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2. Monsanto applied to the national court for judicial review. It claimed that the respondents had infringed the provisions of the directive by granting Clayton Plant Protection Ltd ('Clayton'), on 16 February 1998, marketing authorisation for a new I — The Community legal framework glyphosate-based plant protection product ('the product') on the basis of the data on that active substance provided in 1974 by Monsanto. Monsanto claims that the mar- keting authorisation for such a generic 4. The purpose of the directive, adopted on product may only be granted on condition the basis of Article 43 of the EC Treaty that the applicant is able to provide the (now, after amendment, Article 37 EC), is competent national authority with data to define the uniform rules on the condi- tions and procedures for the authorisation and use of plant protection products. 3 1 — Original language: French. 2 — Council Directive 91/414/EEC of 15 July 1991 concerning the placing or plant protection products on the market (OJ 1991 L 230, p. 1, hereinafter 'the directive'). 3 — Sixth and seventh recitals.

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5. Its main objective is not only to improve of active substances intended for a use agricultural production by the use of effi- specified in Article 2(1).' cacious plant protection products, but also to protect humans, animals and the envir- onment from risks and hazards arising from the unchecked use of those products. 4 For that reason, it is intended to ensure the marketing of safe products which will have no harmful effect on human or animal health or the environment, directly or 8. Article 2(1) indicates that 'plant protec- indirectly. 5Moreover, it aims at eliminat- tion products' must be understood to mean ing barriers to the free circulation of that 'active substances and preparations con- type of goods. 6 taining one or more active substances, put up in the form in which they are supplied to the user...' and which are intended for specific purposes. 9

10. Article 2(5) states that 'preparations' 4 — Fourth, ninth and tenth recitals. are 'mixtures or solutions composed of two 5 — See, in particular, Case C-303/94 Parliament v Council or more substances of which at least one is [1996] ECR I-2943, paragraph 27. 6 — Fifth and sixteenth recitals. an active substance, intended for use as 7 — According to Article 2(11), 'authorisation of a plant protec- plant protection products'. tion product' is the 'administrative act by which the competent authority of a Member State authorises, follow- ing an application submitted by an applicant, the placing on the market of a plant protection product in its territory or in a part thereof'. 9 — Those are, in particular, to protect plants or plant products 8 — Under Article 2(10), 'placing on the market' refers to 'any against all harmful organisms or prevent the action of such supply, whether in return for payment or free of charge, organisms (Article 2(1.1)), preserve plant products (Art- other than for storage followed by consignment from the icle 2(1.3)), and destroy undesired plants (Article 2(1.4)). territory of the Community or disposal. Importation of a 10 — 'Substance' is defined as 'chemical elements and their plant protection product into the territory of the Commu- compounds, as they occur naturally or by manufacture, nity shall be deemed to constitute placing on the market for including any impurity inevitable[y] resulting from the the purposes of this Directive'. manufacturing process' (Article 2(3)).

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13 — Article 19 provides for the involvement of the Standing Committee on Plant Health, set up by Council Decision 11 — That provision relates to the procedure which the Member 76/894/EEC of 23 November 1976 establishing a Standing States must follow for the purpose of authorising experi- Committee on Plant Health (OJ 1976 L 340, p. 25). ments and tests for research or development purposes involving the release into the environment of an unauthor- 14 — It is also provided in Article 5(1)(a) and (b) that the ised plant protection product. residues of such active substances as well as their use, consequent on application consistent with good plant 12 — Article 4(2), (31 and (4) define some of the conditions set protection practice, must not have any harmful effects on out in Article 4(1} relating, in particular, to the duration of human or animal health or any unacceptable influence on such authorisation (Article 4(4)). the environment.

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Those principles were laid down in Direct- tions under which it may be used, and ive 94/43/EC, 1 5amended by Directive to the consequences of its use: 97/57/EC. 16

(i) it is sufficiently effective; 18. Article 4(1) of the directive thus pro- vides:

(ii) it has no unacceptable effect on plants or plant products;

drinking water and ground- lished by the Member State and noti- water, fied to the Commission in accordance with Article 12; within three months of the said notification, the Commission shall consider whether the provisional maximum levels established by the — its impact on non-target spe- Member State are acceptable, and in cies; accordance with the procedure laid down in Article 19 it shall establish provisional maximum levels through- out the Community and these shall remain in force until the corresponding maximum levels are adopted ... (c) the nature and quantity of its active substances and, where appropriate, any toxicologically or ecotoxicologically significant impurities and co-formu- lants can be determined by appropriate In particular: methods, harmonised according to the procedure provided in Article 21, or, if not, agreed by the authorities respons- ible for the authorisation;

(i) Member States may not prohibit or impede the introduction into their territory of products containing pesticide residues provided the resi- (d) its residues, resulting from authorised due level does not exceed the uses, and which are of toxicological or provisional maximum levels set in environmental significance, can be accordance with the first subpara- determined by appropriate methods in graph; general use;

(ii) Member States must ensure that (e) its physical and chemical properties the conditions for approval are have been determined and deemed applied in such a way that the acceptable for the purposes of the provisional maximum levels are appropriate use and storage of the not exceeded.' product;

the Community legislature provided for these active substances within the 12-year transitional measures of two kinds. period referred to in the foregoing sub- paragraph. This programme may require interested parties to submit all requisite data to the Commission and the Member States within a period provided for in the programme. A Regulation, adopted accord- 20. According to Article 8 of the directive, ing to the procedure laid down in Arti- the granting of marketing authorisation in cle 19, will set out all the provisions respect of an active substance not listed in necessary for the implementation of the Annex I is governed by a different set of programme. rules depending on whether the active substance in question is analogous to that contained in a product already on the market two years after notification of the directive (first subparagraph of Art- icle 8(2)), or not 17 (first subparagraph of Ten years following notification of this Article 8(1)). Directive the Commission shall present to the European Parliament and the Council a progress report on the programme. Depending upon the conclusions of the report, it may be decided, according to the procedure laid down in Article 19, 21. Article 8(2) of the directive provides whether, for certain substances, the 12-year that: 'By way of derogation from Article 4 period referred to in the first subparagraph and without prejudice to paragraph 3 or to is to be extended for a period to be Directive 79/117/EEC, 18 a Member State determined. may, during a period of 12 years following the notification of this Directive, authorise the placing on the market in its territory of plant protection products containing active substances not listed in Annex I that are already on the market two years after the During the 12-year period referred to in the date of notification of this Directive. first subparagraph it may, following exam- ination by the Committee referred to in Article 19 of such active substance, be decided by the procedure laid down in that Article that the substance can be included in Annex I and under which conditions, or, After the adoption of this Directive, the in cases where the requirements of Article 5 Commission shall commence a programme are not satisfied or the requisite informa- of work for the gradual examination of tion and data have not been submitted within the prescribed period, that such active substance will not be included in 17 — That case, as will be seen below, is not relevant to the main Annex I. The Member States shall ensure proceedings. that the relevant authorisations are 18 — Council Directive 79/117/EEC of 21 December 1978 prohibiting the placing on the market and use of plant granted, withdrawn or varied, as appropri- protection products containing certain active substances ate, within a prescribed period.' (OJ 1979 L 33, p. 36).

(c) for periods not exceeding 10 years from the date of the decision in each 23. Article 13 of the directive provides for Member State and provided for in the data requirements, data protection and existing national rules, concerning an confidentiality of the data produced by active substance on the market two applicants in support of their applications years after the date of notification of for marketing authorisation. In addition to this Directive ...' the rules relating to the procedure accord- ing to which such data must be submit- ted, 19 that article requires the competent national authorities to respect the confi- dentiality of the data and to protect the rights of a holder of marketing authorisa- 25. In respect of 'active substances already tion over the data which it submitted in on the market two years after notification support of its application for marketing of this Directive', Article 13(6), by way of authorisation. 20 derogation from the general arrangements relating to the production of data, provides that 'Member States may, with due regard for the provisions of the Treaty, continue to apply previous national rules concerning data requirements as long as such sub- stances are not included in Annex I' to the 24. Article 13(3) of the directive thus pro- directive. vides:

26. The directive was notified to the Mem- ber States on 26 July 1991. It entered into 'In granting authorisations, Member States force on that date. Pursuant to Article 23, shall not make use of the information the Member States were to bring into force the laws, regulations and administrative provisions necessary to comply with the 19 — Article 13(1) of the directive. directive within two years following noti- 20 — Article 13(3) and (4) of the directive. fication thereof.

31. Under the scheme currently in force in 29. Under the system in force in the United the United Kingdom, any manufacturer Kingdom, the data relating to the active wishing to obtain authorisation to place a substance and the product submitted in new glyphosate-based herbicide on the support of an application for a first market- market in the United Kingdom must submit ing authorisation of a plant protection a 'me-too' application to the PSD. That product are protected for a period of 10 application is based on the principle that years. 21 For products registered prior to the generic manufacturer must provide data which is equivalent to that provided at the material time by the applicant for primary 21 — See Article 13(3)(c) of the directive. authorisation.

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32. In the present case, the me-too appli- generic plant protection product satisfies cants for glyphosate-based products may the criteria laid down in Article 4(1)(b) to either provide data which is equivalent to (f) of the directive. Monsanto submits that that provided by Monsanto to obtain its that authority must make certain, further- primary authorisation or refer to the data more, that the data provided is still relevant in the package provided by Monsanto in in the light of current scientific and techni- respect of which protection has elapsed, or cal knowledge. a mixture of both.

36. On the other hand, principally on the 33. Whatever approach is adopted, the basis of the wording of Article 8(2) and (3) data which must be produced or cited of the directive, the respondents contend when making a me-too application for a glyphosate-based product are based on the that the directive does not require compli- data provided at the time by Monsanto in ance with the conditions set out in Art- order to obtain its original commercial icle 4(1)(a) to (f) of the directive. They approval in 1974. submit that, during the transitional period, the Member States enjoy a wide discretion as regards the documents which an applic- ant must provide to the competent national authority in support of its application for authorisation to market a generic product.

2. If the answer to Question 1 is in the affirmative, is the Member State under an obligation to apply the requirements of Article 4(1)(b)(i) to (v) to such applications "in the light of current Introductory remarks scientific and technical knowledge"?

38. First and foremost, it is undisputed that the factual context of the questions referred by the national court is that of the granting of a marketing authorisation in respect of a 3. If the answer to Question 1 is in the generic plant protection product during the affirmative, is the Member State also transitional period. under an obligation to apply the requirements of Article 4(1)(c) to (f) to such applications "in the light of current scientific and technical know- ledge"? 39. The directive does not define 'generic product', but the Court had the opportun- ity to explain that concept in Generics (UK) and Others. 22 In that case, the Court was asked to interpret certain provisions of Directive 65/65/EEC, 23 as amended by 4. If the answers to Questions 1, 2 and/or Directive 87/21/EEC 24 and, in particular, 3 are in the affirmative, is the Member to define the concept of 'generic medicinal State under an obligation to ensure that product', also referred to as 'essentially its national provisions concerning the data to be provided (as referred to in Articles 8(3) and 13(6) of the directive) 22 — Case C-368/96 [1998] ECR I-7967. permit an evaluation to be carried out 23 — Council Directive of 26 January 1965 on the approxima- tion of provisions laid down by law, regulation or in accordance with the criteria laid administrative action relating to proprietary medicinal products (OJ, English Special Edition 1965-1966, p. 20). down in Article 4(1)(b)(i) to (v) and (c) 24 — Council Directive of 22 December 1986 (OJ 1987 L 15, to (f) of the directive "in the light of p. 36).

40. The Court took the view that 'generic medicinal product' was to be understood as a medicinal product which, despite being manufactured from the same active sub- stance as that contained in a medicinal product which has been marketed for more 42. Secondly, it is undisputed that a generic than 10 years, has a chemical formulation product is a new product and that it may or method of manufacture which differs not be marketed without a marketing from the primary product, provided that it authorisation having been obtained from is apparent that such differences are not the competent national authorities before- significant, in the light of current scientific hand as required by the directive. 29 and technical knowledge when the applica- tion is being considered, by comparison with the original product as regards quality, safety and efficacy. 25The Court added that the competent national authority could not disregard those three criteria when it was required to determine whether such a 43. As I have already stated, 30marketing product was essentially analogous to a authorisation for a plant protection pro- product authorised more than 10 years duct must be granted in accordance with previously. 26 Article 4 of the directive provided that the active substance contained in that product is listed in Annex I. Otherwise, Article 8(2)

49. By its first question and by part of its fourth question (hereinafter 'the first ques- tion'), the national court wishes to know 45. Nor is it disputed that, in the case in the whether, during the transitional period, the main proceedings, the product in respect of issuing, by the competent national author- which Clayton applied for marketing ity, of a marketing authorisation in respect authorisation is manufactured from that of a plant protection product containing an active substance. active substance analogous to that con- tained in a product 'already on the market two years after the date of notification of this directive' is subject to compliance with the requirements laid down in Art- icle 4(1)(b) to (f) of the directive. If so, the Court is asked to specify the manner in 46. It appears from the foregoing that the which the requirements relating to those active substance at issue was on the market data must be provided by an applicant for on 26 July 1993, that is two years after marketing authorisation of a plant protec- notification of the directive. tion product to the competent national authority in support of such an application.

47. In accordance with the analysis set out by the national court, the facts of the main 50. By its second, third and, in part, its proceedings fall within the scope of the fourth question (hereinafter 'the second procedure laid down in Article 8(2) of the question'), the national court requests the directive. Court to rule on whether the competent

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national authority must take account of accordance with paragraph 2, and before current scientific and technical knowledge such review has taken place, Member when assessing compliance with the condi- States shall apply the requirements laid tions laid down in Article 4(1)(b) to (f) of down in Article 4(1)(b)(i) to (v), and (c) to the directive. If so, the Court is asked to (f) in accordance with national provisions specify the manner in which this is to be concerning the data to be provided.' carried out.

57. 'Review' as referred to in Article 8(3) Annex I but analogous to that contained in must therefore be understood to mean the a product on the market on 26 July 1993. procedure for reviewing marketing author- isation granted in respect of a product containing a substance analogous to that contained in a product on the market two years after notification of the directive — 26 July 1993 — but which has not yet been included in Annex I. That term, it is 60. On the other hand, Clayton and the claimed, refers also to the procedure invol- United Kingdom Government submit that ving the Commission under the programme 'review', within the meaning of Article 8(3) of work provided for in the second to must not be understood as meaning review fourth subparagraphs of Article 8(2) of the of a marketing authorisation granted in directive. That procedure is designed to respect of a product, but only review of an enable active substances placed on the active substance authorised before the market of the Member States to be listed directive was implemented. They thus in Annex I, in accordance with the proced- claim that, where a Member State decides ure provided for by Article 8(3). to review such an active substance, it must comply with the conditions laid down in Article 4(1)(b) to (f). By the expression 'and before such review has taken place', the Community legislature wished to make it clear that, at the end of that procedure, the Member States must defer to the decision taken by the Commission on the active 58. Moreover, the expression 'before such substance under consideration. Thus, if the review has taken place' should be under- Commission decides not to list that active stood as referring to the case where, during substance in Annex I, the Member States the transitional period, an application for a may no longer grant a marketing author- marketing authorisation has been made to isation in respect of a product containing a Member State in respect of a new product that active substance in accordance with containing an active substance analogous national law, but must comply with the to that contained in a product on the requirements of the directive. In other market on 26 July 1993. words, the expression 'before such review has taken place' means 'before the review procedure is completed'.

in order to authorise the marketing of a ment contend, the procedure put in motion plant protection product containing an by the Commission which consists in active substance which is not included in reviewing the active substances authorised Annex I but which was on the market on by the competent national authorities in 26 July 1993, in accordance with Art- order to decide whether or not they are to icle 8(2) of the directive, the Member States be listed in Annex I. are not obliged to apply Article 4(1)(b) to (f) of the directive, but rather the provisions of their domestic law. It must accordingly be considered that, during the transitional period, the Member States enjoy a very wide margin of discretion as regards the procedure and the conditions applicable to new applications for marketing authorisa- tions in respect of a generic product 64. The expression 'before such review has containing an active substance not listed taken place' must therefore be read in in Annex I. conjunction with 'review plant protection products' and accordingly be interpreted in the light of the procedure for review of the authorisation granted to the product itself.

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66. Those requirements are, essentially, years, in a case such as that mentioned in those r e l a t i n g to efficacy (Art- the first subparagraph. As I have already icle 4(1)(b)(i)), harmlessness of the product said, what is involved is an application for both to humans and animals and to the a marketing authorisation in respect of a environment (Article 4(1)(b)(ii), (iv)), and plant protection product containing an to its quality (Article 4(1)(c) to (f)). active substance analogous to that con- tained in a product on the market on 26 July 1993.

69. It is apparent from the wording of Article 8(2) of the directive that it refers 72. Article 8(3) in fine and Article 13(6) of only to the scope of one of the systems the directive, which derogates from the which derogates from the ordinary legal requirements concerning the procedures to procedure laid down in Article 4 of the be observed by the Member States with directive. regard to the production of data, state, however, that national provisions relating to the production of such data are applic- able as long as the harmonisation of the rules and procedures necessary for the full application of the directive has not been 70. Article 8(2) of the directive in fact does carried out by the Commission. In other no more than point out that the Member words, those provisions express the rule States are authorised to grant marketing according to which, during the transitional authorisation for a maximum period of 12 period and pending the adoption of har-

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monised measures, the Member States may application of the directive have still not apply the national provisions in force when been adopted. 31 ensuring compliance of the product with the basic criteria laid down in Art- icle 4(1)(b) to(f).

77. The aim of the directive is to allow free circulation of safe and healthy products within the Community. 32 In order to achieve that aim, the Community legisla- ture proposes to adopt uniform rules on the conditions and procedures for the author- isation of plant protection products. 33 74. It should moreover be borne in mind that, when the directive entered into force, 31 — That is the case with Annex I. The programme of work the annexes relating to 'active substances referred to in Article 8(2) of the directive has still not been completed to date (see, in particular, Commission Regula- authorised for incorporation in plant pro- tion (EC) No 451/2000 of 28 February 2000 laying down the detailed rules for the implementation of the second and tection products' (Annex I), 'risk phrases' third stages of the work programme referred to in (Annex IV) and 'uniform principles for the Article 8(2) of Council Directive 91/414 (01 2000 L 55, p. 25)). evaluation of plant protection products' 32 — See, in particular, the fourth, fifth, sixth, ninth and tenth (Annex VI) had not been adopted and that recitals of the preamble to the directive. 33 — See, in particular, the seventh recital of the preamble to the all the provisions necessary for the full directive.

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79. By contrast, the interpretation which I would suggest to the Court reconciles all the interests involved. Its effect is to require 82. In its defence, the German Government the Member States to observe and apply submitted in particular that the Commis- immediately the provisions of the directive sion's action could not be successful while where possible, while at the same time not all the provisions necessary for the allowing them to continue to apply the application of the directive had been national provisions in force so long as the adopted. The German Government refer- Community has not adopted all the provi- red, in particular, to the fact that no sions necessary for the full implementation authorised active substances had been listed of the directive. I believe that my analysis in Annex I and the difficulty in interpret- makes it possible to approximate to the ing, and thus in applying, Article 13 of the fullest extent possible legislation relating to directive. marketing authorisation for plant protec- tion products and thus to contribute to the aim of ensuring the safety and free circula- 34 — The need to allow products to be placed on the market in order to deal with problems specific to certain States or tion of those products. It makes it possible with emergencies is referred to in the 14th and 18th recitals of the preamble to the directive. moreover to avoid delaying the placing on 35 — Case C-137/96 Commission v Germany [1997] ECR the market of new products that are needed I-6749.

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86. Here, too, there are two conflicting possibilities. 84. Accordingly, for the reasons set out above, I would propose that the Court rule that Article 8(3) of the directive must be interpreted as meaning that the procedure for which it provides is to be applied 87. Monsanto, BAA and the French Gov- whenever a Member State authorises the ernment argue, essentially on grounds of placing on the market of a new plant public health, that the national authorities protection product containing an active competent to grant marketing authorisa- substance analogous to that contained in tions are obliged to ascertain that the data a plant protection product on the market provided by the applicant in support of its two years after the date of notification of application for a marketing authorisation the directive. During the transitional period in respect of a generic product are still and pending the adoption of all the relevant relevant in the light of current scientific and Community provisions, the Member State technical knowledge. is obliged to ensure that the requirements laid down in Article 4(1)(b) to (f) of the directive are fulfilled by the applicant for authorisation by applying, to that end, the

88. On the other hand, the United King- 36 — Ibidem, paragraph 10, emphasis added. dom Government and Clayton maintain

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93. That approach is moreover approved of by the United Kingdom Government. At the hearing, it argued that, under the national rules in force, the competent 91. According to the case-law of the Court, in order to be able to describe a product as 'generic', the national authority must check 37 — See paragraph 40 above.

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authority in the United Kingdom did carry exclusive discretion to proceed to such out that type of check. According to the verification, I would observe that the United Kingdom, in the case in the main account given by the national court of the proceedings, it proved to be the case, after relevant national and legal framework does such a check, that Clayton's product was not seem to confirm the approach of the basically identical to the product manufac- United Kingdom Government. 38 Accord- tured by Monsanto. Moreover, in the event ing to settled case-law, in the framework of of doubt as to the essentially identical the task with which the Court is charged nature of the secondary and primary pro- under Article 177 of the EC Treaty (now ducts or where the national authority had Article 234 EC), it is for the national courts the least concern that, in terms of the and the national courts alone to provide the environment, animal or human health, that Court with 'the factual or legal material product could give rise to risk, the applic- necessary to give a useful answer to the ant for a marketing authorisation was questions submitted to it'. 39 I will consider requested to provide up-to-date data in the factual and legal material submitted by order to clear up such doubts. Furthermore, the national court in its order for reference where national authorities were aware of as having been established. facts requiring a review of the original product, in particular because of new data, they could proceed to review the marketing authorisation granted earlier.

100. The Court has consistently followed 98. As we have seen, one of the objectives that approach so far as concerns the of the directive consists in allowing to be granting of marketing authorisation in placed on the market of the Member States respect of generic medicinal products for only those plant protection products which human use 43 or the issuing of marketing have been shown to be harmless to man, authorisation in respect of generic veterin- animals and the environment. In a field ary medicinal products. 44 In view of the such as that dealt with by the directive, similarity of the wording of the provisions advances in science and technology are of those different directives and of their constant and sometimes rapid. It follows objectives, I believe that the Court should that the data relevant to obtaining a also follow that approach in the framework marketing authorisation in respect of a of the present directive. new product must in principle be assessed in the light of the scientific and technical knowledge available when the application for the grant of marketing authorisation is being considered.

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provides expressly that the Member States 104. I must therefore conclude that the must take care to adjust the requirements competent national authority must assess relating to data in step with advances in whether the conditions laid down in Art- technical and scientific knowledge. 45 icle 4(1)(b) to (f) of the directive have been complied with taking into account the state of science and technology at the time when the application is being considered.

102. The Community legislature also uses occasionally the expression 'appropriate methods' to signify the need to constantly update the data provided in keeping with advances in science and technology. 46 It seems clear to me that a marketing author- 105. The Court is asked to specify the isation issued on the basis of obsolete data manner in which compliance with those would necessarily have been granted inap- requirements must be ensured by the com- propriately. petent national authority.

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Conclusion

107. In view of the foregoing observations, I would propose that the Court give the following answers to the questions referred by the High Court of Justice of England and Wales, Queen's Bench Division (Divisional Court):

(1) Article 8(3) of Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market must be interpreted as meaning that the procedure which it lays down is to be applied whenever a Member State authorises the placing on the market on its territory of a new plant protection product containing an active substance analogous to that contained in a plant protection product on the market two years after the date of notification of the directive. During the transitional period and pending the adoption of the relevant Community provisions, Articles 8(3) and 13(6) of the directive must be interpreted as meaning that the Member State is obliged to ensure that the requirements laid down in Article 4(1)(b) to (f) of the directive are fulfilled by the applicant for authorisation. To that end, the Member State is to apply the national rules in force concerning the production of data.

(2) Article 8(3) of Directive 91/414 must be interpreted as meaning that the Member State must assess whether the conditions laid down in the abovementioned Article 4(1)(b) to (f) have been complied with taking into account the state of science and technology. During the transitional period and pending the adoption of the relevant Community provisions, Art- icles 8(3) and 13(6) of the directive must be interpreted as meaning that Member States are obliged to ensure that the requirements laid down in Article 4(1)(b) to (f) of the directive are fulfilled by the applicant for authorisation. To that end, the Member State is to apply the national rules in force concerning the production of data.