S.I. No. 152/1996:

HEALTH (COMMUNITY PHARMACY CONTRACTOR AGREEMENT) REGULATIONS, 1996

HEALTH (COMMUNITY PHARMACY CONTRACTOR AGREEMENT) REGULATIONS, 1996

The Minister for Health, in exercise of the power conferred on him under Section 59 (4) of the Health Act, 1970 , and with consent of the Minister for Finance, hereby makes the following Regulations:--

1. These regulations may be cited as the Health (Community Pharmacy Contractor Agreement) Regulations, 1996.

2. (1) In these regulations--

"catchment area", in relation to a community pharmacy, means the natural geographic area to which the community pharmacy at its location may reasonably be expected to provide its services to the population in that area;

"chief executive officer" means the chief executive officer of the health board in whose functional area the community pharmacy is located and includes any other officer of the health board designated for the purpose by such chief executive officer;

"community drug schemes" means any scheme involving the supply of medicines or the reimbursement in respect of medicines supplied other than in the GMS;

"community pharmacy" means a shop being lawfully kept open for the dispensing and compounding of medical prescriptions in accordance with the Pharmacy Acts, 1875 to 1977, including the storage and dispensary areas relating thereto, but does not include a pharmacy operated in a hospital, nursing home or similar institution except in circumstances where such shop, operated by or in the said hospital, nursing home or similar institution, is intended to provide for the dispensing and compounding of medical prescriptions to the public at large;

"urban and large town" means a town having a total population of not less than 3,000, including the population in its suburbs and environs, as reported from time to time by the Central Statistics Office in the National Census of Population;

"definite public health need" means that in the catchment area to be served by a new community pharmacy in respect of which an application for a community pharmacy contractor agreement has been made --

(i) in the case of urban and large towns, the catchment area has a population of not less than 4,000 for most of the year;

(ii) in the case of other locations, the catchment area has a population of not less than 2,500 for most of the year; and

(iii) the distance between the premises in respect of which the community pharmacy contractor agreement is being sought and the nearest community pharmacy measured door to door by the shortest lawful access route, is

(a) 250 metres in the case of urban and large towns;

(b) 5 kilometres in rural areas; and

(iv) the community pharmacy contractor agreement applied for will not have an adverse impact on the viability of existing community pharmacies in their respective catchment areas to the extent that it will affect the quality of pharmacy services being provided by them;

"GMS" means the scheme for the provision of medicines under Section 59 (1) of the Health Act, 1970 ;

"health board" means a board established under Section 4 of the Health Act, 1970 ;

"medicines" includes drugs, medicines, reagents and appliances and such other products as may be approved from time to time by the Minister;

"the Minister" means the Minister for Health;

"new community pharmacy" means a community pharmacy which was not open and providing pharmacy services under the Health Act 1970 on or immediately before the coming into force of these Regulations;

"the pharmaceutical contractors' committee" means the pharmaceutical contractors' committee of the Irish Pharmaceutical Union;

"pharmacist" means a registered pharmaceutical chemist, a registered dispensing chemist and druggist or a licentiate of Apothecaries Hall who obtained his licentiate prior to 31st December, 1975;

"community pharmacy contractor agreement" means an agreement entered into between a health board and the proprietor of a community pharmacy in order to enable that pharmacy to provide pharmacy services under the Health Act, 1970 ;

"supervising pharmacist" means the pharmacist under whose personal supervision the community pharmacy is conducted;

"pharmacy contractor" means a proprietor of a community pharmacy who has entered into a community pharmacy contractor agreement with the health board in whose functional area the pharmacy is located.

(2) In these Regulations, unless the context otherwise indicates, any reference to an article shall be construed as a reference to an article contained in these Regulations and any reference in an article to a sub-article shall be construed as a reference to a sub-article of that article.

3. These Regulations shall not apply to any community pharmacy which was open and providing services under the Health Act, 1970 on or immediately before the coming into force of these Regulations.

4. (1) Subject to sub-article (2), these Regulations shall not apply to the relocation of a community pharmacy, which is the subject of a community pharmacy contractor agreement, in any of the following circumstances--

(i) the temporary relocation of a community pharmacy for a maximum period of one year in circumstances involving the renovation or refurbishment of the said pharmacy premises. The chief executive officer may grant his/her approval for an extension of the said period of temporary relocation provided he/she is satisfied that such extension is necessary in order to complete the work within the extended period;

(ii) the permanent relocation of a community pharmacy necessitated by a decision of a statutory authority, other than the health board or the chief executive officer, in circumstances which are wholly outside the control of the pharmacy contractor;

(iii) where the health board or the chief executive officer makes a decision or gives approval to the relocation of other related health services which, in the opinion of the chief executive officer, may adversely affect the viability of a community pharmacy in respect of which a community pharmacy contractors' agreement is held at its existing location;

(iv) where two or more community pharmacies, in respect of which community pharmacy contractor agreements are held, amalgamate;

(v) the permanent relocation of an existing community pharmacy to an adjacent premises with a view to improving the facilities and the community pharmacy services to be provided therein;

(vi) any other exceptional circumstances which the chief executive officer may determine from time to time;

(2) Any relocations referred to in sub-article (1) shall be subject to the following conditions--

(i) the approval in writing of the chief executive officer, following consideration of the provisions of this article, shall have been obtained in respect of the proposed relocation;

(ii) the premises into which the community pharmacy is relocated, its equipment, facilities and staff, and the activities conducted therein shall be such as to meet the requirements of the community pharmacy contractor agreement including such standards in that regard as may be published from time to time by the Pharmaceutical Society of Ireland with the consent of the Minister;

(iii) the distance door to door of the relocated community pharmacy by the shortest possible lawful route from its previous location shall not exceed 250 metres and shall have regard to the impact on existing pharmacy contractors and the availability of community pharmacy services in the catchment area;

(3) Before granting approval under sub-article (2)(i), the chief executive may consult with the Pharmaceutical Society of Ireland and/or the pharmaceutical contractors' committee.

(4) The chief executive officer shall furnish to the applicant for relocation--

(i) any information which he may have received pursuant to consultation held by virtue of sub-article (3);

(ii) any other information which comes into his/her possession in his/her consideration of the application;

and shall consider any further observations submitted by the applicant on foot of the information furnished under this sub-article. Any such observations shall be made within twenty-one days of the date on which the information was furnished to the applicant.

(5) Notwithstanding the provisions of sub-article (2)(iii), the chief executive officer may at his/her discretion allow the relocation of a community pharmacy at a location otherwise than is provided for in the sub-article (1), provided that the relocation reasonably relates to the catchment area in which the community pharmacy was previously located. In reaching a decision under this sub-article, the chief executive officer may consult with the Pharmaceutical Society of Ireland and/or the pharmaceutical contractors' committee.

5. (1) Subject to the provisions of these Regulations, no community pharmacy contractor agreement shall be granted or offered unless the chief executive officer is satisfied in respect of the following conditions--

(i) that there is a definite public health need for the supply of community pharmacy services in the particular catchment area to which an application relates;

(ii) the premises have free and direct access to the public road at all times;

(iii) the proposed premises, its equipment, facilities and staff, and the activities to be undertaken thereon, shall be such as to meet the requirements of the community pharmacy contractor agreement applied for, including any standards for such premises, equipment, facilities, staffing and activities conducted therein as may be published from time to time by the Pharmaceutical Society of Ireland with the consent of the Minister;

(iv) the proposed supervising pharmacist shall have at least three years recent post registration experience in the practice of community pharmacy including up-to-date professional knowledge and experience in the counselling of patients in their use of medicines and is not acting in a similar capacity in respect of any other pharmacy;

(v) the proposed supervising pharmacist shall have a high degree of professional competence including the ability to effectively manage the community pharmacy;

(vi) the proposed pharmacy practice has a reasonable prospect of being viable in the context of the pharmacy services to be provided and that there is a long term commitment to the catchment area which it is intended to serve.

(2) Notwithstanding the provision of sub-article 1(i), the prescribed population and/or distances between premises may be adjusted at the discretion of the chief executive officer to take account of any exceptional demand for community pharmacy services in the catchment area, having regard to the geographic characteristics and public health needs of that area and the overall community pharmacy services in the functional area of the Board and in adjoining boards, where appropriate. In making a decision under this sub-article, the chief executive officer may consult with the Pharmaceutical Society of Ireland and/or the pharmaceutical contractors' committee.

6. A condition of granting a new community pharmacy contractor agreement shall be that a pharmacist having the experience required under sub-article (1)(iv) of article 5 shall be maintained in the position of supervising pharmacist, at the community pharmacy concerned.

7. (1) The applicant for a community pharmacy contractor agreement shall be required to make a detailed application in writing to the chief executive officer of the health board, in whose functional area the community pharmacy is to be located, in the manner determined by the chief executive officer. Such applications shall include the following--

(i) a description of the community pharmacy services to be provided which shall be consistent with the terms and conditions of the community pharmacy contractor agreement;

(ii) such evidence as demonstrates that there is a definite public health need for the supply of community pharmacy services in the particular catchment area to which the application relates;

(iii) evidence of the viability of the pharmacy practice in respect of which a community pharmacy contractor agreement is being sought which shall be based on the projected level of activity expected to be generated from the professional practice of pharmacy, excluding those activities which are not related to the professional practice of pharmacy;

(iv) name, address and registration number (as a pharmacist) of the proposed supervising pharmacist, including details of his/her recent experience in the practice of community pharmacy and of his/her experience in the counselling of patients in their use of medicines, and how he/she has kept up-to-date in his/her professional knowledge;

(v) details of any other pharmacist and other staff to be engaged in the operation of the pharmacy;

(vi) the address of the proposed community pharmacy;

(vii) any other information which may be deemed necessary by the chief executive officer for the purpose of making an application or supplementing an application already made;

(2) (i) Applications shall be determined by the chief executive officer within a period of six months from the date the application is received following consultation with the assessment board established under article 8(1);

(ii) On receipt of an application under these Regulations, the chief executive officer shall immediately publish a notice in a daily newspaper in common circulation in the area to which the application relates, to the effect that he/she has received an application for the supply of community pharmacy services in respect of the particular catchment area, and that any observations may be made in writing to the chief executive officer within two calendar months from the date of publication of the notice. Additional applications may be made in respect of the said catchment area within the said two month period;

(iii) Additional applications received by the chief executive officer in respect of the catchment area, within the said period of two months, shall be in conformity with sub-article (1) and shall be considered by the chief executive officer and determined as if all the applications had been received on the same day as the original application, and as part of the same determination process. The chief executive officer shall not be obliged to publish a notice in respect of such additional applications;

(iv) Each application shall be accompanied by a non refundable fee of £500 payable to the health board.

(3) No action shall be taken by an applicant for a community pharmacy contractor agreement, which in the opinion of the chief executive officer, could be interpreted as attempting to improperly influence members of the assessment board or the chief executive officer in determining the application.

8. (1) The chief executive officer shall establish an assessment board, comprised of an independent chairperson who shall be legally qualified, a senior officer of the health board and a person from a panel of sixteen supervising pharmacists. Such panel shall be maintained by the Minister on the nomination of the Council of the Pharmaceutical Society of Ireland. Membership of the panel shall be for a period of three years. Outgoing members shall be eligible for re-nomination.

(2) The rules of procedures for the conduct of meetings of the assessment board and for the receipt of formal submissions, written and oral, shall be established by the chief executive officer, in establishing the board.

(3) The functions of the assessment board shall be --

(i) to evaluate whether there is a definite public health need for the supply of community pharmacy services in the particular catchment area in respect of which an application or applications have been made;

(ii) to examine all applications received within the period prescribed in sub-article (2)(ii) of article 7;

(iii) to consider any observations received by the chief executive officer pursuant to the notice published by virtue of sub article (2)(ii)of article 7; and

(iv) to make recommendations to the chief executive officer with regard to the granting of a community pharmacy contractor agreement.

(4) The chief executive officer shall furnish to each applicant --

(i) any observations he/she may have received pursuant to the notice published by virtue of sub article (2)(ii)of article 7; and

(ii) any studies or analysis which the chief executive officer or the assessment board may conduct or cause to be conducted as part of the assessment process;

and the chief executive officer and the assessment board shall consider any further observations submitted by applicants on foot of the information furnished under this sub-article. Any such observations shall be made within twenty-one days of the date on which the information is forwarded by the chief executive officer to the applicant.

(5) Before proceeding to complete the examination of the individual applications, the assessment board shall make a recommendation to the chief executive officer as to whether there is a definite public health need, as defined by sub-article (1) of article 2, for the supply of community pharmacy services in the particular catchment area to which the application relates.

(6) The chief executive officer shall furnish to each applicant a copy of the recommendation made under sub-article (5) and shall consider any further observations made by applicants in this regard. Any such observations shall be made within twenty-one days of the date on which the recommendation is forwarded by the chief executive officer to the applicant.

(7) Following receipt of a recommendation from the assessment board as to whether there is a definite public health need, as defined by sub-article (1) of article 2, in the particular catchment area to which the application relates, and consideration of any further observations pursuant to sub-article (6), the chief executive officer may --

(i) request the assessment board to review its recommendation giving reasons for such a request; or

(ii) request the assessment board to complete its examination of each application and to make its recommendations.

(8) In its examination of applications, the assessment board shall have regard to the requirements of the terms and conditions of, and the standard of service to be provided under, the community pharmacy contractor agreement applied for.

(9) In its examination of applications, the assessment board may, at its sole discretion, receive oral submissions from applicants, in support of the original written applications, who in the event that they are not the proposed supervising pharmacist, shall be accompanied by the proposed supervising pharmacist. In the case of a company, the oral submissions shall be made by the managing director, or the secretary of the company, accompanied by the supervising pharmacist.

9. (1) On receipt of the recommendations from the assessment board the chief executive officer shall determine applications and in respect of the individual applications notify in writing each applicant of his/her decision.

(2) Where an offer of a community pharmacy contractor agreement has been made, the successful applicant shall indicate in writing his/her acceptance of the offer within one calendar month of the date of such offer and shall enter into a bond of £5,000 in favour of the health board, which shall be redeemable by the health board, in the event of the applicant not entering into the contract within the prescribed period. The offer shall be personal to the applicant, non-transferable and shall lapse unless the applicant has established the proposed community pharmacy and has entered into a community pharmacy contractor agreement within twelve months of the date of the offer.

(3) The chief executive officer may in exceptional circumstances, and at his/her discretion, extend the aforementioned twelve month time limit.

(4) Where a chief executive officer refuses to offer any community pharmacy contractor agreement on grounds that a definite public health need has not been established, he shall notify in writing each applicant to that effect.

10. (1) Where an application has been refused by a chief executive officer on grounds that a definite public health need has not been established, an applicant may appeal on this ground in writing to the Minister within a period of twenty one days, from the date of notification by the chief executive officer.

(2) An appeal under this article shall be sent by post in an envelope addressed to the "Minister for Health, Hawkins House, Dublin 2".

(3) A person making an appeal under this article shall furnish, immediately on request, to the Minister any information he may require to enable him to decide the appeal.

(4) The chief executive officer shall provide the Minister with all relevant information relating to the decision of the chief executive officer.

(5) A person making an appeal under this article shall, on request, be entitled to receive a copy of all information furnished under sub-article (4).

(6) Where an appeal is made under this article, the Minister may--

(i) uphold the decision of the chief executive officer;

(ii) direct the chief executive officer to reconsider his/her decision in this regard;

(iii) direct the chief executive officer to take such action as the Minister deems appropriate.

11. (1) Notwithstanding the provisions of these Regulations, where the chief executive officer receives an application for a community pharmacy contractor agreement before 1 January 1997, showing that the applicant had, in the twelve months prior to the making of these Regulations, entered into a financial commitment for the procurement of a premises for the specific purpose of opening a community pharmacy, he/she shall grant the said contract, provided that he/she is satisfied that there was such a commitment and that the applicant produces to the chief executive officer --

(i) evidence (e.g. a bank statement) indicating payments in respect of the said commitments, supported by an affidavit of the applicant that the commitments had been entered into within the period concerned; and

(ii) copies of any contracts entered into, supported by an affidavit of the applicant's solicitor attesting to the authenticity of the copies and to the correctness of the dates on which the said contracts were entered into; and

(iii) evidence, supported by an affidavit of the applicant and of the applicant's solicitor, that the said commitments for the procurement of a premises were for the specific purpose of opening a community pharmacy.

(2) The solicitor referred to in sub-article (1) shall have no personal or beneficial interest in the application other than that of a professional nature as a solicitor acting on behalf of the applicant.

12. A chief executive officer may determine that there is a definite public health need for community pharmacy services in a particular area and in such circumstances shall seek applications for a community pharmacy contractor agreement by way of appropriate public advertisement and in accordance with these Regulations. Any applications received in response to such advertising will be processed and determined in accordance with the provisions of article 7.

13. These regulations shall come into operation on the 31st day of May, 1996.

Given under the official seal of the Minister for Health this 30th

day of May, 1996.

MICHAEL NOONAN

Minister for Health

The Minister for Finance consents to these Regulations

Given under the official seal of the Minister for Finance this 30th day

of May, 1996.

RUAIRI QUINN

Minister for Finance

EXPLANATORY NOTE

These Regulations specify the criteria and procedures under which the chief executive officer of the relevant health board shall determine the issue of new community pharmacy contractor agreements for the provision of community pharmacy services under the Health Act, 1970 .