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The Secretary of State for Health, in exercise of the powers conferred upon him by sections 41, 42, 43 and 126(4) and (5) of the National Health Service Act 1977[1] and of all other powers enabling him in that behalf, hereby makes the following Regulations: Citation, commencement, application and interpretation 1. - (1) These Regulations may be cited as the National Health Service (Pharmaceutical Services) (Amendment) Regulations 2004 and shall come into force on 1st April 2004. (2) These Regulations shall apply to England only[2]. (3) The National Health Service (Pharmaceutical Services) Regulations 1992[3] ("the Principal Regulations") are amended in accordance with the provisions of these Regulations. Amendment of regulation 2 2. - (1) In regulation 2(1) (interpretation) -
(b) in respect of whom an annotation signifying that he is qualified to order drugs and appliances from -
(ii) the Nurse Prescribers' Extended Formulary in Part XVIIB(ii) of the Drug Tariff,
is also recorded in that register;";
(c) for the definition of "Local Medical Committee" substitute -
(f) for the definition of "Remission of Charges Regulations" substitute -
(b) indicates that the drugs or appliances ordered on that form may be provided more than once, and specifies the number of occasions on which they may be provided;";
(h) for the definition of "Scheduled drug" substitute -
(ii) the Register of Pharmaceutical Chemists maintained in pursuance of section 2(1) of the Pharmacy Act 1954[6], or (iii) the register maintained in pursuance of Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976[7], and
(b) against whose name is recorded in the relevant register an annotation signifying that he is qualified to order drugs and appliances as a supplementary prescriber.";
(j) omit the following definitions -
(ii) in respect of a PMS contractor, in accordance with paragraph 13 of Schedule 5 to the PMS Regulations;";
(b) in relation to a pharmacist, the register maintained in pursuance of section 2(1) of the Pharmacy Act 1954 (the registers and registration) or the register maintained in pursuance of articles 6 (the registers) and 9 (the registrar) of the Pharmacy (Northern Ireland) Order 1976;";
(b) a PMS contractor who provides repeatable prescribing services under the terms of its agreement which give effect to paragraph 39 of Schedule 5 to the PMS Regulations; or (c) employed or engaged by a GMS contractor who provides repeatable prescribing services under the terms of a contract which give effect to paragraph 40 of Schedule 6 to the GMS Regulations or by a PMS contractor who provides repeatable prescribing services under the terms of an agreement which give effect to paragraph 39 of Schedule 5 to the PMS Regulations;".
(2) For regulation 2(1B) substitute -
(b) the term "dispensing services", in relation to a doctor or to a GMS contractor or a PMS contractor means, any corresponding service provided, not as pharmaceutical services, but under the terms of a GMS contract which give effect to paragraphs 47 to 51 of Schedule 6 to the GMS Regulations or under the terms of a PMS agreement which give effect to paragraphs 45 to 51 of Schedule 5 to the PMS Regulations.".
(3) After regulation 2(4) add -
(b) transitional agreements as defined in article 1(4) of the General Medical Services and Personal Medical Services Transitional and Consequential Provisions Order 2004[17], any reference in these Regulations to a PMS agreement shall be read as including a reference to any equivalent term in the transitional agreement.".
Omission of regulation 2A
(b) who holds a GMS contract, or is a legal and beneficial shareholder, director or company secretary of a company which holds a GMS contract, or is employed or engaged by a person who holds such a contract; or (c) who is a PMS contractor, or is a legal and beneficial shareholder, director or company secretary of a company which is a party to a PMS agreement, or is employed or engaged by a PMS contractor ; or (d) who provides primary medical services pursuant to arrangements made under section 16CC(2)(b) of the Act, or is a legal and beneficial shareholder, director or company secretary of a company which provides primary medical services pursuant to such arrangements, or is employed or engaged by such a provider; or (e) who is a party (other than a Primary Care Trust) to a pharmacy pilot scheme, or a director, officer or employee of such a person, or who provides or assists in providing local pharmaceutical services under a pharmacy pilot scheme,
shall take part in any decision under this regulation.".
Amendment of regulation 7
(3) For regulation 9(7) substitute -
Amendment of regulation 11
(ii) after the words "pharmaceutical services" add "or for whom a GMS contractor or PMS contractor provides dispensing services".
(2) In regulation 11(3), for the words "one mile" substitute "1.6 kilometres".
(2) For regulation 12(1)(d)(i) substitute -
(ia) in whose pharmaceutical list or dispensing doctor list is included the name of a person who, in the opinion of the Primary Care Trust, might be so affected, or".
(3) In regulation 12(1)(e) for the words "Community Health Council" substitute the words "Patients' Forum".
(5) Regulation 12(2A) is omitted.
(b) who is a GMS contractor, or is a legal and beneficial shareholder, director or company secretary of a company which is a GMS contractor, or is employed or engaged by a GMS contractor; or (c) who is a PMS contractor, or is a legal and beneficial shareholder, director or company secretary of a company which is a PMS contractor, or is employed or engaged by a PMS contractor; or (d) who provides primary medical services pursuant to arrangements made under section 16CC(2)(b) of the Act, or is a legal and beneficial shareholder, director or company secretary of a company which provides primary medical services pursuant to such arrangements, or is employed or engaged by such a provider; or (e) who is a party (other than a Primary Care Trust) to a pharmacy pilot scheme, or a director, officer or employee of such a person, or who provides or assists in providing local pharmaceutical services under a pharmacy pilot scheme,
shall take part in any decision under this regulation.".
(7) In regulation 12(13)(a), for the words "general medical services, personal medical services" substitute "primary medical services under Part I of the Act".
(12) In regulation 12(17)(b)(ii)[c], for the words "one mile" substitute "1.6 kilometres".
(bb) whose name is included in the pharmaceutical list or dispensing doctor list[d] of the Primary Care Trust, or any other Primary Care Trust to which a copy of the application was sent under regulation 12(1)(d), or".
(2) Regulation 13(2)(a)(iii) is omitted.
(b) is included in the pharmaceutical list of a Primary Care Trust specified in Schedule 3A.".
(2) For regulation 16B(4)(b) substitute -
Omission of regulation 19
(b) is resident in a controlled locality, at a distance of more than 1.6 kilometres from any pharmacy, and one of the conditions specified in paragraph (3) is satisfied in his case,
he may at any time request in writing a doctor who falls within paragraph (2) to provide him with pharmaceutical services.
(b) engaged or employed by the GMS contractor or PMS contractor
on whose patient list the patient making the request is included.
(ii) any conditions imposed under regulation 12(15) or regulation 13(13)(b) in connection with that grant are such as to permit arrangements to be made under this regulation for the provision of pharmaceutical services by that doctor to the patient; or
(b) immediately before these Regulations came into force arrangements or requirements were in effect under regulations revoked by these Regulations for that doctor or his partner or any previous doctor in his practice to provide drugs or appliances to patients, and the patient -
(ii) has changed his address from that last notified to the Primary Care Trust, or (iii) has not changed his address but, immediately before his acceptance as a patient by that doctor, was being provided with pharmaceutical services by a doctor pursuant to an arrangement or requirement under these Regulations.
(4) If a doctor so requested by a patient under paragraph (1) -
(b) does not so apply within 30 days, the Primary Care Trust may, subject to paragraph (6), require him to undertake such provision and shall give him notice in writing to that effect.
(5) An arrangement made by a Primary Care Trust under paragraph (4)(a) shall -
(b) enable that doctor, any other doctor in his practice or any doctor who subsequently joins his practice to provide pharmaceutical services for the patient so long as the arrangement remains in effect.
(6) A Primary Care Trust shall not under paragraph (4)(b) require a doctor to provide pharmaceutical services to a person on the relevant patient list for that doctor if that doctor satisfies the Primary Care Trust, or on appeal, the Secretary of State that -
(b) in the case of a person to whom paragraph (1)(b) applies, the person would not have serious difficulty, by reason of distance or inadequacy of means of communication, in obtaining drugs and appliances from a pharmacy.
(7) A Primary Care Trust shall give a doctor reasonable notice -
(b) subject to paragraph (8), that, where a person no longer satisfies the provisions of paragraph (1), the doctor shall discontinue the provision of pharmaceutical services to that person.
(8) A notice under paragraph (7)(b) -
(b) shall not be given -
(ii) where regulations 9(10) so requires.
(9) Notwithstanding paragraph (4), where a drug or appliance is one for which a doctor is entitled to an additional payment if he provides it, he may, with the consent of the patient, instead of providing it himself, order it by issuing a prescription to the patient in accordance with paragraph 39 of Schedule 6 to the GMS Regulations.
Amendment of regulation 21
(2) The dispensing doctor list shall indicate the address of the relevant GMS contractor or PMS contractor from whose premises any doctor whose name is included performs primary medical services."
Amendment of regulation 21C
(b) the doctor is no longer performing primary medical services within the area of the Primary Care Trust; or (c) more than 12 months have elapsed since the doctor last provided pharmaceutical services pursuant to the authorisation or requirement to provide such services given by the Primary Care Trust under regulation 20."
Amendment of regulation 24
(b) relates to a particular repeatable prescription and contains the same date as that prescription, (c) is issued as one of a sequence of forms, the number of which is equal to the number of occasions on which the drugs or appliances ordered on the repeatable prescription may be provided, and (d) specifies a number denoting its place in the sequence referred to in paragraph (c)."
(b) omit the definition of "repeatable prescribing doctor".
Amendment of Part II (terms of service for chemists) of Schedule 2
(b) an order for a drug specified in Schedule 2 to the Prescription of Drugs Regulations, signed by, and endorsed on its face with the reference "SLS" by a prescriber; or (c) an order for a restricted availability appliance, signed by and endorsed on its face with the reference "SLS" by a prescriber; or (d) an order for listed drugs signed by a dentist or his deputy or assistant,
a chemist shall, with reasonable promptness, provide the drugs so ordered, and such of the appliances so ordered as he supplies in the normal course of his business.",
(ii) an order for a drug specified in Schedule 2 to the Prescription of Drugs Regulations, not being a controlled drug within the meaning of the Misuse of Drugs Act 1971, other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001, signed by and endorsed on its face with the reference "SLS" by a repeatable prescriber, (iii) an order for appliances, not being restricted availability appliances, signed by a repeatable prescriber, or (iv) an order for a restricted availability appliance, signed by, and endorsed on its face with the reference "SLS" by a repeatable prescriber,
and also presents and associated batch issue; or ",
(bb) in the words following paragraph (a)(ii), for "regulation 4(2)(e), (f) or (q) of the Remission of Charges Regulations", substitute "regulation 5(1)(e) or (2) of the Remission of Charges Regulations",
(iv) in subparagraph (4), for the words "a doctor, a dentist, a supplementary prescriber or an independent nurse prescriber" substitute "a prescriber or a dentist",
(b) in paragraph 3A[22] -
(ii) in subparagraph (9) -
(bb) in the words following sub-paragraph (d) for the word "doctor" substitute the word "prescriber"; and
(c) for paragraph 7(2), substitute -
Amendment of Part III (terms of service for doctors who provide pharmaceutical services) of Schedule 2
(b) he shall provide those drugs or appliances in a suitable container; (c) he shall provide for the patient a drug specified in Schedule 2 to the Prescription of Drugs Regulations only where the conditions in paragraph 42(2) of Schedule 6 to the GMS Regulations are satisfied; and (d) he shall provide for the patient a restricted availability appliance only if the patient is a person, or it is for a purpose, specified in the Drug Tariff.";
(b) for paragraph 11A(2)[23] substitute -
(ii) in the words following sub-paragraph (a)(ii), for "regulation 4(2)(e), (f) or (q) of the Remission of Charges Regulations", substitute "regulation 5(1)(e) or (2) of the Remission of Charges Regulations";
(d) for paragraphs 13 and 14 substitute -
(2) Where a doctor who is authorised or required by a Primary Care Trust under regulation 20 to provide drugs or appliances provides a drug or appliance under pharmaceutical services -
(b) had the drug or appliance been provided by a contractor providing dispensing services under a GMS contract, the contractor would have been entitled to a payment in respect of the drug or appliance by virtue of directions given by the Secretary of State under section 28T[25] of the Act,
the Primary Care Trust shall credit him with the payment.
(b) is a PMS contractor, or is engaged or employed by a PMS contractor, the complaints procedure established in accordance with the terms of a PMS agreement which give effect to paragraph 86 of Schedule 5 to the PMS Regulations,
shall apply in relation to any matter reasonably connected with his provision of pharmaceutical services as it applies as respects to services provided under that contract or agreement.
Amendments to Schedule 3A
Bath and North East Somerset Primary Care Trust Bebington and West Wirral Primary Care Trust Bedfordshire Heartlands Primary Care Trust Birkenhead and Wallasey Primary Care Trust Blackburn with Darwen Primary Care Trust Blackwater Valley and Hart Primary Care Trust Bradford South and West Primary Care Trust Bristol North Primary Care Trust Bristol South and West Primary Care Trust Bromley Primary Care Trust Burnley Pendle and Rossendale Primary Care Trust Burntwood, Lichfield and Tamworth Primary Care Trust Camden Primary Care Trust Castle Point and Rochford Primary Care Trust Central Cornwall Primary Care Trust Charnwood and North West Leicestershire Primary Care Trust Chelmsford Primary Care Trust Cheltenham and Tewkesbury Primary Care Trust Cheshire West Primary Care Trust Cotswold and Vale Primary Care Trust Coventry Primary Care Trust Durham and Chester-le-Street Primary Care Trust Durham Dales Primary Care Trust East Devon Primary Care Trust East Elmbridge and Mid Surrey Primary Care Trust East Hampshire Primary Care Trust East Leeds Primary Care Trust East Yorkshire Primary Care Trust Eastern Birmingham Primary Care Trust Erewash Primary Care Trust Exeter Primary Care Trust Gateshead Primary Care Trust Great Yarmouth Primary Care Trust Harrow Primary Care Trust Hartlepool Primary Care Trust Herefordshire Primary Care Trust Hounslow Primary Care Trust Hyndburn and Ribble Valley Primary Care Trust Ipswich Primary Care Trust Leicester Primary Care Trust Medway Primary Care Trust Mendip Primary Care Trust Mid Devon Primary Care Trust Newbury and Community Primary Care Trust Newcastle Primary Care Trust New Forest Primary Care Trust Newham Primary Care Trust North Birmingham Primary Care Trust North Hertfordshire and Stevenage Primary Care Trust North Liverpool Primary Care Trust North Peterborough Primary Care Trust North Sheffield Primary Care Trust Northamptonshire Heartlands Primary Care Trust Northumberland Primary Care Trust Norwich Primary Care Trust Portsmouth City Primary Care Trust Preston Primary Care Trust Redditch and Bromsgrove Primary Care Trust Sheffield West Primary Care Trust Somerset Coast Primary Care Trust South East Hertfordshire Primary Care Trust South East Oxfordshire Primary Care Trust South East Sheffield Primary Care Trust South Gloucestershire Primary Care Trust South Peterborough Primary Care Trust South Warwickshire Primary Care Trust South West Dorset Primary Care Trust South West Oxfordshire Primary Care Trust South Worcestershire Primary Care Trust Southern Norfolk Primary Care Trust Southwark Primary Care Trust Stockport Primary Care Trust Suffolk Coastal Primary Care Trust Sunderland Teaching Primary Care Trust Sutton and Merton Primary Care Trust Taunton Deane Primary Care Trust Torbay Primary Care Trust Vale of Aylesbury Primary Care Trust Wakefield West Primary Care Trust Walsall Teaching Primary Care Trust West Hull Primary Care Trust West Lincolnshire Primary Care Trust West of Cornwall Primary Care Trust Western Sussex Primary Care Trust Witham, Braintree and Halstead Primary Care Trust Wolverhampton Primary Care Trust Wycombe Primary Care Trust Wyre Forest Primary Care Trust"
Provisions to be revoked
(b) by or in relation to a Community Health Council, such actions shall be deemed to have been taken by or in relation to the Patients' Forum which replaces it.
(2) Where an outline consent has been granted to a doctor prior to 1st April 2004 it shall be deemed to continue on and after that date.
(This note is not part of the Regulations) These Regulations make changes to the National Health Service (Pharmaceutical Services) Regulations 1992 which are consequential upon the National Health Service (General Medical Services Contracts) Regulations 2004 and upon the National Health Service (Personal Medical Services Agreements) Regulations 2004 Regulation 24 extends the scheme which allows chemists to dispense in accordance with repeatable prescriptions, by extending it to those Primary Care Trust areas specified in the amendment. Notes: [1] 1977 c. 49; Section 41 was substituted by the Health and Social Care Act 2001 (c. 15) ("the 2001 Act"), section 42(1), and amended by the National Health Service Reform and Healthcare Professions Act 2002 (c. 17) ("the 2002 Act"), Schedule 2, paragraph 13; and by the Health and Social Care (Community Health and Standards) Act 2003 (c. 43) ("the 2003 Act"). Section 42 was substituted by the National Health Service (Amendment) Act 1986 (c. 66), section 3(1); extended by the Health and Medicines Act 1988 (c. 49), section 17; and amended by S.I. 1987/2202, article 4; by the National Health Service and Community Care Act 1990 (c. 19) ("the 1990 Act"), section 12(3); by the Health Authorities Act 1995 (c. 17) ("the 1995 Act"), Schedule 1, paragraph 30; by the Pharmacists (Fitness to Practice) Act 1997 (c. 19), Schedule, paragraph 6; by the 2001 Act, sections 20(6), 23(5), 40(3), 43(2), (3) and (4) and by Schedule 6 Part 1; and by the 2002 Act, Schedule 2, paragraph 16. Section 43 was amended by the 1995 Act, Schedule 1, paragraph 31; by the Health Services Act 1980 (c. 53), section 21(2); by the National Health Service (Primary Care) Act 1997 (c. 46), section 29(1) and Schedule 2, paragraph 14; by the 1990 Act, Schedule 9, paragraph 18(2); by the 2001 Act, sections 20(7), 42(2) and 43(5); by the 2002 Act, Schedule 2, paragraph 17; and by the 2003 Act Schedule 11, paragraph 19. Section 126(5) was inserted by the 1990 Act, section 65(2); and amended by the 2001 Act, Schedule 5, paragraph 5(13)(d). See section 128(1) of the National Health Service Act 1977 as amended by the 1990 Act, section 26(2)(g) and (i), for the definitions of "prescribed" and "regulations".back [2] As regards Wales, the functions of the Secretary of State under sections 41, 42, 43 and 126 of the 1977 Act were transferred to the National Assembly for Wales under S.I. 1999/672, article 2 and Schedule 1, as amended by the 1999 Act, section 66(5) and as read with section 40(1) of the 2002 Act.back [3] S.I. 1992/662. Relevant amending instruments are 1994/2402, 1996/698, 1998/681, 1998/2224, 1999/696, 2000/593, 2001/2888, 2002/551, 2002/888, 2002/2016, 2002/2469, 2002/2861, 2002/3135, 2003/699, 2003/1084.back [4] Section 16CC was inserted into the Act by section 174 of the 2003 Act.back [7] S.I.1976/1213 (N.I.22).back [12] Section 28C was inserted into the Act by section 21(1) of the National Health Service (Primary Care) Act 1997 (c. 46) and amended by section 4(3), Schedule 3 Part 1 paragraphs 1, 7(1) and 2(a) of the National Health Service Reform and Health Care Professions Act 2002(c. 17); section 40, Schedule 5 Part 1, paragraph 11(1) and (4) of the Health and Social Care Act 2001(c. 15) sections 184, Schedule 11 paragraphs 7 and 14 of the 2003 Actback [14] c.17. Section 15(1) was amended by section 31(2)(a) and Schedule 14, part 1 of the Health and Social Care (Community Health and Standards Act 2003 (c. 43)back [18] Paragraph 3(1ZA)[e] of Schedule 2 was inserted by S.I. 2003/1084back [21] Paragraph 3(1C) of Schedule 2 was substituted by S.I. 2003/1084back [22] Paragraph 3A of Schedule 2 was inserted by S.I. 2003/1084back [23] Paragraph 11A of Schedule 2 was inserted by S.I. 1994/2002 and sub-paragraph (2) was amended by S.I. 2002/551back [24] Paragraph 11B of Schedule 2 was inserted by S.I. 1999/696back [25] Section 28T was inserted by section 175(1) of the 2003 Actback [26] Schedule 3A was inserted by S.I. 2003/1084back
[a] Amended by Correction Slip. Page 5, regulation 7(1), line 1: "insert" should read "substitute"; back [b] Amended by Correction Slip. Page 6, regulation 9(1), within the revised regulation 12(1)(c), "[or dispensing doctor list]" should read "or dispensing doctor list"; back [c] Amended by Correction Slip. Page 7, regulation 9(12), "regulation 12(17)(b)(i)" should read "regulation 12(17)(b)(ii)"; back [d] Amended by Correction Slip. Page 7, regulation 10(1), within the revised regulation 13(2)(a)(ii)(bb), "[or dispensing doctor list]" should read "or dispensing doctor list"; back [e] Amended by Correction Slip. Page 11, footnote [18] should read "Paragraph 3(1ZA) of Schedule 2 was inserted by S.I. 2003/1084"; and back [f] Amended by Correction Slip. Page 17, schedule 1, the reference to "Regulation 24(2)(a)" should read "Regulation 24(2)". back
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