Mr.
Andrew Turner: Will the hon. Lady explain why she would
not get involved in such a dispute? Would there not be such a
dispute?
Sandra
Gidley: There may be a dispute. I am referring to people
with far more legal expertise than I. Perhaps the hon. Gentleman would
like to write to Sir Richard Buxton about
it. Mr.
Andrew Turner: The hon. Lady is reading from a script. I
assume she has something to say that I did not know, but she seems not
to know what made me
intervene.
Sandra
Gidley: I am not quite sure what point the hon. Gentleman
is making. Perhaps he would like to clarify, because I am not sure what
he expects me to
address. Mr.
Andrew Turner: The hon. Lady will say that there were
reasons, but she will not explain them, and I wonder what the reasons
are.
Sandra
Gidley: We are not getting anywhere with such
interventions. I am totally confused by what the hon. Gentleman is
trying to extract from me. I think he is trying to make mischief. I am
not sure that he is aware of what point he wants to make, so I shall
move on, if that is okay with the Committee. I have almost
finished. This
is a measure that the tobacco industry fears more than anything,
because if we introduce something similar in this country and it is a
success, it will be emulated around the world. Even if products are put
under the counter, the plain packaging amendment means that there is no
pack appeal. All the efforts of the tobacco manufacturers have been in
trying to promote smoking—and the packages themselves—as
a sexy product. The aim of that pack design has one purpose: to
increase sales. That has the knock-on effect of increasing
smoking.
People who
are trying to give up often say that seeing a pack of their favourite
brand can act as a real trigger to that yearning. That may be lessened
by a plain packaging amendment where those triggers would not be so
strong.
3.45
pm
Gillian
Merron: I am sympathetic to the points that the hon. Lady
made. The Government certainly do believe that more needs to be done to
develop our understanding of how the packaging of tobacco products
influences smoking by both adults who seek to quit and young people,
and we will keep tobacco packaging under close review.
In my brief
remarks, I should like to focus on the issue of evidence. There is some
evidence that branding on cigarette packs may increase brand awareness
among young people but it is not conclusive. It is also difficult to
separate the impact of large, brightly lit tobacco displays from that
of brand packaging. Both can convey, incorrectly, that smoking is
normal, popular and attractive. While there is also evidence to suggest
that branding on packs may mislead customers about the relative safety
of different tobacco products, that too is very limited. No studies
have been undertaken to show that plain packaging of tobacco would cut
smoking uptake among young people or enable those who want to quit to
do so. Given the impact that plain packaging would have on intellectual
property rights, we would undoubtedly need strong and convincing
evidence of the benefits to health, as well as its workability, before
this could be promoted and accepted at an international
level—especially as no country in the world has introduced plain
packaging.
While we
consider it premature at this stage to take these powers, we are
committed to developing the evidence that is necessary to see whether
this policy could change behaviour and protect young people from the
tobacco industry’s marketing and zeal. The Government policy
will develop further and the necessary changes will be made if and when
appropriate. I hope that, in light of the commitment I have given on
the Government’s behalf—to develop the evidence on plain
packaging and keep the issue of tobacco packaging under
review—the hon. Lady will feel able not to press new clause
10.
Sandra
Gidley: That was quite a brief reply. There was not much
to get my teeth into. It occurs to me that somebody has to be the first
and if we all sit around waiting for somebody else to do it, we will
never get anywhere.
The Minister
made an interesting point when she said that it is difficult to
separate the impact of large, brightly lit displays from the impact of
pack design. By implication, the Minister seemed to be admitting that
the displays are part of the problem. Obviously, it would be useful if
there were an all-party consensus with regard to measures the
Government will take. On the Opposition Benches, we have raised
concerns about a complete under-the-counter supply of tobacco products.
Is there not a case for a compromise that further restricts the way
that products can be displayed and addresses some of those concerns,
but also addresses the concerns of businesses, such as small
newsagents, who fear a rapid overnight change? They do not fear the
changes in the longer term; they are quite happy to see the sales die
out then, but will find it hard to cope with the sudden
change.
Gillian
Merron: The hon. Lady has raised the point, so perhaps I
might give an assurance that it will be a number of years before
smaller shops have to comply. Bigger shops will have to comply first,
and we are working very closely with the representative organisations
to set minds at rest. I also wrote recently to all Members of
Parliament with all this information, and am happy to provide further
information.
Sandra
Gidley: I thank the Minister, but in the short term is
there there not a case for putting an end to some of the flashy
displays that act as a promotion device in themselves? I shall withdraw
the proposed new clause now and reflect on what might be a different
approach on Report, but there is an interest in the House in discussing
as many ways as possible of tackling this problem. We may disagree on
some of the fine detail, but most people are committed to reducing
smoking and, ultimately, to saving lives. I beg to ask leave to
withdraw the clause.
Clause,
by leave,
withdrawn.
New
Clause
11Decriminalisation
of pharmaceutical errors ‘(1)
The Medicines Act 1968 is amended as
follows. (2) In section 67
(Offences under part III) after “sections 52, 58, 63;”
leave out
“64”. (3) In
section 122 (Warranty as defence) in subsection (2) after
“section 63(b)”, leave out “sections 64
and” and insert
“section”.’.—(Mr. Stephen
O'Brien.) Brought
up, and read the First time.
Mr.
Stephen O'Brien: I beg to move, That the clause be read a
Second time.
The new
clause proposes to decriminalise pharmaceutical errors, so that single
dispensing mistakes are treated in the same way as errors in other
medical professions. It is grossly disproportionate that errors
committed by pharmacists are automatically deemed criminal offences,
when those of doctors and other medical professionals are
not.
My reasons
for moving this clause are twofold. First, the criminalisation of
pharmaceutical errors stems from antiquated legislation that bears
little relevance to modern pharmaceutical practices. The Medicines Act
1968 has not been adjusted to accommodate the progress made in
pharmaceutical services over the past 40 or so years. Secondly, the
legislation fits rather uncomfortably with the Government’s
intention to expand the role of the pharmacist to include enhanced
services such as smoking cessation clinics. If pharmacists are to take
on increased responsibilities that extend their contact with patients,
they should be entitled to the same safeguards as the medical
profession.
I am sure
that the Minister will be well aware of the history and background to
all this—the representations to the Royal Pharmaceutical
Society, in particular in the case of Elizabeth Lee who, despite doing
all the right things in trying to atone for her mistake, none the less
ended up with a prison sentence. Most dispensing will take place where
humans have to make the final decisions about the counting and handing
out of medications, so human error will be a factor.
Equally, the
Minister will be aware that early-day motion 1561 has been tabled and
has attracted a number of signatures. Therefore, in the context of the
positive role of pharmacists, I hope that the Minister will be able to
look favourably on this proposed clause. I think the Government are
already signalling that they want to move in this direction, and we
have long had the Medicines and Healthcare products Regulatory Agency.
While the Government are consolidating and reviewing the legislation,
this clause—with these positive signs of potential
change—gives the Minister an opportunity to take prompt action.
I hope that he will therefore support it.
Sandra
Gidley: I need to declare an interest, being a pharmacist
by profession. This proposed new clause is well meant, and I do not
envy the Minister having this issue on his desk. It is useful that so
many Members have signed EDM 1561, showing general support for this.
Elizabeth Lee now has a suspended sentence; she did not go to jail. She
made a single error; the problem was not so much that it was
catastrophic but, more fundamentally, that having discovered that she
had made an error, she got in touch with the patient and found that
they had been taken to hospital.
The court
case found that there was absolutely no interrelationship between the
dispensing error and the patient’s ultimate death. Nevertheless,
due to existing legislation, the judge felt duty-bound to give the
woman a suspended sentence. Not to put too fine a point on it,
Elizabeth Lee has withdrawn from the pharmaceutical register and will
never practise as a pharmacist again. Her career is in ruins.
However, at
the heart of the matter is also a patient safety issue. When a mistake
is made or nearly made, that mistake can be learned from. Mistakes are
often
picked up before they do any harm or the patient takes the medicine, and
most chemists have some mechanism for reporting such errors. I can
recall working for a company that introduced error reporting. Everybody
was suspicious at first, but it then became apparent that there were a
couple of common errors that everybody was making, and changes were
made that had a big impact on reducing the number of
mistakes. The problem
with the case of Elizabeth Lee is that it has made every pharmacist
frightened of admitting to an error, so we stand to lose such learning
experiences. There may be occasions in future when products become
mixed up. People in such situations are only human. If the current
anomaly is allowed to continue, we will go back a stage, because people
will not be open and honest. That is ultimately a bigger danger to the
patient than the potential consequences of amending the legislation,
despite the concerns in some quarters about doing
so.
Mr.
Mike O'Brien: There is a problem, but the clause is not
the place to resolve it. The Government recognise the concerns that the
provision in the Medicines Act 1968 could lead to the criminal
prosecution of pharmacists who make a single error in dispensing
medicine to a patient, and I know that the issue has caused concerns to
pharmacy professional
bodies. There
are, however, circumstances in which sanctions should be available when
the requirement to sell only medicines that are
“of the nature
or quality demanded by the purchaser”
is seriously and
knowingly contravened. The sanction may, for example, be used to
protect against the sale of medicines to the public that are clearly
counterfeit or have been adulterated. We must ensure that the Act
provides sufficient enforcement powers and sanctions to deal with such
serious risks to public health, so I cannot accept the new
clause.
However, some
change to the law is necessary to ensure that cases of genuine clinical
error, such as dispensing the wrong medicine without a degree of
culpability, are dealt with proportionately. A full review of the
Medicines Act 1968 is already under way by the Medicines and Healthcare
products Regulatory Agency, the Department of Health agency responsible
for medicines regulation. The review will include consideration of
possible changes to the law to clarify the issue. The MHRA is working
closely with the Royal Pharmaceutical Society and other stakeholders to
ensure that the law provides the necessary safeguards for the public
while being proportionate in dealing with instances of clinical
error. The
chief pharmacist appeared before the all-party pharmacy group on 16
June to discuss that very issue, as did the presidents of the Royal
Pharmaceutical Society, the Pharmacists’ Defence Association and
the National Pharmacy Association. They all agreed that a detailed
examination of the legislation was needed, coupled with an exploration
with the Crown Prosecution Service whether guidance could be issued in
the interim on how to proceed with potential cases. Indeed, the
president of the Royal Pharmaceutical Society said
that “we
should not rush to replace poor regulation with on-the-hoof
regulation”.
The review of
the Medicines Act 1968 provides the opportunity to work with the full
range of stakeholders
affected by the provision and to create a legislative framework that is
comprehensive, comprehensible and fit for current
purpose. Mr.
Stephen O'Brien: I am grateful to the Minister for making
it absolutely clear that a change in the law is needed. I take
seriously the view that moving from poor legislation to on-the-hoof
legislation could carry more risk. I am sure that the fact that he has
made that commitment will be of some comfort to pharmaceutical
professionals as well as those who represent them and those who signed
early-day motion 1561. I would simply urge the Minister to proceed with
speed in the area. I beg to ask leave to withdraw the
clause. Clause,
by leave,
withdrawn.
New
Clause
12Nicotine
replacement therapy ‘The
Secretary of State shall before 21 July 2009 set out guidance for
consultation with appropriate stakeholders to provide greater access to
nicotine replacement therapy for members of the
public.’.—(Mike
Penning.) Brought
up, and read the First
time. 4
pm
Mike
Penning: I beg to move, That the clause be read a Second
time. It
has been a pleasure to be in Committee with you, Mr. Key,
since Mr. Speaker left. New clause 12 is self-explanatory.
It is a probing amendment that we do not intend to press to a vote. It
seeks to push the Government to have a smoking cessation strategy. The
new Minister said they will come forward with that later in the year,
and nicotine replacement is a very important part of that. A lot of
nicotine replacement is on prescription now, and I want to ensure that
much of that is generic, so that the taxpayer gets value for money. I
also want manufacturers to address nicotine addiction with the strength
of the replacement. All too often I hear of people on nicotine
replacement having, it seems, to chew gum all day to get anywhere near
the level of nicotine addiction that they have from their smoking
habit.
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