Clause 16 - Accountable officers and their responsibilities as to controlled drugs
Health Bill
2:00 pm

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Andrew Murrison (Shadow Minister, Health; Westbury, Conservative)

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.

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Jane Kennedy (Minister of State, Department of Health; Liverpool, Wavertree, Labour)

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.

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Andrew Murrison (Shadow Minister, Health; Westbury, Conservative)

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.

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Jane Kennedy (Minister of State, Department of Health; Liverpool, Wavertree, Labour)

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.

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Andrew Murrison (Shadow Minister, Health; Westbury, Conservative)

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.

Amendment, by leave, withdrawn.

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Andrew Murrison (Shadow Minister, Health; Westbury, Conservative)

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

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Eric Illsley (Barnsley Central, Labour)

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.’.

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Andrew Murrison (Shadow Minister, Health; Westbury, Conservative)

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.

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Jane Kennedy (Minister of State, Department of Health; Liverpool, Wavertree, Labour)

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.

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Andrew Murrison (Shadow Minister, Health; Westbury, Conservative)

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.

Amendment, by leave, withdrawn.

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Andrew Murrison (Shadow Minister, Health; Westbury, Conservative)

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.

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Jane Kennedy (Minister of State, Department of Health; Liverpool, Wavertree, Labour)

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.

2:15 pm
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Andrew Murrison (Shadow Minister, Health; Westbury, Conservative)

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.

Amendment, by leave, withdrawn.

Question proposed, That the clause stand part of the Bill.

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George Young (North West Hampshire, Conservative)

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?

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Jane Kennedy (Minister of State, Department of Health; Liverpool, Wavertree, Labour)

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.

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George Young (North West Hampshire, Conservative)

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

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Jane Kennedy (Minister of State, Department of Health; Liverpool, Wavertree, Labour)

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

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Andrew Murrison (Shadow Minister, Health; Westbury, Conservative)

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.

2:45 pm
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Jane Kennedy (Minister of State, Department of Health; Liverpool, Wavertree, Labour)

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.

Question put and agreed to.

Clause 16 ordered to stand part of the Bill.