Examination of Witnesses (Questions 730-739)
DR GILL
HART, MR
RICHARD GUTOWSKI,
MS HELEN
YOUNG AND
MR ANDREW
DILLON
15 MARCH 2007
Q730Chairman: Could I start by welcoming
those who have come to give evidence to us and members of the
public who have come here today for our 11th public hearing of
the inquiry into Allergy. There is an information note in which
all members of the Committee declare their interests so we will
not be repeating those today because they are on the record already.
I wonder if I might start, I am Lady Finlay, I chair the Sub-Committee
inquiry and I wonder if I might start by asking you to introduce
yourselves and then we will go into the questions. During the
questions it will be really helpful if you can keep your answers
as tight as possible because we have got a lot of questions that
we want to ask you, it means that we can get through them, otherwise
we will have to stop. The other thing is that the acoustics in
this room are not very good, so please speak up and speak clearly,
this is being webcast. Please start, Dr Hart.
Dr Hart: I am Dr Gill Hart. I am the Technical
Director at York Test Laboratories Ltd and I am a biochemist with
expertise in the development of diagnostic tests.
Mr Gutowski: I am Richard Gutowski from the
Medicines and Healthcare Products Regulatory Agency which is an
executive agency in the Department of Health and I have responsibility
for compliance issues relating to medical devices.
Ms Young: I am Helen Young and I am the Clinical
Director and Chief Nurse for NHS Direct which, as the Committee
will know, is the telephone, web and digital television service
for the NHS.
Mr Dillon: I am Andrew Dillon and I am Chief
Executive of the National Institute for Health and Clinical Excellence.
Q731 Chairman: Thank you very much
indeed. I wonder if I could start by asking you what types of
allergy self-testing kits are available to the public and where
they can be obtained?
Dr Hart: I can just speak about the services
that York Test provide. York Test provide an allergy screening
test, which is an IgE test for allergy, direct to the public.
The public have a sample taken, a full blood draw by their GP
or phlebotomist, the sample is posted to us and we run it on a
test in our laboratory. In addition, we provide a service for
IgG testing, a service direct to the public, again a sample kit
is sent out to the general public, they provide the blood sample,
post it back to the laboratory and we provide the results. We
are very aware that this is a huge responsibility in that we do
not provide the consumer with healthcare professional involvement
and we have taken this very seriously, so much so that we have
put our testing services through the same route as would be applicable
to a self-test kit which was on the shop floor in Boots and we
have put it through that regulatory procedure which I can tell
you more about later.
Q732 Chairman: Mr Gutowski, do you
have anything to add to that?
Mr Gutowski: Yes, I have. The majority of allergy
test kits are called skin prick tests and the substance in the
test kit is inserted into the body to produce a reaction and these
kits are in fact regulated as medicinal products.
Q733 Chairman: They are not self-tests,
are they?
Mr Gutowski: No, they are medicinal products
and they are prescription only medicinal products, so they are
not available to the public unless the GP initially writes a prescription,
but, in the main, they are used in testing laboratories either
in general practice or in hospitals. There are allergy test kits
which are regulated as medical devices, and I will come onto the
distinction later because I think there is a separate question
on that, and these are in the main used by testing services as
you have just heard and we are only aware, and this is from our
intelligence, of one of these kits being available to the general
public over the counter. Most of these IVD test kits are used
by testing services where the patient will send the sample to
the testing house and either he will receive the results back
or his general practitioner will.
Q734 Chairman: Dr Hart, when you
do IgE testing, do you send that result back to the GP?
Dr Hart: We give the customer the option of
having the results sent back to the GP or not and in most cases
they choose not to have their results sent back to their GP. In
putting the services that we provide through the IVD Directive
as a self-test testing service, we have given evidence to the
notified body that represents the MHRA which shows that the lay
user in this case can interpret the results that we provide, or
has the MHRA's approval that the lay user can interpret the results
that we provide and act upon them on their own without healthcare
professional involvement.
Q735 Chairman: I wonder if I could
ask Ms Young and Mr Dillon whether NHS Direct recommend the use
of any self-test kits and whether any have been subject to a NICE
appraisal?
Ms Young: From NHS Direct's perspective all
that we would offer in this particular area is health information
advice in relation to evidence that exists that a call or a visit
to the website could access to make a judgment about what type
of product might be suitable and what type of questions they may
wish to ask their general practitioner. We do not make specific
recommendations to a particular product, we would simply advise
and give information on specific questions that were asked of
us.
Q736 Chairman: Are there any self-testing
kits or concepts that you are advising to patients who clock on
with allergy?
Ms Young: To the best of my knowledge most of
the information on our website and that we would advise on is
based on the referral to either a specialist, or, indeed, through
the general practitioner.
Q737 Chairman: Mr Dillon?
Mr Dillon: No, is the short answer to your question.
Q738 Lord Colwyn: I am muddled about
self-testing. Self-testing to me means something that the patient
does themselves. Can you explain it?
Dr Hart: Absolutely. Self-testing in my definition
is when a consumer receives a result, whether it be at home in
doing the self-test kit that they bought in Boots or whether it
be the provision of a result given to that person from a testing
laboratory. My interpretation of the regulations is that they
should both be regulated as self-testing services because no healthcare
professional is involved. I think there is great confusion about
the distinction between the allergy kit or the pregnancy kit that
you buy in Boots compared with the testing service result that
the consumer can also access very readily over the Internet in
Holland & Barrett and various other places where people can
get allergy and food intolerance tests which do not appear to
be fully regulated.
Mr Gutowski: If I could add something to that,
it may be of help. The concept of the self-test kit is enshrined
within the medical device regulations and it is based on the concept
that the test is carried out by a lay person in their home environment,
so they would take the test, whether they have been given it by
a general practitioner or purchased it over the counter, whether
it be an allergy or a pregnancy test kit, they will do the test
at home and the kit itself will give them a result at home with
instructions that came with the kit as to how to make a determination
on the basis of a colour change or whatever as to what the results
of that test is.
Q739 Baroness Perry of Southwark:
Do those definitions include any distinction between whether you
read the result of your test yourself at home as a lay person,
or if you send the sample away and somebody expert gives you the
result?
Dr Hart: I understand that in 2004 the MHRA
and notified bodies jointly decided that not only IVD products,
that is the kits, but also IVD testing services are the direct
end users or consumers without the involvement of healthcare professionals
are designated self-tests and it is my understanding of the regulation
that the CE marking for these services was given a two year extension
from 2003 to 2005, so from 7 December 2005 all testing services
that provide results back to lay users should be equally regulated
as the kits that can be bought in Boots. I think that is what
should happen, it is something that we comply with at York Test,
but it is not common practice.
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