C-55/99

OPINION OF MR FENNELLY — CASE C-55/99

OPINION OF ADVOCATE GENERAL FENNELLY delivered on 6 April 2000 *

I — Introduction registered with the Medicines Agency (Agence du Médicament) in accordance with conditions to be specified by decree before being placed on the market.

1. The present infringement action essen- tially raises a question regarding the pro- portionality of the restriction imposed on the free movement of goods, in the interests of public health, by a national registration system for medical diagnostic reagents. The Court has been invited to assess the issue of proportionality in the light of the provision made for an allegedly less restrictive regis- tration system for in vitro medical diag- nostic devices in a Community harmonising 3. A year after the adoption of this amend- measure which had not yet entered into ment, on 19 January 1995, the French force at the material time. authorities notified the text of a draft decree concerning medical reagents to the Commission in accordance with Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations, 1 and stated, pursuant to Article 9(3) of that Directive, II — Legal and factual context that, for urgent reasons relating to the protection of public health and safety, it was obliged to introduce the measure immediately without any consultations being possible. It cited recent tests of 2. Article L-761-14-1, first indent, of the reagents for diagnosing AIDS and Hepatitis French Public Health Code, inserted by B and C, which had found several to be of Law No 94-43 of 18 January 1994, only mediocre sensitivity, and the urgent requires that reagents intended for use in need for a legal means to require the vitro, either in laboratories, for medical withdrawal from the market of products biological analyses, or by the public, for associated with such serious illnesses which medical diagnosis or pregnancy testing, be did not satisfy the requisite high standards.

6. The draft decree was eventually adopted by the French authorities as Decree No 96- 5. In a letter of 6 April 1995 to the 351 of 19 April 1996 3 (hereinafter 'the Permanent Representative of France to the impugned Decree' or, simply, 'the Decree'). European Union, the Commission raised Article 1 of the Decree makes the market- concerns regarding the system of prior ing of diagnostic reagents in France condi- authorisation for the marketing of all tional on prior registration. Article 2 medical reagents envisaged by the proposed requires the application for registration to decree. It stated that this approach diverged contain a considerable amount of informa- markedly from that in the draft proposal tion about the product and how it is to be for a European Parliament and Council presented to the public, including the Directive on in vitro diagnostic medical requirements already criticised by the Com- devices, 2which would simply require, in mission regarding the therapeutic interest the case of most such devices, the supply of of the product, and the results of stability specified information by manufacturers. A tests as well as those of clinical and system of prior approval would apply only analytical tests. to devices intended for the diagnosis of certain grave illnesses such as AIDS and certain forms of hepatitis. The Commission also questioned the necessity for some of the information which the draft decree would require interested parties to sub- mit — in particular, that regarding the 7. Articles 6 and 7 of the impugned Decree therapeutic interest of the reagent, the provide for the establishment of a consul- results of stability tests even in the case of tative committee on the registration of inorganic reagents, and the results of clin- reagents, composed of representatives of ical and analytical tests in cases where the the State, of the reagent industry and of necessary performance data was already scientific experts. Its function is to give its available in scientific literature —, the opinion, at the request of either the Min- requirement that the file be updated when- ister for Health or the director-general of ever alterations are made to a reagent, the the Medicines Agency, on, inter alia, applic- requirement that a registration number ations for the registration of reagents and

for the evaluation and re-evaluation of 10. In its reply of 3 July 1997, France reagents. Article 3 of the Decree provides observed that the checks performed on that, if the application file referred to in 289 different reagents since 1993 had Article 2 is complete, the director-general resulted in 108 products being withdrawn of the Medicines Agency shall register a from the market and in 25 products being reagent, after having consulted, in certain modified. It noted that those aspects of the cases ('le cas échéant'), the consultative registration system which the Commission committee. Article 4 of the Decree states had criticised were substantially replicated that any alteration affecting the contents of in the approval system for diagnostic the application file must be notified by the devices for certain dangerous illnesses such beneficiary of registration to the Medicines as AIDS and Hepatitis B and C then Agency. envisaged by the draft directive, or were the subject of proposed amendments. It added that the extension of some of these requirements to reagents intended to diag- nose other illnesses was still under discus- sion, that any diagnostic device could be the source of errors whose consequences for patients could be dramatic, and that 8. Article 5 of the impugned Decree mounting public concerns about public requires a reagent's external packaging or, health, fuelled by recent crises, justified a in the absence of external packaging, the high level of protection. packaging of the reagent itself to bear the registration number of the product. Both forms of packaging must also bear the relevant production batch number. The notice accompanying the product must mention the fact of registration. The accompanying notice must also bear the names and addresses of the manufacturer, the distributor and, where applicable, the importer; the packaging is required to bear the name and address of the distributor. 11. On 10 August 1998, the Commission delivered a reasoned opinion stating that the impugned Decree was not justified either by the objective of protecting public health or by that of consumer protection because the restrictions it imposed on the free movement of goods were dispropor- 9. On 15 April 1997, the Commission sent tionate, and invited France to comply with France a letter of formal notice of its view the opinion within two months. The Com- that the Decree constituted a measure mission expanded upon its earlier criticism equivalent to a quantitative restriction on of the requirement that diagnostic reagents the free movement of goods contrary to marketed in France bear a registration Article 30 of the EC Treaty (now, after number. It stated that, as the registration amendment, Article 28 EC), repeating the process did not involve a detailed examina- criticisms summarised above. tion of products before their approval, the

13. Article 3 of the Directive provides that all devices must meet the essential require- ments set out in Annex I, regarding matters such as safety, acceptable levels of risk and 'Whereas it is necessary, essentially for the performance. Annex II to the Directive purpose of the conformity assessment pro- contains two lists of products, the market- cedures, to group in vitro diagnostic med- ing of which is considered to require the ical devices into two main product classes; intervention of notified bodies designated whereas, since the large majority of such by the Member States. List A in Annex II devices do not constitute a direct risk to refers to reagents for determining certain patients and are used by competently blood groups and for the detection, con- trained professionals, and the results firmation and quantification of HIV, HTLV obtained can often be confirmed by other and Hepatitis B, C and D in humans, while List B lists reagents or devices for deter- mining certain other blood groups, for 4 — OJ 1998 L 331, p. 1. measuring blood sugar, and for determin-

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I I I— The present proceedings tion neutral from a substantive point of view'. 9

17. On 16 February 1999, the Commission requested the Court, pursuant to Art- icle 169 of the EC Treaty (now Article 226 19. It is common case that the French rules EC), to declare that the French Republic referred to in the Commission's application was in breach of its obligations under constitute measures with effect equivalent Article 30 of the Treaty as a result of its to a quantitative restriction on imports. establishment, by the Decree, of a registra- They impose delays and additional costs on tion procedure for all medical reagents, and the marketing of reagents. The debate has of its requiring, by the same Decree, that concentrated, therefore, on the issue of the external packaging and the accom- justification and, in particular, on the panying notice for all reagents bear the question whether the Decree, which, the relevant registration number. The Commis- Commission concedes, serves a public sion formally abandoned its complaint health objective, constitutes a proportion- regarding the lack of a mutual recognition ate restriction on trade in goods. It has not clause, in the light of the undertaking given been suggested that the impugned Decree by France that it would amend the Decree. has any discriminatory effect. France opposes the Commission's applic- ation.

21. In contrast with the Directive, the Commission argues that the scope of the Decree is over-broad, by requiring prior 23. It should be noted that under this registration as a condition of placing any rubric of the Commission's case, it has medical reagent on the market, without not made any reference to the degree of distinguishing between products by refer- scrutiny to which reagents are subjected ence to the degree of risk posed, in the during the registration process. As has been event of malfunctioning or unreliability, to seen above, its specific complaints relate to the life and health of persons. certain elements which the application file is required to contain in the case of all products — matters relating to the thera- peutic interest of the product and to the results of stability tests and of clinical and analytical tests — as well as to the need to update the file when products are altered. 22. The Commission initially contended that a registration system would only be justified in respect of reagents related to certain serious conditions such as AIDS and some varieties of Hepatitis, which had been mentioned in France's application to use the urgent procedure and which were also listed in Annex II to the Directive. It later accepted that the detection of other condi- 24. In relation to the requirement that the tions or illnesses cited by France, such as reagent's packaging and accompanying pregnancy and certain inflammatory dis- notice bear the applicable registration eases, could also be of essential importance number, the Commission contends — as to public health, but continued to argue regards all reagents — that the registration that all medical reagents should not be process is merely formal, with the result subjected to an identical registration pro- that publicising the fact of registration in cess. At the oral hearing, the agent for the the manner required gives no particular Commission stated that some 60% of the guarantee of product safety to consumers. It also reiterates the argument from its earlier exchanges with the French autho- 11 — See Case C-129/96 Ititer-Envirotmement Wallonnie v rities that this requirement does not cont- Région Wallonne [1997] ECR I-7411, paragraphs 44 and 45. ribute to the traceability either of defective

26. France submits that the registration process is not merely formal and adminis- trative in character. Although the impugned Decree does not establish a system of checks equivalent to those applied before a marketing authorisation is given for a proprietary medical product — and is not, therefore, as demanding, rigid or time- 25. France states that the Commission consuming —, the information to be pre- bears the burden of proof that the sented with the application file for registra- impugned Decree is disproportionate. 12 It tion permits unreliable or ineffective med- objects to use of the Directive as the point ical reagents to be detected. This require- of reference for the examination of the ment, along with that of presenting any question of the proportionality of the new information about the composition or impugned Decree. It observes that Member performance of reagents, also permits the States remain free, by virtue of Art- compilation of a regularly updated data icle 100a(4) of the EC Treaty (now, after base (such as is also provided for in the amendment, Article 95(4) to (9) EC), to Directive), which is essential for permanent apply national provisions on public health reacto-vigilance. 14 Although not all grounds even after the adoption of har- reagents are tested before registration, the monising measures. Furthermore, the file also forms the basis for later evaluation Court has confirmed that, in the absence or re-evaluation tests by the consultative of harmonised rules, it is for the Member committee on the registration of reagents, States to decide on their intended level of thus permitting long-term surveillance of protection of human health and life and on the market for such products. whether to require prior authorisation for the marketing of products which contain dangerous substances, even if they have already received approval in another Mem- ber State. 13 All of the reagents governed by the Decree permit the detection and treat- ment of illnesses or conditions which require a medical response and which may, in the absence of detection or a 27. As regards the obligatory indication of the registration number of reagents, France

notes the importance of traceability in than the list in Annex II to the Directive, public health contexts, 15 and adds that for determining the degree, if any, of the this number is necessary to prevent confu- allegedly over-broad application of the sion between different versions of a medical French regime. It has not convincingly reagent which bear the same or similar rebutted, and may, perhaps, be understood brand names. as having conceded, France's point that the detection of inflammatory illnesses and of conditions such as pregnancy — neither of which appears in Annex II — may have public health implications as important as those of AIDS and certain forms of hep- atitis. The list furnished by the Commission of illnesses and conditions whose diagnosis IV — Analysis did not merit similar scrutiny included illnesses such as diabetes and problems regarding cholesterol levels which, in the absence of further explanation, appear to the non-expert to be far from minor. It should be possible to deduce from the Commission's complaint the steps which a (i) The allegation of over-breadth Member State should take if the Court were to uphold that complaint. I do not think that this is possible in the present case, since the Commission confines itself 28. I am not persuaded by the main ground exclusively to the distinction adopted in the invoked by the Commission in the present Directive. The latter was not in force at the case, regarding the over-broad application relevant time. Even if it constitutes a help- of the registration regime for medical ful point of reference, it cannot exhaus- reagents established by the impugned tively determine the scope of a Member Decree and the requirement that applic- State's exercise of its power to lay down the ations for registration be accompanied by range of reagents which merit registration. certain information which is alleged to be unnecessary. In my view, the Commission's allegations against France regarding the impugned Decree are, in a number of respects, insufficiently clear or convincing for me to recommend that the Court make the declaration sought by the Commission.

34. In any event, both possible versions of this aspect of the Commission's case have been answered by France in reliance on its 32. The Commission's concern about the power, in the absence of harmonised rules, necessity of providing such documentation to decide on the level of health protection or information seems to me to be logically in its territory. quite distinct from the second element of its case, that a prior registration procedure is not necessary in the case of at least 60% of medical reagents. It is not clear whether, in the Commission's view, prior registration can be dispensed with in these cases, which, as we have seen, are difficult to identify, simply because, by analogy with the Direct- ive, producers or distributors of such 35. The Court's ruling in Harpegnies, devices can be safely required to provide which itself draws on earlier cases such as the necessary information to the authorities Frans-Nederlandse Maatschappij voor Bio- by simple declaration, or, in the alternative, logische Producten 16 and Brandsma, 17 because the Commission regards the regis- that it is for the Member States, in the tration process as merely formal and absence of harmonising rules, to decide on administrative in character, with the result that it is burdensome without making any contribution to the attainment of the 16 - Case 272/80 [1981] ECR 3277, paragraphs 12 and 13. objective of better health protection. 17 — Case C-293/94 [1996] ECR I-3159, paragraph 11.

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their intended level of protection of human adopted to execute it are not overly restric- health and life and on whether to require tive. prior authorisation for the marketing of products containing dangerous substances, can, in my view, be extended by analogy to cover national rules governing approval of products which, while not normally dan- gerous in themselves, may, though only indirectly, pose a danger to the life or health of persons if their diagnostic perform- ance is unreliable.

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20 — Ibid., paragraph 29. 19 — Loc. cit., footnote 10 above, paragraph 30. 21 — See Article 100a(4), second indent, of the Treaty.

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43. The Commission further states simply that the requirement that the application file contain a statement of the therapeutic interest of the reagent concerned seems to 45. The requirement that the file be relate more to the function of the doctor. In updated when products are altered also appears to me to be legitimate, once one accepts the legitimacy of the French system 22 — In this regard, see, for example, Harpegnies, op. cit., of reacto-vigilance based on continuous paragraphs 34 and 35. assessment.

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(ii) The allegation regarding labelling a public-interest objective taking prece- dence over the free movement of goods. 25

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V — Costs other, I recommend that the Court also order, by virtue of Article 69(3) of the Rules of Procedure of the Court, that each 48. As I propose that the Court accept one party bear its own costs in these proceed- part of the Commission's case and reject the ings.

VI — Conclusion

49. In the light of the foregoing analysis, I recommend that the Court:

(1) Declare that the French Republic is in breach of its obligations under Article 30 of the EC Treaty (now, after amendment, Article 28 EC) as a result of its requiring, by Decree N o 96-351 of 19 April 1996, that the external packaging of every medical reagent, or, in the absence of such packaging, the packaging of the reagent itself, bear the national registration number awarded upon the registration of the reagent pursuant to the terms of that Decree;