Case details
Summary
Technical regulatory provisions must be given their natural meaning where their wording is clear. The European Pharmacopoeia requires every replacement bird in a specific-pathogen-free rolling flock to undergo initial testing at point of lay and no later than 20 weeks of age. The subsequent monthly test of a representative five per cent sample does not replace that initial test. The provisions governing rolling flocks and all-in/all-out flocks are complementary. Historical practice, lack of consultation and alleged commercial disproportionality cannot justify departing from clear wording.
Factual background
Wickham supplied eggs from specific-pathogen-free chicken flocks for use in avian live virus vaccines. Its rolling flock system replaced hens by hatching eggs produced within a closed environment. The Veterinary Medicines Directorate required 100 per cent testing of replacement hens at point of lay. Wickham argued that the European Pharmacopoeia required only initial testing during flock establishment, followed by monthly testing of a representative five per cent sample.
Wickham sought certiorari and mandamus to quash and remit the Directorate’s decision of 26 February 1998. Tucker J dismissed the application on 14 July 1999. The appeal concerned the proper construction of European Pharmacopoeia paragraph 5.2.2, subparagraphs (3) and (9), and whether its history, lack of consultation or commercial impact affected that construction.
Held
The Master of the Rolls delivered the judgment, with Lord Justice Peter Gibson and Lord Justice Latham agreeing. The appeal was dismissed with costs agreed at £16,000.
The licensing scheme required compliance with the European Pharmacopoeia. Council Directive 81/852/EEC made the relevant pharmacopoeial monographs applicable.
Subparagraph (3) applies to all replacements in a rolling flock. Its first sentence is a general description of how replacement birds are produced. The option in the second sentence to introduce embryos from another SPF flock does not limit the later references to the replacements described as all replacements. Accordingly, internally hatched replacement birds are included, and all such birds must be tested at point of lay in accordance with the Initial Testing requirements.
Subparagraph (9) refers to each new generation in an established flock. That description fits the rolling flock system, not the all-in/all-out system, where there is no established flock containing a new generation. It therefore requires all replacement hens in a rolling flock to be tested at or before 20 weeks of age. The subsequent monthly testing of a representative five per cent sample follows the initial test.
Subparagraphs (3) and (9) are complementary. Subparagraph (9) had implicitly recognised the rolling flock system before subparagraph (3) gave it express recognition. There was no conflict between them.
The provisions’ historical genesis, earlier practice, the absence of consultation and the alleged disproportionate effect on Wickham’s business could not justify a construction contrary to their clear meaning. The court considered proportionality difficult to apply to this question of construction. The clear wording therefore led inexorably to dismissal of the appeal.
The court’s approach to earlier authorities
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Appellate history
- Court of Appeal (Civil Division): Appeal dismissed with costs agreed at £16,000.
- Queen’s Bench Division, Administrative Court: Tucker J dismissed Wickham’s application for certiorari and mandamus on 14 July 1999.
Lower court decision
Key cases cited
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