Summary
Parties
Grounds
Decision on costs
Operative part
Keywords
1 Approximation of laws - Veterinary medicinal products - Application for marketing authorisation - Information and documents to be provided by the applicant - Right of the competent authority to impose requirements other than those imposed by Directives 81/851 and 81/852 - None - Request for further information - Suspension of the time-limit for granting authorisation - No obligation to state reasons for the request
(Council Directive 81/851, Arts 5, second para., 8, 9, point 3, and 40, and Council Directive 81/852, Annex, Part 1(C))
2 Approximation of laws - Veterinary medicinal products - Application for marketing authorisation - Information and documents to be provided by the applicant - Right of the competent authority to exempt the applicant from compliance with the requirements of Directive 81/851 - None
(Council Directive 81/851, Art. 5)
3 Approximation of laws - Veterinary medicinal products - Application for marketing authorisation - Information and documents to be provided by the applicant - Requirements imposed by Directives 81/851 and 81/852 - Breach of the principle of proportionality - None - Compatible with Articles 30 to 36 of the Treaty
(EC Treaty, Arts 30 to 36; Council Directive 81/851, Article 5, second para., points 3, 4 and 9, and Council Directive 81/852, Annex, Part I(A), (B) and (C))
4 Approximation of laws - Veterinary medicinal products - Application for marketing authorisation - Information and documents to be provided by the applicant - Rules laid down by Directives 81/851 and 81/852 - Infringement by a Member State - Obligation to make reparation for damage caused to individuals - Conditions - Manner of ensuring reparation - Application of national law - Limits
(Council Directives 81/851 and 81/852)
Summary
5 The second paragraph of Article 5 of Directive 81/851 relating to veterinary medicinal products, read in conjunction with the other provisions of that directive and Directive 81/852 on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products, must be interpreted as not authorising the competent authority to require particulars and documents other than those expressly listed in that provision, as set out in detail in the Annex to Directive 81/852. More particularly, the competent authority is not authorised to require an applicant for marketing authorisation
- to disclose the name(s) and address(es) of the manufacturer(s) of the substance used in the manufacture of one of the active ingredients of the veterinary medicinal product concerned and information concerning the manufacturing site(s), unless disclosure of that information constitutes the only reliable means of obtaining a particular required by Directives 81/851 and 81/852;
- to disclose the results of tests carried out on each batch of the substance with a view to approval thereof; or
- to purchase the active ingredient from a specified third party.
Part 1(C) of the Annex to Directive 81/852 does, however, allow particulars to be required of the manufacturing process and control testing methods used by the manufacturer of a starting material. In that regard, it is for the national court to determine whether the substance in question is a starting material within the meaning of the first paragraph of that provision. If it is not, such particulars may nevertheless be required in so far as the features of the process by which the starting material is manufactured from the substance are such that no other means of assessing the purity of the starting material is available.
Moreover, where, under Article 9, point 3, of Directive 81/851, the competent authority requires an applicant for a marketing authorisation to provide further information on the matters referred to in Article 5 of that directive, the time-limits for granting the authorisation laid down in Article 8 of the directive are suspended until that information has been provided. Furthermore, such a request need not state the reasons on which it is based, given that Article 40 of the directive, concerning the obligation to state reasons, applies only to decisions to withhold, withdraw or suspend marketing authorisation.
Finally, the fact that the process by which a medicinal product is manufactured is continuous or other than continuous does not affect the foregoing findings.
6 An application for marketing authorisation for a veterinary medicinal product must fulfil all the conditions laid down in Article 5 of Directive 81/851 for the issue of an authorisation. Consequently, the competent authority is not authorised to exempt an applicant for marketing authorisation from providing a particular or document required under Article 5 of Directive 81/851 even if it appears practically impossible, in a given case, to obtain that information.
7 The Council did not manifestly exceed the limits of its discretion by adopting the provisions in points 3, 4 and 9 of the second paragraph of Article 5 of Directive 81/151 and Part I(A), (B) and (C) of the Annex to Directive 81/852 in so far as they require an applicant for a marketing authorisation for a veterinary medicinal product to provide particulars of the manufacturing process and the control testing methods employed by the manufacturer of a substance used in the manufacture of one of the active ingredients of the medicinal product concerned. There is thus nothing to indicate that those provisions infringe the principle of proportionality.
Directives 81/851 and 81/852 are also, as regards the information and documents required in relation to an application for authorisation, compatible with Articles 30 to 36 of the Treaty. First, the harmonisation of national procedures for the issue of marketing authorisations is designed to eliminate hindrances to the free movement of veterinary medicinal products. Second, even if the stringent requirements imposed by those directives in themselves constitute restrictions, there is nothing to indicate that they are not justified by the safeguarding of public health, which is the essential objective of both directives.
8 A Member State is required to make good loss and damage caused to an applicant for marketing authorisation for a veterinary medicinal product as a result of requests for information and requirements which infringe Directives 81/851 and 81/852 where the rule of Community law infringed is intended to confer rights on individuals, the breach is sufficiently serious and there is a direct causal link between that breach and the damage sustained by the individuals concerned. Subject to that reservation, it is on the basis of rules of national law on liability that the State must make reparation for the consequences of the loss and damage caused by a breach of Community law for which it can be held responsible, with the proviso that the conditions laid down by the applicable national legislation must not be less favourable than those relating to similar domestic claims and must not be so framed as to make it in practice impossible or excessively difficult to obtain reparation.
Parties
In Case C-127/95,
REFERENCE to the Court under Article 177 of the EC Treaty by the Court of Appeal in Northern Ireland for a preliminary ruling in the proceedings pending before that court between
Norbrook Laboratories Limited
and
Ministry of Agriculture, Fisheries and Food
on the interpretation and validity of Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products (OJ 1981 L 317, p. 1) and Council Directive 81/852/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products (OJ 1981 L 317, p. 16),
THE COURT
(Fifth Chamber),
composed of: C. Gulmann, President of the Chamber, M. Wathelet, J.C. Moitinho de Almeida, J.-P. Puissochet and L. Sevón (Rapporteur), Judges,
Advocate General: P. Léger,
Registrar: L. Hewlett, Administrator,
after considering the written observations submitted on behalf of:
- Norbrook Laboratories Ltd, by James McSparran QC, Gerald Barling QC, Mark Orr, Barrister, and Christopher Hodges, Solicitor,
- the United Kingdom Government, by Stephen Braviner, of the Treasury Solicitor's Department, acting as Agent, and Peter Duffy, Barrister, and
- the Commission of the European Communities, by Richard Wainwright, Principal Legal Adviser, and Michel Nolin, of its Legal Service, acting as Agents,
having regard to the Report for the Hearing,
after hearing the oral observations of Norbrook Laboratories Ltd, represented by Gerald Barling; the United Kingdom Government, represented by Stephanie Ridley, of the Treasury Solicitor's Department, acting as Agent, Ronald Weatherup QC and Peter Duffy; and the Commission, represented by Richard Wainwright and Michel Nolin, at the hearing on 27 February 1997,
after hearing the Opinion of the Advocate General at the sitting on 17 April 1997,
gives the following
Judgment
Grounds
1 By order of 27 March 1995, received at the Court on 18 April 1995, the Court of Appeal in Northern Ireland referred to the Court for a preliminary ruling under Article 177 of the EC Treaty a number of questions on the interpretation and validity of Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products (OJ 1981 L 317, p. 1) and Council Directive 81/852/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products (OJ 1981 L 317, p. 16).
2 Those questions were raised in proceedings brought by Norbrook Laboratories Ltd (hereinafter `Norbrook') against the Ministry of Agriculture, Fisheries and Food (hereinafter `the MAFF') concerning the issue of marketing authorisation for a veterinary medicinal product.
The Community legislation
3 Council Directive 81/851 seeks to harmonise the laws of the Member States relating to veterinary medicinal products and, in particular, the conditions for the issue, suspension and withdrawal of marketing authorisation. The first recital in its preamble states that the primary purpose of any rules for the production and distribution of veterinary medicinal products must be the safeguarding of public health. The second recital specifies, however, that that objective must be achieved by means which will not hinder the development of industry and trade in medicinal products within the Community. The third and fourth recitals emphasise the need to eliminate existing hindrances to trade within the Community by approximation of the national provisions. In the eleventh recital it is stressed that the directive is only one stage in the achievement of the aim of freedom of movement of veterinary medicinal products and that new measures will prove necessary, in the light of experience gained, for the removal of the remaining barriers to the free movement of goods.
4 Article 4(1) of Directive 81/851 provides:
`No veterinary medicinal product may be marketed in a Member State unless authorisation has previously been issued by the competent authority in that Member State.'
5 Article 5 provides:
`For the purpose of obtaining the marketing authorisation provided for in Article 4, the person responsible for marketing shall lodge an application with the competent authority of the Member State.
The following particulars and documents shall be appended to the application:
1. name or corporate name and permanent address or registered place of business of the person responsible for marketing and of the manufacturer, if different;
...
3. qualitative and quantitative particulars of all the constituents of the veterinary medicinal product, using the usual terminology but not empirical chemical formulae and giving the international non-proprietary name recommended by the World Health Organisation, if such a name exists;
4. brief description of the method of preparation;
...
9. description of the control testing methods employed by the manufacturer (qualitative and quantitative analysis of the constituents and the finished product, specific tests, e.g. sterility tests, tests for the presence of pyrogens, for the presence of heavy metals, stability tests, biological and toxicity tests, tests on intermediate products);
...'
6 Article 6 of Directive 81/851 provides that the documents and particulars listed in points 8, 9 and 10 of the second paragraph of Article 5 are to be drafted by experts. Article 7 describes the role of those experts.
7 Article 8 requires the Member States to take all appropriate measures to ensure that the procedure for granting marketing authorisation is completed within 120 days after the date of submission of the application. However, in exceptional cases that time-limit may be extended for a further 90 days.
8 Article 9 provides:
`In order to examine the application submitted pursuant to Article [5], the competent authorities of the Member States:
1. shall check that the documentation submitted in support of the application complies with Article 5 and, on the basis of the reports drawn up by the experts pursuant to Article 7, ascertain whether the conditions for the issue of the marketing authorisation have been fulfilled;
2. may submit the medicinal product for testing by a State laboratory or a laboratory designated for this purpose, in order to ensure that the control testing methods employed by the manufacturer and described in the application documents, in accordance with point 9 of the second paragraph of Article 5, are satisfactory;
3. may, where appropriate, require the applicant to provide further information as regards the items listed in Article 5. Where the competent authorities take this course of action, the time-limits specified in Article 8 shall be suspended until the further data required have been provided. Similarly, these time-limits shall be suspended for any period which the applicant may be given to provide oral or written explanations.'
9 Article 11 gives the reasons for which marketing authorisation may be withheld. Under that article, authorisation is to be withheld, inter alia, if the application documents submitted to the competent authorities do not comply with Articles 5, 6 and 7.
10 Article 40 of Directive 81/851 lays down rules concerning, inter alia, the statement of reasons to be given for certain decisions taken pursuant to the directive, and the notification of such decisions.
11 Under Article 41: `No decision to withhold, withdraw or suspend marketing authorisation ... may be taken on grounds other than those set out in this Directive.'
12 Directive 81/852 gives further details concerning the requirements as to the particulars and documents to be submitted with an application for a marketing authorisation.
13 The first paragraph of Article 1 of Directive 81/852 provides:
`Member States shall take all appropriate measures to ensure that the particulars and documents which shall accompany applications for authorisation to place a veterinary medicinal product on the market, pursuant to points 3, 4, 6, 8, 9 and 10 of the second paragraph of Article 5 of Directive 81/851/EEC, are submitted by the persons concerned in accordance with the Annex to this Directive.'
14 That annex is divided into three parts: the first concerns analytical (physico-chemical, biological or microbiological) tests of veterinary medicinal products, the second toxicological and pharmacological tests, and the third clinical trials. Part 1 is subdivided into six points: (A) Qualitative and quantitative particulars of the constituents; (B) Description of method of preparation; (C) Control of starting materials; (D) Control tests during manufacture; (E) Control tests on the finished product; and (F) Stability tests.
15 Part 1(A) states:
`The particulars and documents which shall accompany applications for marketing authorisation pursuant to point 3 of the second paragraph of Article 5 of Directive 81/851/EEC shall be submitted in accordance with the following requirements; if any amendments are made to these requirements for reasons of scientific progress, all grounds shall be stated.
1. Qualitative particulars of all the constituents of the medicinal product means the designation or description of:
- the active ingredient(s), - the constituent(s) of the excipients ...
- the constituents of the pharmaceutical form intended to be ingested or otherwise administered to animals.
These particulars shall be supplemented by any relevant data concerning the container and, where appropriate, its manner of closure.
...'
16 According to the first paragraph of Part 1(B)
`The "brief description of the method of preparation" accompanying the application for marketing authorisation pursuant to point 4 of the second paragraph of Article 5 of Directive 81/851/EEC shall be so drafted as to provide an adequate synopsis of the nature of the operations employed.'
17 The second paragraph of point B indicates what, as a minimum, that description must include.
18 According to the first and second paragraphs of Part 1(C):
`For the purposes of this paragraph, "starting materials" means all the constituents of the proprietary medicinal product and, if necessary, of its container, as referred to in point A, paragraph 1.
The particulars and documents accompanying the application for marketing authorisation pursuant to points 9 and 10 of the second paragraph of Article 5 of Directive 81/851/EEC must include the results of the tests relating to quality control of all the constituents used. These shall be submitted in accordance with the following provisions.'
19 Since the occurrence of the events giving rise to the main proceedings, Directives 81/851 and 81/852 have been amended on several occasions. Those amendments are not therefore relevant as far as the questions referred to the Court are concerned.
The national legislation
20 In the United Kingdom, Directives 81/851 and 81/852 have been deemed to have been implemented by the Medicines Act 1968, as amended, and subordinate legislation made thereunder.
21 Under the Medicines Act 1968, the competent authority for the issue of marketing authorisations is the Licensing Authority, which consists of the Health and/or Agriculture Ministers, who delegate certain executive powers to the Veterinary Medicines Directorate of the MAFF.
The main proceedings
22 Norbrook is engaged in the manufacture and distribution of veterinary medicinal products throughout the world. Those medicinal products include an injectable product known as `Pen & Strep', which is used for the treatment of bacterial infections in cattle, pigs and sheep. Pen & Strep contains two main active ingredients, procaine penicillin and dihydrostreptomycin sulphate (hereinafter `DHS').
23 DHS is manufactured by Norbrook from streptomycin sulphate (hereinafter `SS') by reduction or hydrogenation, whereby the molecular structure of the SS is altered. Once the DHS has been produced it is mixed with the other active ingredient, procaine penicillin, and the non-active ingredients, known as excipients, to make the final product Pen & Strep.
24 Although it is possible to buy DHS from other pharmaceutical manufacturers, and in particular from Rhône-Poulenc Industries SA in France, Norbrook has itself for a number of years manufactured most of the DHS required for its production of Pen & Strep, at lower cost, using SS bought on the open market.
25 Pen & Strep was placed on the market in the United Kingdom for the first time in 1968. After the entry into force of the Medicines Act 1968 on 1 September 1971, Norbrook was granted a Product Licence of Right for Pen & Strep.
26 In accordance with Directive 81/851, all licences previously issued for products of that kind were subsequently reviewed to ensure that the products concerned conformed to the Community rules. Thus, on 28 August 1987 Norbrook lodged an application for a `reviewed' licence, in which it stated that the manufacturer of the DHS would be Rhône-Poulenc Industries SA.
27 Following an application lodged by Norbrook on 9 March 1990 to amend the original application, it emerged that it proposed to manufacture the DHS itself. The MAFF then sought details of the identity, location and manufacturing and control testing methods of the suppliers of the SS.
28 On 13 May 1991 the MAFF informed Norbrook that the licence previously granted for Pen & Strep was to expire on 12 March 1991 and the that `reviewed' licence replacing it did not allow it to use DHS from any source other than Rhône-Poulenc Industries SA, the source indicated in its application of 28 August 1987. No final decision regarding amendment of the application could be taken until the information requested had been supplied. The reference for a preliminary ruling in this case concerns that requirement to supply further information.
29 On an application by Norbrook, judgment was given at first instance by the High Court of Justice in Northern Ireland on 11 December 1992.
30 The MAFF appealed against that judgment, and Norbrook cross-appealed.
31 Taking the view that the decision to be given called for an interpretation of Community law, the Court of Appeal in Northern Ireland referred the following questions to the Court of Justice for a preliminary ruling:
`1. Are Council Directives 81/851/EEC and 81/852/EEC (and in particular Articles 5, 8, 9, 11, 29-31, 35, 40 and 41 of Directive 81/851/EEC and Part 1 of the Annex to Directive 81/852/EEC in the form in which they existed prior to any amendment) to be interpreted as permitting the competent authority of a Member State, in circumstances such as those hereinbefore described:
(a) to require an applicant for marketing authorisation in respect of a veterinary medicinal product ("the Product") to identify or to arrange to be identified to the competent authority the names and addresses of any and all manufacturers of a particular substance ("the Substance") from whom the applicant intends to purchase quantities of the Substance for use in the manufacture by the applicant of one of the active ingredients ("the Active Ingredient") of the Product, and to supply or arrange to be supplied to the competent authority details of the site(s) where the Substance would be manufactured and of the manufacturing processes and control testing procedures used by the manufacturer of the Substance;
(b) to require an applicant for a marketing authorisation to submit to the competent authority for approval the results of such control tests as are required to be carried out upon each batch of the Substance purchased by the applicant, and not to release any batch of the Product until such approval has been given in respect of the relevant batch of the Substance;
(c) to require the applicant (whether by specific licence conditions or by withholding grant of a marketing authorisation or otherwise) either to comply with one or both of the above requirements or to market the Product only where it has been prepared using supplies of the Active Ingredient purchased from a specified third party rather than manufactured by the applicant itself;
(d) to suspend the time-limits for a grant of a marketing authorisation laid down by Article 8 of Directive 81/851/EEC until the applicant has agreed to supply the information referred to in (a) above.
2. Is it material to the answers in questions 1(a) to (d) above whether the process of manufacture of the Product is continuous or other than continuous and if so what would be the effect on the answers to those questions?
3. Would it be material to the answers to questions 1(a) to (d) above if it were not reasonably possible for an applicant to obtain any of the information referred to in question 1(a) and if so what would be the effect on the answers to those questions?
4. (a) If the requests for further information and the other requirements described in question 1 above, or any of them, are prima facie permissible under Council Directives 81/851/EEC and 81/852/EEC, must such requests and requirements comply with the Community law principle of proportionality?
(b) If the answer to (a) is affirmative, are those principles to be applied in this case by the national court or by the Court of Justice?
(c) (i) If they are to be applied by the Court of Justice, do the said requests and requirements or any of them infringe the principles of proportionality?
(ii) If they are to be applied by the national court, by reference to what criteria and considerations must the proportionality of the requests and requirements be assessed?
5. Are Articles 30 to 36 of the EC Treaty to be interpreted as prohibiting requests and requirements such as those described above, or any of them?
6. (a) Is Article 40 of Council Directive 81/851/EEC to be interpreted as applying to the requests and requirements described above?
(b) If so, in what circumstances and by reference to what criteria are the reasons for the imposition of such requests and requirements to be treated as inadequate for the purposes of Article 40, and were such requests and requirements adequately reasoned in the present case?
7. (a) Is a Member State liable as a matter of Community law to compensate an undertaking for damages for loss which it has suffered as a consequence of the imposition of requests and requirements such as those described above which
(i) are incompatible with the provisions of Council Directives 81/851 and/or 81/852;
(ii) infringe the principles of proportionality;
(iii) are prohibited by Articles 30 to 36 of the Treaty;
(iv) are insufficiently reasoned within the meaning of Article 40 of Directive 81/851?
(b) If the answer to Question 7(a)(i), (ii), (iii) and (iv) or any of them is in the affirmative, under what conditions does such liability arise?'
The extent to which the conditions for granting marketing authorisations have been harmonised
32 In order to answer the questions submitted, it is first necessary to consider whether Directives 81/851 and 81/852 regulate exhaustively the conditions for granting marketing authorisation, with the result that the competent authority cannot make such authorisation subject to any condition other than those laid down in those directives and that it must comply with all the requirements of Article 5 of Directive 81/851.
33 It is clear from the system which they establish, viewed as a whole, that Directives 81/851 and 81/852 lay down precise and detailed rules concerning applications for marketing authorisation, examination of such applications and the decisions to be given on them.
34 Article 41 of Directive 81/851 clearly prohibits Member States from imposing, for the issue of marketing authorisations, any requirement other than those laid down by that directive.
35 That prohibition reflects the objective of harmonising national procedures for the issue of marketing authorisations with a view to eliminating hindrances to the free movement of veterinary medicinal products, as stated inter alia in the third and fourth recitals in the preamble to Directive 81/851.
36 The Court has, moreover, already held that Article 21 of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (OJ, English Special Edition 1965-1966, p. 20) must be interpreted as meaning that the suspension or revocation of a marketing authorisation may be decided only on the grounds laid down in that directive or other applicable provisions of Community law (Case C-83/92 Pierrel and Others v Ministero della Sanità [1993] ECR I-6419). As the Advocate General has noted in point 42 of his Opinion, furthermore, the aims and many of the articles of the harmonisation directives concerning marketing authorisations for medicinal products for human and veterinary use, including Article 21 of Directive 65/65 and Article 41 of Directive 81/851, are similar.
37 The United Kingdom Government contests that restrictive interpretation on the ground that Article 9, point 3, of Directive 81/851 allows the competent authority to require an applicant for marketing authorisation to provide further information.
38 It must, however, be pointed out that according to the express wording of that provision, the power of the competent authority to require further information to be provided relates only to `the items listed in Article 5'. It thus applies only to the particulars and documents referred to in Article 5.
39 The function of Article 9, point 3, must therefore be limited to that of allowing the competent authority to call on an applicant for marketing authorisation to provide any particular or document required by Directives 81/851 and 81/852 which is missing from the documentation submitted, and to require such applicant to supply further details when those directives specifically empower it to do so.
40 Furthermore, it is clear from the overall scheme of Directives 81/851 and 81/852 and from the express wording of several of the provisions which they contain - in particular Article 9, point 1, and Article 11 of Directive 81/851 and the first paragraph of Article 1 of Directive 81/852 - that applications for marketing authorisation must fulfil all the conditions laid down by Article 5 of Directive 81/851.
41 Indeed, that is the only interpretation consistent with ensuring that the essential objective of safeguarding public health will be attained.
The first question
42 The first question comprises, essentially, two separate parts. The first, embodied in paragraphs (a) to (c), concerns the requirements imposed by Directives 81/851 and 81/852 for the issue of a marketing authorisation. The second part, contained in paragraph (d), concerns the conditions for suspension of the time-limit for granting marketing authorisation.
The requirements imposed by Directives 81/851 and 81/852 for the issue of a marketing authorisation
43 By the first part of its first question, the national court seeks essentially to ascertain whether, on a proper construction of Directives 81/851 and 81/852, the competent authority is not authorised to require an applicant for a marketing authorisation, (a) to disclose the name and address of the manufacturer or manufacturers of a substance used in the manufacture of one of the active ingredients of the medicinal product concerned (`the substance') together with information concerning the manufacturing sites, (b) to provide particulars of the manufacturing process and control testing procedures used by the manufacturer of the substance, (c) to submit the results of tests carried out on each batch of the substance with a view to obtaining approval or (d), as an alternative to the above requirements, to purchase the active ingredient used for the preparation of the substance from a specified third party.
Particulars of the manufacturer of the substance
44 Under point 1 of the second paragraph of Article 5 of Directive 81/851, an application for marketing authorisation must indicate the `name or corporate name and permanent address or registered place of business of the person responsible for marketing and of the manufacturer, if different'.
45 It is clear from that wording that the particulars which must accompany the application relate only to the person responsible for marketing the finished product, or its manufacturer, if different. There is nothing in point 1 of the second paragraph of Article 5, or in the other provisions of Directives 81/851 and 81/852, which requires submission either of the names and addresses of the manufacturer or manufacturers or of information concerning the site or sites where the substance is manufactured.
46 Conducive to that interpretation is the fact that, subsequently, Commission Directive 92/18/EEC of 20 March 1992 modifying the Annex to Directive 81/852 (OJ 1992 L 97, p. 1) required applicants for marketing authorisation to indicate `the name and address of the manufacturers and the sites involved in the different stages of the manufacture (including the manufacturer of the finished product and the manufacturer(s) of the active ingredient(s), and where relevant the name and address of the importer' (Title I, Part 1(A), second paragraph).
47 Finally, it follows from what has been held in paragraphs 38 and 39 of this judgment that Article 9, point 3, of Directive 81/851 cannot justify requiring the particulars at issue.
48 However, it must be made clear that, if disclosure of the name(s) and address(es) of the manufacturer(s) and information concerning the manufacturing site(s) should prove to be the only reliable means of obtaining certain other information required by Directives 81/851 and 81/852, the competent authority must be authorised to call for those details. In such circumstances, the request does not seek to obtain particulars of the manufacturer of the substance as such, but rather the essential information which may thereby be disclosed in relation to the other particulars required.
Particulars of the manufacturing process and control testing procedures used by the manufacturer of the substance
49 To determine whether the competent authority may require an applicant for marketing authorisation to provide particulars of the manufacturing process and control testing procedures used by the manufacturer of the substance, it is necessary to interpret points 3, 4 and 9 of the second paragraph of Article 5 of Directive 81/851 and Part 1(A), (B) and (C) of the Annex to Directive 81/852, which relate, respectively, to the qualitative and quantitative particulars of the constituents, the description of the method of preparation and the control of starting materials.
50 As has been explained in paragraphs 33 to 39 of this judgment, points 3, 4 and 9 of the second paragraph of Article 5 of Directive 81/851 must be interpreted strictly, as authorising the competent authority to require only the particulars and documents expressly mentioned in those provisions, as set out in detail in the Annex to Directive 81/852.
51 The particulars and documents which may be required vary according to how the substance is classified for the purposes of the provisions cited above.
52 The national court does not classify the SS but merely indicates that it is used in the manufacture of the DHS, which is an active ingredient. It adds that the DHS is manufactured from SS by reduction or hydrogenation, whereby the molecular structure of the SS is altered.
53 According to Norbrook, SS is not an active ingredient or any other kind of constituent of Pen & Strep but a substance which disappears in the process of producing the DHS. It infers that the SS does not fall within the scope of point 3 of the second paragraph of Article 5 of Directive 81/851, as set out in detail in Part 1(A) of the Annex to Directive 81/852.
54 As regards point 4 of the second paragraph of Article 5 of Directive 81/851 and Part 1(B) of the Annex to Directive 81/852, concerning the method of preparation, Norbrook considers that, whilst those provisions require mention to be made of the SS, they do not authorise the competent authority to require particulars of the manufacturing process or control testing methods used by the manufacturer, since the references in those provisions to, in particular, `preparation', `manufacture' and `formula' are references to the final product, namely Pen & Strep.
55 Finally, according to Norbrook, point 9 of the second paragraph of Article 5 of Directive 81/851 and Part 1(C) of the Annex to Directive 81/852 do not allow the disputed information to be demanded since the SS is not a `starting material' as defined in point C.
56 The United Kingdom Government contends, on the other hand, that Part 1(A)(1) of the Annex to Directive 81/852 gives a broad meaning to the expression `particulars of all the constituents' used in point 3 of the second paragraph of Article 5 of Directive 81/851. In its view, that provision requires the particular features of the DHS to be indicated. Since, in the circumstances at issue in the main proceedings, the DHS is manufactured from SS as part of a continuous manufacturing process, details about the SS used are relevant to a precise assessment of the possible public health risks of the DHS.
57 The United Kingdom Government also maintains that the SS is a starting material for the purposes of Part 1(C) of the Annex to Directive 81/852 or at least should be treated as such. It states that information relating only to the DHS would not give an adequate picture of the overall safety of the final product.
58 The Commission states that a strict interpretation of Directives 81/851 and 81/852, as initially worded, might lead to the conclusion that the United Kingdom authorities were precluded from requesting information on the SS, which was a material upstream of the starting material in the production process for Pen & Strep, but not from requesting information on the DHS. Those directives then provided for only one control of starting materials and it was not until later that they were amended on that point.
59 The Commission observes, however, that it could be argued in this case that DHS and SS are very closely related and that the main risk of the occurrence of manufacturing-related impurities lies in the production of the SS. The competent authority should therefore be entitled to seek information on the manufacturing process used for the SS so as to have in its possession the fullest assurances as to the quality of that substance.
60 First, it must be observed here that it is clear from point 4 of the second paragraph of Article 5 of Directive 81/851 and from Part 1(B) of the Annex to Directive 81/852 that those provisions are concerned only with describing the method of preparation of the finished product and not the method of preparation of the constituents of that product. They do not therefore cover a substance such as the SS.
61 Second, Part 1(C) of the Annex to Directive 81/852 defines `starting materials' by reference to the `constituents' as described in point A(1) and then lays down the requirements for submission of the particulars and documents relating to the control testing of such starting materials.
62 Thus, for starting materials listed in pharmacopoeias, point C(1) provides in particular that a simple reference to the pharmacopoeia in question is sufficient for compliance with point 9 of the second paragraph of Article 5 of Directive 81/851.
63 Even where that is the case, however, provision is made in point C(1), in particular the fourth, seventh and eighth paragraphs thereof, for further information to be supplied, where appropriate, in order to verify that the starting material has been prepared by a method not liable to leave impurities. That information may relate to the methods by which the starting material is manufactured and subjected to control testing.
64 For starting materials not in a pharmacopoeia, it is clear from Part 1(C)(2) of the Annex to Directive 81/852 that particulars of manufacturing and control testing methods may be required.
65 It is therefore for the national court to decide whether the SS is a starting material within the meaning of the first paragraph of Part 1(C) of the Annex to Directive 81/852 and, if so, to apply point C in the light of the interpretative guidance given above.
66 Should the national court conclude that the SS is not a starting material within the meaning of first paragraph of Part 1(C) of the Annex to Directive 81/852, both the United Kingdom Government and the Commission submit that the features of this case are still such that the competent authority is entitled to call for the information at issue. DHS and SS are closely related to each other and the main risk of impurities arises in the production of the SS. Consequently, the purity of the DHS can be assessed only by reference to the information requested regarding the SS.
67 It must be borne in mind that, as is clear from the first recital in its preamble, Directive 81/851 is intended primarily to safeguard public health. Therefore, where, after verification of the documents and particulars listed in Article 5, it appears that the medicinal product is harmful, point 1 of the first paragraph of Article 11 allows marketing authorisation to be withheld. That is why, as noted above, Part 1(C) of the Annex to Directive 81/852 allows the competent authority, in certain circumstances, to call for appropriate specifications in order to verify the quality of the finished product.
68 It must therefore be concluded that in particular circumstances where only information concerning the manufacturing process and the method of control testing of the substance from which an active ingredient is manufactured would make it possible to verify the purity of that ingredient and thus to ensure that the medicinal product is not harmful, the competent authority must be authorised to require that information. It is for the national court to establish whether such circumstances arise in the case before it.
Prior approval of batches of the substance purchased by an applicant for marketing authorisation
69 Contrary to the United Kingdom's contention, there is no provision in Directive 81/851 or Directive 81/852 for the competent authority to require the results of tests on each batch to be supplied to it for approval. The seventh paragraph of Part 1(C)(1) of the Annex to Directive 81/852 relates only to the declaration of routine tests in the application for marketing authorisation and not to prior approval of each batch used for the manufacture of a medicinal product.
The obligation to purchase the active ingredient from a specified third party
70 It must be pointed out that nothing in the wording of Directive 81/851 or Directive 81/852 allows marketing authorisation to be granted subject to the requirement that the active ingredient must be purchased from a specified third party.
71 In view of all the foregoing, the answer to the first part of the first question must be that, on a proper construction of the second paragraph of Article 5 of Directive 81/851, read in conjunction with the other provisions of that directive and Directive 81/852, the competent authority is not authorised to require particulars and documents other than those expressly listed in that provision, as set out in detail in the Annex to Directive 81/852. More particularly, the competent authority is not authorised to require an applicant for marketing authorisation
- to disclose the name(s) and address(es) of the manufacturer(s) of the substance and information concerning the manufacturing site(s), unless disclosure of that information constitutes the only reliable means of obtaining a particular required by Directives 81/851 and 81/852;
- to disclose the results of tests carried out on each batch of the substance with a view to approval thereof; or
- to purchase the active ingredient from a specified third party.
Part 1(C) of the Annex to Directive 81/852 does, however, allow particulars to be required of the manufacturing process and control testing methods used by the manufacturer of a starting material. In that regard, it is for the national court to determine whether the substance is a starting material within the meaning of the first paragraph of that provision. If it is not, such particulars may nevertheless be required in so far as the features of the process by which the starting material is manufactured from the substance are such that no other means of assessing the purity of the starting material is available.
Suspension of the time-limit for granting marketing authorisation
72 In paragraph (d) of its first question, the national court asks essentially whether the competent authority may suspend the time-limit for granting marketing authorisation laid down by Article 8 of Directive 81/851/EEC until the applicant has supplied details of the manufacturing process, the control testing methods and the manufacturer of the substance.
73 Having regard to the Court's analysis of the first part of the first question, this question must be construed as relating to the information which the competent authority is authorised to call for on the basis of Article 9, point 3, of Directive 81/851.
74 In that regard, it must be noted that Article 8 of Directive 81/851 lays down a maximum period of 120 days for dealing with an application for marketing authorisation, which in exceptional cases may be extended for a further 90 days.
75 Article 9, point 3, of the same directive, which allows the competent authority, where appropriate, to require the applicant to provide further information as regards the items listed in article 5, stipulates that, where that course of action is taken, the time-limits specified in Article 8 are to be suspended until the further data required have been provided.
76 It is thus clear from those provisions that recourse to Article 9, point 3, of Directive 81/851 suspends the time-limit for granting marketing authorisation.
77 The answer to the second part of the first question must therefore be that, where the competent authority requires an applicant for marketing authorisation to provide information under Article 9, point 3, of Directive 81/851, the time-limits laid down in Article 8 of that directive are to be suspended until that information is provided.
The second question
78 By its second question the national court asks whether the fact that the process of manufacture of the medicinal product is continuous or other than continuous affects the answers to the first question.
79 Neither the order for reference nor the observations submitted to the Court have specified what is meant by `continuous' or `other than continuous'. The Commission has observed, however, that such continuous or other than continuous production relates to the production not of the SS but of the finished product.
80 In those circumstances, there is no reason to consider that the answers to the first question would differ according to whether the production of the medicinal product was continuous or otherwise.
81 The answer to the second question must therefore be that the fact that the process by which a medicinal product is manufactured is continuous or other than continuous does not affect the answers to the first question.
The third question
82 By its third question, the national court asks essentially to what extent the fact that it is not practically possible for an applicant for marketing authorisation to provide certain information is relevant for the purposes of the first question.
83 In view of the answers given to the first question, the third question must be construed as relating to the obligation to provide a particular or document referred to in Article 5 of Directive 81/851.
84 As stated in paragraphs 40 and 41 of this judgment, an application for marketing authorisation must fulfil all the conditions laid down in Article 5 of Directive 81/851 for the issue of an authorisation. Since the aim of strict compliance with those conditions is to safeguard public health, even the fact that it is practically impossible to provide information cannot justify an exception to those conditions. It is incumbent on an applicant for marketing authorisation to ensure that he meets those requirements.
85 The answer to the third question must therefore be that the competent authority is not authorised to exempt an applicant for marketing authorisation from providing a particular or document required under Article 5 of Directive 81/851 even if it appears practically impossible, in a given case, to obtain that information.
The fourth question
86 By its fourth question, the national court wishes to ascertain essentially whether the principle of proportionality restricts the power of the competent authority to request further information and impose the other requirements described in the first question and, if so, whether it is for the Court of Justice or for the national court to apply that principle.
87 In view of the answers given to the first question, the fourth question calls for an answer only with respect to the obligation laid down in points 3, 4 and 9 of the second paragraph of Article 5 of Directive 81/851 and Part 1(A), (B) and (C) of the Annex to Directive 81/852 to provide particulars of the manufacturing process and the methods of control testing used by the manufacturer of the substance.
88 As has already been held in this judgment, the competent authority is required to apply the provisions of Directives 81/851 and 81/852 strictly, in that an applicant for marketing authorisation must provide all the particulars and documents specified therein. In that regard, therefore, those directives do not leave the competent authority any discretion such that it must satisfy itself that, having regard to the principle of proportionality, a particular or document specified by those directives may be required in a specific case.
89 The question must nevertheless be asked whether those provisions themselves are in conformity with the principle of proportionality. As the Court has held, in order to establish whether a provision of Community law complies with the principle of proportionality, it must be ascertained whether the means which it employs are suitable for the purpose of achieving the desired objective and whether they do not go beyond what is necessary to achieve it (see, in particular, Case C-84/94 United Kingdom v Council [1996] ECR I-5755, paragraph 57).
90 In a sphere in which the Community legislature is called on to undertake complex assessments based on technical and scientific information which is liable to change rapidly, judicial review of the exercise of its powers must be limited to examining whether it has been vitiated by a manifest error of assessment or a misuse of powers or whether the legislature has manifestly exceeded the limits of its discretion (see, in particular, United Kingdom v Council, cited above, paragraph 58).
91 In claiming that the principle of proportionality has been infringed in this case, Norbrook asserts that the nature of the requirement to supply particulars of the manufacturing process and control testing methods used by the manufacturer of the substance, in particular the frequent impossibility of compliance and the consequences of such non-compliance, is out of proportion to such infinitesimal risk to public health as might result from ignorance of the manufacturing process and control testing methods.
92 In that regard, it must be borne in mind that the essential objective of the rules concerning the production and distribution of veterinary medicinal products is to safeguard public health (first recital in the preamble to Directive 81/851). The very stringent requirements imposed by Directives 81/851 and 81/852 reflect that imperative.
93 As has already been noted in paragraph 84 of this judgment, it is incumbent on an applicant for marketing authorisation to ensure that he meets those requirements.
94 In view of the paramountcy of the objective of public health, the particular difficulties to which Norbrook refers in providing the particulars in question do not demonstrate that the Council manifestly exceeded the limits of its discretion by adopting the provisions in points 3, 4 and 9 of the second paragraph of Article 5 of Directive 81/151 and Part 1(A), (B) and (C) of the Annex to Directive 81/852, in so far as they require particulars to be provided of the manufacturing process and the control testing methods used by the manufacturer of the substance.
95 It must therefore be concluded that consideration of the fourth question has disclosed no factor of such a kind as to affect the validity, in the light of the principle of proportionality, of the abovementioned provisions of Directives 81/851 and 81/852.
The fifth question
96 In view of the answers given to the first question, the national court's fifth question must be construed as seeking to ascertain whether Directives 81/851 and 81/852 are in conformity with Articles 30 to 36 of the Treaty as regards the particulars and documents required for the purposes of an application for marketing authorisation.
97 It need merely be pointed out in that regard, first, that the harmonisation of national procedures for the issue of marketing authorisations is designed to eliminate hindrances to the free movement of veterinary medicinal products. Second, even if the stringent requirements imposed by Directives 81/851 and 81/852 in themselves constitute restrictions, there is nothing in this case to support the conclusion that they are not justified by the safeguarding of public health, which is the essential objective of both directives.
98 It must therefore be concluded that consideration of the fifth question has disclosed no factor of such a kind as to affect the validity, in the light of Articles 30 to 36 of the Treaty, of Directives 81/851 and 81/852.
The sixth question
99 By its sixth question, the national court wishes to ascertain essentially whether Article 40 of Directive 81/851 must be construed as meaning that a request for the particulars referred to in the first question must state the reasons on which it is based and, if so, what requirements must be met by the statement of reasons.
100 In view of the answers given to the first question, the sixth question must be construed as relating to further information requested by the competent authority under Article 9, point 3, of Directive 81/851 when examining an application for marketing authorisation.
101 The first paragraph of Article 40 of Directive 81/851 provides: `All decisions taken pursuant to Articles 11, 36, 37 and 38, all negative decisions taken pursuant to Article 10 point 2 and Article 19(3) of this Directive and all decisions to withhold authorisation to manufacture or to import from third countries or to suspend or withdraw manufacturing authorisation shall state in detail the reasons on which they are based'.
102 It is clear from the wording of that paragraph and that of the provisions to which it refers that it relates only to decisions to withhold, suspend or withdraw authorisation but not to requests made by the competent authority under Article 9(3) of Directive 81/851.
103 Nor can any obligation to state the reasons on which a request for further information is based be inferred from any general principle of Community law. It is true that Community law imposes an obligation to state the reasons for national decisions affecting the exercise of a fundamental right conferred on individuals by the Treaty (see, in particular, Case 222/86 Unectef v Heylens [1987] ECR 4097, paragraphs 14 and 15). However, in view of its aim, that obligation does not extend to measures such as the one at issue in this case, relating to the examination of an application, by which the competent authority asks an applicant for marketing authorisation to provide further information. In the event of authorisation being withheld on the ground that the applicant has failed to comply with the request for further information, the competent authority is in any event required to state the reasons on which its decision is based.
104 The answer to the sixth question must therefore be that Article 40 of Directive 81/851 must be interpreted as meaning that a request for further information based on Article 9, point 3, of that directive need not state the reasons on which it is based.
The seventh question
105 By its seventh question the national court seeks essentially to ascertain whether a Member State is required to make good loss and damage caused to an applicant for marketing authorisation as a result of requests for information and requirements which infringe Community law and, if so, what conditions govern its liability in that regard.
106 It must be remembered, first, that, as the Court has held repeatedly, the principle of State liability for loss and damage caused to individuals as a result of breaches of Community law for which the State can be held responsible is inherent in the system of the Treaty (Joined Cases C-6/90 and C-9/90 Francovich and Others v Italian Republic [1991] ECR I-5357, paragraph 35; Joined Cases C-46/93 and C-48/93 Brasserie du Pêcheur and Factortame [1996] ECR I-1029, paragraph 31; Case C-392/93 The Queen v H.M. Treasury, ex parte British Telecommunications [1996] I-1631, paragraph 38; Case C-5/94 The Queen v MAFF, ex parte Hedley Lomas [1996] ECR I-2553, paragraph 24; and Joined Cases C-178/94, C-179/94, C-188/94, C-189/94 and C-190/94 Dillenkofer and Others v Germany [1996] ECR I-4845, paragraph 20).
107 It is clear from the above case-law that three conditions must be satisfied for a Member State to be required to compensate for damage thus caused: the rule of law infringed must have been intended to confer rights on individuals; the breach must be sufficiently serious; and there must be a direct causal link between the breach of the obligation resting on the State and the damage sustained by the injured parties (Brasserie du Pêcheur and Factortame, paragraph 51; British Telecommunications, paragraph 39; Hedley Lomas, paragraph 25; and Dillenkofer and Others, paragraph 24, all cited above).
108 As regards the first condition, in providing that an application for marketing authorisation may be refused only for the reasons set out in Directive 81/851, that directive gives individuals the right to obtain authorisation if certain conditions are fulfilled. Those conditions are, as has been held in this judgment, laid down precisely and exhaustively in Directives 81/851 and 81/852. The scope of the right conferred on applicants for marketing authorisation may therefore be adequately identified on the basis of those directives.
109 As regards the second condition, the Court has held, first, that a breach is sufficiently serious where a Member State, in the exercise of its legislative powers, has manifestly and gravely disregarded the limits on its powers (see Brasserie du Pêcheur and Factortame, paragraph 55; British Telecommunications, paragraph 42; and Dillenkofer and Others, paragraph 25, all cited above) and, second, that where, at the time when it committed the infringement, the Member State in question was not called upon to make any legislative choices and had only considerably reduced, or even no, discretion, the mere infringement of Community law may be sufficient to establish the existence of a sufficiently serious breach (see Hedley Lomas, paragraph 28, and Dillenkofer and Others, paragraph 25, both cited above).
110 As regards the third condition, it is for the national court to verify whether there is a direct causal link between the Member State's breach of its obligation and the damage suffered by the individual.
111 Finally, it has been settled case-law since the judgment in Francovich and Others, cited above (paragraphs 41 to 43), that, subject to the existence of a right to obtain reparation which is founded directly on Community law where the three conditions mentioned above are met, it is on the basis of rules of national law on liability that the State must make reparation for the consequences of the loss and damage caused, with the proviso that the conditions for reparation of loss and damage laid down by the national legislation must not be less favourable than those relating to similar domestic claims and must not be so framed as to make it in practice impossible or excessively difficult to obtain reparation.
112 The answer to the seventh question must therefore be that a Member State is required to make good loss and damage caused to an applicant for marketing authorisation as a result of requests for information and requirements which infringe Directives 81/851 and 81/852 where the rule of Community law infringed is intended to confer rights on individuals, the breach is sufficiently serious and there is a direct causal link between that breach and the damage sustained by the individuals concerned. Subject to that reservation, it is on the basis of rules of national law on liability that the State must make reparation for the consequences of the loss and damage caused by a breach of Community law for which it can be held responsible, with the proviso that the conditions laid down by the applicable national legislation must not be less favourable than those relating to similar domestic claims and must not be so framed as to make it in practice impossible or excessively difficult to obtain reparation.
Decision on costs
Costs
113 The costs incurred by the United Kingdom Government and the Commission of the European Communities, which have submitted observations to the Court, are not recoverable. Since these proceedings are, for the parties to the main proceedings, a step in the proceedings pending before the national court, the decision on costs is a matter for that court.
Operative part
On those grounds,
THE COURT
(Fifth Chamber),
in answer to the questions referred to it by the Court of Appeal in Northern Ireland by order of 27 March 1995, hereby rules:
1. On a proper construction of the second paragraph of Article 5 of Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products, read in conjunction with the other provisions of that directive and Council Directive 81/852/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products, the competent authority is not authorised to require particulars and documents other than those expressly listed in that provision, as set out in detail in the Annex to Directive 81/852. More particularly, the competent authority is not authorised to require an applicant for marketing authorisation
- to disclose the name(s) and address(es) of the manufacturer(s) of a substance used in the manufacture of one of the active ingredients of the medicinal product concerned and information concerning the manufacturing site(s), unless disclosure of that information constitutes the only reliable means of obtaining a particular required by Directives 81/851 and 81/852;
- to disclose the results of tests carried out on each batch of such a substance with a view to approval thereof; or
- to purchase the active ingredient from a specified third party.
Part 1(C) of the Annex to Directive 81/852 does, however, allow particulars to be required of the manufacturing process and control testing methods used by the manufacturer of a starting material. In that regard, it is for the national court to determine whether the said substance is a starting material within the meaning of the first paragraph of that provision. If it is not, such particulars may nevertheless be required in so far as the features of the process by which the starting material is manufactured from the substance are such that no other means of assessing the purity of the starting material is available.
Where the competent authority requires an applicant for marketing authorisation to provide information under Article 9, point 3, of Directive 81/851, the time-limits laid down in Article 8 of that directive are to be suspended until that information is provided.
2. The fact that the process by which a medicinal product is manufactured is continuous or other than continuous does not affect the answers to the first question.
3. The competent authority is not authorised to exempt an applicant for marketing authorisation from providing a particular or document required under Article 5 of Directive 81/851 even if it appears practically impossible, in a given case, to obtain that information.
4. Consideration of the fourth question has disclosed no factor of such a kind as to affect the validity, in the light of the principle of proportionality, of points 3, 4 or 9 of the second paragraph of Article 5 of Directive 81/851 or Part 1(A), (B) or (C) of the Annex to Directive 81/852.
5. Consideration of the fifth question has disclosed no factor of such a kind as to affect the validity, in the light of Articles 30 to 36 of the EC Treaty, of Directives 81/851 and 81/852.
6. Article 40 of Directive 81/851 must be interpreted as meaning that a request for further information based on Article 9, point 3, of that directive need not state the reasons on which it is based.
7. A Member State is required to make good loss and damage caused to an applicant for marketing authorisation as a result of requests for information and requirements which infringe Directives 81/851 and 81/852 where the rule of Community law infringed is intended to confer rights on individuals, the breach is sufficiently serious and there is a direct causal link between that breach and the damage sustained by the individuals concerned. Subject to that reservation, it is on the basis of rules of national law on liability that the State must make reparation for the consequences of the loss and damage caused by a breach of Community law for which it can be held responsible, with the proviso that the conditions laid down by the applicable national legislation must not be less favourable than those relating to similar domestic claims and must not be so framed as to make it in practice impossible or excessively difficult to obtain reparation.
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