Mark
Simmonds: I thank the right hon. Gentleman for his
intervention. He makes a sensible point. I am not trying to demean the
role of industrial pharmacists, who clearly play a fundamental role in
the research and development of pharmaceutical products. Down the
chain, they have a direct link with and importance for patients. My
point is about ensuring that the regulatory role undertaken by the MHRA
with respect to industrial pharmacies is not duplicated and replicated
by the
order. May
I also probe the Minister a little further about the retired
pharmacists? Again, I take her point about the non-practising register.
However, in times of emergency —for example, if the UK had
suffered greater prevalence rates of swine flu that were more
serious—there might be an active role for retired pharmacists
with such expertise in providing the relevant drugs to the patients who
need
them. I
am concerned that we might not have either a register under which
retired pharmacists can keep up with pharmaceutical advances—a
point made by my hon. Friend the Member for East Devon—or an
ability for the pharmaceutical bodies to know who they can call back in
to
assist. Those
issues need to be thought about. It would be helpful if the Minister
explained with even more clarity and detail why she and her civil
servants have concluded that it is not appropriate to have a
non-practising
register. The
Minister rightly mentioned the fact that Northern Ireland has for the
moment opted out of the regulation. It would be helpful for those in
Northern Ireland if she set out—if she knows or has the
information to hand—why Northern Ireland has decided not to
participate in this change of regulatory structure. Does she know the
time scales within which they might feel it appropriate in Northern
Ireland to do so? If they do not do this, other issues will be thrown
up that involve the future of pharmacy in Northern Ireland, which I
think would be easier to develop under this structure than the previous
one. However, the Northern Irish people and the pharmaceutical society
there are to maintain it for the
present. My
sixth point relates to costs. The explanatory memorandum makes it clear
that the overall costs of regulation are likely to increase due to the
expansion in
scope that the pharmaceutical council and pharmaceutical societies will
have. Will the Minister explain in more detail the extent of those
additional costs? How will they be covered? Where will they be drawn
from and recouped? Will she assure the Committee that there will be no
additional costs to the taxpayer due to the
order? Paragraph
36(5)(b) of the order will allow different fees for different
geographical locations. Is that merely to allow the Welsh and Scottish
to have different fees from the English, or is it to have different
fees in every primary care trust area in England? That matter causes
some concern.
Another issue
that has been drawn to my attention, in the context of pharmacies
taking on additional service provision, is the importance of
cleanliness in relation to many pharmacies. The GPhC has produced draft
guidelines, which quite rightly refer to the need for good hygiene.
However, they do not directly refer to the responsibility for
preventing health care-associated
infections. Some
pharmacies operate in hospitals, some of which have a big problem with
hospital-acquired infections. The Minister will be aware that the issue
was raised in the Council for Healthcare Regulatory Excellence
consultation document. It will be interesting to know why she and her
officials have decided not to ensure that that important point about
preventing health care-associated infections is included in the
guidance. My
seventh point regards premises inspections. The Minister rightly
referred to a point that has been put to her, to me and, I am sure, to
the hon. Member for Romsey, which is potential duplication. Clearly,
there is a role at the moment for primary care trusts in ensuring that
pharmacy premises are suitable or fit for purpose. That seems to
duplicate the
role. The
Minister mentioned sharing information, but that is not the same as
ensuring that there is no duplication of responsibility and role. Is
the Minister proposing to remove that responsibility from PCTs? Where
pharmacies are co-located in GP surgeries, as with dispensing practices
or in hospitals, will the whole premises have to undergo inspection by
the GPhC? We must be careful to not overburden pharmacies with
administrative and regulatory duplication, particularly when we are
keen for them to take on a larger role in providing services and to
spend more time with their
patients. The
Minister also referred to the core issue of the ability of pharmacists
who qualify abroad to practise in the UK. We must be absolutely sure
that we do not have the same situation that we had in that terrible and
tragic case of a GP providing out-of-hours services in Cambridge, when
he could not communicate with the patient, nor did he seem to have a
detailed understanding of the drugs he was
dispensing.
Mr.
Swire: My hon. Friend makes his customary excellent
points, not least on the ability for pharmacists to be able to
communicate properly and understand what they are prescribing, and, as
importantly, for the patient to understand what they are being told.
However, is he slightly concerned about whether there are sufficient
checks inherent in the order to ensure that the qualifications provided
by pharmacists coming from overseas are genuine? Is he convinced that
enough is being done to put in place a mechanism so that those credits
and qualifications are subject to regular
checks?
Mark
Simmonds: I thank my hon. Friend for his pertinent
intervention. He is absolutely right. The simple answer is yes, I am
concerned—not about some of the more developed countries in the
EU, but about some of those countries that have joined the EU more
recently. I am also concerned about the situation whereby pharmacists
can qualify outside the EU, get a certificate to practise in another EU
country and come to the UK off the back of that historical
qualification. It
is critical that the Minister clarifies what safeguards are in place to
ensure the safety of patients in the UK and tells us what rigorous
checks must be undergone before a pharmacist who has qualified
elsewhere, either in the EU or in the rest of the world, can get on to
the UK register and be allowed to practise. The wording on the ability
of a pharmacist to get on to the register seems to be confused, just as
it is in relation to “visiting” pharmacists who move from
one part of the register to another. The combination of issues relating
to “visiting” pharmacists who might come from outside the
UK is causing
concern. My
next point relates to paragraphs 34(2) and 35(1) on groups of
pharmacists. If I have read the order correctly, it appears to allow
groups of persons to be entered on the register in the event of an
emergency without first identifying who those individuals are. That
could be dangerous. Who will check and ensure that they are fit to
practise? That would be particularly important in an
emergency. Under
paragraph 35(1), people and groups are given the ability
to “order
drugs, medicines and
appliances”, seemingly
without being suitably qualified to do so. I would like the
Minister’s reassurance on that. I accept that I may have
misinterpreted the clause, but it would be helpful for the Minister to
explain what criteria and safeguards are in place and tell us that she
has received assurances that such provisions will be safe and in the
best interests of patients.
My final
point is not specifically related to the order, but while the Minister
and senior pharmacy civil servants are here, it would be helpful if she
confirmed what progress the Department has made towards decriminalising
dispensing errors. The initial guidance was expected before now, in
relation to the 1968
Act. 2.57
pm Sandra
Gidley (Romsey) (LD): I would like to add to the comments
made by the Minister and the hon. Member for Boston and
Skegness—I hope my voice lasts. I will start by declaring an
interest. I am a fellow of the Royal Pharmaceutical Society of Great
Britain and I am also on the practising register, which provides a few
challenges from time to time. The vast majority of pharmacists
recognise the need to split the society, as it has perhaps not
performed either part of its dual role as well as it should have. There
is recognition that the public increasingly expect a body to
concentrate just on
regulation. I
must start with a little bit of a rant. I was quite offended by some of
the comments in the explanatory notes. The notes claim that one of the
benefits of a new regulator will be that changes in regulation
resulting in “fewer dispensing errors”. I would love to
know the evidence base for that, because I do not believe that any
pharmacist goes to work in the morning expecting to
make a mistake. The concern of any professional is to get it right for
the patient, not for the regulator. I found that a rather strange
statement. I
agree that dispensing error rates are possibly too high, but over the
years many firms and individuals have made strenuous efforts to
identify causes of errors and take steps to reduce them. The only
advantage of changing the regulator or the regulatory powers would be
if the regulator had powers over the employers. In my view, one of the
biggest causes of dispensing errors is tiredness. Some companies expect
pharmacists to work for eight, nine or 10 hours without a break, and
nobody seems to have any power to address the problem or put a stop to
that practice.
At a time
when we have measures such as the working time directive, with which
not everyone always agrees, it is important that the regulator has the
power to look at working conditions. I might have overlooked such a
provision, but I could not see one in the documents. I could make the
same comments about the avoidance of serious misconduct incidents. None
the less, I support the proposed
separation. I
want to mention the race equality impact assessment, because 20 per
cent. of the profession are Asian. Some ethnic minority groups have
expressed concern that a disproportionate number of the cases being
taken to the stat comm involve ethnic minorities. It would be helpful
to have some means of monitoring whether there is a fault in the
process or whether something is fundamentally wrong with how cases are
brought to the attention of the
council. The
shadow body, which the Conservative spokesman mentioned, has been set
up under the chairmanship of Bob Nicholls, but I understand that no
member can be officially appointed until the order is approved. I
gather that the new council has held a few informal meetings.
Surprisingly, the draft council appears to be consulting on a new set
of standards. The RPSGB already has a good code of ethics that was
reviewed as recently as late 2007. It was a lengthy and open process
involving the profession and members of the public and it was
independently chaired by Professor Sheila McLean, a medical ethicist of
international repute.
The RPSGB
produced a code with seven clear principles that put patients at the
heart of the agenda, of which we would all approve. As far as I am
aware, the code has not led to any problems, so, on the basis of
“if it ain’t broke don’t fix it”, will the
Minister explain what the problem is with the current code of ethics
and why there has been such an unseemly rush to consult on a new code,
which the new body will not own. The Department of Health appears to
have taken rearguard action, to no apparent benefit. If the Minister
clarifies why that action has been taken, it might put some
pharmacists’ minds at
rest. Paragraph
5 of the order
states: “Before
setting any standards or requirements under this Order, the council
must
consult”.How
can a council that does not officially exist consult on something into
which it has had no input? Will the Minister explain why the existing
standards were not adopted as an interim measure, enabling the new body
to work with the existing standards and adopt them in the light of
experience? That would seem to be a much more sensible and pragmatic
way forward. I suspect that the Minister is unaware of what is going
on.
It is not only
me who is expressing concern. The consultation period had to be
completed by 12 January, which coincides with the busiest time of the
year for community pharmacists, many of whom will not have had time to
study the proposed changes in depth. The English board of the
pharmaceutical society has raised concerns, and the issue has become
the election platform for the next round of board elections.
I am not sure
whether I am allowed to use the word “cack-handed”, but
the way the issue has been handled risks alienating a profession that
supports most of the aims of the
GPhC. I
welcome the standards for retail pharmacies, but I would have liked the
opportunity to be taken to tackle hours at work. Also, the council has
to establish an inspectorate. The start date is supposed to be
April 2010—is that still realistic and will existing
pharmaceutical society staff automatically transfer over? If not, is
there still sufficient time to get an inspectorate in
place? Paragraph
13(3) deals with improvement notices. I note that a notice is deemed as
served “if
it is sent by first class
post”. The
Department obviously has more faith in the postal service than I do.
Should not the legal minimum be recorded delivery, especially as
non-compliance could eventually lead to removal from the register. I
would have liked that provision to be beefed
up. Part
4 deals with the register, which will be much more extensive
than that which currently exists. Paragraph 19(3)(g) refers
to “the
recording of continuing professional development
matters”. Does
that mean that a complete CPD record must be present or will that part
of the register be used just to note problems of which the registrar is
aware? I am not sure that that is entirely clear. At the moment, not
all recorded information is published. Will the Minister clarify which
parts of the register will be matters of public record and which will
not? Finally,
I want to pick up on something the Minister mentioned. She talked about
the fitness to practise cases that are already in train and may be
finished. My understanding is that there was, at one stage, a
significant backlog of fitness to practise cases at the RPSGB. Will
cases that have already been referred to the society have to go through
that body or will cases that have not reached a certain stage be
transferred to the new body? Again, that would impact on how much work
the new regulator could deal with from day
one. I
want to mention titles. It is a shame that the non-practising register
is being dropped as it was very useful. Many people who have objected
regard themselves very much as pharmacists. They have been years on the
register and do not see why that should be taken away. They will not
misrepresent to the public; they have pride in what they are and in the
profession. Calling themselves a retired pharmacist does not quite
satisfy
them. I
ask the Minister, if that is such an important principle to apply to
pharmacists, do the Government plant to introduce the same regulation
for doctors? Far more people who have the title “Doctor”
are sloshing around the system than there are retired pharmacists. It
seems that society would be better served by better
transparency over who is a proper registered medical practitioner,
rather than penalising people who have served a profession well all
their lives only to be told that, no, they cannot use that title any
more. 3.8
pm
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