MR BERNHARD JANSEN AND MR JOSÉ RAMON BIOSCA DE SAGASTUY

11 MAY 2006

Q700 Dr Turner: It was not a question of convenience, was it, because I believe in 2004 Senor Prodi insisted that all Directives should be accompanied by fresh impact assessments?  

Mr Jansen: On what would the impact assessment have been based? The Commission had made its proposal and that proposal was on the table. The Council was discussing adaptations to the proposal all the time, which is normal procedure. It is a moving target. An impact assessment needs to be done on the proposal of the Commission, which had not changed, and the only thing that could be done was to extrapolate the costs. It is not possible for the Commission, it has nothing to do with Mr Prodi or any other such—

Q701 Chairman: Important person.  

Mr Jansen: In the area of health and safety the Commission had a longstanding practice of having impact assessments done before it became the general practice of the Commission. That is not an issue here. We cannot see how we could have had an impact assessment during the debate in the Council when things were changing with time passing. Also, the Parliament has a role to play because this is co-decision. We are not in a position to have an impact assessment each time another suggestion is made concerning the original proposal of the Commission and we do not know whether it will be approved in the end. It is not possible to do that.

Q702 Chairman: To be fair, Mr Jansen, the 1993 impact assessment that was done by the Commission, the Commission agreed was unsatisfactory.  

Mr Jansen: What do you mean?  

Mr Biosca de Sagastuy: Who said that?

Q703 Chairman: We literally heard that this morning.  

Mr Jansen: I am sorry, I have never heard anything of that sort.

Q704 Chairman: From the UK Representation, that it was unsatisfactory and there was a need because science has moved on immeasurably in a period of ten years.  

Mr Jansen: Only to show that there are even bigger risks than was originally thought.

Q705 Chairman: There are now greater risks?  

Mr Jansen: Yes.  

Mr Biosca de Sagastuy: Greater risks and less costs because of technological advances. To give you an example: when the proposal from the Commission was issued in 1993 we got a big reaction from the BBC and broadcasters because they said that maintenance operations could be impaired by the Directive. There is no reaction whatsoever now. Why? Because they have changed their procedures and the technology has changed, so people do not need to be exposed during maintenance operations.

Q706 Bob Spink: I just want to pursue this risk assessment issue while we are on it. Is it accepted that the UK asked for a new risk assessment in 2003 because they thought the 1993 risk assessment was not adequate? Do you accept that the UK asked for that new risk assessment and was refused?  

Mr Biosca de Sagastuy: It was asked for and was discussed in Council and the Council, the majority of delegations, rejected that.

Q707 Bob Spink: Thank you. You have also accepted that it is a moving target, that since 1993, and we are thinking specifically not about the BBC or anything but just MRI technology, imaging technology for medical purposes, the technology and the understanding in that particular branch of science has moved on tremendously fast and there have been massive changes in that area. Do you accept that?  

Mr Jansen: Please, could I—

Q708 Bob Spink: I am sorry, could you answer my question.  

Mr Jansen: There is a misunderstanding. You asked about risk assessment but we are talking about impact assessment, which is not the same thing. We need to be clear on this.

Q709 Bob Spink: We are talking about impact assessment or cost benefit analysis. Do you accept that the understanding and the technology of the industry in imaging for medical reasons has changed since 1993, it has changed dramatically?  

Mr Biosca de Sagastuy: Yes.

Q710 Bob Spink: Yet still you went ahead without a new impact assessment in 2003 even though you accept that things have changed dramatically.  

Mr Jansen: The Council and the European Parliament went ahead, I hope that is clear.

Q711 Bob Spink: The scientific evidence in 1993, I guess, was based on ICNIRP and nothing else, there was no internal research, no external research commissioned, it was just the ICNIRP guidelines.  

Mr Biosca de Sagastuy: No, that is not true.

Q712 Bob Spink: What was it based on?  

Mr Biosca de Sagastuy: The Commission launched a study, as early as 1991, about the health effects of occupational exposure to electromagnetic non-ionizing radiations. It was commissioned from the experts from the National Radiological Protection Board in the UK, the Federal Office of Radiological Protection in Germany and the Instituto Superiore di Sanita in Italy. The experts were asked to perform a critical analysis of scientific literature on the health effects of emf's and to propose basic exposure restrictions based on the scientific evidence found. The results were published in Physica Medica- Vol. VII, N2, April-June 1991. That was done in collaboration with ICNIRP. When negotiations started in Council an update was performed on the  studies undertaken by the German Institute, the  Finnish Institute, the Health Council of the Netherlands—a study commended by the Government of the Netherlands—whose concern was the relationship between electromagnetic fields and health, including potential carcinogenic effects and covered occupational exposure as well as public exposure.

Q713 Dr Harris: These are all peer reviewed and published?  

Mr Biosca de Sagastuy: These are published.

Q714 Dr Harris: Peer reviewed and published in medical journals?  

Mr Biosca de Sagastuy: Yes.

Q715 Dr Harris: That is quite a bundle of paper that you have.  

Mr Biosca de Sagastuy: What I have here is critical analyses of all published scientific literature in the world in the field and in the "references" part of these analyses, including in the guidelines of ICNIRP, all the scientific studies considered are listed. We followed, in addition, the studies done by the American conference of governmental industrial hygienists (ACGIH) and the Institute of Electrical Engineers (IEEE).[3] During the discussions in Council every delegation was accompanied by its own experts. There were experts from all Member States, high level experts. After the first discussion in Council a workshop was organised by the Commission in Luxembourg where all social attache«s of the Permanent Representations were invited and Members of the European Parliament in order for ICNIRP and other relevant societies to give an update on the evolution on the scientific knowledge of the health effects of electromagnetic radiation between 1993 and then and what was the impact on the values put forward by the Commission at the time. We received technical/scientific information and magnetic resonance was discussed extensively in the Council. It was an issue that was raised by several delegations and the conclusion of the experts, as I told you before, was that there was no problem for health personnel but where it could be a problem was with maintenance personnel. That is the reason why they should be protected, because they are exposed to very high levels with very adverse effects.

Q716 Bob Spink: So this research or literature-based trawl took place between 1993 and 2003 and that formed the basis of the limits that were set in 2003 for the Directive. That is true, is it not?  

Mr Biosca de Sagastuy: Yes.

Q717 Bob Spink: At any stage was there any balancing of the impact of this Directive on overall benefits to society, ie whether it would prevent or inhibit the use of MRI scanners in any circumstances?  

Mr Biosca de Sagastuy: No, because at the time the experts said that it would not impact on the use of MRI scanners.

Q718 Chairman: Including the British delegation, there were no concerns raised from the MR community?  

Mr Biosca de Sagastuy: No. Before the discussion in Council an industrial organisation organised a meeting with the manufacturers and medical personnel. It was attended by all social attache«s at the time, if I remember correctly, and the Commission. Later on, during parliamentary discussions, there was an invitation from medical associations to visit MRI equipment in Louvain University Hospital, so parliamentarians knew about it.

Q719 Chairman: And nothing was raised?  

Mr Biosca de Sagastuy: Nothing was raised. It was raised but—