Clause 25

Health Bill [Lords] – in a Public Bill Committee at 4:30 pm on 24 June 2009.

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Pharmaceutical needs assessments

Photo of Stephen O'Brien Stephen O'Brien Shadow Minister (Health)

I beg to move amendment 34, in clause 25, page 28, line 6, after ‘area’, insert

‘including an assessment of local needs for the services of dispensing doctors.’.

Photo of Robert Key Robert Key Conservative, Salisbury

With this it will be convenient to take the following: amendment 35, in clause 25, page 28, line 9, at end insert—

‘(za) placing a duty on primary care trusts to consult patients, Local Involvement Networks and members of the public on local needs for pharmaceutical services.’.

Amendment 33, in clause 25, page 28, line 16, at end insert—

‘(e) requiring the Secretary of State to implement pilot schemes for primary care trusts in carrying out pharmaceutical needs assessments before they are rolled out nationally; and for those pilot schemes to be evaluated 12 months after they commence.’.

Photo of Stephen O'Brien Stephen O'Brien Shadow Minister (Health)

Amendment 34 would place a duty on PCTs to take into account the services of dispensing doctors in their assessment of local pharmaceutical needs. We have now moved on to the clause dealing with pharmaceutical services in England and the needs assessments as they are proposed in the Bill. Amendment 35 would ensure that patients are consulted as part of each pharmaceutical needs assessment. Amendment 33 proposes pilot schemes for PNAs.

Amendment 35 would ensure that each PNA includes patient consultation. The principal purpose of the PNA should be to enhance local pharmaceutical services for patients and ensure that the area covered by the PCT is adequately provided for. We agree with the concept of giving PCTs local control over the provision of pharmaceutical services, but we want to make sure that patient choice is enhanced rather than overruled. At present, the Bill does not make any provision for patients to express their views in the assessment—an odd omission, given that patients are the users of the services provided under a PNA. Will the Minister confirm that the regulations will make provision for patient consultation? My amendment would ensure that PCTs include the results of such a consultation in their published PNAs, so that patients can be assured that their views were taken into account. If a PCT goes against the wishes of patients, the general public will be able to see that that is the case by examining the consultation.

Accounting for the views of patients in PNAs is particularly relevant in rural areas, where pharmaceutical services are less abundant. Many patients have to travel long distances to access services, and consequently people make extensive use of dispensing doctors, so that they can combine their visit to the doctor and the collection of their medicines. There is nothing in the Bill to prevent PCTs from cutting those services. As my noble Friend Lord Howe argued in the other place, many of the pharmacy community are concerned that the current PNAs are

“disproportionately focused on cost-effectiveness and not enough on health need”.

That means that these services face a real risk of being axed.

I have already fought a real battle on the subject in my constituency—with some success, I am glad to say. It revolved to some extent around the definition of what is rural and what is associated with an urban or suburban environment. Having said that, if any sort of assessment  militates against the extension of dispensing doctors, it would be a very real threat to the rural community. Amendment 34 would ensure that the services of dispensing doctors are taken into consideration in PNAs, along with the views of patients, the majority of whom want to keep the services of dispensing practices.

On the management of dispensing practices, I am sure that the Minister will come back to me with the same assurance that his colleague the Minister of State, Department of Health, the hon. Member for Corby (Phil Hope), gave in December 2008: that the Government do not intend to make any changes to the current arrangements for the dispensing of medicines to patients by GPs. However, I am slightly less inclined to trust the good will of the Government, given that they made that pledge last year before the publication of the Bill but they have clearly left a gaping hole in the legislation on that matter.

It is of more concern that the Government appear to be ignoring the wishes of NHS patients. Some 62,675 patients registered with a dispensing practice responded directly to the pharmacy White Paper consultation to express their support for no change to GP dispensing. However, the Bill makes no provision for PCTs to consider the services offered by dispensing doctors in their needs assessment. What firm and evidence-based assurance can the Minister give that patients who are registered with dispensing practices will not see those services axed by their PCTs?

It is fair to say that many of the satellite surgeries of doctors’ practices are, particularly in rural areas, cross-funded because they have a dispensing practice. Far from doctors seeking to increase the drawings from their own practice, it is cross-subsidy that enables them to have a satellite service to reach out into the more remote rural areas. The dispensing practice enables that.

Amendment 33 proposes pilot schemes, which would enable the PCT and the Government to investigate whether the local assessment of pharmaceutical needs results in adequate provision of services. It would also give PCTs a chance to experiment with the format and content of the PNA to ensure that any complications are addressed and that the assessment is wide ranging enough to be taken into account when a provider applies to the pharmaceutical list.

The Government’s own White Paper on pharmacy concedes that

“there is considerable variation in the scope, depth and breadth of PNAs”.

It also states:

“The structure of and data requirements for PCT PNAs require further review and strengthening to ensure they are an effective and robust commissioning tool which supports PCT decisions.”

Although I realise that the Government see the Bill as the occasion for review and strengthening, a pilot programme would be the opportune moment to examine and trial the content of PNAs in a practical setting. PCTs would also be able to adapt to producing more rigorous PNAs. Examples of best practice could be disseminated before the scheme is rolled out across the country.

Anne Galbraith’s 2008 review of NHS pharmaceutical contractual arrangements, which was published alongside the White Paper, made the point that

“Pharmaceutical Needs Assessments...should have a consistent structure across all PCTs and have national comparability in breadth and depth.”

One potentially negative consequence of localisation is that there will no longer be a framework for ensuring that PCTs maintain that comparability across the country. Of course, the regulations will seek to qualify the information contained in the PNA and the manner in which it is conducted. However, we have not had sight of those regulations, so we do not know the extent to which they guide PCTs on the form and content of a PNA. If the Government were to run a pilot scheme and report back to Parliament with the results in 12 months’ time, they would have a solid evidence base from which to move forward. In addition, PCTs would have increased knowledge of how best to utilise the PNA to gain the best possible access to pharmaceutical services for their patients.

Photo of John Pugh John Pugh Shadow Minister (Health), Shadow Minister (Treasury) 4:45, 24 June 2009

I have to apologise for the fact that my hon. Friend the Member for Romsey is not here, because she is the expert on this subject and would have a great deal more to say than I have. I have no problem with the general tenor of what the Government are endeavouring to do. Public authorities have always had to strike a balance so that naked commercial interests do not dominate the pharmaceutical world. The needs of the community are paramount, and there has always been a need to structure the market publicly in some way. Anybody who has been an elected councillor or any sort of elected representative will have been lobbied at some point by a pharmacy or a dispensing physician about their position, their share of the market and the placing of other facilities close to them.

I agree with the hon. Member for Eddisbury that whatever is done needs to be properly and thoroughly evidence-based, and if it is not evidence-based everywhere, it will not be well done. It cannot be lobby-based, because there are plenty of powerful interests in the pharmaceutical world and many prosperous commercial practices that will weigh in heavily to get their way if left to their own devices. I therefore warm to the amendments because they would preserve the rights of dispensing practices, particularly in rural areas, and they make clear that the market must serve patients rather than simply appear by accident and as a result of commercial happenstance.

Photo of Mike O'Brien Mike O'Brien Minister of State (Health Services), Department of Health

I, too, represent a rural area where dispensing doctor’s practices exist and operate, and I very much understand the concerns of some GP practices that, in order to maintain satellite practices, they sometimes have to have funding from a dispensary. Indeed, a dispensary provides a facility for local people in such communities. At the same time, there is always a concern where doctors both prescribe and dispense, and it is right to exercise caution when dealing with that. Dispensing clearly offers an income, so we need to be careful that we deal with the issue appropriately. I believe that, in most cases, doctors act with a professional integrity on which we can broadly rely. However, we need to be continually aware that individuals may not always act with such integrity; the appropriate disciplinary procedures for doctors will deal with that.

On Second Reading, the hon. Member for Eddisbury said:

“The move to pharmaceutical needs assessments is welcome.”—[Official Report, 8 June 2009; Vol. 493, c. 612.]

I am glad that he said that. I make it clear that, as we announced before Christmas, we will not change the current system for determining whether doctors can dispense to their patients. On primary care trusts in rural areas where most dispensing by doctors takes place, it is important that such services are considered within their overall assessments of needs.

It has been asked whether services by dispensing doctors could be at risk from bad PCT decisions on new applications. The current regulations already contain provisions to take into account any prejudice to existing service providers in rural areas from new applicants, and I stress that that safeguard will continue in the new regulatory system.

The clause requires PCTs to undertake and publish their assessments of pharmaceutical needs in accordance with regulations. The Department will work closely with interested parties, including NHS and contractor representatives, as well as doctors, on drafting the requirements. I announced last Thursday the formation of an advisory group for that very purpose. However, not all PCTs need to resort to the services of dispensing doctors. It is important that such services are available for the patients who use them in rural areas, but they have little relevance, if any, in non-rural PCTs across the country. We need to get the issue right, and I hope that my reassurances have been satisfactory and that the amendment will be withdrawn.

Photo of John Pugh John Pugh Shadow Minister (Health), Shadow Minister (Treasury)

The Minister may be able to assist me. He has pointed out the obvious conflict of interest that can exist when one is both dispensing and prescribing medicines. That needs to be addressed. He has suggested that the only way in which it would be addressed is via the ethics committees of local GPs and so on. The issue will, of course, be assessed, determined and established by the PCT, but is there not provision in the legislation, particularly in relation to where a prescribing practice differs radically from what one might expect, to do things other than relying entirely on doctors’ panels judging themselves?

Photo of Mike O'Brien Mike O'Brien Minister of State (Health Services), Department of Health

The hon. Gentleman asks whether there are other provisions in this legislation. I am not aware of any. I shall consider the matter and in due course confirm in writing whether that is the case. It is a reasonable question, and I shall write to him.

Photo of Stephen O'Brien Stephen O'Brien Shadow Minister (Health)

The Minister seizes the point, not least because his constituency has the same characteristics of rurality, at least in part, as no doubt many of ours do. That factor has a big effect on the availability of services and access to them in relation to how the cash flows work for both doctors and dispensing operations.

I was pleased at the way in which the Minister put the Government’s case; he did not go down the same track that was used in defence in the other place by Baroness Thornton, who took issue with the proposal of pilots on the basis that it would delay the national roll-out of PNAs for at least two years. I thought that argument spurious, and I welcome the fact that the Minister did not deploy it. Given his assurance, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Photo of Stephen O'Brien Stephen O'Brien Shadow Minister (Health)

I beg to move amendment 145, in clause 25, page 28, line 24, after ‘assessment’, insert—

‘(e) for appeals to the Secretary of State or a body in relation to the content of the statement made by PCTs.’.

The amendment would enable pharmaceutical services to challenge the content of the PNA. It would ensure that when a PCT was failing to reach standards in its PNA, a potential provider or other body could challenge the statement. That sort of scrutiny will help to ensure that the PNA meets a standard that allows sound decisions to be made on new applications to provide pharmaceutical services.

At the moment, the Bill does not guarantee that PNAs will contain reliable and accurate data. I cite Earl Howe, who said in Grand Committee in the other place:

“We do not know how effectively PCTs will use PNAs, especially given their record to date of disinvesting in enhanced services such as out-of-hours opening and local delivery”.—[Official Report, House of Lords, 11 March 2009; Vol. 708, c. GC477.]

I have been in touch with the pharmaceutical services negotiating committee and I pay tribute to it for its thoughts on the benefits of being able to appeal to PCTs should they carry out the PNA negligently.

It would not be appropriate for a negligent PNA to form the basis of granting applications, and I am concerned that, regardless of the PNA standard, it will still be used as the unequivocal method of determining applications. The National Pharmacy Association said:

“It should be understood that if a PNA identifies an unmet need, then there is an obligation on PCTs, under normal circumstances, to secure provision sufficient to meet that need.”

We must therefore ensure that PNAs provide a rigorous assessment of needs, and that they are kept up to scratch so as to avoid applications being granted on the basis of negligent assessments.

The adequacy of a PNA might cause concern to all those affected in cases when the PCT has been classed as poor by the world class commissioning assessment. Will the Minister clarify whether a pharmaceutical needs assessment would still be used as a basis for granting applications if the PCT that conducted it fell into the category of poor under the WCC assessment?

As the Bill stands, there is no mechanism by which applicants can question a PCT’s assessment, even if it is perceived to be negligent. Although the regulations prescribe some of the content of the PNA, what is to stop a PCT from disregarding local needs in order to prevent a particular service from succeeding in its application? I hope that the Minister will respond to that query.

Photo of Mike O'Brien Mike O'Brien Minister of State (Health Services), Department of Health

Allowing appeal rights would be fundamentally flawed for a number of reasons. I recognise the concerns of the Pharmaceutical Services Negotiating Committee, which has raised questions, but I shall also tell the Committee of some of my concerns.

An appeals system would lead to endless appeals from dissatisfied and potentially conflicting local interests. There will always be some who take a different view, and many of them will find that their commercial or other interests are affected by an assessment. They will have many different views on how that assessment might affect them. It is therefore likely that a multiplicity of concerns would be expressed by a significant number of individuals and businesses. We do not intend to create  some kind of lawyers’ charter where we can have a massive set of new bureaucracies to try and deal with it. We need to avoid that. There is always a balance to be struck between creating new bureaucracy and ensuring that people have the right to make representations. They can make their representations when the assessment is carried out. The assessment will take account of them—or not—and the outcome will be there. Constant appeals over an assessment, which could go on for years, could get expensive.

Secondly, PCTs would potentially incur huge costs defending their decisions under appeal. That is never justifiable in terms of NHS funding at the best of times, and certainly not in the current economic climate.

Thirdly, as a consequence, appeal rights could undermine the principle of pharmaceutical needs assessment as set out in the Bill. This is supposed to be a clear, robust view from the PCT. It is not supposed to be the view of others. Lots of people will have different views and commercial interests of their own, with particular views in terms of their locality or many other things. This is supposed to be an assessment carried out by those required to deploy the NHS funding as to what their priorities are.

There is a fourth objection. I am not aware of any corresponding appeal rights in respect of other strategic commissioning documents such as the joint strategic needs assessment which PCTs carry out. Where there are concerns about a final pharmaceutical needs assessment or where there are grounds to believe that the PCT has not complied with the forthcoming regulations about PNAs, we expect much more straightforward processes.

The proposed legislation already requires us—under subsection (2)(d) to proposed new section 128A—to set out in regulations the circumstances in which a PCT must carry out a new pharmaceutical needs assessment. How every assessment is determined will be a matter for those regulations. For example, it would be triggered in prescribed circumstances such as where a PCT has not complied with the forthcoming regulations which set out how a PCT is to construct its assessment. It might also be applied in circumstances where an assessment has resulted in the PCT making faulty decisions about individual applications which are then upheld on appeal.

I understand the concerns expressed on this issue and on the capacity and capability of PCTs in this area. I refer to earlier amendments under this clause and the comprehensive support programme we are putting in place for PCTs. We need to continue that work. However, I am not persuaded that in this case, the appropriate way to proceed is to create an entirely new and somewhat bureaucratic appeal process. I therefore ask the hon. Gentleman to consider whether it is appropriate to withdraw these amendments.

Photo of Stephen O'Brien Stephen O'Brien Shadow Minister (Health) 5:00, 24 June 2009

I am grateful to the Minister for his response, as much to me as it is to the Pharmaceutical Services Negotiating Committee and others, who I am sure he has had representations from. In effect, that was the response to the position that has been put forward.

In light of what the Minister said I am not minded to press the point—not least because I am equally anxious to ensure that we do not introduce any further levels of  bureaucracy; he knows I am genuinely concerned about that. However, at the same time there is the issue about ensuring that there is not just a simple draconian process which means that some people’s interests could be cut off rather than pursued. If there were some perverse experiences over a couple of years, representations would flow into Government to suggest that there might be a need for some form of appeal. However, on that basis, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Photo of Stephen O'Brien Stephen O'Brien Shadow Minister (Health)

I beg to move amendment 135, in clause 25, page 28, line 24, at end insert—

‘(e) as to differing assessment criteria for urban and rural needs.’.

This is very much linked to the subject matter of our debate on the first group of amendments under this clause. It should be recognised that patients in rural areas may have needs that differ from those of patients living in towns and cities. The amendment seeks to serve that purpose. The area of a PCT may well span both urban and rural geographies. There is no guarantee that it will take into account both areas. We need to ensure that a PCT’s PNA acknowledges the potential requirement for different services among different populations.

As I discussed under the earlier group of amendments, patients in the country make extensive use of dispensing doctors, as do the elderly, who appreciate the convenience of being able to combine the collection of medicines and their visit to the doctor without the burden of an extra trip to the pharmacy. The Minister identified precisely that service on behalf of some of his constituents.

I must express an interest in the issue, as 24 per cent. of England’s dispensing practices are in Western Cheshire PCT—the main PCT of my constituency—and a further 13 per cent. are in Central and Eastern Cheshire PCT, the other one that serves my constituents. Cheshire GP Dr. Nigel O’Callaghan—himself a dispensing doctor—recently outlined the crux of the matter on the Chemist and Druggist website by saying:

“Why not let patients vote with their feet and choose between GPs and Chemists?”

The Dispensing Doctors Association similarly observed in its meeting with me that patient choice was at risk of being restricted if appropriate safeguards were not put in place to maintain a variety of services.

Having not seen the regulations for PNAs, I can only judge the assessments on their track record to date, which, as I have already discussed, is poor in places and far from consistent. It is a worry that once again, the Government may be jeopardising patient choice in rural areas by not ensuring in primary legislation that PNAs cover a breadth of services, of views, including those of patients, and of patient choice. We support PNAs, but they must not limit choice as that defies their objective. I therefore hope that the Minister is able to guarantee that the PNAs will provide for rural and urban populations in their PCTs.

Photo of Mike O'Brien Mike O'Brien Minister of State (Health Services), Department of Health

There are many different criteria by which assessments will need to be made. The first is, of course, the rural-urban one, but “urban” is not a single category—it deploys many different kinds of urban areas. There are inner cities and suburban areas. There are different ways in which categorisation can take place. Remember that the criteria of choice and  access are different. The hon. Gentleman seems to propose that we should, in some way, create a two-tier assessment system, which discriminates in the criteria to be adopted between rural and non-rural areas. I do not think that that is the right approach to take.

Further, regulating to differentiate between the criteria to be adopted risks imposing on PCTs criteria that may not match their assessment of the needs locally—or worse, risks omitting criteria that are crucial to PCTs locally, of which we know nothing at the centre. In our view, PCTs are better able to differentiate for themselves the mix of cities, smaller towns, villages and remote rural areas, and are better able to locally reflect the way in which they feel it is appropriate to do the assessment, rather than seeking to impose—as the Opposition now seek to do—central top-down criteria, by which they tell PCTs what to do. Let the PCTs get on with it and do it themselves. Do not apply this bureaucratic centralisation on them. I say to the hon. Gentleman that I think it is time he withdrew the bureaucratic and unnecessary amendment.

Photo of Stephen O'Brien Stephen O'Brien Shadow Minister (Health)

I think we have reached a point in this Committee where just because the Minister says it, it does not mean that it is. On this particular issue, I do not think that it invokes a high degree of bureaucracy in quite the way he seeks to tease. The main point is to emphasise the need to make an assessment that takes fully into account the difference between rural and urban. I accept that to some degree there is difficulty with the rather all-embracing word “urban”, which can include not only suburban, but even associated villages with an urban centre. I think of the villages that immediately surround Chester; they are only as far from the main part of the outer edges of Chester-urban as they are from the next village, which under the current criteria, is counted in the rural area.

Indeed, such matters lay at the heart of a dispute that was eventually happily resolved, but not until a long and tense campaign had been fought to get the local PCT to recognise the value of a dispensing doctor in the rural area. That doctor was funding a satellite operation in a village close to the edge of where a village would be regarded as being connected with an urban, not rural, environment. As a sign of our earnest approach to the matter and to make sure that we put it on the record how important we consider such matters to be, I wish to press the amendment to a Division.

The issue is something to which we shall necessarily have to return for reassurances, but I drafted the amendment to gain a guarantee from the Minister that pharmaceutical needs assessments will apply to rural and urban populations. Even given his qualification about the imperfection of the word “urban”, it is a useful point by which to demonstrate the determination on the part of the Committee not to let that little aspect of the Bill rest and to show that it has large consequences for many of our constituents, not least those who live in combined rural, urban and semi-urban areas.

Question put, That the amendment be made.

The Committee divided: Ayes 5, Noes 8.

Division number 6 Nimrod Review — Statement — Clause 25

Aye: 5 MPs

No: 8 MPs

Aye: A-Z by last name

No: A-Z by last name

Question accordingly negatived.

Clause 25 ordered to stand part of the Bill.