THE HIGH COURT
			2001 No. 3648P
BETWEEN
SAM McCAULEY CHEMISTS (BLACKPOOL) LIMITED AND MARK SAJDA 
			PLAINTIFFS
AND
PHARMACEUTICAL SOCIETY OF IRELAND, THE MINISTER FOR HEALTH AND CHILDREN, IRELAND AND THE ATTORNEY GENERAL 
			DEFENDANTS
JUDGMENT of Mr. Justice McCracken delivered the 31st day of July, 2002.
	The factual background to this case can be stated very shortly.  The second named plaintiff is a Scottish national who is a qualified pharmacist in the United Kingdom, having graduated from the University of Aberdeen.  The first named plaintiff is one of a group of companies owning a number of pharmacies throughout the country, and is the owner of a pharmacy at Blackpool Shopping Centre in Cork.  This pharmacy only commenced business in October 2000.  The second plaintiff was employed by the first plaintiff from August 2000, and participated in setting up the shop.  Section 2(1)(a) of the Pharmacy Act 1962 provides:-
“A person shall not keep open shop for the dispensing or compounding of medical prescriptions unless 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.”

	The first defendants, which is the regulatory authority for pharmaceutical chemists, has alleged that the second plaintiff is not eligible or qualified to be the supervising person in the first plaintiff’s shop, or in any shop which has been opened for less than three years.  This arises from the implementation of Council Directive No 85/433/EEC by means of the European Communities (Recognition of Qualifications in Pharmacy) Regulations 1991, being statutory instrument number 330 of 1991.  The plaintiffs seek to have this statutory instrument declared invalid pursuant to Article 15.2 of the Constitution which provides:-
“1. The sole and exclusive power of making laws for the state is hereby vested in the Oireachtas: no other legislative authority has power to make laws for the state.”
	The defendants argue that the statutory instrument is valid by virtue of Article 29.4.5 of the Constitution, which provides:-
“No provision of this Constitution invalidates laws enacted, acts done or measures adopted by the State which are necessitated by the obligations of membership of the European Union or of the Communities.”

	The actual provision of the statutory instrument which it has sought to impugn is an amendment of the Pharmacy Act 1962 contained in paragraph four of the instrument by inserting a subsection 3A to Section 2 of the 1962 Act in the following form:-
“In this Section the expressions “authorised person” and “registered pharmaceutical chemist” shall not include a person registered by virtue of Section 22A of the Pharmacy Act (Ireland) 1875 (38 and 39 Vict.c.57) acting in respect of a shop for the dispensing or compounding of medical prescriptions or for the sale of poisons where such shop has been in operation for less than three years.”

	Freedom of movement of workers has been one of the basic principles underpinning the European Union and Article 40 (formerly Article 49) of the Treaty establishing  the European Community required the Council to issue directives or make regulations setting out the measures required to bring about freedom of movement for workers. As part of the general principle, the Treaty also contained provisions in Article 47 (formerly Article 57) relating to the common recognition of qualifications, the relevant portions of which are as follows:-
“1. In order to make it easier for persons to take up and pursue activities as self employed persons, the Council shall, acting in accordance with the procedure referred to in Article 251, issue directives for the mutual recognition of diplomas, certificates and other evidence of formal qualifications.  
.....
3. In the case of the medical and allied and pharmaceutical professions, the progressive abolition of restrictions shall be dependent upon co-ordination of the conditions for their exercise in the various member states.”

	Pursuant to these provisions, two council directives were issued on 16th September 1985.  The first directive, number 85/432/EEC, set out minimum qualifications for pharmacists and the second directive, with which we are concerned, namely number 85/433/EEC, is expressed in its title as being a directive:-
“Concerning the mutual recognition of diplomas, certificates and other evidence of formal qualifications in pharmacy, including measures to facilitate the effective exercise of the right of establishment relating to certain activities in the field of pharmacy.”
	Article 2 of that directive provides:-
“1. Each member state shall recognise the diplomas, certificates and other formal qualifications listed in Article 4 awarded to nationals of member states by other member states in accordance with Article 2 of directive 85/432/EEC by giving such qualifications, as regards the right of access to and pursuit of the activities referred to in Article 1, the same effect in its territory as those diplomas, certificates and other formal qualifications, listed in Article 4, which it itself awards.
2. However member states need not give effect to the diplomas, certificates and other formal certificates referred to in paragraph 1 with respect to the establishment of new pharmacies open to the public.  For the purpose of applying this directive, pharmacies which have been in operation for less than three years shall also be regarded as new.”

	This directive also contained a recital which sets out the background to the provisions of Article 2.2 quoted above, which recital reads:-
“Whereas, under their national policies in the sphere of public health, which seek inter alia to ensure the satisfactory dispensing of medicinal products over their entire territories, certain member states restrict the number of new pharmacies that may be established, while others have adopted no such provision; whereas in these circumstances it is premature to provide that the effects of the recognition of diplomas, certificates and other evidence of formal qualifications in pharmacy must also extend to the pursuit of the activities of pharmacist as the controller of a pharmacy open to the public for less than three years; whereas this problem must be re-examined by the Commission and the Council within a certain period.”

	The provisions of Article 2 of the directive were considered by this Court in the case of Young -v- The Pharmaceutical Society of Ireland and Others (1995) 2 I.R. 91, which challenged the same provisions that are at issue in this case, but on different grounds.  In that case Murphy J. said at p. 102:-
“Thus it would seem that the statutory instruments aforesaid implement and reflect the directives of the council in the first place by requiring the Irish responsible body to extend registration to nationals of member states who hold identified qualifications or alternatively hold other non recognised qualifications but possess certificates testifying to certain periods of study and experience.  The regulations contained in subsections 1 and 2 of Section 22A as inserted by the regulations of 1987, or paragraphs (a) and (b) of subsection 1 of Section 22A as inserted by the regulations of 1991, reflect the two situations as provided by Articles 4 and 6 of the recognition directive.  Section 2 subsection 3A of the Act of 1962, as inserted by both regulations clearly repeats Article 2, sub article 2 of the recognition directive.”

	He also said at p. 105:-
“The general aim to eliminate obstacles to the establishment of professions and businesses in member states and the crystallisation of that objective on the expiration of the transition period has had the effect already noted and it would be impossible to derogate from the provisions of the treaty itself except on the basis of the specified grounds.  As I see it, there is no question of derogation from the requirements of the treaty.  What is permitted (subject to review by the Commission or the Council of the operation of the regulation) is to refrain from recognising the specified diplomas in relation to a particular range of pharmacies.  What the recital makes clear is that to do so would be “premature”.  

	Finally at p.106 he said:-
“The recognition directive is not a document granting, withdrawing or limiting the right of establishment.  That document and all other recognition directives made under Article 57 sub article 1 of the Treaty of Rome 1957 are made to facilitate or, as the provision itself states, “to make it easier for” persons taking up and pursuing activities as self employed persons.  It is a facilitating provision not a substantive one.  I see no reason why the council would not, for the very good reasons which they identified, limit the facility thereby conferred but without prejudicing the basic right.  Certainly, it seems to be crystal clear that that is what they did and what they set out to do.”

	The general position of implementing European law requirements by secondary legislation has been considered in several cases.  The wording of Article 29.4.5 of the Constitution makes it quite clear that Article 15.2 will not invalidate any measure, including a statutory instrument, which is necessitated by the obligations of membership of the European Union.  Some European law requirements, if made by regulation, may become directly effective in this country without any further national legislation.  Other requirements, such as the present one, are laid down by institutions of the European Union with a direction to the member states to incorporate such matters into their national law.  How this is to be done is a matter for each individual member state, and Ireland has in many cases chosen to do this by a statutory instrument made pursuant to Section 3 of the European Union Communities Act 1972.  It is quite clear from Sections 2 and 3 of that Act that this power to make regulations is solely in relation to acts adopted by institutions of the European Communities, and is solely for the purpose of ensuring that such acts have full effect in national law.  Anything contained in a regulation purporting to be made under this power which exceeds this authority will be ultra vires, and if it purports to add to or amend national legislation, it would be void under Article 15.2 of the Constitution. 
	This principle was clearly laid down in Meagher -v- Minister for Agriculture and Food and Others (1994) 1 I.R. 329.  Blayney J. said at p. 360:-
“The Article (Article 189 of the Treaty of Rome) obliges the State to implement the directive and equally obliges the State, in exercise of the discretion given to it, to choose an appropriate method of implementation.  If the State were free not to implement the directive, then clearly, if it were to do so, it would be a voluntary act not necessitated by the obligations of that membership and would not be protected by Article 19, S.4 subs. 5 of the Constitution.  But the State is not free.  It is obliged to implement the directive and so is obliged to choose a method of implementation and, provided the method it chooses is appropriate for the purpose of satisfying the obligations of the State and the measures it incorporates do not go beyond what is required to implement the directive, it is correctly categorised as being necessitated by the directive.  In any instance where the method was not appropriate, or its measures went beyond what was required, it would not be necessitated and would be open to constitutional challenge.”

	In the same case Denham J. said at p. 365:-
“If the directive left to the national authority matters of principle or policy to be determined then the “choice” of the Minister would require legislation by the Oireachtas.  But where there is no case made that principles or policies have to be determined by the national authority, where the situation is that the principles and policies were determined in the directive, then legislation by a delegated form, by regulation, is a valid choice.”

	The matter was considered more recently by the Supreme Court in Maher -v- Minister for Agriculture and Rural Development (2001) 2 I.R. 139.  Keane C.J. said at 
p. 185:-
“I am, however, persuaded by the analysis carried out by Fennelly J. in the judgment that he will deliver that, in the case of  the operation of the super levy scheme, the choices as to policy available to the member states have, in truth, being reduced almost to vanishing point.  As he points out, the scheme which has given rise to these proceedings was essentially the creation of the European Union and, if one seeks to determine the principles and policies which underlie it, one must look, not to any parent legislation in Ireland, but to the treaties of the European Union and the regulations and directives which have established the complex machinery of the common agricultural policy and the common market in milk.  It follows that the making of the regulation was not an impermissible exercise of the legislative role of the Oireachtas and that the applicant’s contentions to the contrary are not well founded.”

	These authorities make it quite clear that it is permissible to implement a directive by way of regulation or statutory instrument if the policy that is being implemented is the policy of the European Union and if the member state does not have to make any policy decisions.  The net issue, therefore, is whether the regulation in this case involved any decision of policy or the exercise of any discretion involving a policy decision by Ireland.  The plaintiff points to the wording of the directive, and in particular of Article 2.2, which provides that member states “need not” give effect to qualifications from other member states with respect to new pharmacies as therein defined as giving each member state a discretion whether to give full recognition to qualifications, or only to give limited recognition by excluding new pharmacies.  The defendants, on the other hand, argue that all that is done by the regulation is to provide for the obligatory recognition of other member states qualifications, and therefore everything in the regulation is in fact necessitated by the provisions of the directive.
	I think to get a better understanding of the position, it is necessary to look at the effect of the regulation on the pre-existing law.  Prior to the regulation the Pharmacy Act (Ireland) 1875 and the Pharmacy Act 1962 regulated who could act as a pharmacist.  The 1875 Act provided for an examination system for persons wishing to be pharmacists and for the registration of persons who qualified under such examination system or who were licensed by Apothecaries Hall, and only persons so registered could practice as pharmacists.  Section 2 of the 1962 Act provided that a person should not keep open shop for the dispensing or compounding of medical prescriptions unless he or she was an authorised person, which was defined in subsection 3 as being a registered pharmaceutical chemist, a registered dispensing chemist and druggist, a licentiate of Apothecaries Hall or, under certain circumstances, a registered medical practitioner.  Persons qualified as a pharmacist in other European Union countries, including the second plaintiff, could not practice their profession in Ireland because they could not become registered without passing the necessary examinations under the 1875 Act.
	The directive obliged Ireland, and other member states, to change this situation.  It imposed an obligation on Ireland to recognise specified qualifications set out in the directive so that they had the same effect as national qualifications.  However, it stopped short of requiring such recognition in all cases because, as stated in the recital, it would be premature to do so, and therefore it did not require recognition in the case of new pharmacies as defined in the directive.  As was said in the passage I have quoted from Young -v- Pharmaceutical Society of Ireland the regulation simply repeats what is in the directive and does nothing more.  The only amendment which the regulation makes to existing national legislation is to extend recognition of qualifications to the extent that it is required to do so under the directive.  It does not in any other way legislate, or amend existing legislation.  Prior to the regulation, the second plaintiff could not have acted as a pharmacist in a new pharmacy, and he still cannot act as a pharmacist in a new pharmacy.  The law has not been changed in that regard. 
	In one sense of course it could be said that there was a policy decision not to extend recognition of other qualifications to new pharmacies.  However, this was not a decision which was in anyway implemented in the statutory instrument.  It is a decision not to change the existing law any further than was required by the directive.  Decisions not to change law are made by government every day and do not require legislation, primary or secondary, to give force to such decisions.  If a policy decision was made not to extend recognition any further than was necessary, that decision does not require the making of a law for the State within the meaning of Article 15.2 of the Constitution, and therefore that Article has no relevance.
	Accordingly, as the only new law which was made or brought into effect by the regulation was law required by virtue of the policy decision of the Council of Ministers as set out in the directive, it is protected by Article 29.4.7 as being necessitated by the obligations of membership of the European Union.  The plaintiff is not entitled to the relief sought.