JBol Ltd, R (on the application of) v The Health Protection Agency

Under Council Directive 98/79/EC, essential requirements for in-vitro diagnostic devices must be assessed by reference to intended purpose and the balance between risk and patient benefit. The Directive does not impose universal sterility where contamination must instead be reduced as far as necessary. Provisions concerning products labelled sterile confirm that sterility is conditional, not generally required. A public body must not issue guidance undermining a Directive’s effectiveness, but guidance is lawful where it accords with the Directive and leaves the technical assessment to the manufacturer and regulator. A CE-marked leak-proof container requirement was sufficiently clear. The application for an extension of time and permission to appeal was dismissed.

The applicant manufactured sterile receptacles for collecting mid-stream urine specimens. The Health Protection Agency changed its guidance from requiring a sterile leak-proof container to requiring a CE-marked leak-proof container.

The Administrative Court, Wyn Williams J, dismissed the applicant’s judicial review claim on 18 February 2011. Permission had been limited to whether the change was unlawful under the relevant Council Directive and Treaty provisions. The applicant renewed its application to the Court of Appeal for an extension of time and permission to appeal. The central issues were whether the Directive required sterility, whether the revised guidance undermined its effectiveness or was insufficiently clear, and whether fresh evidence should be admitted.

The renewed application was dismissed. Ward LJ concluded that the proposed appeal had no real prospect of success. The importance of the issue to the applicant and to public health did not itself provide a sufficient reason to extend time or grant permission.

1. Construction of the Directive. Article 3 of Council Directive 98/79/EC required compliance with the essential requirements in Annex 1, taking account of the device’s intended purpose as stated in the manufacturer’s labelling, instructions and promotional material. Part A required risks to be reduced as far as possible, but permitted them to be weighed against patient benefits. Part B, paragraph 2.1 did not require universal sterility. It required contamination and leakage to be reduced as far as necessary, leaving an evaluative judgment for the manufacturer and regulatory authority.
2. Conditional sterility provisions. Paragraphs 2.3 and 2.4 of Part B and Part 3 of Annex III dealt specifically with products labelled sterile or having a special microbiological state. They prescribed consequences of that status, including packaging, validated processing and documentation, but did not prescribe when a product had to be labelled sterile. The revised guidance was therefore lawful.
3. Effectiveness and clarity. Commission v UK [2006] ECR 1-7471, [2006] 3 CMLR 1322 established that a Member State must not issue misleading public guidance which risks undermining a Directive’s objectives. That principle did not assist the applicant because the Directive did not make sterility essential and the revised guidance accorded with its requirements. The CE-marked leak-proof container requirement was sufficiently clear, with conformity obligations and regulatory enforcement providing an adequate framework.
4. European Standard. The requirement in EN 14254:2004 that sterility was mandatory when the collection system was intended for culture and when the receptacle contained culture media was conjunctive. Both conditions were required. The judge was entitled to accept the expert evidence supporting that construction.
5. Fresh evidence and costs. Any proposed fresh evidence failed the first limb of Ladd v Marshall because it could have been adduced below, and was unlikely to satisfy the second limb because it would not materially affect the result. The application for security for costs required no determination. The applicant was ordered to pay the respondent’s costs of the permission application, with no order for costs on the security application.

• Court of Appeal (Civil Division): Renewed application for an extension of time and permission to appeal dismissed on 12 January 2012.
• Administrative Court: Wyn Williams J dismissed the judicial review claim on 18 February 2011.