2020 No. 468
The Misuse of Drugs (Coronavirus) (Amendments Relating to the Supply of Controlled Drugs During a Pandemic etc.) Regulations 2020
Made
Laid before Parliament
Coming into force in accordance with regulation 1(2)
The Secretary of State, in exercise of the powers conferred by sections 7(1)(b) and (2)(b), 10(1) and (2)(g), 22(1)(a)(i) and 31(1)(a) of the Misuse of Drugs Act 19711, makes the following Regulations.
In accordance with section 31(3) of that Act, the Secretary of State has consulted with the Advisory Council on the Misuse of Drugs.
Citation, commencement and extent1
1
These Regulations may be cited as the Misuse of Drugs (Coronavirus) (Amendments Relating to the Supply of Controlled Drugs During a Pandemic etc.) Regulations 2020.
2
These Regulations come into force on the day after the day on which they are laid before Parliament.
3
These Regulations extend to England and Wales and Scotland.
Amendment of the Misuse of Drugs Regulations 20012
The Misuse of Drugs Regulations 20012 are amended as follows.
Amendment of regulation 23
In regulation 23 (interpretation), in paragraph (1), after the definition of “health prescription” insert—
“health service” means—
- a
in England, the health service as defined by section 275(1) of the National Health Service Act 20064;
- b
in Scotland, the health service as defined by section 108(1) of the National Health Service (Scotland) Act 19785; and
- c
in Wales, the health service as defined by section 206(1) of the National Health Service (Wales) Act 20066;
New regulation 10A4
After regulation 10 (possession of drugs in Schedules 2, 3 and 4), insert—
Directions of a practitioner while a disease is, or in anticipation of a disease being imminently, pandemic etc.10A
1
For the purposes of regulation 10(2)7, the directions of a practitioner may be the directions of a pharmacist, which do not require a prescription, in the following circumstances—
a
as a consequence of a disease being, or in anticipation of a disease being imminently—
i
pandemic, and
ii
a serious risk or potentially a serious risk to human health,
in order to assist in the management of the serious risk or potentially serious risk to human health, the Secretary of State has made an announcement in respect of the supply of drugs specified in Schedule 2, 3 or Part 1 of Schedule 4 as part of the health service;
b
as part of the announcement, the Secretary of State has issued advice to the effect that—
i
in the area to which the announcement relates,
ii
in the particular circumstances specified in the announcement, and
iii
during the period specified in the announcement,
arrangements for the provision of services as part of the health service (“NHS arrangements”) with a person lawfully conducting a retail pharmacy business may include provisions permitting the supply of drugs specified in Schedule 2, 3 or Part 1 of Schedule 4 in accordance with the directions of a pharmacist, provided that the supply is in accordance with regulation 226 or 226A of the Human Medicines Regulations 20128;
c
the person lawfully conducting a retail pharmacy business with whom the NHS arrangements are made complies with the requirements of the arrangements in respect of the supply of drugs specified in Schedule 2, 3 or Part 1 of Schedule 4; and
d
the period specified in the announcement (taking into account any extension) has not ended and the announcement has not been withdrawn or amended in a way that means that the relevant provisions in the NHS arrangements are no longer permitted by the announcement.
2
The period specified in the announcement, as mentioned in paragraph (1)(b)(iii), must initially not be for more than three months, but it may be extended for further periods of not more than three months at a time.
3
Before making, amending (including by way of extension) or withdrawing an announcement under paragraph (1) which relates to—
a
all or any area of Scotland, the Secretary of State must consult the Scottish Ministers;
b
all or any area of Wales, the Secretary of State must consult the Welsh Ministers.
Amendment of regulation 155
In regulation 159 (form of prescriptions), after paragraph (4), insert—
5
For the purposes of paragraph (1)(g), if the intervals to be observed when supplying are changed by a pharmacist in the following circumstances, the changed intervals are treated as the intervals specified by the prescriber—
a
as a consequence of a disease being, or in anticipation of a disease being imminently—
i
pandemic, and
ii
a serious risk or potentially a serious risk to human health,
in order to assist in the management of the serious risk or potentially serious risk to human health, the Secretary of State has made an announcement in respect of the supply of drugs specified in Schedule 2 or 3 as part of the health service;
b
as part of the announcement, the Secretary of State has issued advice to the effect that—
i
in the area to which the announcement relates,
ii
in the particular circumstances specified in the announcement, and
iii
during the period specified in the announcement,
arrangements for the provision of services as part of the health service (“NHS arrangements”) with a person lawfully conducting a retail pharmacy business may include provisions permitting pharmacists to change the intervals in prescriptions for drugs specified in Schedule 2 or 3 supplied under NHS arrangements;
c
the pharmacist who changes the intervals—
i
is the person who is, for the purposes of regulation 16(1)10, the person who supplies the drug on the prescription;
ii
does so as part of and in accordance with NHS arrangements to which the announcement relates; and
iii
does so with the agreement of the prescriber or, if the prescriber is unavailable, a person who is part of the same team responsible for treating the patient for whom the drug is prescribed as the prescriber, and who has been designated by the prescriber as a person who is able to agree this type of change if the prescriber is unavailable; and
d
the period specified in the announcement (taking into account any extension) has not ended and the announcement has not been withdrawn or amended in a way that means that the relevant provisions in the NHS arrangements are no longer permitted by the announcement.
6
The period specified in the announcement, as mentioned in paragraph (5)(b)(iii), must initially not be for more than three months, but it may be extended for further periods of not more than three months at a time.
7
Before making, amending (including by way of extension) or withdrawing an announcement under paragraph (5) which relates to—
a
all or any area of Scotland, the Secretary of State must consult the Scottish Ministers;
b
all or any area of Wales, the Secretary of State must consult the Welsh Ministers.
(This note is not part of the Regulations)