After the excitement of a Division in which so many of my hopes were dashed by the votes cast, by way of introduction clause 26 changes how applicants seeking to provide pharmaceutical services gain entry to a PCTs pharmaceutical list. The Bill proposes that local PCTs should use their pharmaceutical needs assessment to determine entrance to the list. Before this legislation the Government operated a control of entry policy whereby the number of pharmaceutical services was determined centrally.
Amendments 175 and 176, grouped together, may appear to the naked eye to be a technicality, but they raise the pertinent question of whether a PCT can grant applications to provide services from privately arranged services or aspirational services that the PCT is not in a position to commission. Services does not exclude those categories of applicants and there is a danger that, if they can prove that they meet some or all of the needs included in the PNA, the PCT will be duty-bound to grant the application.
While the regulations for PNAs will set out the minimum information that must be included in the needs assessment, there will be no statutory limit on the inclusion of other matters. If a PCTs needs assessment referred to matters other than pharmaceutical services, and an applicant undertook to provide some or all of those other services, the PCT could be forced to grant the application. While there exists a clear definition of pharmaceutical services in the National Health Service Act 2006, there is no such definition for services. Clause 126(8) states:
The services provided under this section are, together with additional pharmaceutical services provided in accordance with a direction under section 127, referred to in this Act as pharmaceutical services.
As the maintenance of a list is part of the arrangements for the provision of pharmaceutical services, the PCT should be required to grant the applications only if the services that the applicant is undertaking to provide, and that are included in the needs assessment, are pharmaceutical services.
That is not to say that pharmaceutical services cannot apply to the list with a view to providing extra services, such as the smoking cessation clinics and extended hours options mentioned in the explanatory notes. We are keen for the role of pharmacies to be expanded, so that the public can benefit more extensively from the skills of our pharmacists across the country. In fact, the Pharmaceutical Services (Advanced and Enhanced Services) (England) Directions 2005 define pharmaceutical services as covering the medicines use review serviceour advanced serviceand the locally commissioned enhanced services, which would include smoking cessation services, the supplementary prescriber service and the prescriber support service.
The Pharmaceutical Services Negotiating Committee has helpfully provided some examples of how PNAs could have an unintended effect on local services. I shall briefly touch upon one of those illustrationsI dare say that the Minister has also had the benefit of what the PSNC has provided to the Committee and to the Department.
There are many excellent private services used by the public, such as the Lloyds pharmacy service, which caters for men attending football matches. It enables a hard-to-reach group to gain access to health-care and lifestyle adviceinterestingly, the topic was raised in Health questions this afternoon. However, if the PCT inadvertently said that it would aspire to provide such a service in its area when a service specification is prepared and the funding is available, then an applicant might apply and offer to provide that as a private service. Since it is mentioned in the PNA as a gap in provision, the PCT may, under sections 129(2)(c) and 129(2A) be duty-bound to grant the application. The service is granted by the PCT but out of its control, as there may not exist an NHS service specification for the service. It can neither halt the service nor control its quality.
One other example may help. A home help service may be commissioned locally but it is commissioned by social care and not by the PCT. If the PCT stated in its PNA that a high proportion of people in its area are housebound and that those people may have difficulty in accessing pharmacies, that could raise concerns about the extent to which social services commission home help. A new applicant could then apply to provide such a service, citing the PNA as evidence of the local need. The PCT could again be obliged to grant the application under section 129(2)(a) and (c) of the National Health Service Act 2006, even though it is not in a position to commission the service and despite the fact that it has no control over that part of the service.
The amendment betrays the need for clear guidance in regulations concerning the content of the PNAs. I hope that the Minister is considering these issues as he drafts the regulations. By limiting the services whose applications can be granted through PNAs to those services that seek to provide essential services, advanced services and enhanced services that are lacking in an area, we can avoid situations of the sort that I have outlined.
To demonstrate the range of services that would be provided under these terms, all of the following services come under the category of pharmaceutical services in the 2006 Act: care home services, out-of-hours services, medication review services, schools services, and screening. That list is in no way exhaustive.
I hope the Minister will acknowledge that the PNAs should be driven by the need to provide a service that is formally absent and that, as the Bill is drafted, there is too much wriggle room for PNAs to be exploited.
The amendments appear to be fairly straightforward and they look innocuous. However, by insertion of the word pharmaceutical they would limit artificially the ability of PCTs to carry out the duties that we want them to carry out.
Clause 26 replaces the current provisions in the 2006 Act that govern whether or not an applicant can provide NHS pharmaceutical services. For the last 20 years or so, that has been determined by the regulatory system known as control of entry. An application will succeed only if a PCT considers it necessary or expedient to grant it, in order to secure adequate provision of NHS drugs services locally. Over the years, that test has been subject to considerable review by the courts.
The control of entry provisions are set out in section 129 of the 2006 Act. Clause 26 of the Bill amends that section to enable PCTs to determine whether a new prospective provider will be admitted to a PCTs drug list or an existing listing would be amended, by reference to or determined against its PNA.
Opposition Members argue that these amendments would clarify the working of that particular provision. I understand that they have the support of the Pharmaceutical Services Negotiating Committee, as they have indicated. However, although the amendments appear to be sensible, the new powers will only ever be exercised in relation to an assessment of pharmaceutical needs and the services that are then offered.
I am not persuaded that we need to say how the new powers will work in practice. The primary intention of the clause is that the applications will be determined by reference to pharmaceutical services and not by reference to some other services. We have already established in our debate on clause 25 that PCTs will be required to assess needs for particular pharmaceutical services in their area. The provisions in clause 26 are directly related back to clause 25, so in our view it will not be possible for a PCT to determine an application under clause 26 unless the services provided are pharmaceutical services, as defined under the 2006 Act.
I might add that the current wording in the 2006 Act, which the new subsection replaces, makes no mention of the word pharmaceutical, nor has the absence of that word caused problems for the courts in determining the regulations that flow from these powers. Therefore, I see no advantage in inserting words that the courts will have to assess, to see whether they have a meaning that goes beyond the court cases that have already examined this issue and lay out a very clear set of criteria that need to be applied. In other words, all that the amendments would succeed in doing is muddying the water for the courts. As a result, they would muddy the water for pharmaceutical services and ensure that the NHS has to go through a series of new court cases to determine exactly what these new words mean, because, in the view of any court, they would not have been inserted unless they were meant to bring about a change.
The Minister makes a powerful point. The courts would, through statutory interpretation of rules, inevitably regard inserting a word as having a genuine intent, and therefore intended consequences. I fully appreciate that argument. To some degree it is helpful that the Minister has put on the record that the provision ties back to clause 25.
That said, the PSNC has clearly demonstrated concerns, and the Minister will have been briefed about them as well. I know that he has sought to address them. Having researched the matter, it is interesting to note, even without the addition of the word pharmaceutical, the breadth of services that are established by law in the phrase in the Bill. That is accepted. As the Minister rightly says, there is a wide amount of case law and interpretative lawthat is the nearest we get in this country to administrative law, which would be more familiar to those who practise law on the continentso effectively, there has been an interpretation already, so I buy the Ministers argument.
However, the intention of the amendment is by no means to muddy the waters. That would not be helpful in any circumstances. Equally, it would be wrong to press the amendment to a Division, given that I suspect this exchange will be re-examined by the PSNC. If it wants to make any further points, I am sure that we will be briefed in advance of Report. Rather than press the amendment to a Division, I leave open the option to raise any issues that the PSNC feels have not been dealt with satisfactorily on Report, and I beg to ask leave to withdraw the amendment.
including a duty for Primary Care Trusts to consult patients on the decision to grant the application.
I admire your ability to sound as though you enthusiastically welcome the arrival of amendment 147, Mr. Key.
That gave me a chance to find the right page.
I am pleased to say that I need not spend too long speaking to this amendment. I am simply reiterating the case I made when speaking to amendments 33, 35 and 34 in relation to clause 25, when I outlined the need for patient consultation in PNAs. I am merely seeking an assurance from the Minister that the manner in which the PCT determines whether to grant an application to the pharmaceutical list will, under regulations, take account of the views of patients. Will the Minister confirm that the regulations on local decisions concerning applications will contain provision for patient consultation?
I am sure that I do not need to reiterate in full the reasons why patient consultation is necessary. To summarise, I can put them into three brief points. First, PNAs should be for the benefit of patients and not focused on cost-effectiveness. Patient consultation will ensure that PCTs acknowledge the reason for the PNA.
Secondly, patients are often best placed to identify local needs for services and can offer valuable insights into the services that work and those that do not. Perhaps this is a good point at which to raise demographics. When there is an ageing population in an area, mobility could be a pertinent issue, even if the area is not rural. Right hon. and hon. Members on both sides of the House have such demographics in their constituencies and have raised those issues.
Thirdly, consultation will help to safeguard services that are used and preferred by patients, so PCTs will be less inclined to cut popular services.
Such a brief reply makes me think that perhaps I need to be slightly cautious before I roll over humbly yet again. We need to bear in mind what we truly mean by the word consultation. Allow me to explain as best I can: in a previous life, I had to tackle the European works councils. The right to consultation in the United Kingdom applied only to those with operations right across European Community member states, which the company that I partly ran had. Interestingly, in every language other than English, and by almost every worker representative, whatever European country they came from, consultation was regarded as a right to attend a forum for an exchange of viewsafter which they could take the wife for a jolly good jolly in some beautiful part of Europe. However, they absolutely respected managements right to make the final decisions.
Only those who represented people in this country were not satisfied with that. To them, consultation meant the need to identify their influence in a decision and the final output. They wanted to know that they had made a difference and that the initial management proposals were amended accordingly. The way in which consultation is used is quite interesting. If we are following the continental European model, the Ministers answer was perfectly satisfactory, but if we are using the definition traditional in this country, it was probably less than satisfactory. On this occasion, I shall assume that he was being a good European and, therefore, I beg to ask leave to withdraw the amendment.
I am very pleased that you, Mr. Key, have been waiting for it. I did not have quite that much enthusiasmbut now I do!
(aa) the terms by which an applicant to the pharmaceutical list is deemed to be compliant with the adoption of a computer system accredited with the Electronic Prescription Service..
I wish to probe the Government about measures taken to ensure that pharmaceutical services granted under the PNAs are compliant with the electronic prescription service. The Minister will be aware that I have become, contrary to my normal inclination, something of an anorak when it comes to IT and anything relating to electronic aspects of the NHS. Before I turn to the amendment, allow me briefly to inform Committee members unfamiliar with the EPS of the background to the initiativeit is really very significant.
GPs were producing electronic prescriptions in primary care years before the Government launched their EPS. Primary care systems even had the capacity to pick up prescribing errors and report them to staff. Currently, GPs enter the prescription into the patients electronic medical record, when an alert will notify them of any prescribing errors. The prescription is then printed on paper and taken to the pharmacy by the patient. The EPS will make this transfer to the pharmacy electronic, which will bring about administrative, but not clinicalthat point needs emphasisingbenefits to the NHS. Why, then, is it so long overdue? If the software that it intends to provide offers a relatively simple functionality, I simply do not understand why it is not being delivered to schedule.
On 23 March 2009, EPS was being used for only 24 per cent. of daily prescription messages, with only 6,440 GP practices actively using the service. Furthermore, since only Release 1 has been implemented, the prescriptions require a paper version to be issued, thus completely undermining the purpose of the system and the intended administrative benefits. That is not to mention the fact that the EPS is part of the national programme for IT, which is four years behind schedule and destined to exceed its £12 billion budget. The Minister will be aware of the context to all this. If the Government could not be relied upon to implement the EPS on time, a big question remains about their record, intent and competence in implementing the rest of the national IT programme.
It is a case not just of delayed results, but of wrongly allocated resources. It is difficult to see what direct clinical benefit to patient care the EPS will bring to primary care, as it performs only an administrative function. My amendment would help to abate some of the delays facing the EPS, should the Government push ahead with the completion of the programme. I want to raise through it the pertinent issue of EPS compatibility as a factor for the pharmaceutical needs assessment to consider. In order to deliver the functionality proposed under the EPS, GP and pharmacy systems have to undergo accreditation to ensure that they are compatible. If the PNA considered the compatibility of pharmaceutical systems before applications to provide services were granted, it could save time and money spent on upgrading incompatible systems to comply with the EPS.
I hope the Minister will concede that, if PNAs do not take into account EPS compatibility, more money could be wasted on making pharmacy systems compliant. Presently, there is nothing in the Bill to prevent a PCT from granting applications from services that do not have the capacity to link up to the EPS. One might regard that as obviousand the failure to do so as patently crass.
If PCTs are given the appropriate tools to assess whether a pharmaceutical service could comply with the EPS, the regulations for the PNAs could include EPS compatibility as a condition for granting an application. I know the Minister has become slightly fond of this response during our exchanges, but I hope he realises that the intention is to get a net gain from bureaucracy, and above all to ensure a sense that the centretop-down, if he wants to throw that point at me againcan help facilitate best practice. However, responsibility and implementation is situated locally, and in the procuring and commissioning process.
This approach would no doubt speed up the roll-out of the EPS programme at the pharmacy endI would be first to cheer thatas it would incentivise applicants to adopt a compliant computer system before applying to provide a service. Is the Minister willing to consider that option? I hope so, and that on this occasion he will accept the amendment.
I am grateful to the hon. Gentleman for raising this issue in such detail. The EPS system would mean that PCTs need to be satisfied that an application is EPS-compliant when considering whether it would be granted on the basis that it secures improvements or provides better access to pharmaceutical servicesat least, that is the intention of the amendment.
I do not accept that the amendment would be helpful or particularly improve the available services. Let me take a few moments to explain the background information to the EPS. I am grateful to the hon. Gentleman for the points he has made, but to use the EPS, pharmacy contractors must have IT systems that have gone through Connecting for Healths rigorous assurance process. Connecting for Health leads on the delivery of the national programme for IT, and its assurance process is made up of a number of key stages, including clinical safety testing and initial implementation in limited numbers of GP and pharmacy sites. Patient safety is obviously paramount. We do not want suppliers to cut corners in order to reach the start of the assurance process faster, only to lose time in the longer term as they fail to meet Connecting for Healths exacting standards.
Authority to deploy Release 1 and Release 2 of the EPS is given separately. While much progress has been made on deploying across the country Release 1 of the EPS, which releases technical infrastructure, I know that Release 2 will be of greater interest as it brings a number of functional changes and associated benefits for patients, prescribers and dispensers. Those include the option for patients to select or nominate a dispenser for their electronic prescription to be sent to their chemist and electronic repeat dispensing produced. [Interruption.] Just a momentlet me run through some of the benefits.
What are the benefits of Release 2 for patients? The first benefit is a more convenient service, with a reduction in trips to the GP practice just to collect a paper prescriptiona point particularly relevant to patients on repeat medication. Some 70 per cent. of prescriptions nationally are issued for repeat medication. The second benefit is greater freedom of choice, making it simpler for patients to use a pharmacist convenient to them. The third benefit is potentially reducing pharmacy waiting times, as, with a phone call, prescriptions can be prepared in advance of a patient arriving. In effect, the information is already there, and they do not have to wait for the piece of paper.
However, what are the benefits for GPs and pharmacies? First, there will be a reduction in the work load in GPs practices generated by patients collecting individual prescriptions from surgeries, particularly repeat prescriptions. Secondly, the ability to sign prescriptions electronically is much more efficient for GPs. Thirdly, GPs will be able to cancel prescriptions electronically at any point until they are dispensed, leading to greater confidence in GPs to use repeat dispensing. Fourthly, there will be a reduction in the need for pharmacy staff to re-key prescription information into pharmacy systems, which is quite a problem in bureaucracy termsI had to get that point in. In time, this will remove the need for pharmacy staff to collect prescriptions where they offer a prescription collection service. Those developments provide significant benefits.
I appreciate the list of benefits, but what is interesting in the Ministers answer so far is that he accepts that we have only managed to get to Release 1 implementation at this stage, and he was relying on where we will get to with Release 2. That said, if Release 2 delivers to that degree and soon, that is a partial answer. Given the track record to date of the progress of the programmes delivery and implementation, particularly Release 2, the Minister might at least want to think aboutthis could be a compromisepostponing implementation of this element until after Release 2 has taken place and proven itself.
Much progress has been made on delivering Release 1 against the background of competing priorities for IT systems suppliers. EPS Release 1 deployment is virtually complete. All GP and pharmacy suppliers have completed the compliance process. The cumulative prescription volume is 207,195,907 as of 11 Junea relatively up-to-date figure. Some 95 per cent. of GP services are technically enabled to deploy the EPS, and 80 per cent. of GP practices are business-enabled. Some 92 per cent. of community pharmacies are technically enabled to deploy the EPS, and 82 per cent. are business-enabled.
On Release 2, all central components have been delivered. There are eight pharmacy systems suppliers delivering nine pharmacy systems for community pharmacies in England. Currently, seven pharmacy systems suppliers are developing EPS Release 2 systems. Initial implementation commissioning is under way at a GP and independent pharmacy, using synthetic patients to conduct technical and clinical assurance activities. We expect nearly all suppliers to have full roll-out approval by the end of 2009, according to the information given to us by systems suppliers.
Quite a lot of progress has therefore been made on Release 2, and we need to continue to monitor it with great care. We know that deploying any computer system has its problems. Over the years, Governments of all persuasions have found that computer systems can cause difficulties. That is also the case in the private sector where large-scale computer projects have been introduced. However, with careful monitoring they can also bring enormous dividends and benefits to users.
We do not feel that the amendment would contribute significantly to delivery leverage for EPS. EPS is an essential component of a modern pharmacy service, and we intend that it should be provided by all NHS community pharmacies. EPS is on everyones agendait is not just an issue for applicants to pharmaceutical lists. We do not agree with the amendment because a successful applicant to a pharmaceutical list currently has up to 15 months to open. In that time, the parameters for EPS compliance may change, so a PCTs compliance assessment at the time of application may be out of date or irrelevant by the time the pharmacy opens.
If we find in future that IT systems are compliant with Release 2 of the EPS but pharmacies are still not delivering the service, we have scope in clause 26 to make provision as to what matters the PCT must or must not take into account for the purpose of determining whether to grant the application. I therefore ask the hon. Gentleman to consider withdrawing his amendment.
I am grateful to the Minister for seeking to address my point. I hope he realises that I raised it in a genuine attempt to be constructive. In resisting the amendment, he prayed in aid the 15-month time period between when the choice is effectively made and implementation. He also prayed in aid the fact that due to the nature of technology, the programming, the system and the compatibility could change during that period.
This is one area where we must be extraordinarily cautious. To the extent that I have found myself dragged, somewhat reluctantly, towards the NHS IT programme, I understand that one will never catch up with the leading edge of technology. One must set a point at which one is trying to achieve a certain standard and say, Thats the standard to be met, and not always worry about things such as the 15-month period. The Minister is absolutely right: the technology may well move forward. The issue is compatibility with a standard that will work to deliver the service.
I will not press the amendment, because I think that the issue requires continuous careful and vigilant monitoring, as the Minister accepted. We need to watch it carefully, as there are fantastic benefits to be gainedhe sought to highlight somebut it could easily trip on the basis that implementation is flawed or time-lagged and there is a lack of capacity for, let alone understanding of, the standards to be applied to achieve compatibility. Although the amendment is the sort that one might want to press to a vote in a somewhat virile way, to demonstrate that one means it, on this occasion I will withdraw it. However, we need to highlight the issue and ensure that the Minister, the Department and the Ministers advisers keep it as a high priority in order to make it work. I beg to ask leave to withdraw the amendment.
including the impact that granting an application would have on existing services..
I am delighted that somebody, in a sedentary position, regards it as a signal victory to have reached amendment 37.
I intend to consolidate some of the issues that have been raised so far. We have discussed the need to consult patients and highlighted the potential impact of the pharmaceutical needs assessment on the services that dispensing doctors offer patients. We have also discussed the different needs of rural and urban populationshowever one wants to describe themand I have sought to ensure that the Minister takes all those matters into account in setting regulations for the PCTs.
In many respects, amendment 37 would solve the problems raised by the Dispensing Doctors Association with regard to offering patients a choice of services. If PCTs were duty-bound to assess what impact granting an application to the pharmacy list would have on existing services, they would have to ensure that the new service would complement and enhance existing services, thereby safeguarding patient choice and potential patient preference for existing services, such as those of dispensing doctors, be they in the Ministers PCT or my own. Hopefully, the PCT would then avoid cutting services unnecessarily or granting applications to provide services that do not add to patient choice or increase patient access to pharmacies or dispensers. PCTs would, of course, still have the right to cut services in circumstances where they breached a term of arrangements under new section 150A of the National Health Service Act 2006.
The amendment is simple. I hope that the Ministers thoughts will turn towards accepting this worthwhile amendment to the Bill.
The amendment aims to oblige PCTs to consider the impact that granting an application would have on existing services. I can see the importance of doing so, but it is also a key concern that the new arrangements for determining entry to a pharmaceutical list should not be used simply as a basis for PCTs to refuse all or any new applications without some clear, robust and objective ground. Just as we saw when the matter was raised in the other place, I am concerned that the consequence of the amendment would be unwittingly to restrict new entries, so it would constrain competition and could undermine new businesses ability to enter the field. The hon. Gentleman looks quizzical, but if he looks at this he will see that it could well be the consequence.
Each and every application will have some impact and effect on contractors; that is unavoidable, but how much is a question of degree based on local factors and circumstances. It is impossible for us, from the centre, to understand the exact impact in every case. We must strive to achieve the right balance between adequate PCT controls and the freedom of contractors to operate without creating disproportionate burdens or costs. When we consulted on this proposal last autumn, we recognised the need to strike that balance. We proposed to use existing factors introduced in the 2005 regulations to the current control of entry tests. These factors are the level of access, the choice and diversity of providers, innovation in service delivery, the services available to specific populations to meet specific health conditions or disease needs and the overall longer-term impact of approving new applications.
We intend to include the criterion of longer-term impact that this amendment proposes in the new regulatory regime. We have not determined that this criterion should have pre-eminence above all other criteria. It is one of a range of factors that PCTs need to consider when determining whether, against its assessment of local needs, an application should be approved or not. PCTs will have to weigh up the facts, look at the evidence carefully and determine the plus and minus points accordingly before reaching their decision.
I also make the observation on the amendment that I think it is equally important that PCTs should consider the longer-term impact when they are minded to refuse an application, not just when they are minded to grant one. Refusing an application may have implications for other businesses and competition in the area. My concern is that the result of this amendment would be to restrict competition, to inhibit business, to prevent new entry of businesses into this area and, in effect, to restrain the market in a way that I did not think the Conservative party believed in. It seems that, in response to lobbying, it is disposed to do that unless the hon. Gentleman decides, as I hope he will, that he will not press this amendment to a vote.
I shall move on swiftly. The Minister has over-egged his case. If one looks carefully at the wording of this amendment, it says that, where primary care trusts have determined to make any kind of recommendation, the regulations may make provision for the manner in which they determine that grant and matters that the primary care trust must and must not take into account for the purposes of determining whether to grant the application, including the effect that granting such an application would have on existing services. Far from restraining competition or inhibiting new business, the fact that they would have to acknowledge that they have taken into account the effect that granting such an application would have on existing businesses might result in their granting an application because it increased competition. They might be concerned that a particular area had no competition, and consider that granting the application would ensure that an efficient service was delivered, prices were kept keen and customers would receive first-class customer services.
The Minister has overplayed his hand, as he has exaggerated what the amendment actually states. It makes explicit what is set out and is referred to in the justification by a primary care trust. A trust must ensure that it has taken into account the effect that granting an application would have on existing services. To be frank, in light of cases that have arisen in my constituency and I dare say in others, the problems have arisen precisely when it appears that there has been no explicit justification to make a recommendation without reference to the effect that it might have on existing servicesnot that it would inhibit new business or restrain competition.
I do not disagree with the point that the hon. Gentleman has just made. When PCTs make these decisions, it is important that they weigh appropriately the impact that a decision will have on local services, and that means the impact on other pharmacies in the area. He may well be right that, in some cases, PCTs have failed to give the appropriate weight to that criterion when they make a decision.
I am grateful to the Minister, because our dialogue has brought us back to where we need to be. We want to ensure that that consideration is made explicit and that we do not end up having unnecessary concerns, disputes or even campaigns locally because there has not been a sufficiently explicit explanation of what lies behind the thinking of a PCT and its recommendations.
On that basis, I do not need to press the issue to a vote. However, it was very important to have clarity in terms of what the amendment was intended to say and, given the way that the Minister provided the counter-argument, I also wanted to make sure that the record was absolutely straight.
The points that the hon. Gentleman has made during his closing speech have made me think a little further about these issues. In due course, as I consider some of the points that he has raised, I may write to him on this matter.