The National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009

Interpretation and application

2.—(1) In these Regulations unless the context otherwise requires–

“the Act” means the National Health Service (Scotland) Act 1978;

“the 1968 Act” means the Medicines Act 1968(1);

“additional professional services” has the meaning assigned to it in regulation 4;

“advanced electronic signature” means an electronic signature, within the meaning of section 7(2) of the Electronic Communications Act 2000(2), which is–

(a)

uniquely linked to the signatory;

(b)

capable of identifying the signatory;

(c)

created using means that the signatory can maintain under his or her sole control; and

(d)

linked to the data to which it relates in such a manner that any subsequent change of data is detectable;

“the Agency” means the Common Services Agency for the Scottish Health Service constituted under section 10 of the Act(3);

“appliance” means an appliance which is a listed appliance within the meaning of section 27(1) of the Act;

“appropriate non-proprietary name” means a non-proprietary name which is not mentioned in any directions given by the Scottish Ministers under section 17N(6) of the Act (other mandatory contract terms)(4) as to the drugs or other substances–

(a)

which may not be ordered for patients in the provision of primary medical services under a general medical services contract;

(b)

except where the conditions in paragraph 40(2) of Schedule 5 to the GMS Contracts Regulations(5) are satisfied, which can only be ordered for specified patients and specified purposes;

“Area Medical Committee” means the committee of that name for the area of a Board recognised under section 9 of the Act(6);

“Area Pharmaceutical Committee” means the committee of that name for the area of a Board recognised under section 9 of the Act;

“Board” means a Health Board within the meaning of section 2(1)(a) of the Act(7);

“chemical reagent” means a chemical reagent included in a list for the time being approved by the Scottish Ministers for the purposes of section 27 of the Act;

“clinical management plan” has the meaning ascribed in article 1(2) of the Prescription Only Medicines (Human Use) Order 1997(8);

“corresponding decision” has the same meaning as in section 32D of the Act(9);

“dentist” means a dental practitioner;

“directed services” means additional pharmaceutical services within the meaning of section 27A of the Act;

“doctor” means a fully registered medical practitioner within the meaning of Schedule 1 to the Interpretation Act 1978(10);

“drugs” includes medicines and chemical reagents;

“Drug Tariff” has the meaning assigned to it in regulation 12;

“electronic communication” has the same meaning as in section 15 of the Electronic Communications Act 2000(11);

“electronic prescription form” means a prescription form as defined in paragraph (b) of the definition of “prescription form”;

“emergency requiring the flexible provision of pharmaceutical services” means an emergency declared by means of a direction to Boards under section 2(5) of the Act to the effect that, as a result of the threatened damage to human welfare caused or which may be caused by the illness designated in the direction, Boards must for a specified period exercise one or more of their functions under regulation 6 or regulation 11(5), subject to any conditions or limitations set out in the direction;

“ePharmacy service” means the electronic system provided by the Agency by which electronic messages are transmitted between pharmacy contractors, doctors and the Agency;

“equivalent body” means–

(a)

in England, a Primary Care Trust, or in relation to any time prior to 1st October 2002 a Health Authority;

(b)

in Wales, a Local Health Board or in relation to any time prior to 1st April 2003 a Health Authority;

(c)

in Northern Ireland, a Health and Social Services Board;

or any successor body;

“equivalent list” means a list kept by an equivalent body;

“GMS Contracts Regulations” means the National Health Service (General Medical Services Contracts) (Scotland) Regulations 2004(12);

“health centre” means premises provided by the Scottish Ministers in accordance with the provisions of section 36(1)(b) of the Act;

“hypodermic needle exchange services” has the meaning assigned to it in regulation 3(3);

“joint discipline committee” has the same meaning as in the National Health Service (Discipline Committees) (Scotland) Regulations 2006(13);

“listed drugs” means such drugs and medicines as are included in a list for the time being approved by the Scottish Ministers for the purposes of section 27(1) of the Act;

“medicinal product” means–

(a)

a medicinal product within the meaning given by Article 1 of Directive 2001/83/EC(14); or

(b)

any product which is not a medicinal product within the meaning given by Article 1 of Directive 2001/83/EC, but which is a medicinal product within the meaning ascribed to it in section 130 of the 1968 Act(15);

“minor relocation” has the meaning assigned to it in regulation 5;

“National Appeal Panel” means the panel constituted under Part II of Schedule 4;

“non-electronic prescription form” means a prescription form as defined in paragraph (a) of the definition of “prescription form”;

“non-proprietary name” in relation to a drug means–

(a)

where the drug is described in a monograph in the current edition in force at the time of the supply of the drug, (as defined in section 103(5) of the 1968 Act)(16), of the European Pharmacopoeia, the British Pharmacopoeia, the British Pharmaceutical Codex, the British National Formulary, the International Pharmacopoeia, the Cumulative List of Recommended International Non-proprietary Names or the Dental Practitioners' Formulary, any name, or abbreviation of the name, at the head of that monograph or, where the name consists of two or more words, any name derived from a suitable inversion of such words which is permitted by that publication; or

(b)

where the drug is not so described but has an approved name, being the name which appears in the current edition in force at the time of the supply of the drug, (as defined in the said section 103(5) of the 1968 Act) of the list of names prepared and published under section 100 of that Act, its approved name;

“nurse independent prescriber” means a person–

(a)

who is registered in the Nursing and Midwifery Register; and

(b)

against whose name is recorded in that register an annotation signifying that he or she is qualified to order drugs, medicines and appliances as a community practitioner nurse prescriber, a nurse independent prescriber or a nurse independent/supplementary prescriber;

“Nursing and Midwifery Register” means the register maintained by the Nursing and Midwifery Council under article 5 of the Nursing and Midwifery Order 2001(17);

“optometrist independent prescriber” means a person–

(a)

who is a registered in the register of optometrists maintained by the General Optical Council in pursuance of section 7 of the Opticians Act 1989(18), or in the register of visiting optometrists from relevant European States maintained under section 8B(1)(a) of that Act(19); and

(b)

against whose name is recorded in the relevant register an annotation signifying that he or she is qualified to order drugs, medicines and appliances as an optometrist independent prescriber;

“Patient Group Direction” has the meaning ascribed in Article 1(2) of the Prescription Only Medicines (Human Use) Order 1997(20);

“pharmaceutical discipline committee” has the same meaning as in the National Health Service (Discipline Committees) (Scotland) Regulations 2006;

“pharmaceutical list” has the meaning assigned to it in regulation 5;

“pharmaceutical services” means those services as defined by section 27 of the Act and includes the provision to persons who are in a Board’s area of listed drugs and medicines which are ordered for those persons by a dental practitioner in pursuance by such dental practitioner of the performance of personal dental services within the meaning of section 1(8) of the National Health Service (Primary Care) Act 1997(21) but not including directed services;

“pharmacist” means a person who is registered in Part 1 or 3 of the Register of Pharmacists maintained under article 10(1) of the Pharmacists and Pharmacy Technicians Order 2007(22) or the register maintained in pursuance of Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976 (23);

“pharmacy contractor” means a contractor who provides pharmaceutical services, or a person lawfully conducting a retail pharmacy business in accordance with section 69 of the 1968 Act(24), who provides pharmaceutical services in terms of arrangements made by a Board under section 27 of the Act;

“pharmacist independent prescriber” means a pharmacist against whose name in the relevant register is recorded an annotation signifying that he or she is qualified to order drugs, medicines and appliances as a pharmacist independent prescriber;

“prescriber” means a doctor, a pharmacist independent prescriber, a nurse independent prescriber, an optometrist independent prescriber or a supplementary prescriber under an agreed clinical management plan;

“prescription form” means–

(a)

a form provided by the Board or the Agency–

(i)

on which the provision of pharmaceutical services may be ordered by–

(aa)

a Board;

(bb)

a dentist pursuant to the provisions of his or her terms of service;

(cc)

a dentist performing personal dental services in accordance with a pilot under Part I of the National Health Service (Primary Care) Act 1997; or

(dd)

a prescriber; and

(ii)

which contains on its reverse side a form of declaration of entitlement to exemption or a statement that a charge has been paid to be completed and signed by the patient named on the form or by a person acting on that patient’s behalf,

and includes a prescription form provided and issued under equivalent arrangements having effect in England, Wales or Northern Ireland; or

(b)

data that are created in an electronic form for the provision of pharmaceutical services ordered by–

(i)

a dentist pursuant to the provisions of his or her terms of service;

(ii)

a dentist performing personal dental services in accordance with a pilot under Part I of the National Health Service (Primary Care) Act 1997; or

(iii)

a prescriber,

and signed with such a person’s advanced electronic signature and transmitted as an electronic communication through the ePharmacy service; or

(c)

a form on which domiciliary oxygen has been ordered–

(i)

by a prescriber in England or Wales for a patient normally resident in England or Wales; and

(ii)

in relation to which the patient named on the form (or a person on the patient’s behalf) completes and signs a declaration of entitlement to exemption or a statement that a charge has been paid;

“provisional pharmaceutical list” has the meaning assigned to it in regulation 8;

“registered pharmacy” means a registered pharmacy within the meaning of section 74 of the 1968 Act(25);

“relevant service” means whole-time service in the armed forces of the Crown in a national emergency or otherwise, or compulsory whole-time service in those forces, including service resulting from any reserve liability, or any equivalent service by a person liable for compulsory whole-time service in those forces;

“restricted availability appliance” means an appliance which is approved for particular categories of persons or for particular purposes only;

“scheduled drug” means–

(a)

a drug, medicine or other substance specified in any directions given by the Scottish Ministers under section 17N(6) of the Act as being a drug or other substance which may not be ordered in the provision of primary medical services under a general medical services contract; or

(b)

except where the conditions in paragraph 40(2) of Schedule 5 to the GMS Contracts Regulations(26) are satisfied, a drug, medicine or other substance which is specified in any directions given by the Scottish Ministers under section 17N(6) of the Act as being a drug or other substance which can only be ordered for specified patients and specified purposes in the provision of primary medical services under a general medical services contract;

“supplementary prescriber” means a person whose name is registered in–

(a)

the Nursing and Midwifery Register;

(b)

Part 1 or 3 of the Register of Pharmacists maintained under article 10(1) of the Pharmacists and Pharmacy Technicians Order 2007,

(c)

the register maintained in pursuance of Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976;

(d)

the part of the register maintained by the Health Professions Council in pursuance of article 5 of the Health Professions Order 2001(27) relating to–

(i)

chiropodists and podiatrists;

(ii)

physiotherapists; or

(iii)

diagnostic or therapeutic radiographers; or

(e)

the register of optometrists maintained by the General Optical Council in pursuance of section 7 of the Opticians Act 1989,

and against whose name is recorded in the relevant register an annotation signifying that he or she is qualified to order drugs, medicines and appliances as a supplementary prescriber or, in the case of the Nursing and Midwifery Register, a nurse independent/supplementary prescriber;

“supply form” means a form issued by a Board to record a supply of pharmaceutical services under the terms of a Patient Group Direction issued by a Health Board in accordance with Article 12C of the Prescription Only Medicines (Human Use) Order 1997(28) (exemption for persons conducting a retail pharmacy business who supply or administer prescription only medicines under a Patient Group Direction);

“suspended by direction of the Tribunal” means suspended as respects the provision of pharmaceutical services by a direction of the Tribunal made pursuant to section 32A(2) or section 32B(1) of the Act(29) or to any provisions in force in England and Wales or Northern Ireland corresponding to those provisions;

“terms of service” means the terms of service for pharmacists and pharmacy contractors contained or referred to in Schedule 1;

“the Tribunal” means the Tribunal constituted under section 29 of the Act(30).

(2) These Regulations shall apply to a person, firm or body corporate (other than a dental practitioner) providing pharmaceutical services (which includes the supply of appliances by appliance suppliers) as they apply to a pharmacist.

(3) Unless the context otherwise requires–

(a) any reference in these Regulations–

(i) to a numbered regulation is a reference to the regulation bearing that number in these Regulations,

(ii) to a numbered Part or Schedule is a reference to the Part of, or Schedule to, these Regulations bearing that number,

(iii) to a form thereby prescribed includes a form substantially the same; and

(b) any reference in a regulation or in a Schedule to these Regulations to a numbered paragraph is a reference to the paragraph bearing that number in that regulation or Schedule.

(1)

1968 c. 67.

(2)

2000 c. 7.

(3)

Section 10 was amended by the 1980 Act, Schedule 6, paragraph 2, the 1990 Act, Schedule 10, paragraph 1, the Health Act 1999 (c. 8) (“the 1999 Act”), Schedule 4, paragraph 44 and the Health and Social Care (Scotland) Act 2005 (asp 13) (“the 2005 Act”), Schedule 2, paragraph 2.

(4)

Section 17N was inserted by the Primary Medical Services (Scotland) Act 2004 (asp 1) (“the 2004 Act”), section 4. The current directions are the “Directions as to the drugs, medicines or other substances which may, or may not, be ordered for patients in the provision of primary medical services under a general medical services contract” given on 18th March 2004, and published on Scottish Health on the Web (SHOW) at http://www.show.scot.nhs.uk/sehd/pca/PCA2004(M)11.pdf.

(5)

Paragraph 40(2) was amended by S.I. 2007/206.

(6)

Section 9 was amended by the 1990 Act, section 29(4) and (5) and the 1999 Act, Schedule 4, paragraph 43(a) and (b).

(7)

Section 2(1)(a) was amended by the 1983 Act, Schedule 7, paragraph 1, the 1990 Act, section 28(a), the National Health Service Reform (Scotland) Act 2004 (asp 7), schedule 1, paragraph 1(2) and the 2005 Act, schedule 2, paragraph 2(2).

(8)

S.I. 1997/1830. The definition of “clinical management plan” was inserted by S.I. 2000/1917.

(9)

Section 32D was inserted by the 2005 Act, section 27.

(10)

1978 c. 30, the definition of “registered medical practitioner” was amended by the Medical Act 1983 (c. 54), Schedule 5, paragraph 18.

(11)

The definition of “electronic communication” was amended by the Communications Act 2003 (c. 21) Schedule 17, paragraph 158.

(12)

S.S.I. 2004/115, amended by the Charities and Trustee Investment (Scotland) Act 2005 (asp 10), schedule 4, Part 2, paragraph 18(a), S.S.I. 2004/162 and 215, 2005/337, 2006/247, 2007/206 and 501, 2008/27 and S.I. 2007/289.

(13)

S.S.I. 2006/330.

(14)

O.J. No. L 311, 28.11.2001, p.67.

(15)

Section 130 was amended by the Animal Health and Welfare Act 1984 (c. 40), Schedule 1, paragraph 3 and S.I. 1994/3119, 2005/50 and 2006/2407.

(16)

Section 103(5) was amended by the 1988 Act, section 22(6).

(17)

S.I. 2002/253 to which there are no relevant amending instruments.

(18)

1989 c. 44; section 7 was amended by S.I. 2005/848.

(19)

Section 8B was inserted by S.I. 2005/848.

(20)

The definition of Patient Group Direction was inserted by S.I. 2000/1917.

(21)

1997 c. 46.

(22)

S.I. 2007/289. Article 10(1) was amended by S.I. 2007/3101.

(23)

S.I. 1976/1213 (N.I. 22).

(24)

Section 69 was amended by the Statute Law (Repeals) Act 1993 (c. 50), Schedule 1, Part XII, and S.I. 1976/1213 (N.I. 22), 2007/289 and 3101.

(25)

Section 74 was amended by the Statute Law (Repeals) Act 1993, Schedule 1, Part XII.

(26)

Paragraph 40(2) was amended by S.S.I. 2007/206.

(27)

S.I. 2002/254.

(28)

Article 12C was inserted by S.I. 2000/1917, and amended by S.I. 2000/2899, 2003/696 and 2007/2178.

(29)

Sections 32A and 32B were inserted by section 8 of the National Health Service (Amendment) Act 1995 (c. 31).

(30)

Section 29 was amended by the Health and Social Security Act 1984, Schedule 8, Part I and by the National Health Service (Amendment) Act 1995, sections 7 and 9 and the Schedule.