CELEX: C2000/335/52
Language: en
Date: 2000-11-25 00:00:00
Title: Case C-322/00: Action brought on 30 August 2000 by the Commission of the European Communities against the Kingdom of the Netherlands

25.11.2000           EN                     Official Journal of the European Communities                                       C 335/29
    —    The power newly conferred on the Commission to                —     Infringement of the duty to state reasons (Article 253
         draw up ‘guidance on the collection, verification                   EC): the recitals in the preamble give the misleading
         and presentation of adverse reaction reports ...’                   impression that the directive carries out no more than a
         [Article 29g(a)] is in particular of substantive signifi-           merely technical adaptation to international develop-
         cance for the scope of the duty of notification                     ments in pharmacovigilance and the related development
         [Article 29d(4)] and for the examination of pharma-                 of data-processing and therefore provide a false picture
         covigilance data with regard to suspension, with-                   as to the justification of the legal basis claimed by the
         drawal or variation of the authorisation for a                      Commission (Articles 29i and 37a of Directive
         medicinal product (Article 29h). The power of the                   75/319/EEC).
         Commission to adopt rules, the content of which is
         not yet even known, classifiable purely within the
         area of institutional law, clearly does not constitute
         a rule for adapting the directive to ‘scientific and
         technical progress’.
    —    Article 29d(2) and (3) of the new version will in
         future limit the duty of notification devolving on            Action brought on 30 August 2000 by the Commission
         the undertaking concerned to notification of the              of the European Communities against the Kingdom of the
         ‘competent authority of the Member State in whose                                        Netherlands
         territory the incident occurred’, and thus alters its
         substantive content. This amendment would be                                          (Case C-322/00)
         acceptable from a health-policy perspective if the
         data-processing network to be set up by the Agency
                                                                                               (2000/C 335/52)
         under the new version of Article 29f could also
         guarantee the provision of equivalent information,
         in terms of time and quality, to the authorities              An action against the Kingdom of the Netherlands was brought
         of the other Member States; however, this data-               before the Court of Justice of the European Communities
         processing network is not yet in existence, and it is         on 30 August 2000 by the Commission of the European
         not envisaged that it will be set up before or shortly        Communities, represented by Gregorio Valero Jordana and
         after the period for transposition of the contested           Christopher Van Der Hauwaert, of its Legal Service, acting as
         directive has expired.                                        Agents, with an address for service in Luxembourg at the office
                                                                       of Carlos Gómez de la Cruz, of its Legal Service, Wagner
    —    Article 29d(4) of the new version alters the existing         Centre, Kirchberg.
         duty to notify suspected serious adverse reactions
         occurring in the territory of a non-member country,           The Commission of the European Communities claims that
         inasmuch as — at least according to the English-              the Court should:
         and French-language versions — such adverse reac-
         tions will in future be notifiable only if they are           1.    declare that, by failing to adopt the necessary laws,
         unexpected. This means that risks involved in the                   regulations and administrative measures referred to in
         use of medicinal products which must in principle                   Articles 4 and 5(4) and (5) and points 1, 2, 4 and 6 of
         be regarded as being known will no longer be                        part A of Annex II and points 1(2), 1(3) and 2 of Annex III
         covered, in particular the ‘known’ risk of viral                    to Council Directive 91/676/EEC of 12 December 1991
         transmission in the case of medicinal products                      concerning the protection of waters against pollution
         containing biological components. This amendment                    caused by nitrates from agricultural sources (1), the
         likewise does not constitute an adaptation to ‘scien-               Kingdom of the Netherlands has failed to fulfil its
         tific and technical progress’.                                      obligations under that directive;
    —    The option for the marketing authorisation holder             2.    order the Kingdom of the Netherlands to pay the costs.
         to negotiate notification periods, introduced by
         Article 29d(7) of the new version, constitutes a
         substantive amendment having nothing to do with               Pleas in law and main arguments
         adaptation to ‘scientific and technical progress’.
                                                                       —     Absence in the Netherlands action programme of any
    —    Article 29d of the new version defines the person                   provisions relating to the minimum capacity, as pre-
         having the duty to notify as being in future the                    scribed by the directive, of storage vessels for livestock
         ‘marketing authorisation holder’ rather than, as                    manure (Article 5(4)(a) in conjunction with point 1(2) of
         previously, ‘the person responsible for placing the                 Annex III to the directive);
         medicinal product on the market’. As a result, a duty
         to notify will no longer be imposed on potential              —     Absence in the Netherlands action programme of any
         licensees of the marketing authorisation holder or on               mandatory provisions concerning the limitation of the
         parallel importers, who, together with the original                 land application of fertilisers, taking into account the
         vendor of the medicinal product, are regarded in the                climatic conditions, rainfall and irrigation (Article 5(4)(a)
         Member State concerned as being the persons                         in conjunction with point 1(3)(b) of Annex III to the
         responsible for placing the product on the market.                  directive);
 ---pagebreak--- C 335/30               EN                   Official Journal of the European Communities                                    25.11.2000
—    Absence in the Netherlands action programme of pro-                    IKA’s Medical Committee of Appeal, is consistent with
     visions concerning the limitation of the land application              the provisions set out above of Articles 31 and 36
     of fertilisers based on a balance between (a) the foreseeable          of Regulation (EEC) No 1408/71 of the Council and
     nitrogen requirements of the crops and (b) the nitrogen                Articles 31 and 93 of Regulation (EEC) No 574/72 of the
     supply to the crops from the soil and from fertilisation               Council since, even if it were accepted that those pro-
     (Article 5(4)(a) in conjunction with point 1(3) of                     visions in principle confer on the Member States discre-
     Annex III to the directive);                                           tion — in respect of benefits including sickness benefits
                                                                            in kind to pensioners temporarily staying in the territory
—    Absence in the Netherlands action programme of                         of a Member State other than the one in which they reside,
     measures ensuring that the amount of livestock manure                  which benefits must be considered also to comprise the
     applied to the land each year does not exceed the amount               provision of hospital treatment — to enact provisions
     per hectare prescribed by the directive (Article 5(4)(a) in            establishing as an additional condition for the refund of
     conjunction with point 2 of Annex III to the directive);               the costs relating to the benefits the, albeit ex post facto,
                                                                            authorisation of those costs, it is in any event not entirely
—    Absence in the Netherlands action programme of                         clear and free from doubt whether they additionally allow
     measures relating to points which should have been                     the Member States to enact provisions establishing as a
     covered in the code of good agricultural practice                      necessary condition for the grant of such authorisation
     (Article 5(4)(b) in conjunction with Annex III to the                  that requirements be met similar to those laid down in
     directive and Article 4(1)(a) in conjunction with Annex II             the aforementioned provision of the IKA Regulations at
     to the directive);                                                     issue, that is to say requirements which are related to the
                                                                            immediate need for provision of hospital treatment;
—    Absence in the Netherlands action programme of any
     additional or reinforced measures relating to dry, sandy          (b) whether, on the basis that services comprising the
     soil (Article 5(5) of the directive).                                  provision of care within hospitals constitute services
                                                                            within the meaning of Article 60 of the EC Treaty, the
(1) OJ 1991 L 375, p. 1.                                                    aforementioned provision of the IKA Regulations, even if
                                                                            it were considered, to the extent referred to above, not to
                                                                            be contrary to the above provisions of the Council
                                                                            Regulations, is consistent to that extent with Articles 59
                                                                            and 60 of the EC Treaty;
                                                                       (c)  if Question (b) is answered in the negative, whether the
Reference for a preliminary ruling by the Diikitiko                         rule laid down by that provision of the IKA Regulations
Protodikio Thessalonikis (First Chamber, Three Judges)                      is justified on grounds of public health which are related
by judgment of that court of 31 January 2000 in the case                    to the provision of a balanced hospital service accessible
of Idrima Kinonikon Asfalision against Vasilios Ioannidis                   to everybody resident within Greece and therefore falls
                                                                            within the exceptions in Article 56 of the EC Treaty;
                         (Case C-326/00)
                                                                       (d) whether, on the basis that the entitlement to sickness
                                                                            benefits in kind and, by extension, the claim for refund
                         (2000/C 335/53)
                                                                            of the costs relating to them constitute ‘possessions’
                                                                            within the meaning of Article 1 of the Protocol to the
Reference has been made to the Court of Justice of the                      European Convention for the Protection of Human Rights
European Communities by judgment of the Diikitiko Protodi-                  and Fundamental Freedoms, signed in Paris on 20 March
kio Thessalonikis (Administrative Court of First Instance,                  1952, the aforementioned provision of the IKA Regu-
Thessaloniki) (First Chamber, Three Judges) of 31 January                   lations — even if it were considered that to the extent
2000, received at the Court Registry on 4 September 2000 for                referred to above it is not contrary to the aforementioned
a preliminary ruling in the case of the Idrima Kinonikon                    provisions of the Council Regulations and of the EC
Asfalision (Social Security Institution; ‘IKA’) against Vasilios            Treaty, or, that is to say on the contrary basis, that it is
Ioannidis on the following questions:                                       justified in accordance with the matters previously set
                                                                            out — is consistent to that extent with the first paragraph
(a)  whether Article 3a(4)(g) of the Hospital Care Regulations              of Article 1 of the Protocol; and
     of the IKA, in the version in force at the time of the
     defendant’s hospital treatment, to the extent that it laid
                                                                       (e)  if Question (d) is answered in the negative, whether the
     down as an additional requirement, before the IKA may
                                                                            rule laid down by the aforementioned provision of the
     in very exceptional cases — namely in cases where a
                                                                            IKA Regulations is justified on grounds of public interest
     particular illness of the pensioner of the IKA seeking
                                                                            which are connected with preservation of the financial
     their refund manifested itself suddenly while he was
                                                                            stability of the social security system and therefore falls
     temporarily staying abroad or he was transferred there
                                                                            within the exceptions in the second paragraph of Article 1
     urgently in order to avert a real risk to his life — refund
                                                                            of that Protocol.
     the costs of treatment which has already taken place in
     hospital abroad, that the director of the competent
     regional branch of the IKA must grant the related
     authorisation after an opinion has been given by the