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The control-of-entry reforms
Originally introduced in 1987, “control of entry” is
the system the NHS uses to determine whether a contractor can provide
NHS pharmaceutical services. The original system required that,
to be granted a contract to provide NHS services, a new pharmacy
must be “necessary and desirable”.
Following a 2003 Office of Fair Trading report on retail pharmacy
services, the Government proposed a set of reforms to the control-of-entry
system and, in line with these, the system was substantially reformed
when the NHS (Pharmaceutical Services) Regulations 2005 came into
force on 1 April 2005. The reforms allowed primary care trusts
to consider choice and competition when assessing an application,
allowed minor relocations across PCT boundaries, without requiring
full applications, and imposed time limits on applications. They
also exempted pharmacies which fulfilled a number of conditions
from the “necessary and desirable” requirement, including
pharmacies in large shopping developments over 15,000m2, those
intending to open for more than 100 hours a week, those that are
part of a one-stop primary care centre and those that are wholly
internet-based or mail-order-based. The Health Act is due to introduce
two further reforms, which enable PCTs to make reasonable charges
for applications and to take into consideration provision of over-the-counter
medicines and other health care products and advice. |
When the Government set out to reform the control-of-entry system in
2003 (see Panel right), its aim was “to maintain and
improve access to all pharmacists in all communities whilst continuing
to raise standards, encouraging innovation and excellence”.
The Government argued that “simple deregulation” was not the best
way to achieve this. It wanted, rather, to move cautiously towards deregulation
and, in line with this, committed to reviewing the changes it made to regulations
in April 2005 “to assess their effect on access to and choice of NHS pharmaceutical
services for patients”, and is due to report on the outcome of its assessment
by the end of October.
As part of that review, the Department of Health undertook a consultation, which
closed last week. In response pharmacy groups have variously argued some of the
following: that some of the regulations have been sensible and well received;
that the new regulations have gone far enough already and that they should now
be tightened up so that loopholes are closed; that they have already gone too
far and should be reined in; and that it is simply too early to assess the impact
of the changes.
Impact of reforms
The Royal Pharmaceutical Society argues that there is, as yet, no evidence
that the changes, in particular the automatic exemptions, have achieved
what they set out to. “One of the intentions of the reforms was
to promote an increase in consumer choice,” it says in its response, “but
the Society has yet to see any evidence that this has occurred, other
than a rise in the number of applications for new pharmacies, mostly
in urban areas.”
However, the Company Chemists’ Association argues that the new
regulations have increased choice for patients and reflect modern consumer
habits. “[Patients] now have pharmacies in many locations previously
denied to them, locations that reflect the changes in shopping patterns
that have taken place in the last decade,” it says.
The Society and the Independent Pharmacy Federation argue that competition
and choice has been too simplistically linked to premises supply or the
price of over-the-counter medicines. The IPF suggests, instead, that
patient access and choice needs to be understood in the context of professional
service. The Society agrees. The increasing development of specialist
community pharmacists will require, it says, “a collaborative approach
among pharmacists that is unlikely to occur were the control-of-entry
requirements further relaxed”.
The awarding of a single contract cannot, it adds, be considered in isolation,
as these exemptions allow, but must be considered in the context of pharmaceutical
services across a whole health economy. “The Society would like
to see these exemptions to the ‘necessary and desirable’ test
removed,” it says.
The Pharmaceutical Services Negotiating Committee believes that the introduction
of the concept of “competition and choice” has opened up
the market — about 40 per cent of full non-exempt applications
that were granted used this provision, it says. However, it adds, 45
per cent of these applications were for premises adjacent to GP surgeries.
The PSNC is concerned that, if successful, such applications could undermine
the local network of pharmacies. “We suggest that urgent action
is needed to retain the network of local pharmacies and this can be achieved
by ensuring that direction of prescriptions is prohibited,” it
says.
The large proportion of new applications granted for pharmacies planning
to provide pharmaceutical services for 100 hours or more a week is also
of concern, the respondents warn. The National Pharmacy Association argues
this exemption is creating uncertainty for pharmacists and the pharmacy
network. The PSNC argues that PCTs need to check that pharmacies opened
under this exemption are complying with it.
“The PCT should ensure, by rigorous but fair monitoring arrangements,
that the public are able to access the full range of pharmaceutical services
for the full 100 hours per week,” it says. And it draws attention
to a number of enquries about applications designed to fulfil the letter,
but not the spirit, of this regulation, by having, for instance, a pharmacist
who is on the premises for the full 100 hours who can sleep there and
be woken by a buzzer, or having access to a pharmacist only through a
hatch.
The potential to submit “blocking applications” — that
is, frivolous applications used to hinder the processing of genuine ones — also
needs to be removed, the CCA and PSNC argue. The CCA suggests that a
simple statement of intent by the applicant would be sufficient to limit
such applications, but the PSNC argues that applicants should be required
to provide some written evidence (such as a business plan or confirmation
of ability to secure premises) that they will be able to provide pharmaceutical
services if the application is granted. Too early to tell?
Although pharmacy respondents have welcomed the opportunity to reflect
on the changes to the control-of-entry regulations, such a review is,
they argue, premature. “It may be too soon after the legislative
changes for any significant effect to be noticed,” the Society
says.
The CCA argues that, although at the start of the review in June the
new regulations had been in place approximately 15 months, new pharmacy
openings have only taken place within the past six months, because of
the long application and appeal process. “The CCA believes that
it is too early to determine the impact of the new contracts [awarded
under the new control-of-entry regulations] on the level or quality of
pharmaceutical services in any one area or nationally.”
The NPA also urges the Government to think carefully before making any
final decisions. “At this time pharmacy needs stability and confidence
to invest in delivering the new contract and improving services to patients,” it
says.
The PSNC agrees. It argues that the overall impact on the network of
pharmacies will not become apparent for some time, but that too much
instability will obstruct development of NHS community pharmacy services
and so there should be no further deregulation. |
The
Pharmaceutical Journal