Statutory Instruments
MEDICINES
Made
20th August 2001
Laid before Parliament
21st August 2001
Coming into force
11th September 2001
The Secretary of State, considering that the authorisation of the use of electronic communications by this Order for any purpose is such that the extent (if any) to which records of things done for that purpose will be available will be no less satisfactory in cases where use is made of electronic communications than in other cases, in exercise of the powers conferred on him by sections 8 and 9 of the Electronic Communications Act 2000(1), hereby makes the following Order:—
1.—(1) This Order may be cited as the Prescription Only Medicines (Human Use) (Electronic Communications) Order 2001 and shall come into force on 11th September 2001.
(2) This Order extends to Great Britain only(2).
(3) In this Order, “the principal Order” means the Prescription Only Medicines (Human Use) Order 1997(3).
2. Article 15 of the principal Order is amended as follows—
(a)in paragraph (1), after “For the purposes of section 58(2)(a)” there is inserted “, and subject to paragraph (2A),”;
(b)there is inserted after paragraph (2)—
“(2A) For the purposes of paragraph (1), where a prescription is issued and dispensed in England and the conditions specified in paragraph (2C) are fulfilled, the prescription may, as an alternative to fulfilling the conditions specified in paragraph (2)(a) and (b), fulfil instead the conditions specified in paragraph (2B).
(2B) The conditions referred to are that the prescription shall be—
(a)created in an electronic form and signed with an electronic signature and transferred to the person by whom it is dispensed as an electronic communication (including where it is so transferred through one or more intermediaries); or
(b)entered on a document where—
(i)the prescription is created electronically and signed with an electronic signature and both the data and the signature are entered on the document in a non-legible manner;
(ii)the prescription is created in writing on the document, as referred to in paragraph (2)(b), and is signed with an electronic signature which is entered on the document in a non-legible manner; or
(iii)the prescription is created in an electronic form which is entered on the document in a non-legible manner, and is signed as referred to in paragraph (2)(a),
and transferred to the person by whom it is dispensed by physical means.
(2C) The conditions referred to are that—
(a)the prescription is issued by a doctor—
(i)under or by virtue of the National Health Service Act 1997(4); or
(ii)as part of the performance of personal medical services in connection with a pilot scheme under the National Health Service (Primary Care) Act 1977(5),
and dispensed by a person lawfully conducting a retail pharmacy business within the meaning of section 69; and
(b)the Secretary of State is satisfied that—
(i)the use of electronic means in order to create, sign and transfer prescriptions (or whichever of those purposes is applicable) is appropriate for the purposes of a pilot scheme on the use of electronic prescribing, in relation to both the doctor and the person lawfully conducting a retail pharmacy business concerned, and in relation to the premises at which the prescription is dispensed; and
(ii)the particular electronic means used by both the doctor and the person lawfully conducting a retail pharmacy business concerned are suitable for the purposes of such a pilot scheme.”;
(c)in paragraph (3), after “paragraph (2)” there is inserted “or, where applicable, paragraph (2B)”; and
(d)after paragraph (4), there is added—
“(5) In paragraphs (2B) and (2C)—
“doctor” has the same meaning as in section 132(1);
“electronic communication” has the same meaning as in section 15 of the Electronic Communications Act 2000;
“electronic signature” has the same meaning as in section 7 of the Electronic Communications Act 2000.”.
Signed by authority of the Secretary of State for Health
Hazel Blears
Parliamentary Under-Secretary of State,
Department of Health
20th August 2001
(This note is not part of the Order)
This Order is made under sections 8 and 9 of the Electronic Communications Act 2000, which enable an Order under that Act to amend subordinate legislation for specified purposes.
In this case, the Order amends the Prescription Only Medicines (Human Use) Order 1997, to permit National Health Service prescriptions which are issued as part of a pilot scheme on the use of electronic prescriptions, to be created, signed and transferred by electronic means, provided that specified conditions are met.
The Order extends to Great Britain only, and applies to National Health Service prescriptions which are issued and dispensed in England.
2000 c. 7. For the definition of “the appropriate Minister”, see sections 9(1) and 10(1).
By virtue of section 4 of, and Schedules 2 and 3 to, the Northern Ireland Act 1998 (c. 47), the subject matter of the principal Order is a transferred matter in relation to Northern Ireland.
S.I. 1997/1830, amended by S.I. 1997/2044, 1998/108, 1178 and 2081, 1999/3463, 2000/1917, 2899 and 3231.