C-21/96
ECLI:EU:C:1997:251
- Súd
- Súdny dvor Európskej únie
- IČS
- 61996CC0021
- Zdroj
- eur-lex.europa.eu ↗
COMMISSION v SPAIN
OPINION OF ADVOCATE GENERAL LA PERGOLA delivered on 27 May 1997 *
1. By this action, the Commission is asking This case relies, in particular, on the failure the Court for a declaration that, by failing to to transpose Articles 3, 4 and 5 of the Direc- transpose certain provisions of Council tive. The first of those articles provides that: Directive 84/466/Euratom ' (hereinafter 'the 'The competent authorities shall draw up an Directive') into national law, the Kingdom of inventory of medical and dental radiological Spain has failed to fulfil its obligations. The equipment and nuclear medical installations Spanish Government submits that the action and shall establish criteria of acceptability for should be rejected on the ground that it has radiological installations and nuclear medical correctly transposed the normative content installations. All installations in use must be of the Directive into national law. kept under strict surveillance with regard to radiological protection and the quality con- trol of appliances. The competent authorities shall implement the necessary measures to improve inadequate or defective features of installations subject to such surveillance. They shall ensure as soon as possible that all Legislative framework installations which no longer meet the crite- ria specified in the first paragraph are taken out of service or replaced. Direct fluoro- scopic examinations without the use of image intensification shall be carried out only in exceptional circumstances.'
2. While recognizing the beneficial effects of ionizing radiation at a diagnostic and thera- peutic level, the Directive, the transposition of which is in dispute, aims to limit its use as The exact wording of Article 4 is as follows: much as possible. To that end, provisions 'Each Member State shall take such steps as have been adopted to discourage 'any unnec- it may consider necessary to discourage the essary proliferation of radiological installa- unnecessary proliferation of equipment for tions' and to 'ensure that users have the nec- radiotherapy, radiodiagnosis and nuclear essary competence and experience to avoid medicine.' inappropriate uses of these techniques'. 2
* Original language: Italian. 1 — Council Directive 84/466/Euratom of 3 September 1984 lay- ing down basic measures for the radiation protection of per- sons undergoing medical examination or treatmcnt.(OJ 1984 L 265, p. 1). Finally, Article 5 provides that: 'A qualified 2 — See the seventh recital in the preamble to the Directive. expert in radiophysics shall be available to
I - 5483
OPINION OF MR LA PERGOLA — CASE C-21/96
sophisticated departments of radiotherapy However, the argument put forward by the and nuclear medicine.' defendant cannot be accepted. As the Com- mission rightly recalls, the Court has consis- tently held that: 'The question whether a Member State has failed to fulfil its obliga- tions must be determined by reference to the situation in the Member State as it stood at the end of the period laid down in the rea- soned opinion and ... the Court cannot take Substance account of any subsequent changes'. 3 In this case, Royal Decree 2071/1995 was only noti- fied to the Commission on 26 February 1996, whilst the period laid down in the rea- soned opinion expired on 10 September 1993. As a result, even if it is assumed that Article 3 of the Directive the Decree amounts to a correct transposi- tion of the Directive — which is disputed by the applicant — that transposition would, in any event, have been late. Consequently, from this point of view there are good grounds for declaring the Commission's 3. In the course of the proceedings the action for failure to fulfil obligations to be Commission abandoned its action in so far justified. as it related to the obligation, laid down in Article 3 of the Directive, to keep radiologi- cal installations under surveillance. Although the reasons for this partial abandonment have not been explained in the written sub- Article 4 of the Directive missions, the Court can only take note of this decision and Umit its examination to the other aspects of the alleged failure to fulfil obligations.
4. Furthermore, the defendant disputes the Commission's assessment that there has been a failure to transpose Article 4 of the Direc- tive. In its opinion, the purpose of the provi- As regards the Commission's allegation that sion (namely to discourage the unnecessary Article 3 of the Directive has not been trans- proliferation of equipment for radiotherapy, posed, the Spanish Government claims that radiodiagnosis and nuclear medicine) has this provision was correctly transposed into been achieved by adopting the following national law by the adoption of Royal measures: the national survey of existing Decree 2071/1995 of 22 December 1995 installations, the development of criteria for which establishes the qualitative criteria for the distribution of resources, the guidelines the radiodiagnostic field. This decree, pub- lished in the Official Journal on 23 January 1996, was notified to the Commission on 26 3 — Judgment in Case C-133/94 Commission v Belgium [1996] February 1996. ECR 1-2323, at paragraph 17.
I - 5484
COMMISSION v SPAIN
for clinical practice as well as a series of pro- which do not cover radiology or nuclear visions adopted by the autonomous commu- medicine. nities concerning the authorization, creation and modification of treatment centres.
Reference to the legislation adopted by the autonomous communities is also immaterial. That legislation, in fact, concerns the grant of However, this argument must also be administrative authorizations for the estab- rejected. Firstly, if it is true that compiling a lishment and management of health centres, national inventory is a matter of clear impor- but does not contain any provisions regard- tance in view of the planning for the subject- ing planning and restrictions on the number matter in question, as soon as it allows a of installations referred to in Article 4 of the complete survey of the existing installations, Directive. Moreover, those provisions only I do not see how this measure can, in itself, concern 4 out of the 17 regional communi- discourage 'the unnecessary proliferation of ties, giving no indication of the situation in equipment' in existence, as Article 4 of the the others. Directive requires. Unless there are specific measures which limit the number of installa- tions and regulate their siting, a mere survey of the latter is of purely descriptive value.
Finally, the Spanish Government's argument that Article 4 of the Directive leaves the Member States a wide discretionary power as to the measures considered necessary to Moreover, as for the criteria for the alloca- achieve the objective laid down in the article tion of funds, it is enough to point out that, is no longer tenable. In its opinion, the as the Spanish Government has accepted in decision to transpose the article by the mea- its defence, they concern solely radiotherapy sures referred to cannot be challenged. This installations and do not cover those for argument is, however, unconvincing. I do radiodiagnosis and nuclear medicine, which not deny that Article 4 leaves the Member are nevertheless referred to in Article 4 of States some discretion in the choice of the the Directive. As a result, even assuming that measures to adopt. Nevertheless, those mea- the policy of allocating funds is a measure sures must be adopted and they must be aimed at discouraging 'the unnecessary pro- appropriate to ensure the desired purpose is liferation of installations', it does not, never- achieved, which is not the case here or only theless, concern all of these, so that transpo- partly the case. I therefore consider that on sition would only be partial. The same this point the Commission's action should applies to the guidelines for clinical practice, be upheld.
I - 5485
OPINION OF MR LA PERGOLA — CASE C-21/96
Article 5 of the Directive worthy of consideration: the draft Decree has not yet been approved and, in any event, transposition is still late and this does not cure the failure to fulfil obligations. As far as the first argument is concerned, it is enough 5. By disputing the failure to transpose to recall that Article 5 provides that a quali- Article 5 of the Directive the defendant Gov- fied expert in radiophysics shall be available ernment claims that, since 1995, notices of 'to sophisticated departments of radio- competition for access to specialized health therapy and nuclear medicine'. Even though training plans also cover posts for hospital the notices of competition for specialization radiophysics training. Moreover, it reports in radiophysics may enable specialists to be that it has drawn up a draft Royal Decree trained, the measures do not, as a general introducing and regulating the official quali- rule, require an expert in radiophysics and fication of specialist in hospital radiophysics nuclear medicine to be present, as is required and that the procedure for the adoption of by Article 5. that draft is at an advanced stage.
In my view, the action brought by the Com- That line of defence is also bad. Likewise the mission is therefore well founded in this argument to which I have just referred is not respect.
Conclusion
I n t h e light of the above considerations, I p r o p o s e t h a t the C o u r t should:
(1) declare that, b y failing t o a d o p t w i t h i n t h e prescribed p e r i o d all the p r o v i s i o n s necessary t o i m p l e m e n t Articles 3 , 4 a n d 5 of C o u n c i l Directive 8 4 / 4 6 6 / E u r a t o m of 3 S e p t e m b e r 1984 laying d o w n basic measures for t h e radiation p r o t e c t i o n of p e r s o n s u n d e r g o i n g medical examination o r t r e a t m e n t , except for the obligation t o k e e p r a d i o d i a g n o s t i c installations u n d e r surveil- lance as p r o v i d e d for b y Article 3 of t h a t Directive, the K i n g d o m of Spain has failed to fulfil its obligations;
(2) o r d e r the K i n g d o m of Spain t o p a y t h e costs.
I - 5486