Clause
26New
arrangements for entry to pharmaceutical
list 5.15
pm
Mr.
Stephen O'Brien: I beg to move amendment 175, in
clause 26, page 28, line 37, at
beginning insert
‘pharmaceutical’.
The
Chairman: With this it will be convenient to discuss
amendment 176, in
clause 26, page 28, line 37, after
first ‘the’, insert
‘pharmaceutical’.
Mr.
O'Brien: 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 PCT’s 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 PCT’s 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
service—our advanced service—and 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
illustrations—I 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 advice—interestingly, 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.
Mr.
Mike O'Brien: 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 PCT’s 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.
Mr.
Stephen O'Brien: 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 law—that is the nearest we
get in this country to administrative law, which would be more familiar
to those who practise law on the continent—so effectively, there
has been an interpretation already, so I buy the Minister’s
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. Amendment,
by leave, withdrawn.
Mr.
Stephen O'Brien: I beg to move amendment 147, in
clause 26, page 29, line 5, after
‘application’, insert
‘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.
The
Chairman: I do indeed, Mr.
O’Brien.
Mr.
O'Brien: 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.
Mr.
Mike O'Brien: Under the 2005 NHS pharmacy regulations,
patient and other local community interest groups are already notified
of applications and have the right to make representations to the PCT.
I have no plans to change those rules. They ought to have been
consulted
already. 5.30
pm
Mr.
Stephen O'Brien: 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 views—after which they
could take the wife for a jolly good jolly in some beautiful part of
Europe. However, they absolutely respected management’s 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
Minister’s 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. Amendment,
by leave,
withdrawn.
The
Chairman: Now we come to the one that we have been waiting
for—amendment
36.
Mr.
Stephen O'Brien: I am very pleased that you,
Mr. Key, have been waiting for it. I did not have quite that
much enthusiasm—but now I do!
I beg to move
amendment 36, in clause 26, page 29, line 5, at end
insert— ‘(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 initiative—it 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 patient’s
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
clinical—that point needs emphasising—benefits 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
obvious—and 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
centre—top-down, if he wants to throw that point at me
again—can 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 end—I would be first to cheer that—as 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.
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