I ASSENT Medical (Group Practice Scheme) MEDICAL (GROUP PRACTICE SCHEME) (PHARMACEUTICAL
SERVICES) REGULATIONS 2008
© Government of Gibraltar (www.gibraltarlaws.gov.gi)
1973-14
Subsidiary
2008/036 Subsidiary Legislation made under s. 11 of the Medical (Group Practice
Scheme) Act.
MEDICAL (GROUP PRACTICE SCHEME)
(PHARMACEUTICAL SERVICES) REGULATIONS 2008
(LN. 2008/036)
Commencement 15.5.2008
Amending
enactments
Relevant current
provisions
Commencement
date
LN. 2011/200 rr. 2 & 18(2) 13.10.2011
2015/010 rr. 2, 15(1), (2), (3)(c), (4), 18(2) 15.1.2015
EU Legislation/International Agreements involved:
______________________
ARRANGEMENT OF REGULATIONS.
Regulation
PART I
PRELIMINARY
1. Title and commencement.
2. Interpretation.
PART II
SCHEME MEMBERS’ LIST
3. Scheme Members’ List.
4. Notification to be entered in Scheme Members’ List.
5. Form of notification.
6. Removal and substitution from Scheme Members’ List.
7. Sanctions for breaches of statutory duty.
PART III
Medical (Group Practice Scheme) MEDICAL (GROUP PRACTICE SCHEME) (PHARMACEUTICAL
SERVICES) REGULATIONS 2008
© Government of Gibraltar (www.gibraltarlaws.gov.gi)
1973-14
Subsidiary
2008/036 TERMS OF SERVICE
8. Interpretation of Part.
9. General duties of Scheme Members.
10. Indemnity insurance.
11. Duty to maintain good faith and reasonable competence.
12. Sub-contracting of work.
13. Duty to prepare and dispense prescriptions.
14. Length of prescription.
15. Payment of Scheme Members.
16. Other charges.
17. Opening hours.
18. Licensing of medicines.
19. Supply of information.
20. Voluntary removal of name from list.
PART IV
FINAL PROVISIONS
21. Revocation.
22. Transitional provisions.
Medical (Group Practice Scheme) MEDICAL (GROUP PRACTICE SCHEME) (PHARMACEUTICAL
SERVICES) REGULATIONS 2008
© Government of Gibraltar (www.gibraltarlaws.gov.gi)
1973-14
Subsidiary
2008/036 In exercise of the powers conferred on me by section 11 of the Medical
(Group Practice Scheme) Act, and of all other enabling powers, I have
made the following Regulations–
PART I
PRELIMINARY
Title and commencement.
1. These Regulations may be cited as the Medical (Group Practice Scheme)
(Pharmaceutical Services) Regulations 2008 and shall come into operation
on the date of publication.
Interpretation.
2. In these Regulations and unless the context otherwise requires–
“appliances” shall include dressings;
“authorised prescriber” means a person who by virtue of an enactment is
authorised to issue prescriptions, subject to any limitations imposed
on that person under that enactment;
“Authority” means the Gibraltar Health Authority established under
section 3 of the Medical (Gibraltar Health Authority) Act;
“formulary” means such list of medicinal products and appliances
available for prescribing and dispensing under the Scheme, being
medicinal products and appliances listed in the Gibraltar National
Formulary published on behalf of the Authority, as the Authority
may from time to time notify pharmacists;
“Gibraltar Drug Tariff” means the statement published in accordance
with regulation 8, as amended from time to time;
“medicinal product” means any substance or article (not being an
instrument, apparatus or appliance) which is manufactured, sold,
supplied, imported or exported for use wholly or mainly in either or
both of the following ways, -
(a) by being administered to one or more human beings or animals
for a medicinal purpose;
(b) in any of the following circumstances–
Medical (Group Practice Scheme) MEDICAL (GROUP PRACTICE SCHEME) (PHARMACEUTICAL
SERVICES) REGULATIONS 2008
© Government of Gibraltar (www.gibraltarlaws.gov.gi)
1973-14
Subsidiary
2008/036 (i) in a pharmacy or hospital;
(ii) by a practitioner;
(iii) in the course of a business which consists of or includes
the retail sale or the supply in circumstances
corresponding to retail sale, of herbal remedies; or
(iv) as an ingredient in the preparation of a substance or
article which is to be administered to one or more human
beings or animals for a medicinal purpose;
However, “medicinal product” does not include–
(a) substances used in dental surgery for filling dental cavities;
(b) bandages and other surgical dressings, except medicated
dressings where the medication has a curative function which is
not limited to sterilising the dressing;
(c) substances and articles of such other descriptions or classes as
may be specified by an order made by the Minister for the
purposes of this regulation;
“nurse practitioner” has the same meaning as in the Medicines
(Prescription Only) Regulations, 1987;
“pharmacist” means any person registered as a pharmacist under Part III
of the register established pursuant to section 7 of the Medical and
Health Act 1997;
“pharmacy” means any premises duly registered under section 69 or other
applicable provision of the Medical and Health Act 1997 and the
Pharmacy Regulations where medicinal products are lawfully
provided by a registered pharmacist;
“Pharmacy Regulations” means the Medical and Health (Registration of
Pharmacies) Regulations 2008 or any amended or modified
version, or replacement thereof;
“prescribing optometrist” has the same meaning as in the Medicines
(Prescription Only) Regulations, 1987;
“proceedings” means any proceedings before the Authority;
Medical (Group Practice Scheme) MEDICAL (GROUP PRACTICE SCHEME) (PHARMACEUTICAL
SERVICES) REGULATIONS 2008
© Government of Gibraltar (www.gibraltarlaws.gov.gi)
1973-14
Subsidiary
2008/036 “registered dentist” means a dentist registered under Part II of the register established pursuant to section 7 of the Medical and Health Act
1997;
“registered doctor” means a doctor registered under Parts I, IA or IB of
the register established pursuant to section 7 of the Medical and
Health Act 1997;
“sale by retail” means selling a substance or article to a person who buys
it otherwise than for–
(a) selling or supplying it; or
(b) administering it, or causing it to be administered to one or more
human beings,
in the course of a business carried on by that person;
“Scheme Member” means any pharmacist or pharmacy entered in the
Scheme Members’ List maintained under regulation 3;
“Scheme Pharmaceutical Services” means the supply, whether by way of
sale by retail or free of charge to the person to whom it is supplied
of medicinal products against a prescription issued under the
Scheme and for the payment of which the Authority is liable.
(2) Terms used in these Regulations but not defined shall be construed in
accordance with the provisions of the Medical (Group Practice Scheme) Act
as amended from time to time.
PART II
SCHEME MEMBERS’ LIST
Scheme Members’ List.
3.(1) The Authority shall maintain a Scheme Members’ List.
(2) The Authority shall, in January of each year, cause the Scheme
Members’ List to be published in the Gazette.
Notification to be entered in Scheme Members’ List.
4.(1) A pharmacist, or more than one pharmacist in partnership, or owner or
proposed owner of a pharmacy carrying on the business of a pharmacy in
Medical (Group Practice Scheme) MEDICAL (GROUP PRACTICE SCHEME) (PHARMACEUTICAL
SERVICES) REGULATIONS 2008
© Government of Gibraltar (www.gibraltarlaws.gov.gi)
1973-14
Subsidiary
2008/036 premises registered under regulation 3 of the Pharmacy Regulations who wishes to be entered in the Scheme Members’ List as a Scheme Member in
order to provide Scheme Pharmaceutical Services shall give four weeks
notice to the Authority, in such form as the Authority may require, of his
desire to be included in the Scheme Members’ List.
(2) A person who has given notice under subsection (1), shall be included
by the Authority in the Scheme Members’ list as a Scheme Member with
effect from the date four weeks from the date notice was given by him under
sub-regulation (1).
(3) A Scheme Member who wishes–
(a) to open additional premises from which to provide
Scheme Pharmaceutical Services; or
(b) to change the address from which he provides Scheme
Pharmaceutical Services,
shall not be entered in the Scheme Members’ List in respect of such
additional or other premises unless such premises are registered under
regulation 3 of the Pharmacy Regulations.
Form of notification.
5.(1) A person who knowingly–
(a) gives any false information in connection with a notification
under regulation 4(1); or
(b) makes any false entry in the form in respect of any such
notification,
shall be guilty of an offence and punishable on summary conviction to a fine
at level 3 on the standard scale.
(2) A notification under regulation 4(1) on behalf of a partnership may be
made by one partner in the name of all partners jointly.
(3) A notification under regulation 4(1) on behalf of a company
incorporated in Gibraltar or elsewhere shall be signed by all the directors
thereof provided that the Authority may, in its absolute discretion waive or
modify this requirement in cases where the Authority is satisfied about the
repute of the applicant and that compliance is unduly onerous in practice.
Removal and substitution from Scheme Members’ List.
Medical (Group Practice Scheme) MEDICAL (GROUP PRACTICE SCHEME) (PHARMACEUTICAL
SERVICES) REGULATIONS 2008
© Government of Gibraltar (www.gibraltarlaws.gov.gi)
1973-14
Subsidiary
2008/036 6.(1) Where a Scheme Member has died and the Authority has decided not
to exercise its discretion under sub-regulations (2) and (3), the Authority
shall remove the Scheme Member’s name from the Scheme Members’ List.
(2) Where the Authority determines that a Scheme Member has died (the
“first Scheme Member”) and that the executors or personal representatives
of his estate intend the deceased’s business to be taken over by a pharmacist
who is not a Scheme Member, the Authority shall, amend the Scheme
Members’ List to include that pharmacist as a Scheme Member in
substitution for the first Scheme Member.
(3) Where the Authority determines that a Scheme Member has ceased to
practice by reason of ill health (the “first Scheme Member”), and that he
intends his business to be taken over by a pharmacist who is not a Scheme
Member, the Authority shall, amend the Scheme Members’ List to include
that pharmacist as a Scheme Member in substitution for the first Scheme
Member.
(4) Where the Authority determines that a Scheme Member has not, for a
period of six months, provided Scheme Pharmaceutical Services, the
Authority may, in its absolute discretion, remove the pharmacist’s name
from the Scheme Members’ List.
(5) Before making any determination under sub-regulation (4), the
Authority shall–
(a) give the Scheme Member not less than 28 days notice of its
intention; and
(b) afford the Scheme Member an opportunity of making written
representations to the Authority or, if he so decides, oral
representations.
(6) Where, under sub-regulation (4), the Authority determines to remove a
Scheme Member from the Scheme Members’ List, it shall give notice in
writing of its decision to the Scheme Member.
Sanctions for breaches of statutory duty.
7.(1) The Authority may take such action as it deems necessary to
investigate compliance by Scheme Members with the provisions of these
Regulations and of the principal Act.
(2) Where prima facie evidence exists of a failure in compliance by a
Scheme Member with the provisions of these Regulations or of the principal
Medical (Group Practice Scheme) MEDICAL (GROUP PRACTICE SCHEME) (PHARMACEUTICAL
SERVICES) REGULATIONS 2008
© Government of Gibraltar (www.gibraltarlaws.gov.gi)
1973-14
Subsidiary
2008/036 Act, the Authority may suspend the Scheme Member from the Scheme Members’ List for a period not exceeding four months, pending the
investigation and determination of the case.
(3) The Authority may, in the course of its investigations under this
regulation, require the Scheme Member to attend before the Authority or
before such person as the Authority may appoint to answer questions and
otherwise to furnish information and to require the production of such books
or papers as the Authority may require.
(4) Following the conclusion of its investigation, the Authority may
determine–
(a) that no further action need be taken;
(b) that the Scheme Member should be issued with a written
warning;
(c) that a fine not exceeding a sum equivalent to level 3 on the
standard scale be recovered from the Scheme Member whether
by deduction from payments due or which may become due to
him or otherwise;
(d) that a payment made to the Scheme Member in circumstances
where it was not due be recovered by deduction from other
payments due or which may become due to him or otherwise;
(e) that the Scheme Member be suspended from the Scheme
Members’ List for a period not exceeding 12 months either
generally or in respect of a specified pharmacy;
(f) that the Scheme Member be removed from the Scheme
Members’ List either generally or in respect of a specified
pharmacy;
(5) If the Authority determines that a Scheme Member has, in exchange
for a Scheme prescription given any person any credit (whether immediate
or deferred), or any value or monies worth, or any article or product, or any
medicinal product other than the medicinal product specified in such a
prescription, the Authority shall (after obtaining the agreement of the
Minister) on the first such occasion impose a fine of £5,000, on the second
such occasion suspend the Scheme Member for a period of six months and
on the third such occasion remove the Scheme Member from the Scheme
Members’ List.
Medical (Group Practice Scheme) MEDICAL (GROUP PRACTICE SCHEME) (PHARMACEUTICAL
SERVICES) REGULATIONS 2008
© Government of Gibraltar (www.gibraltarlaws.gov.gi)
1973-14
Subsidiary
2008/036 (6) If any Scheme Member is removed from the Scheme Members’ List under sub-regulation (5), then notwithstanding any other provision of these
Regulations neither that Scheme Member nor any pharmacy owned (in
whole or in part) by that Scheme Member (or any of them, if more than one)
whether in their own name (or names), as partners or by a company in which
they or any of them own shares legally or beneficially, shall be entered in the
Scheme Members’ List, without the consent of the Minister responsible for
Finance.
(7) The Authority shall, as soon as practicable, notify the Scheme Member
in writing of a determination under this regulation and shall include with the
notice a statement of the reasons for the determination.
PART III
TERMS OF SERVICE
Interpretation of Part.
8. In this Part unless the context otherwise requires–
“bank holiday” shall be construed in accordance with the Banking and
Financial Dealings Act;
“basic price” means either the price of any item stated in the Gibraltar
Drug Tariff published on behalf of the Authority or, if the price of
the item is not stated in the Gibraltar Drug Tariff, the price
published by the manufacturer or supplier or, in default, the price
determined by the Minister with responsibility for Health;
“Chief Executive” means the Chief Executive or Deputy Chief Executive
of the Authority;
“Head Pharmacist” means the Head Pharmacist of the Authority;
“item” means any product which is in the formulary;
“normal hours” means on days other than bank or public holidays, the
hours of:
9.00 a.m. to 7.00 p.m. Monday to Friday, and
9.00 p.m. to 1.00 p.m. Saturday,
or such other hours as the Chief Executive may, from time to time,
require;
Medical (Group Practice Scheme) MEDICAL (GROUP PRACTICE SCHEME) (PHARMACEUTICAL
SERVICES) REGULATIONS 2008
© Government of Gibraltar (www.gibraltarlaws.gov.gi)
1973-14
Subsidiary
2008/036 “prescription” or “prescriptions” means an item or items on a
prescriptions form as the case may be;
“prescription form” means such form issued by the Authority from time
to time for the purposes of recording items that have been
prescribed;
“prohibited schedule” means the list of medicinal products not available
for prescription which the Authority may publish from time to
time;
“public holiday” shall be construed in accordance with the Interpretation
and General Clauses Act.
General duties of Scheme Members.
9.(1) Scheme Members shall comply with the provisions of these
Regulations, the principal Act, the Medical and Health Act 1997 and with
any rule of law for the time being in force relating to his professional duties.
(2) Scheme Members shall not engage in conduct prejudicial or
discreditable to his profession or to the Authority.
(3) Scheme Members shall make their practice as pharmacists their
primary occupation, unless the Chief Executive has otherwise approved.
Indemnity insurance.
10.(1) Scheme Members shall have and maintain professional indemnity
insurance in respect of claims for damages, of up to a minimum of £4.5
million, including £500,000 on any single claim for damages.
(2) In this Regulation, “professional indemnity insurance” means
indemnity insurance against loss or damage arising from claims in respect of
civil liability incurred–
(a) in the supply of a medicinal product which is the subject of a
prescription under the Scheme;
(b) in the failure to supply a medicinal product which is the subject
of a prescription under the Scheme; or
(c) in the giving of pharmaceutical advice to customers regarding
the proper treatment to soothe or cure any ailment, taking all
reasonable circumstances into account.
Medical (Group Practice Scheme) MEDICAL (GROUP PRACTICE SCHEME) (PHARMACEUTICAL
SERVICES) REGULATIONS 2008
© Government of Gibraltar (www.gibraltarlaws.gov.gi)
1973-14
Subsidiary
2008/036 Duty to maintain good faith and reasonable competence.
11.(1) Scheme Members shall act with reasonable competence and good
faith in all their professional activities.
(2) Scheme Members shall ensure that their pharmacies are efficiently and
properly administered and particularly ensure that an adequate stock of
pharmaceutical products is kept.
(3) Scheme Members shall ensure that their pharmacies are, when open,
supervised by a registered pharmacist.
Sub-contracting of work.
12.(1) Scheme Members shall not sub-contract the provision of services
under the Scheme to another pharmacy or pharmacist.
(2) Sub-regulation (1) shall not act to prevent Scheme Members from
employing pharmacists for the purpose of operating or managing
pharmacies.
Duty to prepare and dispense prescriptions.
13.(1) Scheme Members who have available the medicinal products and
appliances necessary to prepare a prescription issued under the Scheme shall
accept, prepare and dispense the prescription.
(2) Scheme Members shall supply all items included in a single
prescription which they are authorised to supply under the Scheme and,
should they be unable to do so, shall redirect the patient to another pharmacy
which is for the time being included in the Scheme Members’ List.
(3) Scheme Members who have dispensed medicinal products pursuant to
sub-regulation (1) shall submit all prescriptions and other forms for payment
as directed by the Authority.
Length of prescription.
14. Scheme Members shall, only with the prior written approval of the
Head Pharmacist, provide items on a prescription to cover a period of more
than one month.
Payment of Scheme Members.
Medical (Group Practice Scheme) MEDICAL (GROUP PRACTICE SCHEME) (PHARMACEUTICAL
SERVICES) REGULATIONS 2008
© Government of Gibraltar (www.gibraltarlaws.gov.gi)
1973-14
Subsidiary
2008/036 15.(1) Scheme Members shall be paid by the Authority in accordance with the provisions of sub-regulations (2), (3) and (4) for medicinal products
supplied to patients.
(2) In order to qualify for payment under sub-regulation (1), medicinal
products dispensed must not be excluded by the prohibited schedule and
must be written by a registered doctor, dentist or authorised prescriber on a
prescription form issued by the Authority under the Scheme.
(3) Scheme Members will be paid the following in respect of each item
dispensed–
(a) the basic price;
(b) an additional 15 % to the basic price; and
(c) a dispensing fee of £1.80 subject to a maximum total payment
to all Scheme Members of £750,000 in any financial year.
(4) Where the maximum referred to in subregulation (3) is exceeded, the
payments under subregulation (1) shall at the end of the financial year be
adjusted on a pro rata basis and any adjustment required shall be applied to
Scheme Members in financial year following the financial year in which
payments were made.
Other charges.
16. Scheme Members shall charge and receive, on behalf of the Authority,
from every person presenting a prescription form issued by the Authority
under the Scheme (other than persons on whose prescription it is indicated
that they are entitled to free or reduced cost medicines), such payment as
may be prescribed from time to time under the principal Act.
Opening hours.
17.(1) The Authority may stipulate the hours during which Scheme
Members shall open their pharmacy to the public outside normal hours.
(2) The Authority shall submit to Scheme Members notice of which
pharmacy shall be open during such hours and every Scheme Member shall
display in his pharmacy window in a prominent position for the benefit of
the public the name and address of the pharmacy which is so open.
(3) The Scheme Member due to open outside normal hours under sub-
regulation (1) shall be under a duty to do so.
Medical (Group Practice Scheme) MEDICAL (GROUP PRACTICE SCHEME) (PHARMACEUTICAL
SERVICES) REGULATIONS 2008
© Government of Gibraltar (www.gibraltarlaws.gov.gi)
1973-14
Subsidiary
2008/036 (4) The Scheme Member whose duty it is to open outside normal hours shall be under a duty to make up prescriptions in cases of emergency at all
times when no other pharmacy is open and shall provide the Authority with
a contact telephone number and address in Gibraltar for the purpose thereof.
(5) The Scheme Member whose duty it is to open his pharmacy outside
normal hours under this regulation shall be paid the sum of £500 for every 7
day week in respect of which the services specified in this regulation are
actually provided.
Licensing of medicines.
18.(1) For the purposes of the Scheme and, subject to sub-regulation (2), no
Scheme Member shall sell, supply or export any medicinal product or
procure the sale or supply of a medicinal product unless there is in existence
in relation to the medicinal product–
(a) a current product licence granted under the provisions of the
Medicines Act 1968 of the United Kingdom;
(b) a current marketing authorisation issued under the Medicines
for Human Use (Marketing Authorisation etc.) Regulations
1994 of the United Kingdom (S.I. 1994/3144); or
(c) a current marketing authorisation issued by the European
Agency for the Evaluation of Medicinal Products pursuant to
Council Regulation (EEC) No: 2309/93.
(2) The restrictions imposed by sub-regulation (1) shall not apply in
respect of a medicinal product listed in the Gibraltar National Formulary
which has been prescribed by a registered doctor, dentist or authorised
prescriber for administration to a particular patient of his.
Supply of information.
19. Scheme Members shall supply, in response to a request from the
Minister responsible for Health or the Authority, within 30 days of the
notification of the request, any information which may be relevant to the
purpose of conducting an inquiry into any matter covered by these
Regulations, or any other subsidiary legislation made under the principal
Act.
Voluntary removal of name from list.
20. Scheme Members wishing to cease their membership shall give two
months written notice of the same to the Chief Executive.
Medical (Group Practice Scheme) MEDICAL (GROUP PRACTICE SCHEME) (PHARMACEUTICAL
SERVICES) REGULATIONS 2008
© Government of Gibraltar (www.gibraltarlaws.gov.gi)
1973-14
Subsidiary
2008/036
PART IV
FINAL PROVISIONS
Revocation.
21. The Medical (Group Practice Scheme) (Pharmaceutical) Regulations are
hereby revoked.
Transitional provisions.
22(1). A person who, on the date of the coming into effect of these
Regulations was a Scheme Member as defined in the Medical (Group
Practice Scheme) Regulations or was established as a pharmacy in Gibraltar
registered under the Medical and Health Act 1997, shall be a Scheme
Member for the purposes of these Regulations and shall be entered in the
Scheme Members’ List under these Regulations as of the date that these
Regulations come into effect.
(2) For the avoidance of doubt the pharmacies that are automatically
entered in the Scheme Members’ List under regulation 3 and are thus
Scheme Members from the date that these Regulations come into force are
the following pharmacies–
(a) Baglietto Pharmacy, 61 Governor’s Street;
(b) Bell Pharmacy, 27 Bell Lane;
(c) Calpe ICC Pharmacy, Unit G9 ICC;
(d) Calpe 93 Pharmacy, 93 Main Street;
(e) Calpe 232 Pharmacy, 232 Main Street;
(f) Crown Pharmacy, 4 Casemates Square;
(g) Louis Pharmacy, F12 ICC;
(h) Morrison’s Pharmacy, Morrisons Westside;
(i) Mill Pharmacy, 21/2/a City Mill Lane;
(j) New Pharmacy, 19 Main Street;
Medical (Group Practice Scheme) MEDICAL (GROUP PRACTICE SCHEME) (PHARMACEUTICAL
SERVICES) REGULATIONS 2008
© Government of Gibraltar (www.gibraltarlaws.gov.gi)
1973-14
Subsidiary
2008/036 (k) Trafalgar Pharmacy, 48/50 Main Street;
(l) Valmar Pharmacy, 11a Main Street.
