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

The Directive did not require urine-collection containers to be sterile in every case. Sterility was required only where reasonable judgment, taking account of the device’s intended purpose and the Directive’s objectives, showed it to be necessary. The words “where necessary” in Annex 1 Part B paragraph 2.1 qualified the obligation to reduce contamination risks as far as possible. Guidance could therefore lawfully permit the use of CE-marked leak-proof containers which were not sterile in the strict sense. A footnote reproducing the Directive should, however, reproduce the qualification accurately.

Jbol Ltd challenged the Health Protection Agency’s version 7 guidance on urine collection and transport. Earlier guidance referred to sterile containers, whereas the revised guidance required a CE-marked leak-proof container. The claimant argued that Directive 98/79/EC required sterility and that the revised guidance was unlawful and misleading. The central issue was the proper interpretation of the Directive’s essential requirements, particularly Annex 1 Part B paragraph 2.1 and paragraph 9.2 of BS EN 14254.

1. Claim dismissed. The Directive did not require containers used for collecting and transporting urine to be sterile as strictly defined.
2. Article 3 required the essential requirements in Annex 1 to be applied taking account of the intended purpose of the device. Annex 1 Part B paragraph 2.1 required contamination and leakage risks to be reduced as far as possible only where necessary. Whether sterility was necessary was a matter of reasonable judgment, informed by the device’s intended purpose and the objectives of the Directive.
3. Paragraph 9.2 of BS EN 14254 imposed mandatory sterility only where the collection system was intended for culture of the specimen and the receptacle contained culture media. The court accepted the evidence that universal containers used for urine collection and transport fell outside that requirement.
4. The evidence established that aseptically produced universal containers presented a negligible additional contamination risk compared with strictly sterile containers, particularly given other contamination risks during collection. The Agency was therefore entitled to remove the sterility requirement from its guidance.
5. The guidance’s reference to a CE-marked leak-proof container was sufficiently intelligible. The footnote omitted the words “where necessary” and could mislead an uneducated reader, but that defect did not establish unlawfulness or justify relief. The principles in Commission of the European Communities v UK [2006] IRLR 888 had no application on the facts.
6. An amendment application made at the hearing was not pursued. Had it been pressed, it would have been dismissed because it was very late, lacked a good reason for delay and raised no general public interest requiring determination.