Neutral Citation Number: [2009] EWHC 63 (Admin)
Case No: CO/4679/2008
IN THE HIGH COURT OF JUSTICE
QUEEN'S BENCH DIVISION
ADMINISTRATIVE COURT
Royal Courts of Justice
Strand, London, WC2A 2LL

Date: 22 January 2009 

Before:

MR JUSTICE SIMON
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Between:

	The Queen (on the application of Hidden Hearing Limited)
	Claimant	
	and
		
	The Hearing Aid Council	Defendant	
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(Transcript of the Handed Down Judgment of
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Mr James Goudie QC and Mr Akhlaq Choudhury (instructed by Lawrence Graham LLP) for the Claimant

Mr James Maurici (instructed by Beachcroft LLP) for the Defendant

Hearing date: 14 January 2009 
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Judgment
Mr Justice Simon: 
Introduction 
1.	This is an application for Judicial Review brought by the Claimant (Hidden Hearing Ltd) against the Defendant (‘the HAC’). The claim is brought in respect of a Guidance Note issued by the HAC in February 2008 which, the Claimant submits, should be immediately withdrawn since it sets out a 
manifestly incorrect definition of ‘dispensing’ which is liable to cause confusion and uncertainty. 
2.	The relevant part of the Guidance reads:
Dispensing is a process defined in law and in the Council's regulations, and includes both clinical and commercial practices involved in the retail sale of hearing aids. Such processes may include (but are not limited to) taking case histories, testing someone's hearing, assessing the clinical nature of a person's hearing loss and making onward referrals if appropriate, fitting aids and post-fitting rehabilitation work.
3.	The Claimant argues that the definition of dispensing contained in the Guidance is inconsistent with, and extends beyond, the statutory definition of dispensing contained in s.14 of the Hearing Aid Council Act 1968 (‘the Act’). 
"dispenser of hearing aids" means an individual who conducts or seeks to conduct oral negotiations with a view to effecting the supply of a hearing aid, whether by him or another, to or for the use of a person with impaired hearing; and references to the dispensing of hearing aids or to acting as a dispenser of such aids shall be construed accordingly.
4.	The Claimant submits that although some of the processes described in the Guidance may constitute dispensing, in the sense of conducting or seeking to conduct oral negotiations with a view to effecting the supply of a hearing aid, the fitting of such aids and post-fitting rehabilitation work does not fall within the statutory criteria, since they are activities which are conducted after the supply of the hearing aid has been effected.
5.	The HAC submits that the Act is concerned with consumer protection in the particular context of healthcare rather than with the commercial aspects of a sale. A particular mischief which was intended to be addressed by the Act was the fitting of hearing aid devices by those unqualified to do so; and the Guidance is wholly consistent with, and is expressly stated to be subject to the definitions set out in, the Act. In addition the HAC submits that the Court should not grant relief in relation to the terms of a guidance note which is non-statutory and non-binding
The statutory background
6.	The HAC was established by the Act,
to register persons engaged in the supply of hearing aids, to advise on the training of persons engaged in such business, and to regulate trade practices, and for purposes connected therewith.
7.	The Act was amended by the Hearing Aid Council (Amendment) Act 1989,
in order to make further provision for the regulation, conduct and discipline of persons engaged in dispensing hearing aids … and for purposes connected with those matters. 
8.	By s.1(1) of the Act, the HAC has, 
the general function of securing adequate standards of competence and conduct among persons engaged in dispensing hearing aids, together with the specific functions assigned to it by or under … [the Act].
9.	Section 1(3) of the Act provides that the HAC,
… shall draw up standards of competence for dispensers of hearing aids and codes of trade practice for adoption by such dispensers and by persons employing such dispensers and shall from time to time review those standards and codes and may vary them as it considers appropriate.
10.	Section 1(5) states that the HAC, 
shall publish in such manner as it considers appropriate … any code or standard drawn up under this section …
11.	Section 2 of the 1968 Act provides for the establishment and maintenance of a register of dispensers of hearing aids and a register of persons employing such dispensers.
12.	Section 3 is in the following terms:
(1)	It shall be unlawful at any time more than six months after the commencement of this Act for –
(a) 	any person other than –
(i)		a person registered under this Act as a dispenser of hearing aids; or
(ii)		a person whose name has been notified to the registrar of the Council and who is undergoing full-time training with a view to being registered as a dispenser of hearing aids and acting under the supervision of a registered dispenser;
to act as a dispenser of hearing aids;
(b)	any person whose name is not for the time being entered in the register maintained pursuant to section 2(1)(b) of this Act to employ any person to act as a dispenser of hearing aids; or
(c)	any person whose name is entered in the register which is so maintained to employ a person other than –
(i)		a person registered under this Act as a dispenser of hearing aids; or 
(ii)		a person whose name has been notified to the registrar of the Council and who is undergoing full-time training with a view to being registered as a dispenser of hearing aids and acting under the supervision of a registered dispenser,
to act as a dispenser of such aids.
(2)	A person who contravenes subsection (1) of this section shall be guilty of an offence and shall be punishable upon summary conviction by a fine not exceeding level 4 on the standard scale.
13.	Section 7(1)-(3) of the Act provides for a number of penalties, including erasure or suspension from the register, upon being convicted of a crime or having been adjudged by the Disciplinary Committee to have either (i) been guilty of serious misconduct or (ii) to have contravened any code of trade practice published by the HAC under s.1 of the Act.
14.	Section 9 provides for an appeal to the High Court against a decision by the Disciplinary Committee to impose a penalty under s.7.
15.	I have already set out the definition of ‘dispenser of hearing aids’ in s.14 of the Act. The section also gives other definitions: 
"employer of dispensers" includes any person who enters into any arrangements with an individual whereby that individual undertakes for reward or anticipation of reward to act as a dispenser with a view to promoting the supply of hearing aids by that person; and references to the employing of dispensers and their employment shall be construed accordingly;
"hearing aid" means an instrument intended for use by a person suffering from impaired hearing to assist that person to hear better but does not include any instrument or device designed for use by connecting conductors of electricity to equipment or apparatus provided for the purpose of affording means of telephonic communication;
"prescribed" means prescribed by rules made by the Council pursuant to section 4 of this Act;
"supply" means supply by way of retail sale or by way of hire; but does not include a sale to a person acquiring for the purposes of trade.
The 2008 Code of Trade Practices 
16.	A new Code of Practice, replacing previous versions made in 1992, 1996 and 1999, received the written approval of the Secretary of State, as required by s.1(4) of the Act, and came into force on 1 February 2008.
17.	Rule 3 of the 2008 Code provides,
Dispensers shall at all times give the best possible advice they can to their clients regarding hearing aids and their use.
18.	Rule 27 of the Code repeats commentary which had been in previous versions of the Code, in relation to the obligations in respect of trainees.
Notified supervisors must ensure that, except as permitted under Rules 28 and 19, their notified trainees:
(a) dispense hearing aids only when under their own supervision or under the physical supervision of another supervisor (and for the avoidance of doubt, dispensing includes, but is not restricted to, examination of clients, otoscopy, audiometry, ear-impressioning and hearing aid fitting) …
19.	The Code uses the same definition of the phrase ‘dispenser of hearing aids’ as is used in the Act, Rule 31.
The Guidance Note 
20.	On 28 February 2008 the HAC issued the Guidance Note which is the subject of these proceedings. It is common ground that the Guidance Note is non-statutory and non-binding. It is addressed to Higher Education Institutes, registered employers, hearing aid dispensers, registered dispensers and notified trainees; and is expressed to be concerned with 
Changes to the regulations governing students and trainee dispensers.
21.	The introduction to the Guidance Note is in the following terms:
Changes to the regulations governing students and trainee dispensers
The Secretary of State for Business, Enterprise and Regulatory Reform has approved changes to the Standards of Competence (2007) and Code of Practice (2004) as it affects the training and registration of hearing aid dispensers/audiologists. These changes have been approved following consultation conducted over the summer of 2006 on the introduction of a foundation degree in hearing aid audiology and the subsequent consultation in late 2007 on the change from the current company-based training route to the foundation degree as the minimum requirement for registration and training as hearing aid dispensers/audiologists. I am writing to advise you of these changes, what they mean for HEIs, employers, registered supervisors, audiology students and trainee dispensers, and what actions you need to take to ensure you comply with the law and the new regulations. I also want to ensure that HEIs that place BSc Audiology students on clinical placements involving the dispensing of hearing aids understand the current law as it affects them and their students.
There then follows the paragraph which is the subject of challenge:
First, it is important to set out the legal position in relation to individuals involved in dispensing. It is illegal for a person to act as a dispenser of hearing aids or be involved in dispensing unless they are either (a) registered with the Hearing Aid Council or (b) notified to the Council as being in training with a view to becoming a hearing aid dispenser. Dispensing is a process defined in law and in the Council's regulations, and includes both clinical and commercial practices involved in the retail sale of hearing aids. Such processes may include (but are not limited to) taking case histories, testing someone's hearing, assessing the clinical nature of a person's hearing loss and making onward referrals if appropriate, fitting aids and post-fitting rehabilitation work. Undertaking such work where it is unrelated to the retail sale of hearing aids is not covered by these legal restrictions.
22.	The HAC points out first, that the primary focus of the Guidance Note is on the newly introduced qualifications; and, secondly, that the last sentence is an important part of the Guidance Note which is plainly correct and is not challenged.  
Background
23.	The Claimant’s business employs Dispensing Assistants (DAs) to support and assist its approximately 200 Registered Hearing Aid Dispensers (RHADs). RHADs are on the HAC’s Register of Dispensers and are therefore authorised to dispense hearing aids, within the meaning of the Act.
24.	The Claimant’s projected business model, which involves increasing use of DAs, is described by Mr Rudge, a director of the Claimant, in his witness statement. 
25.	At a first consultation a RHAD will take a case history from the customer and will assess the customer’s lifestyle and hearing requirements. The RHAD then undertakes a physical examination of the ear, before testing the customer’s hearing using conventional procedures. If there is a hearing loss, the RHAD explains to the client the various options available and their cost. If the client decides to proceed with the purchase of a hearing aid, the RHAD completes the appropriate paperwork and a deposit is taken. A Confirmation of Order form is completed containing full financial details of the transaction. This form is signed by the RHAD and the client; and the final task is to take an impression of the client’s ear.
26.	A second appointment takes place, normally within two weeks of the first, at which the purchased hearing aid is fitted. After the fitting there may be a speech test and, if appropriate, limited audiometric procedures to ensure that there is benefit to the client’s hearing. The client is then shown insertion and removal techniques, and how to clean the aid and change batteries. Payment is then finalised in accordance with the Confirmation of Order. In §36 of his witness statement Mr Rudge states:
The financial arrangements have already been agreed with the RHAD at the first consultation, and the fitting of the aid is a technical process that can be taught to an appropriately supervised (DA). Accordingly, where appropriate, the above tasks are completed by a Dispensing Assistant or will be in the future following (the Claimant’s) projected business model. 
The words ‘where appropriate’ beg a number of questions.
27.	At the second appointment a further ‘follow-up’ visit is arranged within six weeks of the fitting so as to assess the client’s progress. Further assistance is provided as and when it may be required as part of the contracted service. 
28.	The Claimant’s DAs carry out after-care services such as carrying out minor repairs and servicing of aids, and providing batteries and accessories; and, since these occur after the agreement to purchase has been entered into, they are considered by the Claimant to occur after ‘negotiations with a view to effecting the supply’ of hearing aids; and consequently not to constitute dispensing as defined by the Act. 
Discussion and Conclusion
29.	In its Skeleton Argument the Claimant argued that the primary issue was whether the Guidance Note was ultra vires the 1968 Act in so far as it sought to apply a definition of dispensing that was inconsistent with and/or broader than that provided under the Act. In the course of argument Mr Goudie QC focussed his complaint on 2 particular aspects of the Guidance Note: the reference to fitting of hearing aids and post-fitting rehabilitation work. Although recognising that the Guidance Note was non-binding, he submitted that it purports to be authoritative and is likely to be regarded as such by those to whom it is addressed. 
30.	There is plainly a background of antipathy between the parties. The Claimant regards the actions of the HAC as having the effect, if not the intention, of illegitimately thwarting the use of DAs in its business. I note that the HAC’s letter of 25 April 2008 in response to the Claimant’s pre-action protocol letter was expressed in language which might reasonably have reinforced this view. The HAC in turn regard the present application as an improper attempt to obtain the Court’s approval of the Claimant’s use of unregistered DAs on the basis of insufficient information.
31.	There is plainly a potential tension between increasing requirements for qualification of dispensers and the wishes of the Claimant, for no doubt sound business reasons, to deploy unqualified personnel where appropriate and lawful.
32.	The Claimant submits that the application of the Guidance Note is not ‘fact sensitive’. In the words of §36 of the Claimant’s Skeleton Argument,
The Court is simply being invited to determine the meaning of a statutory provision and whether the Guidance Note is consistent with that provision. It is not necessary to have a factual basis upon which to make such a determination: see R (Association of British Travel Agents Ltd) v Civil Aviation Authority [2006] EWHC (Admin) 13.
33.	However, in my view, there is an important difference between the ABTA case and this case: the ABTA case was advanced on the basis that the relevant Guidance there could not ‘on any factual basis be right.’ In the present case there has been no opportunity to investigate the facts and the Guidance is expressed in qualified terms.
34.	The words to which ‘real objection’ are taken by the Claimant can be summarised as follows:
The dispensing process may include fitting aids and post-fitting rehabilitation work (emphasis added)
35.	In my view, if a discretionary remedy is to be granted in relation to this non-statutory and non-binding Guidance Note, the Claimant must show that fitting aids and post-fitting rehabilitation work cannot be part of the dispensing process. It is not appropriate for the Court to consider the position by reference to general, hypothetical cases and circumstances. In the words of Munby J in R (The Howard League for Penal Reform) v The Secretary of State for the Home Department [2002] EWHC 2947 (Admin)at §140, 
Judges do not sit as umpires on controversies in the Academy. Nor is it the task of a judge when sitting judicially – even in the Administrative Court – to set out to write a textbook or practice manual or to give advisory opinions.
36.	I accept Mr Maurici’s submission that the overall purpose of the 1968 Act was consumer protection in a particular health context. However, this does not greatly advance the matter, so far as the statutory definition is concerned, particularly where, as Mr Goudie QC points out, the breach of the provisions of the Act may give rise to a prosecution. This is a matter which I have taken into account.
37.	The normal meaning of the word ‘dispense’ in a medical context suggests the giving out of medicine or medical equipment in accordance with the exercise of appropriate professional judgement. A Dispensing Chemist will dispense medicine in accordance with (and, in some circumstances without) a doctor’s prescription. In either case the Dispensing Chemist will exercise independent judgment as part of the dispensing.
38.	In the case of hearing aids, one would expect that the act of dispensing a hearing aid would extend to the fitting of the aid, in order to ensure that what was supplied was appropriate. It might be said that s.14 of the Act adopts an unnecessarily obtuse definition of dispensing technically sensitive equipment. It quite reasonably defines dispensing by reference to what a dispenser does; but defines what a dispenser does by confining it to someone who ‘conducts … oral negotiations with a view to effecting the supply of a hearing aid.’ 
39.	The Claimant submits that, on the proper application of the defining words, a dispenser is someone who conducts oral negotiations with a view to effecting the supply of a hearing aid and that, once the negotiations have concluded, the act of dispensing has ceased and subsequent activities in relation to the hearing aid do not constitute dispensing. It was in this context that Mr Goudie QC relied on the speech of Lord Keith of Kinkel in R v. Maginnis [1987] 1 AC 303 at 309A
The word ‘supply,’ in its ordinary natural meaning, conveys the idea of furnishing or providing to another something which is wanted or required in order to meet the wants and requirements of that other. It connotes more than mere transfer of physical control of some chattel or object from one person to another … the additional concept is that of enabling the recipient to apply the thing handed over to purposes for which he desires or had a duty to apply it.
He submitted that the oral negotiations ended at the end of the first consultation when the supply of the hearing aid was effected.
40.	While I take into account the definition of supply set out in Maginnis and the further case of Interfact and anor v. Liverpool City Council [2005] EWHC 995 (Admin), it seems to me that a Court should be hesitant about applying a definition of ‘supply’ in one statutory context (supply of drugs) to a wholly different statutory context (regulation of health professionals). As Lord Goff noted (in his dissenting speech at 314C), the word ‘supply’ is not always precisely used. Even on the Claimant’s view of the case it is not clear why the taking of an impression of a client’s ear should be carried out by a RHAD (see Mr Rudge’s witness statement at §36) since at that stage the agreement has been signed.
41.	If it were necessary to express a view about the ambit of dispensing, I would have been inclined to the view that conducting ‘oral negotiations with a view to effecting the supply of a hearing aid’ is not confined to discussions which precede the supply of a hearing aid. The words ‘with a view to effecting the supply’ must be given their proper weight. On this basis ‘dispensing’ would include ‘oral negotiations’ in relation to what may be difficult clinical decisions as to whether a hearing aid which had been supplied was suitable, even if no other hearing aid was supplied in substitution. 
42.	If this is right, then the fitting of the hearing aid and post-fitting rehabilitation work at least may constitute part of the dispensing process.
43.	However, it is unnecessary, and perhaps undesirable (since there are no established facts), to form a concluded view about this. This is a matter which is more sensibly resolved by a clearer definition of ‘dispensing’ in the light of modern technology, education and practice, and after proper consultation.
44.	It is unnecessary to form a concluded view because, in my judgment, the present claim should be determined on a more limited basis. 
45.	As noted above, Rule 27 of the Codes of Trade Practice require that notified supervisors of trainee RHADs must, subject to exception, ensure that their notified trainees dispense hearing aids only when supervised; and clearly includes within the definition of dispensing ‘hearing-aid fitting.’ The Code was drawn up under s.1(3) of the Act, followed consultation, and has binding effect. The inclusion of ‘hearing-aid fitting’ has been expressed to be within the definition of ‘dispensing’ since at least 1996. 
46.	In these circumstances, and where the Guidance Note expressly states that ‘dispensing’ is defined by law and regulation, I do not accept that the statement in a non-binding Guidance Note that fitting a hearing aid may amount to dispensing gives rise to a right to have the Guidance Note quashed. First, the use of the word ‘may’ does not suggest the wide assertion of ‘a manifestly incorrect definition’. Secondly, a general assertion that the fitting of hearing aids amounts to dispensing has been in the Code for many years without challenge. Thirdly, the Claimant has itself recognised that where the line should be drawn is unclear. When writing to the HAC in August 2007 the Claimant enclosed a job description of DAs. This included under the heading ‘Purpose’,
Fundamental to the role is an exclusion from any duties or function that may be regarded as the function of a ‘dispenser of hearing aids’ as defined … (emphasis added) 
47.	In the light of the above, it is not in my judgment for the Administrative Court to decide where the line is to be drawn in circumstances where grey areas are acknowledged as likely to occur and where the facts may be in issue.  
48.	The inclusion of ‘post-fitting rehabilitation work’ is less straightforward. On the Claimant’s view of matters, it may occur up to 6 weeks after the fitting of the hearing aid and is less obviously part of dispensing in either its statutory or its more generally understood meaning. The question for determination is whether the Claimant can show that it is manifestly incorrect to say that ‘post fitting rehabilitation work’ may constitute dispensing. In my judgment it cannot. As the Claimant accepted in §25 of the Detailed Statement of Grounds, post-supply work is not restricted to RHADs ‘save where such work might be with a view to effecting supply.’ Mr Goudie QC explained that the concession referred to the possibility of a new supply being made; but it illustrates the difficulty of making any prescriptive assertions or findings without a proper factual basis. 
49.	In any event it would not be right, in my judgment, to quash the Guidance Note because it included the assertion that ‘post-fitting rehabilitation work’ might constitute dispensing, particularly in the light of the qualification that dispensing is a process defined in law and in the HAC’s regulations.
50.	For these reasons I refuse the Claimant’s application to quash either the Guidance Note or the small part of it which is now in issue; and I further decline to order its withdrawal.