The
Committee consisted of the following
Members:
Chairman:
Mr.
Clive Betts
Battle,
John
(Leeds, West)
(Lab)
Creagh,
Mary
(Wakefield)
(Lab)
Gidley,
Sandra
(Romsey) (LD)
Griffiths,
Nigel
(Edinburgh, South)
(Lab)
Jackson,
Glenda
(Hampstead and Highgate)
(Lab)
Jenkin,
Mr. Bernard
(North Essex)
(Con)
Kawczynski,
Daniel
(Shrewsbury and Atcham)
(Con)
Keen,
Ann
(Parliamentary Under-Secretary of State for
Health)Lamb,
Norman
(North Norfolk)
(LD)
Linton,
Martin
(Battersea)
(Lab)
McCartney,
Mr. Ian
(Makerfield)
(Lab)
Simmonds,
Mark
(Boston and Skegness)
(Con)
Swire,
Mr. Hugo
(East Devon)
(Con)
Waltho,
Lynda
(Stourbridge)
(Lab)
Wilson,
Phil
(Sedgefield)
(Lab)
Wilson,
Mr. Rob
(Reading, East)
(Con)
Sarah Davies, Committee
Clerk
attended the
Committee
Eighth
Delegated Legislation
Committee
Wednesday 13
January
2010
[Mr.
Clive Betts in the
Chair]
Draft Pharmacy Order 2010
2.30
pm
The
Parliamentary Under-Secretary of State for Health (Ann
Keen): I beg to
move,
That
the Committee has considered the draft Pharmacy Order
2010.
It
is a great pleasure to serve under your chairmanship, Mr.
Betts. The order establishes the General Pharmaceutical
Councilthe GPhCwhich will be the new regulator for
pharmacists, pharmacy technicians and pharmacy premises in Great
Britain. It will complete the separation of professional regulation
from professional leadership in pharmacy, signalled by the powers under
the Health and Social Care Act 2008. Measures in the Act enable the
transfer of all the regulatory functions of the Royal Pharmaceutical
Society of Great Britain and the Pharmaceutical Society of Northern
Ireland to the
GPhC.
Northern
Ireland Ministers have decided not to transfer the functions of
Northern Irelands pharmaceutical society at this stage, but
they have the power to do so in the future. A section 60 order to make
such changes would be subject to consultation and the affirmative
resolution procedure, with debate taking place in the Northern Ireland
Assembly. The order will enhance public confidence in the ability of
the pharmacy regulator to protect the public, deal with poor
professional standards and allow the leaders of the pharmacy
professions to advocate for those
professions.
The
order was approved by the Scottish Parliament in December last year, as
the regulation of pharmacy technicians is a devolved issue. For the
Committees information, it will also be debated in the other
place
tomorrow.
I
bring to the attention of hon. Members two small typographical errors
in the order. Legal advice from both the Department of Health and the
Scottish Government is that the order can be amended prior to it being
made, and my officials will therefore arrange for a corrected version
to be presented to the Privy
Council.
The
references to paragraph (1)(g) under article 11(2) and (3) should, in
fact, be references to paragraph (1)(f).
[Interruption.] I ask the Committee to bear with
me, Mr. Betts. Similarly, the second paragraph of the
preamble to the order should have referred to Her Majesty, with the
advice of her Privy Council, as the person making the instrument, as
opposed to the Secretary of State and the Scottish
Minister.
I
want also to bring to the Committees attention three further
small amendments to the order, which are required as a result of the
Lisbon treaty entering into force on 1 December. References in articles
21(4)(b), 22(2)(b) and 66(2) to the Treaties are now
required to be replaced by references to the EU
Treaties.
The
order continues the process of implementing the Governments
programme to improve patient safety through the reform and
modernisation of the regulation of the health care professions, as set
out in the White Paper Trust, Assurance and Safety. It
also brings pharmacy into line with the arrangements for other health
care professions that have separate bodies for regulation and
representation for the profession. Both roles are necessary, but cannot
be performed in the same organisation without creating a conflict of
interest between the needs of public safety and professional
leadership.
I
am aware that, during public consultation on the order, there was a
great deal of debate on restricted titles and the proposal not to have
a non-practising register. I would therefore like to take time to go
through the provisions of the order and deal with some of the issues
that have been
raised.
Part
1 contains preliminary matters, including commencement provisions and
interpretation. Part 2 makes provision for the establishment of the
council and its statutory committees, in addition to setting out the
key functions and core purpose of a professional regulator in the 21st
century, which is to safeguard patients and the publicin
particular, those using the services of registrants and the services
provided by registered
pharmacies.
Part
3 sets out the powers the council will have with regard to registered
pharmacies. For the first time, there will be a power to set standards
for pharmacies. Provision is also made for the inspection of premises
and the powers of inspectors appointed by the GPhC are set out. What
sets the pharmacy regulator apart from other professional health and
social care regulators is the regulation of registered pharmacy
premises. We have chosen to maintain the regulation of professionals
and premises within the same organisation so that a more holistic
approach to the delivery of pharmaceutical services can be taken
forward.
We
have heard concerns about the potential for the duplication of
regulation and inspection, and I assure members of the Committee that
provision has been made in the order for sharing information with other
regulators to help to avoid duplication of
activity.
Part
4 sets out the criteria for an individual pharmacist or pharmacy
technicians entry to the register and the educational
requirements of both professions. It also sets out the standards
expected of those who are registered and the requirement that they will
continue to demonstrate how they meet those standards through
continuing professional development. In addition, it describes the
arrangements for entry to the register for those coming from the
European Union and from overseas. Schedule 2 covers entry to
the register for visiting practitioners. Fitness to
practise procedures are set out alongside appeals and sanctions in part
5.
Amendments,
repeals, transitional provisions and savings are dealt with under
schedules 4, 5 and 6. Schedule 4 amends the Medicines Act 1968. As that
Act is a UK-wide instrument, the arrangements ensure that the current
position in relation to pharmacy premises in Northern Ireland remains
untouched. Particular attention has been paid to ensure the smooth
transfer of the regulatory functions from the RPSGB to the GPhC under
schedule 5 transitional arrangements. That means that no current
student will be disadvantaged by the transfer, and
fitness to practise cases already in train
can be completed. TUPEthe Transfer of
Undertakings (Protection of Employment) Regulations 1981 and
2006for affected staff is covered here, and I assure members of
the Committee that a communications programme is in place to keep the
staff well
informed.
The
separation of professional leadership and regulation in pharmacy
received widespread support during the consultation on the draft order.
However, it would be remiss of me not to deal with what are termed
restricted titles and the non-practising register. The
RPSGB has traditionally held a non-practising register for those
pharmacists who are no longer working in the profession, but who wish
to maintain their contact. They will now be able to join the
professional leadership body and continue their allegiance with
pharmacy. Given that option for those who have retired and are no
longer practising, we propose that the regulator should concern itself
only with registering and regulating active
professionals.
However,
the restricted titles of pharmacist and
pharmacy technician are bound by membership of the
RPSGB. In future, they will be restricted to registrants of the GPhC.
The loss of those titles has been felt keenly by a small but vocal
minority of, in the main, retired pharmacists. Clearly, they are
eligible to call themselves retired pharmacists, but they must not
mislead the public on the currency of their advice or
expertise.
Others
have suggested that academic or industrial pharmacists do not need to
register because their systems are already regulated, which seems to
miss the point of professionalism. There is an individual obligation
above and beyond that of systems regulation that defines a health care
professional as opposed to any other member of the work
force.
Mr.
Hugo Swire (East Devon) (Con): The issue of retired
pharmacists is interesting. Given their tremendous expertise, often
built up over a lifetime, they would be a loss to the medical world
should they be unable to practise or have their knowledge accessed in
some way. If they are to be retained the register, therefore, will they
be kept up to date with modern science, and the prescription of modern
drugs in particular? The technology is changing quickly and they could
do refresher courses now and then to keep them live, as it
were.
Ann
Keen: I believe that that comes under the leadership area
of the order. Many retired pharmacists have already expressed their
willingness to be involved in that leadership, where their continuing
interest and possible development may take
place.
To
continue, as opposed to any other member of the work force, a health
care professional has a different obligation. Such professionals must
ensure that the patients interest and public safety are
paramount. That applies to those teaching the next generation of
professionals and to those developing, licensing and marketing new
medicines. For those reasons, the order requires that such
professionals must register with the GPhC if they want to use the
restricted
titles.
In
closing, I thank you, Mr. Betts, and commend the order to
members of the
Committee.
2.41
pm
Mark
Simmonds (Boston and Skegness) (Con): I join the Minister
in saying what a pleasure it is to serve under your guidance,
Mr. Betts. I also thank the Minister
for her introductory remarks. I would like to probe some of the issues
she raised and elicit a little more information about why the
Government have come to some of their
conclusions.
There
is cross-party support for the importance of the role that pharmacy has
in providing health care. All political parties want an increased and
enhanced role for pharmacynot just in providing services, but
in the all-important dissemination of information to patients and in
the prevention and public health arena in particular. Obviously, the
Conservative party is keen for the opportunity to create a greater such
focus to be
given.
I
shall not repeat what the Minister explained about the order, but it is
important for the Committee to be aware that the pharmacists themselves
are generally in favour of it and the distinct separation to which she
referred, which, as she said, will bring pharmacy into line with other
medical professions. We think that important, as does the RPSGB, which
the Minister, the hon. Member for Romsey, who speaks for the Liberal
Democrats, and I met and kept in contact with as the order was being
drawn
up.
I
want to raise 10 key points. It would be helpful if the Minister and
her key civil servants responded to them this afternoon. First, on the
timing of the order, clearly, the RPSGB was disappointed that it was
not introduced earlier. It has been in train for a considerable time
and I would like her to explain the
delay.
The
Committee may be interested to know that there is an obscure Government
document, which can be found on the internet, called The
Governments Forward Regulatory Programme. There are two
annexes to the programme, which detail the progress of subsequent
regulations. Annex BMeasures without a definite implementation
datesays:
Following
review, these will not be brought in before April 2011 at
the earliest, and subject to further consultation some may never come
into
force.
The
order is one of
those.
The
Minister and her civil servants might like to look at page 86, which
clearly includes the order creating the GPhC. I am interested to know
why it appears in that documentwe are discussing it today,
howeverbecause its appearance clearly caused angst in the
pharmaceutical
world.
The
second issue is whether the Minister thinks it appropriate that the
pharmaceutical council was appointed in September 2009, with all the
costs inherent in that appointment, even though it could not come into
operation prior to the order being put in place. Was it right for
pharmaceutical bodies to do that before the Committee had scrutinised
the
order?
The
Minister rightly raised a concern in relation to pharmacists in
industry, who do not have a patient focus or a role in interacting with
patients. There seems to be evidence that there will be duplication
between the role of the Medicines and Healthcare products Regulatory
Agency in regulating professional pharmacists in industry and the
proposals set out in the
order.
I
take the Ministers points about professionalism and the
importance of having the register in one place, but there is far too
much duplication in many areas of the national health service already
and we do not want to create more. That is particularly important in
relation to the continuing professional development of those in
industrial pharmacy. It is important that CPD, which
is a critical part of a pharmacists role, as my hon. Friend the
Member for East Devon correctly pointed out, is relevant to the role of
the individual pharmacist. It would be helpful if the Minister
explained that further, particularly as part 2 says that its main
purpose
is to protect,
promote and maintain the health, safety and well-being of the public
when exercising functions that affect the
public.
Clearly,
pharmacists working in industry do not fit comfortably into that
category.
Mr.
Ian McCartney (Makerfield) (Lab): The hon. Gentleman has
made an interesting point. Pharmacists may not have a relationship with
a patient, but they would certainly have a relationship in the
workplace with fellow workers and, potentially, with customers of the
organisation that they work in. Health and safety would be paramount
irrespective of any patient
relationship.