THE HIGH COURT
JUDICAL REVIEW
HC 217/04
[1996 No. 301 J.R.]
BETWEEN
COLLOONEY PHARMACY LTD
APPLICANT
AND
NORTH WESTERN HEALTH BOARD
RESPONDENT
and
THE HIGH COURT
JUDICAL REVIEW
			[1996 No. 331 J.R.]
BETWEEN
HOLLY HILL PHARMACY LIMITED
					APPLICANT
AND
SOUTHERN HEALTH BOARD
	 RESPONDENT
Judgment of Mr. Justice Aindrias Ó Caoimh delivered the 14th  day of May, 2004
	
	By orders of this Court made 14th October, 1996 and the 6th November, 1996 (Kelly J.) the first and second applicants were given leave to institute these applications for the following relief:
(a)	An order of certiorari quashing a decision of the respondent made in or about the month of August, 1996 to unilaterally impose the terms of a new community pharmacy contractor agreement (‘the agreement’) on the applicant herein as a condition of the applicant continuing to fully participate in the arrangements made by the respondent pursuant to s. 59 of the Health Act, 1970 for the supply of drugs, medicines and medical and surgical appliances to eligible persons. 
(b)	A declaration that in purporting unilaterally to impose all the provisions of the agreement on the applicant, the respondent has acted ultra vires s. 59 of the Health Act, 1970. 
(c)	A declaration that the imposition of the provisions of clause 6 (2) of the agreement is ultra vires the powers of the respondent under s. 59 of the Health Act, 1970 and/or void as being inconsistent with s. 2 of the Pharmacy Act, 1962.
(d)	A declaration that in particular clauses 19 (1), 19 (3), 19 (5), 20 (1), 22 (3) and 22 (6) and 23 (1) of the agreement are ultra vires the powers of the respondent under s. 59 of the Health Act, 1970.
(e)	If necessary, a declaration that clause 6 (2) of the agreement is contrary to Articles 6 and 48 of the EC Treaty.
	By further order of this Court made 29th April, 2002 (McKechnie J.) the applicants were further given leave to amend their statements of grounds by the inclusion of fresh grounds.
The grounds upon which this relief is sought is a follows:
1.	Section 59 of the Health Act 1970 imposes on the health boards, including the respondent, an obligation to make arrangements for the supply, without charge, of drugs, medicines and medical and surgical appliances to eligible persons. In pursuance of this obligation, the respondents have entered into contracts with the owners of pharmacies whereby such persons are obliged to supply drugs, medicines, medical and surgical appliances to eligible persons and entitled to reimbursement and certain fees in consideration therefor.
2.	The applicants entered into such a contract with the respondents on or about the 1st day of September 1995 ("the existing contract").
3.	The Minister for Health is authorised to make regulations, with the consent of the Minister for Finance, for the purposes of s. 59 of the Health Act, 1970. In May, 1996 the Minister made the first such regulations, the Health (Community Pharmacy Contractor Agreement) Regulations, 1996 ("the 1996 Regulations"). Article 3 of the Regulations purports to exclude their application to any community pharmacy which was open and providing services under the Health Act, 1970 on or immediately before the coming into force of the 1996 Regulations. The pharmacy owned by the applicant was such a community pharmacy.
4.	By letter dated the 8th day of August, 1996, the respondent sought to require the applicant to enter into a new community pharmacy contractor agreement ("the new agreement") within one week.
5.	The applicant objects to the inclusion of certain clauses in the new agreement as hereinafter appears. The applicant sought to enter into negotiations in relation to the said clauses with the respondent. The respondent has indicated an unwillingness to enter into any negotiations in relation to the terms of the new agreement.
6. 	Community pharmacy contractor agreements in identical terms to the terms of the new agreement are being imposed by all health boards upon the owners of all community pharmacies in Ireland. The new agreement is stated by the respondent to have been drawn up pursuant to an agreement to be entered into by representatives of the Department of Health, health boards, General Medical Services (Payments) Board and the Irish Pharmaceutical Union on the future provision and improvement of community pharmacy services under the Health Act, 1970. 
7. 	The continued full participation by the applicant in the arrangements for the provision of pharmacy services under the Health Act 1970 is an economic necessity for the commercial viability of the applicant's pharmacy. Thus, in order to preserve its position, the applicant has executed the new agreement subject to its contention that certain of the clauses are ultra vires and void and upon the stated objection to challenge the imposition of same in an application for judicial review.
8.	Clause 6 (2) of the new agreement requires that the pharmacy contractor ensures, inter alia, that the nominated supervising pharmacist has at least three years experience in the practice of community pharmacy. This clause is ultra vires s. 59 of the Health Act, 1970 and is contrary to the terms of s. 2 of the Pharmacy Act, 1962 which enables a body corporate to keep open a pharmacy provided it is personally supervised by a qualified pharmacist.
9.	Clause 19 (1) of the new agreement provides that the agreement is to automatically terminate in the case of a body corporate where the supervising pharmacist either ceases to be entitled to practise or ceases to keep open the pharmacy. The severity of this clause is irrational and unreasonable in law and represents a disproportionate interference with the property rights of the applicant. Whilst the applicant accepts that the pharmacy must at all times be supervised by a qualified pharmacist it ought in fairness be entitled to provide a replacement supervising pharmacist upon an existing supervising pharmacist ceasing to so act. 
10.	Clauses 19 (3) and 19 (5) effectively permit the terms of the agreement to be altered without the consent of the applicant in the absence of any regulations made by the Minister under s. 59 of the Health Act, 1970. Such provisions are unreasonable and uncertain in law and represent a potential disproportionate interference with the applicant's property rights. They are accordingly ultra vires s. 59 of the Health Act, 1970. 
11.	Clause 20 (1) provides that where a supervising pharmacist ceases to act in that capacity, the agreement terminates one month after that date unless a new statement as specified in this clause is submitted and accepted by a chief executive officer of a health board. The said clause is irrational, haphazard and unreasonable in law in that; 
(i) no guidance is provided with regard to how the chief executive officer will exercise his/her discretion and;
(ii) it is unreasonable to expect a replacement permanent pharmacist to be found within one month.
It is accordingly, ultra vires s. 59 of the Health Act, 1970.
12.	Clause 22 (6) provides that where the pharmacy contractor is a body corporate and the supervising pharmacist dies, the agreement automatically terminates one month from the date of such death. The chief executive officer of the respondent is given the power to award a new contract to any other party. The death of a supervising pharmacist does not in any way affect the status of the applicant as a contractor, save that it is, of course, required to find a new supervising pharmacist. This provision is irrational, haphazard and unreasonable in law and represents a disproportionate interference with the applicant's property rights as it does not give the applicant an opportunity of replacing the deceased pharmacist. It is also inconsistent with clause 20 (1) and permits the chief executive officer of the respondent to grant a community pharmacy contractor agreement in respect of the applicant's premises to another party and does not indicate the manner in which his/her discretion should be exercised.
13.	 Clause 22 (3) provides for the automatic termination of the agreement in the case of a change in the ownership or in the beneficial ownership of the applicant. It would thus appear that even the smallest change in the share ownership of the applicant might result in the automatic termination of the agreement. The clause, in addition, stipulates that "a new agreement shall be required by the said body corporate". The clause contains no criteria to determine the entitlement of the applicant to any such new agreement. The said provisions are accordingly, uncertain, unreasonable and disproportionate in law and accordingly, ultra vires s.59 of the Health Act, 1970.
14.	Further, if, which is denied, clause 6 (2) of the contractor agreement is not void from the grounds set out above then it is void as being contrary to Article 6 and 48 of the EC Treaty in that, it discriminates against pharmacists from other member states who are less likely to have experience in "community pharmacy" as defined in the schedule to the new agreement. It accordingly discriminates against them as potential employees as a supervising pharmacist of the applicant.
15. 	Without prejudice to the foregoing, no regulations have been made pursuant to s. 59 of the Health Act, 1970 which authorises the respondent to impose upon the applicant a new contractor pharmacy agreement.
16. 	Such further and other grounds as may be advanced in due course.
17.	At all material times, the said 1996 Regulations were ultra vires the provisions of s. 59(4) of the 1970 Health Act.   The said regulations were revoked by the Minister for Health by the making of the Health (Community Pharmacy) Contractual Agreement) Regulations, 1996 (Revocation) Regulations, 2002, following advice from the Attorney General to this effect.  The new agreement sought to be imposed upon the applicants was and is designed to regulate the provisions of services under s. 59 of the 1970 Act and was and is entirely predicated on the existence and validity of the 1996 Regulations.
18.	Without prejudice to the foregoing, if (which is denied) the new agreement is not dependent or contingent on the validity and existence of the 1996 Regulations, the imposition of the new agreement is nevertheless ultra vires s. 59 of the 1970 Act as an attempt to make regulations “relating to the service under this section” otherwise than by means of valid regulations promulgated by the Minister for Health and Children with the consent of the Minister for Finance.   
19.	There are no principles or policies contained in s. 59 which would justify the respondent in imposing on the applicant an agreement in relation to the provision of pharmacy services under the Health Act, 1970 in the terms of the new agreement and in particular, an agreement containing one or more of clauses 6 (2), 19 (1), 19 (3), 19 (5), 22 (3) or 22 (6) of the new agreement. 
The application of the second applicant is grounded upon an affidavit of Patrick Durcan, former solicitor and member of the Pharmaceutical Society of Ireland who describes himself as a director of the applicant company.   He states that since 1995, the applicant has been the owner of a pharmacy at Holly Hill Shopping Centre, Cork known as Holly Hill Pharmacy.  Previously the applicant was the holder of a community pharmacy contract with the respondent.  By letter dated 15th September, 1995 the respondent acknowledged receipt of the completed community pharmacy contract from the applicant.  Pursuant to this contract the applicant supplied drugs, medicines and medical and surgical appliances to eligible persons.  The applicant was reimbursed by payments made by the GMS Payments Board. It is stated that the rates of pay are not stated in the contract but were in accordance with the specified schedule which was increased from time to time.   The applicant is a wholly owned subsidiary of McSweeney Group Limited.   Mr. Durcan describes himself as a director of McSweeney Group Limited which is the holding company for companies which own a number of pharmacies in Ireland.  It is stated that pharmacy services are provided for eligible persons pursuant to arrangements made by the health boards including the respondents pursuant to s. 59 of the Health Act, 1970.   Until May, 1996 no regulations were made for the purpose of that section.  The Minister for Health in May, 1996 made the Health (Community Pharmacy Contractor Agreement) Regulations 1996 (S.I. No. 152 of 1996) (hereinafter referred to as “the 1996 Regulations”).
	Mr.  Durcan states that in August, 1996 the respondent wrote to the applicant effectively seeking to impose upon the applicant a new community pharmacy contractor agreement (“the new agreement”).  The applicant had already received a copy of the agreed recommendations of the Department of Health/Irish Pharmaceutical Union on the provision and improvement of community pharmacy services under the Health Act, 1970.  It is stated by Mr. Durcan that the correspondence suggested that the new agreement is being imposed pursuant to the agreed recommendations of the Department of Health and the Irish Pharmaceutical Union approved by the Minister.  It is stated that the Irish Pharmaceutical Union had no authority from the applicant to agree to any changes in its existing contract with the respondent.   It is stated that Mr. Gerard Browne who is employed by the applicant as a supervising pharmacist of his pharmacy is a member of the Irish Pharmaceutical Union.  He was not consulted about the terms of the new agreement nor was he asked to approve its terms.   
	Mr. Durcan states that whilst there does not exist any regulation made under s. 59 of the Health Act, 1970 which applies to existing community pharmacies, the new agreement sought to be imposed by the respondent on the applicant appears to result from administrative practices of the Department of Health and the health boards.   Mr. Durcan says that he is aware from the pharmacies owned by the McSweeney Group Limited in other health board areas that each of the health boards sent to the community pharmacies in its area identical letters in August, 1996 together with the identical new community pharmacy contractor agreement.  It is stated that the existence of a community pharmacy contract is absolutely vital to the commercial viability of any pharmacy.  Mr. Durcan says that as far as he is aware there is no or practically no pharmacy in the State which does not have an existing contract of this kind with the appropriate health board.  He says that as appears from the letter of 8th August, from the respondent, the applicant was required to execute the new contract within one week.  He states that by reason of the applicant’s concerns, he took legal advice, wrote the respondent by letter dated 29th August, and advised the respondent of this.  He states that thereafter a meeting was arranged between the representatives of Collooney Pharmacy Limited, a sister company of the applicant and the North Western health board to discuss Collooney Pharmacy’s concerns with the new agreement.  It is stated that in the course of that meeting it was made clear by Mr. John Hayes, Deputy Administrator of the General Practice Unit of the North Western Health that he had no power to alter or re-negotiate the terms of the new agreement.   He undertook to pass on the concerns of the Collooney Pharmacy Limited but stressed that the execution of the new agreement was a matter for the applicant.  It was understood by the representatives of Collooney Pharmacy Limited that unless the new agreement was executed there was a distinct danger that the Collooney Pharmacy Limited would be excluded from the list of pharmacies supplying hi-tech drugs and would not be entitled to payment at the new and higher rates of payment now agreed.  It is stated that in addition, there are certain educational grants which might not be made available to Collooney Pharmacy Limited.   Mr. Durcan states that naturally it would be just as commercially damaging to the applicant if its pharmacy were excluded from the list of pharmacies supplying hi-tech drugs as it would be for Collooney Pharmacy Limited.  It is stated that until now such drugs had not been supplied through the pharmacies.  In addition, the applicant would find it difficult to compete with other pharmacies in the area if it was receiving payment at a lower rate.
	It is stated that under the Pharmacy Act, 1962, a pharmacy may be owned by an individual pharmacist or a body corporate provided that the pharmacy is personally supervised by a qualified pharmacist.  The vast majority of pharmacies in Ireland are owned either by an individual pharmacist or by a company owned by the supervising pharmacist or his family.  There are relatively few pharmacy groups such as the applicant and its holding company in Ireland.  It is stated that in a group such as the McSweeney Group Limited, the supervising pharmacist in each pharmacy will be an employee of the company owning the particular pharmacy as in the case of the applicant and will not normally be either a director or shareholder of the pharmacy owner or the holding company.   It is stated that the position of such pharmacy owners does not appear to have been taken into account in the new agreement or alternatively the new agreement is intended to discourage the existence of such groups. 
	Mr. Durcan indicates the clauses in the new agreement to which objection is taken.  He refers to clause 6 (2) which requires that all supervising pharmacies have a minimum of three years experience.   It is stated that this clause is not to come into operation until 1st September, 2001.  It mirrors the provisions of Article 5 of the 1996 Regulations but that provision is under challenge in judicial review proceedings being brought by the McSweeney Group Limited against the Minister for Health.  It is stated that the objection in both instances is the same; namely that the imposition of such a provision is ultra vires s. 59 of the Health Act, 1970 and in particular is inconsistent with the provisions of s. 2 of the Pharmacy Act, 1962 which enables a body corporate to keep open a pharmacy provided that it is supervised by a qualified pharmacist.  It is stated that there is no post registration experience required under the Pharmacy Acts.   Also under that section a qualified pharmacist is entitled to keep open a shop.  He states further his belief that a person such as the applicant is less likely to employ pharmacists from other EC Member States as they are less likely to have experience in community pharmacy, as defined in the new agreement, than Irish pharmacists.   In these circumstances, he believes that it contravenes Articles 6 and 48 of the EC Treaty.  
	Mr. Durcan also states objection to clause 19 (1) which he states will mean that the applicant’s agreement with the respondent will automatically terminate if its supervising pharmacist ceases to practise or to keep open the applicant’s pharmacy.  It is stated that this clause is inconsistent with clause 20 (1) given that there is a period of one month’s grace thereunder.   It is stated that while obviously, a pharmacist may leave the employment of the applicant from time to time or it is even possible that a pharmacist employed by the applicant might for some reason cease to be entitled to practise, it is unreasonable that the applicant should not be given an opportunity of employing a new supervising pharmacist.  He states his belief that this clause is unreasonable and disproportionate in law and ultra vires s. 59 of the Health Act 1970.  Thirdly, an objection is raised that clause 20 (1) provides that where a supervising pharmacist ceases to act in that capacity, the agreement terminates one month after that date unless a new statement as specified in the clause is submitted and accepted by the chief executive officer of the respondent.  It is stated that it is unreasonable to expect the applicant to find within one month or possibly less a new permanent supervisory pharmacist.   He states further that there are no objective criteria as to how the chief executive officer will exercise his or her discretion.  He accepts that a locum pharmacist will have to be put in charge in order to keep the pharmacy open under the Pharmacy Act of 1962.  The fourth objection relates to clause 22 (6) which provides that the agreement will remain in force for only one month following the death of the supervising pharmacist.  He states that it appears wholly unreasonable and disproportionate that the applicant’s contract should be terminated by reason of the death of the supervising pharmacist.   He believes the clause is also inconsistent with clause 20 (1).  He states that in addition the chief executive officer is given the power to award the contract in respect of the applicant’s premises to any other party.   Again, he believes that this is unreasonable and disproportionate.  He says that there appears to be no reason why the applicant should not be given an opportunity of replacing the deceased supervising pharmacist.  
	Mr. Durcan says that the fifth objection is that clauses 19 (3) and 19 (5) effectively permit the Minister by agreement with the Pharmaceutical Contractors Committee or in the event of a dispute between them, a third party, to impose new terms in the agreement between the applicant and the respondent.  He states that this clause reflects the quasi statutory nature of the terms being imposed by the respondent on the applicant.  He states his belief that this appears unreasonable in the circumstances where the Minister has made no regulations which apply to the agreement under s. 59 of the Health Act, 1970 to so permit the imposing of new terms on the applicant without its consent.  He says that the interests of the applicant as a member of a corporate group owning pharmacies, may in certain respects differ from the majority of pharmacy owners and hence its interest would not necessarily be protected by the Pharmaceutical Contractors Committee.  
	Mr. Durcan objects to clause 22 (3) which provides for the automatic termination of the agreement in the case of any change in the ownership or beneficial ownership of the applicant.  He contends that this clause is uncertain as it appears open to the interpretation that even the smallest change in the share ownership of either the applicant or its holding company might result in the automatic termination of the agreement.   He believes that this represents a totally disproportionate and unreasonable interference with the arrangements in relation to the ownership of the applicant and its holding company.  He believes further that there is no objective justification for such a clause and that it is ultra vires s. 59 of the Health Act and void. 
	Mr. Durcan says that clauses 19 (1), 20 (1), 22 (3), 22 (6) and 23 (1) will make it commercially almost impossible for the applicant as a company owned by persons not acting as its supervising pharmacist to avoid the termination of the new agreement with the respondent.  He indicates that the applicant accepts that at all times its pharmacy will have to be personally supervised by a qualified pharmacist.   He states, however, there would appear no objective grounds for which the terms of any community pharmacy contractor agreement between the applicant and respondent should not permit the applicant to maintain its agreement with the respondent notwithstanding that the supervisory pharmacist might die or leave its employment and permit the applicant a reasonable period of time in which to employ a new pharmacist.  He states that any such reasonable provisions would not prejudice the objectives sought to be achieved by the respondent under the new agreement.   
	Mr. Durcan indicates that the contracts were duly completed and returned by the applicant on 29th October, 1996.  He indicates that the contracts were completed under protest.  He says that there are also aspects of the contract to which objection is taken in respect of which he is advised the respondent has acted ultra vires.  In these circumstances, he indicates that they were advised to complete the contract but the execution of the contract was accompanied by a letter which was expressly designed to preserve the applicant’s position pending the outcome of the challenge to the validity of the 1996 Regulations and the unilateral imposition of the pharmacy contracts.  He indicates that it was greatly to their surprise, therefore, that they learned that the respondent did not accept that they had completed the contracts.  
	An affidavit has been sworn by Mr. Gerardus Bernardus Hoff, on behalf of the first applicant.  He states that he is pharmacist and a member of the Pharmaceutical Society of Ireland and he comes from Rotterdam in the Netherlands.  He states that he is a director of Collooney Pharmacy Limited and indicates that this company has been the owner of the pharmacy at Main Street, Collooney, known as Collooney Pharmacy.  He indicates that this company was the holder of a community pharmacy contract with the respondent, the North Western health board dated 7th March, 1995.  He indicates also that pursuant to this contract this applicant was also engaged in supplying drugs, medicines and medical and surgical appliances to eligible persons.  Mr. Hoff makes similar averments to those of Mr. Durcan in his affidavit, pertaining to the applicant Collooney Pharmacy Limited.   He indicates that whilst there do not exist any regulations made under s. 59 of the Health Act, 1970 which apply to existing community pharmacies, the new agreement sought to be imposed by respondent on the applicant appears to result from administrative practices of the Department of Health and the health boards.   He refers to the meeting between representatives of that applicant and the respondent to discuss the applicant’s concerns with the new agreement.  He indicates that in the course of the meeting it was made clear by Mr. John Hayes, deputy administrator of the General Practice Unit of the North Western health board that he had no power to alter or re-negotiate the terms of the new agreement.  Mr. Hoff refers to the various clauses of the new agreement and in like manner to Mr. Durcan he outlines the objection to the various clauses of the new agreement.   
	Identical statements of opposition have been filed on behalf of each of the respondents in these proceedings in which the following grounds are raised
1.		The respondent did not unilaterally impose the terms of a new community pharmacy contractor agreement on the applicant as a condition of the applicant continuing to participate in the arrangements made by the respondent pursuant to s. 59 of the Health Act 1970, for the supply of drugs, medicines and medical and surgical appliances to eligible persons as alleged or at all. Rather, the agreement which the applicant is seeking to impugn herein derives from negotiations (and an agreement) between the Department of Health and the Irish Pharmaceutical Union representing pharmacists' interests and the applicant's interests in that certain of the applicant's officers and agents are members of the Irish Pharmaceutical Union which said union is the holder of a negotiating licence pursuant to the Trade Union Acts.  This said licence entitles the said union to represent the interests of community pharmacists in this country. 
2.		Further to the contents of paragraph 2 aforesaid, the new community pharmacy contractor agreement (the new agreement), was only concluded after comprehensive discussions and negotiations over an extended period and was negotiated nationally between the Department of Health and the said Irish Pharmaceutical Union. The Pharmaceutical Contractors Committee of the Irish Pharmaceutical Union engaged in the actual negotiations on behalf of pharmacists while the applicant, its officers and servants were fully acquainted with the said negotiations and did not object to same. 
3.		The respondent contends that since the applicant raised no objections during the said negotiation process referred to aforesaid, although appraised of all aspects thereof, it is estopped from seeking to impugn the new agreement which derived from a lengthy process of consultation and agreement.
4.	Section 59 of the Health Act 1970 imposes an obligation on health boards to make arrangements for the provision of pharmacy services in respect of certain categories of patients as occurred in the instant case in that the new agreement resulted from the said negotiations and an agreement between the Department of Health and the Irish Pharmaceutical Union.  Accordingly, in entering into the new agreement with the said union, the respondent was acting in conformity with its duties and under statute.  
5.	The respondent contends that the new agreement herein is intra vires the provisions of s. 59 of the Health Act 1970 in all respects in that it will contribute to the improvement of pharmacy services in the respondent’s catchment area and place a greater emphasis on the professional role of the pharmacist in the patient/pharmacist relationship.  Furthermore, the new agreement will effect improvements in the quality of community pharmacy services to the benefit of patient and pharmacist alike and accordingly the applicant will be a beneficiary thereunder.
6.	The respondent denies that the new agreement is being imposed by the respondent in that the terms of the new agreement are only applicable to pharmacy contractors who enter into a contract with the relevant health boards.   Thus a contractor is entitled to operate under the terms and conditions of his existing contract.  Further, the terms which the applicant is seeking to impugn were negotiated and agreed by the applicant’s agents and on the applicant’s behalf and without any dissent from the applicant.
7.	The respondent contends that a period of at least three years experience in the practice of community pharmacy is reasonable and indeed essential so as to enable the pharmacist to take full responsibility for the operation of a community pharmacy and to ensure that he is in a position to establish a quality community care service with the objective of promoting and protecting public health.  Since the respondent has a duty of care to its patients it is entitled to insist that the provision of pharmacy services on its behalf are properly organised and satisfactory in every respect. The respondent further contends that this requirement is intra vires the Health Act 1970, and is consistent with s. 2 of the Pharmacy Act 1962.  Accordingly the respondent denies the applicant's assertion to contrary effect at para. [8] of the statement of grounds herein and submits that clause 6 (2) of the new agreement is valid and reasonable.
8.	The respondent contends that if a supervising pharmacist ceases to practise pharmacy or retires, then it is proper and reasonable that the new agreement should terminate also and any such termination would be without prejudice to any entitlements which the pharmacist had prior to such termination. In the event of a pharmacist ceasing to be entitled to keep his premises open, the pharmacist concerned would have had his name removed from the register. In the premises, the contract should be terminated particularly in the interests of protecting public health. Without prejudice to the foregoing, there is no provision in the new agreement which would preclude the previous contractor from arranging another supervising pharmacist to take responsibility for the supervision of the pharmacy or to obtain a new contract or to dispose of the pharmacy as a going concern. The respondent therefore denies that the clause 19 (1) of the new agreement is irrational and unreasonable in law or represents a disproportionate
interference with the applicant's property rights.-
9.	Clauses 19 (3) and 19 (5) of the new agreement do not permit the terms of the agreement to be altered without the consent of the applicant in the absence of' any regulations made by the Minister for Health under s. 59 of the Health Act 1970; and the respondent will refer to these clauses of the new agreement with greater particularity at the trial of the action.  Further, the making of regulations pursuant to s. 59(2) of the Health Act, 1970 does not impinge on the new agreement or the contents of the same and the respondent denies that the said clauses are ultra vires s. 59 of the Health Act, 1970 as contended for or at all.  
10.	(1)	Insofar as the applicant contends that the period of one month as provided for at clause 20 of the new agreement is irrational, haphazard and unreasonable in law, the respondent denies these assertions and contends that one month is the longest period within which the public should be expected to await the appointment of a new supervisory pharmacist.   Accordingly, the respondent denies that it is unreasonable to expect the applicant to find a new or replacement pharmacist with this period and the employment of a locum pharmacist will obviate any alleged difficulties in this connection.  Further, the Pharmacy Acts require that a qualified pharmacist be present to supervise a pharmacy and the dispensing of drugs as long as is remains open for business. 
(2) 	The respondent does not accept that the chief executive officer has an untrammelled discretion as implied by the applicant and rejects the applicant's objection to the chief executive’s role under clause 20 (1) of the new agreement. Furthermore, it is contended that the said clause is reasonable and valid and intra vires the said Act of 1970.
11.	The respondent denies that clause 22 (6) is irrational, haphazard or unreasonable in that where a party to a contract dies, this in ordinary course gives rise to a termination of the agreement. Accordingly, in the event of the death of the supervising pharmacist, the new agreement will come to an end and the authority vested in the respondent's chief executive officer under clause 22 (6) to award a new agreement to another party in such circumstances, arises from the requirement to provide and maintain an essential community pharmacy service particularly in an area where no other pharmacy service is available. The respondent therefore submits that clause 22 (6) is reasonable and certain and intra vires the Act of 1970 and is not inconsistent with clause 20 (1) as asserted or at all.  In particular the respondent denies that clause 22 (6) vests the chief executive officer with the alleged discretion or an untrammelled discretion as contended for or at all.
12.	Insofar as the applicant is contending that clause 22 (3) of the new agreement is uncertain, unreasonable and disproportionate in law, the respondent contends that changes in the ownership or beneficial ownership are matters which can be foreseen. In summary the purpose of clause 12 (3) of the new agreement is to ensure that the provisions of clause 21 (1) are complied with insofar as they relate, by way of example, to the involvement of a doctor in the ownership of a pharmacy who is practising in the area concerned. The respondent is also concerned to prevent persons involved in criminal activity (and particularly controlled drugs), having access to pharmacy agreements. It is intended therefore that the chief executive officer will have a discretion to refuse contracts in the above instances and the respondent submits that clause 22 (3) is valid, reasonable and in conformity with the purposes of pharmacy legislation and in particular s. 59 of the Health Act 1970.  
13.	The respondent denies that clause 6 (2) of the new agreement is void in that it is contrary to Article 6 and Article 48 of the EC Treaty and the respondent rejects the contention that pharmacists from other EC Member States are less likely to have experience in community pharmacy as asserted at all. 
14.	The provisions of s. 59(2) of the Health Act 1970 insofar as they relate to regulations made by the Minister for Health are not relevant to the new agreement and the applicant’s contention in its statement of grounds to the effect that the respondent is not authorised to enter into (or impose) a new pharmacy agreement in the absence of such regulations, finds no support in s. 59(2) of the said Act. 
15.	The applicant will not suffer from any detriment or prejudice by virtue of any provision of the new agreement nor is the applicant contending that any particular term thereof is or has impinged adversely on its business as to cause the applicant loss or damage. In substance the applicant’s alleged misgivings and objections to the new agreement relate to hypothetical state of affairs and this Honourable Court in the exercise of its discretion should refuse the applicant the relief as claimed or any part thereof.
Each of these statements of grounds of opposition have been verified by an affidavit of Mr. Alan Aylward who is a principal officer in the General Medical Services Division of the Department of Health.   
Mr. Aylward states his belief that s. 59 of the Health Act, 1970 places an obligation on health boards to make arrangements for the provision of pharmacy services to certain categories of patients.   He indicates that this obligation is fulfilled through the medium of contractual arrangements with community or retail pharmacists.  The terms of such contracts derive from negotiations between the Department of Health and the Irish Pharmaceutical Union.   He states that since this union is the holder of a negotiating licence, which entitles it to represent the interests of community pharmacists in this country, in 1994 negotiations commenced between the Department and the Irish Pharmaceutical Union in relation to a claim for dispensing fees in the context of the General Medical Services Scheme (the GMS Scheme) in this case.  He states that this claim fell within the compass of the relevant public pay agreement, the so called Programme for Competitiveness and Work, which only permitted special payment increases in return for changes in structures, work practices and other conditions of service.   
Mr. Aylward says that the provenance of the new agreement derived in part from the said negotiations in 1994, in that the parties accepted that any new contract for the provision of State funded pharmacy services would impose new obligations on contract holders and would contribute in significant measure to the improvement of pharmacy services in consideration for increased payments to pharmacy contractors and other associated benefits to which he refers.  
Mr. Aylward indicates that the new agreement resulted from comprehensive discussions over an extended period and was negotiated nationally between the Department of Health and the Irish Pharmaceutical Union.   He indicates that the Pharmaceutical Contractors Committee of the Irish Pharmaceutical Union engaged in the actual negotiations on behalf of pharmacists.   He refers to the fact that Mr. Brian Rafferty is a member of the Irish Pharmaceutical Union and is the supervising pharmacist of Collooney Pharmacy Limited.  He states that he should have been aware of the negotiations and the details of same.  He believes that he should have had full access to the information which the Irish Pharmaceutical Union disseminated to its membership during the negotiations since it is his understanding that the union was in continuous communication with its members at all material times.   On this basis he expresses difficulty in accepting that the Irish Pharmaceutical Union’s deliberations on the agreement were not communicated to Mr. Rafferty notwithstanding the assertions that he was not consulted at any time nor was he asked to approve the agreements.   Mr. Aylward indicates that the previous agreements between the pharmacists and the Department of Health and health boards have been negotiated and concluded in the self same manner that was adopted in respect of this agreement whilst it is unclear whether Mr. Rafferty ever objected at any time to the agreed recommendations of the Department of Health/Irish Pharmaceutical Union. He states that since the negotiations were of a protracted nature it was notorious amongst Department of Health officials and the pharmacists profession that comprehensive discussions were in train which would have important ramifications for patients and pharmacists alike.   
Mr. Aylward indicates that the new agreement replaced an existing contract for the provision of services under the Health Act of 1970.  The new agreement places a greater emphasis on the professional role of the pharmacist in the patient/pharmacist relationship and provides for the increased accountability of all parties engaging in the dispensing of medicines under publicly funded schemes.  He indicates that the Minister for Health has accepted this agreement which relates to the provision of community pharmacy services within the meaning of s. 59 of the Health Act, 1970.   He stresses his belief that this agreement will achieve significant improvements in the overall quality of community pharmacy services and patient care whilst it is important to emphasise that it does not relate exclusively to the so called hi-tech medicine scheme.   He states that the hi-tech medicine scheme is one element only in a series of measures provided for in the agreement.   
Mr. Aylward refers to a circular that issued in July, 1996 from the Department of Health which indicated the existence of a new and more effective arrangement for dispensing of hi-tech drugs through community pharmacies and the provision of grants to enable community pharmacists to maintain and update their professional skills by recourse to an approved continuing education course in the practice of pharmacy.  The circular indicated that the sum of £250,000.00 had been provided for the year 1996  and an annual sum of £500,000.00 would be made available in subsequent years for this purpose.   The circular indicated the provision of funding to support community pharmacists undertaking the upgrading of their equipment for the purposes of improving information technology and telematic linkages with health boards and the General Medical Services (Payments) Board.   The circular indicated a 3 % increase in fees payable to community pharmacist under the General Medical Services Scheme, the Drug Costs Subsidisation Scheme and the Long Term Illness Scheme.   
He states that it is clear that the primary purpose of the new agreement is the enhancement of the professional role of the community retail pharmacists in the context of public health administration by health boards pursuant to their statutory obligations.  He states that the new applicants for a community pharmacy contract must meet particular conditions as are provided for in the agreement including the following: The proposed premises must have free and direct access to the public road at all times which is designed to ensure that pharmacies operating in shopping centres, for example, provide an out of hours service on a rota basis with other pharmacies in the area.  A supervising pharmacist must possess the required experience, professional knowledge and ability to manage the pharmacy, the proposed pharmacy must have a reasonable prospect of being viable so as to insure quality of service.
	Mr. Aylward explains the nature of hi-tech medicines in the context of the new agreement.  He states that hi-tech drugs are the product of developments in bio-technology and therapeutics and they comprise of a range of medicines for the treatment of ailments which formerly presented particular difficulties in that there was no effective treatment for the same.  In many instances this required the lengthy hospitalisation of such patients.  He states that certain of these drugs were developed in response to the recent advances in hospital medicine including transplant surgery.  He states that in view of the nature of this medication, its limited use and high prices which it commands, a practice emerged in the past whereby hi-tech drugs tended to be distributed through hospitals.  He states that this resulted in a diminution in the role of pharmacists who in many instances had no professional involvement in the supply of the particular product.  He states that it was recognised by all concerned that this was an unsatisfactory state of affairs since it had adverse ramifications both for pharmacists and patients alike particularly from the standpoint of safety and quality of care.  He states that the new hi-tech scheme has been introduced to ensure that patients have easier access to these drugs while pharmacists in turn will be afforded the opportunity of monitoring a patients’ therapy with particular reference to interaction with other medication.  He states that since these medicines are highly complex, the involvement of the pharmacist in the monitoring treatment is extremely important.  He stresses that pharmacists participating in the scheme have agreed to forego the traditional “mark up” payment agreement for hi-tech medicines and have accepted a monthly patient care fee instead.  He states that the hi-tech scheme is a limited one in that it encompasses 7,500 patients only at an estimated cost of £15 million annually.  He indicates by way of contrast that the State’s overall expenditure in medicines in the community is estimated at £216 million annually.  He states that a number of hi-tech drugs had, prior to the introduction of the hi-tech scheme, been supplied through community pharmacists.  He states that of the total estimated costs of these drugs (£15 million per annum) the sum of £3.84 million represents the annual value of such drugs as have been supplied through the General Medical Services Scheme.  He states that these drugs have now been removed from the General Medical Services Scheme where a dispensing fee of approximately £1.67 per item applied while they have been included in the hi-tech scheme where a monthly patient care fee of £28.33 applies.  He states that while this appears to give rise to a loss of approximately £3,000 per pharmacy that this is £3.84 million in respect of 1,162 pharmacies.  He states his belief that the loss to the individual pharmacy is negligible when one has regard to the difficulties attendant on supplying certain of these drugs, having regard to the level of the dispensing fee.  He states that in view of the high costs of particular hi-tech drugs and the size of the dispensing fee, particular pharmacies did not, as a matter of policy, involve themselves in the supply of these drugs since they doubtless perceived them as yielding a poor financial return.  
	Mr. Aylward says that there is no question of the imposition of a new community pharmacy contract or agreement by respondent and the terms of the new agreement are only applicable to pharmacy contractors who have entered into a contract with the relevant health boards.  On this basis he states that a contractor is entitled to operate under the terms and conditions of his existing contract.  He states, however, that if a contractor is unwilling to sign the new agreement he believes that it is unrealistic that he should expect the terms thereof to be applied to him.  He states his belief that the provisions of the new agreement are essential for the proper management of the health service by health boards in their respective areas.
 	Mr. Aylward indicates that there is no difficulty in the supervising pharmacists acting for each outlet operated by a company.  He states that there is the long standing recognition that the period of at least three years experience in the practice of community pharmacy is essential to enable the pharmacist to take full responsibility for the operation of a community pharmacy.  He states that this is also essential in the context of establishing a quality community care service and protecting public health.  He states that the health boards have a duty of care to their patients and accordingly are entitled to insist that pharmacy services provided on their behalf are satisfactory in all respects.  
	Mr. Aylward indicates his belief that if a supervising pharmacist ceases to practise pharmacy, that is to retire, it is logical that the agreement should terminate also.  He says that such a termination would obviously be without prejudice to any entitlements which the contractor had prior to such terminations.  He states that in the event of a pharmacist ceasing to be entitled to keep his premises open the pharmacist concerned would have had his name removed from the register and he believes that in such circumstances it is reasonable that the contract should be terminated in the interests of protecting public health.  He believes that there is nothing in the clause of the agreement which would preclude the previous contractor from arranging another supervising pharmacist to take responsibility for the supervision of the pharmacy and to obtain a new contract or to dispose of the pharmacy as a going concern.    He states that the period of one month is eminently reasonable in that it is the longest period within which the public should be expected to wait the appointment of a new supervisory pharmacist.   He does not accept that it is unreasonable to expect the applicant to find a new pharmacist within this period.  He believes that the applicant’s concern in this connection can be addressed by the employment of a locum pharmacist.  He says that under the Pharmacy Acts, a pharmacist must be present to supervise the pharmacy in the dispensing of drugs as long as it remains open for business and he believes therefore that the one month stipulation must be viewed in this context.  He does not accept that the chief executive officer will have an untrammelled discretion and on this basis he does not accept the objection stated to the chief executive’s role.  
	He states that in the event of the death of the supervising pharmacist the agreement will come to an end one month after the event.  He stresses the view that the authority vested in the chief executive officer under clause 22 (6) to award a new agreement to another party in such circumstances arises from the need to provide and maintain an essential community pharmacy service particularly in an area where no pharmacy service is available.  He states that clause 19 (3) is similar to a provision in the contract between the Minister for Health and the Irish Medical Organisation for the provision of general practitioner services under s. 58 of the Health Act, 1970.  
	He says that the changes in the ownership or beneficial ownership are matters which can be foreseen and the purpose of clause 22 (3) is to ensure that the provisions of clause 21 (1) are met insofar as they relate by way of example, to the involvement of a doctor in the ownership of a pharmacy who is practising in the area concerned.  He states that a further purpose is to prevent persons involved in criminal activity (and particularly controlled drugs), having access to pharmacy agreements.  He indicates that the chief executive officer has a discretion to review his contracts in the above instance.   
	An affidavit has been sworn by St. John Dundon, solicitor who indicates that he is a partner in the firm of Dundon, Callanan, solicitors.  He indicates that previous to these proceedings the McSweeney Group Limited instituted judicial review proceedings in which it was applicant and the Minister for Health and the Attorney General were respondents.  It is indicated that in those proceedings the applicant challenged the validity of the 1996 Regulations.   He indicates that these proceedings were ultimately compromised and settled in July, 1998.  As part of that settlement the Minister undertook to do certain things by the end of December, 1998.  He states his belief that the Minister did not meet his commitment and despite extensions of time afforded to him by the applicant in those proceedings, the Minister was still in default.   He indicates the proceedings were re-entered and came on for hearing on 20th March, 2002.  He indicates that on 31st January, 2002, the Minister by Statutory Instrument No. 28 of 2000 revoked the 1996 Regulations.   In those circumstances, Mr. Justice Kelly indicated in an ex tempore judgment on 20th March, 2002, that the matter was then moot, the regulations having been revoked by the Minister for Health and in circumstances where the Minister tendered to the Court an undertaking that he would not make any new regulations under the existing s. 59(4) of the Act of 1970.   
	Mr. Dundon indicates that shortly after the introduction of the 1996 Regulations, the respondent introduced a new GMS contract which the applicants contend was imposed on them by the respondents.   He indicates that those proceedings came on for hearing along with the McSweeney proceedings in February, 1998.  He indicates that at that stage it was agreed that the within proceedings would be adjourned generally with liberty to re-enter to await the outcome of the challenge to the 1996 Regulations.
Submissions:-
Having referred to the history to these proceedings, Mr. Gerard Hogan S.C. for the applicants submits that the applicants had no role in relation to the new contract, disliked many of its features, had never agreed to its terms and sought to discuss the matter with the respondents.   It is stated that it was clear on behalf of the respondents that their administrators had no power to alter or re-negotiate the terms of the agreement.  It is stated that since participation in the GMS Scheme is absolutely essential for the commercial viability of any pharmacy and its general reputation with members of the general public, the applicant sought to challenge the validity of aspects of the agreement.   Following an application for interlocutory relief, it was agreed between the parties that the applicant might execute the agreement but entirely without prejudice to its right to challenge those features of the agreement with which it was dissatisfied.  
Counsel refers to s. 59 of the Act of 1970 and indicates that it imposes on health boards an obligation to make arrangements for the supply, without charge, of drugs, medicines and medical and surgical appliances to eligible persons.  Counsel refers to s. 59(4) of the Act of 1970 which authorises the Minister for Health with the consent of the Minister for Finance to make regulations regulating the service under s. 59.  Section 59 provides as follows: 
“(1) A health board shall make arrangements for the supply without charge of drugs, medicines and medical and surgical appliances to persons with full eligibility.
(2) When a person with limited eligibility, or a person with full eligibility who does not avail himself of the service under subsection (1), satisfies the chief effective officer of the health board that, in respect of a period and to an amount determined by regulations made by the Minister, he has incurred expenditure on drugs, medicines and medical and surgical appliances which were obtained on the prescription of a registered medical practitioner and were for the treatment of that person or his dependants, the health board shall make arrangements to meet the balance of the cost, or a proportion thereof (as may be prescribed) of the person's being supplied in respect of that period with such drugs, medicines and medical and surgical appliances.
(3) A health board may make arrangements for the supply without charge of drugs, medicines or medical and surgical appliances to persons suffering from a prescribed disease or disability of a permanent or long-term nature.
(4) Regulations relating to the service under this section shall be made with the consent of the Minister for Finance.”	
The GMS contract, although contractual in form is in the reality a form of quasi- legislation or quasi statutory instrument insofar as it contains elements of regulation of the service provided by the respondents.  In this regard counsel refers to the judgment of Henchy J. in McCord v. Electricity Supply Board [1980] I.L.R.M. 153.   Counsel indicates that the prime elements of the regulation may be found at clause 6 (2) describing the three year requirement and at clause 19 (3) and 19 (5) providing for the unilateral alteration of the contract following agreement between the Minister for Health and the I.P.U.  Counsel indicates that the GMS contracts were first unilaterally imposed on the community pharmacies in the summer shortly after the coming into force of the 1996 Regulations.   He submits that GMS contracts were and are designed to regulate the provision of services under s. 59 of the Act of 1970 and were and are entirely predicated on the existence of and continued validity of the 1996 Regulations.   Counsel submits that some features of the GMS contract expressly refer in terms to the 1996 Regulations.  Counsel submits that the quasi legislative character of the contract is further underscored by the provisions of clause 19 (3) and clause 19 (5).   These clauses state as follows:
19(3)  “This agreement is to be construed as contingent upon the terms agreed or to be agreed between the Minister and the Pharmaceutical Contractors’ Committee regarding arrangements for the provision of pharmaceutical services under the provision of the Health Act, 1970.  The pharmacy contractor and the board agree that any changes in the terms of such arrangements, which may be agreed between the Minister and Pharmaceutical Contractors’ Committee shall be incorporated into this agreement and the terms of this agreement shall be construed accordingly, following the issue of a notification of such agreed changes by the Minister.”
19(5) 	“The terms and conditions of this agreement between the Pharmaceutical Contractors’ Committee and the Minister may be subject to such review after a period of five years.  In default of agreement on any such review, the means of this agreement shall be subject to mediation and recommendation by a third party appointed by the Minister following consultation with the Pharmaceutical Contractors’ Committee.  Any alterations to the agreement between the Minister following consultation with the Pharmaceutical Contractors’ Committee arising from the review provided for in this clause shall be incorporated into this agreement and the terms of this agreement shall be construed accordingly, following the issue of a notification of such agreed changes by the Minister.  The terms and conditions of this agreement may also be extended for such specified periods with the agreement of the Minister and the Pharmaceutical Contractors’ Committee.”
	Counsel submits that a contract which provided for the unilateral alteration of its terms following an agreement between two parties, neither of whom are in fact parties to the contract would be a curious one indeed.  Counsel submits that in truth the GMS contracts are ultra vires s. 59(4) of the Act of 1970 as an attempt via the form of contract to make regulations “relating to the service under this section”, otherwise than by means of valid regulations promulgated by the Minister for Health and Children with the consent of the Minister for Finance.   Counsel submits that the quasi legislative character of the GMS contracts is also highlighted by reference to individual and specific provisions of the contract.   In this regard counsel refers to clause 6 (2) of the agreement requiring the pharmacy or contractor to ensure that the nominated supervising pharmacy must have at least three years experience in the practice of community pharmacy.  Counsel indicates that it is not disputed but that a GMS contract is essential to the commercial viability and reputation of any pharmacy.  Accordingly, it is submitted that the three year requirement stipulated by clause 6 (2) amounts de facto to an attempt to interfere with the rights conferred by s. 2 of the Pharmacy Act, 1962 which provides, inter alia:
(1) A person shall not keep open shop for the dispensing or compounding of medical prescriptions unless—
( a ) the person is an authorised person and the shop and the dispensing and compounding of medical prescriptions therein are personally supervised by the person or by an authorised person, or
( b ) the person is—
(i) the legal personal representative of a person who at the time of his death was lawfully keeping open shop for the dispensing or compounding of medical prescriptions, or
(ii) the trustee or committee of a person lawfully keeping open shop for the dispensing or compounding of medical prescriptions who is adjudged bankrupt or becomes an arranging debtor or becomes of unsound mind,
and the shop and the dispensing and compounding of medical prescriptions therein are personally supervised by an authorised person, or
( c ) the person is a body corporate and the shop and the dispensing and compounding of medical prescriptions therein are personally supervised by a person who is a registered pharmaceutical, chemist, a registered dispensing chemist and druggist or a licentiate of Apothecaries Hall and is employed by the body corporate in a whole-time capacity and is not acting in a similar capacity for any other body corporate or any authorised person or on his own behalf.
    	 (2) A person shall not keep open shop for the sale of poisons unless—
( a ) the person is either an authorised person or a registered druggist and the shop is personally managed by the person or an authorised person or a registered druggist, or
( b ) the person is—
(i) the legal personal representative of a person who at the time of his death was lawfully keeping open shop for the sale of poisons, or
(ii) the trustee or committee of a person lawfully keeping open shop for the sale of poisons who is adjudged bankrupt or becomes an arranging debtor or becomes of unsound mind,
and the shop is personally managed by an authorised person or a registered druggist, or
( c ) the person is a body corporate and the shop is personally managed by a person who is a registered pharmaceutical chemist, a registered dispensing chemist and druggist, a licentiate of Apothecaries Hall or a registered druggist and is employed by the body corporate in a whole-time capacity and is not acting in a similar capacity for any other body corporate, any authorised person or any registered druggist or on his own behalf.”
  Section 2(3) provides that an “authorised person” means a registered pharmaceutical chemist.   
	Counsel submits that there are no principles and policies contained in s. 59(4) which would have enabled the respondent to impose a condition of this kind.  It is submitted that by vesting the Minister for Health with a power to make regulations in relation to the service, the Oireachtas did not intend to confer a power whereby the right of any qualified pharmacist to operate as a supervising pharmacist could thereby be interfered with.   In this context counsel refers to O’Neill v. Minister for Agriculture and Food [1998] 1 I.R. 539.   Nor did the Oireachtas intend by s. 59(1) of the Act of 1970 to confer on the respondent health boards a power to interfere with the statutory right of a body corporate to keep open a pharmacy supervised by a registered pharmaceutical chemist as is permitted by s. 2(1)(c) of the Act of 1962.  It is submitted that the respondent cannot achieve by means of administrative practice that which would be ultra vires if it were attempted by means of regulations promulgated under s. 59(4).
	Counsel refers to the automatic termination clause as set out in clause 19 (1) of the agreement.  Counsel submits that this provides that the agreement automatically terminates in the case of a body corporate where the supervising pharmacist either ceases to be entitled to practise or ceases to keep open the pharmacy.  It is submitted that given the normal turnover of supervising pharmacists, this means that the holder of the GMS contract would find that the contract is frequently terminated.  It is submitted that there is no objective reason which would justify a drastic provision of this kind and accordingly, that this clause is irrational, haphazard, and unreasonable in law.   
	Dealing with the provisions of clause 19 (3) and clause 19 (5), referred to by counsel as the unilateral alteration clause, it is submitted that these clauses permit the terms of the GMS contract to be unilaterally altered and changed without the consent of the pharmacy contractors following agreement between the Minister and the Pharmaceutical Contractors’ Committee of the Irish Pharmaceutical Union.  It is submitted that these provisions illustrate the quasi legislative nature of the GMS contract and are unreasonable in themselves.  It is submitted that the provisions are accordingly ultra vires s. 59(4) of the Act of 1970, in as much as they amount to regulation of the service otherwise than by means of valid regulations validly promulgated under the terms of the Act of 1970.   It is submitted that, quite a part from that, it is entirely unreasonable in law that the contractual arrangements between the parties can be unilaterally altered in this way and that an arrangement between the Minister and the Pharmaceutical Contractors’ Committee “regarding arrangements for the provision of pharmaceutical services under the provisions of the Health Act 1970” could be made binding in this fashion.  This is especially so, since if such arrangements were to be made by means of regulation under s. 59(4) of the Act of 1970, the applicant would have had the protection that the consent of the Minister for Finance could also have been required and, in theory at least, such regulations could have been annulled by either Houses of the Oirechtas.
	Dealing with clause 20 (1) counsel indicates that this provides that where a supervising pharmacist ceases to act in that capacity, the GMS contract terminates one month after that date unless a new agreement nominating a new community pharmacist as specified in clause 20 (1) has been furnished to and accepted by the chief executive officer of the relevant health board.   It is submitted that this clause is also ultra vires and irrational and unreasonable in law in that firstly, no guidance is afforded as to how the chief executive officer will exercise his or her discretion and secondly, it is unreasonable to expect a replacement permanent pharmacist to be found within one month. 
	Counsel refers to clause 22 (6) which provides that where the pharmacist contractor is a body corporate and the supervising pharmacist dies, the GMS contract automatically terminates one month from the date of such death.   The relevant chief executive officer of the individual health board is thus given the power to award a new GMS contract to any other party.  Counsel submits that as the death of the supervising pharmacist does not in any way effect the status of the applicant as contractors (save that they would be required to find a new supervising pharmacist), this provision is haphazard and arbitrary in the sense identified by the Supreme Court in Doyle v. An Taoiseach [1986] I.L.R.M. 693.  Counsel submits that this provision would also appear to be inconsistent with clause 20 (1) and permits a chief executive officer of a health board to grant a GMS contract in respect of the applicant’s premises to another party and provides no guidance whatsoever as to how such discretion should be exercised.
	Counsel refers to clause 22 (3), the change in ownership rule, which provides for the automatic termination of the agreement in the case of a change of ownership or in the beneficial ownership of a community pharmacy contractor in question.  It is submitted that even the most minute change in the share ownership of the applicant would result in the automatic termination of the agreement.  Counsel refers to this clause which stipulates that “a new agreement shall be required by the said body corporate.”  It is submitted that this clause contains no criteria for which the entitlement of such contractor to any new agreement may be terminated.  On this basis it is submitted that the provisions are unreasonable, haphazard and disproportionate in law and ultra vires s. 59 of the Act of 1970.   On this basis counsel submits that the GMS contract is in reality a form of quasi legislation or a quasi statutory instrument which attempts to make regulations for the provision of the service to patients within the meaning of s. 59(4) of the Act of 1970.  Counsel refers to the clause 6 (2) of the contract providing for the three year experience requirement and submits that this is ultra vires s. 2 of the Act of 1962.  It is submitted that even if such a clause were not ultra vires s. 2 of the Act of 1962 it could only be imposed by means of valid regulations under s. 59(4) of the Act of 1970.  Clause 19 (3) and clause 19 (5) are unreasonable in law and as much as they allow for the unilateral alteration of the contract and the one month rules contained in clauses 20 (1) and 22 (6) are haphazard and unreasonable and thus ultra vires.   Finally, it is submitted that the change in ownership rule in clause 22 (3) is unreasonable in that it provides for the automatic termination of the GMS contract by reason of any change in the share ownership for a body corporate, no matter how minute.  On this basis it is submitted that the rule is unreasonable and arbitrary.  
On behalf of the respondent in each case it is submitted by Maurice Collins S.C. that by virtue of the provisions of ss. 26 and 59 of the Act of 1970, the respondent health board is required and entitled to make arrangements with persons and bodies (pharmacists) to provide drugs, medicines and similar products to eligible and specified persons.  It is submitted that it is reasonable and necessary to have a uniform and standard form of contract with pharmacists for the provision of such services.  Reference is made to the fact that the terms of the agreement were the product of an extensive process of consultation and negotiation between representatives of the health boards, the General Medical Services (Payments) Board, the Department of Health and the Irish Pharmaceutical Union, a registered trade union within the meaning of the Trade Union Acts, authorised to negotiate on behalf of its members.  This is the same procedure which had been adapted to negotiate the terms of previous agreements for the provision of pharmacy services by pharmacists to health boards.  It is stated that the agreement is analogous to the agreement for the provision of services by general practitioners under s. 58 of the Act of 1970.   It is stated that the procedure adopted in arriving at the agreement is similar to that which found favour with O’Hanlon J. in his decision in The Association of General Practitioners Limited v. The Minister for Health [1995] 1 I.R. 382.  
It is submitted that the contract is not a contract of adhesion as referred by Henchy J. in McCord  v. The Electricity Supply Board [1980] I.L.R.M. 153.  Counsel refers to the fact that in that case the terms of conditions were drawn up entirely by the Electricity Supply Board and offered to their customers on a take it or leave it basis.   The contract in this case was not drawn up by the health boards or the Minister for Health but rather emerged as an agreed contract from the process of negotiations.  The respondents accept that in entering into contracts with pharmacists under the provisions of ss. 26 and 59 of the Act of 1970, they are discharging a statutory obligation.  Counsel submits that in doing so that they acted fairly and reasonably as is required in such circumstances.   Counsel refers to Deane and Others v. Voluntary Health Assurance Board (Unreported, High Court, 22nd April, 1993) and Zockoll Group Limited v. Telecom Eireann [1990] 3 I.R. 287 at 315.  Counsel submits that the process of negotiation and consultation by which the terms of the contract were agreed was eminently fair and reasonable.  Pharmacists were fully represented at those negotiations through the Irish Pharmaceutical Union.   The supervising pharmacist Mr. Brian Rafferty, attached to the Collooney Pharmacy is a member of the Irish Pharmaceutical Union.  Counsel refers to the fact that the applicant has not suggested that it objected to the Irish Pharmaceutical Union conducting negotiations on its behalf or that it sought some separate involvement in the negotiations.   
It is further submitted that the respondent acted fairly and reasonably towards the applicant in offering to the applicant a contract on the same terms as was offered to all other existing community pharmacies in 1996.  Having regard to the overall scheme of the arrangement put in place it was not open to the respondent to negotiate variations on the agreed terms with individual pharmacies and it could not fairly have done so.  It is submitted that the respondent health boards were not directly the authors of the terms of the agreement, although like other parties, their interests were represented at the negotiations.   The applicant in each case has chosen to seek relief against the respondent health board.  It is submitted that the Court has to consider whether the respondents discharged their obligations under the Act of 1970 fairly and reasonably in offering to enter into a contract with the applicants on terms agreed in the collective negotiations.  It is submitted that it is not part of this Court’s function to act as an appellate body for parties dissatisfied with particular terms of a negotiated contract.   Although the applicants object to some of the terms, there are others which are clearly to their advantage.  This is the natural and inevitable result of any process of negotiation involving parties with disparate interests.  
In the circumstances it is submitted that it may not be appropriate for the Court to embark upon a review of the individual terms of the agreement as sought by the applicant.  If such a review is thought appropriate, it is submitted that the applicant will be required to establish a high degree of unfairness or unreasonableness to attract the Court’s intervention.   It is also submitted that the unfairness or unreasonableness of any clause to which exception was taken would have to be established in the context of the agreement as a whole.   
It is submitted that while the applicant seems to contend that the agreement is in someway dependant on the provisions of the revoked regulations of 1996 that this is not so.   Article 3 of the 1996 Regulations expressly provided that the regulation should not apply to any community pharmacy which was opened and providing services under the Act of 1970 on or immediately before the coming into force of the regulations.  It is submitted that the applicant pharmacy was in each case such a pharmacy.   
Dealing with the impugned clauses of the agreement it is submitted as follows:-
Clause 6 (2)	
The role assigned to supervising pharmacists under the contract carries a heavy professional responsibility.  It is submitted that part of the overall agreement arrived at in the negotiations involved increasing this responsibility, amongst other ways, through the hi-tech drugs scheme.  It is submitted that there is nothing unfair or unreasonable in requiring that the pharmacist appointed to that role, in addition to having the necessary academic qualifications, should also have three years appropriate experience.  It is submitted that the proposition that a newly qualified pharmacist, on the day after qualification, should be entrusted with sole and full professional responsibility for a community pharmacy seems the more surprising.  It is submitted that this clause does not in any way interfere with the provisions of s. 2 of the Act of 1962 as amended.  That section, in effect establishes the minimum legal requirements and professional qualifications required of a pharmacist.  It does not mean that the respondent in entering into a major contract for the supply of pharmaceutical services to eligible persons is not entitled to seek that the pharmacist to be given primary professional responsibility should also have an appropriate level of experience.  
Clause 19 (3) and Clause 19 (5)
These clauses permit changes in the arrangements for the provision of pharmaceutical services and in the clauses contained in the agreement to be agreed between the Minister and Pharmaceutical Contractors Committee.  It is submitted that they do not provide for unilateral alterations.  Neither the applicant nor the respondent can bring about a change in the relations under these clauses.  They both agree to accept changes agreed between the Minister for Health and the Pharmaceutical Committee.  These would be unusual clauses if the agreement between the applicant and respondent was a simple once off agreement.  However, it is not a unique agreement.  In order for health boards to discharge their statutory obligations reasonably and fairly, it is necessary and appropriate that the terms on which health boards engage the services of pharmacists should be standard terms.  It is also necessary to provide an orderly mechanism for those terms to be altered as may be required.  The mechanism provided for in clause 19 (3) and clause 19 (5) is a mechanism which has been agreed in the process of negotiation and is in itself reasonable. 
Clause 19 (1), 20 (1) and 20 (6)
	The respondent submits that the combined effect of these clauses is perfectly reasonable.  Clause 19 (1) deals with the situation where an individual pharmacy contractor, or in the case of a company, the supervising pharmacist ceases to be entitled to practise as a pharmacist or in fact ceases to keep open shop.  In both cases it is submitted that it is entirely necessary and reasonable that the agreement should terminate.  
	Clause 20 (1) provides the mechanism for the appointment by a company of the supervising pharmacist and for the replacement of the nominated supervising pharmacist by another.   This clause provides the mechanism for dealing with the replacement of a nominated supervising pharmacist in the ordinary course of a continuing business.  It is not understood why the applicant takes exception to the period of one month.  In the case of any planned replacement of one supervising pharmacist by another the company would presumably notify the health board of the change in supervising pharmacist before it in fact occurred.  It is submitted that the one month period would presumably deal with the situation where the incumbent supervising pharmacist ceased to act as a result of some unexpected event.  It is submitted that there is nothing unreasonable in requiring the company to nominate a new supervising pharmacist within a period of one month.  If the company does not do so there is nothing in the contract which would prevent the company from seeking a new agreement.   
	Clause 22 (6) deals specifically with the event of the death of an individual pharmacist or in the case of a company, a supervising pharmacist.  In the case of a supervising pharmacist the existing contract would continue under the terms of clause 20 (1) provided within a period of one month after the death of the supervising pharmacist, a new supervising pharmacist had been nominated.  In the case of an individual contractor the agreement would terminate one month after the death of the individual contactor.  The final sentence of the clause would, however, appear to contemplate a new agreement being granted for a continuing pharmacy business at the premises where the deceased pharmacist had carried on business. 
Clause 20 (1) and Clause 22 (3)
Having regard to the importance of the services being provided to a health board by a community pharmacy it is entirely necessary and appropriate that the beneficial ownership of a limited liability company seeking to operate a community pharmacy should be identified to the health board.  It is submitted that it is clearly appropriate that any change in ownership should be notified to the health board and the agreement should be reviewed in the light of that change in ownership.  Provided there was nothing objectionable in the new beneficial ownership it is submitted that it is to presumed that the health board would enter into a new agreement with the ownership.   It is submitted that the applicants have not shown any change in its beneficial ownership or any contemplated change.  It is submitted that the objection to this clause, as to the other clauses, is made on a hypothetical basis.  It is submitted that in the circumstances the applicants cannot demonstrate any significant likely prejudice arising from this clause even on a hypothetical basis.   
It is submitted that insofar as the applicants only challenge certain provisions of the contract that it follows that the applicants do not dispute that in principle a health board may, for the purposes of making the ‘arrangements’ referred to in s. 59(1) and (3) of the Act of 1970 and, so far as relevant, the arrangements referred to in s. 53 of the same Act require pharmacies to enter into a contract with it and may include in that contract detailed provisions regarding the manner which the relevant services are to provided by those pharmacies.   
In this regard it is submitted that while s.59 does not, in express terms, permit health boards to enter into a contract for the purposes of making the arrangements required by that section, such a power is clearly one which is necessarily and properly required for carrying into effect the objectives of s.59 or which are fairly to be regarded as incidental to or consequential upon the functions imposed on the health board by s. 59.   In this regard counsel refers to the judgment of Keane J. in Deane v. V.H.I.  (Unreported, High Court, 22nd April, 1993).
Counsel refers to the position of the applicants when the contract was furnished for execution where the applicant Collooney Pharmacy Limited responded by stating “we have now carefully considered the terms of the new Contractor Agreement for the provision of community pharmacy services.  We are in principle, ready and willing to sign such a contract and indeed welcome it subject, however, to a number of amendments to which we respectfully draw your attention”. 
It is submitted that of relevance is the fact that ever since this applicant acquired its pharmacy in Collooney in 1995 its entitlement to supply drugs, medicines and medical and surgical appliances to eligible persons was governed by the terms and conditions of  a contract with the health boards.  It is submitted that nothing appears to turn on the terms of this contract.  It is submitted however, that the existence of the contract appears to be relevant in two respects.  Firstly, the fact that the applicant was content to enter into this contract underscores the fact that its objection is not to the requirement to enter into a contract with the health board per se, but only to the inclusion in that contract of the terms which the applicant seeks to impugn.   Secondly, the fact that at the time it was being asked to execute the new form of contract by the health board, the applicant had an existing contract with the board is relevant to its assertion that the new contract was “imposed” on it.  
Counsel stresses that the applicant could have chosen not to sign the new contract.  However, this is not what it chose to do.  It wished to have the benefits of the new contract, amongst them higher rates of payment, the capacity to dispense so called hi-tech drugs and access to educational grants, and it chose to sign the contracts.   On this basis it is submitted that the assertion that the terms of the new contract were imposed on the applicant is unsustainable.  It is submitted that the applicant has a choice.  It could have continued to operate on the basis of its existing contract.   By reasons of commercial advantage, it decided not do so and instead signed the new contract, in the full knowledge of its terms and conditions.  In the circumstances, it is submitted that this can only be characterised as a voluntary act on the part of the applicant.  It is submitted that having obtained the additional benefits available as a result of signing the new contract the applicant seeks by means of these proceedings to avoid the provisions to which it objects.  Having signed the contract and having received the considerable additional benefits available under it, it is submitted that the applicants ought not to be permitted to do so.  It is submitted that their conduct amounts to an example of approbation and reprobation.  
Counsel acknowledges that prior to signing the contract the applicants sought the amendment of certain of its provisions and were informed in response that terms of the contract were not open to negotiation.  It is submitted that this does not alter the fact that the terms of the contract were not determined unilaterally but were in fact the product of detailed negotiation between the Department of Health, the health boards, the General Services (Payments) Board and the Irish Pharmaceutical Union, representing the interests of pharmacies in the State.  It is submitted that the Minister and health boards were not obliged to negotiate with every pharmacist and/or pharmacy owner on an individual basis and acted properly and reasonably in negotiating with the I.P.U., a registered trade union authorised to negotiate on behalf of its members.  Counsel refers to the decision of this Court, O’Hanlon J. in Association of General Practitioners  Limited v. Minister for Health [1995] 1 I.R. 382.  It is submitted that this decision is of considerable importance.  The proceedings involved a complaint by the applicant, a company to promote the interest of doctors in general practice, and a number of its members that the Minister had declined to consult with them when negotiating the terms and conditions applicable to G.P. contracts for the supply of GMS services under s. 26 of the Act of 1970.   The Minister did, however, consult with the Irish Medical Association and the Medical Union and then with the Irish Medical Organisation which was formed by the merger of the two aforementioned bodies.   O’Hanlon J. described the process of determining these terms and conditions in the following terms, at p. 388:- 
“Accordingly, in relation to the provision of free medical services by general practitioners for eligible persons under the Act, the procedure followed is that the several health boards enter into contracts with the doctors, but the terms and conditions to be offered to the doctors are determined beforehand by the Minister so that uniformity is attained on a nationwide basis.   
The Act imposes no express obligation on the Minister to consult the medical profession or its representatives or anyone else before deciding on the appropriate terms and conditions, but the Minister has at all times adopted the very prudent course of engaging in lengthy discussions between representatives of the Department of Health and the doctors before completing the blueprint on which the health boards are to act.”
It is submitted that an identical process was undertaken in relation to the terms and conditions of the contract at issue in these proceedings.  Counsel refers to the fact that the complaint that the Minister should have consulted with the plaintiff company as well as with the I.M.O. was not accepted by the learned judge.  At p. 391 of the report he stated as follows:-
“This is quite a formidable body of precedent in cases where the relevant circumstances were close enough to those obtaining in the present case.   Speaking generally, I do not consider that there is any obligation imposed by ordinary law or by the Constitution on an employer to consult with or negotiate with any organisation representing his employees or some of them, when the conditions of employment are to be settled or reviewed. 
The employer is left with freedom of choice as to whether he will negotiate with any organisation or consult with them on such matters, and is also free to give a right of audience to one representative body and refuse it to another, if he choose to do so.”
	Counsel submits that, in the instant case, it is not suggested that the Minister and the health boards should have consulted with some other representative body on the applicants’ behalf or that the interests of the applicants are in any material respect different to the interests of other pharmacists.  Nor is it suggested that objection was ever taken by the applicants to the fact that the Minister and the health boards were negotiating with the Irish Pharmaceutical Union.  Furthermore, it appears that the supervising pharmacist of Collooney Pharmacy Limited was at all times a member of that body.   On this basis it is submitted that the observations of O’Hanlon J. in the passage cited apply with still greater force.  Counsel also refers to the fact that a complaint addressed by O’Hanlon J. related to the fact that the agreement precluded health boards from departing from the terms and conditions negotiated with the Irish Medical Organisation.   At p. 393 O’Hanlon J. indicated that this appeared to him to be quite defensible having regard to the importance of securing uniformity in terms and conditions of employment for all doctors participating in the G.M.S., so far as it was possible to do so.  
	Counsel submits that the same importance in securing uniformity applies in the instant case to the supply of drugs and medicines to eligible persons under s. 59 of the Act of 1970.  Counsel submits that it would be wholly impracticable and indeed undesirable to have a process of individual negotiation or to have a situation where different pharmacies were subject to materially different terms and conditions in respect of the provision of the same services.  In the circumstances, it is submitted that the fact that the health board was not in a position to negotiate with the applicant in either case in relation to amending the terms of the contract gives rise to no valid complaint on the applicants’ part in either case and less still does it provide any basis for impugning the contract or any of its provisions.   
	Counsel submits that the analogy sought to be drawn by the applicants with McCord v. Electricity Supply Board [1980] I.L.R.M. 153 is false.   In that case customers were required to agree standard terms and conditions which were determined unilaterally by the E.S.B. and which could be altered as it saw fit.  In the instant case the contract is a product of detailed discussion and negotiation with the accredited representatives of pharmacists in the State.  It is submitted furthermore that the undisputed evidence is that compared with the contract which it replaced the contract provides for a significant level of new and/or additional benefits for participating pharmacists albeit, it also provides for more onerous conditions in certain respects.  On this basis it is submitted that it represents a typical product of any negotiating or bargaining process with both sides making gains but also having to make concessions.   
	Counsel indicates on behalf of the respondents that they concede that the terms and conditions of the agreement must be strictly construed and must be operated fairly and reasonably.  Counsel indicates that this was the approach of O’Higgins C.J. in McCord v. E.S.B. [1980] I.L.R.M 153.    It is submitted that this is consistent with the approach adopted by Keane J. in Deane v. V.H.I. (Unreported, High Court, 22nd April, 1993) in which he stated at p. 97 of the judgment as follows:
“The V.H.I. is not a private commercial organisation.  It is a public body established by the Oirechtas with statutorily defined objects and powers.  While the enabling Act undoubtedly confers on the V.H.I. a wide discretion, under the ultimate control of the Minister, as to how it carries out these objectives and the manner in which it uses it powers, in common with other bodies of this nature it must use the powers entrusted to it fairly and reasonably.  That obligation which must, if necessary, be enforced by the court, exists not merely in the case of its subscribers and potential subscribers, but also in the case of the providers of health care, such as the plaintiffs with whom the V.H.I. may have reason to deal and who, for their part, have no practicable alternative to dealing with the V.H.I.”.
	Counsel indicates the acceptance on the part of the respondents that the contract is to be construed strictly and must be operated fairly and reasonably.  They do not assert that their powers under s. 59 are untrammelled and indicate that they have never so asserted.   They accept that the powers conferred by s. 59 can only be exercised for the purpose of ensuring that the objectives of s. 59, that is the supply of drugs, medicines and medical and surgical appliances to eligible persons, is effectively achieved.  It is submitted, however, that the health boards are entitled to include terms intended to secure the provision of a high quality and reliable service to eligible persons.  It is submitted that this is what has been done in the instant case and the contract does not go beyond what is reasonably necessary in this regard or contain conditions which could properly be said to be outside the scope of s. 59.   It is further submitted that the fact that certain provisions of the contract address matters which could also have been addressed in regulations made for the purposes of s. 59 is not relevant to the resolution of the issues before the Court.  Counsel submits that the contract is not expressed to be and is not dependant on the existence of regulations.  The absence of regulations does not relieve the health boards of the duty to make arrangements for the purposes of s. 59 or circumscribe their power to make such arrangements as appear appropriate.   
	Counsel submits that the contract must be adjudged on its own merits and by reference to the circumstances that now obtain.   In particular, in considering how the provisions impugned by the applicants may operate in practice, the Court must, it is submitted, proceed on the footing that the 1996 Regulations have been revoked and that, in consequence, the provisions of those regulations restricting the grant of new contracts are no longer material.  
	Counsel refers to the fact that the applicants’ complaints are couched in hypothetical terms.  It is submitted that it is striking that notwithstanding the fact that a period of nearly seven years has now lapsed since the proceedings commenced, the applicants have failed to put before the Court any evidence of any actual difficulty having arisen in relation to the operation of the contract.  The inevitable inference is that no difficulties have in fact arisen, notwithstanding the concerns expressed by the applicants since 1996.  
	Counsel submits that the applicants are inviting this Court to constitute itself as some form of contracts review board, taking a blue pencil to the those provisions of the contract which might, at some point in the future, operate in an unfair or unreasonable manner.  Counsel submits that this is inappropriate.  It is submitted that the Court is not there to render advisory opinions, founded on hypothesis.  Counsel refers to the fact that the applicants have not pointed to any instance where the health board has operated the contract unfairly or unreasonably.  It is submitted that if such an instance occurs the applicants will have a remedy at that stage and the Court will have real and definite issue to determine.  In the absence of any evidence of actual difficulty, it is submitted that the Court should not be drawn into adjudicating in a necessarily abstract manner on the terms of the contract.  
	Dealing with clause 6 (2), it is submitted that this cannot be impugned unless it can be shown to be unreasonable and it is submitted that the applicants have not put any material before the Court to support any such conclusions.  With regard to the contention that this clause is invalid having regard to the provisions of s. 2 of the Act of 1962, counsel submits that the clause could not and does not purport to amend s. 2 of the Act of 1962, which continues in full effect.  It is submitted that the clause merely relates to the supervision of community pharmacies which wish to participate in the GMS scheme and it is not in any sense inconsistent with s. 2 which does not deal with the conditions in which authorised persons or bodies corporate may participate in the GMS scheme, still less confer upon such persons any right to participate in such a scheme. 
	Dealing with clauses 19 (3) and 19 (5) again it is submitted that there is no evidence that these provisions have operated in a manner detrimental to the applicants.  It is submitted that rather than underscoring the “quasi legislative character of the contract” they merely reflect the process by which the terms of the contract came to be agreed and the possibility that changes to the contract may be negotiated by the same process in the future.  It is submitted that in the context of any particular amendment or amendments being agreed it might be open to the applicants to assert that, having regard to the nature and or extent of the amendments involved, it would be unfair or unreasonable to rely on these clauses in that regard.  It is submitted however that this is not an issue which arises at this stage or one which can be resolved by the Court in these proceedings.   
	Dealing with clauses 19 (1), 20 (1), 22 (3) and 22 (6), relating to termination, counsel concedes that a certain difficulty arises with the language of these provisions.  It is submitted that the cardinal provision is clause 20 (1) which provides that where a supervising pharmacist ceases to act in that capacity, that contract will terminate in one month unless another supervising pharmacist is nominated and accepted by the chief executive officer in that period.  It is submitted that while the language of clause 19 (1) and clause 22 (6) may be difficult to reconcile with clause 20 (1) insofar as there is a conflict or inconsistency between those clauses, it would, on ordinary principles of contract law, be open to the court, where any difficulty arose to apply the provisions of clause 20 (1) even in the case of retirement or death of the supervising pharmacist.  Counsel submits that it would be open to the Court in such circumstances to restrain the health board from relying on the provisions of clause 19 (1) or 20 (6) in the event that the Court considered that would be unfair or unreasonable, having regard to the principles established in McCord v. E.S.B. [1980] I.L.R.M. 153 and the other cases referred of Deane v. V.H.I. (Unreported, High Court, 22nd April, 1993) and Zockoll Group Limited v. Telecom Eireann [1998] 3 I.R. 287.   Counsel submits that these are the very arguments that the applicants could be anticipated to make if an actual difficulty were to arise.  It is submitted that it suits the applicants’ present purposes to present the terms of the contract in as stark and absolute manner as possible.  
	Counsel submits that the health boards operate the provisions of clause 20 (1) in relation to all circumstances in which a supervising pharmacist ceases to act, that is in cases of retirement and death as well as in cases where the supervising pharmacist simply changes his or her employment.  In such circumstances, it is submitted that the contract is not treated as having been terminated and a period is allowed for the nomination of another supervising pharmacist, who may of course be a locum.  
	Counsel submits that insofar as a complaint is made regarding the one month period that there is no evidence before this Court that this in practice gives rise to a difficulty.  It is submitted that in any event it is clear that the respondents cannot and in practice do not enforce this time limit where it would be unfair or unreasonable to do so.   Counsel submits that it must borne in mind that, whatever may have been the potential consequences of losing a contract while the 1996 Regulations were in force, as matters stand, even if the applicants were to lose their contracts by reason of the operation of any of the clauses at issue, there would be nothing to prevent them applying for a further contract immediately and nothing which would justify the refusal of such a contract in such circumstances.  It is submitted that this applies equally to clause 22 (3) of the contract.  In this regard it is indicated that the respondents accepted that were they to rely on this provision in circumstances which made it unfair or unreasonable to do so, a remedy would lie with applicants.   

CONCLUSIONS 
	In the first place it is to be noted that the provisions of s. 59 of the Act of 1970 have been re-enacted in an amended form by s. 1 of the Health (Miscellaneous Provisions) Act, 2001.  However, insofar as these proceedings were taken prior to the enactment of that Act, I believe it is appropriate to address the arguments in this case in light of the earlier provision and without prejudice to the points being made by the applicants in these proceedings.   
	Section 59 of the Act enables health boards to make arrangements for the supply without charge of drugs, medicines and medical and surgical appliances to persons with full eligibility.  The provision of this section enabling arrangements to be made does not preclude the health board from entering into any contractual arrangements with any party.  Sub-section 4 of s. 59 which provided for the making of regulations by the Minister related to the services under the section.   I do not take the view that the power vested in the Minister to make regulations in any way precludes health boards from making any contractual arrangements such as those made in this case.  
	While the applicants have submitted through their counsel that the contract at issue in these proceedings must be treated as a contract of adhesion, I believe that a distinction may be drawn between the contract in this case and the contract such as that at issue in McCord v. Electricity Supply Board [1980] I.L.R.M. 153.  It is clear that the contract at issue in these proceedings was one which was the result of a process of negotiation between representative bodies and State authorities.   
	While it is clear that neither the applicants nor the respondent health boards, are in a position to change the terms of the agreement, insofar as it is considered necessary to secure uniformity in the terms and conditions pertaining to the supply of services under s. 59, I believe that this Court is assisted by the decision of O’Hanlon J. in Association of General Practitioners Limited v. Minister for Health [1995] 1 I.R. 382 in which this Court considered as quite defensible, having regard to the importance of securing uniformity in terms and conditions of employment with doctors participating in the GMS, so far as it was possible to do so, to fetter the discretion of health boards with regard to their power to enter into any fresh agreement.   
	I believe that it is appropriate nevertheless, to consider whether the terms contained in the agreement are such as to be inherently unreasonable or at variance with the spirit, if not the letter of s. 59 of the Act of 1970.  
	With regard to clause 6 (2) of the agreement the essential case made is that this amounts to an interference with the rights conferred by s. 2 of the Pharmacy Act, 1962.   It is clear that the Act does not impose a three year limitation on persons keeping opened shops for dispensing or compounding of medical prescriptions.   However, it is clear that pharmacists may continue to act under the terms of the Act of 1962 in circumstances where they are not bound by any contractual terms such as those relating to the applicants herein.  I do not consider that the contract at issue in these proceedings is such as to amount to an interference with the provisions of the Act of 1962 and in particular s. 2 thereof which remains, notwithstanding the terms of the contract.  In this regard I accept the submissions made by counsel on behalf of the respondents to the effect that s. 2 of the Act of 1962 establishes a minimum legal requirement and professional qualification required of a pharmacist.  I also accept that it does not mean that the respondents in entering into major contracts for the supply of pharmaceutical services to eligible persons are not entitled to seek that the pharmacists being given primary professional responsibility should not also have an appropriate level of experience. 
	With regard to the further challenge raised to the individual sections addressed in these proceedings I accept the submission of counsel for the respondent that the attack is essentially hypothetical in nature insofar as no particular instances have been indicated to this Court by either of the applicants whereby they have been affected by any application of the clauses at issue.  No evidence has been put before this Court of any actual difficulty having arisen in relation to the operation of the contract by either of the applicants.   
	I accept as correct the submission made by counsel on behalf of the respondents that the contract has to be construed in a reasonable manner and must be construed strictly and operated fairly.  With regard to clause 6 (2) I accept the submission made on behalf of the respondents that they were entitled to include provisions, the purpose of which was to ensure the provision of high quality services to eligible persons.  I believe that having regard to the nature of the services, including the complexity of pharmaceuticals, that it can not be said to have been unreasonable to stipulate a requirement for three years relevant experience in the case of a supervising pharmacist.  
	With regard to clauses 19 (3) and 19 (5) pertaining to any proposed changes to the agreements at issue in these proceedings I do not believe it to be unreasonable that the parties who negotiated the agreement or contract would agree to the possible change in the terms of any such arrangements that might be entered into.  
	With regard to clauses 19 (1), 20 (1) 22 (3) and 22 (6), dealing with the termination of the agreements in certain circumstances, it has been conceded on behalf of the respondents that a certain difficulty arises with the language of these provisions.   Counsel for the respondents refers in particular to the clause 20 (1) which provides that where a supervising pharmacist ceases to act in that capacity the contract will terminate one month thereafter unless another supervising pharmacist is nominated and accepted by the chief executive officer within that period.
	I do not accept that clause 22 (6) can be construed as entitling the chief executive officer to grant a contract in respect of the applicants’ premises to another party without their approval.   I believe that the clause in question must be construed on a reasonable basis.  It must furthermore be stated that no evidence has been put before this Court to suggest that at any time has either of the respondents sought to apply this clause in the manner contended for by the applicants.   
	With reference to clause 22 (3) which provides for the automatic termination of the agreement in the case of a change of ownership or in the beneficial ownership of the community pharmacy contractor in question, I accept that on its face this suggests that even the most minute change in the share ownership of the applicant would result in the automatic termination of the agreement.  I understand the submissions that have been made on behalf of the respondents to amount in effect to a concession that this clause does not sit comfortably with the other clauses in the agreement and I believe that on its face it is some what unreasonable and disproportionate especially as a change in ownership may be very incidental in nature.   On the other hand a significant change in ownership could have a bearing but I believe that in any such circumstance a clause providing for the notification of the change in share ownership and provision allowing for the termination in certain circumstances to be effected within a reasonable period would avoid the criticism that has been levelled at this particular clause.  
However, it has again to be conceded that at no stage has it been suggested that this clause has been applied by either of the respondents as against the applicants or any other persons.   I should add that I accept the submission made on behalf of the respondents that it is appropriate that the beneficial ownership of a limited liability company seeking to operate a community pharmacy should be identified to the health boards.   As submitted by counsel, it is clearly appropriate that any change in ownership should be notified to the health board and that the agreement should be reviewed in the light of that change of ownership.  As submitted, provided there was nothing objectionable in the new beneficial ownership, it is to be presumed that the health board would enter into a new agreement with the new ownership.  However, I believe that insofar as the clause 23 (1) and clause 22 (3) provide for an automatic termination in the agreement that this could arise in the event of the death of a beneficial owner of a share in a limited liability company.  In the circumstances I believe that the requirement for a new agreement has not been established to be necessary in all cases.   On the other hand it has not been demonstrated by either of the applicants that they have been significantly prejudiced by reason of the particular clauses in question insofar as no suggestion has been made that these clauses are sought to be called into effect by the respondents.   
	In conclusion in all the circumstances of the case I do not propose to make any order of certiorari quashing the impugned decisions or to make any formal declaration of the nature sought in these proceedings.