Mr John Denham (Minister of State, Department of Health; Southampton, Itchen, Labour)

I beg to move amendment No. 217, in page 54, line 7, at end insert `;

(h) any other description of persons which appears to the appropriate Ministers to be a description of persons whose profession is regulated by or under a provision of, or made under, an Act of the Scottish Parliament or Northern Ireland legislation and which the appropriate Ministers consider it appropriate to specify.'.

Mr David Madel (South West Bedfordshire, Conservative)

With this it will be convenient to take Government amendments Nos. 213 and 216.

Mr John Denham (Minister of State, Department of Health; Southampton, Itchen, Labour)

It may be helpful if I explain briefly how the next few clauses relate to one another. Clause 60, together with clause 44 and parts of clause 42, deals with the extension of prescribing rights. The remainder of clause 42 and clause 43 deal with the remote provision of NHS pharmaceutical services--home delivery, mail order and internet services. The genesis of these clauses is the final report of the ``Review of Prescribing, Supply and Administration of Medicines'', which was published in March 1999.

The review, by Dr. June Crown, made a number of recommendations relating to the prescribing and supply of medicines. One of its major recommendations was that legal authority to prescribe in the United Kingdom, including authorising NHS expenditure, should be extended beyond the current prescribers--doctors, dentists and some nurses. It also recommended that legal authority for new professional groups to prescribe should normally be limited to areas within the expertise and competence of each group. Two types of prescriber were recognised: independent prescribers, who would be responsible for the assessment of patients with undiagnosed conditions and for decisions about their clinical management, and supplementary prescribers, previously known as dependent prescribers, who would be responsible for the continuing care of patients who have been clinically assessed by an independent prescriber. The review also recommended that Ministers should receive advice on granting prescribing rights to new professional groups from a UK-wide advisory body, set up under the Medicines Act 1968.

The provisions in clauses 60, 44 and parts of clause 42 help us to implement the review's most important recommendations. Clause 60 amends section 58 of the Medicines Act 1968, and deals with the prescribing of prescription only medicines, whether privately or dispensed as a cost to the NHS. Clauses 42 and 44 make like changes to the National Health Service Act 1977, in respect of ordering drugs and other items on the NHS.

We consulted the NHS and relevant professional organisations before agreeing to implement the main recommendations of the review. A strong majority of the organisations consulted on the review's recommendations were in favour of extending prescribing rights to other health professionals. That is why we are now taking powers that will enable us to implement those recommendations through orders. I

was glad that on Second Reading the proposals were supported by both sides of the Chamber. Action to extend the rights to prescribe medicines will help to break down the divisions between health professions and play an important role in the introduction of more flexible team working throughout the NHS.

I shall give one or two examples of the potential benefits of extended prescribing rights. Physiotherapists may be able to prescribe non-steroidal anti-inflammatory drugs and analgesics rather than having to refer their patients to a GP, and optometrists could prescribe medicines for the treatment of conjunctivitis and other eye infections. However, the proposals will also mean better and speedier access for patients to the medicines they need, as envisaged in the NHS plan.

Clause 60 does not confer any prescribing rights. Instead, it makes it possible for Ministers to extend by order such rights to members of any recognised and regulated health profession. Patient safety will, of course, be paramount during implementation, particularly when considering whether to grant prescribing rights for specific medicines to a professional group. An advisory body under the Medicines Act will take account of concerns when considering the granting of prescribing rights to any specific group of health professionals. That advisory body will make recommendations to Ministers. More detailed proposals for granting prescribing rights for specific medicines to a particular group of health professionals will be subject to both informal and formal consultation with relevant organisations.

The Government amendments are related. Clause 60(3) lists the registered health professionals who may be considered for prescribing rights. Government amendment No. 217 extends that list to ensure that health professions, regulated under separate Scottish and Northern Ireland legislation, have the same potential right to prescribe as health professionals regulated under the specified Acts of Parliament.

Clause 42(3) lists the registered health professionals whose prescriptions may be dispensed under the NHS in England and Wales. Government amendment No. 213 extends that list to ensure that prescriptions of Scottish and Northern Irish regulated professionals will be able to be dispensed in England and Wales.

Finally, clause 44(3) lists the registered health professionals whose prescriptions may be dispensed under the NHS in Scotland. Government amendment No. 216 amends that list to make similar provisions in Scotland for health professionals regulated under Northern Ireland legislation.

Mr Desmond Swayne (New Forest West, Conservative)

I have a number of questions for the Minister. First, how will the advisory body be constituted? Will it comprise members of the professions that are to obtain prescribing rights under the regulations? The Royal College of Nursing wants to know why midwives and nurses are not included in the list in amendment No. 213. He will be aware that the limited content of the current nurse prescribers formulary has proved frustrating, and that the royal college wants the full British national formulary to be accessible to all licensed nurse prescribers.

The electronic mail message that I received from the royal college states:

``The RCN calls on the Government to ensure that nurses who have specialist training can prescribe controlled drugs as well as having access to an increased range of other prescription only medicines. This would mean, for example, specialist pain control nurses could prescribe controlled drugs such as diamorphine for patients with a clinical need.''

That description seems consistent with what the Minister said about different groups with different expertise being able to prescribe in a particular way. Will he respond to that point when he answers the debate?

Concern has been expressed about the degree of restriction that regulations may place on legitimate prescribing powers. If regulations are to specify in detail what drugs can be prescribed and in what circumstances, they will rapidly become cumbersome and out of date. It will be difficult for dispensing pharmacists to keep abreast of changes in products and what is available for patients. The benefits that those patients may obtain from those products, and the most up-to-date clinical practices will be constrained by regulation . How quickly can we expect the regulations to be reviewed to accommodate pharmaceutical developments?

There must be absolute clarity about where clinical responsibility lies. Perhaps the Minister will say something about that. Will it lie with those who gain the new prescribing rights? The Minister commented on the independence of those people, but the implications were not clear. Will the new prescribing rights be independent of the existing prescribers—general practitioners and consultants—or will they be dependent on an existing prescriber, who will take full responsibility?

What safeguards does the Minister plan to provide to ensure communication between multiple prescribers, to avoid interactions between the drugs prescribed for a patient by several eligible professionals?

Dr Peter Brand (Isle of Wight, Liberal Democrat)

The Minister is right to attempt to outline the professional groups that should have prescribing rights and to consider specific drugs in relation to those groups. I also invite him to consider the specific settings or circumstances under which prescribing takes place. I share some of the concerns expressed by the hon. Member for the nicer bit of the New Forest—the hon. Member for New Forest, West (Mr. Swayne)—as accountability and teamwork should be strengthened rather than confused by the provisions.

Let us deal with dependent prescribers—that is not a happy term—in a hospital. I imagine that a specialist diabetic nurse would prescribe according to protocols accepted by the diabetic team, which would include a consultant. If so, there should be shared accountability within that team for what happens to the patient. If prescribing occurs outside that unit, the nurse practitioner would become responsible by himself or herself.

It would be nice if the Minister gave some thought to the possible conflicts within a team. A specialist asthma nurse may be keen to follow the guidelines of the British Thoracic Society--which are excellent, although some eccentric asthma physicians do not hold by them. The nurse prescriber would have a good basis to act independently as a prescriber, but would be in a difficult position if the consultant, who was part of an asthma team in a hospital, was not prepared to back up the prescriptions that had been issued.

In primary care, teamwork has probably evolved more than in hierarchical, hospital-based structures. However, there is sometimes wooliness as to who is a member of the core primary care team and who is an adjunct, and therefore important but not integral. Where does the definition of dependent and independent prescriber begin and end?

Clearly, independent practitioners—physiotherapists, ophthalmologists and others who rightly have wider prescribing rights—would not necessarily fit into a primary care team on a day-to-day basis. It is more difficult for them to share local protocols on how to deal with particular diseases. In the relevant circumstances, the practitioner would be totally responsible for the prescribing, in the same way as a practitioner, a nurse practitioner or a pharmacist in a walk-in centre should be responsible for a prescription that he or she has issued. I am, however, slightly concerned about the lack of a clear mechanism by which the responsibility could be passed on to members of the team caring for the patient.

General practitioners are worried about the case law covering what could happen once a hospital pathology department or diagnostic imaging department had obtained abnormal results, in a process that had been initiated by a hospital consultant, and had sent a copy to a general practitioner. If the hospital failed to act on the abnormal results, and things went amiss, and if the GP had not acted on the results that were copied to him or her, there would be joint liability. I am slightly concerned, given the proliferation of agencies that are now involved with the care of patients, that that could become an increasing problem.

Out-of-hours co-operatives have established a fairly tight regime of information sharing and handing over of responsibilities. When an out-of-hours service ceases to operate at 8 o'clock in the morning and passes over the notes of the events of the night, liability for the patients transfers immediately back to the GP with whom the patient is registered. In a walk-in clinic matters are not so clear. The GP may not receive notification. There is no statutory responsibility to share information.

Information may be shared in the form of a fax that arrives at 11 o'clock on a Saturday morning, which may not be seen until 11 o'clock on a Monday, after the Monday morning rush, when people begin to look at the faxes that have arrived. In the meantime, for a day and a half the patient concerned may have been on inappropriate treatment, or may have needed further treatment, without follow-up. Would that situation impose a liability on the practitioner, who had not sought the information but on whom it had been thrust? Would responsibility be thrust upon the practitioner?

My difficulty with clause 60 is that all such matters are left to regulations. Issues of accountability are very important, and I wonder whether the Government are being unwise in not specifying in the Bill where responsibility will lie for the actions of the professional groups that they are rightly including in the provisions. The need for insurance and legal accountability can of course be discussed under amendment No. 278, which will no doubt be moved by the hon. Member for New Forest, West, but I should like the Minister's response on the general points.

Mr John Denham (Minister of State, Department of Health; Southampton, Itchen, Labour)

Hon. Members have raised wide-ranging issues, which I shall deal with as succinctly as possible.

The hon. Member for New Forest, West first asked about the nature of the advisory committee. The power is given under the Medicines Act 1968 either to create a new committee or to ask an existing committee, such as the Committee on Safety of Medicines, to make recommendations to Ministers on which medicines may be prescribed by new groups of prescribers. The Bill allows a committee to be established or an existing committee to be given that responsibility before clause 60 comes into force. We shall not decide until later this year whether to build on the experience of existing committees, such as the Committee on Safety of Medicines, or to establish a new committee. However, the existing body has a great deal of relevant expertise, and I hope that the hon. Gentleman will accept my assurance that a newly established body would be based on the experience of relevant health professionals.

The second issue raised by the hon. Gentleman was about prescribing by nurses. The Crown report, which will be implemented under the Bill, drew a distinction between independent prescribers and supplementary prescribers. Under the Medicinal Products: Prescription by Nurses etc Act 1992, nurses are already able, under certain circumstances, to act as independent prescribers, which means that they take on the full clinical responsibility for their prescriptions. The Bill also allows nurses and other professions to act as supplementary prescribers. One reason why nurses are not included as independent prescribers is that they already have that power.

Between October 2000 and the beginning of 2001, the Department consulted on proposals to extend nurse prescribing over a wider range of medicines and a wider group of nurses. We received hundreds of comments and are examining them carefully. That consultation, in part, explored the issue raised by the hon. Gentleman. We could work through the entire formulary, saying that some drugs could be prescribed and others not, but about 17,000 different items are listed. We would either have to start again whenever new drugs came into the formulary or issue a more limited list. We may identify other ways of setting out the categories of drugs appropriate for nurse prescribing. The consultation document raised that issue: from memory, it set out five options, but we have not formed a firm view about which one to pursue.

Mr Desmond Swayne (New Forest West, Conservative)

Can I edge the Minister towards a view? The royal college put its view forcibly that the whole formulary should be available to nurses, and that it should be up to them to use their professional discretion not to prescribe outside their areas of expertise. Nursing is, of course, a professional organisation and is regulated as a profession. We should expect nurses to take that responsibility.

Mr John Denham (Minister of State, Department of Health; Southampton, Itchen, Labour)

I understand that that is the view of the Royal College of Nursing; it will have been reflected in responses to our consultation. However, counter views have been expressed that must also be taken into account; some have argued that only those who have gone through a full medical training should automatically be assumed to have the ability to prescribe freely from the entire national formulary. We consulted on that issue, and Ministers will have to consider it and bring forward recommendations in due course.On the hon. Gentleman's original question, nurses have independent prescriber rights and will be able to have supplementary prescriber rights under the Bill.

The hon. Gentleman raised an important point, which we shall need to address through guidance, about communications between people who may be prescribing under different circumstances. We shall obviously have to get that right. The investment that we are making in the development of the electronic patient record should ease that considerably. It should also deal with some of the issues raised by the hon. Member for the Isle of Wight about the transmission of information from NHS Direct, out-of-hours services or walk-in centres to a GP. We will need to ensure that there is an appropriate flow of information between one prescriber and another.

That is likely to be particularly important for independent prescribers who are exercising full clinical responsibility for the decisions they take about the prescriptions that they write. It is obviously an issue for supplementary prescribers, too, but they will be prescribing under the oversight of independent prescribers. For the supplementary prescriber, it is the independent prescriber who retains overall clinical responsibility.

The hon. Member for the Isle of Wight raised a wide range of issues, some of which go to beyond the provisions of clause 60. Currently, two independent prescribers, such as a GP and a hospital doctor, may take decisions about the same patient.

Dr Peter Brand (Isle of Wight, Liberal Democrat)

The Minister is right, but accountability in that case is absolutely clearcut. Responsibility for the overall care of a patient in a hospital is taken by the consultant through clinical governance, and eventually by the chief executive of that hospital. As soon as the patient comes out of hospital, unless on leave as a patient under the mental health legislation, the responsibility becomes totally that of the general practitioner. There may occasionally be a dispute when patients have their pills changed between hospital visits and coming out, and vice versa. That system may not be desirable, but the accountability is clear, whereas in the Bill it is not.

Mr John Denham (Minister of State, Department of Health; Southampton, Itchen, Labour)

The principle must surely be the same as it is now, so by extension accountability must lie with the prescriber and the organisation to which they are responsible. The hon. Gentleman has highlighted the need to work closely with the professions when we implement the clause so as to deal with the practical issues arising from the extension of prescribing powers and to ensure safety and clear accountability. The hon. Gentleman said that we should have provided for that in the Bill. I suspect that it is better to try to achieve that outcome through the regulations, rather than attempt to anticipate or predict every possible eventuality in the Bill. I know that the hon. Gentleman supports the broad thrust of Government policy, and I am sure that he will be the first to scrutinise the more detailed proposals as they are introduced. He obviously has great knowledge and expertise in this area.

Dr Peter Brand (Isle of Wight, Liberal Democrat)

In that process, will the Minister also consider the requirements for clinical governance and re-accreditation of prescribers in exactly the same way as doctors are, quite rightly, required statutorily to undergo re-accreditation and to audit their work through clinical governance?

Mr John Denham (Minister of State, Department of Health; Southampton, Itchen, Labour)

Re-validation of doctors, re-certification of dentists and the equivalent process in other professions are the responsibility of the professional bodies. Just as for consultants' contract we have tried to ensure that NHS appraisal of consultants directly ties in with, aligns with and is supportive of the General Medical Council's re-validation process, we will want to ensure that we are supportive of reasonable measures by other professional organisations to make sure that their members are fulfilling their proper professional responsibilities. We work with the professional regulatory organisations in the area of professional regulation. Clearly, the narrower area of prescribing in the NHS, to which this provision largely applies, must come within the NHS's own clinical governance arrangements. We should bear in mind the fact that not all the prescribing rights under discussion would be exercised within the NHS as full professional responsibilities. We must co-operate with the professional organisations for all the professionals in that category, and ensure that we have the right clinical governance arrangements in the NHS, where most of those people will be working.

Mr Desmond Swayne (New Forest West, Conservative)

Could I bring the Minister back to the problem of the regulations becoming over-prescriptive, so that it would be difficult to revise them to keep abreast of pharmaceutical developments? How will the regulations work? Will they be general, enabling regulations, or will they specify, in detail, who may prescribe what? If the latter is the case, the effect may be to deny patients some of the most up-to-date developments simply because of the limitation of the regulations.

Mr John Denham (Minister of State, Department of Health; Southampton, Itchen, Labour)

All that I can say is that I do not have the answer to that today, but we will have to get it right for the extension of nurse prescribing. It is reasonable to assume that nurses will have a wider range of prescribing responsibilities than the other health professionals who will be covered by the legislation. The options that we put forward in our consultation document range from the ability to prescribe absolutely anything to the ability to prescribe from a list of five permitted items. There are various options in between those two extremes, ranging from building up an approved list to ruling out certain types of prescribing. We have not yet completed our response to that consultation.

Eventually, we may need to take different approaches to different professional groups. Some of those mentioned in the legislation may have a very limited formulary available to them, certainly in the early days. Having a list of approved items may be the way forward—I do not know. For others, we may need a more flexible approach. I acknowledge the relevance of the hon. Gentleman's point, but we should examine the matter in detail in the context of the current consultation on nurse prescribing rights. We must ensure that we get it right.

Dr Peter Brand (Isle of Wight, Liberal Democrat)

The Minister is right in saying that most of the work will be done by members of NHS-based teams. I support the plea of the hon. Member for New Forest, West that we should not restrict members of those teams by sheer formulae, because that has been so frustrating in nurse prescribing. Everyone should be able to work within their competence to the benefit of patients. There is often a shared approach, and perhaps the question of who should prescribe what should be determined locally.

I would be worried if the Minister were suggesting that membership of a professional group would determine what a person could prescribe. The Minister has a real problem. Presumably, once an item is allowed for those belonging to a professional group, from that point on it would be allowable on the basis of only two criteria: the specificity of drugs and membership of that professional group. Such an arrangement would give scope to independent practitioners, some of whom are wonderful and invaluable, and join in with the teamwork, but a number of whom have exiled themselves from teamwork in the NHS, because they have eccentric ideas. It is important to recognise the different pressures on people who are not part of a therapeutic team. Audit and control of those groups is important. This part of the Bill greatly extends not only responsibilities, but opportunities for doing harm.

As the Minister acknowledged, I support the widening of prescribing powers. The present powers are demeaning to professionals. That is nothing to do with teams having to be doctor-led or anything like that; it is about protecting the patient, which is best done through teamwork and shared responsibility. However, the Minister must recognise that we are opening the door to people working in isolation, and to people not being prepared to link into the NHS network—or into private networks that work for the benefit of patients rather than practitioners.

Mr John Denham (Minister of State, Department of Health; Southampton, Itchen, Labour)

I did not intent to give the impression that clause 60 provides that this group must have the same power under all circumstances. For example, it is necessary for prescribing nurses to be specifically trained in prescription before they can prescribe. Clearly, location and function is important, not just the membership of a profession or a wider policy. The hon. Gentleman is right about that.

Amendment agreed to.

Mr Desmond Swayne (New Forest West, Conservative)

I beg to move amendment No. 278, in page 54, line 12, at end insert—

`(1C) An order under subsection (1A) may specify requirement as to indemnity insurance which must be maintained by a person exercising any rights conferred upon him by such order.'.

The amendment would provide a useful power for the Secretary of State when making orders under subsection (1A). It would enable him, but it does not require him, to specify that indemnity insurance should be maintained by those exercising rights conferred on them by such orders. In other words, those who have acquired the new prescribing rights may, at the discretion of the Secretary of State, have to take out indemnity insurance.

It is a probing amendment, to try to put pressure on the Minister to explore what should happen when something goes wrong and where liability should lie. It would also have the useful function of providing a means of redress through indemnity insurance. However, I caution the Minister, because indemnity insurance is not a cheap option—I am sure that he already knows that. Such insurance is, by custom, relatively expensive, and Ministers may wish to protect professionals from that requirement and allow the NHS to continue to pay out rather than have the professionals paying out through insurance. That is an entirely proper consideration.

Dr Peter Brand (Isle of Wight, Liberal Democrat)

It is a useful amendment. Indeed, I hope that the Government will consider tabling a similar amendment on Report. Some members of the national health service family are already covered through national health service indemnity arrangements, but it is vital that those who are not otherwise covered—especially those working independently—should carry indemnity insurance or be a member of an association that covers them, otherwise patients will be left without effective redress should things go wrong.

3.45 pm

Mr John Denham (Minister of State, Department of Health; Southampton, Itchen, Labour)

The amendment raises a series of interesting issues. As the hon. Member for New Forest, West said, it would give Ministers the power by order to require new prescribers to carry indemnity insurance. It is possible to see both sides of the argument. In some cases, legislative powers already exist—for instance, the Health Act 1999 provides the power to regulate new professions. On the other hand, the vast majority of registered health professionals already carry indemnity cover through their membership of professional organisations or trade unions. For example, physiotherapists and chiropodists carry indemnity insurance through their membership of their professional bodies, the Chartered Society of Physiotherapists and the Society of Chiropodists and Podiatrists. The UKCC, which is the statutory regulatory body for nurses, midwives and health visitors, strongly advises all nurses in practice to have indemnity insurance through one of the professional organisations or trade unions. Of course, where new prescribers are employed by an NHS trust or primary care trust, NHS employers' liability will apply.

As Committee members will know, the Health Act 1999 gave us the ability to require indemnity insurance for general medical and dental practitioners and the facility to extend that requirement to optometrists or pharmacists, the need for which we are keeping under review. For other professions, it is currently a matter for guidance and strong recommendation by the existing regulatory bodies.

I have thought carefully, and I think the issue is whether clause 60 is the right place for the provision and whether it should be specifically in relation to prescribing, or whether at some point it should be addressed more generally under the law relating to professions. My feeling is that this is not the appropriate place to take this measure although I recognise the arguments—and the reasons for them. The hon. Gentleman expressed some awareness of the dilemmas that are involved. If we were to be persuaded, however, that there was a need to enforce professions to have liability insurance, we should apply such a measure to the professions and not necessarily just in relation to clause 60 of this Bill.

Mr Desmond Swayne (New Forest West, Conservative)

I thank the Minister for his comments and I concur largely with the analysis he has give, although I think that this is an that is worth considering further and we may do so. Meanwhile, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 60, as amended, ordered to stand part of the Bill.