R v The Minstry of Agriculture, Fisheries and Food and Another

JurisdictionEngland & Wales
JudgeMR JUSTICE POPPLEWELL
Judgment Date03 November 1995
Judgment citation (vLex)[1995] EWHC J1103-14
CourtQueen's Bench Division (Administrative Court)
Docket NumberCO/1400/94
Date03 November 1995

[1995] EWHC J1103-14

IN THE HIGH COURT OF JUSTICE

QUEEN'S BENCH DIVISION

CROWN OFFICE LIST

Before: Mr Justice Popplewell

CO/1400/94

Regina
and
The Minstry of Agriculture, Fisheries and Food
Ex Parte British Agrochemicals Association Limited

MR D PANNICK (Instructed by Hammond Suddards, London, EC2) appeared on behalf of the Applicant.

MR C VAJDA for MR K PARKER QC (Instructed by Treasury Solicitors, London SW1) appeared on behalf of the Respondent.

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JUDGMENT,

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( )

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Friday, 3rd November 1995

MR JUSTICE POPPLEWELL
4

THE PARTIES

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The Applicant is a limited company which represents 37 members of the Agrochemicals Manufacturing Industry. The Ministry of Agriculture Fisheries and Food (MAFF) are responsible for the safety of pesticides marketed or imported into the United Kingdom. Their powers are exercised by an executive agency namely the Pesticide Safety Directorate (PSD).

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THE APPLICATION

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The Applicants challenge the legality of the arrangements (control arrangements) made by the Respondents for the importing of pesticides on the ground that it is contrary to the Directive 91/414 EEC.

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THE REFERENCE

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At the conclusion of the oral argument before me I came to the conclusion that the decision in this case involved serious questions of Community Law necessitating reference to the European Court of Justice under Article 177 of the Treaty of Rome. The approach of the United Kingdom Courts is succinctly set out in the decision of R v Stock Exchange ex parte Else Limited (1993) QB534 where at page 545 D Sir Thomas Bingham MR said:

"I understand the correct approach in principle of a National Court (other than a final Court of Appeal)to be quite clear. If the facts have been found and the Community Law issue is critical to the Courts final decision the appropriate course is ordinarily to report the issue to the Court of Justice unless a National Court can with complete confidence resolve the issue itself. In considering whether it can with complete confidence resolve the issue itself the National Court must be fully mindful of the differences between national and community legislation of the pitfalls which face the National Court venturing into what may be an unfamiliar field of the need for uniform interpretation throughout the community and of the great advantages enjoyed by the Court of Justice in construing Community Instruments. If the National Court has any real doubt it should ordinary refer."

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I am quite clear that I cannot resolve the issue with complete confidence. The facts are not in dispute and the community law issue is critical to the Courts final decision.

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THE FACTS

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Prior to October 1986 there was no statutory regulation of pesticides in the United Kingdom there were voluntary arrangements. The Food and Environment Protection Act 1985 contained powers to prevent pesticides being put on the market in the United Kingdom without first obtaining statutory approval. Those powers were contained in the Control of Pesticides Regulations 1986 SI No.1510. By Section 16 of the 1985 Act the objective of the scheme was 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.

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A supplier who intended to put a pesticide on the market which contains a new active ingredient or a new formulation had to satisfy a rigorous approval procedure involving the supply of a very large amount of data which was to be evaluated by the Respondents. There is no dispute that it is an expensive matter and takes a considerable amount of time.

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Where a person sought to import into the United Kingdom pesticides identical to or different only in non material respects from a pesticide which had already received approval from the United Kingdom a faster "parallel import approval system" was created by the 1986 control arrangements shortly before the Pesticide Regulation 1986 came into effect.

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The 1986 control arrangements were limited to parallel imports from the EC and were based on the master approval holder certifying that the product was a genuine parallel import. In 1989 new control arrangements were introduced also limited to parallel imports from other EC Member States. The main difference between the 1986 and 1989 scheme was that the latter relied on self certification by the parallel importer that the product being imported was identical to a product for which United Kingdom licence had already been obtained.

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On 15 July 1991 Council Directive 91/414/EEC was published. By Article 23 it was to be implemented within two years following notification i.e. 26 July 1993. On 18 February 1994 control arrangements were introduced replacing those issued on 25 July 1989. These arrangements extended the previous system to cover imports from outside the European Community. One reason for introducing a simplified parallel import scheme in the first place was the United Kingdom's obligation under Article 30 and 36 of the EEC Treaty requiring the abolition of all measures of equivalent effect to quantitative restrictions on imports.

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The relevant provision of the 1994 control arrangements are as follows:

"MAFF Arrangements For The Approval Of Parallel Imports Of Pesticides Identical To Products Having Extant Provisional Or Full Approval Under The Control Of Pesticides Regulations.

Pursuant to Regulation 5 of The Control of Pesticides Regulations (COPR) made under Section 16 of the Food and Environment Protection Act 1985, the Minister of Agriculture, Fisheries and Food and the Secretary of State, (the Ministers) acting jointly, hereby make the following arrangements for the approval of imported pesticide products identical products having extant provisional or full approval under COPR.

No person shall advertise, sell, supply, store or use pesticide product in the United Kingdom unless the Ministers have jointly given in respect of it a provisional or full approval under Regulation 5 of CUPR and all relevant conditions are complied with.

Introduction

1. These arrangements set out the terms and conditions for the approval of imported pesticide products intended to be advertised, sold, supplied, stored or used in the United Kingdom………

Identicality

3(a) For the purpose of these arrangements an imported product is deemed to be identical to a master product if……

(ii)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.

(b)Where an imported product is manufactured under licence, information on the licensed source and the specification of the product may be required to prove identicality with the UK product."

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Master product is interpreted as being "United Kingdom UK approved product to which identicality is claimed and which is not itself a parallel import".

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By Clause 6:

"Applicants should submit their application for approval ……..The form must be fully completed and accompanied by:-

(i) a covering letter giving the name of both the master product and the imported product and the type of approval sought, and……

(iii) 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)a sample of the original label of the product to be imported,or

(b)a copy of the label of the product for which the importer is seeking approval to import……"

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By Clause 9:

"The registration authority may require the provision of such additional information as it considers necessary in support of an application. Where the registration authority arranges for the chemical analysis of samples provided by applicants, the results of analyses will be confidential to the registration authority."

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The Council Directive in its material parts reads as follows. The preamble reads:

"Whereas plant production has a very important place in the Community:

Whereas plant production yields are continually affected by harmful organisms including weeds; whereas it is absolutely essential to protect plants against these risks to prevent a decline in yields and to help to ensure security of supplies;

Whereas one of the most important ways of protecting plants and plant products and of improving agricultural production is to use plant protection products;

Whereas these plant protection products can have non-beneficial effects upon plant production; whereas their use may involve risks and hazards for humans, animals and the environment, especially if placed on the market without having been officially tested and authorized and if incorrectly used;

Whereas in view of the hazards, there are rules in most Member States governing the authorization of plant health products; whereas these rules present differences which constitute barriers not only to trade in plant protection products but also to trade in plant products and thereby directly affect the establishment and operation of the internal market:

Whereas it is therefore desirable to eliminate such barriers by harmonizing the provisions laid down in the Member States:

Whereas uniform rules on the conditions and procedures for the authorization of plant protection products must be applied by the Member States:

Whereas such rules should provide that plant protection products should not be put on the...

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