Examination of Witnesses (Questions 740-759)
MR BERNHARD
JANSEN AND
MR JOSÉ
RAMON BIOSCA
DE SAGASTUY
11 MAY 2006
Q740 Bob Spink: When you
turn on a huge magnetic field ferrous objects are attracted to
it, did the Commission not feel that there was an easier way of
improving health and safety than this Directive to prevent scissors
and chairs flying around? Did they not think that there was an
easier way to achieve that aim without this Directive?
Mr Biosca de Sagastuy:
Again, you are thinking that this Directive was for the use of
magnetic resonance equipment, and it is not. It is a Directive
for protection of the health and safety of workers against the
risk of exposure from electromagnetic fields.
Q741 Bob Spink: I am aware
that MRI equipment could have been excluded and any dangers that
were there from high magnetic fields could have been covered in
other and more relevant regulations by member nations, for instance.
The Health and Safety Executive have rules to protect workers
from this in our country anyway.
Mr Biosca de Sagastuy:
You might have rules to protect your workers in your country but
we have to ensure that equivalent rules are set up across the
Community.
Chairman: We understand.
We are not going into that area.
Q742 Dr Harris: On this
issue of your belief that it is not going to have an effect, as
we have heard you say, on the use of MRI equipment according to
protocol currently in existence, COCIR, which is the industry
body, say in a statement of 6 April 2006: "The EMF Directive
contains limit values that will negatively impact the use of MR
equipment and may prevent its use." Not only that, but they
claim they put in a paper to the Commission expressing similar
concerns in April 2003 yet you say you did not hear any complaints
from industry, so we will have to get to the bottom of that.
Mr Biosca de Sagastuy:
I did not say that. I said we had a meeting with the industry
and social attache«s had a meeting with the industry and
MEPs had a meeting with the industry and medical personnel.
Q743 Chairman: You said
there was no problem.
Mr Biosca de Sagastuy:
This was issue was discussed extensively at Council and all of
the experts said the same thing, that the impact from magnetic
resonance equipment of non-ionising radiation on health personnel
would be negligible because the levels of exposure are below the
limit values set out by the Directive.
Q744 Dr Harris: That was
the expert advice, opinion, of the people of the Council with
their experts, I understand that. But I am asking you whether
you were aware of the view of industry, COCIR, which is Siemens
and Philips and so forth, where they say that it will—not
may—negatively impact the use of MR equipment and may prevent
its use.
Mr Biosca de Sagastuy:
That is an opinion, like my opinion or his opinion.
Q745 Dr Harris: I understand
that. I just want to clarify what you said earlier. Whether you
were aware of what I said just now? I am a little confused, and
I will have to look at the record, but I want to give you the
chance to make it clear. I got the impression that you said you
had not heard until now at least, certainly not during the passage
of the Directive, of any concerns by industry in relation to the
impact on correct use of MR equipment. I am a little confused
about whether what you are saying reflects what was in meetings
or in documents?
Mr Biosca de Sagastuy:
Okay. Of course we received letters in the Commission when the
discussions were raised in Council, so did all delegations in
the Council and Members of the European Parlianment. We received
letters from manufacturers, industry associations, medical personnel,
and that was the reason why this subject was discussed in Council
and in the European Parliament. I feel that you are putting questions
to the Commission that do not belong to the Commission, they belong
to the legislator and the legislator is the Council and Parliament.
Q746 Dr Harris: Understood.
I can assure you that certainly I will be putting the same questions
to them. You said that the Commission had not heard complaints?
Mr Biosca de Sagastuy:
That is not true. I never said that.
Dr Harris: Okay, I am
sorry.
Q747 Chairman: We misunderstood
you and it is important that we have corrected that because that
was not what we understood.
Mr Biosca de Sagastuy:
We received letters from manufacturers and we had a meeting at
the beginning of the discussions in Council with the social attache«s.
We met with COCIR, Siemens, Philips, medical personnel in our
offices in Luxembourg several times.
Q748 Chairman: And they
had concerns?
Mr Biosca de Sagastuy:
That is normal process for negotiating a Directive.
Q749 Dr Harris: I know.
They did express concerns at those meetings?
Mr Biosca de Sagastuy:
Yes. Those concerns were raised and discussed in Council.
Q750 Dr Harris: I want
to move the discussion now to theoretical stuff. From the Commission's
point of view, to what extent do you think the precautionary principle
was used in the origination and passage of this Directive?
Mr Biosca de Sagastuy:
I think it was not used at all.
Q751 Dr Harris: So what
you are saying is that people raising concerns—
Mr Biosca de Sagastuy:
There is no mention in the Directive about the precautionary principle,
nor in the Framework Directive.
Q752 Dr Harris: Is that
because people do not think that the precautionary principle is
a good principle to use when there is uncertain science but a
potential risk?
Mr Biosca de Sagastuy:
Again, the Directive is based on sound scientific principles.
If you dispute the opinion of the world authority in this field,
which is ICNIRP, it is your right to do so, but I cannot follow
that.
Q753 Dr Harris: So what
you are saying, because I do understand you I think, is even though
this is controversial amongst some people it cannot be "blamed
on"—or people should not complain about the use of—the
precautionary principle because actually the figures are based
on good science. I think I understand what you are saying. In
the press release of 18 November 2005, Commissioner Spidla stated:
"The Directive is designed to protect workers against excessive
exposure to MRI and EMF which scientific experts agree is dangerous
for health". I would be interested to know on what basis
there is agreement of scientific experts that excessive exposure
to MRI is dangerous for health.
Mr Biosca de Sagastuy:
You will have to put this question to Commissioner Spidla.
Q754 Chairman: Do you
agree with him?
Mr Biosca de Sagastuy:
No, not on that particular sentence.
Q755 Dr Harris: He also
said in this press release: "The risk of MRI is a real one
for everybody who is exposed to it regularly, not to parents or
their children undergoing treatment." Would you agree with
that statement?
Mr Biosca de Sagastuy:
Yes.
Q756 Dr Harris: "The
risk of MRI is a real one and everybody who is exposed to it regularly
. . . ."
Mr Biosca de Sagastuy:
I think what Commissioner Spidla meant in that sense was: is MRI
equipment safe and is there no risk in using MRI and the answer
is no.
Q757 Dr Harris: You are
saying that there is risk from using MRI because of the danger
of excessive exposure to variable level fields, is that right,
acute exposure?
Mr Biosca de Sagastuy:
Could you say that again, please?
Q758 Dr Harris: I just
want you to expand on your interpretation of Commissioner Spidla's
view that the risk of MRI is a real one for everybody who is exposed
to it regularly.
Mr Biosca de Sagastuy:
I said what I said. MRI equipment is not an intrinsically safe
machine so its use has risks due to exposure to electromagnetic
fields that these machines emit, therefore the Directive shall
be applied to the personnel who are exposed to electromagnetic
fields coming from MRI equipment. There is no reason why medical
personnel should not be protected as any other worker in the European
Community would be protected and have the same levels of protection
as anybody else. I think this is the meaning of Commissioner Spidla's
press release of 18 November 2005.
Q759 Bob Spink: Do you
accept that this Directive could, or at least the medical industry
in the UK believes it will, force medical staff to use x-rays
more and, therefore, suffer a greater level of risk from radiation?
Mr Biosca de Sagastuy:
No, that is not true.
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