R v The Ministry of Agriculture, Fisheries and Food (acting by its executive agency The Pesticides Safety Directorate) ex parte and Another
| Jurisdiction | England & Wales |
| Judge | MR JUSTICE RICHARDS |
| Judgment Date | 04 November 1999 |
| Judgment citation (vLex) | [1999] EWCA Civ J1104-12 |
| Court | Court of Appeal (Civil Division) |
| Date | 04 November 1999 |
| Docket Number | Case No : CO/1400/94 |
[1999] EWCA Civ J1104-12
IN THE HIGH COURT OF JUSTICE
QUEEN'S BENCH DIVISION
CROWN OFFICE LIST
Royal Courts of Justice
Strand, London
WC2A 2LL
Mr Justice Richards
Case No : CO/1400/94
Mr David Pannick QC and Mr Thomas De La Mare instructed by Hammond Suddards (Solicitors) London, EC27 5ET appeared on behalf of the Applicant.
Mr Kenneth Parker QC instructed by the MAFF Legal Department Solicitors appeared on behalf of the Respondent.
Thursday 4 November 1999
In May 1994 the applicant ("British Agrochemicals") brought judicial review proceedings to challenge the legality of arrangements made by the respondent ("MAFF"), acting through its executive agency the Pesticides Safety Directorate ("PSD"), for allowing imported pesticides onto the market in the United Kingdom. In November 1995 Popplewell J ordered that questions of EC law be referred to the European Court of Justice ("the ECJ") for a preliminary ruling. The ECJ gave its judgment on 11 March 1999. The matter now comes back to this court for a decision on the legality of the challenged arrangements. Unfortunately the parties cannot agree on the meaning or effect of the ECJ's judgment.
The Control Arrangements
Since the coming into force of the Control of Pesticides Regulations 1986 ( SI 1986 No.1510), made under powers conferred by the Food and Environment Protection Act 1985, no pesticides can be put on the market in the United Kingdom without first obtaining statutory approval. The basic objectives of the statutory scheme, as explained in section 16(1)(a) of the 1985 Act, are to protect the health of human beings, creatures and plants, to safeguard the environment, and to secure safe, efficient and humane methods of controlling pests. The approvals system is rigorous, expensive and time-consuming.
That approvals system was considered inappropriate where persons sought to import into the United Kingdom pesticides that were regarded as materially identical to a product that had already received approval. A fast-track approval scheme was therefore created for such parallel imports. The scheme as originally introduced by the 1986 Control Arrangements was limited to parallel imports from other EC Member States and was based on the "master" approval holder certifying that the product was a genuine parallel import. New Control Arrangements were introduced in 1989, still limited to parallel imports from other Member States but with a different method of determining that the imported product was identical to the master product. The system of pre-approval checking was replaced by a system which relied on the applicant guaranteeing identicality between the imported product and the master product, backed up by a system of post-approval of the imported product by means of monthly returns and, where appropriate, the provision of samples.
The scheme was extended and modified by the 1994 Control Arrangements which are the subject of the present challenge. Those arrangements, made pursuant to regulation 5 of the 1986 Regulations, came into force on 14 March 1994. They extend the scheme to cover imports from outside the European Union. They provide for the approval of imported pesticide products "identical to products having extant provisional or full approval" under the 1986 Regulations.
Two aspects of the 1994 Control Arrangements are central to the present dispute. First, the definition of identicality in paragraph 3(a):
"For the purpose of these arrangements an imported product is deemed to be identical to a master product if—
the active ingredient in the imported product is manufactured by the same company (or by an associated undertaking or under licence…) as the active ingredient of the UK master product and is the same within variations accepted by the registration authority;
and
the formulation of the imported product is produced by the same company (or by an associated undertaking or under licence) as that of the UK master product and any differences in the nature, quality and quantity of the components are deemed by the registration authority to have no material effect on the safety of humans, domestic animals, livestock, wildlife or the environment generally or on efficacy."
Secondly, certain provisions are directed at the information that an applicant must supply or may be required to supply. Paragraph 6 provides for an application to be submitted on a prescribed form, which contains the following categories of information: applicant's details; details of product to be imported (including name of product and its manufacturer, active ingredient(s) and concentration in formulation, and type of formulation); details of approved product to which identicality is claimed (including name of product and its manufacturer, and registration number); a statement of reasons for the belief that the product to be imported is identical to the approved product; and details of the packaging and labelling of the imported product. In addition, paragraph 6(ii) requires the applicant to provide copies of a draft label meeting requirements laid down; and paragraph 6(iii) requires the applicant to provide:
"evidence that the product to be imported is identical (within the terms of these arrangements) to the UK master product. This should be either:
a sample of the original label of the product to be imported, or a copy of the label of the product for which the importer is seeking approval to import."
Paragraph 9 states that the registration authority "may require the provision of such additional information as it considers necessary in support of an application". For examples of such information, cross-reference is made to paragraph 17 which, under the heading "monitoring", provides that the registration authority "may require the provision of any information it considers necessary at any time after approval has been given for an imported product" and that such information may include copies of various documents or samples of the imported product.
The Directive
Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market ("the Directive") lays down uniform rules on the conditions and procedures for the grant of marketing authorisations for plant protection products. According to Article 2(1) of the Directive, "plant protection products" means "active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user" and intended for specific uses. Under Article 2(1), "any supply, whether in return for payment or free of charge, other than for storage followed by consignment from the territory of the Community or disposal" constitutes placing on the market. Importation of a plant protection product into the territory of the Community is deemed to constitute placing on the market for the purposes of the Directive.
Article 3(1) provides that "Member States shall prescribe that plant protection products may not be placed on the market and used in their territory unless they have authorised the product in accordance with this Directive", save for immaterial exceptions.
Article 4 lays down the conditions which a plant protection product must satisfy in order to be authorised. In particular, by Article 4(1)(a) Member States are to ensure that a plant protection is not authorised unless its active substances are listed in Annex I. As at the date of the proceedings before the ECJ, no active substances had been included in Annex I, though some now have been. Further conditions which must be satisfied are laid down in Article 4(1)(b)(i) to (v) and (c) to (f).
1.Article 8 contains transitional measures and derogations. Article 8(2) provides that—
"a Member State 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 date of notification of this Directive."
The Commission is to commence a programme of work for the gradual examination of these active substances within the 12 year period. There is provision for examination of active substances by a standing committee and for decisions to be made on whether an active substance is or is not to be included in Annex I. Member States are to ensure that the relevant authorisations are granted, withdrawn or varied, as appropriate, within a prescribed period. By Article 8(3)—
"Where they review plant protection products containing an active substance in accordance with paragraph 2, and before such review has taken place, Member States shall apply the requirements laid down in Article 4(1)(b)(i) to (v), and (c) to (f) in accordance with national provisions concerning the data to be provided."
Article 13 governs data requirements. By Article 13(6), for active substances already on the market two years after notification of this Directive, Member States may, with due regard for the provisions of the Treaty, continue to apply national rules concerning data requirements as long as such substances are not included in Annex I.
The ECJ's judgment
In its judicial review proceedings British Agrochemicals contended from the outset that the 1994 Control Arrangements were in breach of the Directive. One element of the case was that the Directive did not allow for a...
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