Dáil Éireann debate -
Tuesday, 3 Apr 2001

Vol. 533 No. 6

Written Answers. - Pharmacy Regulations.

Deirdre Clune

Question:

216 Ms Clune asked the Minister for Health and Children the reason a person who qualified as a pharmacist in the United Kingdom cannot own, manage or operate a pharmacy here for three years, in view of the fact this rule does not apply to Australia or New Zealand; and if he will make a statement on the matter. [9757/01]

Minister for Health and Children (Mr. Martin):

Section 2 of the Pharmacy Act, 1962, provides for the keeping of open shop for the dispensing of medical prescriptions and sale of poisons. The legislation does not restrict the ownership of pharmacies but provides that the dispensing and compounding of medical prescriptions must be under the personal supervision by an "authorised person" as defined under section 2(3) of the Act. A shop for the sale of poisons must also be under the personal management of an "authorised person" as defined under section 2(3). The European Communities (Recognition of Qualifications In Pharmacy) Regulations, 1987 (S.I. No. 239 of 1987) amended the Pharmacy Act, 1962 by the insertion in section 2 of a new subsection – subsection 3A – which further defined an "authorised person". This was further defined in the European Communities (Recognition of Qualifications in Pharmacy) Regulations, 1991 (S.I. No. 330 of 1991). The purpose of S.I. No. 239 of 1987 and S.I. No. 330 of 1991 was to give statutory effect in this country to EEC Council Directives 85/432/EEC, 85/433/EEC and 85/584/EEC. These regulations provide for the mutual recognition of qualifications in pharmacy in respect of nationals of member states and include the provision that a pharmacy in this State which has been in operation for less than three years shall not be managed or supervised by a pharmacist who qualified in another EC member state.

Attempts were made by the European Com mission on several occasions to introduce measures which would facilitate the free movement of pharmacists. However, restrictions in most member states on the freedom of pharmacists to open new pharmacies became a major stumbling block to the adoption of any Council directives which would provide for the free movement of pharmacists. Member states that had restrictions on the opening of new pharmacies were unwilling to remove them and other member states, including Ireland, were unwilling to support a measure which would impact unfairly on their own graduates. For example, while Irish graduates would be restricted from opening pharmacies elsewhere, their peers from other member states would not be restricted from opening pharmacies in Ireland and in other countries with no such controls. Eventually, a compromise proposal was worked out which provided for a derogation incorporated in Article 2.2 of Council Directive 85/433/EEC which was a derogation from the obligation to recognise EC qualifications in respect of "new pharmacies" in this case pharmacies which have been in operation for less than three years. Regulations were then made in this country to give statutory effect to the directives and which availed of the derogation concerned. Issues arising from unrestricted pharmacy openings were later addressed in Ireland by the introduction of the Health (Community Pharmacy Contractor Agreement Regulations), 1996. However, these regulations quickly became the subject of a judicial review and it was decided to defer any change to the regulations dealing with the mutual recognition of qualifications until all legal issues concerning the Health (Community Pharmacy Contractor Agreement) Regulations, 1996 were resolved.

My view is that the use of the derogation provided for in Article 2.2 of Council Directive 85/433/EEC is not a satisfactory solution in the longer term. The derogation provided for and introduced in this country did not impact on the pre-existing arrangements in respect of pharmacy graduates travelling between this country and Australia and New Zealand.

The Deputy will appreciate, however, that it would be premature to amend the regulations providing for the mutual recognition of qualifications until all legal issues concerning the Health (Community Pharmacy Contractor Agreement) Regulations, 1996 have been resolved.