CELEX: 62000CJ0229
Language: en
Date: 2003-06-12
Title: Judgment of the Court (Sixth Chamber) of 12 June 2003. # Commission of the European Communities v République de Finlande. # Failure of a Member State to fulfil obligations - Directive 89/105/EEC - Failure to apply the procedure prescribed in Article 6 of that directive to decisions determining the categories of medicinal products qualifying for higher-rate cover - Failure to provide objective and verifiable grounds for negative decisions. # Case C-229/00.

Case C-229/00 Commission of the European CommunitiesvRepublic of Finland
            «(Failure of a Member State to fulfil obligations – Directive 89/105/EEC – Failure to apply the procedure prescribed in Article 6 of that directive to decisions determining the categories of medicinal
               products qualifying for higher-rate cover – Failure to provide objective and verifiable grounds for negative decisions)»
            
            
               
                  Opinion of Advocate General Tizzano delivered on 11 July 2002 
                     
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                  Judgment of the Court (Sixth Chamber), 12 June 2003  
                     
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            Summary of the Judgment
         
         
                  1..
                  Approximation of laws – Medicinal products – Directive 89/105 – Medicinal products for human use – Positive list of medicinal products covered by a national sickness insurance scheme – Obligation of the Member States to apply the procedure laid down in Article 6 to decisions establishing categories of medicinal
                     products qualifying for higher-rate cover  
                  (Council Directive 89/105, sixth recital, Arts 1 and 6(1)) 
         
                  2..
                  Actions for failure to fulfil obligations – Proof of failure – Burden on Commission – Submission of evidence that the obligation has not been fulfilled  (Art. 226 EC; Council Directive 89/105) 
         
         1.
          The purpose of Directive 89/105 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, according to Article 1 thereof, is to ensure that
         any national measure to control the prices of medicinal products for human use or to restrict the range of medicinal products
         covered by their national sickness insurance systems complies with the requirements of that directive. The decisions pursuant
         to which certain medicinal products qualify for higher-rate cover constitute a means of determining the extent of the range
         of medicinal products covered by the sickness insurance scheme and likely to be used in the treatment of such or such an illness.
          Moreover, according to the sixth recital in the preamble to the directive, ensuring the effectiveness of the directive also
         requires that the persons concerned can 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. Thus,
         national legislation which exempts decisions establishing the categories of medicinal products subject to higher-rate cover
         from the obligations under Article 6(1) which applies where a medicinal product is only covered by the sickness insurance
         scheme after the competent authorities have decided to include it in a positive list of medicinal products covered by that
         scheme, does not satisfy the requirements of that directive. see paras 37-40, operative part
         
         2.
          In proceedings under Article 226 EC for failure to fulfil an obligation, it is incumbent upon the Commission to prove the
         allegation that the obligation has not been fulfilled and to place before the Court the information needed to enable it to
         determine whether the obligation has not been fulfilled. However, generalised failure on the part of the administrative authorities
         to comply with Directive 89/105 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. cannot be inferred from a few defective cases in
         practice. see paras 53, 55
      

      
      
      
      
      
      
      
      
      
      
      
      
      
      
      
            
            JUDGMENT OF THE COURT (Sixth Chamber)12 June 2003  (1)
         
         
            
         
               ((Failure of a Member State to fulfil obligations – Directive 89/105/EEC – Failure to apply the procedure prescribed in Article 6 of that directive to decisions determining the categories of medicinal
                  products qualifying for higher-rate cover – Failure to provide objective and verifiable grounds for negative decisions))
               
               
            In Case C-229/00, 
            
            
             Commission of the European Communities,  represented by I. Koskinen and H. Støvlbæk, acting as Agents, with an address for service in Luxembourg,
            
            
            applicant, 
            
            v
             Republic of Finland,   represented by T. Pynnä and E. Bygglin, acting as Agents,with an address for service in Luxembourg,
            
            defendant, 
            
            APPLICATION for a declaration that, by not adopting the laws, regulations and administrative provisions necessary to comply
            with 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 (OJ 1989 L 40, p. 8), in particular
            by not applying the prescribed procedure to decisions determining a category of special cover and, with regard to the prescribed
            obligations, by not providing the applicant with a sufficient statement of reasons based on objective and verifiable criteria
            in the case of negative decisions, the Republic of Finland has failed to fulfil its obligations under that directive and in
            particular Article 6 thereof,
            
            
            THE COURT (Sixth Chamber),,
            
            composed of: J.-P. Puissochet, President of the Chamber, C. Gulmann, V. Skouris, F. Macken (Rapporteur) and J.N. Cunha Rodrigues, Judges, 
            
            Advocate General: A. Tizzano, Registrar: H. von Holstein, Deputy Registrar, 
            
            
            having regard to the Report for the Hearing,after hearing oral argument from the parties at the hearing on 25 April 2002, 
            
            after hearing the Opinion of the Advocate General at the sitting on 11 July 2002, 
         gives the following
         
         
         Judgment
         1
            
         By application lodged at the Court Registry on 8 June 2000, the Commission of the European Communities brought an action under
         Article 226 EC for a declaration that, by not adopting the laws, regulations and administrative provisions necessary to comply
         with 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 (OJ 1989 L 40, p. 8,  
         the directive), in particular by not applying the prescribed procedure to decisions determining a category of special cover and, with regard
         to the prescribed obligations, by not providing the applicant with a sufficient statement of reasons based on objective and
         verifiable criteria in the case of negative decisions, the Republic of Finland has failed to fulfil its obligations under
         that directive and in particular Article 6 thereof. 
         
            
               Law
            Community law
         
         
         2
            
         The sixth recital in the preamble to the directive states that  
         it is urgently necessary to lay down a series of requirements intended to ensure that all concerned can verify that the national
         measures do not constitute quantitative restrictions on imports or exports or measures having equivalent effect thereto. 
         
         
         3
            
         Article 1(1) of the directive provides that: Member States shall ensure that any national measure, whether laid down by law, regulation or administrative action, to control
         the prices of medicinal products for human use or to restrict the range of medicinal products covered by their national health
         insurance systems complies with the requirements of this directive.
         
         
         4
            
         The first and second subparagraphs of Article 2 of the directive provide that: The following provisions shall apply if the marketing of a medicinal product is permitted only after the competent authorities
         of the Member State concerned have approved the price of the product:
         
         (1)
         Member States shall ensure that a decision on the price which may be charged for the medicinal product concerned is adopted
         and communicated to the applicant within 90 days of the receipt of an application submitted, in accordance with the requirements
         laid down in the Member State concerned, by the holder of a marketing authorisation. The applicant shall furnish the competent
         authorities with adequate information. If the information supporting the application is inadequate, the competent authorities
         shall forthwith notify the applicant of what detailed additional information is required and take their final decision within
         90 days of receipt of this additional information. In the absence of such a decision within the abovementioned period or periods,
         the applicant shall be entitled to market the product at the price proposed. 
         
         
         (2)
         Should the competent authorities decide not to permit the marketing of the medicinal product concerned at the price proposed
         by the applicant, the decision shall contain a statement of reasons based on objective and verifiable criteria. In addition,
         the applicant shall be informed of the remedies available to him under the laws in force and the time limits allowed for applying
         for such remedies.
         
         
         
         5
            
         The first, second and third subparagraphs of Article 6 of the directive provide: 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. Where a Member State does not permit an application to be made under this Article before the competent authorities have agreed
         the price to be charged for the product pursuant to Article 2, the Member State concerned shall ensure that the overall 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 subparagraph. 
         
         
         (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. 
         
         
         (3)
         Before the date referred to in Article 11(1), Member States shall publish in an appropriate publication and communicate to
         the Commission the criteria which are to be taken into account by the competent authorities in deciding whether or not to
         include medicinal products on the lists.
         
         
         
         6
            
         It is apparent from Article 11(1) of the directive that the Member States must bring into force the laws, regulations and
         administrative provisions necessary to comply with the directive by 31 December 1989. The directive should have been transposed
         in Finland by 1 January 1995, the date of accession of the Republic of Finland to the European Union. 
         National law
         
         
         7
            
         It is apparent from Articles 5(a) and 9 of the sairausvakuutuslaki (Finnish law on sickness insurance) as amended in 1993
         that, in order for a medicinal product to be covered by the sickness insurance scheme, the holder of a licence to market the
         medicinal product (
         marketing licence) must apply to the lääkkeiden hintalautakunta (Commission for Medicine Prices), stating a reasonable wholesale price which
         it undertakes to observe. If that wholesale price is accepted by that Commission, the medicinal product concerned is automatically
         entered on the list of reimbursable products subject to the ordinary scheme of insurance cover, under which 50% of the price
         over FIM 50 is reimbursed per purchase. 
         
         
         8
            
         Pursuant to Article 23, first subparagraph of the hallintomenettelylaki (Law No 598/1982 on administrative procedures (
         Law No 598/1982), a refusal to enter a medicinal product  
         shall contain a clear statement of the rights and obligations of the party concerned or the other factors upon which the decision
         is based. 
         
         
         9
            
         The first subparagraph of Article 24 of Law No 598/1982 provides: The decision shall contain a statement of the principal facts and the rules and provisions justifying it.
         
         
         10
            
         A right of appeal exists from the decisions of the Commission for Medicine Prices to the relevant courts. 
         
         
         11
            
         In addition to the ordinary scheme of insurance cover, there are two schemes of higher-level cover which provide for the following
         levels of cover: 
         
         
         ─
            75% of the price over FIM 25 per purchase, where the medicinal product is essential for the treatment of a serious or chronic
            illness; 
         
         
         
         ─
            100% of the price over FIM 25 per purchase where the medicinal product is generic and of equivalent effect to a medicinal
            product which is essential for the treatment of a serious and chronic illness. 
         
         
         
         
         12
            
         The Council of Ministers is to determine by decree those serious and chronic illnesses in respect of which a patient may receive
         higher-level cover for the cost of medicinal products and is to draw up a general list of the active ingredients used in a
         medicine to combat those illnesses. 
         
         
         13
            
         Since that decision establishing the list of active ingredients used in medicinal products which may then receive that cover
         was not adopted pursuant to an individual application, as a matter of Finnish law it is not subject to the provisions of the
         directive, in particular Article 6(1) thereof. Therefore, that decision does not contain a statement of reasons, the persons
         concerned have no right to be heard and neither the preparatory documents nor the decree are open to judicial review. 
         
         
         14
            
         After the Council of Ministers has adopted that decree, the Kansaneläkelaitos (
         Institute for Social Security) is to draw up a list of specialist medicinal products on the market in Finland and already covered by the basic scheme of
         insurance cover which contain an active ingredient listed in that decree. That decision, which is published, is not open to
         judicial review. 
         Pre-litigation procedure
         
         15
            
         Following the receipt of a complaint, the Commission requested the Finnish Government to provide further information on the
         administrative procedure for entering medicinal products on the list. Not satisfied with that reply, on 29 May 1998 the Commission
         sent the Republic of Finland a letter of formal complaint requiring it to comply with the directive, first, by providing that
         decisions as to the inclusion of a medicinal product in a category qualifying for higher-rate cover comply with the requirements
         of Article 6 of the directive and, second, by requiring decisions refusing to accept the price of specialist medicinal products
         to contain a statement of reasons based on objective and verifiable criteria, pursuant to the second subparagraph of Article
         2 of the directive, and not the standard wording in the following terms:  
         The application is refused because the applicant has not provided detailed reasons such as to enable the proposed wholesale
         price to be adjudged reasonable.
         
         
         16
            
         By letter of 20 July 1998, the Republic of Finland acknowledged that last complaint, stating that the procedure had been amended
         in that regard, but challenged the assertion that the procedure for determination of the medicinal products qualifying for
         higher-rate cover fell within the directive. 
         
         
         17
            
         On 17 December 1998, the Commission issued a reasoned opinion in which it reiterated the complaint concerning the decisions
         establishing the categories of medicinal products qualifying for higher-rate cover and stated, in particular, that the Finnish
         Government's assertion that negative decisions were accompanied by an adequate statement of reasons was not supported by any
         law or regulation. 
         
         
         18
            
         By letter of 8 February 1999, the Finnish authorities stated, first, that they had not infringed the first subparagraph of
         Article 6 of the directive in so far as the decision fixing the medicinal products qualifying for higher-rate cover was taken
         by the Council of Ministers. Second, they stated that they had remedied the several shortcomings which occurred in practice
         with regard to the obligation to include in the negative decision the statement of reasons laid down in the second subparagraph
         of Article 2 of that directive. 
         
         
         19
            
         The Commission therefore brought the present action for a declaration from the Court of a failure to fulfil obligations in
         the terms set out at paragraph 1 of the present judgment and an order that the defendant pay the costs.  
         
         
         20
            
         The Republic of Finland contends that the Court should dismiss the action as inadmissible or unfounded and order the Commission
         to pay the costs. 
         SubstanceThe complaint concerning the decisions establishing the categories of medicinal products subject to higher-rate cover  
         
         
         21
            
         By its first complaint, the Commission alleges against the Republic of Finland that neither the Council of Ministers' decision
         nor the subsequent decision of the Institute for Social Security establishing the medicinal products qualifying for the scheme
         of higher-rate cover comply with the requirements laid down by Article 6 of the directive. 
         
         
         22
            
         In that regard, the Commission criticises the fact that the persons concerned are given no opportunity to argue their point
         of view during the decision procedure referred to in the preceding paragraph and that, because of that, the competent authorities
         are under no obligation to give reasons for the inclusion or exclusion of an active ingredient in the scheme of higher-rate
         cover. 
         
         
         23
            
         Yet Article 6 of the directive concerns not only the entry of a product on the list of specialist medicinal products covered
         by the national sickness insurance scheme, but also subsequent decisions, failing which it would be easy for the Member States,
         without infringing the directive, to circumvent the obligations laid down by it and thus to compromise the attainment of its
         objectives. 
         
         
         24
            
         The Finnish Government claims that the first subparagraph of Article 6 of the directive governs solely the application procedure
         for the entry on the list of specialist medicinal products reimbursed under the national sickness insurance scheme. The decision
         of the Council of Ministers concerning the list of active ingredients falling within the scheme of higher-rate cover is not
         taken in the context of an application within the meaning of that provision. 
         
         
         25
            
         According to that government, the Council of Ministers does not take a decision on an application to enter a medicinal product
         in the list of medicinal products qualifying for higher-rate cover since, in that regard, it merely establishes by decree
         a list of illnesses and active ingredients following which the Institute for Social Security draws up the list of medicinal
         products containing an active ingredient covered by the decree.  
         
         
         26
            
         The Finnish Government concludes from this that that procedure is not covered by the first subparagraph of Article 6 of the
         directive. 
         
         
         27
            
         In its view, the Council of Ministers' decree on higher-rate cover falls within the scope of the third subparagraph of Article
         6 of the directive and not the first. 
         
         
         28
            
         Moreover, the interpretation advocated by the Commission would result in an interference in the establishment of the intervention
         criteria used in the Finnish sickness insurance scheme, contrary to the purpose of the directive and the case-law of the Court
         to the effect that, as a matter of Community law,  the Member States are free to organise their own social security systems
         and to adopt provisions intended to govern the consumption of medicinal products in order to promote the financial stability
         of their health insurance schemes (Case 238/82  
          Duphar and Others  [1984] ECR 523). 
         Findings of the Court
         
         
         29
            
         On the Finnish Government's argument alleging an interference in the organisation of the national social security schemes,
         it is sufficient to state that the action brought by the Commission in no way calls in question the method of financing or
         the structure of the social security system but seeks solely to secure observance by the Finnish legislation of the requirements
         laid down in Article 6 of the directive, which, moreover, relate neither to the functioning of the register and the inclusion
         on it of medicinal products nor to the possibility of having the cost of a medicinal product borne by the scheme (Case C-424/99
          
          Commission  v  
          Austria  [2001] ECR I-9285, paragraph 26). 
         
         
         30
            
         On the question whether the Republic of Finland complies with the requirements of Article 6 of the directive, the Finnish
         Government claims, first, that that provision does not apply on the ground that the Council of Ministers' decree does not
         result in a medicinal product being entered on the list of medicinal products qualifying for higher-rate cover, but refers
         to certain active ingredients. 
         
         
         31
            
         In that regard, Article 6 of the directive applies where a medicinal product is only covered by the sickness insurance scheme
         after the competent authorities have decided to include it in a positive list of medicinal products covered by that scheme.
         
         
         
         32
            
         It is apparent from the description of the Finnish scheme that, even though the Council of Ministers does not directly decide
         on the inclusion of certain medicinal products in the list of medicinal products qualifying for higher-rate cover, the decision
         of the Council of Ministers to include certain active ingredients in the scheme of higher-rate cover necessarily has the effect
         of making specialist medicinal products subject to that scheme where they contain such ingredients and a marketing licence
         has been issued in respect of them by the competent authorities. 
         
         
         33
            
         Moreover, following that decision of the Council of Ministers, the Institute for Social Security has no discretion and is
         required to enter on the list of medicinal products qualifying for higher-rate cover all those medicinal products containing
         an active ingredient referred to in that decision, in respect of which a marketing licence has been issued and whose wholesale
         price has been approved.  
         
         
         34
            
         It follows that the Council of Ministers' decision constitutes a bundle of individual decisions on the inclusion of certain
         medicinal products in one of the social security schemes, so as to bring it within the provisions of Article 6 of the directive.
         
         
         
         35
            
         Second, the Finnish Government challenges the applicability of the first subparagraph of Article 6 of the directive on the
         ground that, unlike that for the purposes of ordinary cover, the decision to include a medicinal product in the list of medicinal
         products qualifying for higher-rate cover is not taken in response to an application by the person concerned. 
         
         
         36
            
         The first subparagraph of Article 6 of the directive only applies to schemes in which the persons concerned lodge an application
         for inclusion in a list. 
         
         
         37
            
         In that regard, the purpose of the directive, according to Article 1 thereof, is to ensure that any national measure to control
         the prices of medicinal products for human use or to restrict the range of medicinal products covered by their national sickness
         insurance systems complies with the requirements of that directive (
          Commission  v  
          Austria , cited above, paragraph 30). 
         
         
         38
            
         The decisions pursuant to which certain medicinal products qualify for higher-rate cover constitute a means of determining
         the extent of the range of medicinal products covered by the sickness insurance scheme and likely to be used in the treatment
         of such or such an illness. 
         
         
         39
            
         Moreover, according to the sixth recital in the preamble to the directive, ensuring the effectiveness of the directive also
         requires that the persons concerned can 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. 
         
         
         40
            
         However, those objectives would be compromised if, as the Finnish Government claims, a Member State were able to introduce
         a dual procedure for the establishment of a list of medicinal products qualifying for higher-rate reimbursement, one pursuant
         to the obligations laid down by the first subparagraph of Article 6 of the directive, the other being exempt in part from
         those obligations and, in part, not complying with the objectives laid down by that directive. 
         
         
         41
            
         Therefore, a declaration of failure to fulfil obligations must be made in respect of the first complaint. 
         The complaint concerning the statement of reasons for decisions refusing to accept the price of medicinal products
         
         
         42
            
         By its second complaint, the Commission alleges a failure on the part of the Republic of Finland to ensure that the competent
         Finnish authority provides a statement of reasons for decisions refusing to accept the prices of medicinal products, contrary
         to the directive. Moreover, the grounds of those decisions, where they are given, are not based on objective and verifiable
         criteria. According to the Commission, a comparison between Articles 23 and 24 of Law No 598/1982 and the provisions of the
         directive seems to show that the latter are stricter than the Finnish legislation with regard to the obligation to state reasons.
         
         
         
         43
            
         The Finnish Government raises a plea of inadmissibility against that complaint on the ground that, during the pre-litigation
         procedure, the Commission challenged solely the practice adopted by the competent authority, which had been remedied, and
         not the compatibility of the Finnish legislation with the directive. 
         
         
         44
            
         It should be recalled in that regard that, in accordance with settled case-law, the letter of formal notice from the Commission
         to the Member State, and then the reasoned opinion issued by the Commission, delimit the subject-matter of the dispute, so
         that it cannot thereafter be extended. The opportunity for the State concerned to submit its observations, even if it chooses
         not to avail itself thereof, constitutes an essential guarantee intended by the EC Treaty, adherence to which is an essential
         formal requirement of the infringement procedure. Consequently, the reasoned opinion and the proceedings brought by the Commission
         must be based on the same complaints as those set out in the letter of formal notice initiating the pre-litigation procedure
         (Case C-365/97  
          Commission  v  
          Italy  [1998] ECR I-7773, paragraph 23).  
         
         
         45
            
         Thus, in so far as a judgment declaring that a Member State has failed to fulfil its obligations establishes the basis of
         liability which that State may incur as a result of its default and constitutes a condition precedent to the bringing of proceedings
         under Article 228 EC, the Member State must be afforded the opportunity, in the course of the pre-litigation procedure, to
         refute in their entirety the allegations made against it by the Commission (
          Commission  v  
          Italy , cited above, paragraph 24). 
         
         
         46
            
         However, that requirement cannot be carried so far as to mean that in every case the statement of complaints in the letter
         of formal notice, the operative part of the reasoned opinion and the form of order sought in the application must be exactly
         the same, where the subject-matter of the proceedings has not been extended or altered (
          Commission  v  
          Italy , cited above, paragraph 25).  
         
         
         47
            
         In the present case, in spite of the summary statement of reasons for the second complaint in the letter of formal notice
         and the reasoned opinion in which reference is made to a defective practice in respect of the statement of reasons for decisions
         refusing to accept the price of medicinal products, it is, however, alleged against the Republic of Finland in the operative
         part of the reasoned opinion that they did not adopt the laws, regulations and administrative provisions necessary to comply
         with the directive. 
         
         
         48
            
         It follows that the second complaint is admissible. 
         
         
         49
            
         As for the merits, the Commission, on the basis of a few examples of the Finnish system in practice, claims that the statement
         of reasons for negative decisions does not comply with the provisions of the directive, which require a more detailed statement
         of reasons than that laid down by Finnish law. 
         
         
         50
            
         In that regard, as the Finnish Government rightly pointed out, first, it is apparent from Articles 23 and 24 of Law No 598/1982
         that any administrative decision must contain a statement clearly setting out the rights and obligations of the party concerned
         and all the factors taken into account and the legislative provisions upon which the decision is based (see, in that regard,
         paragraphs 8 and 9 hereof). 
         
         
         51
            
         Second, the examples of a failure to state reasons put forward by the Commission do not reveal a practice which infringes
         the provisions of the directive. 
         
         
         52
            
         Indeed, it is apparent from the data supplied by the Finnish Government, which have not been challenged by the Commission,
         that whilst, in 1999, 3 266 decisions were taken by the Commission for Medicine Prices, only 133 contained an inadequate statement
         of reasons. 
         
         
         53
            
         However, generalised failure on the part of the administrative authorities to comply with the directive cannot be inferred
         from a few defective cases in practice. 
         
         
         54
            
         Accordingly, it cannot but be held that the Commission has not shown how the Finnish practice or legislation was contrary
         to the provisions of the directive. 
         
         
         55
            
         It is settled case-law that in proceedings under Article 226 EC for failure to fulfil an obligation, it is incumbent upon
         the Commission to prove the allegation that the obligation has not been fulfilled and to place before the Court the information
         needed to enable it to determine whether the obligation has not been fulfilled (see, in particular, Case C-159/94  
          Commission  v  
          France  [1997] ECR I-5815, paragraph 102 and Case C-263/99  
          Commission  v  
          Italy  [2001] ECR I-4195, paragraph 27). 
         
         
         56
            
         In those circumstances, it must be held that the second complaint is unfounded. 
         
         
         57
            
         It follows from all the foregoing that, by not adopting the laws, regulations and administrative provisions necessary to comply
         with the directive as regards the decisions establishing the categories of medicinal products subject to a higher rate of
         health insurance cover, the Republic of Finland has failed to fulfil its obligations under the first and second subparagraphs
         of Article 6 of that directive. 
         
         Costs
         58
            
         Under Article 69(2) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been
         applied for in the successful party's pleadings. However, under Article 69(3) of those Rules, the Court may order that the
         costs be shared or that the parties bear their own costs where each party fails on one or more heads. In this case, since
         the parties have each been partially unsuccessful, each must be ordered to bear its own costs. 
         
         On those grounds, 
         
         
         
            
            THE COURT (Sixth Chamber)
         
         
         hereby:  
         
            
            1.
             Declares that, by not adopting the laws, regulations and administrative provisions necessary to comply with 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
             as regards the decisions establishing the categories of medicinal products subject to a higher rate of health insurance cover,
               the Republic of Finland has failed to fulfil its obligations under the first and second subparagraphs of Article 6 of that
               directive;  
            
            
            2.
              Dismisses the remainder of the action;  
            
            
            3.
              Orders each party to bear its own costs. 
            
            
                  Puissochet
               
               
                  Gulmann 
               
               
                  Skouris 
               
            
                  Macken
               
               
                  Cunha Rodrigues 
               
               
                  
               
            
                  
               
               
                  
               
               
                  
               
            
                  
               
               
                  
               
               
                  
               
            
                  
               
               
                  
               
               
                  
               
            
            
            
            
            
            
            
            
         
         
         Delivered in open court in Luxembourg on 12 June 2003. 
         
         
         
         
                  R. Grass 
               
               
                  J.-P. Puissochet  
               
            
         
         
         
                  Registrar
               
               
                  President of the Sixth Chamber
               
            
      
      
          1 –
            
             Language of the case: Finnish.