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

This is a renewed application for an extension of time to appeal and for permission to appeal directed by Munby L.J. to be heard on notice to the respondent. The respondent has applied for security of costs in the event that permission be granted and, Mr Martin Chamberlain being present in court to make that application, I heard him briefly oppose the permission application. At the conclusion of the oral hearing I reserved judgment partly because of a shortage of time and partly because, although I was unpersuaded by Mr Patrick Green, for the applicant, his tenacious submissions delivered with his customary skill and charm, and the importance of this appeal for the applicant, justified my taking time to reflect. Alas, for the applicant, I am satisfied that there is no real prospect of success for an appeal against the order made by Wyn Williams J. on 18th February 2011 when he dismissed the applicant’s claim for judicial review. Since this is not a full appeal, I shall set out my reasons succinctly.

After much research and, no doubt, much expense, the applicant designed and now manufactures a receptacle for the collection of mid-stream urine specimens for microbiological culture and analysis. One distinguishing feature of this device is that it is well and truly sterile. It is, therefore, a much more sophisticated device than the cheaper “universal containers” in common use which are manufactured in such a way as to have a sterility assurance level of 1 in a thousand as opposed to a truly sterile container which must reduce the level of contamination to less than 1 in a million. One must not lose sight of the fact that urine samples run the risk of other contamination by bacteria from, for example, the skin, urethra, and vagina and from faeces.

The respondent Health Protection Agency, a statutory body, issues guidance in a British Standard BSOP 41 on “Investigation of Urine”. Version 6 of that guidance issued on 1st May 2008 specified that “specimen transport and storage” should be by means of a “sterile leak-proof container in a sealed plastic bag” and that the recommended method for routine use in the collection of the specimen was for the voided urine to be collected “into a sterile container”, the emphasis being added by me. Sometime in about November 2008 version 6.1 was issued and the term “CE marked leak-proof container” replaced “sterile leak-proof container”. This seems to have led to some protest from the applicant and indeed, the commencement of this claim, and version 6.1 was withdrawn but replaced by version 7 on 20.10.2009. Version 7 now provides for specimen transport and storage to be by “CE marked leak-proof container” and for mid-stream to be collected into a “CE marked leak-proof container”, those phrases being clarified in a footnote which reads

“The requirements of the EU in vitro Diagnostic Medical Devices Directive (1998/79/EC Annex 1B 2.1) state that such devices must “reduce as far as possible contamination of and leakage from, the device during use and, in the case of specimen receptacles, the risk of contamination of the specimen. The manufacturing processes must be appropriate for these purposes.” ”

The applicant claimed in the proceedings for judicial review as now constituted that the change in guidance in version 7 was unlawful in that it removed the requirement prescribed by that Directive (and, until then, contained in the guidance itself) that containers should be sterile. The case was brought on various grounds, including lack of proper consultation, but permission to move for judicial review was eventually granted by Holman J. limited to one issue only, namely whether:

“The Defendant’s decision is unlawful on the basis of the Defendant’s duties under Council Directive 90/79/EC and Articles 249 and 10 of [the Treaty].”

The case therefore turns on the proper construction of the Directive.

Article 2 requires Member States to take all necessary steps to ensure that devices of the kind with which I am concerned be placed on the market and/or put into service only if they comply with the requirements laid down in the Directive and Member States are obliged to monitor the security and quality of those devices. Article 3 provides that the devices must meet the essential requirements set out in Annex 1, taking account of the intended purpose of the devices concerned. “Intended purpose” means the use for which the device was intended according to the data supplied by the manufacturer on the labelling, in the instructions for use and/or in promotional materials. Article 9 requires that for all devices other than those covered by Annex II and devices for performance evaluation (and that means the devices with which I am concerned), the manufacturer shall, in order to affix the CE marking, follow the procedure referred to in Annex III and draw up the EC declaration of conformity required before placing the devices on the market. Article 16 requires that devices considered to meet the essential requirements referred to in Article 3 must bear the CE marking of conformity when they are placed on the market.

The essential requirements set out in Annex A include in Part A the general requirement that devices be designed and manufactured in such a way that when used under the conditions and for the purposes intended they do not compromise the clinical condition or the safety of patients. Any risks associated with their use must be acceptable when weighed against the benefits to patients. The manufacturer must “eliminate or reduce risks as far as possible”. Part B deals with design and manufacturing requirements and paragraph 2 is relevant:

“2.

Infection and microbial contamination

2.1

The devices and the manufacturing processes must be designed in such a way as to eliminate or reduce as far as possible the risk of infection to the user or other persons. The design must allow easy handling and, where necessary reduce as far as possible contamination of, and leakage from, the device during use and, in the case of specimen receptacles, the risk of contamination of the specimen. The manufacturing processes must be appropriate for these purposes.

…

2.3

Devices labelled either as “STERILE” or as having a special microbiological state must be designed, manufactured and packed in an appropriate pack …

2.4

Devices labelled either as “STERILE” or as having a special microbiological state must have been processed by an appropriate, validated method.

…”

Part 3 of Annex III requires the manufacturer to declare and affirm that its products, which must have the CE marking affixed in accordance with Article 16, meet the provisions of the Directive. The manufacturer must ensure that the manufacturing process follows the appropriate principles of quality assurance and there must be systematic procedures for review. The manufacturer must prepare certain technical documentation and “in the case of sterile products or products with a special micro-biological state or state of cleanliness, a description of the procedures used”.

The European Standard EN 14254:2004 has the status of a British Standard. The relevant provisions are:

“9.1

If a manufacturer claims that the interior of an unopened or unused receptacle, or the whole receptacle, is sterile, or has a special micro-biological state, the container interior and any accessory or additive shall have been subjected to a validated process designed to achieve that claim. Validation of the sterilisation process is the responsibility of the manufacturer.

9.2

Sterility is mandatory when the collection system is intended for the culture of the specimen and when the receptacle contains culture media.”

The applicant’s case is that both because the respondent is an emanation of the state bound to ensure the effectiveness of the Directive and also because it is a public body with specific statutory functions to protect the community against infections and other dangers to health, it cannot wash its hands of the task of giving guidance as to what the effect of the Directive is in practical terms which version 6 did when it required sterility. It cannot delegate to the manufacturer the important task of considering whether or not a particular device meets with the essential requirements of the directive. Thus the essence of the applicant’s case is not only that the devices for the collection, transport and storage of urine specimens must be sterile but also that sterility is required by the Directive.

I cannot accept that argument. Article 3 requires that the devices must meet the essential requirements set out in Annex 1 but Article 3 explicitly provides that account is to be taken of the use for which the device is intended according to the data supplied by the manufacturer. Paragraph 1 of Part A of Annex 1 deals in a general way with the manner in which devices are to be designed and manufactured. Risks are not required to be wholly eliminated but balanced against (“weighed against”) the benefits to patients. A margin of appreciation is therefore allowed to the manufacturer. The essential requirements for design and manufacture are set out in paragraph 2.1 of Part B of the Annex. Paragraph 2.1 does not impose any requirement for the device to be sterile. It provides instead that the design must “where necessary” (my emphasis) eliminate or reduce contamination as far as possible. It is for the manufacturer to decide to what extent it is necessary for his device to reduce the risks of infection. The Directive clearly envisages that not all devices will be sterile and there is no requirement for the total elimination of risk of contamination. It is within the power of the regulatory authority to decide whether or not the device must be sterile and accordingly whether or not something less than absolute sterility will or will not compromise the health and safety of the patient. Where the line is to be drawn involves an exercise of judgment. To decide not to require absolute sterility cannot be said to be (and indeed is not alleged to be) irrational. For what it is worth, the respondent’s expert working party was of the view that sterility was not necessary taking into account the purpose for which the containers are used. The expert evidence accepted by the judge was to the same effect. Since the Directive does not prescribe sterility, the change in the guidance cannot be held to be unlawful. That was the view of the judge: see paragraphs 26-28 of his judgment which I need not set out in detail. The judge was correct in his interpretation of the Directive and there is no real prospect of upsetting his conclusion.

That sterility is not required by paragraph 2.1 is made all the more emphatic by paragraphs 2.3 and 2.4 which do deal with devices which are labelled “STERILE”. I note that even here paragraphs 2.3 and 2.4 do not prescribe when the device is to be labelled sterile: it merely specifies what is required if and when the device is so labelled. The point to be made is that where it is necessary to refer to sterility, the Directive does so. It is, therefore, quite clear to me that the Directive envisages that some devices will be sterile but that not all devices will be sterile, or must be sterile or even that they must be sterile if that is technically possible.

So, in my judgment, the answer to the issues defined by Holman J.’s order is that the respondent’s decision to remove the requirement for sterility is not unlawful on the basis of the defendant’s duties under Council Directive 98/79/EC and the Treaty.

The argument for the applicant taken a little further is that the guidance in version 7 undermines the effectiveness of the Directive. The applicant relies on Commission v UK [2006] ECR 1-7471, [2006] 3 CMLR 1322 where the United Kingdom was held to have failed to fulfil its obligations under the Working Time Directive which required Member States to take the necessary measures to ensure that every worker is entitled to minimum daily and weekly rest periods. The guidelines issued by the Department stated only that “employers must make sure that workers can take their rest but are not required to make sure they do take their rest”. As stated the guidelines were incompatible with the obligation to ensure the full and effective implementation of the Directive. The extent of the obligation was to be ascertained in the light of the objective to be achieved by the Directive and “a Member State may not create the risk, by misleading recommendations of its public bodies, that the practical application of its national laws runs counter to the objectives of a Directive”: see paragraph 73 of the judgment of the ECJ.

Mr Martin Chamberlain does not dispute the proposition that if sterility is considered in the Directive to be essential for urine collection containers, then the respondent, as an emanation of the State, would act unlawfully by issuing guidance which implies some lesser standard will do. The flaw in the applicant’s argument, he submits, is that the Directive does not make sterility essential and that being so, version 7 is fully in accordance with both the requirements and the objective of the Directive. I accept Mr Chamberlain’s submission.

The next argument advanced by Mr Green is that whereas the guidance in version 6 was clear in that all would understand the need for the devices to be sterile, the substituted guidance linking the design and manufacture of the device to a CE marking is opaque. Again I agree with Mr Chamberlain that the requirement for a “CE marked leak-proof container” is not unclear or vague. Since the burden of the Directive is directed at the manufacturer, it is for the manufacturer to satisfy himself that his design and manufacturing process will deliver whatever microbiological state or state or cleanliness it claims for its device and that the device has been produced by an appropriately validated method. The manufacturer is required by Article 9 of the Directive to draw up the necessary Declaration of Conformity that his product meets the provisions of the Directive which applied to it before he places the device on the market. Annex 3 makes clear “in the case of sterile products, the documentation must include a description of the manufacturing procedure” and here, once again, we see a special rule, not one of universal application but of application to the exceptional case of the sterile product. It serves to emphasise that sterility is not always required. In the result the manufacturer knows what is required of it in order to fix a CE standard and the consumer knows what standard the product will attain. There is sufficient certainty. If the manufacturer affixes a CE mark which the product does not attain, then the Medicines and Healthcare Products Regulatory Agency can take the necessary enforcement action.

Mr Green draws comfort from paragraph 9.2 of the Euro standard EN 14254 which it may be convenient to repeat:

“Sterility is mandatory when the collection system is intended for the culture of the specimen and when the receptacle contains culture media.”

He submits that upon the proper construction of this paragraph sterility is mandatory both when the collection system is intended for the culture of the specimen and also, as another case requiring sterility, when the receptacle contains culture media. The judge relied on the expert evidence of Professor Duerden. He was entitled to do so. There was no expert evidence to contradict it. The applicant’s managing director, Mr Levinson, was not an expert properly so-called, and the judge was fully entitled to take account of his views but to reject them. The judge concluded in paragraph 24:

“As a matter of interpretation I am satisfied that the mandatory requirement for sterility for "the collection system" referred to in paragraph 9.2 of the Standard applies only when that system is intended for the culture of the specimen and when the receptacle contains culture media. I see no reason to interpose the word "or" after "and" as the Claimant would have me do. I see no reason to reject Professor Duerden's view as to what is meant by the phrase "the collection system" in paragraph 9.2.”

I agree with the judge.

The applicant seeks to refute this construction by reliance on an email from Mrs Akpo Whitney, the Regulatory Affairs Specialist (Devices) sent to the applicant on April 21st 2008 where she says at paragraph 9.2:

“In our opinion this means that sterility is mandatory in both circumstances, i.e. for a collection system that does not contain culture media but is intended to be used to culture a specimen and when a receptacle contains culture media.”

As the judge rightly observed of Professor Duerden’s evidence,

“I accept, of course, that ultimately it is for the court and not the Professor to determine the meaning to be given to paragraph 9.2 of the Standard.”

The same observation applies to the views of Mrs Whitney. I simply do not agree with her.

I reject the applicant’s case for another reason. I can readily see the argument that the applicant’s device is part of the collection system since it is clearly treated by BSOP 41 as a device for “specimen collection” and so, as a matter of ordinary language, it is part of the collection system. The system is intended at some point in the process for the culture of the specimen or can be used for the culture of the specimen. So the applicant’s device meets the first part of paragraph 9.2. If that alone is enough to impose the mandatory requirement of sterility, then the second part of 9.2 is utterly otiose and superfluous. It would not matter then whether or not the receptacle contains culture media. If the collection system envisages the culture of the specimen it would not matter whether the receptacle contained the culture media or not. It would have been perfectly simple for the Directive to provide that these containers be sterile. It did not do so. The natural and ordinary meaning of paragraph 9.2 is that “and” is used conjunctively not disjunctively so I reject Mr Green’s submissions.

There is some suggestion in the written documents before me that the applicant would seek leave to admit fresh evidence not placed before the judge, namely an email sent by Professor Duerden to Mr Levinson in 2004. However, as the applicant has acknowledged, it could have relied upon this email before the judge had its significance been appreciated at that stage. In other words the applicant acknowledges that the first limb of Ladd v Marshall cannot be satisfied. I am not at all convinced that the second limb would be satisfied either: this email does not seem to me seriously to undermine the Professor’s evidence so as to have an important influence on the outcome of the case. I would therefore reject any attempt to introduce any fresh evidence.

I appreciate how important this case is for the applicant. I appreciate that the issues bear on matters of public health and that they are, as such, important. Those are not, however, matters which constitute a compelling reason to allow this appeal which, on its merits has, in my judgment, no real prospect of success. Had I been satisfied that there was such a prospect, I would have extended the time for the appeal but for the reasons I have set out, albeit shortly, but nonetheless after long and careful deliberation, I am satisfied the application must be dismissed.

The respondent had applied for security for costs as a condition of any permission of appeal. In the circumstances it is not necessary to deal with that application.

Since this application for permission was listed on notice to the respondent, the usual order should prevail, namely that the applicant should bear the respondent’s costs of and incidental to this application to be assessed if not agreed. Since the respondent chose to make an application for security for costs before the court had dealt with the application for permission, there should be no order for costs in favour of the respondent in respect of that application for security.