Secretary Of State For Environment, Food & Rural Affairs v Crop Protection Association UK Ltd & Anor

A parallel-imported plant protection product need not have a formulation literally identical in every respect to the product authorised in the importing Member State. The competent authority may use a simplified authorisation procedure where the products have a common origin, the same active ingredient, materially the same formulation and the same effect, subject to adequate protection of health, safety and the environment. Differences in formulation are permissible where they have no material adverse effect. A literal identity requirement would be disproportionate and an unjustified restraint on trade.

The appeal concerned arrangements operated by the Pesticides Safety Directorate for authorising parallel imports of plant protection products under Council Directive 91/414. Richards J had declared unlawful the part of the arrangements permitting an imported product whose formulation was not the same in every respect as the United Kingdom master product. The Secretary of State appealed that ruling. The respondents accepted the ruling concerning the active ingredient but maintained their request for a further reference to the European Court of Justice, relying on an apparent conflict between British Agrochemicals Association [1999] ECR I-1499 and Rhone-Poulenc [1999] I-8789. The central issue was whether literal identity of formulation was required.

1. Appeal allowed. Part (b) of the declaration made below was varied so that parallel importing was permitted without requiring the imported pesticide’s formulation to be identical in every respect to that of the master approved product.
2. The court construed the European Court of Justice authorities together. References to manufacture according to the “same formulation” were understood as requiring sameness in all material respects, rather than literal identity. The relevant question was whether differences affected the product’s safety, efficacy or relevant environmental effects.
3. The court relied particularly on R v Medicines Control Agency, ex p Rhone-Poulenc [1999] I-8789, whose paragraph 45 expressly contemplated differences in excipients where the imported product had the same active ingredient and therapeutic effect and posed no problem of quality, efficacy or safety. The court considered that reasoning applicable to pesticides as well as pharmaceuticals.
4. The simplified procedure remained subject to effective verification by the competent authority. The Pesticides Safety Directorate had to be satisfied that the imported product did not create a problem concerning health, safety, the environment, efficacy or quality. The court accepted that the authority had the means to make that assessment.
5. A literal same-formulation requirement would be disproportionate to the needs of safety and would unjustifiably restrict trade contrary to articles 28 and 30 of the Treaty. No further reference was necessary. DEFRA received the costs of the appeal and the day’s hearing; the remaining costs were adjusted as ordered.

• Court of Appeal (Civil Division): Appeal allowed and the declaration below varied.
• Queen’s Bench Division (Crown Office): Richards J declared paragraph 3(a) of the 1994 Control Arrangements unlawful insofar as it permitted parallel imports whose formulation was not the same in every respect as the master approved product. The decision is reported at [2000] EuLR 149.