Secretary of State for the Environment, Food and Rural Affairs v Crop Protection Association UK Ltd
| Jurisdiction | England & Wales |
| Judge | LORD JUSTICE KEENE,LORD JUSTICE SIMON BROWN,LORD JUSTICE MANTELL,LORD JUSTICE LATHAM |
| Judgment Date | 09 November 2001 |
| Neutral Citation | [2001] EWCA Civ 841,[2001] EWCA Civ 1656 |
| Docket Number | C/00/6489/6009,Case No: C/2000/0137 |
| Court | Court of Appeal (Civil Division) |
| Date | 09 November 2001 |
[2001] EWCA Civ 1656
IN THE SUPREME COURT OF JUDICATURE
COURT OF APPEAL (CIVIL DIVISION)
ON APPEAL FROM THE QUEEN'S BENCH DIVISION
(CROWN OFFICE)
(Mr Justice Richards)
Royal Courts of Justice
Strand,
London, WC2A 2LL
Lord Justice Simon Brown
Lord Justice Mantell and
Lord Justice Latham
Case No: C/2000/0137
Mr Kenneth Parker QC & Mr Paul Harris (instructed by Mr Mayur Patel of Legal Dept., DEFRA, London SW1) for the Appellant
Mr David Pannick QC & Mr Tom de la Mare (instructed by Hammond Suddards & Edge of London EC2M 4YH) for the Respondent
Mr Mark Brealey & Miss Kelyn Bacon (instructed by Mr Robert Madge of Legal Dept., National Farmers' Union of London WC2H 8HL) for the Intervener
This is an unusual appeal. It is brought by the Department for the Environment, Food and Rural Affairs (DEFRA, formally MAFF), acting by its executive agency the Pesticides Safety Directorate (PSD), against the order of Richards J made on 4 November 1999 declaring unlawful part of the control arrangements operated by the PSD with regard to the parallel import of plant protection products (pesticides). A parallel import is one which is permitted by reference to its essential identicality to a product already authorised for use on the U.K. market (a master approved product). The appeal concerns parallel imports coming from another Member State where their use is already authorised. The parallel import regime is, I may note, different from the concept of mutual recognition where reliance is placed on the other Member State's own authorisation. Richards J's judgment is now reported: R v MAFF, ex p. British Agrochemicals Association [2000] EuLR 149. Not all of it is under appeal. The one critical issue remaining alive is whether the formulation of the parallel import has to be literally the same as that of the master approved product.
The challenge to PSD's arrangements was made as long ago as May 1994. It was brought by the respondents, a company representing 37 members of the agrochemical manufacturing industry, then known as the British Agrochemicals Association Limited. It has already been the subject of a reference to the ECJ, the court's judgment being given on 11 March 1999 – R v MAFF ex p. British Agrochemicals Association [1999] ECR I-1499 (hereafter BAA). The essential issue before Richards J was as to the proper interpretation of that judgment. Following Richards J's order, however, the ECJ on 16 December 1999 gave judgment in R v Medicines Control Agency, ex p.Rhone-Poulenc [1999] I-8789 (hereafter Zimovane), a case concerning the closely related question of arrangements by the MCA for the parallel import of pharmaceutical products.
Mr Parker QC for the appellants (supported by Mr Brealey for the National Farmers Union which, with leave, has appeared as Intervener in the appeal) submits that Richards J's interpretation of BAA was incorrect and that, even if originally that was unclear, any doubts have been laid to rest by the subsequent judgment in Zimovane Mr Pannick QC for the respondents asserts to the contrary that BAA was clearly in his favour and that Richards J correctly interpreted it. That notwithstanding, however, he accepts that the ECJ's judgment in Zimovane appears to have been inconsistent with its earlier ruling and that he cannot, therefore, ask us simply to dismiss this appeal. Rather he seeks a further reference to the ECJ to resolve the issue once and for all, acknowledging that in the meantime the effect of the disputed part of Richards J's judgment should properly be stayed. It is accordingly this court's essential task to decide what the ECJ meant in each of its two judgments – BAA and Zimovane– and in particular whether there remains any real doubt as to the proper resolution of the issue still outstanding in these proceedings. That is why at the outset I ventured to describe the appeal as unusual.
With that brief introduction let me turn next to explain just what it was that Richards J decided and why it is that the respondents are not pursuing their cross appeal against part of it. This requires some account of the background to the challenge but this I shall give in the most abbreviated form; the interested reader will find it in greater detail in paragraphs 1–11 of the judgment below.
Under Council Directive 91/414 uniform rules are laid down on the conditions and procedures for the grant of marketing authorisations for pesticides. Such products are defined by Article 1(1) as "active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to …" (and there is then set out the various uses for which these products are intended). Such products are not to be placed on the market unless duly authorised. Importation of such products into a Member State is deemed to constitute placing them on the market.
The control arrangements under challenge were made in 1994 and provide for the approval of imported pesticide products "identical to products having extant provisional or full approval" under the Regulations governing authorisation by which the Directive was implemented. The challenge was made both to the test of "identicality" to be applied by PSD and to the procedure they would use for verifying the identicality of the parallel import. Identicality was defined in paragraph 3(a) of the arrangements as follows:
"For the purpose of these arrangements an imported product is deemed to be identical to a master product if –
(i)
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; (ii)
the formulation of the imported product is produced by the same company (or by an associated undertaking 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."
The arrangements dealing with verification need no longer be quoted. This part of the challenge was rejected and, although the subject of a cross-appeal for which permission was granted, the respondents no longer pursue it. Their explanation for this, however, ought to be recorded. The fact is that since judgment was given below the PSD have tightened up their verification procedures. Mr Pannick makes it plain that if the PSD were ever to revert to their previous practice or any other practice significantly less rigorous than that now adopted, CPA might well wish to pursue the issue afresh.
Let me, therefore, return to the issue of identicality and indicate next the basis on which paragraph 3(a) of the arrangements was challenged. The respondents were advancing essentially two arguments. Their first and wider argument was that the Directive did not allow for a fast-track procedure at all: full testing of the imported product was required just as if there were no comparable product already authorised for the UK market. The respondents' narrow submission, however, was that, at the very least, paragraph 3(a) of the arrangements affords the PSD altogether too wide a discretion to allow imported products onto the market on the basis of identicality to a master approved product. Paragraph 3(a)(i) allows the PSD to admit the imported product even though its active ingredient is not the same but merely similar to that of the master product. An ingredient is not "the same" if it is "the same within variations accepted by the registration authority". Paragraph 3(a)(ii) likewise allows for parallel imports where the product's formulation is similar to but not the same as the master approved product, the registration authority having the discretion to deem any differences to be immaterial.
Following the ECJ's ruling in the case, to which I will shortly return, Richards J concluded that both limbs of paragraph 3(a) of the arrangements were unlawful, his judgment being crystallised in the following declaration (part (a) of which I set out in an amended form agreed by counsel to replace what is erroneously contained in the court order):
"Paragraph 3(a) of the 1994 Control Arrangements is unlawful as being in breach of Directive 91/414 because it purports to allow for parallel importing even though (a) the active ingredient of the imported product is not the same (both as to nature and percentage) as that of the master approved product (within the tolerances permitted for the master approved product) and (b) the formulation of the imported product is not the same in every respect as that of the master approved product."
The PSD now accept part (a) of that declaration, i.e. that parallel importing is permissible only if the active ingredient is the same as that in the master approved product, and accordingly that part is not appealed. They continue to dispute, however, the judge's ruling that the formulation of the imported product must be the same in every respect as that of the master approved product; and this, therefore, remains, as earlier stated, the single issue arising on the appeal. I...
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