CELEX: 62003CC0245
Language: en
Date: 2004-09-30 00:00:00
Title: Joined opinion of Mr Advocate General Tizzano delivered on 30 September 2004. # Merck, Sharp & Dohme BV v Belgian State. # Reference for a preliminary ruling: Conseil d'État - Belgium. # Directive 89/105/EEC - Medicinal products for human use - Application for entry on a positive list - Nature of the time-limit for responding - Mandatory nature - Consequences of exceeding the time-limit. # Case C-245/03. # Glaxosmithkline SA v Belgian State. # Reference for a preliminary ruling: Conseil d'État - Belgium. # Directive 89/105/EEC - Medicinal products for human use - Application for entry on a positive list - Nature of the time-limit for responding - Mandatory nature - Consequences of exceeding the time-limit where a decision refusing entry is annulled. # Case C-296/03.

OPINION OF ADVOCATE GENERALTIZZANOdelivered on 30 September 2004(1)
         Case C-245/03Merck, Sharp & Dome B.V. v Belgian State (Reference for a preliminary ruling from the Conseil d'État (Belgium))Case C-296/03S.A. GlaxoSmithKline v Belgian State (Reference for a preliminary ruling from the Conseil d'État (Belgium))
            (Directive 89/105/EEC  –  Medicinal products for human use  –  Inclusion in a positive list of reimbursable medicinal products  –  Application for inclusion  –  Time-limit for the reply  –  Nature  –  Effects of expiry)
            
      
         
        1.        By two separate orders the Conseil d’État (Council of State), Belgium, has referred two questions to the Court of Justice
      for preliminary rulings concerning Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures
      regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems
      
         			(2)
         		 (hereinafter ‘Directive 89/105/EEC’ or ‘the Directive’), in particular Article 6 thereof on the procedure for including such
      products in the lists of medicinal products covered by such systems. 
      
      
        2.        In both cases the Conseil d’État is essentially seeking the guidance of the Court of Justice as to the nature of the time-limit
      laid down in the Directive by which the national authorities are required to issue decisions on applications for the inclusion
      of medicinal products on such lists and the effect of the time-limit expiring without a decision having been issued.
      
      
      I –   Legislative framework 
      
       A –  Community law 
      
        3.        By Directive 89/105/EEC the legislator has taken a ‘first step’ towards the removal of obstacles to intra-Community trade
      in medicinal products resulting from the disparities between measures taken by the Member States ‘in order to control public
      health expenditure’ (second, fourth and sixth recitals).
      
      
        4.        That ‘first step’ consists in the adoption of several measures, the objective of which is not to ‘affect national policies
      on price setting and on the determination of social security schemes’ but merely to ensure transparency of measures relating
      to the marketing of medicinal products so that the parties concerned ‘can verify that the national measures do not constitute
      quantitative restrictions on imports or exports or measures having equivalent effect thereto’ (sixth recital).
      
      
        5.        In the present case particular regard should be had to Article 6(1) which reads as follows:
      ‘The following provisions shall apply if a medicinal product is covered by the national health insurance system only after
      the competent authorities have decided to include the medicinal product concerned in a positive list of medicinal products
      covered by the national health insurance system. 
       1.       Member States shall ensure that a decision on an application submitted, in accordance with the requirements laid down in the
      Member State concerned, by the holder of a marketing authorisation to include a medicinal product in the list of medicinal
      products covered by the health insurance systems is adopted and communicated to the applicant within 90 days of its receipt.
      Where an application under this article may be made before the competent authorities have agreed the price to be charged for
      the product pursuant to Article 2, or where a decision on the price of a medicinal product and a decision on its inclusion
      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 information supporting the application is inadequate, the time-limit shall be suspended and the competent authorities
      shall forthwith notify the applicant of what detailed additional information is required.
                …’
      
      
        6.        Article 6(2) provides as follows:
      ‘2.     Any decision not to include a medicinal product in the list of products covered by the health insurance system shall contain
      a statement of reasons based upon objective and verifiable criteria, including, if appropriate, any expert opinions or recommendations
      on which the decision is based. In addition, the applicant shall be informed of the remedies available to him under the laws
      in force and of the time-limits allowed for applying for such remedies’.
      
      
       B –  National law 
       Case C-245/03, Merck 
      
        7.        At the time of the facts in Case C-245/03, under Belgian law the inclusion of medicinal products on the list of reimbursable
      medicinal products was governed by the Law of 9 August 1963 and by the Royal Decree of 2 September 1980.
      
      
        8.        It is sufficient for the purposes of this case to point out that the provisions in force at the time in question did not confer
      definite legal effects on the expiry of the time-limit provided for in Article 6 of the Directive. It is clear from the case-file,
      however, that even when that time-limit had expired, the authorities still had the power to allow or refuse an application
      for inclusion.
      
      
        9.        Pursuant to the general rules of Belgian administrative law, however, where an application has been submitted to an administrative
      authority which fails to make a decision within the time-limit provided for in law, the applicant may give formal notice to
      the authority concerned to make a decision within four months. At the end of that period, the application is deemed to have
      been refused and the applicant is able to challenge the implied refusal in the administrative courts. 
         			(3)
         		 Case C-296/03, GlaxoSmithKline 
      
      
        10.      At the time of the facts in Case C-296/03 the national legal framework described above had changed. The approval of medicinal
      products for reimbursement was now governed by the Law of 14 July 1994, 
         			(4)
         		 as amended and enacted by the Law of 10 August 2001 
         			(5)
         		 and the Royal Decree of 21 December 2001 
         			(6)
         		 respectively.
      
      
        11.      Under the new provisions, the purpose of whose adoption was to transpose the Directive fully into Belgian law, when an application
      to include a medicinal product is submitted, the competent authorities have a period of 180 days to make a recommendation.
      In the absence of any express decision at the end of that period, the application is deemed to have been approved under the
      terms proposed by the applicant (Article 35a(3)).
      
      
      II –   Facts and procedure 
       In Case C-245/03, Merck 
      
        12.      On 2 February 1993 Merck, Sharp & Dome, a company incorporated under Netherlands law and active in the production and marketing
      of medicinal products (‘Merck’), applied to the Belgian authorities for approval for reimbursement in respect of the proprietary
      medicinal product Proscar.
      
      
        13.      Following a lengthy administrative procedure during which various competent technical bodies gave opinions opposing approval,
      on 27 February 1995 the Minister for Social Affairs and Pensions informed Merck of his own decision to reject the application.
      
      
      
        14.      Having instituted legal proceedings, on 7 June 1996 Merck obtained an annulment of that decision from the Conseil d’État on
      the ground that it had been taken not by the King, who is the competent person in the matter, but by the Minister.
      
      
        15.      Merck then gave the administrative authorities formal notice to comply with that ruling and include Proscar on the basis of
      the application made in 1993.
      
      
        16.      The expiry of the four-month time-limit given in the letter of formal notice without a decision being made amounted to an
      implied refusal of the application. That refusal was the subject of further proceedings by Merck before the Conseil d’État
      which, because of uncertainties as to the interpretation of the Directive, stayed the proceedings and referred the following
      question to the Court of Justice for a preliminary ruling:
      ‘Must the time-limit of 90 days, which may be extended for a further 90 days, mentioned in the first subparagraph of Article
      6(1) of Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the prices of
      medicinal products for human use and their inclusion in the scope of national health insurance systems, be regarded as a merely
      indicative time-limit or as a mandatory time-limit and, if the time-limit is mandatory, what are the consequences of exceeding
      it as regards the response to be given to the application for inclusion of a medicinal product in the list of medicinal products
      covered by the health insurance system?
       Must exceeding the time-limit be deemed to constitute inclusion in the abovementioned list?’
      
      
        17.      Written observations in the proceedings to which that question gave rise have been submitted by Merck, the Belgian, Danish,
      Finnish, Netherlands and Norwegian Governments and the Commission.
      
      
        18.      Merck, the Belgian and Finnish Governments and the Commission also made submissions at the hearing of 14 July 2004.
       Case C-296/03, GlaxoSmithKline 
      
      
        19.      On 3 December 2001 GlaxoSmithKline S.A., also a company active in the production and marketing of medicinal products (‘Glaxo’),
      applied to the Belgian authorities for the inclusion of the vaccine Infanrix hexa on the list of reimbursable products. That
      application, as submitted and supplemented on 1 and 22 January 2002, was refused by the Belgian authorities on 27 June that
      year. 
      
      
        20.      Glaxo then brought proceedings before the Conseil d’État which annulled that refusal on 11 December 2002 on the grounds that
      it was based on inaccurate material facts and that the statement of reasons was inadequate. 
      
      
        21.      On the strength of that ruling, on 7 January 2003 Glaxo asked the administrative authorities to include their medicinal product.
      According to Glaxo, the time-limit allowed in law for determining approval for reimbursement had already expired. That precluded
      the competent authorities from being able to make a further decision on the application, which therefore had to be deemed
      to be implicitly accepted.
      
      
        22.      The Belgian authorities, however, took another view, and decided that after the annulment of the first decision, they had
      a further time-limit in law by which to make a decision on the inclusion on the list of the medicinal product. Consequently,
      on 17 January 2003, the Belgian authorities informed Glaxo of a second refusal and provided a better statement of reasons.
      
      
        23.      The new decision was also contested before the Conseil d’État, which referred the following question to the Court of Justice
      for a preliminary ruling pursuant to Article 234 EC:
      ‘Must the time-limit of 90 days, which may be extended for a further 90 days, referred to in the first subparagraph of Article
      6(1) of Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the prices of
      medicinal products for human use and their inclusion in the scope of national health insurance systems be considered to be
      a strict time-limit precluding, upon expiry, the adoption of any decision, even where an initial decision adopted timeously
      has been annulled?’
      
      
        24.      Written observations in the proceedings to which that question gave rise have been submitted by Glaxo, the Belgian, Danish,
      Netherlands and Norwegian Governments and the Commission.
      
      
        25.      Glaxo, the Belgian and Finnish Governments and the Commission also made submissions at the hearing of 14 July 2004.
      
      
      III –   Legal analysis 
      
        26.      As we have seen, in both cases the Conseil d’État is seeking a ruling from the Court of Justice on the interpretation of Article
      6 of Directive 89/105/EEC, which provides for a time-limit of 90 days (which may be extended by a further 90 days) by which
      the competent national authorities must make a decision on applications for inclusion of a medicinal product in a positive
      list of medicinal products covered by the national health insurance system.
      
      
        27.      The referring court is particularly seeking guidance from the Court of Justice as to: (a) whether that time-limit is mandatory
      or merely indicative; (b) the consequences of the expiry of that time-limit where (i) the competent authority has not made
      any decision whatever within the time-limits and (ii) the competent authority adopted an initial decision within the time-limits
      which was later annulled in legal proceedings.
      
      
        28.      As the central issues in the two cases broadly overlap, I shall examine them jointly; first, however, I shall briefly assess
      the jurisdiction of the Court of Justice, contested by Glaxo in its written observations, to give a ruling in Case C-296/03.
      
      
        Jurisdiction of the Court of Justice to give a ruling in Case C-296/03 
      
      
        29.      As pointed out above, Glaxo first contests the admissibility of the reference in Case C-296/03. It is of the view that a reply
      by the Court of Justice to the question referred is not necessary for resolving the main proceedings. It considers that the
      outcome of the case will clearly be based on Article 35a(3) of the Law of 14 July 1994, which not only provides beyond the
      shadow of a doubt for a mandatory time-limit but also states that infringement of that provision results in the automatic
      inclusion of the medicinal product concerned in the list of reimbursable medicinal products. It is therefore not necessary
      to examine Community law for an outcome which will clearly become apparent on the basis of national law.
      
      
        30.      In my view that argument cannot be accepted.
      
      
        31.      It is settled case-law that only in exceptional cases where ‘it is quite obvious that the ruling sought by that court on the
      interpretation or validity of Community law bears no relation to the actual facts of the main action or its purpose, [or]
      where the problem is hypothetical’ 
         			(7)
         		 does the Court of Justice have no jurisdiction to reply to a question referred for a preliminary ruling by a national court.
      
      
        32.      I am not of the opinion that those conditions are satisfied in the case at hand. In Case C-296/03 the subject-matter of the
      main proceedings relates in fact to the effect of the procedural time-limit provided for in Article 6 of the Directive, which
      was ultimately transposed into Belgian law by the Law of 10 August 2001. The interpretation of the Community rule therefore
      seems to be  clearly  related to the subject-matter of the main proceedings and is  manifestly  relevant to the outcome of those proceedings.
      
      
        33.      Furthermore, in contrast to the argument put forward by Glaxo, I am not of the opinion that the new provision  clearly  resolves all the issues raised by the Conseil d’État in Case C-296/03. The national court does not specifically give a view
      on the consequences of the 180-day time-limit being exceeded in the event that a decision adopted timeously is annulled, and
      that is the essential issue in the question referred in that case.
      
      
        34.      I am therefore of the view that the Court has jurisdiction to reply to the question referred for a preliminary ruling by the
      Conseil d’État in Case C‑296/03, and I will now examine that question together with the question referred in Case C-245/03.
      
        Mandatory nature of the time-limit provided for in Article 6 of the Directive  
      
      
        35.      On this point I believe I am able to concur with the solution proposed by Merck, the Danish, Finnish, Netherlands and Norwegian
      Governments and the Commission, which argue that the time-limit is mandatory in nature and that therefore the national authorities
      are required to make a decision on applications for inclusion on the list of reimbursable proprietary medicinal products within
      a period of 90 days which may, in the circumstances provided for in the Directive itself, be extended by a further 90 days.
      
      
        36.      It is my view that that interpretation is clear from the wording and structure of Article 6.
      
      
        37.      In so far as the wording of Article 6 is concerned, that article clearly states that ‘Member States shall ensure that a decision
      … is adopted and communicated to the applicant within 90 days of its receipt.’ 
      
      
        38.      In my opinion, the use of the verb ‘ensure’ in the indicative mood and the precise description of the length of the time-limit
      and the day from which it is to be calculated serve to indicate that the Member States are subject to a strict requirement
      to make a decision within the time-limits provided for. The wording as it stands is difficult to reconcile with the idea that
      the national authorities may be able to disregard such a precisely described time-limit. 
      
      
        39.      In addition, however, to the signals inherent in the wording, this interpretation appears to be borne out by the structure
      of Article 6 as well, which specifically provides for extending and suspending the time-limit in question. Indeed, the article
      states that ‘where an application … may be made before the competent authorities have agreed the price to be charged for the
      product … , or where a decision on the price of a medicinal product and a decision on [approval for reimbursement] are taken
      after a single administrative procedure, the time-limit shall be extended for a further 90 days’. It goes on to say that ‘the
      time-limit shall be suspended’ ‘if the information supporting the application is inadequate’.
      
      
        40.      It seems to me that a clear description such as that given in Article 6 of the circumstances for extending and suspending
      the time-limit is also difficult to reconcile with the idea that the Member States are free to extend or simply to disregard
      the time-limit, even where the circumstances expressly provided for do not obtain.
      
      
        41.      I note, too, that this reading of the article appears to be consistent with the essential purpose of the Directive, which
      is to allow ‘the persons concerned [to] verify that the official entry of medicinal products on the list corresponds to objective
      criteria and that there is no discrimination between national medicinal products and those from other Member States’. 
         			(8)
         		
      
        42.      Were the States able freely to exceed the time-limit provided for in the contested provision, the persons concerned would
      not be in a position to ascertain whether the procedures and decisions relating to their applications were proceeding on objective
      criteria and, more particularly, whether those procedures and decisions were being drawn out for reasons associated with the
      non-national origin of the medicinal products in question. Pharmaceutical firms from other Member States would be unable to
      make a definitive assessment as to whether procedures were transparent because the length of time involved would be at the
      discretion of the national authorities.
      
      
        43.      On this point, therefore, I conclude that the time-limit of 90 days, which may be extended for a further 90 days, mentioned
      in the first subparagraph of Article 6(1), must be regarded as a mandatory time-limit.
      
        Consequences of exceeding the time-limit where no decision has been taken  
      
      
        44.      Having reached that conclusion, we should examine the consequences of that mandatory time-limit expiring where no decision
      has been made by the competent authorities. In particular, it must be established whether in such circumstances the application
      to include the medicinal product should be deemed to have been implicitly accepted, resulting in the automatic inclusion of
      the product concerned in the list of medicinal products covered by the national health insurance system. 
      
      
        45.      Merck argues that the reply to that question should be in the affirmative. It maintains that exceeding the time-limit entails
      implied acceptance of the application for reimbursement and places the national authority under an obligation to confirm that
      acceptance by adopting a merely declarative decision. Merck maintains that that is the only outcome which would make it possible
      to safeguard the effectiveness of the Directive, the objective of which is precisely to prevent the creation of barriers to
      the free movement of medicinal products within the Community.
      
      
        46.      The Belgian, Danish, Finnish, Netherlands and Norwegian Governments and the Commission, however, are of a different view and
      rule out the possibility of expiry of the time-limit resulting in automatic inclusion of a medicinal product in the list of
      reimbursable products.
      
      
        47.      The Commission in particular, while acknowledging that automatic inclusion is a particularly effective means of implementing
      the Directive, observes that where it was intended that failure to comply with a time-limit would be penalised by automatic
      acceptance of an application, that intention was expressly stated in the Directive (Article 2(1) and Article 3(1)). The absence
      of a provision to that effect in respect of applications for approval for reimbursement therefore demonstrates that it was
      not the legislator’s intention for such a penalty to be imposed on States in that particular circumstance.
      
      
        48.      The Finnish and Norwegian Governments add that to allow automatic inclusion of a medicinal product when the time-limit expires
      might undermine national social security policies, which fall within the exclusive competence of the Member States. It would
      restrict the power of States to determine which medicinal products were to be covered under national health insurance systems.
      
      
        49.      For my part, I shall first recall that Article 6(1) of the Directive places the Member States under a clear and precise obligation
      to ensure that ‘a decision [on reimbursement] … is adopted and communicated to the applicant’ within a time-limit of 90 days
      (which may, in the circumstances provided for, be extended for a further 90 days).
      
      
        50.      I note also, as all the parties taking part in these proceedings have done, that the Directive contains no provisions relating
      to failure to fulfil that obligation, thereby leaving open the question whether automatic consequences can be inferred when
      the time-limit in question expires.
      
      
        51.      Conflicting arguments have been put forward on that point, with some arguing that expiry entails implied rejection of an application
      for reimbursement (the absence of a reply is to be taken as a refusal) and some that it entails automatic acceptance of such
      an application (the absence of a reply is to be taken as consent).
      
      
        52.      Taking the latter argument first, I should say straight away that taking the absence of a reply as consent would undoubtedly
      be an effective means of implementing the requirement to take a decision within 180 days. Indeed, that very device was introduced
      by Belgium under the Law of 10 August 2001 and, on the basis of the statements made by Belgium at the hearing, it has not
      only secured an implied decision for those persons concerned where the authorities have not made a decision within the time-limits,
      but has also led the authorities to reorganise themselves so that they are nearly always able to make a decision within the
      prescribed time-limits. 
      
      
        53.      That is not, however, the issue raised here. As Merck states, the point at issue is whether,  where there is no provision to that effect in national legislation,  Article 6 of the Directive requires that the consequence of exceeding the time-limit in question is implied acceptance of
      the application for reimbursement. 
      
      
        54.      Analysis of the scheme and the purposes of the Directive, however, over and above the fact that there is no express indication
      to that effect in the Directive, as we have seen, leads me to rule out that outcome.
      
      
        55.      Examination of other provisions of the Directive makes it apparent that where it was intended that failure to comply with
      a time-limit would be penalised by automatic acceptance of an application, that intention was expressly stated in the Directive.
      
      
        56.      Thus Article 2(1), on applications for setting the price at which medicinal products may be marketed, provides that ‘in the
      absence of … a decision within the abovementioned period or periods the applicant shall be entitled to market the product
      at the price proposed’. 
      
      
        57.      Similarly, the third subparagraph of Article 3(1), referring to applications to increase the price of a medicinal product
      already on the market provides that ‘in the absence of … a decision within the abovementioned period or periods, the applicant
      shall be entitled to apply in full the price increase requested’.
      
      
        58.      As the Commission has rightly pointed out, in that context it seems reasonable to interpret the absence in Article 6 of a
      provision on the absence of a reply being taken as consent as a deliberate choice on the part of the legislator not to impose
      a consequence of that kind directly on the Member States where procedures for approval for reimbursement are concerned.
      
      
        59.      Moreover, providing for the absence of a reply to be taken as consent only in respect of applications for setting prices and
      not for applications for approval for reimbursement appears wholly justifiable and consistent with the purposes of the Directive.
      Whereas tacit approval of the former has no repercussions whatever for the budgets of the national health systems, implied
      acceptance of the latter would have significant consequences in that regard. The Member States would be in the position of
      having to pay reimbursement in respect of certain medicinal products, and moreover would be in that position even before it
      had been ascertained whether those products satisfied the requirements laid down for that purpose. It should therefore be
      of no surprise that the Community legislator, who seems to move very cautiously in this field (see points 3 and 4 above) in
      order to prevent undue encroachment upon national powers (sixth recital) did not provide in the Directive for the absence
      of a reply to be taken as consent in respect of procedures concerning reimbursement.
      
      
        60.      In view of the foregoing I have come to the conclusion that where the Member States have not made a provision to that effect
      when transposing the Directive, Article 6 of the Directive does not require implied acceptance of the application for reimbursement
      to be the consequence of exceeding the time-limit in question.
      
      
        61.      Moving on to the argument that expiry of the time-limit in question without a decision having been made should in contrast
      be treated in the same way as rejection of the application for reimbursement (the absence of a reply is to be taken as a refusal),
      the immediate objection might be that that outcome seems to be precluded by the Directive itself. Article 6(2) of the Directive
      provides as follows: ‘any decision not to include a medicinal product in the list of products covered by the health insurance
      system shall contain a statement of reasons based upon objective and verifiable criteria’. An implied refusal would therefore
      run counter to the wording of that subparagraph in so far as it could not contain a statement of either the reasons for non-approval
      of reimbursement or the criteria upon which it is based. 
      
      
        62.      It really appears to me that that contention is slightly over-formalistic and fails to have regard to the fact that the requirement
      of a statement of reasons can only be complied with, obviously, where a decision rejecting an application is made, not where
      no reply is given. Moreover it could be observed that, once the possibility of its being regarded as tacit assent has been
      ruled out, the absence of a decision within the established time-limits produces in practice the same results as a refusal.
      
      
      
        63.      It is true, however, that the possibility of expressly treating the absence of a decision in the same way as an implied rejection
      raises serious, well-founded concerns because as a general rule an outcome of that kind ought to be explicitly provided for
      in the legislation and therefore ought not to have to be inferred by way of an interpretation.
      
      
        64.      In any event, whether it is interpreted as an implied rejection or as a failure to comply with the obligation to adopt a decision,
      expiry of the time-limit without a decision having been made constitutes, in my opinion, unlawful conduct. As such it must
      be noted that that conduct may be directly challenged as provided for in national law and may therefore open the way to an
      action for damages, also as provided for in national law or, in the absence of any such law in that regard, Community law.
      
      
        65.      I note that the Court has consistently held that under Article 10 EC ‘the Member States are required to take all appropriate
      measures, whether general or particular, to ensure fulfilment of their obligations under Community law’, in particular those
      measures necessary in order to ‘nullify the unlawful consequences of a breach of Community law’. 
         			(9)
         		
      
        66.      In particular, it follows from that case-law that in order to ensure ‘the full effectiveness of Community rules’, States are
      to grant individuals the opportunity ‘to obtain redress when their rights are infringed by a breach of Community law for which
      a Member State can be held responsible’; 
         			(10)
         		 failure by national authorities to comply with the time-limit laid down under Article 6 of the Directive is just such a breach.
      
      
      
        67.      Finally, as the Commission notes in its written observations, there is also the possibility of bringing an action against
      the defaulting State pursuant to Article 226 EC for breach of the obligations imposed by Directive 89/105/EEC. Inappropriate
      though such proceedings may appear to be (in terms of time and procedure) for satisfying the requirements of the persons concerned,
      recourse to such action might none the less persuade the Member States to organise themselves better so as to be able to make
      a decision on reimbursement in respect of medicinal products within the time-limits provided for.
      
      
        68.      In view of the foregoing, I therefore propose that the reply to the question referred in Case C-245/03 should be to the effect
      that the time-limit of 90 days, which may be extended for a further 90 days, mentioned in the first subparagraph of Article
      6(1), must be regarded as a mandatory time-limit.
      
      
        69.      Failure to comply with that time-limit therefore constitutes unlawful conduct which is subject to the penalties provided for
      in national and Community law.
      
      
        70.      By contrast, expiry of the time-limit without a decision having been made does not, unless the Member State has provided otherwise
      when transposing the Directive, result in automatic inclusion of a medicinal product on the list of products covered under
      the health insurance system.
      
        The consequences of exceeding the time-limit where an initial decision adopted timeously has been annulled  
      
      
        71.      Before replying to the Conseil d’État we must first ascertain the consequences of exceeding the time-limit provided for in
      Article 6 of the Directive where the competent national authorities had timeously adopted an initial decision on approval
      for reimbursement which was later annulled in legal proceedings. In particular, it must be established whether in such circumstances
      the expiry of the time-limit precludes the adoption of a further decision replacing the decision which was annulled.
      
      
        72.      Glaxo, the Netherlands and Danish Governments and the Commission are of the view that Directive 89/105/EEC does not determine
      the consequences of exceeding the time-limit where the decisions in question have been annulled by the courts.
      
      
        73.      In the view of Glaxo, such situations are governed instead by national law, which does not allow a further decision to be
      adopted and therefore can result only in implied acceptance of the application for reimbursement which was originally proposed.
      
      
        74.      The reading of national law given by the Belgian Government is the complete reverse of this: the Belgian Government considers,
      as does the Finnish Government, that where an initial decision adopted timeously has been annulled, the competent authorities
      have a further time-limit in law in which to make a decision on approval for reimbursement.
      
      
        75.      The Commission points out for its part that there is no general principle of Community law which imposes the legal consequences
      proposed by Glaxo or those suggested by the Belgian Government. It is of the view that under Community law as it stands at
      present it is for national law to determine the effects of the annulment of the decisions at issue here.
      
      
        76.      It refers in that regard to the well-known case-law of the Court stating that in the absence of specific Community rules governing
      a matter, it is for the legal system of each Member State to lay down the procedural rules governing actions for safeguarding
      rights which individuals derive from Community provisions with direct effect. Such rules, however, ‘must not be less favourable
      than those governing similar domestic actions nor render virtually impossible or excessively difficult the exercise of rights
      conferred by Community law’. 
         			(11)
         		
      
        77.      Looking at the issue from that standpoint, I note that Article 6 of Directive 89/105/EEC governs only some aspects of the
       administrative  procedure for the inclusion of medicinal products among the reimbursable products; it says nothing in regard to the subsequent
      stage initiated by an action against the decision which brings that procedure to an end.
      
      
        78.      Indeed:
      –         Article 6(1) lays down clearly and precisely the time-limit within which a decision on the application for reimbursement is
      to be adopted and communicated, and it also refers to the suspension and extension of that time-limit;
      –         Article 6(2) identifies some of the requirements of the decision, stating that the decision is to be accompanied by the reasons
      for it and information stating the ‘remedies available to [the applicant]  under the laws in force  and … the time-limits allowed for applying for such remedies’. 
         			(12)
         		
      
        79.      Consequently, as the Commission has rightly noted and as is clear from the wording of Article 6(2), it is for Belgian procedural
      law to lay down how the decisions in question can be challenged, and in particular the consequences of the annulment of such
      decisions. It is therefore in the light of national law that it must be determined whether, as Glaxo argues, upon the expiry
      of the period of 180 days following the submission of the application a further decision on reimbursement is precluded, or
      whether by contrast, as the Belgian Government maintains, a further time-limit for a second decision runs as from the annulment.
      
      
        80.      I am, however, of the view that even if domestic law were to allow the adoption of a further decision, Community law would
      impose a restriction on the Member States’ discretion in the matter to the effect that the further decision could not be taken
      indefinitely, but would have to be taken within a reasonable time and in any event within a period similar to but not exceeding
      the period of time provided for in Article 6.
      
      
        81.      In the absence of such a restriction it would be ‘excessively difficult’ for the persons concerned to exercise their right
      to obtain a reasoned decision within the mandatory time-limit of 90 days (which may be extended by a further 90 days). The
      Member States would be able to lay down a time-limit for enforcing a ruling longer than that provided for in the Directive
      in respect of the conclusion of the administrative procedure. However, were that the case, the annulment would in no way safeguard
      the right referred to above of the persons concerned; indeed, it would place them in a much worse situation than the one they
      faced prior to the administrative ruling being given.
      
      
        82.      In view of the foregoing I therefore propose that the reply to the Conseil d’État in Case C-296/03 should be that Article
      6 of Directive 89/105/EEC does not determine the effects of the annulment of decisions on the inclusion of medicinal products
      in the lists of products covered by the national health insurance systems.
      
      
        83.      It is therefore for domestic law to determine whether, where a decision adopted timeously is annulled, the expiry of the original
      time-limit precludes the competent authorities from adopting a further decision.
      
      
        84.      Where, however, domestic law allows the adoption of a further decision, that decision is to be taken within a reasonable time-limit
      and in any event within a period of time similar to but not exceeding the period of time provided for in Article 6.
      
       
      IV –   Conclusion 
       In view of the foregoing, I propose that the reply to be given by the Court to the Conseil d’État should be as follows: 
      – In Case C-245/03
       The time-limit of 90 days, which may be extended for a further 90 days, mentioned in the first subparagraph of Article 6(1)
      of Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the prices of medicinal
      products for human use and their inclusion in the scope of national health insurance systems must be regarded as a mandatory
      time-limit.
       Failure to comply with that time-limit therefore constitutes unlawful conduct which is subject to the penalties provided for
      by national and Community law.
       By contrast, expiry of the time-limit without a decision having been made does not, unless the Member State has provided otherwise
      when transposing the Directive, result in automatic inclusion of a medicinal product on the list of products covered under
      the health insurance system.
      – In Case C-296/03
       Article 6(1) of Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the prices
      of medicinal products for human use and their inclusion in the scope of national health insurance systems does not determine
      the effects of the annulment of decisions on the inclusion of medicinal products on the lists of products covered by the national
      health insurance systems.
       It is therefore for domestic law to determine whether, where a decision adopted timeously is annulled, the expiry of the original
      time-limit precludes the competent authorities from adopting a further decision.
       Where, however, domestic law allows the adoption of a further decision, that decision is to be taken within a reasonable time-limit
      and in any event within a period of time similar to but not exceeding the period of time provided for in Article 6.
      
       1 –
         
         Original language: Italian.
      
      2 –
         
         OJ 1989 L 40, p. 8.
            
         
      
      3 –
         
         See Article 14 of the consolidated laws on the Conseil d’État.
            
         
      
      4 –
         
         Law of 14 July 1994 on compulsory insurance, health care and reimbursement.
            
         
      
      5 –
         
         Law of 10 August 2001 on health care measures.
            
         
      
      6 –
         
         Royal Decree of 21 December 2001 laying down the procedures, time-limits and conditions concerning assistance under compulsory
            health insurance, health care and reimbursement of the cost of proprietary medicinal products.
            
         
      
      7 –
         
         Case C-36/99  Idéal  tourisme  [2000] ECR I-6049, paragraph 20. See also Case C-343/90  Lourenço Dias  [1992] ECR I-4673, paragraphs 17 and 18; Case C-83/91  Meilicke  [1992] ECR I‑4871, paragraph 25; Case C-415/93  Bosman  and  Others  [1995] ECR I‑4921, paragraph 61, and Case C-437/97  EKW and Wein & Co.  [2000] ECR I‑1157, paragraph 52.
            
         
      
      8 –
         
         Case C-229/00  Commission  v  Finland  [2003] ECR I‑5727, paragraph 39.
            
         
      
      9 –
         
         See Case 6/60  Humblet  [1960] ECR 559, and Joined Cases C-6/90 and C-9/90  Francovich  and  Others  [1991] ECR I‑5357, paragraph 36.
            
         
      
      10 –
         
         . Francovich , paragraph 33. On the principle of Member State liability for a breach of Community law and the conditions for such liability
            see also Joined Cases C-46/93 and C-48/93  Brasserie  du  Pêcheur  and  Factortame  and  Others  [1996] ECR I-1029; Case C-392/93  British Telecommunications  [1996] ECR I-1631; Joined Cases C‑178/94, C‑179/94, C-188/94, C‑189/94 and C-190/94  Dillenkofer  and  Others  [1996] ECR I‑4845; and Case C-5/94  Hedley Lomas  [1996] ECR I-2553.
            
         
      
      11 –
         
         Case C-312/93  Peterbroeck  [1995] ECR I‑4599, paragraph 12. See also Case 33/76  Rewe  [1976] ECR 1989, paragraph 5; Case 45/76  Comet  [1976] ECR 2043, paragraphs 12 to 16; Case 68/79  Just  [1980] ECR 501, paragraph 25; Case 199/82  San Giorgio  [1983] ECR 3595, paragraph 14; Joined Cases 331/85, 376/85 and 378/85  Bianco  and  Girard  [1988] ECR 1099, paragraph 12; Case 104/86  Commission  v  Italy  [1988] ECR 1799, paragraph 7; Joined Cases 123/87 and 330/87  Jeunehomme and Others  [1988] ECR 4517, paragraph 17; Case C-96/91  Commission  v  Spain  [1992] ECR I-3789, paragraph 12; and  Francovich , paragraph 43.
            
         
      
      12 –
         
         My italics.