C-424/99
ECLI:EU:C:2001:309
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OPINION OF MR TIZZANO — CASE C-424/99
O P I N I O N OF ADVOCATE GENERAL TIZZANO delivered on 31 May 2001 1
I — Introduction I I — Relevant provisions
A — Community legislation
2. Article 1(1) of the directive provides that: 1. In this case, brought by the European Commission under Article 226 EC, the Court of Justice is called upon to determine whether the Republic of Austria has failed to fulfil its obligations under the EC Treaty 'Member States shall ensure that any by not adopting or by not communicating national measure, whether laid down by to the Commission all the measures neces- law, regulation or administrative action, to sary for complete transposition of Council control the prices of medicinal products for Directive 89/105/EEC of 21 December human use or to restrict the range of 1988 relating to the transparency of mea- medicinal products covered by their sures regulating the pricing of medicinal national health insurance systems complies products for human use and their inclusion with the requirements of this Directive.' in the scope of national health insurance systems (OJ 1989 L 40, p. 8; hereinafter 'the directive'). In particular, the Commis- sion complains of infringements of Arti- cle 6 of the directive, both in respect of the maximum period of 90 days allowed to the 3. Article 6 of the directive provides that: national authorities for deciding on appli- cations to include a product in the list of medicinal products covered by the national health insurance system, and in regard to the remedies afforded to the applicant under that article against such decisions. 'The following provisions shall apply if a medicinal product is covered by the national health insurance system only after 1 — Original language: Italian. the competent authorities have decided to
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include the medicinal product concerned in agreed the price to be charged for the a positive list of medicinal products cov- product pursuant to Article 2, the Member ered by the national health insurance State concerned shall ensure that the over- system. all period of time taken by the two procedures does not exceed 180 days. This time-limit may be extended in accordance with Article 2 or suspended in accordance with the provisions of the preceding sub- paragraph. 1. Member States shall ensure that a decision on an application submitted, in accordance with the requirements laid down in the Member State con- cerned, by the holder of a marketing authorisation to include a medicinal 2. Any decision not to include a medicinal product in the list of medicinal pro- product in the list of products covered ducts covered by the health insurance by the health insurance system shall systems is adopted and communicated contain a statement of reasons based to the applicant within 90 days of its upon objective and verifiable criteria, receipt. Where an application under including, if appropriate, any expert this Article may be made before the opinions or recommendations on competent authorities have agreed the which the decision is based. In addi- price to be charged for the product tion, the applicant shall be informed of pursuant to Article 2, or where a the remedies available to him under the decision on the price of a medicinal laws in force and of the time-limits product and a decision on its inclusion allowed for applying for such remedies. within the list of products covered by the health insurance system are taken after a single administrative procedure, the time-limit shall be extended for a further 90 days. The applicant shall furnish the competent authorities with adequate information. If the informa- …'. tion supporting the application is inadequate, the time-limit shall be suspended and the competent authori- ties shall forthwith notify the applicant of what detailed additional informa- tion is required. 4. Under Article 11(1) of the directive:
Where a Member State does not permit an application to be made under this Article 'Member States shall bring into force the before the competent authorities have laws, regulations and administrative provi-
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sions necessary to comply with this Direc- doctor contracted to the social insurance tive by 31 December 1989 at the latest...'. body with which the patient is registered and if it is a product which that doctor may prescribe without restriction because it is included in the list of medicinal products published by the Hauptverband der öster- reichischen Sozialversicherungsträger (Prin- 5. The obligations referred to in the Direc- cipal Federation of Austrian social insur- tive have applied to the Republic of Austria ance organisations; hereinafter the 'Federa- since it joined the European Community, tion'). 2 Alternatively, it is possible to on 1 January 1995. obtain cover for a medicinal product that is not on the list where a qualified doctor of the competent social insurance body accepts that it is necessary and appropriate to use it having regard to the patient's state of health; in such case, it must issue an authorisation. B — National law
6. The Austrian national health insurance system enshrines the right of insured per- 8. Under Articles 31(3)(12) and 133(2) of sons to be covered against the costs of all the ASVG, the Federation has the task of medicinal products which, according to the keeping a register (hereinafter the 'register') diagnosis of the doctor in charge of the containing the list of those medicinal case, are from time to time considered products which may be prescribed in gen- necessary and appropriate. More specifi- eral or subject to specified conditions (for cally, Articles 116 and 122(1) of the Allge- example, for certain groups of patients or meines Sozialversicherungsgesetz (General by age categories, or to be given in specified Law on Social Security; hereinafter the quantities or forms). 'ASVG') provide that each insured person is entitled, in respect of himself and the members of his family, to benefits from the national health insurance system compris- ing, among other items, adequate and appropriate medical treatment, including the relevant medicinal products, but with- 9. The procedure for including a medicinal out that being in excess of what is necessary product in the register is subject to specific (Article 133 of the ASVG). rules, although these were adopted only recently (Soziale Sicherheit, No 11/98 of
2 — In fact, by virtue of the particular relationship between them and the social insurance bodies of the patients whom they are treating, 'contracted doctors' operate as a kind of representative for those bodies and they may therefore 7. Article 350 of the ASVG recognises prescribe medicinal products, subject to the conditions entitlement to cover in respect of the costs specified in the ASVG and, if these are on the register, they are paid for direct by the competent body (Article 361(1) of of a medicinal product if prescribed by a the ASVG).
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27 November 1998, Communication graph 2(5)), and make its own recommen- No 104/1998, page 853; hereinafter the dation not more than six months after the 'rules' or 'rules of procedure') and were complaint is made. notified to the Commission on 3 March 1999 in connection with the response to the reasoned opinion of 30 December 1998.
12. At all events, the Federation must decide within 180 days after the applica- tion is lodged whether and on what condi- tions it is able to accept it [Para- 10. An application for inclusion in the graph 2(7)(a)]. However, the time-limit is register must be made to the relevant office suspended if the Federation asks the appli- of the Federation, which conducts the cant undertaking for further particulars preliminary examination (Paragraph 2(1) regarding the technical or administrative of the rules of procedure) of the applica- information specified in Annex I to the tion. The outcome of the examination is rules of procedure [Paragraph 2(7)(a)] and notified at the same time to the small it may be extended by 60 days if there is an technical advisory board and to the appli- exceptional workload at the Federation cant (Paragraph 2(2)). That board makes a offices: this occurs if more than 100 recommendation in the case [Para- applications to register medicinal products graph 2(3)(a)] and this is notified to the are submitted within a three-month period applicant. [Paragraph 2(7)(b)], but the Federation may not invoke such an event more than three times within a period of two years [Paragraph 2(7)(b)].
11. If the recommendation is unfavourable, the applicant has six weeks to submit a written complaint to the Federation, appending it together with any additional documents regarding those products to the I I I— Legal Analysis a p p l i c a t i o n for i n c l u s i o n [ P a r a - graph 2(4)(a)]. The complaint is then re- examined by the small technical advisory board, which may request further informa- t i o n from t h e a p p l i c a n t [ P a r a - graph 2(4)(b)]. If that board does not make A — Introduction a recommendation in favour of the appli- cant, it passes the complaint, the additional information, if any, and any observations of its own, to the main technical advisory board. The latter has to verify that the 13. The Commission makes two separate opinion is 'reasonable' ('nachvollziehbar') complaints regarding the Republic of Aus- or, if necessary, must amend it (Para- tria: first, that the rules of procedure lay
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down a time-limit of 180 days within 16. I would make one final point before which the Federation is required to decide moving on to the merits of the case. The on applications to include a medicinal Commission is asking the Court to declare product in the register, whereas Article 6(1) that, by failing to notify or by failing to of the directive, as has been seen, sets a adopt fully the measures required for limit of 90 days; and secondly that a implementation of the directive, the Repub- complaint against an unfavourable opinion lic of Austria has failed to fulfil its obliga- by the small technical advisory board tions under the EC Treaty. However, it is cannot be regarded as a remedy within clear from the application lodged that, the meaning of the last sentence of Arti- when it responded to the reasoned opinion, cle 6(2) of the directive. the Austrian Government informed the Commission that it had adopted the rules of procedure and it also submitted the text of those rules, showing at least implicitly that it considered it was fulfilling its obligations. However, whether or not it did so consider, I feel that once the rules had been forwarded the Republic of Aus- 14. The defendant government contends, tria cannot be said to have failed to inform primarily, that the register referred to in the Commission of the measures intended Article 133(2) of the ASVG does not con- to transpose Article 6 of the directive. Nor stitute a 'positive list' within the meaning of did the applicant press this point at the Article 6 of the directive and that this hearing. I shall therefore examine below provision cannot therefore be applied to only the objections that the implementing the Austrian system; it contends in the provisions which the Austrian Government alternative that the time-limits and reme- notified to the Commission fail to comply dies laid down in the rules of procedure with the Directive. comply with the provisions of Article 6.
B — Is the register referred to in Arti- cle 133(2) of the ASVG structured as a 'positive list' within the meaning of Arti- 15. In its application in the present case, cle 6 of the Directive? the Commission no longer included a third complaint which had been raised in the reasoned opinion of 30 December 1998, on the failure to respond regarding the require- ment to state reasons for unfavourable decisions on applications for inclusion in 1. Arguments of the parties the register, although that requirement is imposed in Article 6(2) of the directive. In fact, Article 2(3)(b) of the rules of proce- dure now provides that the Federation must provide a written statement of reasons for its decisions and the Commission has there- 17. As has been seen, the Republic of fore withdrawn this head of claim. Austria is raising a preliminary and general
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objection to the Commission's application, appropriate treatment. 3 Furthermore, that is, that the register kept by the according to the Austrian Government, Federation is not a 'positive list' within the possibility of obtaining reimbursement the meaning of Article 6 of the Directive in the case of medicinal products not and that in this case, therefore, the condi- included in the register is not just theore- tions for applicability of that provision are tical, if it is considered that around 15% of not met; nor are, a fortiori, the require- the expenditure incurred by the national ments laid down therein whose infringe- social insurance system for reimbursement ment the Commission is alleging. of medical costs is accounted for by this possibility. And that does not take into account the medicinal products dispensed in hospitals, where no condition of inclu- sion in the register applies.
18. In support of its objection, the Austrian Government chiefly stresses the actual wording of Article 6 — particularly the introductory passage. The defendant claims 20. In the end, the defendant government that this provision clearly shows that a list observes, the register kept by the Federa- of medicinal products constitutes a 'posi- tion does not constitute an exhaustive list tive list' only where inclusion on that list is of the range of medicinal products covered the sole means of accepting a medicinal by the national health insurance system. Its product for cover by the national health usefulness lies rather in its function as a insurance system. working tool, as a kind of manual, for contracted doctors, enabling them more easily to check which of the medicines they propose to prescribe are covered by the social insurance body with which their patient is registered, without having to seek specific authorisation. Furthermore, the Austrian Government continues, it also makes it possible to reduce the costs of the national social insurance system 19. However, in the Austrian system, even because it compels the pharmaceutical a medicinal product excluded from the companies, in exchange for inclusion of a register kept by the Federation may be medicine in the register, to give discounts reimbursed, provided that the patient obtains authorisation from his own health insurance body; just as, on the other hand, 3 — This conclusion is borne out also by the case-law of the the prescribing of a medicine included in Oberster Gerichtshof (the supreme court in social insurance matters), referred to by the Austrian Government (see in the register gives absolutely no guarantee of particular the judgment of 13 December 1996, 10 Ob S 62/94, and further references), which considers that, under reimbursement if it were found to be Article 133(1) of the ASVG, those registered under the unsuitable for or disproportionate to the national health insurance system are entitled to cover of the costs of all medicinal products which they actually need, actual requirements of necessary and regardless of whether these are included in the register.
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on its cost, even to the extent that those and considers that the conditions for its firms almost benefit more from non-inclu- application are fully satisfied. First, the sion of the medicine in the register rather Federation may be regarded as one of the than inclusion (but perhaps this 'sacrifice' is 'competent authorities' referred to in that offset by the wider distribution of the provision. Secondly, the register of medi- product that is presumably guaranteed by cines must be treated as a 'positive list' registration). within the meaning of the directive since normally the medicines listed there are reimbursed by the national health insur- ance system. On the other hand, it notes the fact that a medicinal product not included in the register may also be reimbursed because, as we have seen, that is permitted only on the basis of a specific authorisation from a qualified doctor of the social 21. In broader terms still, the Austrian insurance body. But, according to the Government objects that, in purporting to Commission, the criteria for giving such classify the register as a 'positive list' within authorisation — that is, that the medicinal the meaning of the directive, thus misinter- product is suitable and necessary for the preting its nature and function, the Com- insured person's state of health — are so mission is seeking to interfere in the vague that it is not possible to predict with organisation of a national system of social certainty whether a product not included in insurance and in determination of the the register can be reimbursed or not, with conditions attaching to entitlement to ben- the result that real certainty on that point efit. It quite clearly constitutes unlawful can be achieved only by inclusion in the interference by the Community in a matter register; and that is precisely the condition which is reserved to the exclusive power of laid down in Article 6 of the Directive for a the Member States, as has long since been 'positive list' and, hence, for application of explained in the case-law of the Court, 4is that provision. expressly confirmed in Article 152(5) EC, as amended by the Treaty of Amsterdam, 5 and, finally, is reaffirmed in the directive (sixth recital).
23. The Commission's response to the 22. For its part, the Commission insists Austrian objections to the alleged Commu- that Article 6 of the directive is applicable nity interference in a sector reserved to State competence is that the directive has no such purpose and no such outcome. It 4 — See judgment in Case C-158/96 Kohtl [1998] ECR I-1931, seeks only to impose certain minimum rules paragraphs 17 and 18, and further references. on transparency regarding national mea- 5 — In the new version, the provision states clearly that: 'Community action in the field of public health shall fully sures to restrict the range of medicinal respect the responsibilities of the Member States for the organisation and delivery of health services and medical products covered or reimbursed by national care ...'. health insurance systems (Article 1). In
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particular, this is intended to avoid possible titative restrictions on imports or exports measures having equivalent effect to quan- or measures having equivalent effect titative restrictions on import or export. thereto' (sixth recital).
2. Evaluation
25. Here I must stress that, although the directive confirms that pursuit of the aims set out therein must not affect national policies on the determination of social security schemes, it does not rule out that 24. I begin by observing that on this latter this might occur 'as far as it is necessary to point I find it difficult to disagree with the attain transparency within the meaning of Commission. The present application does this Directive' (sixth recital). not call in question either the policy decisions or the competence of Austria in social insurance matters, and therefore does not call in question the current organisation of its system of medical assistance, which the Commission has indeed expressly remarked upon favourably; even less does it question the conditions regarding entitle- ment to reimbursement of medicinal pro- 26. Indeed, it is the Community legislature ducts. The Commission's claims do not in itself which has adopted this viewpoint fact relate either to the foundation of the inasmuch as, while respecting national system or to the criteria underlying its policies in the matter, it has in fact been operation; similarly, acceptance of these concerned to use coordinating rather than claims would have no effect on the exis- harmonising legislation for progressive tence or operation of the register, on the attainment of conformity with Community inclusion or non-inclusion of any medicine law of national measures to control public therein, or on its reimbursable status. At health expenditure by restricting the range issue in the present case are only — and of medicinal products covered by health then, so to speak, only as part of an insurance systems. The directive is part of unchanged system — certain specific this process, standing as a 'first step' operational rules of the system that are towards 'further harmonisation' of those intended to secure compliance with general measures (sixth and seventh recitals) and principles of objectivity and transparency the progressive elimination of disparities for the purposes explicitly stated in the that exist between them, since these might directive and which, as I have said, are to 'hinder or distort intra-Community trade in '... ensure that all concerned can verify that medicinal products and thereby directly the national measures [governing inclusion affect the functioning of the common of medicinal products in national health market in medicinal products' (fourth reci- insurance systems] do not constitute quan- tal).
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27. I would add that these concerns — 29. Having eliminated this objection of which, I repeat, are those of the Commu- principle, let us turn to the principal nity legislature even before of the Commis- argument used by the defendant govern- sion — seem fully in line with the princi- ment, which is that the register kept by the ple, which the Court of Justice has consis- Austrian Federation under Article 133(2) tently enunciated, that, in exercising the of the ASVG cannot be regarded as a competence to organise their social security 'positive list' under Article 6 of the Direc- systems, the Member States must comply tive. with Community law. 6 Even more specifi- cally, those concerns reflect the position stated in Duphar (which in fact prompted the adoption of the Directive 7 ), where — with reference to the criteria laid down by a Member State for including reimbursable 30. As I have pointed out, the Austrian medicinal products in a limitative list — Government is relying here primarily on the Court clearly affirmed that Community the actual wording of the introductory law, in that instance Article 30 of the EC passage in Article 6 of which, for conve- Treaty (now, after amendment, Arti- nience, I shall quote again: 'The following cle 28 EC), requires those criteria to be provisions shall apply if a medicinal prod- objective and verifiable, 8 in order to pre- uct is covered by the national health vent any discrimination to the detriment of insurance system only after the competent imported products. authorities have decided to include the medicinal product concerned in a positive list of medicinal products covered by the national health insurance system' (my ita- lics). According to the defendant govern- ment, this wording means that the provi- sion applies only to national social insur- ance systems where reimbursement of medicinal products is allowed solely on those products included in a specific list. If this is not so, because — as in the case of 28. To conclude on this point therefore, it Austria — the costs can also be covered seems to me that the objection is not (even if on certain conditions) for medi- substantiated. Indeed, perhaps the defen- cines not included in the list, the circum- dant government must have been aware of stances described in Article 6 would not this if, in the course of the pre-litigation obtain. procedure, it adopted those rules of proce- dure which do in fact seem prompted by the intention of ensuring that the Austrian health insurance system complies with the principles of transparency and objectivity. 31.1 readily agree that this provision is not particularly well worded; but I do not 6 — For example, see Kohll, paragraph 19. 7 — See the Commission report accompanying the proposal for believe that this allows the inferences that the directive (COM(86) 765 final, of 23 December 1986, the Austrian Government draws from it. point II. 1). 8 — Judgment in Case 238/82 Duphar and Others [1984] Indeed, it seems clear to me that the logic of ECR 523, paragraphs 17 to 22. this provision, and the intention of the
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directive, cannot but mean that Article 6 is 33. However, for me the decisive factor is referring to all cases where inclusion of a that here we have a provision which is medicinal product in a list entails auto- intended to guarantee one of the corner- matic reimbursement of it. The fact that in stones of Community legislation, namely one Member State there is a register rather the free movement of goods. According to than a 'positive list', or that in that Member well-known and settled case-law, this State reimbursement is also under certain requires a broad interpretation of the conditions permitted for medicines not relevant requirement and, thus, an inter- included in the list, cannot detract from pretation which is not restrictive of its the only factor relevant here, which is, that scope or prejudicial to its efficacy. 9But to include a medicinal product in the list that is precisely the result that would be normally means that it is automatically achieved if the Austrian Government's reimbursed. That is in fact the supposition argument were accepted, for it would mean on which application of the directive is removing from the scope of Article 6 based; it is also why the directive requires, national health insurance systems which for the purpose stated in the sixth recital, essentially satisfy the conditions set out that inclusion in the list be attended with therein, with the additional risk of encoura- the maximum objectivity and transparency. ging Member States to evade, by means of formal and nominalistic arrangements, the obligations imposed in the directive, thereby prejudicing its efficacy.
34. In conclusion, I consider that the pro- 32. I believe that this is the only interpreta- visions of Article 6 of the Directive apply to tion of this provision which reconciles its a list, such as the register referred to in wording, which is open to discussion, with Article 133(2) of the ASVG, which guar- the declared intent of the directive. This antees acceptance by the national health interpretation is also supported by the insurance system of the medicinal products wording of Article 1(1) of the directive, included therein, even if that system also under which: 'Member States shall ensure that any national measure, whether laid down by law, regulation or administrative 9 — Amongst more recent precedents, see Case C-346/97 action, to... restrict the range of medicinal Braathens [1999] ECR I-3419, paragraph 24, and Case C-437/97 EKW and Wein & Co. [2000] ECR I-1157, products covered by their national health paragraph 41, with further references. Similarly, see also the consultative opinion of 24 Novemher 1998 from the Court insurance systems complies with the of the European Free Trade Association regarding Article 4 requirements of this Directive' (emphasis of the directive, on measures to freeze prices or medicinal products (Case E-2/98, FIS, Reports 172, in particular added). points 20 to 22).
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enables the cost of medicines not included by the health insurance system are taken in the list to be reimbursed under specific after a single administrative procedure'. conditions.
C — The time-limit within which the Fed- 37. At the hearing, the defendant govern- eration must adopt a decision regarding an ment's representative confirmed that this application to include a medicinal product was indeed how the Austrian system oper- in the register referred to in Article 133(2) ated in this regard, given that the Federa- of the ASVG tion examines the price for a medicinal product at the same time as the application to register it. The Commission has cast doubt on the correctness of that assertion. Yet it seems to me that it has been unable to 35. Turning now to the two specific objec- show either that examination of the price tions raised by the Commission, I shall for the medicinal product is not contem- begin with that relating to the disparity in poraneous with examination for inclusion the time-limits laid down in Article 6(1) of of the product in the register or that these the directive (90 days) and in Para- examinations are only occasionally con- graph 2(7)(a) of the rules of procedure temporaneous. (180 days) within which an application for inclusion of a medicinal product in a positive list and in the register, respectively, must be decided.
38. But it is well known that, in cases 36. In its defence, the Republic of Austria brought under Article 226 EC, 'it is incum- maintained that the time-limit of 180 days bent on the Commission to prove that the specified in the rules of procedure should obligation has not been fulfilled and to be held to comply with the directive since place before the Court the information the Federation's decision-making process necessary to enable it to determine whether on whether to include a product in the that is so'. 10 That has not occurred in the register entails overall monitoring of the present case and I therefore consider that in price at which the product is offered to that respect, the Commission's application insured persons. Now Article 6(1) of the cannot be upheld. directive allows the time-limit laid down therein to be extended by 90 days to a total of 180 days where 'a decision on the price 10 — For recent judgments, see those in Case C-96/98 Commis- sion v France [1999] ECR I-8531, paragraph 36, in Case of a medicinal product and a decision on its C-337/98 Commission v France [2000] ECR I-8377, inclusion within the list of products covered paragraph 45, and in Case C-55/99 Commission v France 2000] ECR I-11499, paragraph 30.
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39. However, I do consider the objection D — Remedies against decisions on appli- raised by the Commission at the hearing to cations to include medicinal products in the the provision in the rules of procedure register referred to in Article 133(2) of the which allows a possible 60-day extension ASVG of the 180-day time-limit, where an exces- sive administrative burden falls on the Federation's offices (see Article 2(7)(b) of the rules of procedure) to be substantiated. First, the directive makes no provision for this possibility and, secondly, the grounds for the extension cannot justify a deroga- tion from the maximum time-limit pre- 41. As I have indicated, the Commission scribed by the directive. As is well known, alleges finally that the Austrian system does the Court has consistently held that a not provide effective remedies for those Member State may not plead provisions, concerned, although Article 6(5) of the practices or circumstances of its own legal directive provides that any 'decision' to system in order to justify non-compliance exclude a medicinal product from the with the obligations laid down in a direc- positive list of products is to contain 'a tive. 11 statement of reasons based on objective and verifiable criteria... including, if appropri- ate, any expert opinions or recommenda- tions on which the decisions are based' and that the applicant is to be 'informed of the remedies available to him under the laws in force...'.
40. However, as I have indicated, the Commission in fact only raised the objec- 42. According to the Commission, the tion at the hearing; it clearly did not do so complaint against the initial opinion of in the reasoned opinion, since the Austrian the 'small technical advisory board' re- rules of procedure were not then available ferred to in Paragraph 2(4)(a) of the rules to it, but neither did it do so in the of procedure is not a remedy capable of application, nor throughout the written affording to those concerned genuine and part of the procedure. This objection being effective protection. Nor can it be held that therefore clearly substantially out of time, the condition is satisfied in that, where the it cannot, under the Court's Rules of small technical advisory board gives a Procedure (Article 42(2)), be taken into further negative opinion, the application consideration. The objection must there- for inclusion may be submitted to re- fore be declared inadmissible. examination by the 'main technical advi- sory board'. Although, as the Austrian Government objects, this body, just as the 11 — See, for example, Case C-42/89 Commission v Belgium [1990] ECR I-2821, paragraph 24, and Case C-71/97 small technical advisory board, consists of Commission v Spain [1998] ECR I-5991, paragraph 15. technical and professional persons entirely
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independent of the social insurance bodies, the Court's case-law under which, where a some appointed for a specified period and Community provision, as in the present others appointed for an unlimited period, case, requires the Member States to provide none the less these boards are still merely remedies against decisions by national' review bodies within the Federation rather authorities in order to protect rights stem- than truly independent judicial bodies and, ming from Community law, although that furthermore, do not have any real decision- provision leaves the State free to choose the making power, inasmuch as they can only appropriate methods for implementing the make recommendations. requirement, it has in contemplation some real 'system of judicial review' before independent courts and not administrative or similar appeals. 12In turn, this case-law is in fact simply the expression of a more general approach by the Court, guided by 43. The Austrian Government has respon- the notion that 'the requirement of judicial ded by stressing in particular the technical control of any decision of a national competence and the independence of the authority reflects a general principle of members of the main technical advisory Community law stemming from the con- board; reference was also made at the stitutional traditions common to the Mem- hearing, if I have understood aright, to ber States [which] has been enshrined in the Austrian tradition in the social insur- Articles 6 and 13 of the European Conven- ance sector, of providing for appeals to be tion for the Protection of Human Rights heard by administrative bodies consisting and Fundamental Freedoms'. 13 of professional persons rather than for judicial appeals, given the technical nature of the issues.
44. However, in requiring the applicant to be informed of his 'remedies', Article 6 of 46. It is therefore difficult to reconcile with the Directive is clearly referring to remedies this case-law a system which, like the affording full and effective protection of Austrian one, provides only for appeals to the rights of those concerned, that is to say, bodies that not only are not judicial in remedies of a judicial nature. The require- nature but also lack decision-making ment in that Article to provide a statement of the reasons for decisions whether to 12 — See Case C-120/97 Upjohn [1999] ECR I-223, para- include a medicinal product in the list is graph 2 9 , relating to Article 12 of Council Directive based on the supposition that it will be 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by Law, Regulation or Administra- possible for the decision to be submitted to tive Action relating to proprietary medicinal products (OJ, English Special Edition 1965-1966 (I), p. 20), which judicial review. provides that: 'Ail decisions [refusing, suspending or revoking marketing authorisations for proprietary medic- inal products] shall state in detail the reasons on which they are based. A decision shall be notified to the party concerned, who shall at the same time be informed of the remedies available to him under the laws in force and of the time-limit allowed for the exercise of such remedies'. 13 — Case C-97/91 Borelli v Commission [1992] ECR I-6313, 45. But, over and above that, it appears to paragraph 14, with further references, Case C-1/99 Kofisa Italia [20011 ECR I-207, p a r a g r a p h 4 6 , a n d Case me to be of decisive importance to recall C-226/99 Siples [2001] ECR I-277, paragraph 17.
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power, since they can only give opinions or IV — Costs make recommendations, the final decision being reserved to the Federation.
48. Under Article 69(2) of the Rules of Procedure, the unsuccessful party is to be 47. Given the foregoing, I have to conclude ordered to pay the costs if they have been that, on this point, the Republic of Austria applied for in the successful party's plead- has failed to fulfil its obligations under ings. Since the Commission has asked for Article 6(2) of the Directive and that, costs to be awarded in its favour and in therefore, albeit on this more limited view of my considerations concerning ground, the Commission's action must be determination of the action, I consider that upheld. the application for costs should be granted.
V — Conclusion
49. In light of the foregoing considerations, I therefore propose that the Court should declare that:
(1) By failing to adopt all the laws, regulations and administrative provisions for complete transposition of Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of national health insurance systems, the Republic of Austria has failed to fulfil its obligations under the EC Treaty.
(2) The Republic of Austria is ordered to pay the costs.
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