Clause 18:     Controlled drugs: power to enter and inspect

105.     Clause 18 creates a power for police constables or other authorised persons to enter the premises of healthcare providers and to inspect the arrangements for the safe management of controlled drugs. This power would go beyond the existing provision in section 23 of the Misuse of Drugs Act 1971, which is limited to entering the premises of a person carrying on business as a producer or supplier of any controlled drugs. The intention is that the inspections would generally be carried out by police constables or by accountable officers appointed under clause 16 and their staff, although the clause allows for other persons to be authorised by the relevant authority.

106.     Subsection (1) sets out the general power. Subsection (3) allows the authorised person to take copies of relevant records and retain them. Subsection (4) defines the persons who would be authorised to carry out inspections, including accountable officers and staff of designated bodies and allows the relevant authority to authorise other persons in addition to accountable officers and their staff, while subsection (5) enables the relevant authority to exclude particular categories of designated bodies from the general authorisations under subsection (4). Subsection (7) allows the relevant authority to define more closely the categories of premises which are subject to inspection, subject to the general constraints of subsection (6).

Clause 19:     Offences in connection with power to enter and inspect

107.     Clause 19 creates an offence for obstructing a person making an inspection or deliberately concealing material or information relevant to the inspection. The offence is similar to that in section 23 of the Misuse of Drugs Act. Subsection (1) defines the circumstances in which an offence is committed and subsections (2) and (3) the maximum penalties on conviction.

Clause 20     Guidance

108.     Clause 20 allows the relevant authority to give guidance to designated bodies and responsible bodies about the appointment of the accountable officer, the accountable officer's functions and the duty to co-operate. Designated bodies and responsible bodies must have regard to guidance in exercising their functions (subsection (4)). The intention is that regulations will set out the essential requirements relating to accountable officers.

Clause 21:     Crown application

109.     Clause 21 extends the provision in this Chapter to the Crown and to people in the public service of the Crown. Subsection (2) provides that the Crown will not be criminally liable for contravention of any provision in this Chapter but any such contravention maybe declared unlawful by the relevant court.

Clause 22     Relevant authorities

110.     Clause 22 sets out which authorities (the relevant authorities) have responsibility for the powers set out in this chapter. The Secretary of State will exercise the functions to cover England and (after consulting the Scottish Ministers) Scotland, the National Assembly for Wales will exercise the functions for Wales and the Department of Health, Social Services and Public Safety will exercise the functions for Northern Ireland.

Clause 23      Interpretation

111.     Clause 23 defines the terms used in this chapter and details of the relevant legislation.

PART 3 CHAPTER 2

MEDICINES AND PHARMACIES

112.     Chapter 2 of Part 3 of the Bill provides for the amendment of provisions of the Medicines Act 1968, and certain other enactments, relating to pharmacies, pharmacists and the sale and supply of medicines.

113.     Part 4 of the Medicines Act 1968 (sections 69 to 84) contains provisions relating to the registration of retail pharmacies, the lawful conduct of retail pharmacy businesses and prohibitions on the use of certain titles, emblems etc. relating to pharmacy. Under the existing provisions, a person, whether a corporate body or an individual, is only lawfully conducting a retail pharmacy business if at each pharmacy premises from which they conduct their business, the retail supply of medicines, or the supply of medicines in circumstances corresponding to retail sale (e.g. the dispensing of medicines in accordance with NHS prescriptions) is under the "personal control" of a pharmacist. The provisions of the Bill change these arrangements, by removing the requirement for personal control and substituting new requirements under which there must be a "responsible pharmacist" , responsible for the safe and effective running of the pharmacy business.

114.     Other provisions of the Medicines Act require that certain activities relating to medicines may be conducted only by or under the supervision of a pharmacist. The provisions of the Bill amend the Act in order to enable Ministers to prescribe conditions which must be complied with if that activity is to be considered as done under the supervision of a pharmacist. The policy intention is to clarify the pharmacist's obligations to supervise.

115.     In addition to the provisions of the Bill, the Government propose to make orders under the existing powers of the Medicines Act, so as to enable registered and suitably trained staff working in a pharmacy to supervise the preparation, dispensing, sale and supply of medicines, without direct supervision by a pharmacist. The policy intention is that the pharmacist can use his clinical skills and training to offer a wider range of services, including away from the pharmacy (for example, in health centres and clinics).

116.     This part extends to the entire United Kingdom.

Clause 24:     Requirements about supervision

117.     Clause 24 relates to the requirements in the Medicines Act 1968 relating to the supervision of certain activities by pharmacists.

118.     Clause 24(1) amends section 10 of the Medicines Act. Under the Act a licence is required to manufacture or supply medicinal products; section 10 of the Act provides for various exemptions from the licensing requirements of the Act where, in certain circumstances, a pharmacist, or a person acting under the supervision of a pharmacist, prepares, assembles, dispenses or supplies a medicine. Clause 24(1) inserts new subsections in section 10. These confer on the "Health Ministers" (i.e. the Secretary of State for Health and the Northern Ireland Department for Health, Social Services and Public Safety) a power to make regulations prescribing conditions which must be complied with if that activity is to be considered as done under the supervision of a pharmacist. If any of the prescribed conditions apply to that activity and are met, that will be sufficient for the activity in question to be considered as done under supervision. In addition, the new powers will extend to prescribing conditions in relation to "remote supervision" - i.e. where the pharmacist supervises an activity without being present at the pharmacy (e.g. by using a video link). The policy intention is that the regulations will clarify the pharmacist's obligations to supervise.

119.     Clause 24(2) amends section 52 of the Medicines Act. Section 52 of the Act imposes conditions on the sale or supply of any medicine which is not a "general sale list" medicine; in particular that any transaction for the sale or supply of a medicine to a customer must be carried out by, or under the supervision of, a pharmacist. A general sale list medicine is one which may be sold in retail premises which can be secured so as to exclude the public, but which are not a pharmacy (e.g. a supermarket or newsagent shop). Clause 24(2) makes amendments to section 52, identical to those for section 10; i.e. enabling the Health Ministers to make regulations relating to the requirements for supervision by a pharmacist.

Clauses 25 to 28:     pharmacy premises

120.     Under section 75 of the Medicines Act, a retail pharmacy must be registered. The register is administered by a registrar appointed by the Royal Pharmaceutical Society of Great Britain (or, in Northern Ireland, the Pharmaceutical Society of Northern Ireland). The applicant for registration must be a person "lawfully conducting a retail pharmacy business". In addition, section 52 requires that a medicine, other than a general sale list medicine, must be sold or supplied by such a person. Sections 69 to 72 specify the conditions which must be complied with if a person is to considered to be lawfully conducting the business. Section 70 specifies conditions for individual pharmacists or partners. Section 71 specifies those for corporate bodies. Section 72 specifies conditions where a pharmacist carrying on a retail pharmacy business dies or is otherwise prevented from carrying on his business (e.g. if he is adjudged bankrupt) and a representative carries on his business.

121.     Under the existing provisions, at each pharmacy premises the business of retail sale of medicines (whether general sale list medicines or not) or the supply of such medicines in circumstances corresponding to retail sale (e.g. the supply of medicines in response to NHS prescriptions) must at all times be under the personal control of a pharmacist.

122.     Clauses 25 to 28 amend these provisions; in particular, to remove the requirement for personal control and replace this with a requirement that for each pharmacy premises, there must be a "responsible pharmacist" in charge of the business of retail sale or supply of medicines.

Clause 25:     Control of pharmacy premises: individuals and partnerships

123.     Clause 25(1) substitutes a new section 70 of the Medicines Act, which relates to the requirements for retail pharmacy businesses carried on by individuals or partnerships. The effect of the substitution is to replace the requirement for each pharmacy to be under the personal control of a pharmacist with a requirement that for each pharmacy premises, there should be a responsible pharmacist. The responsible pharmacist must be in charge of the pharmacy business, in so far as it relates to the retail sale of medicines, or the supply of medicines in circumstances corresponding to retail sale (e.g. the supply of the medicines in accordance with NHS prescriptions).

124.     The new section 70(3) replaces the existing requirement in section 70 for the pharmacist in personal control of the pharmacy to exhibit conspicuously in the pharmacy his registration certificate. In practice, where there is more than one pharmacist working in a pharmacy, each will display his or her registration certificate. To avoid doubt as to the responsible pharmacist in charge of the pharmacy, section 70(3) requires the responsible pharmacist to display conspicuously in the pharmacy a notice stating that he is the pharmacist in charge at that time, and which includes details of his registration number.

125.     New section 70(4) provides that where the pharmacy business is carried on by an individual, the responsible pharmacist must be that person or another pharmacist. Where a pharmacy business is carried on by a partnership, the responsible pharmacist must be one of the partners (in Scotland, one of the partners who is a pharmacist) or another pharmacist.

126.     New section 70(5) sets out a requirement that where pharmacy premises in Great Britain have been registered for less than three years, the responsible pharmacist may not be a pharmacist who is a pharmacist by virtue of section 4A of the Pharmacy Act 1954 (i.e. a pharmacist who is qualified in another EU state whose qualification is recognised in the UK). Article 2(1) of Directive 85/433/EEC provides for Member States to recognise specified diplomas etc awarded by other Member States. Article 2(2) however provides for a derogation under which member States need not give effect to the diplomas with respect to pharmacies open to the public, which have been in operation for less than 3 years. Section 70(5) exercises that derogation in relation to Great Britain.

127.     Clause 25(2) makes a consequential amendment to section 78 of the Medicines Act (which relates to the prohibition on the use of certain titles, emblems etc relating to pharmacy), replacing references to "personal control" with references to the pharmacist in charge of the pharmacy business at the premises.

Clause 26:     Control of pharmacy premises: bodies corporate

128.     Clause 26 alters section 71 of the 1968 Act, which relates to the requirements for a retail pharmacy business carried on by a body corporate. The requirement in section 71 for a body corporate conducting a pharmacy business to have a superintendent pharmacist remains. Section 71 is however altered so as to remove the existing requirement that at pharmacy premises where the business is carried on, the retail sale or supply of medicines must be under the personal control of a pharmacist. This requirement is replaced by a requirement to have a responsible pharmacist, subject to the same conditions as apply under the new section 70 substituted by clause 25. Clause 26(2) makes a consequential amendment to section 124(2)(b) of the Act, which concerns offences by bodies corporate.

Clause 27:     Control of pharmacy premises: representative of a pharmacist in case of death or disability

129.     Clause 27 amends section 72 of the Medicines Act 1968, which specifies the conditions where a pharmacist carrying on a retail pharmacy business dies or is otherwise prevented from carrying on his business (e.g. if he is adjudged bankrupt) and a representative carries on his business. Clause 27 amends the provisions so as to remove the requirement that at each premises the retail pharmacy business is under the personal control of a pharmacist, replacing it with a requirement for there to be a responsible pharmacist, as in the amended sections 70 and 71.

Clause 28:     The responsible pharmacist

130.     Clause 28 inserts a new section 72A of the Medicines Act, to make provision in relation to the "responsible pharmacist" mentioned in sections 70, 71 and 72 of the 1968 Act (as amended by the Bill).

131.     Section 72A(1) places a duty on the responsible pharmacist to secure the safe and effective running of the pharmacy business in question, insofar as this concerns the retail sale of medicines, or the supply of medicines in circumstances corresponding to retail sale (e.g. the supply of medicines in accordance with NHS prescriptions). Section 72A(2) states that a pharmacist may not be in charge of more than one set of pharmacy premises except in circumstances specified in regulations made by the Health Ministers (i.e. the Secretary of State for Health and the Northern Ireland Department for Health, Social Services and Public Safety). Section 72A(3) to (5) impose requirements relating to the procedures which must be established and maintained by the responsible pharmacist and as to record keeping.

132.     Section 72A(6) provides for the Health Ministers to make further provisions in regulations in relation to the responsible pharmacist. Section 72A(7) then provides that those regulations may in particular make provision about the matters referred to in section 72A(1) to (4); i.e. the duties of the responsible pharmacist, the circumstances in which a person may be a responsible pharmacist in respect of more than one set of premises at a time, the duty to establish and maintain procedures and the duty to keep records. Furthermore, section 72A(7) provides that the regulations may make provision for a variety of related matters including: the qualifications and experience that a pharmacist must have to be a responsible pharmacist; the responsible pharmacist's absence from the pharmacy (for example, to impose conditions as to how long a responsible pharmacist may be absent); his supervision of the preparation, assembly, dispensing and supply of medicines at the pharmacy when he is not present; the circumstances in which he may supervise such activities at a pharmacy when he is not the responsible pharmacist for that pharmacy; the format and content of procedures to secure the safe and effective running of the business; and the form and content of the records which must be made by the responsible pharmacist.

133.     Section 72A(8) provides that if a pharmacist does not have the qualifications and experience specified in the regulations, he cannot act as a responsible pharmacist. If such a person is in charge of the retail sale/supply of medicines at a pharmacy, the person carrying on the retail pharmacy business in question will not be lawfully conducting that business.

134.     Under section 72A(9) and (10), if a pharmacist is absent from the pharmacy for a period longer than that permitted in the regulations, or is named as responsible pharmacist for more than one pharmacy without satisfying the requirements in the regulations which govern such matters, they cannot be considered for the purposes of these provisions as being in charge of the business at the pharmacy. Unless another responsible pharmacist is appointed for the pharmacy, the person carrying on the retail pharmacy business in question will not be lawfully conducting that business.

135.     Clause 28(2) makes a consequential amendment to section 77 of the Medicines Act, which deals with the annual return which every person carrying on a retail pharmacy business must make to the registrar responsible for keeping the register of retail pharmacies under the Act. The clause removes the requirement to send to the registrar the name of the pharmacist in personal control of the retail pharmacy business.

136.     Clause 28(3) amends section 84 of the Medicines Act 1968, which relates to criminal offences under Part 4 of the Act. The new provision makes it a criminal offence for a person to fail to comply with the record keeping requirements imposed under the new section 72A. Any person guilty of the offence would be liable on conviction in the magistrates' court to a fine not exceeding level 3 on the standard scale (currently £1,000).

137.     In relation to other obligations under section 72A, e.g. those requiring the responsible pharmacist to ensure safe and effective running of the pharmacy business and to maintain procedures to secure such running, it is proposed that enforcement will be dealt with under the legislation governing the provision of pharmaceutical services under the NHS and/or the regulation of the pharmacy profession.

138.     Clause 28(4) and (5) makes consequential amendments to sections 108 and 110 of the Medicines Act, which relate to enforcement. The amendments ensure that, as with the enforcement of other provisions of the Act relating to the retail sale of medicines, arrangements may be made for the enforcement of the provisions of section 72A relating to record keeping by the Pharmaceutical Societies of Great Britain and Northern Ireland.

Clause 29:     Order-making powers

139.     Clause 29 amends section 129(5) of the Medicines Act, which provides that regulations under the Act may make different provision for different areas or in relation to different cases or different circumstances. The amendment extends this power to orders made under the Act. This means that if, as is proposed, the Health Ministers make further orders under the Act to enable acts to be carried out by registered and suitably trained pharmacy staff, rather than by or under the supervision of a pharmacist, those orders may make different provision for different parts of the United Kingdom.

Clause 30: Orders under section 60 of the Health Act 1999

140.     Clause 28 amends Schedule 3 to the Health Act 1999, which makes provision about Orders in Council under section 60 of the Act. Orders under that section may make provision in relation to the regulation of health care professions. Clause 28 omits paragraph 2(2) of Schedule 3, so as to remove the limitation that orders under section 60 may not make amendments to the Medicines Act 1968 except in relation to a profession regulated by the Pharmacy Act 1954.

PART 4

PART 4 CHAPTER 1

PHARMACEUTICAL SERVICES

141.     Chapter 1 concerns pharmaceutical services provided under section 41 of the National Health Service Act 1977 ("the 1977 Act").

142.     Pharmaceutical services are provided by pharmacy contractors (who may supply and sell medicines, drugs and appliances) and by appliance contractors (who may only supply or sell appliances such as trusses, wigs, stomacare aids). Collectively, pharmacy contractors and appliance contractors are known as "chemists".

143.     In order to provide pharmaceutical services, it is necessary for a chemist to make an application to a Primary Care Trust (PCT) in England to be included in its pharmaceutical list (see section 42(2)(a) of the 1977 Act).

144.     In Wales, following the abolition of Health Authorities in April 2003, the applications envisaged by section 42(2)(a) would, by operation of section 27 of the Government of Wales Act 1998, be made to the National Assembly for Wales (the Assembly). However, the Assembly has delegated the functions in respect of pharmaceutical services, that were formerly undertaken by Health Authorities, to Local Health Boards (LHBs).

145.     An application may only be granted where the PCT or the LHB is satisfied that it is necessary or desirable to grant the application in order to secure in the neighbourhood in which the premises are located the adequate provision of pharmaceutical services. This is known as the "necessary or desirable test" or "control of entry test".

146.     This is provided for in section 42(2)(c) of the 1977 Act and, for England, in regulation 12 of the National Health Service (Pharmaceutical Services) Regulations 2005 S.I. 2005/641 ("the Regulations") (as amended). Certain exemptions to that test are set out in regulation 13 of the Regulations.

147.     In Wales, the necessary or desirable (or control of entry) test is contained within regulation 4 of the National Health Service (Pharmaceutical Services) Regulations 1992 S.I.1992/662 ("the 1992 Regulations"). There are currently no exemptions to the test contained within the 1992 Regulations.

148.     Chapter 1 provides for two changes. First, clause 31 provides for charges to be levied in respect of a chemists' application to a pharmaceutical list. Secondly, clause 32 provides for regulations to be made authorising a PCT or LHB to take account of any proposals contained in applications relating to the sale or supply of over the counter medicines and other healthcare products and advice in relation thereto.

Clause 31:     power to charge

149.     Clause 31(1) inserts new sections 42A and 42B into the 1977 Act. These sections give the Secretary of State for Health (section 42A in relation to England) and the Assembly (section 42B in relation to Wales) powers to enable charges to be levied in respect of an application to be included in a pharmaceutical list. The fee may be determined either by the Secretary of State (or the Assembly) or by PCTs (or LHBs) where the Secretary of State (or Assembly) so directs.

150.     Section 42A(1) enables the Secretary of State to give directions to PCTs requiring them to charge a fee for two types of applications to the pharmaceutical list. First, an application from a person who is not already included in a pharmaceutical list (section 42(2)(c)(i) of the 1977 Act). Secondly, an application from a person who is already included in a pharmaceutical list, but who wants to provide different services or to provide services from different premises (section 42(2)(c)(ii)).

151.     Section 42A(4) requires the Secretary of State to publish any directions he gives under this section. Publication may be by electronic means.

152.     Section 42A(5) requires a Primary Care Trust, where it determines the fee, to publish the fee. This would most likely be achieved by publishing the amounts of fees on the PCT website or, where the PCT does not have one, on the website of its Strategic Health Authority.

153.     Section 42B makes equivalent provision in relation to Wales, save that section 42B(2) additionally enables the Assembly to specify the level of the fee or fees and, as the powers within section 126(4) of the 1977 Act would not be available if the Assembly were to specify the level of the fee or fees payable, it also contains power to enable the Assembly to vary the level of any fee or fees charged and to make different provision for different cases or descriptions of cases.

154.     Additionally, section 42B(3) makes provision for the operation of sections 42B(4) and (5) in circumstances where the Assembly delegates its functions of receiving or determining the applications referred to in section 42(2)(c)(i) or (ii) of the 1977 Act. Sections 42B(4) and 42B(5) are in analogous terms to sections 42A(1) and 42B(2).

155.     Clause 31(2) makes a minor amendment to section 126(4) of the 1977 Act which will in particular allow directions under section 42A or 42B to make different provision for different cases or classes of cases.

Clause 32:     Applications for provision of pharmaceutical services

156.      Clause 32 amends the 1977 Act by inserting new subsections (2B) and (2C) into section 42. Subsection (2B) provides for regulations to be made authorising a PCT or LHB to take account of any proposals contained in the application relating to the sale or supply of over the counter medicines and other healthcare products and advice related to the supply of such products.

157.     Subsection (2B) sets out the circumstances in which the sale or supply of over the counter medicines and other health care products and advice related thereto can be taken into account.

158.     First, subsection (2B)(a) requires that there must be two or more applications for inclusion in a PCT's (or LHB's) pharmaceutical list. The applications may be from:

159.     The applications must relate to the same neighbourhood as each other. Accordingly, the provision does not apply where a PCT (or LHB) receives and determines a single application alone.

160.     Secondly, those applications must be considered together by the PCT (or LHB) (subsection (2B) (b).

161.     Thirdly, the PCT (or LHB) must be satisfied that, if each application was considered separately, each would meet the "necessary or desirable test" (as described above). However, the PCT (or LHB) must also be satisfied that if all the applications were taken together, the necessary or desirable test would not be met (subsection (2B)(c)).

162.     Where the conditions of subsection (2B) are met (and assuming the Secretary of State or the Assembly makes Regulations), subsection (2C) enables the PCT (or LHB) to take into account, in their assessment of which application or applications to grant, the proposals in such applications relating to the sale or supply of over-the-counter medicines or other healthcare products or advice related thereto. Sale or supply of over-the-counter medicines are not pharmaceutical services since such products are not supplied as part of NHS pharmaceutical services (unless ordered as part of a NHS service - for example by means of a NHS prescription). Over-the-counter medicines do not include the supply of medicines against a private prescription. Healthcare products are products and services for the diagnosis, prevention, monitoring or treatment of illness or handicap or for the promotion or protection of health.