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The Secretary of State for Health, in exercise of the powers conferred on him by sections 41, 42, 43, 45(1ZA) and 126(4) of the National Health Service Act 1977[1], section 39(2) of the National Health Service (Primary Care) Act 1997[2], sections 38, 41, 64(8) and 65(1) and (2) of the Health and Social Care Act 2001[3] and sections 38(5) and (7) and 39 of the National Health Service Reform and Health Care Professions Act 2002[4], 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 (Local Pharmaceutical Services Etc.) Regulations 2002 and shall come into force on 12th December 2002. (2) These Regulations apply to England only[5], except regulation 15, which applies to England and Wales. (3) In these Regulations -
Amendment of the National Health Service (Pharmaceutical Services) Regulations 1992 2. The National Health Service (Pharmaceutical Services) Regulations 1992[6], which in this Part are referred to as the principal Regulations, are amended in accordance with the following provisions of this Part. Amendment of regulation 2 3. In regulation 2 (interpretation), in paragraph (1) -
(b) in the definition of "Local Dental Committee", for "general dental services in a locality;" substitute "general dental services or personal dental services in an area; and in this definition, "personal dental services" has the meaning assigned to it in section 1(8) of the 1997 Act;"; (c) in the definition of "Local Medical Committee", after "general medical services" insert "or personal medical services"; (d) in the definition of "Local Pharmaceutical Committee", after "pharmaceutical services" insert "or local pharmaceutical services"; (e) after the definition of "locality", insert -
(b) a person lawfully conducting a retail pharmacy business in accordance with section 69 of the Medicines Act 1968[7], or (c) a supplier of appliances,
who provides local pharmaceutical services under a pharmacy pilot scheme;";
(b) in accordance with a pharmacy pilot scheme -
(ii) where the local pharmaceutical services provided under that scheme are provided at the same or similar hours as pharmaceutical services provided by a pharmacy falling within paragraph (a) of this definition;";
(g) in the definition of "pilot scheme", after "pilot scheme" insert "(except in the expression "pharmacy pilot scheme")"; and
Amendment of regulation 2A
(b) in paragraph (2), after paragraph (c) insert -
Amendment of regulation 6
(ii) any local pharmaceutical services provided under a pharmacy pilot scheme which are of the same description as any pharmaceutical services specified in the application;"; and
(b) for paragraph (6) substitute -
(b) who is a pilot scheme provider, or a director, officer or employee of a pilot scheme provider, or who performs or assists in performing personal medical services under a pilot scheme; or (c) 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
(b) in paragraph (2), after sub-paragraph (c) insert -
Amendment of regulation 8
(b) in paragraph (2)(b)(i), for "regulation 5(1)(c) or regulation 5(2)(c)" substitute "regulation 5(1)(c) or (ca) or regulation 5(2)(c) or (d)".
Amendment of regulation 9
(b) in paragraphs (6) and (7), for "or pharmaceutical services by any chemist" substitute "pharmaceutical services by any chemist, or local pharmaceutical services by any LPS chemist".
Amendment of regulation 11
(b) in paragraph (2)(b), after "pharmaceutical services", insert ", local pharmaceutical services".
Amendment of regulation 12
(b) for paragraph (1)(d) substitute -
(ii) which has entered into a pharmacy pilot scheme under which local pharmaceutical services are provided by a person who, in the opinion of the Primary Care Trust, might be so affected; and";
(c) in paragraph (2)(c), after "dispensing doctor list", insert ", or who provides local pharmaceutical services under a pharmacy pilot scheme entered into by that Primary Care Trust,";
(ii) any local pharmaceutical services provided under a pharmacy pilot scheme which are of the same description as any pharmaceutical services specified in the application;
(b) any information available to the Primary Care Trust which, in its opinion, is relevant to the consideration of the application; and
(e) for paragraph (10) substitute -
(b) who is a pilot scheme provider, or a director, officer or employee of a pilot scheme provider, or who performs or assists in performing personal medical services under a pilot scheme; or (c) 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.";
(f) in paragraph (13)(a), after "dispensing services" insert ", local pharmaceutical services";
Amendment of regulation 13
(ii) any person whose name is included in the medical list, pharmaceutical list, or Part 2 of the dispensing doctor list of the Primary Care Trust or any other Primary Care Trust or Health Authority to which a copy of the application was sent under regulation 12(1)(d), (iii) any person to whom a copy of the application was sent under regulation 12(2A), or (iv) any person who provides local pharmaceutical services under a pharmacy pilot scheme entered into by the Primary Care Trust or any other Primary Care Trust to which a copy of the application was sent under regulation 12(1)(d),
but in the case of a person specified in heads (ii), (iii) or (iv) above, that person may make an appeal only if he has submitted evidence pursuant to regulation 12(3) in connection with the application; and".
Amendment of Schedule 2
(c) in sub-paragraph (14) -
(ii) after "they are required" insert "(or, in the case of LPS chemists, have undertaken)", and (iii) at the end insert "or local pharmaceutical services, and, in the case of LPS chemists, of the type of local pharmaceutical services which they provide."; and
(d) in sub-paragraph (15) -
(ii) after "pharmaceutical services" insert "or local pharmaceutical services", and (iii) at the end insert "; but a chemist may make an arrangement with an LPS chemist under this sub-paragraph only where that LPS chemist provides local pharmaceutical services which are of a similar description and extent as the pharmaceutical services which he would ordinarily provide.".
Further amendment of the principal Regulations
(b) for "an Health Authority's or Primary Care Trust's", in each place where it occurs, there is substituted "a Health Authority's or Primary Care Trust's".
Duty of Primary Care Trust in relation to local pharmaceutical services 16. In section 15[9] of the Act (duty of Primary Care Trust and Health Authority in relation to family health services), after subsection (1ZB) insert -
(b) in accordance with regulations, to perform such other functions in relation to those arrangements as may be prescribed.
(1ZD) Regulations under subsection (1ZC)(b) may, in particular, prescribe functions in relation to training.".
Supply of goods and services by the Secretary of State
(b) in subsection (4) -
(ii) after paragraph (aa) insert -
Use of accommodation
(b) the provision of local pharmaceutical services in accordance with LPS arrangements, he may".
Recognition of Local Pharmaceutical Committees
(ii) the persons mentioned in sub-paragraph (i) above and the persons providing local pharmaceutical services in the Primary Care Trust's area,"; and
(b) in subsection (3), after paragraph (d) insert -
Functions of Local Pharmaceutical Committees
(b) in subsection (1C) -
(ii) after paragraph (d) insert -
(c) in subsection (4), for "or section 28C dental practitioners,", substitute ", section 28C dental practitioners or persons providing local pharmaceutical services,".
Charges for the supply of drugs to treat venereal disease
(b) after paragraph (c) insert -
Commission for Health Improvement
Amendment of the National Health Service (Payment of Remuneration - Special Arrangement) Order 1988 28. In the National Health Service (Payment of Remuneration - Special Arrangement) Order 1988[25], in article 2 (functions conferred on District and Special Health Authorities), after "pharmaceutical services" insert "or local pharmaceutical services". Amendment of the Prescription Pricing Authority Constitution Order 1990 29. In the Prescription Pricing Authority Constitution Order 1990[26] -
(b) in article 5 (constitution of the Pricing Authority) -
(ii) in paragraph (c), after "pharmaceutical services" insert "or local pharmaceutical services;".
Amendment of the National Health Service Trusts (Membership and Procedure) Regulations 1990
Amendment of the National Health Service (General Medical Services) Regulations 1992
(b) a person lawfully conducting a retail pharmacy business in accordance with section 69 of the Medicines Act 1968; or (c) a supplier of appliances,
who is included in the list of a Primary Care Trust or Health Authority under section 42 of the Act, or who provides local pharmaceutical services in accordance with LPS arrangements;".
(3) In regulation 36 (determination of question whether a substance is a drug, and recovery of cost), in paragraphs (1), (7)(b), (8) and (17), after "pharmaceutical services" insert "or local pharmaceutical services".
(b) in paragraph 44 -
(ii) in sub-paragraph (2), after "Schedule 11 to these Regulations" insert "(whether for supply as part of pharmaceutical services or local pharmaceutical services)"; and
(c) in paragraph 45(3), after "pharmaceutical services" insert "or local pharmaceutical services".
Amendment of the National Health Service Litigation Authority Regulations 1995
Amendment of the Primary Care Trusts (Membership, Procedure and Administration Arrangements) Regulations 2000
(ii) in sub-paragraph (i), after "pilot scheme health service body" insert "or a PHS body as defined in section 33(6) of the Health and Social Care Act 2001".
Amendment of the Commission for Health Improvement (Functions) Regulations 2000
Amendment of the Health Service Medicines (Control of Prices of Specified Generic Medicines) Regulations 2000
Amendment of the Health Service Medicines (Information on the Prices of Specified Generic Medicines) Regulations 2001
Amendment of the National Health Service (Local Pharmaceutical Services and Pharmaceutical Services) Regulations 2002
7A. Where, pursuant to directions given by the Secretary of State under paragraph 2(4) of Schedule 2 to the Act, a Local Pharmaceutical Committee is, prior to submission of proposals for a pilot scheme, consulted by the Primary Care Trust for whose area the Committee was formed, it shall be a function of the Committee to -
(b) in the light of the conclusions which the Committee reaches as a result of that consideration, give advice to the Primary Care Trust about that effect.".
Regulation 2(1), in the definition of "chemist" Regulation 2(1), in the definition of "controlled locality" Regulation 2(1), in the definition of "locality" Regulation 2(1), in the definition of "pharmacist" Regulations 3 to 6 Regulations 7 and 8 Regulations 9 and 10 Regulations 12 to 14 Regulations 17, 18 and 20 Regulation 21(1) Regulation 22(1) Schedule 2, paragraphs 4, 11 and 12(1). (This note is not part of the Regulations) These Regulations (except regulation 15) make further provision in connection with the establishment of pilot schemes for the provision of local pharmaceutical services under Chapter I of Part 2 of the Health and Social Care Act 2001. Part I of the Regulations contains amendments to the National Health Service (Pharmaceutical Services) Regulations 1992 ("the principal Regulations"). The key changes are as follows - - insertion of a definition of "LPS chemist", to mean a chemist who provides local pharmaceutical services under a pilot scheme (regulation 3(e)); - amendment of the definition of "pharmacy" to cover premises where local pharmaceutical services are provided (regulation 3(f)); - amendment of regulation 4(4) and 6(1) of the principal Regulations so that, when a Primary Care Trust considers whether it is necessary or desirable to grant an application for the provision of pharmaceutical services, it must take into account any local pharmaceutical services that are provided in that neighbourhood (regulation 5 and 7(a)); and - amendment of regulation 12 of the principal Regulations so that a Primary Care Trust must take into account the impact of granting an application which falls to be determined under that regulation upon any local pharmaceutical services provided in the neighbourhood (regulation 12(f), (g), (h) and (i)). Regulation 15 corrects an error in amendments to the principal Regulations made by the National Health Service Reform and Health Care Professions Act 2002 (Supplementary, Consequential etc. Provisions) Regulations 2002, in connection with the substitution of references to "Health Authority or Primary Care Trust" in place of references to "FHSA". Part II of the Regulations makes modifications of certain provisions of primary legislation. Regulations 16 to 25 make modifications to the National Health Service Act 1977. In particular, regulation 16 amends section 15 of that Act so as to require a Primary Care Trust to operate procedures for dealing with complaints about the provision of local pharmaceutical services; and regulations 19 and 20 amend sections 44 and 45 of that Act so that a Primary Care Trust may recognise a Local Pharmaceutical Committee which represents both practitioners providing pharmaceutical services and those providing local pharmaceutical services. Regulation 26 amends the Health Service Commissioners Act 1993 to provide that a person providing local pharmaceutical services may be investigated by the Health Service Commissioner for England, and regulation 27 amends the Health Act 1999 to provide that the Commission for Health Improvement has functions in relation to providers of local pharmaceutical services. Part III of the Regulations contains amendments to secondary legislation which are consequential upon the implementation of pilot schemes for local pharmaceutical services. In particular, regulation 31 amends the National Health Service (General Medical Services) Regulations 1992, providing that the word "chemist" in those Regulations includes a chemist providing local pharmaceutical services, and making other minor changes. Regulation 37 amends the National Health Service (Local Pharmaceutical Services and Pharmaceutical Services) Regulations 2002 to provide that a Local Pharmaceutical Committee must, if consulted regarding a proposal for a pilot scheme, consider the effect of the proposal on the provision of pharmaceutical services in their area and advise accordingly. Notes: [1] 1977 c. 49; see section 128(1), as amended by the National Health Service and Community Care Act 1990 (c.19) ("the 1990 Act"), section 26(2)(g) and (i); by the Health Act 1999 (c. 8) ("the 1999 Act"), Schedule 4, paragraph 38(2); and by the Health and Social Care Act 2001 (c. 15) ("the 2001 Act"), Schedule 5, paragraph 5(14), for the definitions of "prescribed" and "regulations". Section 41 was substituted by the 2001 Act, section 42(1), and amended by the National Health Service Reform and Health Care Professions Act 2002 (c. 17) ("the 2002 Act"), Schedule 2, paragraph 13. 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 1990 Act, section 12(3); by the Health Authorities Act 1995 (c. 17) ("the 1995 Act"), Schedule 1, paragraph 30; by the 2001 Act, section 43(2), (3) and (4); 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) ("the 1980 Act"), section 21(2); by the National Health Service (Primary Care) Act 1997 (c. 46) ("the 1997 Act"), section 29(1) and Schedule 2, paragraph 14; by the 1990 Act, Schedule 9, paragraph 18(2); by the 2001 Act, section 42(2) and 43(5); and by the 2002 Act, Schedule 2, paragraph 17. Section 45(1ZA) was inserted by the 2002 Act, section 5(9). Section 126(4) was amended by the 1990 Act, section 65(2); and by the 1999 Act, Schedule 4, paragraph 37(6).back [5] As regards Wales, the functions of the Secretary of State under sections 41, 42, 43 and 45 of the National Health Service Act 1977 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.back [6] S.I. 1992/662; relevant amending instruments are S.I. 1993/2451, 1995/644, 1996/698, 1998/681, 1999/696, 2001/2888, 2002/888, 2002/2016 and 2002/2469.back [8] Regulation 2A was inserted by S.I. 2001/2888.back [9] Section 15 was amended by the Health and Social Security Act 1984 (c. 48), sections 5(2) and 24; the 1990 Act, section 12(1)(b); the 1995 Act, Schedule 1, paragraph 6; the 1997 Act, section 41(10) and Schedule 2, paragraphs 3 and 4; the 1999 Act, section 65 and Schedule 4, paragraphs 4 and 8; and the 2002 Act, Schedule 2, paragraph 2 and Schedule 3, paragraph 11.back [10] Section 17 was substituted by the 1999 Act, section 12(1), and amended by the 2002 Act, Schedule 1, paragraph 7.back [11] Relevant amendments to section 26 were made by the 1980 Act, section 3(1); the 1995 Act, section 2 and Schedule 1, paragraph 14; the 1997 Act, section 41(10) and Schedule 2, paragraphs 3 and 5; the 1999 Act, section 65 and Schedule 4, paragraphs 4 and 11; and the 2002 Act, Schedule 1, paragraph 12.back [12] Section 281 was inserted by the 1997 Act, section 41(10), Schedule 2, paragraphs 3 and 7.back [13] In section 44, subsection (B2) was inserted by the 2002 Act, section 5(4); subsection (3) was inserted by the 1999 Act, section 11(1) and (4), and amended by the 2001 Act, Schedule 5, paragraph 5(7), and the 2002 Act, section 5(6).back [14] In section 45, subsection (1ZA) was inserted by the 2002 Act, section 5(9); subsection (1C) was inserted by the 1999 Act, section 11(6), and amended by the 2002 Act, section 5(11); subsection (4) was inserted by the 1999 Act, section 11(8).back [15] Section 85 was amended by the 1990 Act, section 66(1) and Schedule 9, paragraph 18(7); the 1995 Act, section 2(1) and Schedule 1, paragraph 41; the 1999 Act, section 65(1) and Schedule 4, paragraphs 4 and 25; S.I. 1999/2795, article 2; the 2001 Act, Schedule 5, paragraph 5(9); and the 2002 Act, Schedule 1, paragraph 23; and modified by the 1997 Act, Schedule 2, paragraph 20.back [16] Section 86 was amended by the 1990 Act, section 66(1) and Schedule 9, paragraph 18(8); and the 1999 Act, section 65 and Schedule 4, paragraphs 4 and 26; and modified by the 1997 Act, Schedule 2, paragraph 21.back [17] Section 103(1) was amended by the 1997 Act, section 41(10) and Schedule 2, paragraphs 3 and 25.back [18] Section 41A was inserted by the 1997 Act, section 27(1), and amended by the 2002 Act, Schedule 2, paragraph 14.back [19] See regulation 2 of S.I. 2002/888.back [20] Schedule 12, paragraph 1(1)(b) was amended by the 1997 Act, section 41(10) and Schedule 2, paragraphs 3 and 31.back [22] Section 2A was inserted by the Health Service Commissioners (Amendment) Act 1996 (c. 5), section 1; and amended by the 1997 Act, section 41(10) and Schedule 2, paragraph 68, and the Health Service Commissioners (Amendment) Act 2000 (c. 28), section 1.back [24] Section 20 was amended by the 2002 Act, Schedule 1, paragraph 49.back [25] S.I. 1988/865, as amended by S.I. 1996/971 and 2002/2469.back [26] S.I. 1990/1718; relevant amending instruments are S.I. 1996/971 and 2002/2469.back [27] S.I. 1990/2024. Relevant amending instruments are S.I. 1996/1755, 1998/646, 2000/2434, 2001/3786 and 2002/2469.back [28] S.I. 1992/635; relevant amending instruments are S.I. 1995/3093, 1996/702, 1997/730, 1997/2468, 1998/682, 1998/2838, 1999/326, 2001/2890 and 2002/2469.back [29] S.I. 1995/2801; relevant amending instruments are S.I. 1998/646, 2000/696 and 2002/2469.back [30] S.I. 2000/89; relevant amending instruments are S.I. 2001/3787, 2002/557 and 2002/2469.back [31] S.I. 2000/662, amended by S.I. 2002/2469.back [34] S.I. 2002/888, amended by S.I. 2002/2469.back
ISBN 0 11 044162 1
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