuse. Clearly, the problem in the Harold Shipman case lay with his having personal access to the drug and a population on whom he could use it, apparently legitimately. That is less of an issue for veterinary surgeons, although, having said that, I suspect that I shall be roundly condemned by the animal welfare lobby. If we have that repository of controlled drugs in the veterinary profession, it is important that we make some allowance for it. If we are going to regulate controlled drugs in this way, I suggest that we need to reflect that in the Bill. However, it is not reflected there; there is no reference to accountable officers in the context of the veterinary profession.

There is a vague mention of training, to which I have referred already, in subsection (6)(c). My experience of health care bodies is that when resources are tight, training cops it first; that is my worry. The emphasis on training in my amendments is in part driven by the imperative to make sure that it is at the heart of what is going on in respect of clause 16 and its sister clauses. We must make it absolutely clear that training is not a bolt-on, added extra—not something that we will do if we can afford it—but something that, within the fabric of the clause and certainly in the context of accountable officers, is absolutely essential before we consider nominating or appointing anybody to that important position.

We have not considered new prescribers. The Government would like to bring on line new prescribers, particularly members of the nursing profession, such as those who work in palliative care. Quite rightly, the Government are attempting to extend the sorts of things that nurses can do autonomously. That is fine; we support them on that. However, the Minister needs to accept that as that is done, the envelope within which abuses may happen is widened. That is axiomatic. I should be interested to know what assessment the Minister has made of the increased risk that that otherwise desirable change will introduce.

We have not had any real mention of where the national programme for IT in the NHS, or NHS Connecting for Health, will fit in the context of accountable officers. I always get slightly nervous when a Government change the title of an organisation. That is what the Government have done in the case of NPfIT, which is now called NHS Connecting for Health, so it is hardly surprising when we open our newspapers and see that the whole thing looks like it is going for a ball of chalk. Nevertheless, it is important that the Minister says what part she expects NPfIT, or NHS Connecting for Health, or whatever we want to call it, to play in the audit trail and where accountable officers will be pegged within that. It is important that we use NPfIT to audit what is going on in the context of controlled drugs. Accountable officers will have to be well briefed on the use of IT and NPfIT.

It would be nice to know if the Minister accepts the importance of NPfIT and NHS Connecting for Health in the audit of controlled drugs. What happens if Mr. Granger’s dismay is well placed and the whole thing comes to a sticky end? Where does that leave this crucial function? There are 101 other important functions that no doubt are relying on the success of NPfIT, but we are talking about one function that might rely heavily on it. What happens if we do not have that strand of the audit trail as a result of the collapse of NPfIT and NHS Connecting for Health?

I must press the Minister and ask why she has decided on this model for the control of controlled drugs, rather than Dame Janet Smith’s recommendation for an overarching structure. That is a crucial point. I make no judgment on which I think would be better—I am not necessarily in as good a position to judge as the Minister is—but no doubt she will have considered both options, which are fundamentally different. It would be interesting if the Minister could give us some idea of the thought processes that have gone into determining that accountable officers are the preferable model, rather than the overarching inspectorate that Dame Janet wanted.

Dame Janet’s model might have put in place a more manageable structure for connecting various responsible bodies. We will discuss, in the debate on clause 17, co-operation between health bodies and other organisations. I can see real difficulties under this system, with accountable officers of health care bodies having to decide whether and how they should co-operate with their neighbour. All sorts of issues to do with confidentiality arise. There will be deliberation about whether it is reasonable in a particular circumstance to divulge information. We are dealing with what are often sensitive cases: not people going into hospital to have their hernia repaired, or their in-growing toenail sorted out, but people who are often vulnerable and certainly would not want their medical condition divulged to anybody outside their immediate medical advisers. We are talking about highly sensitive information and, unless we get the confidentiality issue right, I can see people being put off seeking medical care and, perhaps, putting off going to methadone clinics because they are concerned that the information will be shared with their GP, for example. One advantage of Dame Janet’s model would be that the overarching structure might pull together all the different NHS bodies and individual bodies would not be faced with the dilemma of whether to share precious information with somebody else in an undefined way and thereby breach medical confidentiality.

I am sure that the Minister will have sought the advice of ethicists about the matter before going down this pathway, but it is a hornet’s nest. Because there is uncertainty, I suspect that bodies will be reluctant to share information even when it is appropriate that they should do so. One chief advantage of the multi-professional, over-arching jobbie suggested by Dame Janet is that it would, to a large extent, get round the issue of co-operation and sharing information, which could be something of a showstopper in certain circumstances. I shall end with that, if I may. The Minister has a good idea of the issues that I am concerned about, but I ask her specifically to address why she has decided to take up the accountable officer model outlined in clause 16 and not the overarching inter-professional model recommended by Dame Janet.

Jane Kennedy (Labour, Liverpool, Wavertree)

The hon. Gentleman asked many detailed questions. If I miss some of them, I may need to write to him and to the Committee. I shall begin with a couple of quick responses. On the hon. Gentleman’s fears about extensions to independent prescribing—that is, the role of nurse prescribers and, to a degree, of pharmacy technicians—controlled drugs would not be prescribed. Even in the case of palliative care, a nurse prescriber would prescribe such drugs only if directed by the clinical management plan agreed by a doctor. With regard to vets, there are observers from the Department for Environment, Food and Rural Affairs and the field of veterinary science on the controlled drugs advisory group, and we are working with them to develop policy in that area.

The hon. Gentleman has caused us to pause for a moment to consider the serious circumstances under which we are doing this work. As he said, the role of the accountable officer is part of a package of provisions intended to strengthen the governance and accountability arrangements for the safe management of controlled drugs in health care. The clause provides the legislative framework for the programme of action in the Government’s response to the fourth report of the Shipman inquiry, which I mentioned earlier.

Controlled drugs are medicines that are used to treat a variety of clinical conditions, such as severe chronic pain in palliative care. They are subject to special legislative controls because of the potential for abuse. As the hon. Gentleman correctly pointed out, that potential was illustrated by the Harold Shipman case, which led us to introduce these additional measures.

A key finding of the Shipman inquiry was that a variety of people had concerns about Dr. Shipman’s practice, but no single person had ever drawn together those concerns or the information held by individuals. The accountable officer will be responsible for all aspects of the safe and effective use and management of controlled drugs. The accountable officer will have information on the requisitioning, storage and destruction of controlled drugs in their organisation and information on the quality and quantity of prescribing and dispensing such drugs. That list may have answered some of the points that the hon. Gentleman raised.

The disposal of controlled drugs is specified in clause 23, which we have not yet reached. It defines the accountable officer’s responsibility to include disposal. The witnessing of destruction is covered in regulations to the Misuse of Drugs Act 1971. Some of the proposed changes to those regulations will provide accountable officers with a great deal of information about the prescribing habits of professionals in private and NHS practices. The data will be collated nationally and any discrepancies will be highlighted to the accountable officer for follow-up at local level. I shall come to the issue that the hon. Gentleman raised about Dame Janet’s main recommendations.

Many of the measures required to enhance the audit trail will be covered by the Misuse of Drugs Act 1971, which is managed by the Home Office. I reassure the hon. Gentleman that officials from the Department of Health are working closely with the Home Office to put in place the measures that are necessary. It is our intention that all private prescriptions will be collected and analysed, all prescriptions for controlled drugs will require prescriber identification and all orders from manufacturers and wholesalers will be collated and analysed.

We are discussing restrictions to the prescribing of controlled drugs with the GMC, the General Dental Council, the Royal Pharmaceutical Society and the Nursing and Midwifery Council. We are currently working on that issue and, in some cases, those organisations are consulting their members on restrictions on prescribing. They are considering whether, for example, a practitioner should be able to prescribe controlled drugs for themselves or for their family. They have all been key stakeholders in developing the approach we adopted and I am grateful for the co-operation we have received from the professions in doing that.

In NHS primary care, the accountable officer of the primary care trust will be responsible for all its independent contractors, such as GPs, dentists and out-of-hours services. All NHS secondary care providers will be required to appoint an accountable officer. We accept the need for better oversight of the use of controlled drugs in the NHS. No one studying the Shipman case who then saw the outcomes of Dame Janet’s inquiry could argue with that. However, I have been persuaded that it is better done at local level as an integral part of the local clinical governance machinery.

The Healthcare Commission will give additional assurance that local arrangements are fit for purpose. The hon. Gentleman will be pleased to hear that we will make regulations to provide detail on which organisations must appoint an accountable officer and the criteria for that appointment. We have probably already covered that subject. The regulations will set out the responsibilities of the officer in relation to the management of controlled drugs including storage, carriage and safe custody, prescribing, administration, recovery and disposal of these drugs and the requirement to follow best practice. The regulations also allow for the creation of offences punishable by a fine, as we discussed briefly, and for other procedures for enforcing the provisions.

Although we cannot guarantee that the provisions would prevent another Harold Shipman, we are confident that poor practice would be detected much earlier if such measures were in place. That is why I am happy to commend the clause to the Committee.

Clause 17 - Co-operation between health bodies and other organisations

Andrew Murrison (Conservative, Westbury)

I beg to move amendment No. 15, in page 16, line 47, at end insert—

‘(f)for measures to protect the confidentiality of patient records.’.

Eric Illsley (Labour, Barnsley Central)

With this it will be convenient to discuss amendment No. 16, in clause 20, page 19, line 14, at end insert—

‘(e)confidentiality in the transfer of data that is attributable to individual patients between cooperating bodies.’.

Andrew Murrison (Conservative, Westbury)

I was so taken with the Minister’s speech that I felt I ought to reflect on it and I could not find my place, but I have now.

We are largely content with the clause, but it deals with issues of confidentiality that trouble us a little. In my rather discursive remarks on clause 16, I said what I needed to say but I shall reiterate it in the context of clause 17. We need to be clear about the transfer of patient-identifiable material between various health bodies. That worries me considerably. I cite the example of a methadone clinic, where we are dealing with people who are quite vulnerable. We are not only dealing with the generality of medical practice, which is important in itself, but on top of that we are talking about people who have a range of conditions that are sensitive in many respects.

Controlled drugs can be used for a variety of things. They can be used for palliative care, but they can also be related to drug abuse and other sensitive areas of practice. Therefore, it is particularly important that we pay close attention to issues of medical confidentiality. We need to be clear that in transferring material from one body to another for the purposes of the clause, we are doing so in a way that is highly sensitive and preserves, as far as possible, the confidentiality of those individuals.

During this brief debate, I want to press the Minister on that matter and seek her assurance that she recognises the extent of the potential abuse that could take place and the possibility that people will be dissuaded from seeking medical advice for particular conditions if they are not absolutely confident that the organisation that they are seeking attention from will deal carefully and sensitively with information given to it in confidence. The way in which the provisions are drafted means that there is the potential for the whole thing to look far more diffuse to somebody who is seeking help in that way. That is my chief concern. We have talked about how Dame Janet’s initial recommendation might be of assistance in that respect, but clearly the Minister has chosen a different pathway. I hope that she can give me some assurances about the use of the information, particularly in respect of confidentiality.

Jane Kennedy (Labour, Liverpool, Wavertree)

We do not feel that the amendments are necessary. I hope to reassure the hon. Gentleman that the necessary safeguards already exist. We already plan to provide advice to organisations to ensure that patient confidentiality is upheld. We have already issued for consultation draft guidance on strengthened governance arrangements that makes it clear that organisations should follow existing NHS guidance on confidentiality and protect patient confidentiality. As part of that, the guidance makes it clear that patient information should normally be used only in an anonymised form. Where it is needed in an identifiable form, patient consent should be sought. The only exceptions to that would be where the organisation judges that there is a serious risk to health and safety that outweighs the need to maintain confidentiality. Guidance on confidentiality can already be issued under clause 20(1)(b), which we have not reached yet. That provision allows for guidance to be issued on the discharge of the accountable officer’s responsibilities.

I appreciate the spirit in which the hon. Gentleman has moved his amendment. He is right to reinforce the need to protect patient confidentiality. We believe that the clause does that and that the protocols and procedures are already in place to ensure that. However, I take his point. I hope that he will withdraw his amendment and accept the reassurances that I have offered.

Andrew Murrison (Conservative, Westbury)

The Minister has sort of given me some reassurance. Obviously, she understands that this is a difficult area. I suppose that there is no obvious way forward. At the end of the day, if we are going to safeguards patients, clearly there will have to be some sort of transfer of information. The purpose of amendments Nos. 15 and 16, which apply to clauses 17 and 20 respectively, but which are closely related, was to make the Minister aware of our concerns about confidentiality. We have expressed those concerns elsewhere in connection with NHS Connecting for Health and NPfIT and no doubt we will return to the matter at greater length at some point in the future.

Some people might be discouraged from seeking treatment, which is a pity. However, at the end of the day, I guess that a judgment has to be made. I accept the Minister’s assurances and recognise that if we are to enhance the safety of patients, we will have to allow the transfer of information. I hope that it will not be patient-specific unless absolutely necessary and that it will be generic wherever possible. With that in mind, I beg to ask leave to withdraw the amendment.

Clause 18 - Controlled drugs: power to enter and inspect

George Young (Conservative, North West Hampshire)

The Committee should pause for 90 seconds—the length of time for which I propose to speak—before it confers on somebody other than a police officer the right to enter a citizen’s home against their wishes, which is what the clause does. From the definition of “any relevant premises” in subsection (7) it seems that such premises could include the home of a pharmacist or GP. The powers to enter and inspect will not be confined to a police officer; they will be given to an authorised person who is defined in the clause.

If one considers subsection (2), which puts parameters around those powers, all one needs to do to exercise those powers is to turn up at a reasonable hour and produce the written authority of the person exercising them. The constraints seem rather flimsy on what could be a draconian power, particularly if one considers subsection (3)(b), when the person who has the power can take away relevant records kept on the premises. The least I should expect under subsection (2) is reasonable grounds for suspecting that an offence might have been committed, or, under the clause, guidelines about when the Government envisage the appropriate exercise of those powers. There is very little about that.

This is a potentially draconian power. It will be given to an authorised person, as defined in subsection (4), who can turn up any time before 9 o’clock at the home of a GP or a pharmacist and, with a letter, which is the written authority of the person exercising the power, demand to come in. We should pause for 90 seconds and press the Minister about exactly how those powers will be used.

The House has been sensitive about giving tax and VAT inspectors and Revenue and Customs employees the powers to enter peoples’ homes against their wishes. However, clause 18 extends that privilege with, as far as I can see, very little explanation about when the powers might be used.

Jane Kennedy (Labour, Liverpool, Wavertree)

I have thought long and hard about the matter, and I share some of the right hon. Gentleman’s concerns that we should not take those powers lightly, and nor have we. Physical inspections, the power to enter the premises and to inspect, and the general powers in the clause are only one aspect of the new monitoring and inspection arrangements. Persons exercising those powers would not be able to enter the home of a GP or a pharmacist unless that home was used for the provision of health care or for the supply or administration of a controlled drug. That is the proviso.

When an inspector turns up to carry out a routine inspection, there will be no problem and the inspection will be complied with. A number of people, including in the case of pharmacists, the Royal Pharmaceutical Society, can do that. We anticipate that there may be occasions when objections will be made, but it is necessary to allow the inspectors the right to insist on being granted entry.

The intention is that routine inspections should normally be carried out by the accountable officers appointed under the clause that we have just debated. Inspections will be carried out also by regulated bodies that already have powers of entry. As the right hon. Gentleman rightly said, the powers may be used only at reasonable hours and with the production of written authority. The regulated bodies are not explicitly mentioned in the clause, as many already have powers of entry to the relevant organisations. The Royal Pharmaceutical Society has the power to enter community pharmacies and request records.

I appreciate the concerns that the right hon. Gentleman has raised. The provision is not as draconian as he fears it may be; it will be used only on rare occasions and probably when there are already concerns about the premises to be inspected. I hope that he will reflect on my comments as I shall reflect on his.

We have not taken the powers lightly; we have thought about them carefully. In the context of the other package of measures that we are putting forward, the provision is an important part of the Bill.

Clause 19 - Offences in connection with power to enter and inspect

Andrew Murrison (Conservative, Westbury)

There is very little with which we could take issue in the clause, as it is reasonably technical. However, I seek the Minister’s clarification. As I understand it, the clause would give penalties similar to those outlined in section 23 of the Misuse of Drugs Act 1971 in respect of a failure to allow access to the relevant person to commercial premises that have to do with controlled drugs. If the Minister were able to confirm that the penalties and the offences that are set out in the clause are similar to, and comparable with, section 23 of the 1971 Act, we would be content.

Jane Kennedy (Labour, Liverpool, Wavertree)

I can give the hon. Gentleman that assurance. Those things are comparable. I hope that, in that brief way, I have been able to reassure him.

Clause 24 - Requirements about supervision

Jane Kennedy (Labour, Liverpool, Wavertree)

I beg to move amendment No. 90, in clause 24, page 21, leave out lines 10 to 14 and insert—

‘(7B)Conditions prescribed under subsection (7A) may relate to supervision in the case where the pharmacist is not at the place where the thing is being done, and in that case the thing is not to be so considered if no such conditions are prescribed.

(7C)In any case, compliance with any applicable conditions is sufficient for the thing to be so considered.” ’.

Eric Illsley (Labour, Barnsley Central)

With this it will be convenient to discuss Government amendment No. 91.

Jane Kennedy (Labour, Liverpool, Wavertree)

My habit in Committee is usually to move relatively quickly in order to make progress and to answer briefly at the end of a debate any concerns raised.

The clause seeks to make clear our intention to set out in regulations the requirements as to the conditions that must be complied with before a pharmacist may discharge his duty to supervise from another location, which is what we are introducing as part of the clause. As originally drafted, the measure provided simply that regulations could be made to specify what would constitute adequate supervision. If no regulations were made, the measure as originally drafted did not clarify whether or not the use of remote technology was otherwise acceptable. The provision is fairly straightforward, so I will sit down and see whether there is further debate on it.

Andrew Murrison (Conservative, Westbury)

We have some concerns about the clause, which I hope that you will allow us to express in a clause stand part debate, Mr. Illsley. We seek clarification of the Minister’s expectations of pharmacists in respect of telemedicine and remote supervision of the sort that she mentioned. It is important that she understands the limitations of those media, and it is not clear from what she briefly said that she does. I would be grateful for further clarification about exactly what she is getting at by tabling the amendments.

Jane Kennedy (Labour, Liverpool, Wavertree)

The amendment will clarify the pharmacist’s obligation and will make provision for the appropriate use of new technologies that enable pharmacists to supervise dispensing activity safely when away from pharmacy premises. The hon. Gentleman is right that we must consider what those technologies are. We intend to set out in regulations where the pharmacist is required to be personally involved in the preparation, sale and supply of medicines, or the supervision of those activities, and the conditions for use of new technologies.

For example, the conditions might include the use of technologies such as robotics or a video link, which can help the pharmacist meet their supervision obligations from another location. That is what we mean by remote supervision. With the aid of appropriate technologies, the pharmacist may continue to meet his or her responsibilities, through the ability to remain in contact, to provide professional advice to staff and patients.

In most circumstances, use of a telephone alone would be insufficient to meet the pharmacist’s supervision requirements. It would not allow the pharmacist to check the prescription being dispensed, and he would be reliant on information from pharmacy staff. Effectively, we are tightening the provisions.

However, there are technologies that allow the pharmacist to see a prescription electronically. Also, video links can support face-to-face contact with both staff and patients. We want new technologies to be used in a way that maintains patient safety. We intend to consult key stakeholders on the regulations, including conditions that could support remote supervision through the use of new technologies. That way, the regulations will reflect the rapid pace of change in this area. I hope that that brief comment reassures the hon. Gentleman. I appreciate the spirit in which he raised his concerns.

Steve Webb (Liberal Democrat, Northavon)

I am grateful for the opportunity for a brief stand part debate, because we are now on a new chapter of the Bill. It would be helpful if the Government could put on record a bit more of their thinking, because the clause gives them power to make various regulations. The pharmacists of Britain want to know a bit more about what is intended, so that they can plan ahead. I hope that the Minister will take our questioning in that spirit. We just want to understand a bit more about what is planned.

It is my understanding of the clause and this chapter of the Bill that the Medicines Act 1968 contained the concept of personal control by a pharmacist, to the extent that if the pharmacist pops over the road to a shop, or something like that, certain things cannot be sold. We are moving from that situation to one in which the pharmacist has to ensure that things are done under the supervision of a “responsible” pharmacist, not necessarily one on the premises. We have just heard the beginnings of a discussion about whether that would mean having a pharmacist on the other end of a video link, or that the pharmacist had put in place some other alternative arrangement.

I admit that I have an open mind on the subject. Certainly, it seems a reasonable assumption that there may be people working in pharmacies other than fully qualified pharmacists who have skills that have not so far been tapped. I am all in favour of using the talents of those who have already had some training and could do some things. The problem is the all-or-nothing nature of the provision. In one way, I am more relaxed about a pharmacist being on the other end of a video link in another pharmacy than about a pharmacist simply being off the premises and therefore uncontactable in some sense.

The Minister may say that the Government are asking pharmacists to put in place structures—that is, to train people, to have procedures and protocols, and to have feedback at the end of the day on what was prescribed and to whom, and so on. It seems an all-or-nothing issue, because currently we say that a person cannot be sold medication that is not on the general sale list unless the pharmacist is physically there, but clause 24 and succeeding clauses take away that requirement. I guess the question is, if it has been necessary for the last 37 years to have a pharmacist present, what has changed? Have we been over-regulating for 37 years?

Jane Kennedyindicated assent.

Steve Webb (Liberal Democrat, Northavon)

The Minister nods, which is interesting. So, have we been over-regulating, or are we reacting to a shortage by lowering standards? If we are saying, “Actually, we never really needed the pharmacists to be there, and 37 years on, we have just realised it,” then that is a strange argument. The regulatory impact assessment says that the provisions in the 1968 Act were unclear in that respect, which is interesting. We have got by with them for 37 years, and only now do we seem to need to clarify them. That is surprising.

What sorts of requirements are we talking about? The Royal Pharmaceutical Society has suggested that the regulations should include provisions for the responsible pharmacist to be contactable when absent and in a position to return without undue delay. It would be helpful if the Minister could clarify whether that is the sort of thing that the Government have in mind.

For example, if simply being on the other end of a video link is good enough, why should not a qualified pharmacist be in charge of not one or two but 10 or 15 pharmacies? He or she could sit in front of their video link all day, dispensing—if that is the right word—wisdom. In respect of clause 24 and later clauses, once we have agreed that someone does not physically have to be present, there is no obvious reason why the number should be restricted to two or three. There is the potential to go a long way from where we are now. The Minister may say, “No, we don’t mean that, we just mean they can pop out to meetings with local GPs for half an hour,” but either pharmacists need to be there or they do not. If they do not need to be there, but just to be accessible, the powers given by the clause could be far-reaching.

However, unless the Government intend to specify in regulations that pharmacists can be responsible for, say, only two premises simultaneously, or if no limit is specified in regulations, the change could be far more radical than we have been led to believe.

I have misgivings about the view that we have been wrong for 37 years and now we need to change, that the regulations so far have been unduly restrictive and that it is safe to relax the restrictions. The Committee must therefore know far more about what the Government plan to put in the regulations that the clause gives them the power to introduce. I have a number of reservations and anxieties and I look forward to hearing what the Minister has to say.

Andrew Murrison (Conservative, Westbury)

What has changed in the past 37 years are the expectations we put on pharmacists. The hon. Member for Northavon (Steve Webb) made an interesting point: he asked why limits were being imposed and why there could not simply be a central pharmacists’ bureau—“Pharmacy Direct” or something like that—from which someone sitting centrally could dispense advice with the aid of telemedicine and the telephone. A case could be made for that being okay in terms of patient safety. If someone can read the prescription on the computer screen and electronically accept that it is appropriate, it should be all right. Indeed, because it provides an audit trail, theoretically such a system might even be better than someone just giving the nod and the wink to a prescription in a pharmacist’s shop.

What seems to have changed in the past few years is what we expect of pharmacists. What Ministers expect, and what Conservative Members would support, is the extended role of the pharmacists, which means face-to-face contact. I do not know the intention of the limits that the Minister wishes to set on the absence of pharmacists from their premises, or what drives it. It is said to be safety, but I suspect, and hope, that it might be more than that. I hope that it is a desire to increase the extended role of the pharmacist in respect of the services that they offer, not just in the community, which is stated in the guidance note, but also in their premises. That means face-to-face contact; giving authoritative, credible advice to patients who visit those highly accessible premises.

We have probably all visited pharmacists in our constituencies who are expanding their role—they measure blood pressure, do tests for diabetes and a range of other things—and pushing the boat out in terms of the responsibility that they are prepared to accept, the sort of advice they give to people and the autonomy with which they practise. For that to work, there must be an accessible pharmacist in the practice. If they are not accessible, they are nothing at all.

In recasting their image of pharmacists, people are looking for someone who is there, and accessible. The advantage that pharmacists have over GPs is that they are in the high street and behind fewer barriers than is traditionally the case with general medical practitioners. I hope that such thinking lies behind the Minister’s intention that there should be a limit on the number of practices that pharmacists are able to supervise. If that is not the case, I am inclined to agree with the hon. Member for Northavon that all that would be needed was some superintendent pharmacist, remotely located, sitting behind a computer screen and fielding calls from the periphery put in by people with a basic level of training perhaps not that much greater than that of anybody who is engaged in selling a product. If that is the case, the safety case for restricting the number of premises pharmacists can supervise has not yet been made to my satisfaction. I know that it has been cited by representative bodies of the pharmaceutical profession, and they may be right. However, to date, I have been less than convinced that they are.

I am wholly signed up to the idea that if the role of pharmacists is to be extended and people are to have confidence in pharmacists in their new role, which is what we all want to see, then it has to be conducted one to one and face to face rather than one conducted at arm’s length from some remotely located office.

Steve Webb (Liberal Democrat, Northavon)

I follow with interest what the hon. Gentleman is saying and have some sympathy with it. However, would it not be possible for that to happen now with no legislative change at all? Presumably, we could just say to pharmacists that we want them to be more face to face, out at the counter chatting to people and not behind the scenes. This is about spreading pharmacists more thinly, which is perhaps the opposite of what the hon. Gentleman wants to see.

Andrew Murrison (Conservative, Westbury)

The hon. Gentleman makes a good point. We have to face the difficulty with making pharmacists more accessible. By putting them out in to the community, and sending them into general practitioner’s surgeries to do smoking cessation clinics and the rest of it, we are spreading them very thinly. That, of course, creates a problem. When someone goes to collect their prescription or for some health care advice, as they have been encouraged to expect to be able to do in their high-street chemist, they will find that the pharmacist is not there and they are faced by a very nice but relatively unskilled person who is simply retailing items. Next time, they will not have the same level of confidence in their high-street chemist.

The Minister will have to decide to what extent she will push pharmacists out into the community to do outreach and to what extent she will have them in the high street, where they are a reliable point of contact for people who seek health care advice. We are expecting pharmacists to spread themselves relatively thinly, so we cannot necessarily reconcile those two things. That is absolutely correct.

I hope that the Minister will be able to reassure us that she is not stretching pharmacists too thinly and that she will pursue the model of high-street pharmacy that she and her colleagues have been encouraging these past few years. I hope that she will focus heavily on the idea that people should have confidence that in their high street there will be a reliable, regular pharmacist with whom they will be able to have face-to-face contact and to discuss the increasing range of health care conditions that I believe the Minister intends should be the province of pharmacy.

Jane Kennedy (Labour, Liverpool, Wavertree)

Clause 24 deals only with the supervision of the sale and supply of prescriptions and pharmacy medicines, including remote supervision, not the personal control of a pharmacy by a pharmacist. We will be dealing with that in later clauses. There are variations in the interpretation of the pharmacist supervision requirements in section 10 and section 52 of the Medicines Act 1968. For example, the degree to which the pharmacist must personally supervise the preparation, assembly, sale and supply of medicines from the pharmacy, and the degree to which he must be involved in those activities, is unclear. Consequently, that often has to be determined by the courts. The aim is simply to remove the confusion about precisely what level of involvement a pharmacist must have in an individual transaction to be properly regarded to have supervised it personally.

We are not pushing pharmacists out into the community in the way that the hon. Member for Westbury (Dr. Murrison) suggests. Pharmacists—particularly those working in a communal pharmacy—are constrained from making better use of non-pharmacist staff by the supervision requirements in the Medicines Act 1968. Those provisions tie the pharmacist to the dispensing bench. They are restricted from making wider use of their clinical training to offer other services from the pharmacy, such as advice on the effective use of medicines.

I am sure that all parties would want pharmacies and pharmacists to be better able to use non-pharmacist staff, and to improve the use of their different skills and experience. We are introducing new arrangements that allow the pharmacist to delegate certain preparation-dispensing and supply activities to non-pharmacist staff. For example, the pharmacist may clinically check the prescription, and then instruct a suitably trained dispensing assistant to select the appropriate pre-packaged medicine from the pharmacy shelves, to cross-check that with another member of pharmacy staff, and to hand it over to the patient, without the further direct involvement of the pharmacist. Let me offer another example: a dispensing assistant may select the medicine from the shelves and make it ready for handing to the patient after the pharmacist has checked it.

Where suitably trained staff support the pharmacist, both of those practices are acceptable and can be done perfectly safely. The clause allows us to make the law clear on that point through regulations. We would have to legislate to make that change; we would need to do that. I sometimes look to find ways in which we can ease the regulatory burden while retaining and reinforcing safe practices, and this is a straightforward and sensible way to do that. The pharmacist does not need to supervise personally at all times suitably qualified and trained staff, such as pharmacy technicians, who are working to written procedures for safe working set down by the pharmacist in charge of the pharmacy.

At the same time as exercising this new power, we intend to use existing powers in the Medicines Act 1968 to enable suitably trained and registered pharmacy technicians, or other suitably trained health professionals, to supervise the dispensing or sale of medicines, except for certain activities that must be undertaken by the pharmacist. There will always be things that the pharmacist does that they will be required to do.

Steve Webb (Liberal Democrat, Northavon)

The Minister says that there will always be some things that only the qualified pharmacist can do. Can she give the Committee a flavour of what she means by that? What can be legitimately delegated to the technicians, and what can the pharmacists alone do, and what does that imply for the physical presence of the pharmacist?

Jane Kennedy (Labour, Liverpool, Wavertree)

I am cudgelling my brain, but at this moment I cannot think of an example. However, I will get examples, and I will write to the hon. Gentleman to explain them, so that he has a picture of exactly what we envisage taking place. At present, however, I cannot offer such an example without inspiration.

Without the amendments and the clause, the pharmacist would be tied in a way that would not enable us to achieve the development of their role and fully exploit their skills.

Clause 25 - Control of pharmacy premises: individuals and partnerships

Steve Webb (Liberal Democrat, Northavon)

I beg to move amendment No. 123, in clause 25, page 22, line 2, at end insert

‘but nothing in this section shall be taken to require a pharmacist to be present on those premises when medicinal products on a general sale list are sold by retail.’.

This is a probing amendment; we seek clarification. Clause 25 deals with individuals and partnerships. I have questions about the implications of the clause in respect of the particular case of what are called general sale list products—products that do not need a pharmacist to be present to be sold, such as the kind of product that someone might buy in a garage shop. We simply want to be clear that clause 25 would have no impact on general sale list products or on the requirement for pharmacists to be present. If the Minister can reassure us that that is implicit or, indeed, explicit in the clause, we would be more than happy.

Jane Kennedy (Labour, Liverpool, Wavertree)

I appreciate the way in which the hon. Gentleman moved the amendment. The Medicines Act 1968 does not require a pharmacist to supervise the sale of general sale list medicines. The public can buy those medicines in several retail outlets, such as newsagents, garage shops and supermarkets—we all know them—without the need for a pharmacist to be present on the premises. However, the lack of clarity about the personal control requirements in the Act has led to the common interpretation that pharmacists exercise control over the pharmacy business only when they are physically present in the pharmacy. That has led to the view that the exercise of personal control over the pharmacy requires the pharmacist to be present when general sale list medicines are sold. Thus, an anomaly has been created. Someone may buy a general sale list medicine from a local corner shop, but if he visits a pharmacy, and the pharmacist is not present, he must go elsewhere to make the purchase. That is nonsense.

The Bill replaces the personal control requirement with a requirement that each pharmacy should have a responsible pharmacist in charge of the pharmacy business in so far as it relates to all medicines, including those on the general sale list. The responsible pharmacist will not be required to be on the premises at all times, and it will be for the pharmacist to decide whether the pharmacy will sell general sale list medicines when he or she is not physically present. We assume that most responsible pharmacists will decide that their pharmacies can do so.

As a result of the changes in the Bill, the present anomaly will disappear, so the hon. Gentleman’s amendment is not necessary. I hope that that addresses his concerns in tabling the amendment. The Bill places pharmacies on a more equal footing with other outlets selling general sale list medicines.

Steve Webb (Liberal Democrat, Northavon)

In a sense, our amendment related to the opposite group of premises—those where general sale list medicines are on sale and there is currently no requirement for supervision. We merely sought to clarify that clause 25 would not introduce a new requirement, and the Minister has broadly satisfied me that that is indeed the case. I beg to ask leave to withdraw the amendment.

Steve Webb (Liberal Democrat, Northavon)

In her response on clause 24, the Minister indicated that some of our remarks might have been more appropriately directed at clause 25, and I apologise if that was the case. However, I just want to gnaw away further on the issue of supervision.

Would it be accurate to say that we are dealing in clause 25 with a calculated risk? I do not say that pejoratively; I simply think that that, objectively, is what we are doing. For the past 37 years, we have said that a pharmacist must be present, and if they nipped out to the loo or went over the road, the pharmacy could not sell medicines. We are now saying that we want pharmacists to do other things, so we will allow pharmacies to make available medicines that they have not been allowed to make available for the past 37 years without a pharmacist being present. We are trying to minimise the risk arising from that relaxation of the rules by setting out in regulations who can sell medicines and in what circumstances.

My question is whether the Government have done any risk assessment on clause 25. There must be a risk associated with selling medicines without a pharmacist being present, when they would hitherto never have been sold with a pharmacist present. There must be a risk associated with the pharmacist being on the other end of a webcam or a phone and not being physically present. How big a risk is that? Has the nature of that risk been assessed? How far will the regulations limit that risk?

Do the Government envisage that in the vast majority of cases a pharmacist will still be physically present? That is an important question for us on these Benches. Is the regime that is envisaged one in which pharmacists will have a bit of spare time in which they can be away from the premises if they have to do something worth while, but that that will be exceptional—the norm will still be that the main pharmacist attached to one set of premises will be there? Alternatively, are we envisaging a world in which, because we are convinced that the change is very low risk and there are enough trained people out there to cover for them, pharmacists will play a light-touch supervisory role? Are we changing from hands-on, got-to-be-on-the-premises people, without whom nothing can be sold, to a regime of light-touch oversight of several premises? How far down that route do the Government expect clause 25 to take us?

Jane Kennedy (Labour, Liverpool, Wavertree)

I agree with what I think is the hon. Gentleman’s main concern. The public place importance on being able to see and obtain advice from the pharmacist. It is important for people to be able to identify the responsible pharmacist in a pharmacy, and that is where clarification is needed. The law does not specifically say that a pharmacist has to be present, but that is how it has been interpreted. We expect that the responsible pharmacist will spend the majority of his or her time in the pharmacy. The way the time of pharmacists is used is down to the contracts between them and the primary care trusts that commission their services.

Because we want the public to have the reassurance of knowing who the responsible pharmacist is in a pharmacy, we have taken the step of changing the requirement in section 70 of the 1968 Act for the pharmacist in personal control of the pharmacy to exhibit conspicuously in the pharmacy his or her registration certificate.

In practice, most, if not all, pharmacists working in pharmacies display their certificates, so there is an expectation that they will always be there. Now, we are going to say that the responsible pharmacist will be required to display conspicuously in the pharmacy a notice stating that he is the pharmacist in charge of the pharmacy on that day and at that time, and giving his registration number. That will help the public to identify the pharmacist in charge, particularly in cases in which more than one pharmacist is present in a pharmacy. It will also allow the public to know when the pharmacist in control is not physically present.

Subsection (5) replicates the current provision that somebody who has been registered as a pharmacist in Great Britain for less than three years may not be in charge of a pharmacy. I hope that I have answered the hon. Gentleman’s concerns. The way in which the law has developed in this area is a little strange, and I think that what we are doing will be welcomed. I know that there are concerns that our intention is to dilute the role of the pharmacist. That is not the case. Indeed, we are working closely with the Royal Pharmaceutical Society to ensure that we maintain the strong support that we have among pharmacists for the developments in this legislation.

I have inherited a piece of work that has been under way for many years, and this change is a sensible step. In taking it, we can be confident that we are retaining the regulations necessary to allow for patient safety to be properly maintained.

Clause 26 - Control of pharmacy premises: bodies corporate

Andrew Murrison (Conservative, Westbury)

Clause 26 gives us the opportunity to have another bite of the cherry. It deals also with the issue of supervision—writ large, I suppose, because we are dealing with bodies corporate. We might understand that to mean, for example, some of the larger chains of pharmacies.

My concerns and those of the hon. Member for Northavon (Steve Webb) have not been entirely explored by the Minister; perhaps she will think about the issue further in our debate on this clause. There seem to be two aspects to the argument about supervision. One concerns safety and one concerns the quality of the extended role of the pharmacist. We can all understand that it is important for someone to be on hand to check prescriptions and make sure that there are no drug interactions or other technical matters such as name conflicts. As the Minister has hinted, many of those tasks can be dealt with through remote and electronic means, such as telemedicine, which embrace new technology.

If we took that to its logical conclusion, as the hon. Member for Northavon pointed out, we could produce a system in which a superintendent pharmacist employed by Boots the Chemist sat in an office in London and fielded calls from the hundreds of pharmacies scattered around the country. The quality of the advice given would probably be very good and it would clearly be auditable in a way that it currently is not. That model therefore has some advantages. It is for the Minister to say why a limit needs to be set on the number of pharmacies that a pharmacist might be able to supervise, if the argument is to do with patient safety. I think that the Minister may struggle to explain that, but I should be interested to hear her thoughts.

There is another strand to the question, however, which concerns the developing role of the pharmacist. It relates to large pharmacies in the same way as small single pharmacist-owned premises of a traditional sort, in a high street. The argument for limiting the number of pharmacies that can be supervised in those circumstances is far clearer. If we are to develop the role of the pharmacist in that way, which would be a good thing, it makes sense to ensure that individuals who turn up at high-street chemists can have confidence that they will deal with a qualified pharmacist, because of the issues of accessibility and immediacy that lie at the heart of the developing role of the pharmacist.

The more I think about the two aspects of the matter, the more I am convinced by the questions of the quality of the extended role of the pharmacist, and the less I am convinced by questions of safety. The whole matter comes to a head when we consider bodies corporate and how larger chains of pharmacies might manage with one superintendent pharmacist sitting in an office dispensing advice. He or she would certainly tick the box for safety—at least I have not seen any convincing evidence to the contrary—but manifestly not the box for face-to-face patient contact.

With those issues in mind, I must press the Minister on why and how she will insist on a particular number of pharmacies that a pharmacist may supervise. I suspect that the number will be low—in fact, from what we understand comes later in the Bill, I suspect that it is one. If so, I should be grateful to know the rationale for that. One can easily demolish the safety rationale but not—quite the reverse—the rationale based on the extended role of the pharmacist. What is driving the Minister’s thinking in limiting the number of pharmacies that pharmacists may supervise?

Jane Kennedy (Labour, Liverpool, Wavertree)

The limitation on the number of pharmacies that a pharmacist can supervise and be responsible for is something that we shall come to on clause 28, but it might help the Committee if we deal quickly with it now. The clause sets the general rule that a pharmacist will generally be in charge only of one pharmacy. Clause 26 replaces the requirement under section 71 of the Medicines Act 1968 that requires each pharmacy carried on by a body corporate to be under the personal control of the pharmacist with a requirement for each pharmacy to have a responsible pharmacist. Those requirements are essentially the same as those in clause 25, which relates to small pharmacies owned by individuals and partnerships, except for subsection (1)(a) of the new section 71 that deals with the superintendent pharmacist, which is really what the clause is about.

A body corporate conducting a pharmacy business must appoint a superintendent pharmacist, the rule of whom is company wide. The superintendent pharmacist is there to ensure that the body corporate meets the statutory requirements relating to pharmacy premises. He has an important standard-setting role for the conduct of the pharmacy business, including how it reflects standards set by the professional regulatory bodies. The clause ensures that the role of the superintendent pharmacist will continue, as now, under the Medicines Act. The responsible pharmacist, under clause 28, will continue to be under the direction of the superintendent pharmacist.

We sought views on the role of the superintendent pharmacist, as the pharmacist in control of each pharmacy is subject to the general direction of the superintendent pharmacist. The response to public consultation was that more detailed debate was needed on the role of the superintendent pharmacist before considering changes so, for now, we are concentrating on the responsible pharmacist as the key change that will end the uncertainties that we have just debated about personal control requirements.

We shall continue to discuss with the profession how we can develop further the role and where further regulatory reform needs to take place. As now, the responsible pharmacist will continue to be under the direction of the superintendent pharmacist and, other than the changes that we have discussed, there will be little further change to the role.

Clause 28 - The responsible pharmacist

Andrew Murrison (Conservative, Westbury)

I beg to move amendment No. 17, in clause 28, page 24, line 24, leave out from ‘time’ to end of line 25.

Eric Illsley (Labour, Barnsley Central)

With this it will be convenient to discuss the following: Government amendment No. 92.

Amendment No. 19, in clause 28, page 24, line 41, after ‘pharmacist’, insert ‘having regard to—

(a)the establishment of clear lines of accountability within the pharmacy;

(b)provision for the responsible pharmacist to be contactable when absent;

(c)the maximum time for the responsible pharmacist to return to the pharmacy; and

(d)provision for the responsible pharmacist to justify any absence.’.

Andrew Murrison (Conservative, Westbury)

I will deal with amendments Nos. 17 and 19. The first amendment would delete in relation to the provision that

“A person may not be the responsible pharmacist in respect of more than one set of premises at the same time”,

the words

“except in circumstances specified by the Health Ministers in regulations.”

We want to make it clear that a pharmacist may be responsible for just one pharmacy at any one time and the amendment would remove the expectation that Ministers may be able to alter that.

If the Minister is not minded to accept the amendment, I hope that she will at least give the Committee an idea of the circumstances she envisages in which it would be acceptable for a pharmacist to supervise more than one pharmacy. In a sense, I suppose that she has covered some of that ground already, but now is an opportunity to explore further the rationale behind the limitation of the number of premises that a pharmacist can supervise.

The Minister has been good and has answered the worries of hon. Members. Nevertheless she has not really dealt with the central issue of whether we are being driven by a safety case or by a need to protect and enhance the extended role of the pharmacist. As I have said about previous clauses, it is increasingly my view that the safety case can be made for remote supervision. Perhaps we are not at that stage at the moment. We would have to explore the matter further, but we are going in that direction.

The case for the extended role of the pharmacist is far less clear and that is why I am suggesting in a probing way that we delete the words whereby pharmacists can supervise more than one set of premises at Ministers’ discretion. That is the intention of amendment No. 17.

Amendment No. 19 is a little more complicated because it would establish parameters under which pharmacists may operate. As part of the amendment, we have laid out a number of parameters that Ministers would have to consider in drafting regulations in relation to the responsible pharmacist. Those parameters concern the establishment of clear lines of accountability within pharmacies, the provision for the responsible pharmacist to be contactable when absent, the maximum time for the responsible pharmacist to return to the pharmacy, and provision for the responsible pharmacist to justify any absences. In other words, we are saying that the pharmacist will normally be at the pharmacy.

We are saying that it is not really acceptable for pharmacists to regard their pharmacy as a base camp from which they operate an itinerant practice, so that they cannot reliably be found at the pharmacy at any one time. That approach seems to cut across the developing role of the pharmacist that we have seen in recent years, which we regard as a fairly positive thing. I would be concerned if it became the rule rather than the exception that pharmacists were absent from their premises and doing, other albeit worthwhile, things. I hope that the Minister will consider our amendments favourably.

Jane Kennedy (Labour, Liverpool, Wavertree)

Amendment No. 92 is a minor technical amendment to the Medicines Act 1968. I appreciate the main concern that the hon. Gentleman has articulated. Under the 1968 Act, maintaining patient safety is paramount. We believe that the changes proposed and the conditions to be set in the regulations will maintain patient safety. I accept that there is anxiety about the opportunities that might arise to exploit any flexibility in the rule of “one responsible pharmacist, one pharmacy.” However, the intention is that regulations will be tightly drawn as to the specified circumstances and conditions that must be met to allow exceptions to that general rule. Those regulations will be subject to further discussion and consultation with all interested parties.

I think that, by and large, we agree that the general rule should be “one responsible pharmacist, one pharmacy”, but we also think it sensible to allow sufficient flexibility to consider and, if necessary, to respond to circumstances that may arise in which a responsible pharmacist might be permitted to be responsible for more than one pharmacy at any one time.

Let me give the Committee a couple of examples. There may be changes in the way in which pharmacy services are provided, such as a case in which the responsible pharmacist controls the supply of certain medicines in another location. For example, a pharmacy service might be provided to offer sale of over-the-counter medicines to meet the needs of a large number of people attending an event that extended over several days. The service might be delivered by trained staff, such as pharmacy technicians, with the pharmacist responsible for a pharmacy in a nearby village or town also becoming responsible for the safe running of that additional pharmacy.

Amendment No. 17 would restrict a responsible pharmacist to one pharmacy only in exercising his duty and, as I have just described, there are circumstances in which I believe that that greater flexibility should be allowed. Amendment No. 19 would restrict the responsible pharmacist as to when and how he might be absent from the pharmacy. The proposed changes are unnecessary, as there is already provision in relation to that in the Bill. We would expect the pharmacy for which the pharmacist is responsible to be the responsible pharmacist’s main place of work. We would also expect them to remain contactable so that they can provide advice or arrange for another pharmacist to do so. These provisions and other provisions on, for example, written procedures will ensure the safe and effective running of the pharmacy, including when the responsible pharmacist is away from the pharmacy. As I said, we expect the responsible pharmacist to be on the premises, by and large, but the provision allows for consideration of developing services, which is a sensible route to follow.

The new provisions will help to remove restrictions on the pharmacist’s ability to provide a range of other services, including working with other health professionals such as GPs. We intend the regulations to set out the conditions that must be met to permit an exception to the rule of “one responsible pharmacist, one pharmacy”. The House will have the opportunity to debate those regulations later.

As I said, amendment No. 92 is a minor drafting amendment that tightens the regulation-making power to provide not only that responsible pharmacists may be responsible for more than one pharmacy, but that the regulations may require the responsible pharmacist to comply with certain conditions. Such regulations need to be tightly drawn. We intend to consult representative bodies on the circumstances in which it may be appropriate to consider an exception to the “one responsible pharmacist, one pharmacy rule”. I therefore hope that the Committee will accept amendment No. 92. I also hope that I have reassured the hon. Member for Westbury, and that he will withdraw his amendment.

Andrew Murrison (Conservative, Westbury)

The Minister has undertaken to ensure that regulations are—in her words—tightly drawn. I therefore beg to ask leave to withdraw the amendment.

Andrew Murrison (Conservative, Westbury)

I beg to move amendment No. 18, in clause 28, page 24, line 40, after ‘Ministers’, insert

‘, having consulted with representative bodies,’.

Eric Illsley (Labour, Barnsley Central)

With this it will be convenient to discuss amendment No. 122, in clause 28, page 25, line 29, at end insert—

‘(12)Before making regulations under this section the Health Ministers shall consult such persons as appear to them to represent persons providing pharmaceutical services.’.

Andrew Murrison (Conservative, Westbury)

Amendment No. 18 is a simple amendment that follows on from several rather similar amendments that we have tabled to the Bill. It would insert into the Bill the need to consult representative bodies before Health Ministers make further provisions relating to the responsible pharmacist. It is driven by the profession’s desire to influence what happens, and by a feeling that it is appropriate for Ministers to consult pharmacists closely before they make any regulations under the Bill. That is entirely reasonable.

The Minister said in relation to the previous group of amendments that she intended to consult representative bodies, which is a good thing. Nevertheless, it is appropriate to insert such a duty into the Bill, because consulting representative bodies is important. I very much hope that she will consider the amendment favourably.

Stephen Williams (Liberal Democrat, Bristol West)

The hon. Gentleman was uncharacteristically brief, so I rise briefly to speak to amendment No. 122, which seeks to achieve a similar object. We discussed consultation in our consideration of part 1, in which the Minister with responsibility for public health resisted the suggestion that the Royal Institute of Public Health should be consulted. I hope that the Minister present will have an entirely different attitude. If the legislation is to work, it is important that all the bodies with a professional interest are consulted, and I hope that, just for once, the Government will be open minded and accept an Opposition amendment.

Jane Kennedy (Labour, Liverpool, Wavertree)

I am always open minded—well, mostly. I shall consider the hon. Gentleman’s point and, if necessary, I will write to him. However, both amendments are unnecessary. The Bill inserts new sections into the Medicines Act 1968. Section 129(6) of that Act already imposes a statutory requirement for there to be consultation of representative interests before making regulations. By virtue of that section, we already have a statutory obligation to consult interested parties before making regulations under the new powers inserted into the Act by this Bill. I therefore recommend that the Committee rejects the amendments. I appreciate the tone in which the hon. Member for Westbury moved amendment No. 118, but I hope that he does not press it to a vote, because that would be a shame at this late stage, in an afternoon just before Christmas.

Andrew Murrison (Conservative, Westbury)

I detect a note of desperation. For that reason alone, I am tempted to press the amendment to a vote, but as it is Christmas, I shall not. The Minister has given us plenty of reassurances and the point about consulting representative bodies is on the record. That is good. With that in mind, and in the spirit of Christmas, I beg to ask leave to withdraw the amendment.

Clause 31 - Power to charge

Steve Webb (Liberal Democrat, Northavon)

I beg to move amendment No. 121, in clause 31, page 26, leave out lines 20 to 40 and insert

‘(1)The Secretary of State may give directions to a Primary Care Trust requiring it to charge a fee to persons who make an application referred to in section 42(2)(c)(i) or (ii) to the Primary Care Trust.

(2)The Secretary of State shall in the directions specify the fee to be charged, which may vary according to the type of application being made but not according to the place in England where it is made.

(3)Before determining the amount of any fee to be charged the Secretary of State must consult such organisations as he thinks fit that appear to him to represent persons providing pharmaceutical services and such organisations as he thinks fit that appear to him to represent Primary Care Trusts.

(4)The Secretary of State must publish in such manner as he thinks fit any directions he gives under this section.’.

Eric Illsley (Labour, Barnsley Central)

With this it will be convenient to discuss amendment No. 21, in clause 31, page 26, line 28, at end insert

‘(c)require Primary Care Trusts to refund the fee if an application is not determined within 28 days.’.

Steve Webb (Liberal Democrat, Northavon)

We are powering ahead, which is great, and we come now to part 4, which deals with pharmaceutical services. The clause relates to the power for charges to be levied in respect of a chemist’s application to a pharmaceutical list. I hope that at some point we discuss the broader issues of entry and control of entry in respect of pharmaceutical supply. A number of us are concerned about the position of community pharmacies and the small local pharmacist as distinct from a pharmacist in a supermarket or something similar. I hope that we will discuss some of those issues in due course, but amendment No. 121 is much more specific. It would replace lines 20 to 40 on page 26 of the Bill, which contain provisions on the power to charge relating to England. The amendment is essentially a reformulation of those provisions.

Subsection (2) of the amendment would ensure that when the Secretary of State determines what fee can be charged, variation of the charge for any given type of application in different parts of England will be precluded, although there could be variation according to the nature of the application. This is an England-only clause, and we are trying to get consistency in the charges that might be levied, rather than allow charges that might vary according to primary care trust.

Beyond that, many of the reformulations in our amendment are similar to the original clause. For example, subsection (3) of the amendment is about consultation, and consultation provisions are in the original clause. The amendment would not much change the spirit of what is already in the Bill, but it would avoid some unnecessary variation in fees across the country. We think that it would tidy things up a bit, although that might be going a bit far. That is the spirit behind the amendment.

Andrew Murrison (Conservative, Westbury)

I think we are grinding to a conclusion, although not before we consider a couple of helpful amendments, the second of which is our amendment No. 21. It is quite simple and has to do with our concern that the determinations should be made in a timely fashion.

I am afraid that businesses constantly tell us that they are frustrated by bureaucracy failing to deliver within a reasonable time frame. Amendment No. 21 would insert words that allow the fee to be refunded if the matter is not determined within 28 days. That seems entirely reasonable to us, and I hope that the Minister, in a spirit of trying to ensure that business is dealt a fair hand, will consider it carefully.

Very few commercial organisations would consider our amendment unreasonable. Given that we are dealing with the interface between the NHS and commercial organisations, both working together to provide a service to patients, it seems appropriate to ensure that any requirements of the regulations are discharged within a reasonable time. Twenty eight days seems reasonable to us and would give an incentive for things to be determined speedily and in a timely fashion.

Jane Kennedy (Labour, Liverpool, Wavertree)

Clause 31 introduces a power to charge fees, as has been described. Primary care trusts will be required to levy such charges, which applicants will have to pay. We envisage that the Secretary of State, rather than primary care trusts, will determine the level of fee to ensure consistency. Fees would be determined only after consultation with appropriate bodies. However, a facility for primary care trusts to set the charges may be desirable in future, in line with our general policy of devolving decision making to the local level as far as possible. Subsections (2)(b) and (3)(b) of proposed new section 42A will require primary care trusts to determine and undertake local consultations on such fees in accordance with national requirements set out in the directions. That is the background.

The amendments pose an interesting set of challenges. I cannot support amendment No. 121, and shall explain why. First, Although the hon. Member for Northavon said that it would apply only in England, it would introduce different charging regimes in England and Wales. That is not what the measures intend.

Secondly, the amendment would prevent differential fee levels from being set for different types of application between different primary care trusts. In other words, there would be only one fee level for a particular type of application, and that would be determined nationally. That determination would only ever be for the Secretary of State to make, but we do not envisage that the Secretary of State is likely to want to determine fees differentially, according to which primary care trust decides an application. However, should the Secretary of State decide that that power is needed, the amendment would prevent that from occurring.

Thirdly, the amendment would mean that the Secretary of State could not, at any time he or she might choose, devolve the decision about fees to primary care trusts. As I made clear, such devolution of powers would be subject to whatever national requirements the Secretary of State chose to set out in directions, including in relation to whatever consultations the PCT must first undertake locally.

The amendment would make the determination of fees always the responsibility of the Secretary of State and would mean that they could never be devolved to PCTs. That does not sit well with the Prime Minister’s principle for public sector reform, which makes it clear that there is a need to devolve decision making to the lowest level wherever appropriate. We had some fun at the expense of the hon. Member for Northavon about the centralising nature of Liberal Democrat policy, but in the spirit of bonhomie I resist the temptation to go down that route.

I assure the Committee that we do not envisage directing PCTs simply to set whatever fees they think appropriate, but the Secretary of State might want to set out in directions a maximum fee that PCTs may charge for each type of application and leave it to them to consult on the fee levels that they wish to set up to that maximum level. The amendment would prevent that. I reassure the Committee that we have no intention of allowing PCTs to set extortionate or excessive fee levels. We would always ensure that they were reasonable, proportionate and fair in relation to the work involved for the NHS. For those reasons, I cannot support or accept the amendment.

Amendment No. 21—it is confusing to have amendments Nos. 121 and 21; I keep having to remind myself which one I am referring to—would give the Secretary of State powers to require PCTs to do as the amendment describes. There is undoubtedly a need for pharmacy applications to be dealt with as quickly as possible. That concern was acknowledged in the reforms of pharmaceutical services that we made earlier this year. The NHS (Pharmaceutical Services) Regulations 2005 introduced new time limits for the determination of applications.

With applications for inclusion in PCT pharmaceutical lists, the regulations require PCTs to reach decisions

“as soon as is practicable, and in any event within ... four months ... of receipt”

unless there is “good cause” to extend that time limit. There are several stages to go through before a PCT can reach a decision, one of which involves notifying interested parties about the application and giving them 45 days in which to comment. Interested parties include the local pharmaceutical and medical committees, persons on the PCT’s pharmaceutical list who are likely to be significantly affected and the patient’s forum for the PCT area. We do not want to reduce that consultation period, because the organisations concerned need time to respond meaningfully. I know from comments made by the hon. Member for Westbury in previous discussions how important he views consultation to be. Therefore, we would never want to exercise a power such as that proposed in the amendment, as it would mean PCTs refunding fees charged on new applications every time.

Other types of application are more straightforward, such as one from a chemist who wishes to move a short distance or ones involving a change of ownership. Those are dealt with administratively by PCTs, and the regulations require them to reach a decision within 30 days either to grant the application or to determine that the normal procedure should apply. Therefore, the PCTs must still check the details; they must still prepare reports and reach their decision. Although many such applications will be clear cut, we will have to build in contingencies to allow for circumstances in which a PCT quite reasonably and through no fault of its own takes longer than 28 days to decide. For example: a PCT might have to clarify details with the applicant; an application might contain factual inaccuracies; or a PCT might have to carry out other checks on the applicant, such as into their fitness to provide NHS services.

It would be difficult to capture in directions the potential range of circumstances that might reasonably apply in such cases, and it would be unreasonable to require a PCT to make a refund if it has simply followed the correct legal procedures and processes. The current regulations make sufficient provision for applications to be dealt with efficiently and effectively. PCTs do not need any greater incentives to act speedily under the regulations.

I appreciate the reason behind the amendment, but I ask the hon. Member for Northavon to withdraw it, given my explanation of Government policy.

Steve Webb (Liberal Democrat, Northavon)

As a committed decentraliser, I am chastened by the Minister’s response and urgently beg the Committee’s leave to withdraw the amendment.

Clause 32 - Applications for provision of pharmaceutical services

Steve Webb (Liberal Democrat, Northavon)

I have a couple of questions for the Minister. In line 42 there is a reference to two or more applications to provide pharmaceutical services in the same neighbourhood. Would the Minister clarify what is meant by “neighbourhood” in that context? Is it a town, a county or a PCT area? What is the scope of the clause?

I hinted at my other question during my earlier intervention. All of us would want the character of community pharmacies to be maintained. Individual pharmacies have a role, as do big chains, and where applications are made by two pharmacies, or where an application is made by a new one in the same neighbourhood as an existing one, what criteria would the Government use for determining which should be allowed to operate? Do they just wish to encourage entry and competition?

I am worried that if it is a matter of full-blooded, full-throated competition, there is a danger that community pharmacies and the services they provide, which bring something distinctive to our neighbourhoods, might be driven out of business by the chains. They can cross-subsidise, and drive out smaller pharmacies that are not able to do that, to the long-term detriment of variety, quality and customer service. Would the Minister put on record the criteria that the Department require to be used locally in deciding between competing applications in a neighbourhood? It would be helpful if she could do that and clarify what constitutes a neighbourhood.

Jane Kennedy (Labour, Liverpool, Wavertree)

One of the beauties of devolving decision making to a local level is that it allows me to stand up in Committee and say that it is for the PCT to decide what the definition of “neighbourhood” is when it is inviting applications for a particular service. That will be determined by local circumstances. On the hon. Gentleman’s other point about the criteria, to make sure I get it right I will undertake to write to him, if he will allow me. I shall circulate the letter to Committee members so that everyone can see the criteria that we intend to apply.

Andrew Murrison (Conservative, Westbury)

The hon. Member for Northavon makes a fair point. There does seem to be the potential for a lawyers’ beanfeast on the definition of “neighbourhood”. In determining the matter, PCTs may decide that two pharmacies are both in a neighbourhood, but one pharmacy might say, “We are in the next town, albeit one that is very close”. There is scope to be a little clearer about what is meant by “neighbourhood”. It might be simply defined as being in one PCT area. “Neighbourhood,” although it sounds very cosy, does not seem to be sufficiently clear to avoid giving lawyers a meal ticket.

Jane Kennedy (Labour, Liverpool, Wavertree)

It has been my regular experience that in devolving decision making to the locality, very reasonable points are raised, like the ones raised by the hon. Gentleman and the hon. Member for Northavon, and I shall consider them. What constitutes a neighbourhood will be greatly influenced by local factors, but in my letter I shall flesh out our thinking on how we expect PCTs to work in relation to the definition of “neighbourhood”, if that is of assistance to the Committee.

Clause 33 - Arrangements for dispensing of medicines

Andrew Murrison (Conservative, Westbury)

I have to say that we were expecting a little more explanation. It is customary when tabling an amendment for some explanation to be given. Opposition Members, who have tabled many amendments during the past several days, have been exhaustive in their explanation of them. For the Minister simply to move the amendment formally does not cut the mustard. I would be grateful if she could explain the intention of the amendment.

Jane Kennedy (Labour, Liverpool, Wavertree)

There is a saying in Liverpool: God loves a trier. That was an example.

The subject matter of the Medicines Act 1968 is reserved, but NHS legislation is devolved. Amendment No. 82 comes forward with the agreement of Scottish Ministers who were unable to conclude discussions when the Bill was introduced.

This amendment to section 17S of the National Health Service (Scotland) Act 1978 will bring NHS legislation in Scotland into line with the proposed changes to the 1968 Act, which are implemented by part 2 of the Bill. In the same way, clause 33 relates to NHS legislation covering England and Wales.

I hope that that explanation of the purpose of the amendment satisfies the Committee.

Gillian Merron (Labour, Lincoln)

I beg to move, Mr. Illsley, that you, the Clerks and the Committee have a very happy Christmas and new year.

Further consideration adjourned.—[Gillian Merron.]