CO Ref CO/587/2007, CO/2242/2007 and CO/2189/2007
Neutral Citation Number: [2008] EWHC 289 (Admin) 
IN THE HIGH COURT OF JUSTICE
QUEEN’S BENCH DIVISION
ADMINISTRATIVE COURT

Royal Courts of Justice 
Strand
London WC2 

Date: 21 February 2008

BEFORE 
HIS HONOUR JUDGE HICKINBOTTOM
SITTING AS AN ADDITIONAL JUDGE OF THE HIGH COURT
- - - - - - -

BETWEEN

	THE QUEEN ON THE APPLICATION OF ASSURA PHARMACY LIMITED	Claimant	
	-and-		
	NATIONAL HEALTH SERVICES LITIGATION AUTHORITY (FAMILY HEALTH SERVICES APPEAL UNIT)	Defendant	
	-and-		
	(1) FYLDE PRIMARY CARE TRUST (2) CO-OP HEALTH CARE LIMITED	Interested Parties	
			
	AND BETWEEN		
			
	THE QUEEN ON THE APPLICATION OF ASSURA PHARMACY LIMITED	Claimant	
	-and-		
	NATIONAL HEALTH SERVICES LITIGATION AUTHORITY (FAMILY HEALTH SERVICES APPEAL UNIT)	Defendant	
	-and-		
	(1) CALDERDALE PRIMARY CARE TRUST (2) E MOSS LIMITED TRADING AS ALLIANCE PHARMACY	Interested Parties	
			
	AND BETWEEN		
			
	THE QUEEN ON THE APPLICATION OF ASSURA PHARMACY LIMITED	Claimant	
	-and-		
	NATIONAL HEALTH SERVICES LITIGATION AUTHORITY (FAMILY HEALTH SERVICES APPEAL UNIT)	Defendant	
	-and-		
	(1) WEST KENT PRIMARY CARE TRUST (2) CANTERBURY PHARMACIES LIMITED (3) DAY LEWIS PLC (4) BOOTS THE CHEMIST LIMITED (5) A E HOBBS LIMITED	Interested Parties	
- - - - - - -
(Transcript of the Handed Down Judgment of
WordWave International Limited
A Merrill Communications Company
190 Fleet Street, London EC4A 2AG
Tel No:  020 7404 1400, Fax No: 020 7831 8838
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- - - - - - -
James Findlay and Peggy Etiebet (instructed by Sharpe Pritchard) appeared for the Claimants.
Philip Coppel (instructed by Bevan Brittan) appeared for the Defendants.
Thomas Roe (instructed by Charles Russell LLP) appeared for  Co-op Health Care Limited.
Beverley Lang QC (instructed by David Charlton, Alliance Boots Group Legal Services) appeared for E Moss Limited trading as Alliance Pharmacy.
Patrick Green (instructed by Vertex Law LLP) appeared for Canterbury Pharmacies Limited.
The other Interested Parties did not appear.
- - - - - - -
Judgment

Introduction

1.	In each of these three claims the Claimants Assura Pharmacy Limited (“Assura”) seek to quash a decision of the Pharmacy Appeals Committee appointed by the Family Health Services Appeal Unit of the Defendant Authority (“the PAC”) to dismiss an appeal against the refusal of the relevant Primary Care Trust (“PCT”) of an application to admit Assura to the National Health Service (“NHS”) Pharmaceutical List in respect of a proposed pharmacy within the area covered by that particular PCT.  The applications are brought with the permission of Walker J, given on 11 May 2007. 

2.	Admission to the pharmaceutical list is a precondition of dispensing NHS prescriptions and other pharmaceutical services.  99% of trading pharmacies are on that list: and, of those pharmacies, about 80% of their income is derived from dispensing prescriptions.  Without NHS prescriptions, it is unlikely that a pharmacy will be commercially viable.  These claims therefore have considerable commercial importance to both Assura, and a number of the interested parties which are the owners of pharmacies in areas in which Assura wish to operate and for which they have sought admission to the list.  Furthermore, the claims raise important and novel issues for PCTs, the PAC and those involved in the business of owning and operating pharmacies, concerning the proper approach to the statutory criteria for admission to the list.

3.	The three actions concern the following particular decisions.

(i)	The Freckleton Claim:  Assura seek to quash a decision made by the PAC on 30 November 2006 dismissing an appeal against the earlier decision of the Fylde PCT to refuse Assura admission to the list in respect of a proposed pharmacy in the vicinity of Preston Old Road/Kirkham Road in Freckleton, Lancashire.  There is currently one pharmacy in Freckleton, operated by Co-op Health Care Limited (“Co-op”), which intervened in the claim in support of the PAC’s decision.  

(ii)	The Todmorden Claim:  Assura seek to quash a decision made by the PAC on 25 January 2007 dismissing an appeal against the earlier decision of the Calderdale PCT to refuse Assura admission to the list in respect of a proposed pharmacy in the immediate vicinity of a new health centre development, Lower George Street, Todmorden, Yorkshire.  There are currently two pharmacies in Todmorden, both operated by E Moss Limited trading as Alliance Pharmacy (“Alliance”), which intervened in the claim in support of the PAC’s decision.

(iii)	The Tunbridge Wells Claim:  Assura seek to quash a decision made by the PAC on 22 January 2007 dismissing an appeal against the earlier decision of the South West Kent PCT to refuse Assura admission to the list and to allow the application of Canterbury Pharmacies Limited (“Canterbury”) for preliminary consent to be included in the list in respect of a pharmacy in the vicinity of a new health centre development, St John’s Road, Tunbridge Wells, Kent.  Canterbury intervened in the claim in support of the PAC’s decision.

The Statutory Scheme

4.	The identity of the statutory provisions which are relevant to these claims (helpfully set out in the written submissions of James Findlay and Peggy Etiebet, Counsel for Assura) was uncontentious.

5.	The decisions under challenge were made pursuant to a statutory scheme founded upon Sections 41-42 of the National Health Service Act 1977 as amended (“the 1977 Act”).  Those provisions have since been consolidated within Part 7 Chapter 1 of the National Health Service Act 2006 (“the 2006 Act”), to which I shall return (Paragraph 8 below).  Suffice it here to say that (i) the relevant provisions of the 2006 Act are similar to the 1977 Act: and (ii) the detailed regulatory framework provided by the relevant regulations remains unchanged and has effect as if it were made under the 2006 Act (Section 4 of, and Paragraph 1(2) of Schedule 2 to, the National Health Service (Consequential Provisions) Act 2006).

6.	Section 41(1) of the 1977 Act imposed a duty on every PCT to arrange for the provision to persons in their area of essential pharmaceutical services such as the prescription of drugs and appliances by a doctor or dentist in pursuance of his NHS functions, in accordance with regulations to be made by the Secretary of State for the purpose.  Section 41A enabled the Secretary of State to give directions to a PCT either requiring or empowering them to arrange for the provisions of “additional pharmaceutical services” over and above the essential services, such as care home service, home delivery service, needle and syringe exchange service and patient group direction service.  “Pharmaceutical services” was defined for the purposes of the Act as services provided under Section 41 together with any additional services provided under Section 41A (Section 41(2)).  (There is a specific alternative and more restricted definition of “pharmaceutical services” in certain regulations: see Paragraph 11(iii) below). 

7.	Section 42 required the Secretary of State to make regulations for ensuring that Section 41 services were secured, including directions for the preparation of lists by PCTs of those entitled to make provision of pharmaceutical services and for applications for admission to such lists.  In particular, by Section 42(2)(c) such regulations were required to include provision:

“that, except in prescribed cases… -

(i)	an application for inclusion in such a list by a person not already included and 
(ii)	an application by a person already included in such a list for inclusion also in respect of services or premises other than those already listed in relation to him, 

shall be granted only if the [PCT is] … satisfied in accordance with the regulations, that it is necessary and desirable to grant it in order to secure in the neighbourhood in which the premises are located the adequate provision by persons included in the list of services, or some of the service provided in the application”. 

Therefore, this provision required regulations to be made to control entry to the pharmaceutical list which exclusively prescribed by whom NHS prescriptions could be met: and “control of entry” is used as shorthand to describe the process whereby PCTs assess whether it is necessary or desirable for a new pharmacy to dispense NHS prescriptions in order to secure adequate pharmaceutical services in a particular neighbourhood. 

8.	Section 129 of the 2006 Act substantively replicates these provisions, in largely the same wording.  However, (i) the “shall” following subparagraphs (i) and (ii) is replaced by “may”: and (ii) “necessary or desirable” is replaced by “necessary or expedient”.  It was common ground before me that these changes did not affect the substance of the provision.  I agree.  In particular, although “desirable” has been replaced by “expedient” in the primary legislation, the phrase “necessary or desirable” is retained in the regulations designed to implement that legislation (see Paragraph 9 below) which, as I have already noted (Paragraph 5 above), although pre-dating it are now treated as if made under the 2006 Act.  The wording of the regulations (“necessary or desirable”) has remained unaltered: and therefore, although the relevant test is still described as “the necessary or desirable test”, “desirable” must be construed in terms of “expediency”, both before as well as after the introduction of the 2006 Act.

9.	The current applicable regulations are the National Health Service (Pharmaceutical Services) Regulations 2005 (2005 SI No 641, “the 2005 Regulations”), which came into force on 1 April 2005.  Regulation 12(1) provides for control of entry to pharmaceutical lists as follows: 

“(1)	…[A]n application shall be granted by the [PCT] only if it is satisfied that it is necessary or desirable to grant the application in order to secure, in the neighbourhood in which the premises from which the applicant intends to provide the services are located, the adequate provision, by persons included in a pharmaceutical list, of the services, or some of the services, specified in the application (‘the necessary or desirable test’)”. 

This regulation replicates its immediate predecessor (i.e. Regulation 4(4) of the National Health Service (Pharmaceutical Services) Regulations 1992, 1992 SI No 662 as amended: “the 1992 Regulations”).

10.	Regulation 12(2) of the 2005 Regulations sets out matters to which the PCT must have regard when considering the “necessary and desirable” test: 

“[I]n considering whether the necessary or desirable test is satisfied, a [PCT] shall have regard in particular to –
 
(a)	whether or not any of the following services are already provided by persons in the neighbourhood in which the premises named in the application are located -

(i)	any pharmaceutical services or directed services specified in the application provided by persons, included in a pharmaceutical list, or any directed services the applicant agrees to provide if his name is included in the pharmaceutical list… ;
(ii)	…

(b)	whether the recipients of pharmaceutical services already have a reasonable choice with regard to - 

(i)	the pharmaceutical services or directed services provided in the neighbourhood in which the premises named in the application are located, by persons included in a pharmaceutical list, and

(ii)  the persons included in a pharmaceutical list from whom such recipients may obtain pharmaceutical services or directed services in the neighbourhood in which the premises named in the application are located;

(c)	any other information available to the [PCT] which, in its opinion is relevant to the consideration of the application; and 

(d)	any representations received by the [PCT] …’.

11.	Regulation 12(2) calls for a number of comments.

(i)	Although the four listed factors are ones to which the PCT must “in particular” have regard, in my view this does not indicate that they must give especial weight to these factors or any of them.  The regulations merely require the PCT, when considering the “necessary and desirable” test, to have regard to these factors, in addition to any other relevant factors.  None of the factors is determinative, or given pre-eminent or enhanced weight.  The weight given to these factors or any of them is a matter for the decision-maker. 

(ii)	The factor listed at Regulation 12(2)(a) concerns the provision of services in the sense of access and availability, and includes such factors as geographical location and hours.  Choice in Regulation 12(2)(b) is a discrete factor - separate from access/availability in the previous subparagraph - to which a decision-maker must have regard when considering the application of the “necessary or desirable” test.  No doubt there is some relationship between these two factors: but, at the root of much misunderstanding and misapplication of these criteria is the elision of these two factors, or at least the failure to consider choice as a separate factor from simple access/availability of services (see, e.g., Paragraph 76 and following below).  The statutory scheme requires regard to be had to each of these factors.

(iii)	“Directed services” is a reference to additional pharmaceutical services provided in accordance with a direction under Section 41A of the 1977 Act: and “pharmaceutical services” for the purposes of the regulations means pharmaceutical services other than directed services, i.e. for the purposes of the regulations, “pharmaceutical services” is restricted in meaning to the essential Section 41 services (Regulation 2) (cf the different, wider definition in the Act itself: see Paragraph 6 above).  

12.	Regulation 12(2) of the 2005 Regulations again effectively replicates its immediate predecessor (i.e. Regulation 6 of the 1992 Regulations), with one important exception.  There was no equivalent in the 1992 Regulations to Regulation 12(2)(b) of the 2005 Regulations: although choice may arguably be a relevant factor in considering adequacy of the provision of services, under the 1992 Regulations there was no express requirement imposed upon the PCT to consider “whether the recipients of pharmaceutical services already have a reasonable choice with regard to” either pharmaceutical services or those on the pharmaceutical list who provide them.  The proper scope of that requirement, introduced for the first time in the 2005 Regulations, is at the heart of the Freckleton and Todmorden Claims: and, although the statutory scheme and “necessary or desirable” test “have been much litigated” (R (Lowe) v The Family Health Services Appeal Authority [2001] EWCA Civ 128 (“Lowe”) at Paragraph 2, per Laws LJ), that particular requirement has not previously been considered by any court.

13.	Before I turn to deal with the individual claims, it would be helpful if I were to make some general comments upon the statutory provisions which I shall do under the following heads:

(i)	Procedure (Paragraphs 14-18 below).
(ii)	The “Necessary or Desirable” Test: The Adequacy of Provision (Paragraphs 19-42).
(iii)	The “Necessary or Desirable” Test: The Choice Factor (Paragraphs 43-62).

Procedure

14.	An application by a person for inclusion in or amendment to a pharmaceutical list is made to the relevant PCT (Regulation 5 of the 2005 Regulations).  Inclusion on a list may be in a corporate name, and an application may be made in the name of a body corporate (see, e.g., Paragraph 2 of Schedule 4).  Although the list is of service providers, any application is for the provision of such services “from premises” (Regulation 5(1)(a)): details of the premises have to be given in any application (Paragraph 3 of Schedule 4), and a further application has to be made by anyone already on the list if he wishes to relocate (Regulation 5(1)(b)).  

15.	Unless an exemption is claimed under Regulation 13 (see Paragraph 18 below), the application must also include “reasons why the applicant considers the granting of the application is necessary or desirable in order to secure the adequate provision of pharmaceutical services in that neighbourhood” (Paragraph 5 of Schedule 4).  This reflects the fact that insofar as there is any burden of proof as to that necessity or desirability, then it effectively falls upon the applicant (R (Tesco Stores Limited) v The Family Health Services Appeal Authority [1999] EWHC 714 (Admin), [1999] Lloyd’s LR Med 377 at page 384 col 1).  Unless the PCT is satisfied that the granting of the application is necessary or desirable then it cannot grant the application.

16.	The PCT may determine an application with or without a hearing (Regulation 24).  However, from 19 January 2007, the PCT was obliged to ensure that it had sight of all relevant documents when considering an application (Regulation 24(2)(b), as amended by SI 2006 No 3373).

17.	An appeal against a decision by a PCT on an application under Regulation 12 by an applicant or interested party lies to the Secretary of State (Regulation 29) who, under his powers under the National Health Service Litigation Authority (Establishment and Constitution) Order 1995 (1995 SI No 2800, as amended), has directed that the relevant functions be performed by the Defendant Authority, which performs them through the PAC of its Family Health Services Appeal Unit.   

18.	Regulation 13 of the 2005 Regulations provides that the control of entry provisions of Regulation 12 shall not apply in respect of certain premises, including “premises which the applicant is willing to keep open for at least 100 hours per week for the provision of pharmaceutical services” and to which the PCT attaches a condition that the premises are kept open for the provision of pharmaceutical services for at least that time.  Otherwise, the control of entry criteria in the “necessary or desirable” test will apply.

The “Necessary or Desirable” Test: The Adequacy of Provision

19.	The relevant parts of Regulation 12 of the 2005 Regulations setting out the requirements of the “necessary or desirable” test are set out above (Paragraphs 9-10).  On the face of the provisions of that regulation, the test requires a three-stage approach:

(i)	First, the PCT must identify the relevant “neighbourhood”.  In none of the cases before me was the identity or extent of the neighbourhood in issue, and I need not refer to this further.

(ii)	Because an application can only be granted if the PCT is satisfied that it is necessary or desirable to grant the application in order to secure the adequate provision of pharmaceutical services in that neighbourhood, the PCT can only grant an application if the provision of relevant services is not already “adequate”.  I deal with the correct approach to the issue of adequacy below: but, on the face of the provisions, the PCT is bound to make a judgment as to whether the provision of relevant services in the neighbourhood is already adequate.  If the provision is adequate, then the PCT must refuse the new application: if it is not, then the PCT must move to the third issue.

(iii)	If there is an inadequacy of provision of relevant services, before the application is granted the PCT must be satisfied that it is necessary or desirable to grant the application in order to secure adequate provision of such services.  That requires a second exercise of judgment on their part.

20.	From the face of Regulation 12, those are the relevant - and apparently simple - requirements of the “necessary or desirable” test, as indeed identified by each of the parties before me and also helpfully set out in Paragraph 8 of the judgment in Lloyds Pharmacy Limited v The National Appeal Panel and E A Bairds (N’Ards) Limited (2004) P65/03 (“Lloyds Pharmacy”) in which the Inner House of the Court of Session considered the equivalent statutory provision, namely Regulation 5(10) of the National Health Service (Pharmaceutical Services) (Scotland) Regulations 1995 (1995 SI No 414), a regulation applying in Scotland in substantially similar form to Regulation 12 of the 2005 Regulations.  I return to this case below (Paragraphs 28 and following).

21.	Nevertheless, difficulties in construction have arisen.  “Adequacy” is at least capable of being defined in absolute terms, i.e. in terms of fulfilling a required standard.  If it is, then in any particular set of circumstances, “adequacy” is either met or it is not, in the sense that the standard is either fulfilled or it is not.  However, such a definition is in potential tension with the earlier phrase which sets out the test for securing adequacy, namely “necessary or desirable”.  As Laws LJ put it in Lowe (at Paragraph 14.3):  “If the provision [of pharmaceutical services] were inadequate, it would simply be necessary to make it up by granting the application.  If it were adequate, the application would have to be refused.”  The word “desirable” would therefore be otiose - it is clearly distinct from and antithetical to “necessary” - and it is a tenet of construction that some content should be given to words used in statutory provisions, on the basis that Parliament could not have intended to use empty words.

22.	This tension has been considered by the higher courts in both England & Wales and Scotland, which have adopted different approaches to the concept and definition of “adequacy” in this context.  

23.	In Lowe, Laws LJ resolved the tension by finding that “adequacy” in Regulation 4(4) of the 1992 Regulations (the predecessor of Regulation 12 of the 2005 Regulations, and in substantially similar terms) must be a relative rather than an absolute concept.  

24.	In Paragraph 12, he quoted from the judgment of Sir Louis Blom-Cooper QC sitting as a Deputy High Court Judge in  R (Baker) v Yorkshire Regional Health Authority (1996) 35 BMLR 118 (“Baker”) at pages 128-9, as follows:

“Value judgments can never be precise, and they are susceptible to individual variation.  They lack any arithmetical calculation; they are not commensurate with any fixed standards.  They are the product of intellectual intuition.  Hence, the decision-maker, applying the phrase in Regulation 4(4), may properly entertain doubts about the adequacy of any service provision.  And if the decision-maker is a committee, the members comprising the committee’s decision [sic] can reach only a consensus of value judgments ranging from the adequate to the inadequate, within the range of epithets along the continuum, from barely to seriously inadequate, or barely to entirely adequate. The lack of precision in the noumenon ‘adequate’ permits of a construction that imports a margin of appreciation in the application of the judgment about adequate provision.  It is in this respect that the legislature intended to bring to bear the ‘necessity’ or ‘desirability’ concepts into relationship with ‘adequate provision’.  Thus the decision-maker asks himself/herself/itself, whether there is or is not adequate provision of the resources specified in the application.  If the answer is ‘wholly adequate’, the conclusion will be the need to secure an adequate provision in the form of granting the application to supply them.  If the answer if borderline - i.e. falls just one side of the or another of the line - then resort to ‘desirability’ will be preferred to fill a possible, although not certain, gap in the service provision.  Does this give sufficient distinction in Regulation 4(4) to the two words ‘necessary’ or ‘desirable’?  I think it does…

My conclusion is that sense and meaning can be adequately accorded Regulation 4(4) in its entirety, by the decision-maker applying a loose value-judgment as to the adequacy of the service provision, as it exists, and employing, secondarily, the concepts of necessity and desirability in a fashion sufficient to supply the satisfaction to the decision-maker that the service specified in the applicant should be granted his, her or its application [sic] …

If there is a doubt in the mind of the decision-maker whether the current service provision is ‘adequate’, he may properly invoke the ‘desirability’ test, whereas ‘necessity’ would not be apt to supplement a service provision that might marginally qualify as being ‘adequate’”.

25.	Laws LJ then continued (Paragraphs 13-14):

“13.	Regulation 4(4) has, I think, caused difficulty, and in consequence given rise to much litigation, because its terms invite the decision-maker to make not one but (potentially at least) a series of value judgments; and because of the antithesis between ‘necessary’ and ‘desirable’, it is by no means entirely clear what is the relationship between the various possible judgments which may (depending upon the facts) fall to be made.”

I briefly pause there, to express agreement with that paragraph.  Particularly, Laws LJ perceptively and accurately identifies the real challenging issue raised by the “necessary and desirable” test, namely the relationship between the various value judgments that the decision-maker (initially, in England, the PCT) is required to make in applying the test.  

26.	Laws LJ continued (the marked emphases being his): 

“14.	For my part, I agree with the general direction of Sir Louis Blom-Cooper’s reasoning in Baker.  With great respect, however, the language deployed is perhaps unnecessarily complex, and it is to be noted that the text of the report is here and there corrupt.  I believe that the regulation’s true construction may be expressed somewhat more simply through these following five steps.

1.	A licence to provide pharmaceutical services is only to be granted under Regulation 4(4) for the purpose of securing in the relevant neighbourhood the adequate provision by listed pharmacists of the serves in question.  So much is plain and elementary. 

2.	What is ‘adequate’ is a question of degree.  There is, as it has been described, a spectrum or ‘continuum’ of adequacy. 

3.	That is, I think, ordinarily a feature of the term ‘adequate’ as a matter of language.  But it is in any case a necessary feature of the term as it is used in Regulation 4(4) since if it were otherwise - if ‘adequate’ were to denote a single sharp edge, such that any given set of facts would fall plainly upon one or other side of it - then it would be impossible to arrive at any construction of the earlier phrase, ‘necessary or desirable’, other than one in which the word ‘desirable’ were otiose.  If the provision were inadequate, it would simply be necessary to make it up by granting the application.  If it were adequate, the application would have to be refused.

4.	It follows that, while on the surface the first question for the decision-maker is simply whether existing provision is adequate, the real question is where on the sliding scale or spectrum of adequacy does this case on its facts belong.

5.	To this, the logically available answers are: 

(a)	Wholly adequate.  There is no magic in the word ‘wholly’: it simply refers to a state of affairs in which there is no question but that the existing provision suffices.
 
(b)	Wholly inadequate.  Again there is no magic in the adverb.  This looks at a state of affairs where further provisions must necessarily be made.
 
(c)	Marginal, or somewhere between (a) and (b).  There the decision-maker may conclude that it is desirable to grant the application in order to secure adequate provision.  But 

(d)	There may be some slippage between what it marginal and the extremes, wholly adequate or wholly inadequate.  To that extent there may be slippage also between what is necessary and desirable.  The judgment to be made is emphatically pragmatic”. 

27.	Therefore, Laws LJ considered “adequacy” a relative rather than an absolute concept - thus there can be degrees of adequacy in this context - which he considered gave substance to “desirable” which he was concerned otherwise would have no content.  Where the provision of relevant services fell between “wholly adequate” and “wholly inadequate”, then, although a decision-maker cannot say that provision would be necessary, “the decision-maker may conclude that it is desirable to grant the application in order to secure adequate provision”.  

28.	The Courts of Scotland have taken a different approach when they have considered the construction of the equivalent statutory provision, namely Regulation 5(10) of the National Health Service (Pharmaceutical Services) (Scotland) Regulations 1995 (1995 SI No 414).  As I have noted, that regulation is in substantially similar form to Regulation 12 of the 2005 Regulations which apply in England.

29.	The Court of Session considered the adequacy of provision issue in Lloyds Pharmacy.  The case was heard after Lowe, which was debated before the Inner House.  The court took a different view of the meaning of “adequacy”, finding that it naturally and in context connoted an absolute concept.  

30.	Having identified the neighbourhood question (which was not in issue in the case before the court), Lord Drummond Young giving the judgment of the court said (at Paragraphs 8-11):

“8.	… Thereafter, in our opinion, the decision-maker must approach an application in two stages.  First, it must consider whether the existing provision of pharmaceutical services in the relevant neighbourhood is adequate.  If it decides that such provision is adequate, that is the end of the matter and the application must fail.  If it decides that such provision is not adequate, it must go on to consider a second question: whether the provision of pharmaceutical services at the premises named in the application is “necessary or desirable” in order to secure adequate provision.  We consider that such a two-stage approach is inherent in the logical structure of Regulation 5(10).  The fundamental criterion against which the application is to be judged is the adequacy of pharmaceutical services in the relevant neighbourhood.  A deficiency in those services must exist before an application can be granted.  Consequently the existence of such a deficiency must be identified before it is necessary to consider what may be done to provide a remedy.  The second question relates to the manner in which an identified deficiency is remedied.”

I pause there to note that this analysis derives from the face of the words of the statutory provision and, as I have noted above (Paragraph 19), it is the analysis to which all of the parties were drawn in this case.  

31.	Lord Drummond Young continued:

“9.	In relation to the first question, we are of opinion that ‘adequacy’ is a simple concept, in the sense that there is no room for different degrees of adequacy, or a spectrum of adequacy.  Either the pharmaceutical services available in the neighbourhood are adequate or they are not.  That seems to us to be inherent in the ordinary meaning of the word, which denotes a sufficiency for a particular purpose, in this case the provision of pharmaceutical services in the relevant neighbourhood.  The standard of adequacy is a matter for the decision-maker, whether that is the Pharmacy Practice Committee or the National Appeal Panel [the decision-making equivalents of the PCT and PAC, in Scotland].  In either case, the decision-maker is a specialist tribunal, and can be expected to apply its knowledge of the pharmaceutical business to the task of determining the appropriate standard.

10.	The question that the decision-maker must address is the adequacy of the existing provision to serve the neighbourhood in question.  In addressing that question, however, it is in our opinion proper to have regard to probable future developments, for two reasons.  First, the standard of adequacy in a particular neighbourhood will obviously change with time.  The relevant neighbourhood may change, for example through the construction of new housing developments or the movement of population out of inner-city areas.  Likewise changes inevitably occur in pharmaceutical practice, and the standard of “adequate” pharmaceutical provision must accordingly develop over time.  The proposal under consideration may well provide an illustration of how pharmaceutical practice is developing, and may be relevant to show what sort of provision is possible in the neighbourhood.  We are in full agreement with the Lord Ordinary that changes in pharmaceutical practice should be taken into account by the decision-maker.  Secondly, Regulation 5(10) uses the word ‘secure’ in relation to the adequate provision of pharmaceutical services.  That word seems to us to indicate that the decision-maker can look to more than merely achieving a bare present adequacy of pharmaceutical provision.  ‘Secure’ suggests that it should be possible to maintain a state of adequacy of provision into the future.  That indicates that the decision-maker must have some regard to future developments, in order to ensure that an adequate provision can be maintained.  The decision-maker must, however, determine the adequacy of the existing provision of pharmaceutical services at a specific time, the time of its decision.  It must accordingly reach its conclusion on the adequacy of the existing provision on the basis of what is known at that time, together with future developments that can be considered probable rather than speculative.  The decision-maker must also bear in mind that the critical question at this stage of its reasoning is the adequacy of the existing provision, not the adequacy or desirability of some other possible configuration of pharmaceutical services in the neighbourhood.

11.	If the decision-maker determines that the existing provision of pharmaceutical services in the relevant neighbourhood is inadequate to meet the needs of the neighbourhood, it must go on to consider the question of how the deficiency can be remedied.  It is at this point that it must consider whether the proposal in the application is “necessary or desirable in order to secure adequate provision of pharmaceutical services in the neighbourhood”.  In this context, two expressions used in the regulation call for comment.  First, the words “necessary or desirable” are intended in our opinion to give flexibility in the manner in which a shortfall in provision is remedied.  If the proposal under consideration does no more than make up the shortfall, that proposal will obviously be ‘necessary’ to secure adequate provision of pharmaceutical services in the neighbourhood.  In some cases, however, the proposal may go further, and result in a degree of over-provision.  The use of the word ‘desirable’ is in our view intended to permit the approval of such a proposal, if the decision-maker is satisfied that, notwithstanding the over-provision, the proposal is still ‘desirable’ in order to secure adequacy.  It should be noted, however, that the expression ‘necessary or desirable’ is only relevant to the second question that the decision-maker must consider, namely how an identified inadequacy is to be remedied.  It is not in our opinion relevant to the first question, whether such inadequacy exists in the first place.  Secondly, as we have already noted, the use of the word ‘secure’ seems to us to indicate that it should be possible to maintain a state of adequacy of provision into the future.  That could in some cases result in some over-provision.  Subject to these comments, however, the question of whether a proposal is necessary or desirable in order to secure an adequate provision of pharmaceutical services is a matter for the Pharmacy Practice Committee or the National Appeal Panel as a specialist tribunal.”

32.	The Court of Session therefore construed “adequacy” as an absolute concept, but gave “desirability” content in relation to an application which would, if granted, not only remedy any identified insufficiency of services but lead to provision over and above the standard of adequacy.

33.	I approach this issue, and particularly comment upon Lowe, with especial diffidence, because:

(i)	The approach and test proposed for the future by Laws LJ was adopted by Thorpe LJ (Paragraph 28): and, although he expressed further comments which suggest he was not perhaps as much of a relativist as Laws LJ, the third member of the Court of Appeal (Buxton LJ) expressly adopted the reasoning of Laws LJ (Paragraph 24).

(ii)	In Lowe, the judge at first instance (Janet Smith J, as she then was) gave permission to appeal to enable the Court of Appeal to give authoritative guidance (Paragraph 2).

(iii)	The guidance was intended to be “emphatically pragmatic”.  It was given 7 years ago, and there is no evidence that decision-makers have had difficulties with it in practice. 

(iv)	No party before me sought overtly to challenge the propositions set out by Laws LJ in Lowe.

(v)	It is at least arguable that the propositions formed part of the ratio decidendi of the case.

34.	However, I do propose to make some comments, for the following reasons.  First, I have been invited to lay down guidelines that may be helpful in practice to decision-makers and applicants in applications for admission to a pharmaceutical list, and it is difficult to do that without considering the different approaches set out in Lowe and Lloyds Pharmacy.  Furthermore, in relation to identical wording of parallel statutory schemes, it is unsatisfactory for there to be apparently conflicting authorities in England and Scotland, especially if the authorities are capable of being substantially reconciled: and, in my respectful view, although Lowe and Lloyds Pharmacy travel by different routes, I do not consider their consideration of the central issue in relation to the “necessary or desirable” test (i.e. the various value judgments that the decision-maker is required to make in applying the test: see Paragraph 25 above) to be entirely at odds.  In particular, I do not consider the differences in analysis apparent from those cases should result in any significant difference in the practical exercise of discretion or decisions that any decision-maker has to make when applying that test.

35.	When considering the current provision of pharmaceutical services in the relevant neighbourhood, both Lowe and Lloyds Pharmacy require a decision-maker to make a value judgment in respect of the standard of such services which if met will be adequate and if not met will be inadequate.  That is a clear requirement of the statutory scheme.  That standard will depend upon all of the circumstances, including the nature of the relevant locality and pharmaceutical practice either of which may change over time.  In that sense, the standard is therefore not fixed.  Setting that standard is a matter of judgment for the decision-maker, i.e., in England, the PCT and on appeal the PAC.  That judgment will be unimpeachable except by way of judicial review upon the usual grounds that in coming to a judgment the decision-maker has erred as a matter of law.

36.	On an application, having decided what standard of pharmaceutical services in the relevant neighbourhood would be adequate, the decision-maker must assess the actual current provision against that standard and decide whether the current provision falls above or below that standard.  There will be easy cases, in which the current provision is clearly well above or well below the standard.  These are the cases described by Laws LJ as “wholly adequate” and “wholly inadequate” respectively.  

37.	Other cases will be less clear cut.  It is in these cases that the difference in analysis between Lowe and Lloyds Pharmacy becomes apparent.  In Lowe, these cases are described in terms of being somewhere in the middle of a spectrum of adequacy, in which extra provision is not “necessary” but in which the decision-maker, without deciding whether existing provision is below a particular standard, may conclude that it is “desirable” to grant the application.  In other words, the decision-maker has a discretion in these cases as to whether the test is passed.  In Lloyds Pharmacy, these cases would be regarded as being within the decision-maker’s proper margin of appreciation in respect of adequacy such that it would be open to a decision-maker properly and lawfully to decide that the appropriate standard of provision is not already met.  In those cases where he draws the standard such that the provision is inadequate, then he would go onto the further question of whether it is necessary or desirable to grant the application to secure in the neighbourhood the adequate provision of such services.  In relation to that question, he would exercise his discretion a second time.

38.	Therefore, these analyses are clearly different and the exercise of discretion by the decision-maker is taken at different stages of the decision-making process and, in terms of process, in different ways.  Under Lowe, leaving aside cases in which the provision of services is obviously (or “wholly”) adequate or inadequate, the decision-maker has to decide where mid-spectrum of adequacy a particular set of circumstances lies before exercising his discretion as to whether the provision proposed by the application is “desirable”.  Under Lloyds Pharmacy, the decision-maker in these cases exercises his discretion (i) to decide whether current provision is above a standard which he identifies and, if it is not, (ii) to decide whether the provision proposed in the application is “necessary or desirable” in order to secure such adequate provision.

39.	However, although the intellectual process required of each analysis is formally different, in respect of the “necessary and desirable” test looked at as a whole each give a disxretion to the decision-maker and in substance this margin is wide and at least similar.  I consider that appears from consideration of the two cases read as a whole, together with the judgment of Sir Louis Blom-Cooper in Baker (which informed the Court of Appeal judgment in Lowe), and that is why I have quoted from those three cases at some length.  

40.	In particular, the Lowe approach requires the decision-maker to assess where on the spectrum of adequacy a particular set of circumstances lies and, in respect of this, (i) the decision-maker must have a wide discretion, similar to the discretion exercised by a decision-maker under Lloyd Pharmacy when he is considering whether a set of circumstances is over or under the adequacy line: and (ii) when, under the Lowe analysis, the decision-maker comes to consider whether the proposed provision is “desirable”, where on the spectrum he has put the case must be a particularly important factor.  Leaving aside the issue of the extent to which a decision-maker can take into account future developments (with which Lowe does not grapple), Lowe effectively elides the decision-maker’s consideration of discretion into one exercise, whereas the Lloyds Pharmacy splits that exercise into two.  However, looking at the test as a whole, in any particular case the aggregate of the exercise of discretion is similar and that discretion will at least very likely if not inevitably be exercised with the same result, such that, whichever analysis is adopted the same result as to whether the “necessary or desirable” test is passed will apply.  In my respectful judgment, the difference between the two cases is not so much substantive but more one of intellectual analysis of the decision-making process that is unlikely to make a significant difference at a practical level to the overall decision (as to whether the “necessary or desirable” test) is passed.  It is noteworthy that Laws LJ emphasised that the exercise of the decision-maker’s judgment was “emphatically pragmatic”, and not to be the subject of any niceties of intellectual analysis.

41.	Given that the different analyses give rise to a similar substantial decision-making process at a practical level, it is unnecessary for me to determine which of the intellectual analyses put forward in Lowe and Lloyds Pharmacy is correct.  However, insofar as Lowe is not binding on me, I should say that I prefer the analysis set out in Lloyds Pharmacy, for the following reasons.

(i)	Whilst it may be brave of a judge to give any opinion as to the ordinary usage of a word in the face of the respective courts of appeal of England & Wales and Scotland disagreeing upon that usage, in my respectful view I do not consider that Sir Louis Blom-Cooper QC and Laws LJ are correct in considering that, in ordinary language, “adequacy” is a relative concept and that consequently there is a spectrum or continuum of adequacy.  “Adequate” derives from “adequatus” (“equalised”), and its primary meaning was “equal in magnitude or extent; commensurate; neither more nor less” - and by extension it has come to mean “commensurate in fitness; equal or amounting to what is required; fully sufficient, suitable or fitting” (Oxford English Dictionary, 2nd (Garner) Edition, Oxford University Press (1989): emphasis added).  Although it has come to be used primarily qualitatively, meaning sufficient to fulfil a specific requirement particularly in respect of an identified standard or ability, this definition does not allow for any relativity.  Therefore, one may have adequate conversational French for the purposes of holiday-making.  However, if one has complete fluency in French, that may be said to be more than adequate for holiday-making: but to say that is “wholly adequate” is tautological.  In respect of the ordinary usage of the word, I respectfully agree with Lord Drummond Young.

(ii)	However, I accept that in law “adequacy” is a concept which takes its meaning from its context (see, e.g., R (A) v National Asylum Support Service [2003] EWCA Civ 1473, [2004] 1 WLR 752).  However, in context, in the relevant provisions with which I am concerned, other than the possible tension between “adequacy” as an absolute concept and giving “desirable” some content (with which I deal below: see Paragraph 41(iv)), there is nothing in the primary or secondary legislation which adopts the “necessary or desirable” test that requires “adequate” to have anything other than its ordinary meaning.  Indeed, if it were intended to import relativity, one would have expected a different word or term to have been used: but, if not that, one would perhaps have expected the term to have been the subject of some better definition.  For example, “choice” clearly imports relativity - one can certainly have a spectrum of choice - and, when that concept was introduced by Regulation 12(2)(b) of the 2005 Regulations, that was done by reference to “reasonable choice”.  For the reasons I have given, I do not consider that, in ordinary language, one can have “reasonable adequacy”: but, had the draftsman intended “adequacy” to be a relative concept, one might have expected at least some such terminology.

(iii)	Of course, words may acquire a meaning different from the ordinary meaning by way of legal usage.  “Adequate consideration” in the law of contract is an example of an instance in which “adequate” has acquired such a legal meaning (although not, of course, one importing relativity).  I was not referred to any authorities upon the meaning of “adequate” in other legal contexts, understandably perhaps as, if the word does have some meaning other than the ordinary meaning, then that alternative meaning must be context-driven.  However, in R (A) v National Asylum Support Service [2003] EWCA Civ 1473, [2004] 1 WLR 752, the Court of Appeal considered “adequate” accommodation which the National Asylum Support Service is bound to provide an asylum seeker and his family under Section 122 of the Immigration and Asylum Act 1999.  “Adequate” was regarded as an absolute concept: “A balancing exercise has to be carried out with the question at the forefront - is the accommodation adequate for the needs of the disabled children in the circumstances which persist at that moment in time?” (at Paragraph 60, per Waller LJ).  Closer to the wording of the statutory provisions which are pertinent in the case before me, in R (Gosforth Allotments & Garden Association) v Secretary of State for the Environment (1996) 72 P&CR D38, the court considered “adequate provision” under Section 8 of the Land Settlement Facilities Amendment Act 1925.  Under that section, the Secretary of State shall not give an authority consent to sell etc an allotment unless he is satisfied that “adequate provision” is made for the displaced allotment holders.  Although the issues raised were different from those in this case (as it was there argued that “adequate provision” was a reference to the standard of facilities the allotment holders had previously enjoyed), the court held that the issue was “more naturally answered by reference to the allotment holders’ reasonable needs”.  Although not powerful authority, this again suggests the setting of a standard (with a margin of appreciation allowed for in the concept of reasonableness) which the proposed alternative arrangements for displaced allotment holders would or would not meet, i.e. an absolute concept.  There is nothing in these authorities that compel a definition of “adequate” that is any different from its ordinary meaning.

(iv)	Laws LJ accepted that, “on the surface the first question for the decision-maker is simply whether existing provision is adequate” (Paragraph 14.4, his emphasis), by which I understand him to mean that, on the face of the words used in the provision, the question for the decision-maker is whether the provision of pharmaceutical services reaches the appropriate standard as identified by the decision-maker - or not.  However, he considered himself driven to import relativity into the term because otherwise “it would be impossible to arrive at any construction of the earlier phrase, ‘necessary or desirable’, other than one in which the word ‘desirable’ were otiose”.  If the provision were inadequate, it would simply be necessary to make it up by granting the application.  If it were adequate, the application would have to be refused.” (Paragraph 14.3).  However, I find the alternative analysis suggested by Lloyds Pharmacy to be compelling, particularly as “desirable” has to be read in the context of “expediency” (see Paragraph 8 above).  Had “necessary” been used alone, that may have inhibited decision-makers from granting applications which would have the effect of not merely remedying any identified inadequacy, but also going beyond that with the result that, if the application were granted, there would be provision over and above the standard of adequacy.  This is particularly so given the extent to which the decision-maker can take into account future developments, as noted in Lloyds Pharmacy.  Similarly, if a deficiency in provision is identified, and there are two competing applications that each would remedy that shortfall, in respect of each it is arguable that it is not “necessary” for the application to be granted (because of the existence of the other application): whereas it may be clear that it is “desirable” or “expedient” to grant one of the two (see the Tunbridge Wells Claim, Paragraphs 103 and following below).  Consequently, “desirable” (or “expedient”) is given content, allaying the concerns of Laws LJ.  

(v)	However, I find that the analysis in Lloyds Pharmacy is not only more in line with the ordinary meaning of the wording of the text of the regulation on their face, but it is also more consistent with the internal mechanism of the statutory scheme and more helpful for the decision-maker who has to apply the test.  It is, in terms of rationality and logic, the more satisfactory.  It was common ground between all of the various parties before me that, ignoring the neighbourhood issue, the “necessary or desirable” test required a two-stage approach (as identified in Lloyds Pharmacy at Paragraph 8, set out at Paragraph 30 above: see also Paragraph 9 above).  First, the decision-maker must consider whether the existing provision of pharmaceutical services in the neighbourhood is adequate.  Second, if the decision-maker decides that the provision is inadequate, he moves to a second question, i.e. whether the provision of services as proposed on the application is “necessary or desirable” in order to secure adequate provision.  Even if the two questions can be brought together as Laws LJ does, the Lloyds Pharmacy analysis more closely follows the scheme of the statutory provisions (which suggest there should be a two-stage process) and, I believe, better focuses the decision-maker on the value judgments he is required to make in applying the test.  As Buxton LJ stressed in Lowe (at Paragraph 25) the regulation speaks of simple “adequacy”: and it is important that the decision-maker focuses on that concept rather than any test formulated around “whole adequacy”, particularly as Laws LJ himself made clear that that phrase “simply refers to a state of affairs in which there is no question but that the existing provision suffices” (Paragraph 14.5(a)).  It also avoids possible pitfalls, such as that of Baker in which Sir Louis Blom-Cooper suggested that, where circumstances were such that provision of pharmaceutical services in a neighbourhood were (marginally) adequate, nevertheless a decision-maker might decide that it is “desirable” to grant an application.  That would contravene the clear terms of the statute and regulation, which require inadequacy of provision before an application is granted.  Further, considering “adequacy” as a relative concept would suggest that the task of the decision-maker is to determine what will maximise the provision of services and providers of services within a neighbourhood - thereby to “increase the adequacy” of such services.  That is not the task, which is a simple one: to determine, in all of the circumstances and with a wide margin of appreciation, whether the existing provision of pharmaceutical services in a neighbourhood is adequate or not: and thereafter to consider whether the services proposed in the new application are “necessary or desirable” to meet the identified deficiency.                  

42.	For these reasons, although (as I have stressed) in their practical consequences the analyses are essentially similar and either analysis properly applied will lead to the same substantive exercise of discretion and the same result, I prefer the analysis of the relevant statutory provisions set out by the Court of Session in Lloyds Pharmacy.  This focuses the decision-maker’s mind firmly on the decisions which, on the face of the statutory provisions, he is required to make and is less likely to lead to difficulties and errors in the decision-making process.

The “Necessary or Desirable” Test: The Choice Factor

43.	Regulation 6 of the 1992 Regulations set out a number of factors to which the decision-maker had to have regard in considering whether the “necessary or desirable” test was satisfied.  Those factors were replicated in Regulation 12(2) of the 2005 Regulations with the addition of Regulation 12(2)(b) as follows:

“whether the recipients of pharmaceutical services already have a reasonable choice with regard to - 

(i)	the pharmaceutical services or directed services provided in the neighbourhood in which the premises named in the application are located, by persons included in a pharmaceutical list, and

(ii)  the persons included in a pharmaceutical list from whom such recipients may obtain pharmaceutical services or directed services in the neighbourhood in which the premises named in the application are located;…”.

The proper approach to this factor - the “choice factor” - was the main issue between the parties in the Freckleton and Todmorden Claims.

44.	The PAC (supported by those companies with interests in the pharmacies currently providing services in the relevant neighbourhoods) submitted that “choice” in this context had a restricted meaning, in the following ways.

(i)	Mr Philip Coppel for the PAC submitted that the “reasonable choice with regard to” pharmaceutical services and the persons included in the pharmaceutical list was different from “reasonable choice of” such services and persons.  The latter would require the decision-maker to consider whether there was a reasonable choice of services, and discretely whether there was a reasonable choice of persons providing those services.  The wording of the regulation meant that the factor that the decision-maker had to take into account was singular or unitary: he was required to consider simply whether recipients of pharmaceutical services had a reasonable choice, although in that consideration the decision-maker must have regard to services and persons.  

(ii)	Mr Coppel submitted that, if I acceded to his submission in respect of singularity, where there was only one source of pharmaceutical service provided by one person, there was nevertheless a “choice” for those who sought a service, in that they could obtain that service from the single source or not.  If both the singularity submission and this submission were good, then there would only be an absence of choice in circumstances in which there were no pharmaceutical services at all provided in a neighbourhood.  Of course, whether any choice were “reasonable” would depend upon all of the circumstances, and if there were only one provider with a single pharmacy, then that might be less than a reasonable choice.  However, that would be a value judgment for the decision-maker to make.

The interested parties who appeared all more or less adopted and developed the first ground.  Mr Coppel had less support for the second ground.

45.	Mr Findlay for Assura submitted that the reference in Regulation 12(2)(b)(i) to “the pharmaceutical services or directed services provided in the neighbourhood” is disjunctive, in that choice has to be considered in relation to each relevant service.  For example, as he put it (Skeleton Argument, Paragraph 50), it could be that there was a choice of essential pharmaceutical services (which, in effect, every pharmacy has to provide) but a lack of choice as to directed services either as a whole or in respect of any directed service.  I agree with this interpretation which, as Mr Findlay submitted, is supported by the wording in Regulation 12(1) in its reference to “… the services, or some of the services…”

46.	Further, Mr Findlay did not agree with Mr Coppel that the choice factor was a singular one.  He submitted that there was effectively no difference between “reasonable choice with regard to” something and “reasonable choice of” something: and the statutory wording required the decision-maker to consider both whether there was a reasonable choice of services, and whether there was a reasonable choice of persons providing those services.

47.	However, he sought to go further.  He referred to various documents coming into existence both before and after the introduction of the 2005 Regulations, for example:

(i)	The Control of Entry Regulations and Retail Pharmacy Services in the UK: A Report of an OFT Market Investigation (OFT609) (March 2003)
(ii)	Proposals to Reform and Modernise the NHS (Pharmaceutical Services) Regulations 1992 (Department of Health GR 1909) (August 2003)
(iii)	Report of the Advisory Group on the Reform of the NHS (Pharmaceutical Services) Regulations 1992: Advice to the Secretary of State for Health (Department of Health) (January 2004)
(iv)	The Final Regulatory Impact and Competition Assessment: NHS (Pharmaceutical Services) Regulations 2005 (Department of Health) (March 2005)
(v)	The NHS (Pharmaceutical Services) Regulations 2005: Information for Primary Care Trusts (Department of Health) (August 2005 and February 2007 Revision)
(vi)	Review of Progress on Reforms in England to the “Control of Entry” System for NHS Pharmaceutical Contractors: Consultation Document (Department of Health GR 6559) (June 2006) and
(vii)	Review of Progress on Reforms in England to the “Control of Entry” System for NHS Pharmaceutical Contractors: Report (Department of Health GR 7334) (November 2006).

On the basis of these documents, Mr Findlay submitted that Regulation 12(2)(b) was introduced to increase choice and competition into the pharmacy market: the November 2006 document (Document (vii) above) indicated that the aim of the reforms was to “promote consumer choice and to harness the benefits of increased competition” (Paragraph 2.7).  Those aims can and should be taken into account in two ways.  In construing the regulation one should have in mind the purpose of increasing choice and competition, and give Regulation 12(2)(b) a purposive construction.  Similarly, decision-makers should have particular regard to “choice” when considering the “necessary or desirable” test.

48.	I cannot accept the entirety of the submissions of either party.  In my view, they each go too far.  

49.	The law relating to the correct methodology for ascertaining legislative intent is well-established.  “…[I]t is a cardinal constitutional principle that the will of Parliament is expressed in the language used by it in its enactments” (Wilson v First County Trust Limited (No 2) [2003] UKHL 40, [2004] 1 AC 816 at Paragraph 67, per Lord Nicholls): “…what is to be ascertained is the meaning of what Parliament has said and not what Parliament meant to say” (Black-Clawson International Limited v Papierwerke Waldhof-Aschaffenburg AG [1975] AC 591 at page 645C per Lord Simon of Glaisdale).  

50.	There are exceptions to this principle.  For example, contemporary Parliamentary material may be used to clarify Parliamentary intention when the words ultimately used have a number of shades of meaning, to resolve the ambiguity (Black-Clawson, at page 646B-G).  

51.	Furthermore, other material may be relevant to a challenge to a decision-maker’s decision, even if not relevant to the issue of statutory construction.  For example, if the Secretary of State issues guidance for decision-makers, and there is a radical departure from the guidance, then, although not relevant to the construction of the relevant provisions, the guidance may be relevant to a challenge because the decision-maker may be under an obligation to explain why he has taken that radically different approach (R (Boots the Chemist) v The Family Health Services Appeal Authority and Lloyds Pharmacy Limited [2005] EWHC 2025 at Paragraph 10). 

52.	However, in this case, recourse to materials other than the words of the statutory/regulatory provisions themselves is unnecessary.  There are no ambiguities that call for resolution.  Regulation 12(2)(b) requires the decision-maker, when considering the “necessary or desirable” test, to have regard to whether recipients of services have a reasonable choice with regard to pharmaceutical services and those who provide them in the neighbourhood.  This factor of choice is relevant to both (i) whether existing provision of services is adequate, and (ii) if not, whether the proposed services in the application go to securing such adequate provision.  On its face, to require that decision-makers have regard to whether recipients of services have a reasonable choice when considering those two questions is a simple and clear statutory requirement.

53.	I agree with the submission of Mr Coppel that the textual analysis of non-statutory material into which Mr Findlay sought to draw us only serves to distract attention from the words and true meaning of Regulation 12.  The mischief of looking behind the words used by Parliament alluded to in cases such as Black-Clawson is well-illustrated in this case itself.  The OFT report (referred to in Paragraph 47(i) above) recommended the complete abandonment of control of entry requirements, and the opening up of pharmacies to the free market.  It is clear from the later documents emanating from the Department of Health to which I was referred that the Government rejected this recommendation and the discussions which eventually fruited in the 2005 Regulations ranged widely over various options that attempted to balance the perceived benefits of choice and competition with the potential harm that might be done by an entirely free market particularly in sparsely populated areas.  All that can be derived from the contemporaneous documents is that the Government were exercised about where that balance should be, and the best means of achieving it through regulation.  If ever there was a case for wariness in moving from the path lit by the words Parliament have used in statute and regulation, into the swamps of other materials, this is it.

54.	As I have said, such reckless interpretative behaviour is unnecessary in this case: because the words used by Parliament are unambiguous.  The reasonable choice of both services and providers referred to in Regulation 12(2)(b) has to be considered when a decision maker is considering the “necessary or desirable” test.  It is implicit in the regulation that there may be benefits in choice of services and/or provider: although the term “reasonable choice” also makes clear that not all choice is good, because the possibility of “unreasonable choice” is at least postulated.  

55.	In considering the “necessary or reasonable” test, a decision-maker must have regard to the choice described.  Mr Findlay suggested that choice as a factor may be more important - have more weight - than other factors (see also Paragraph 11(i) above): but that is not identified in the regulation.  Whilst choice is a factor that must be taken into account, like other relevant factors, weight is a matter for the decision-maker.  As has been said :

“Provided that the… authority has regard to all material considerations, it is at liberty (provided it does not lapse into Wednesbury irrationality) to give them whatever weight the… authority thinks fit or no weight at all.  The fact that the law regards something as a material consideration… involves no view about the part, if any, which it should play in the decision-making process.” (Tesco Stores Limited v Secretary of State for the Environment [1995] 1 WLR 759 at page 780, per Lord Hoffmann).

In that sense, Regulation 12 contains no in-built bias in favour of promoting choice.

56.	“Choice” is a concept which in ordinary language conveys the freedom to choose from a number of things or actions.  It requires there to be at least one alternative.  “Hobson’s choice” was referred to by a number of advocates during the debate before me.  As I understand it, Thomas Hobson owned stables in Cambridge in the 1600s, and insisted on hiring out horses on a strict rotation basis to ensure each horse was evenly worked.  A customer was therefore directed to a particular horse, and could not select any other horse.  In ordinary language, “Hobson’s choice” is no choice at all.

57.	Choice cannot exist in vacuo: it must relate to specific things or actions.  Insofar as Mr Coppel suggested to the contrary in his first submission (Paragraph 44(i) above), I reject that suggestion.  To what does “reasonable choice” in Regulation 12(2)(b) relate?  There are only two possibilities, namely:

(i)	“pharmaceutical services” referred to in the first line of the paragraph (before the reference to “reasonable choice”): or

(ii)	“the pharmaceutical services” and “the persons” as described in subparagraphs (i) and (ii) of Regulation 12(2)(b).

The wording of Regulation 12(2)(b) could have been clearer.  Why “or directed services” is omitted from the first line of Regulation 12(2)(b) after “the recipients of pharmaceuticals services…” is something of a mystery, given the restricted meaning of “pharmaceutical services” in the 2005 Regulations and that those words are included after “pharmaceutical services” in subparagraphs (i) and (ii) of the Regulation 12(2)(b).  One would have thought that recipients of directed services would be entitled to consideration here, as much as the recipients of essential “pharmaceuticals services”.  However, that omission does not appear to favour either particular construction of the rest of the regulation set out above.

58.	In relation to that construction, I am persuaded by the thrust of Mr Coppel’s submissions that the former is the better and the proper construction.  The phrase “whether the recipients of pharmaceutical services already have a reasonable choice” could, in my view, properly stand alone, the reasonable choice referring back to “pharmaceutical services”.  As Mr Coppel contended, I consider that the use of the phrase “reasonable choice with regard to” (rather than “reasonable choice of”) is also telling.  It would have been easy for the draftsman to have used the simpler and more usual phrase had the intention been to relate reasonable choice to those specific matters identified in subparagraphs (i) and (ii): and, although not an identical formulation, “regard” here resonates with “in considering whether the necessary or desirable test is satisfied, a [PCT] shall have regard in particular to…” the various matters listed in Regulation 12(2)(a)-(d), where the word clearly indicates matters each of which is to be taken into account when the test is considered.  Furthermore, given that the factor is defined by reference to “recipients of pharmaceutical services”, such recipients would perhaps be more concerned with the choice of services they have rather than with the persons who provide those services (although a  restriction in providers may be detrimental to recipients if that restriction diminishes the perceived benefits of choice in relation to services).  

59.	Therefore, although it can be unhelpful to paraphrase regulatory provision, in my judgment the proper construction of Regulation 12(2)(b) is as if the provision read: 

“whether the recipients of pharmaceutical services already have a reasonable choice [of pharmaceutical services having regard to] (i) the pharmaceutical services or directed services provided in the neighbourhood…and (ii) the persons included in the pharmaceutical list from whom such recipients may obtain pharmaceutical services or directed services in the neighbourhood….”

Therefore, when the decision-maker is considering the “necessary or desirable” test, he must have regard to whether recipients of pharmaceuticals services already have a reasonable choice of such services, taking into account the services already provided in the neighbourhood and the persons who provide them.  It is in that sense a unitary factor.

60.	However, whether regarded as a unitary factor (as I find) or as two separate factors, it is unlikely to make much difference in practice.  The factors set out in Regulation 12(2) are merely ones to which the decision-maker must have regard when considering the “necessary or desirable” test.  The factors are not determinative, nor are they to be given any particular weight.  In considering whether recipients already have a reasonable choice of pharmaceutical services, the decision-maker is bound to have regard to both the services available in the neighbourhood and those who provide them.  Given that weight is a matter for the decision-maker, in practice there will be very little (if any) difference between that exercise and an exercise in which the decision-maker is bound to take into consideration both whether the recipients of pharmaceutical service have a reasonable choice of service, and discretely whether they have a reasonable choice of persons providing them.  Regard has to be had by the decision-maker of the number and identity of persons on the pharmaceutical list who provide services in the neighbourhood at some stage of the decision-making process on any view.

61.	Finally in respect of the choice factor, I do not accept Mr Coppel’s submission that one has a choice of pharmaceutical services if there is only one source and provider of such services, on the basis that a recipient of the services has a choice: to use that single facility, or not to use it: a submission which appears to be reflected in Paragraph 28 of Co-op’s Grounds for Contesting the Claim.  As indicated above, “choice” necessarily conveys the freedom to choose from a number of things or actions.  It requires there to be at least one alternative.  Although if there were a choice between using a facility and not using it would amount to a choice of action, it would not amount to a choice of service.  Someone with a prescription to fulfil would not regard there being any choice of service in the neighbourhood if he could only fulfil that prescription at a single facility: just as a customer of Mr Hobson would not have regarded himself as having any choice of horse.  

62.	However, it must be remembered that reasonable choice is only one factor that the decision-maker has to take into account when considering the “necessary or desirable test”: and that the weight given to that factor relative to other factors is a matter for him.  Choice - its presence, its absence or its extent/reasonableness - is not (or rather is not necessarily) the determinative factor.  Even where there is limited or even no choice, it is still open to a decision-maker to find that, taking all the relevant factors into account, the provision of pharmaceutical services in the neighbourhood is adequate. 
  
Guidance

63.	I have been asked to give practical guidance to those involved in both making and deciding applications to admit a person to the NHS Pharmaceutical List in respect of particular premises (a particular pharmacy).  On the basis of the above, I consider the appropriate approach for decision-makers properly to be a three-staged approach, as follows.

(i)	First, the PCT must identify the relevant “neighbourhood”.  I understand that there may be issues arising from this in the future and, as the extent of “neighbourhood” was not in issue before me in any of the claims, I make no further comment about it.

(ii)	Second, because an application can only be granted if the PCT is satisfied that it is necessary or desirable to grant the application in order to secure the adequate provision of pharmaceutical services in that neighbourhood, the PCT can only grant an application if the provision of relevant services is not “adequate”.  The PCT is bound to make a judgment as to whether the provision of relevant services in the neighbourhood is already adequate, i.e. whether the existing provision at least fulfils an appropriate standard which the decision-maker must identify.  In making this judgment:

(a)	In considering adequacy, the decision-maker must have regard to all relevant factors, including those listed in Regulation 12(2), which themselves include (i) whether and the extent to which the services proposed in the application are already provided in the neighbourhood, and the accessibility of such services: and (ii) whether and the extent to which the recipients of services have a choice of such services.  In respect of choice of services, the decision-maker must have regard to both the services already provided in the neighbourhood and by whom they are provided.

(b)	In addition to the factors listed in Regulation 12(2), the decision-maker must have regard to all other relevant factors, including the nature of the neighbourhood and (without speculating) probable future developments e.g. in relation to the neighbourhood and pharmaceutical practice.

(c)	The weight given to these relevant factors (whether or not listed in Regulation 12(2)) is a matter for the decision-maker.

(d)	The decision-maker will err in law if he fails to take into account any relevant factor (including those listed in Regulation 12(2)), or takes into account any factor that is irrelevant.

(e)	Having regard to all relevant factors, the decision-maker must determine whether the existing provision of pharmaceutical services in the relevant neighbourhood is or is not adequate.  Where the provision easily satisfies the identified standard of adequacy, the decision-maker may make that clear: and the term “wholly adequate”, whilst etymologically dubious, conveys the necessary message.  Similarly, “wholly inadequate” where the provision easily fails to satisfy that standard.  However, the standard set by Parliament is not that the provision has to be of a standard greater than adequate: and a finding by the decision-maker that the provision is adequate or inadequate is the only requirement.  Such a finding is both necessary and sufficient.  As the PCT (or, on appeal, the PAC) has been identified by Parliament as the appropriate decision-maker - and the exercise requires the exercise of a qualitative value judgment - the discretion is a wide one, and it is only if the decision-maker strays outside this wide ambit that his decision will be challengeable as irrational or perverse.   

(f)	If the decision-maker finds the provision adequate, then he must refuse the new application.  If he finds the provision inadequate, then he must go on to consider the third issue.

(iii)	If the decision-maker finds that the present provision of services is inadequate he must go on to consider the question of how the deficiency can be remedied, i.e. to consider whether the proposal in the application is “necessary or desirable in order to secure adequate provision of pharmaceutical services in the neighbourhood”.  

(a)	Because securing adequate provision is a criterion for the exercise of this discretion, the factors listed in Regulation 12(2) (include the factors of provision/accessibility and choice) are again at least indirectly relevant.

(b)	Where the services proposed in the new application would result in an overprovision of services (i.e. services at a higher level than the standard of adequacy identified by the decision-maker) - so that it cannot be said that it is necessary to allow the application in toto to secure merely adequate provision, the decision-maker may still find that acceptance of the application is “desirable” to ensure that the deficiency in services is remedied even at the cost of excess provision. Again, in determining what is necessary or desirable in this context, there is a wide discretion in the decision-maker. 

(c)	If the decision-maker finds that the proposal in the application is “necessary or desirable in order to secure adequate provision of pharmaceutical services in the neighbourhood” he will allow the application.  If he not satisfied that it is “necessary or desirable”, he will refuse it.

The Freckleton Claim

64.	The factual background to this claim is uncontentious.

65.	It is common ground that the relevant neighbourhood is the village of Freckleton.  It has one pharmacy, which is sited at the single health centre which accommodates two medical practices comprising a total of twelve doctors.  The health centre is some distance from the village centre (about 10 minutes’ walk).  About 3 miles away is the town of Kirkham, which has two surgeries and five pharmacies.  

66.	The Claimants made an application under the 2005 Regulations on 8 March 2006.  It was rejected by the PCT without an oral hearing on 8 June.  Assura appealed on 13 June, the second ground of appeal being that, “It is clear from the decision letter that there has been no consideration of choice by the PCT in this case”.  Following preliminary consideration by the PAC, a hearing was considered necessary and a panel was appointed which conducted a site visit, held a hearing on 26 October and reported on 9 November.  The PAC substantively adopted most of the panel’s findings and conclusions, and sent its decision letter to the Claimants on 30 November 2006 finding “the proposed pharmacy neither necessary nor desirable to secure the adequate provision of pharmaceutical services for the neighbourhood” (Paragraph 4).  It consequently dismissed the Claimants’ appeal.

67.	Assura seek to challenge that decision of the PAC on two interrelated grounds, namely that the PAC failed (i) to deal with the issue of “choice” adequately or at all within its decision, and (ii) to give adequate reasons for its decision. 

68.	The panel found that the population of Freckleton was about 8,000: although 7,000 worked at a large factory at Warton, within the neighbourhood, and many of those may have lived outside.  The daily population was estimated at 10,000-15,000.  Both the panel and PAC dealt with the population in three categories:

(i)	The general practitioner for about 82% of the resident population practised out of the medical centre.  The only pharmacy in the neighbourhood was on the same site.  Those patients therefore had “an excellent provision of pharmaceutical services at the same site and at the same time as they attended the doctor” (Paragraph 8.2.3.4 and 8.2.4).

(ii)	Of the 18% who did not obtain their medical services from the health centre, “the patients had a complete adequacy of pharmaceutical services, either by obtaining such services from the health centre in Freckleton or by going to a pharmacy in Kirkham or indeed elsewhere if they did not reside in Kirkham” (Paragraph 8.2.5).

(iii)	As the employees not resident in Freckleton would require pharmaceutical services in Freckleton only very rarely or in exceptional emergency circumstances, their needs would be provided by the existing pharmacy in Freckleton health centre.

69.	The panel therefore concluded that “the existing provision of pharmaceutical services to all those either resident in or visiting the neighbourhood was totally adequate” (Paragraph 8.3).  The panel continued (in Paragraph 8.4):

“Having come to that conclusion, the panel felt that it did not have to make a specific finding as to whether or not there was an adequate choice of pharmaceutical services to hose within the neighbourhood, as suggested by Mr Daly on behalf of the [Claimants].

Choice, one of a number of considerations that the panel has to take into account when assessing whether or not there is an existing adequacy of pharmaceutical service.  Having concluded that the vast majority of residents of Freckleton obtained the medical and pharmaceutical services at the new health centre, and that those who did not would obtain them in Kirkham or wherever else they lived, then in all within the proposed neighbourhood had an adequate provision of pharmaceutical service.  Even if they lived outside Freckleton, the likelihood is that they would travel by car or public transport and therefore be able to access pharmaceutical services on their way to or from Freckleton, if they did not wish to obtain the service in Freckleton.”

70.	The PAC said (at Paragraph 3.6) that, with regard to adequacy, in respect of those whose doctor was at the health centre, they “accepted and adopted the panel’s recommendation at Paragraph 8.2.4.2” (see Paragraph 68(i) above).  In relation to the 18% who did not have a doctor at the health centre, “for the reasons advanced by the panel”, they concluded it was not necessary to grant the licence (Paragraph 3.7):

“However, the Committee did not consider the pharmacies in Kirkham to provide a reasonable alternative within the neighbourhood.  The Committee recognised that the indicators were that the majority of Freckleton had privately owned properties, thereby no real issues of deprivation, and that the information available did not indicate an issue of access for that population when in the vicinity of the proposed site.  The Committee accepts that there is a potential gap for this population however insufficient evidence had been adduced in order to render present pharmaceutical services inadequate.”

Finally, the PAC concurred with the panel so far as the factory workforce were concerned and:

“In the Committee’s view, any potential shortfall in adequacy for these workers was likely to add little weight to the issue as there was no evidence that their purpose for being at [the factory] included accessing pharmaceutical services” (Paragraph 3.7).

71.	Therefore, as already noted above, the PAC found that “the proposed pharmacy neither necessary nor desirable to secure the adequate provision of pharmaceutical services for the neighbourhood” (Paragraph 4): and they consequently dismissed the Claimants’ appeal.

72.	For the reasons set out below (Paragraphs 73-82), I consider that, in dismissing the appeal, the PAC erred in law.

73.	I bear in mind that the PAC’s decision was not drafted by Parliamentary Counsel, nor is it to be construed as if it was (Seddon Properties v Secretary of State for the Environment (1981) 42 P&CR 26 at page 28).  Decision letters such as this, like similar letters in the field of planning (to which pharmacy applications have some parallels), are to be considered on a “straightforward down-to-earth reading… without excessive legalism or exegetical sophistication” (Clarke Homes Ltd v Secretary of State for the Environment (1993) 66 P&CR 253 at page 272-3, per Sir Thomas Bingham MR).  

74.	In the same vein, I also accept of course that “the mere absence of mention of a factor in the text of a decision does not necessarily mean that it was not considered” (R (Tesco Stores Limited) v The Family Health Services Appeal Authority [1999] EWHC 714 (Admin), [1999] Lloyd’s LR Med 377 at page 381 col 1): and, further, that in this case the PAC (and the panel before them) did have choice in mind, in that both referred to it.  The panel identified grounds of the Claimants’ appeal before them that were firmly based on the choice factor, and an alleged failure by the PCT to take that factor properly into account (Panel Report, Paragraphs 3.1 and 3.2): they recorded the submissions made by the Claimants on this issue (see, e.g., Paragraph 6.2.30-36, 6.2.40 and 7.2.7) and those of opponents (e.g. Paragraph 7.3.9): and, as I have recorded (Paragraph 69 above), the panel referred to choice in Paragraph 8.4 of their report.  The PAC at their preliminary consideration are recorded as having had “regard to Regulation 12(2), the necessary or desirable test, and, in considering that test, had regard in particular to Regulation 12(2)(3) and (4) of the [2005 Regulations]” (Paragraph 4.3): and the PAC, in addition to adopting much that the panel had to say in any event, also expressly stated in their decision letter (at Paragraph 3.2):

“The Committee had regard to Regulation 12(1), the necessary or desirable test, and in considering that test, had regard in particular to Regulation 12(2)…”

75.	I also accept that “choice” was not one of the principal controversial issues before the panel or PAC in the sense that it was common ground between (and no doubt obvious to) all the participants in the enquiry that, in the neighbourhood, there was only one pharmacy and consequently only one source of any pharmaceutical services.  

76.	However, “choice” nevertheless occupied a good deal of time at the oral hearing, because the proper approach to choice was very much in issue.  The submission on behalf of the Claimants was put by Mr Daly, and recorded in the panel report (at Paragraph 7.2.7), as follows:

“Choice is part of the test of adequacy although not a separate test.  Regulation 12(2) of the 2005 Regulations asked whether or not there is a reasonable choice of pharmaceutical services within the neighbourhood proposed.  Mr Daly suggested to the panel that if one thought of where one lived (e.g. Freckleton) where there was a pharmacy within the health centre and another pharmacy outside that health centre closed, then the neighbourhood was left with one pharmacy only and within the health centre. Question therefore did that give the reliant population a choice of pharmaceutical services?  Mr Daly thought it did not.”

Mr Brooker put the case for Co-op (of course, opposing the application), as follows (as recorded in Paragraphs 7.3.9-7.3.10 of the Panel Report):

“… [R]eference is made to choice in the neighbourhood.  This is only part of the necessity/desirability criteria that the panel had to consider and he pointed out that the choice must be reasonable not just “choice”. In this instance there had been no complaints about the service being offered by his pharmacy, they were offering a full pharmaceutical service, dispensing had increased considerably and the premises where the pharmacy was located could not be faulted.  This surely gave everyone reasonable choice.  Those who were mobile had other options from which to obtain their pharmaceutical services.

…  Mr Brooker suggested that the panel had to look at adequacy as a whole before choice was even considered.” 
.    
The principal controversial issue was therefore not as to the fact of what services were provided and by whom - that was common ground - but the correct approach to those facts as a matter of law, upon which the parties (i.e. the Claimants and Co-op) were deeply divided.

77.	On this issue, Mr Brooker’s submissions were in my view fundamentally flawed.  In them, he confused the factors effectively set out in Regulations 12(2)(a) and (b) respectively, namely (i) access and availability of services and (ii) choice of services: or at least failed to recognise that, although there may well be a relationship between the two, choice is a discrete factor that the decision-maker must take into consideration, over and above access/availability of services.  Whilst it may be that, in considering whether existing provision of pharmaceutical services is adequate, the excellence of access and availability of services may be such as to override even a complete absence of choice - indeed, it may be that choice would positively detract from that access and availability, for example by making the existing service economically unviable - it is incumbent upon a decision-maker to do that balancing exercise.  No matter how excellent access and availability may be, Parliament through the scheme requires regard to be had to choice.

78.	On this issue, unfortunately the panel and PAC appear to have been persuaded by Mr Brooker.  

79.	Despite their references to “choice” and the relevant regulatory provisions that require the decision-maker to have regard to it when considering the “necessary or desirable” test, they appear to have considered the access and availability of pharmaceutical services to be, broadly, very good - and consequently the panel did not consider it necessary to consider choice at all.  Having considered access and availability in some detail (and been impressed by it), the PAC concluded in Paragraph 8.3 that provision of services was “totally adequate”.  They then went on to say:

  “Having come to that conclusion, the panel felt that it did not have to make a specific finding as to whether or not there was an adequate choice of pharmaceutical services to those within the neighbourhood, as suggested by Mr Daly on behalf of the [Claimants].

The criticism of this is not that the panel failed to make “a specific finding” in relation to whether there was an adequate choice of services - there is no obligation for such a finding to be made, but only for regard to be had as to whether there is a reasonable choice of services.  However, this passage reveals that their entire approach to choice was wrong.  They effectively set out the correct approach in the next subparagraph of their report:

“Choice, one of a number of considerations that the panel has to take into account when assessing whether or not there is an existing adequacy of pharmaceutical service…”  

but, unfortunately, they patently did not take this approach.  Having assessed the provision of services as being very good, they appear to have considered it unnecessary to take choice into account at all, and certainly appear not in fact to have taken it into account.  That appears from the positioning of the reference to choice (after their conclusion that existing provision was “totally adequate”): from Paragraph 8.4: and from what immediately follows the reference to choice.  In the succeeding passage, there is no reference to choice except possibly a reference to those who worked in (but lived outside) Freckleton being able to access pharmaceutical services on their way to and from work, “if they did not wish to obtain services in Freckleton”.  However, insofar as that is a reference to choice at all, then (i) it is faint, and (ii) it is somewhat undermined by the eventual PAC decision letter which indicated that they did not consider pharmacies in Kirkham to be a reasonable alternative within the neighbourhood (Paragraph 3.7) and they accepted there was a potential shortfall of adequacy in relation to the factory workers (Paragraph 3.8).  Whether they accepted the submission of Mr Brooker or not, in my judgment the panel patently erred in their approach to the choice factor.

80.	The PAC followed them.  Although referring to Regulation 12(2), the letter does not expressly refer to choice at all.  So far as material, it adopts the approach and findings of the panel.  There is nothing in the PAC decision letter which is sufficient to save their decision from the errors of the panel. 

81.	In this case, in the neighbourhood there was in fact no choice of pharmaceutical services at all, there being only one pharmacy.  The PAC (and the panel before them) were clearly impressed by the service provided by that pharmacy, but they did not engage with the factor of choice at all.  The entire absence of choice was not determinative - it would have been open to the PAC to find that, even absent any choice, there was an adequate provision of pharmaceuticals services for the relevant recipients.  However, in considering adequacy, they failed to consider the effect of there being no choice.

82.	Of course, the approach that the panel and PAC took was reflected to an extent in the submissions made on behalf of the PAC by Mr Coppel.  As indicated above (Paragraph 44), he submitted on behalf of the PAC that, where there was only one source of pharmaceutical service provided by one person, there was nevertheless a “choice” for those who sought a service, in that they could obtain that service from the single source or not.  Where that sole source provided excellent pharmaceutical services, it would perhaps be a very likely conclusion that such a choice would be “reasonable”.  For the reasons I have given (Paragraph 61 above), that underlying submission is bad: but, given the PAC’s attachment to it, it is perhaps not surprising that they took the view they did take concerning choice in this case.  They failed to have substantive regard to choice at all when they considered whether the existing provision of pharmaceutical services in the relevant neighbourhood of Freckleton were adequate.  At the very least, in the words of Laws LJ in Lowe (at Paragraph 21), “one simply cannot be confident that [the PAC] here have adopted the right approach”.  Indeed, in their decision letter they appear positively to have adopted an improper approach.  They consequently erred in law.

83.	The exercise of discretion under Regulation 12 is essentially one for the PCT and, on appeal, the PCA - of course applying the law correctly.  Although the discretion may well have been exercised in the same way had the PCT acted lawfully and adopted the proper approach to Regulation 12(2)(b), I am not in a position to say that the discretion would inevitably have been exercised in the same way as it was purportedly exercised if choice had been taken into account as it should have been.  In the circumstances, I shall quash the decision of the PAC and remit it for proper determination.  Whilst of course, they must apply the law correctly, I reiterate that, if they do so, the weight they give to the various relevant factors (including choice) is entirely a matter for them.  Nothing in this judgment should be read as to require otherwise.

The Todmorden Claim

84.	At all relevant times, there have been two pharmacies in Todmorden, both operated by the same company (Alliance).  Both provide the essential pharmaceutical services, but not directed services.  In respect of some directed services (e.g. needle exchange, patient group direction, and care home service) the evidence from the Claimants to the PAC was that the two pharmacies “choose not to compete” (see Paragraphs 4.36-4.38 of the PAC decision letter of 25 January 2007).  For the purposes of this application, I shall accept that as being the case.

85.	On 16 May 2006, the PCT determined that two rural areas adjacent to Todmorden (Cornholme and Walsden), with an aggregate population of 5,500 and dispensing lists of 2,000 patients, should cease to be controlled, i.e. within 3 years prescriptions issued by doctors in those villages could no longer be dispensed by the surgeries and there would be a corresponding increase in demand within pharmacies in Todmorden.  An appeal was launched against this decision, but that appeal was dismissed by the PAC on 7 September 2006.  That decision is not challenged. 

86.	The Claimants made an application to be admitted to the pharmaceutical list on 20 June 2006, the relevant premises being within the immediate vicinity of a new health centre development in Todmorden.  The application was rejected by the PCT on 21 November, and the Claimants appealed on 28 November 2006 explicitly raising the issue of choice and future demand arising from the rural areas decision.  The PAC refused the appeal in a decision letter dated 25 January 2007, and it is that decision that the Claimants now seek to challenge. 

87.	The PAC dealt with the issues of increased demand and choice as follows:

“5.11		The PCT’s decision letter stated that there was no indication that existing pharmacies are unable to meet demand for services.  That ‘it is possible they would struggle should there be a major increase in demand for services’ appeared to be a matter for speculation.  The [PAC] was aware of the applicant’s suggestion on appeal, that transfer of dispensing patients from doctors dispensing list following the [PAC] decision that nearby Cornholme and Walsden are no longer controlled localities, and regeneration in Todmorden will increase demand for pharmaceutical services.  The applicant has referred to views said to be expressed by Todmorden Town Council to the PCT, that pharmaceutical services are already ‘stretched’.  The [PAC] having regard to the above statements was provided with no information to demonstrate that existing pharmacies are unable to meet present demand or would be unable to cope with increased demand for services.

5.12		The [PAC] noted a central issue of the appeal was the perceived lack of choice of pharmaceutical services and service provider, given that both existing pharmacies in the neighbourhood are operated by [Alliance].  Whilst the PCT’s decision letter had suggested there is a ‘question of choice’ it was also acknowledged that both pharmacies are under separate management and made separate decisions.  The [PAC] was mindful that ‘reasonable choice’ does not override the necessary or desirable test of securing adequacy.  The Regulations do not indicate that choice cannot be secured where pharmacies are operated by the same company.  Should there be any reason to believe that there was any inadequacy of services linked to both existing pharmacies being owned by the same company, there could potentially be grounds for granting the application.  This was not the case here.  The [PAC] had no reason to believe that the population do not have a reasonable choice of service and service provider available to them.

5.13		… The [PAC] had no reason to believe that because one pharmacy provides services that the other may not, there was a need for additional services to secure adequacy.”  

88.	The Claimants challenge this decision on two grounds.

89.	First, they submit that the PAC erred in finding in Paragraph 5.11 that it had no information to demonstrate that the existing pharmacies would be unable to cope with increased demand for services which, given the evidence to that effect, was an irrational or perverse finding.  The available evidence in relation to demand is set out in Paragraph 79 of the Claimants’ Skeleton Argument.

90.	However, the PAC decision letter in fact says:

“The [PAC] having regard to the above statements was provided with no information to demonstrate that existing pharmacies are unable to meet present demand or would be unable to cope with increased demand for services” (emphasis added).

There was evidence of concerns as to the capacity of the two pharmacies to cope with the additional demand that would arise from the rural areas decision, e.g. Todmorden Town Council are recorded as saying that “the pharmacy in Todmorden is already stretched and would have difficulty in providing a satisfactory service to more customers” (7 September 2006 PAC decision letter, relating to the rural areas issue).  However, in Paragraph 5.11 the PAC were clearly not saying there was no evidence to that effect - they were saying that the evidence to that effect had not, in their view, demonstrated an inability to cope with present or foreseen increased demand.  That was a decision open to the PAC to make on the evidence before them.  The fact that they did not state that matters relating to potential future demand were as firm as they might have been or the Claimants’ believed them to be (see, e.g., Paragraph 79(a) and (c) of their Skeleton Argument) does not significantly detract from this.  This ground has no significant merit.

91.	The second ground again concerns the choice factor.  The issue is set out at Paragraph 69 of the Claimants’ Skeleton Argument:

“In finding that it had ‘no’ reason to find that the population did not have a reasonable choice of service and service provider when in fact there was only one service provider with two premises/contracts providing services to the neighbourhood the [PAC] failed to deal with the issue of choice as introduced by the 2005 Regulations or at all.”

92.	Before I deal with the matters raised by Mr Findlay in support of this contention, let me deal with a submission made by Miss Beverley Lang QC for Alliance, i.e. that under Regulation 12(2)(b) each pharmacy is a separate “person”.  In support, she relied upon the following:

(i)	The fact that a pharmaceutical list lists each premises used as a pharmacy - so that the Alliance pharmacies in Rose Street and Bridge Street, Todmorden, have separate entries - and they each have a separate contract with the PCT as they are required to do under the Regulations.  However, as I have explained (Paragraph 14 above),  although each set of premises from which the business is to be run has to be the subject of a separate application, the list is a list if the providers of pharmaceutical providers.  Separate contracts, separate premises and even separate entries on the list does not mean that, in Regulation 12, “person” can be equated to “pharmacy” or “premises”.

(ii)	The primary objective of the statutory scheme is to ensure that there is adequate provision of pharmaceutical services in any neighbourhood, rather than to require that in every neighbourhood there should be more than one provider.  That, with respect, is obviously correct.  In particular, the scheme does not require there to be more than one provider in any neighbourhood: it requires a decision-maker to have regard to whether there is a reasonable choice of pharmaceutical services in that neighbourhood, which includes having regard to whether there is a reasonable choice of provider as I have set out above (Paragraphs 43 and following).  Miss Lang prayed in aid the NHS (Pharmaceutical Services) Regulations 2005: Information for PCTs (February 2007 Revision) which says, at Paragraph 3.75 under the heading, “The extent to which there is a reasonable choice of providers in the neighbourhood which may be improved by additional providers”:

“[PCTs] should assess the extent to which there is a reasonable choice of providers of services in a neighbourhood.  For example, a neighbourhood with one provider but a high demand for diverse or more accessible services which are not being met may benefit from an additional provider of services who can cater for these needs.  This may be an existing provider seeking to expand his business.  Alternatively, it could be a brand new provider where an existing provider is unable to expand his current range of services to meet these needs.”  

She submitted that this passage envisages that a “reasonable choice” of providers may be achieved by allowing an existing provider to expand his business.  That may be a suggestion in this passage: but, as she submitted in relation to Mr Findlay’s attempts to introduce all sorts of extra-statutory material, the extent to which I can take this into account is limited and is limited to the vanishingly small if, as I consider, the statutory provisions are unambiguous.

(iii)	Miss Lang submitted that “choice” is qualified by the word “reasonable”: and therefore even where there is only one provider in multiple pharmacies it is open to a decision-maker to find that the choice of provider is not reasonable.  However, as I have found (see Paragraphs 57-58 above), “reasonable choice” refers to “pharmaceutical services” and not directly to “persons” in Regulation 12(2)(b)(ii).  

93.	I am entirely unpersuaded that the reference in Regulation 12(2)(b)(i) to “persons included in a pharmaceutical list” is a reference to pharmacies (which are premises) rather than the applicants whose names appear on the list (who are legal persons).  The obvious meaning of the phrase is that it is a reference to applicants who are admitted to the pharmaceutical list.  The list is expressly of such persons, and not of pharmacies or premises (Regulation 5): and the application forms stress that it is the applicant who is applying to be admitted to the list (Part 3 Schedule 4 to the 2005 Regulations).  In my judgment, “persons included in a pharmaceutical list” means exactly that.  Despite Miss Lang’s efforts, the point is beyond sensible contention.

94.	I now return to Mr Findlay’s submissions in support of his proposition that the PAC erred in the manner in which they dealt with the choice factor (see Paragraph 91 above).  

95.	First (Skeleton Argument, Paragraphs 70-72), he submitted that the PAC erred in concluding that “the regulations do not indicate that choice cannot be secured where pharmacies are operated by the same company”.  I can deal with this shortly.  I have found that “reasonable choice” refers to the provision of pharmaceutical services (Paragraphs 57-58 above): and, although in considering that issue under Regulation 12(2)(b)(ii) a decision-maker must have regard to “the persons included in a pharmaceutical list from whom such recipients may obtain pharmaceutical services or directed services in the neighbourhood in which the premises named in the application are located”, he may conclude that there is a reasonable choice of services even if they are provided by one provider.  That they are so provided is just one matter he must take into account when considering the issue of reasonable choice of services.

96.	Second (Skeleton Argument, Paragraph 74), he submitted that the PAC erred in finding there was no reason to believe that the population did not have a reasonable choice of services, particularly because with regard to directed services or some of them there was no such choice.  Alliance provided these from one or other (but not both) of their two pharmacies.  

97.	I will come back to the wording of the last sentence of Paragraph 5.12 of the PAC’s decision letter (from which Mr Findlay quotes, and upon which he specifically relies) shortly.  However, I am satisfied that, in substance, the PAC dealt with the issue of choice and directed services properly and lawfully.  The issue was clearly before them (see Paragraphs 4.36 of their decision letter and following), and in Paragraph 5.13 they said:

“… The [PAC] had no reason to believe that because one pharmacy provides services that the other may not, there was a need for additional services to secure adequacy.”  

That shows that they took into account the fact that, in relation to some services there was effectively no choice, and nevertheless decided that the provision of those services in the neighbourhood was adequate.  I cannot say they erred in law here.

98.	Third (Skelton Argument, Paragraphs 75-76), Mr Findlay submitted that, when read as a whole, Paragraphs 5.11-5.13 show that the matter was determined “primarily by reference merely to availability of services and failed to direct itself in accordance with 2005 Regulations”.  Whilst I accept that the PAC gave considerable weight to access and availability of services, weight was of course a matter entirely for them.  I cannot accept that, when those paragraphs are looked at as a whole, the PAC can be seen to have misdirected themselves in relation to choice.  In Paragraph 5.12, they correctly noted that choice was factor to be taken into account, and not a determinative issue: and they then proceeded to have regard to choice, taking into account that the pharmacies in Todmorden were both managed by the same provider company.  They found that this did not lead to an inadequacy of provision, in the circumstances of Todmorden.  That was a finding open to them to make on the evidence.  It is unimpeachable.

99.	Fourth (Skeleton Argument, Paragraph 78), it is submitted that the PAC failed to follow guidance, and failed to give reasons for failing to do so.  No particulars are given.  I am satisfied that the PAC did not err in law in any such failure.  They had an obligation to apply the statutory scheme which they properly did.  

100.	Fifth (Skeleton Argument Paragraph 77), in the alternative the Claimants submit that the PAC failed to give adequate reasons for their decision.  This is really not a separate ground: in that the real submission is that the reasons betray that the PAC adopted (or may have adopted) the wrong approach to choice.  For the reasons I have given, I do not agree.  I have sufficient confidence that, in this case, the PAC did adopt the right approach: and the reasons are sufficient within the terms of South Bucks District Council v Porter (No 2) [2004] UKHL 33, [2004] 1 WLR 1953 (at Paragraph 36, per Lord Brown).

101.	Mr Findlay relied heavily upon the last sentence of Paragraph 5.12 of the PAC decision letter:

“The [PAC] had no reason to believe that the population do not have a reasonable choice of service and service provider available to them.”

I accept that this is not happily worded.  Even if, as I consider, this meant that the PAC did not consider there was sufficient evidence before them to persuade them that the recipients of pharmaceutical services in the relevant neighbourhood “do not have a reasonable choice of service and service provider available to them”, this is inaccurate.  They have no choice of service in relation to some directed services, and no choice of provider at all.  However, that sentence has to be looked at in context.  I am satisfied that, looking at the decision letter (and particularly Paragraphs 5.11-5.13) as a whole, despite the terms of the sentence to which Mr Findlay took exception, in substance the PAC adopted the correct approach to the choice factor.  Unhappily as this sentence is put when taken out of context, the decision letter has to be read as a whole: and I do not consider that this single sentence betrays any substantive misunderstanding on their part.

102.	For these reasons, I am not satisfied that the PAC erred in law in their decision in this case: and I consequently dismiss the claim.

The Tunbridge Wells Claim

103.	This claim does not concern the choice factor provisions of Regulation 12.  It raises a different but potentially important issue in relation to the circumstances in which an error of fact on the part of a decision-maker may amount to an error of law.

104.	In this claim, it is common ground that the provision of pharmaceutical services in the relevant neighbourhood (in Tunbridge Wells) was inadequate.  On 8 March 2006, the Claimants made an application for preliminary consent for inclusion in the pharmaceutical list.  On 30 March, Canterbury (who had a pharmacy in the area, and who had initially objected to the Claimants’ application) made a similar application by way of change of premises.  The PCT found that the identified deficiency might be made good by the provision offered by either one of two applicants and it was therefore necessary or desirable that one application be granted, the issue being which of the two should have their application granted.  If the merits of the respective applications were equal, the Claimants contended that theirs ought to have been granted, as made the first in time.  

105.	On 4 October 2006, the PCT found in favour of Canterbury’s application.  On 22 January 2007, the PAC dismissed an appeal by the Claimants against that decision: and it is that decision which the Claimants now challenge. 

106.	Mr Findlay submitted (Skeleton Argument, Paragraph 11) that the decision letter of 22 January 2007 indicated that the PCT’s finding that the provision of pharmaceutical services in the relevant neighbourhood was inadequate was unchallenged, and identified that the appeal turned on which of the two applicants should be chosen to remedy the identified deficiency (Paragraph 5.7): it dismissed concerns that if Canterbury succeeded that would create an inadequacy in the area from which they were relocating (Paragraph 5.8): it dealt with the priority of applications indicating that this would be given weight only if the merits of the applications were otherwise equal (Paragraph 5.9): and it gave little weight to the Claimant’s higher service level and its assertions as to certainty (Paragraphs 5.10 and 5.12).  He submitted that it is only in Paragraph 5.11 that factors favouring Canterbury are identified, before coming to its conclusion - that the Canterbury application be favoured, and the appeal dismissed - in Paragraph 5.13.  Although the decision letter itself indicates that there were more criteria than those in Paragraph 5.11 favouring Canterbury, for the purposes of this application, in favour of the Claimants I accept that analysis.

107.	Paragraph 5.11 stated:

“The [PAC] noted [Assura’s] claim that their application had offered to provide the same opening hours on Saturday as [Canterbury] albeit the former’s were listed as ‘proposed hours’.  It is a fact that the core contractual hours offered by [Canterbury] included Saturday mornings.  The [PAC] noted the PCT’s undisputed reference to the PCT’s [PNA], which it was said had indicated concern over ‘the relative lack of Saturday opening hours’.  The [PAC] considered that the opening hours of [Canterbury] should be preferred as to alter these would require permission from the PCT whereas non-core hours only required 90 days’ notice of alteration.  Their application would meet a gap identified in the PNA…” (emphasis added)

108.	In addition to Paragraph 5.11 quoted above, at Paragraph 2.12 of the PAC decision letter, it said:

“The Committee [this is a reference to the PCT, as it is in the section dealing with the PCT decision], aware that the PNA and the PCT had identified the relative lack of Saturday opening hours as a matter of concern, agreed that the [Canterbury] application be approved and the [Assura] application be refused.”

This was a direct quotation from the penultimate paragraph of the PCT decision letter of 4 October 2006.   

109.	Some notes of explanation may assist at this stage.  Any applicant’s “core contractual hours” for pharmacy opening hours are limited to 40 per week, but they can (and, inevitably, are) supplemented by other proposed hours.  As the decision letter indicates, core hours cannot be altered without the permission of the PCT: alteration of non-core hours merely requires notice to be given to the PCT.  The Claimants accept that it is a positive distinguishing feature for hours that cover any identified gap in provision to be core hours rather than otherwise, and that the PCT or PAC could properly found a decision on that distinction.  The Claimants’ application did not include any Saturday or Sunday hours within the contractual hours.  The Canterbury application included Saturday mornings.  

110.	The Claimant’s challenge is based upon one discrete ground, as follows (Skeleton Argument, Paragraph 2):

“The sole ground upon which the Claimant asks this Court to quash the decision is that the [PAC’s] decision was based upon a mistake as to existing fact, which gave rise to unfairness.  The mistake made was that the [PAC] wrongly assumed that a Pharmaceutical Needs Assessment (“PNA”) had indicated concern over the relative lack of Saturday opening hours.  It had not done so.  That mistake led to unfairness because a material reason given by the [PAC] in refusing the Claimants’ application and allowing Canterbury’s was that Canterbury’s application would more certainly meet the gap as to Saturday opening hours allegedly identified in the PNA”

111.	This ground is based upon the principles set out in E v Secretary of State for the Home Department [2004] EWCA Civ 49, [2004] QB 1044, with regard to the circumstances in which a mistake of fact giving rise to unfairness may constitute an error of law amounting to a head of challenge to the tainted decision.  There is a tension between the impulse of justice to correct a manifest error when identified and the vital principle of finality of judicial decisions, which has given rise to differing judicial and academic views on that issue.  Having reviewed those contrasting views, Carnwath LJ in E (giving the judgment of the Court) continued:

“63.	In our view, [R (A) v Criminal Compensation Board] [1999] 2 AC 330 points the way to a separate ground of review, based on the principle of fairness.  It is true that Lord Slynn distinguished between ‘ignorance of fact’ and ‘unfairness’ as grounds of review.  However, we doubt if there is any real distinction.  The decision turned, not on issues of fault or lack of fault on either side; it was sufficient that ‘objectively’ there was unfairness.  On analysis, the ‘unfairness’ arose from the combination of five factors: (i) an erroneous impression created by a mistake as to, or ignorance of, a relevant fact (the availability of reliable evidence to support her case); (ii) the fact was ‘established’, in the sense that, if attention had been drawn to the point, the correct position could have been shown by objective and uncontentious evidence; (iii) the claimant could not fairly be held responsible for the error; (iv) although there was no duty on the Board itself, or the police, to do the claimant’s work of proving her case, all the participants had a shared interest in co-operating to achieve the correct result; (v) the mistaken impression played a material part in the reasoning.

64.	If that is the correct analysis, then it provides a convincing explanation of the cases where decisions have been set aside on grounds of mistake of fact.  Although planning enquiries are also adversarial, the planning authority has a public interest, shared with the Secretary of State through his inspector, in ensuring that development control is carried out on the correct factual basis…  The same thinking can be applied to asylum cases…  [The Secretary of State] has a shared interest with the appellant and the tribunal in ensuring that decisions are reached on the best information.  It is in the interests of all parties that decisions should be made on the best available information…

65.	….

66.	In our view, the time has now come to accept that a mistake of fact giving rise to unfairness is a separate head of challenge in an appeal on a point of law, at least in those statutory contexts where the parties share an interest in co-operating to achieve the correct result.  Asylum law is undoubtedly such an area.  Without laying down a precise code, the ordinary requirements for a finding of unfairness are apparent from the above analysis of the Criminal Injuries Compensation Board case.  First, there must have been a mistake as to existing fact, including a mistake as to the availability of evidence on a particular matter.  Secondly, the fact or evidence must have been ‘established’, in the sense that it was uncontentious and objectively verifiable.   Thirdly, the appellant (or his advisers) must not have been responsible for the mistake.  Fourthly, the mistake must have played a material (not necessarily decisive) part in the tribunal’s reasoning.”

112.	Those principles are now well-established in some areas subject to judicial review, notably asylum.  However, on behalf of those opposing the judicial review before me, it was submitted that the principles of E do not apply to a claim before a PAC, because in such claims (i) the PAC are not required to apply the “anxious scrutiny” that is applied to asylum cases, and (ii) the parties do not share an interest in co-operating to achieve the correct result, that point being particularly pointed in this case in which the protagonists are two pharmacies contesting who should provide services in a small neighbourhood of Tunbridge Wells.

113.	I do not accept those submissions.

114.	I accept that there have been relatively few areas of judicial review in which E has been directly applied: it has been applied mainly in the context of asylum cases.  However, even before E, in a number of planning cases it was assumed that a material fact is a proper ground for the court to quash a decision of a planning inspector (e.g. Hollis v Secretary of State for the Environment (1984) 47 P&CR 351 cited in  “Judicial Review of Administrative Action”, de Smith, Woolf & Jowell, 6th Revised Edition (Sweet & Maxwell) (2007) at page 565, and other cases there cited: it is noteworthy that the learned authors of de Smith do not suggest that there is any restriction in the scope of cases covered by the principles in E).  In R (L) v London Borough of Wandsworth [2006] EWHC 694 (Admin), Jack J applied the principles in a judicial review in the context of special education needs: but it is unclear whether the application of E in that context was in issue or simply assumed.  Closest to the case before me, in R (Boots the Chemist) v The Family Health Services Appeal Authority and Lloyds Pharmacy Limited [2005] EWHC 2025 (Admin), in the context of an application by a pharmacy to relocate, Nicholas Blake QC sitting as a Deputy High Court Judge appears to have assumed that the principles of E applied, although he held that on those principles there was no error of law on the facts of that case.    

115.	In any event, in the passage I have quoted from E, Carnwath LJ (at Paragraph 64) indicated he considered that the principles did apply to planning cases: indeed, he refers to planning cases even before asylum.  In planning cases, the relevant parties have an interest in arriving at the correct result on the correct factual basis: “Although planning enquiries are also adversarial, the planning authority has a public interest, shared with the Secretary of State through his inspector, in ensuring that development control is carried out on the correct factual basis.”  As I have noted, this is reflected in the early planning cases in which the court was prepared to set aside a decision on the basis of factual error.  

116.	That asylum cases warrant particularly anxious scrutiny does not appear to have dissuaded the Court of Appeal in E from considering that the principles they set out applied in the planning sphere.  Despite the potential consequences of failed asylum claims for the claimant, planning cases too require some proper consideration: and the degree of scrutiny that a category of case properly requires does not in any event appear to be anything like a determinative factor in any categorisation of case suggested by E.  Whilst no doubt the circumstances of any case or category of case will be relevant to the application of E, there is no reason of principle or precedent as to why the requirement for the initial decision-maker or tribunal of “anxious scrutiny” should be a pre-requisite.

117.	Cases concerning decision on applications for admission to the pharmaceutical list bear some substantial similarity to planning cases: and certainly it can properly be said that the PCT as well as the Secretary of State acting through the PAC have a similar strong public interest in coming to the correct result on the correct factual basis.  Whilst in cases such as the one before me there are clearly issues between competing applicants, that is no different from a planning context in which there is frequently such competition: and this clearly does not diminish the interest of the public bodies in obtaining the correct result.  Those interests are the same whether there is only one applicant or multiple applicants seeking to cover a perceived deficiency in provision of relevant services.

118.	Therefore, with regard to acting upon an incorrect basis of fact, “it now seems clear that it has arrived” as a ground of judicial review (“Administrative Law”, Wade & Forsyth, 9th Edition (Oxford University Press) (2004) at page 278).  For the reasons I have given above, whilst it will be for other courts in the future to consider the full scope of the applicability of the principles set out in E, I am more than satisfied that those principles apply to decisions such as those of a PAC on an application for admission to a pharmaceutical list including the decision of the PAC that is the subject of this claim.

119.	E laid down four criteria for identifying a mistake of fact by a tribunal that causes unfairness such as to render the final decision of that tribunal challengeable as a matter of law.  Of those, for the purposes of this claim and in favour of the Claimants I am prepared to accept that the Claimants have satisfied three, namely:

(i)	That there was a mistake of fact.  Those opposing the challenge (the PAC and Canterbury) submitted that there was no such mistake, because the PAC merely referred to “the PCT’s undisputed reference to the PCT’s [PNA], which it was said had indicated concern over ‘the relative lack of Saturday opening hours’”.  That was a true reference, and the PNA, of which the PCT clearly had sight, was never before the PAC.  Therefore, it was submitted that the PAC properly took into account the evidence before it.  However, I do not consider that that will do.  Leaving aside any obligation on the PAC to obtain relevant documents (see Paragraph 14 above), on a proper analysis I accept Mr Findlay’s submission that the PNA did not suggest that there was a gap in the provision of pharmaceutical services so far as Saturday hours was concerned.  Looking at the PNA as a whole, this is relatively clear.  The reference under the heading “Out of Hours” to “very limited access” to getting a prescription dispensed beyond the working day or Sundays is not a reference to Saturdays at all: this is apparent from the table which sets out “Apparent gaps in provision” which identifies “a clear need” but refers to current provision as “Four pharmacies only across the PCT”.  Reference back to the Service table shows that this is almost certainly a reference to pharmacies with the “intention to open weekdays after 6.30” (four in number), and not those with an “intention to open on Sat” (a total of 22 in the PCT area and nine in Tunbridge Wells, eight all day and one mornings only).  I accept that the PNA did not disclose any apparent shortfall in provision on Saturdays: and this was misunderstood by the PCT.  Although there was other evidence before the PCT as to the general desirability of Saturday opening (e.g. see Paragraphs 4.63-4.65 of the 22 January 2007 decision letter), the PAC nevertheless adopted this mistake in relation to the perceived shortfall of provision in services on Saturdays.  The fact that they did so not on the basis of seeing the actual PNA but only on the reportage of the PCT does not seem to me to be in point.

(ii)	That the mistaken fact or evidence has been ‘established’, in the sense that it is objectively verifiable.  I do not consider that this is entirely straightforward for the Claimants, but for the purposes of the claim I accept that the PNA is sufficiently clear and unambiguous to make the mistake patent.  

(iii)	  That the mistake played a material part in the tribunal’s reasoning.  Although there was other evidence suggesting that Saturday opening was beneficial in any event, I accept that the identification of a provision gap played a material part in the PAC’s thinking.  The fact that the Canterbury proposal had Saturday hours in the core hours appears to have been the advantage of their application over that of the Claimants which did swing (or at least may have swung) the contest between the two applications their way.  That was based on the (unfortunately mistaken) premise that a perceived gap in provision for Saturdays had been identified in the PNA.  On that basis, that mistake was material to the PAC’s decision.  

120.	However, for a claimant to rely upon the ground, “[he] (or his advisers) must not have been responsible for the mistake”.  This goes to the unfairness that must result from the mistake before a ground of challenge is allowed.  The PAC and Canterbury submitted that, in this case, the Claimants were themselves responsible for the mistake which occurred.  This requires a brief return to the facts surrounding the Claimants’ application.

121.	The Claimants made their application on 8 March 2006.  Given that there was some form of burden on the Claimants as applicant, the information in the application was scant indeed, the application merely identifying the relevant neighbourhood and then asserting that the application is “both necessary and desirable” in order to secure adequate provision of pharmaceutical services in that area.  

122.	Be that as it may, the Claimants well understood the potential importance of the PNA, which was not publicly available.  They wrote to the PCT on 1 August 2006 requesting a copy of it and made a further request by telephone on 12 October (the day the appeal from the PCT decision was lodged): but it was not in fact supplied until 4 December 2006 when it was sent in an email headed “Pharma needs assessment doc”.  In the meantime, the PCT had held a hearing on 21 September, and sent their decision letter (adverse to the Claimants) on 4 October.  At the hearing, although Saturday hours were discussed, the Claimants say that the PNA was neither referred to nor disclosed; and there is no reference to any perceived gap in provision on Saturdays being identified in the PNA.  That appears to be reflected in the minutes of that hearing.  Nevertheless, the decision letter of 4 October, as noted above, said:

“The Committee, aware that the PNA and the PCT had identified the relative lack of Saturday opening hours as a matter of concern, agreed that the [Canterbury] application be approved and that the [Assura] application be refused.”

The Claimants were therefore aware from that decision letter that the PNA had been relied upon by the PCT in relation to the perceived gap in Saturday provision.  They appealed on 12 October, and in their grounds of appeal identified the Saturday hours issue as the apparently determinative one so far as the PCT were concerned. 

123.	The PNA was provided on 4 December 2006, two days before the Claimants’ submissions to the PAC on the appeal were due (and, as I understand it, were in fact filed).  The Claimants say that they were unable to deal with the PNA in time, particularly because (i) their Mr Daly (who was dealing with the matter) was not in the office on 4 and 5 December), and (ii) the document provided on 6 December was in unusual form and they were “uncertain as to its identity” (Grounds for Review, Paragraph 22(iii)(g)), i.e. they were unsure that it was in fact the PNA at all.  However, even if the form was unusual, (i) the document was sent in an email headed “Pharma needs assessment doc”: (ii) the document itself has a footer on each page, “Pharma Needs assessment final doc”: and (iii) annex 2 to the document is headed, “Pharmaceutical Needs Assessment”.  The Claimants had no excuse for thinking that this was anything other than the PNA.  That they then undertook “further research… to ascertain whether the PNA was the actual adopted PNA”, which was still on going as at 22 January 2007 (6 weeks later) (Grounds for Review, Paragraph 22(iii)(h)) is difficult to comprehened, and was certainly not reasonable.

124.	Despite knowing that their application was pending, the Claimants did not submit any comments upon the PNA (and did not draw the attention of the PAC to any material error in the PCT’s understanding of the PNA) either in their submissions of 6 December, or before the PAC’s decision letter of 22 January 2007, or indeed before the letter before action in their judicial review claim of 28 February 2007.  The Claimants say that they thought there would be an oral hearing before the PAC, and would have explored this issue at any such hearing: but, although they initially made a request for an oral hearing, they never pursued the request nor were they ever led to believe by the PAC that there would be such any hearing.  In the circumstances, it not reasonable of them to have expected a hearing or to fail to raise any issue that arose from the PNA with the PAC as soon as they reasonably could.  It was not open to the Claimants to have appreciated the potential importance of the PNA and have the PNA in their possession, but sit on their hands for several weeks during which the PAC made and communicated their decision.

125.	In the circumstances, I consider that this mistake of fact was materially contributed to by the Claimants themselves, such that they must take responsibility for it.  They appreciated that the PNA was an important document:  and, even if others were at fault (e.g. the PCT for misunderstanding the PNA; and the PAC for not ensuring it had sight of a relevant document (see Paragraph 16 above), namely the original PNA and relying upon the PCT’s apparently uncontentious assessment of it), I do not consider that this excuses the Claimants’ responsibility for not raising this issue before they did.  In my view clearly, they should have raised it before the PAC’s decision letter of 22 January, and they had every opportunity to do so.  They singularly failed to act reasonably.  The principle of finality is an important one in the administration of justice, and it makes it incumbent upon parties to proceedings (including those involving administrative justice and the public interest) to be reasonably diligent in making submissions and correcting errors of fact as and when they arise, rather than waiting until after the relevant decision has been made and seeking then judicial review.  

126.	The consequences of the Claimants’ failure to raise this issue when reasonably they ought to have done are evidenced before me.  Despite the fact that an inadequacy in the provision of pharmaceutical services has been identified in the relevant neighbourhood, as a result of this challenge it has been impossible to address that deficiency.  That has resulted from the delay in the Claimants’ raising this issue, which they could and should have raised before the 22 January 2007 decision was made.     I appreciate that the delay was not deliberate in this case, but the Claimants’ failure to open their eyes to the evidence and raise the issue reasonably promptly was at least extremely careless if not reckless.

127.	I therefore hold that the Claimants cannot avail themselves of the mistake of fact that for the purposes of this claim (perhaps generously to the Claimants) I have accepted occurred in this case, because it did not give rise to appropriate unfairness to them so as to trigger the head of claim.   

128.	For these reasons, I dismiss this claim.

Conclusion

129.	For the reasons set out above, in relation to the individual claims (subject to submissions on the form of the order):

(i)	In Claim No CO/597/2007 (the Freckleton Claim), I allow the claim, quash the decision of the PAC dated 30 November 2006 and remit the matter to the PAC for decision.

(ii)	In Claim No CO/2242/2007 (the Todmorden Claim), I dismiss the claim.

(iii)	In Claim No CO/2189/2007 (the Tunbridge Wells Claim), I dismiss the claim.

I shall hear submissions on the question of costs.

His Honour Judge Gary Hickinbottom
21 February 2008