Health Act 2006 (c. 28)

(The document as of February, 2008)

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(b)

the promotion and protection of public health;

"health care professional"--

(a)

in relation to England and Wales, has the meaning given by section 28X(3)(a) of the National Health Service Act 1977 (c. 49) (referred to in this Act as "the 1977 Act"),

(b)

in relation to Scotland, has the meaning given by section 17D(2) of the National Health Service (Scotland) Act 1978 (c. 29), and

(c)

in relation to Northern Ireland, has the meaning given by Article 15C of the Health and Personal Social Services (Northern Ireland) Order 1972 (S.I. 1972/1265 (N.I. 14));

"illness"--

(a)

in relation to England and Wales, has the meaning given by section 128(1) of the 1977 Act,

(b)

in relation to Scotland, has the meaning given by section 108(1) of the National Health Service (Scotland) Act 1978, and

(c)

in relation to Northern Ireland, has the meaning given by Article 2(2) of the Health and Personal Social Services (Northern Ireland) Order 1972;

"relevant authority" is to be read in accordance with section 24;

"relevant records" has the meaning given by section 20(9);

"responsible body" has the meaning given by section 18(2).

(2) In this Chapter any reference to the management or use of controlled drugs includes--

(a) the storage, carriage and safe custody of such drugs,

(b) the prescribing and supply of such drugs,

(d) the recovery of such drugs when no longer needed, and

(e) the disposal of such drugs.

Chapter 2 Medicines and pharmacies

26 Requirements about supervision

(1) In section 10 of the Medicines Act 1968 (c. 67) (which provides for exemptions for pharmacists in relation to certain dealings with medicinal products), after subsection (7) insert--

" (7A) The Health Ministers may make regulations prescribing conditions which must be complied with if a thing is to be considered for the purposes of this section as done under the supervision of a pharmacist.

(7B) Conditions prescribed under subsection (7A) may relate to supervision in the case where the pharmacist is not at the place where the thing is being done, and in that case the thing is not to be so considered if no such conditions are prescribed.

(7C) In any case, compliance with any applicable conditions is sufficient for the thing to be so considered. "

(2) In section 52 of that Act (sale or supply of medicines not on general sale list)--

(a) the existing text is to be subsection (1),

(b) after that subsection insert--

" (2) The Health Ministers may make regulations prescribing conditions which must be complied with if a transaction mentioned in subsection (1)(c) is to be considered for the purposes of this section as done under the supervision of a pharmacist.

(3) Conditions prescribed under subsection (2) may relate to supervision in the case where the pharmacist is not on the premises, and in that case the transaction is not to be so considered if no such conditions are prescribed.

(4) In any case, compliance with any applicable conditions is sufficient for the transaction to be so considered. "

27 Control of pharmacy premises: individuals and partnerships

(1) For section 70 of the Medicines Act 1968 (pharmacy business carried on by individual pharmacist or by partners) substitute--

" 70 Business carried on by individual pharmacist or by partners

(1) The conditions referred to in section 69(1)(a) of this Act are that subsections (2) and (3) of this section are both satisfied as respects each of the premises where the retail pharmacy business is carried on and medicinal products, other than medicinal products on a general sale list, are sold by retail.

(2) This subsection is satisfied if a responsible pharmacist who satisfies the requirements of subsections (4) and (5) of this section is in charge of the business at those premises, so far as concerns--

(a) the retail sale at those premises of medicinal products (whether they are on a general sale list or not), and

(b) the supply at those premises of such products in circumstances corresponding to retail sale.

(3) This subsection is satisfied if a notice is conspicuously displayed at those premises stating--

(a) the name of the responsible pharmacist for the time being,

(b) the number of his registration under the Pharmacy Act 1954 or (in relation to Northern Ireland) the Pharmacy (Northern Ireland) Order 1976, and

(4) The responsible pharmacist must be--

(a) the person carrying on the business, or

(b) if the business is carried on by a partnership, one of the partners or, in Scotland, one of the partners who is a pharmacist, or

(5) In relation to premises in Great Britain that have been registered pharmacies for less than three years, the responsible pharmacist may not be a person who is a pharmacist by virtue of section 4A of the Pharmacy Act 1954 (qualification by European diploma) or any corresponding provision applying to Northern Ireland. "

(2) In section 78 of the Medicines Act 1968 (c. 67) (restrictions on use of titles, descriptions and emblems), in subsection (7), for the words from "under whose" to the end substitute "who is in charge of the business at those premises (so far as concerns the retail sale of medicinal products or the supply of such products in circumstances corresponding to retail sale) is also a pharmacist".

28 Control of pharmacy premises: bodies corporate

(1) For section 71 of the Medicines Act 1968 (pharmacy business carried on by body corporate) substitute--

" 71 Business carried on by body corporate

(1) The conditions referred to in section 69(1)(b) of this Act are--

(a) that the retail pharmacy business, so far as concerns the keeping, preparing and dispensing of medicinal products other than medicinal products on a general sale list, is under the management of a superintendent in respect of whom the requirements specified in subsection (6) of this section are fulfilled, and

(b) that subsections (2) and (3) of this section are both satisfied as respects each of the premises where the business is carried on and medicinal products, other than medicinal products on a general sale list, are sold by retail.

(2) This subsection is satisfied if a responsible pharmacist who satisfies the requirements of subsections (4) and (5) of this section is in charge of the business at the premises mentioned in subsection (1)(b) of this section, so far as concerns--

(a) the retail sale at those premises of medicinal products (whether they are on a general sale list or not), and

(b) the supply at those premises of such products in circumstances corresponding to retail sale.

(3) This subsection is satisfied if a notice is conspicuously displayed at those premises stating--

(a) the name of the responsible pharmacist for the time being,

(b) the number of his registration under the Pharmacy Act 1954 or (in relation to Northern Ireland) the Pharmacy (Northern Ireland) Order 1976, and

(4) The responsible pharmacist must be--

(a) the superintendent mentioned in subsection (1)(a) of this section, or

(b) a manager or assistant subject to the directions of the superintendent and who is a pharmacist.

(6) The requirements referred to in subsection (1)(a) of this section in relation to a superintendent are that--

(a) he is a pharmacist,

(b) a statement in writing signed by him, and signed on behalf of the body corporate, specifying his name and stating whether he is a member of the board of that body or not, has been sent to the registrar, and

(2) In section 124 of the Medicines Act 1968 (c. 67) (offences by bodies corporate), in subsection (2)(b), for "subsection (1)(a)" substitute "subsection (4)(b)".

29 Control of pharmacy premises: representative of pharmacist in case of death or disability

In section 72 of the Medicines Act 1968 (representative of pharmacist in case of death or disability), for subsection (2) substitute--

" (2) The conditions referred to in section 69(1)(c) of this Act are--

(a) that the name and address of the representative, and the name of the pharmacist whose representative he is, have been notified to the registrar, and

(b) that subsections (2A) and (2B) of this section are both satisfied as respects each of the premises at which the business is carried on and medicinal products, other than medicinal products on a general sale list, are sold by retail.

(2A) This subsection is satisfied if a responsible pharmacist is in charge of the business at the premises mentioned in subsection (2)(b) of this section, so far as concerns--

(a) the retail sale at those premises of medicinal products (whether they are on a general sale list or not), and

(b) the supply at those premises of such products in circumstances corresponding to retail sale.

(2B) This subsection is satisfied if a notice is conspicuously displayed at those premises stating--

(a) the name of the responsible pharmacist for the time being,

(b) the number of his registration under the Pharmacy Act 1954 or (in relation to Northern Ireland) the Pharmacy (Northern Ireland) Order 1976, and

30 The responsible pharmacist

(1) After section 72 of the Medicines Act 1968 (c. 67) insert--

" 72A The responsible pharmacist

(1) It is the duty of the responsible pharmacist mentioned in sections 70, 71 and 72 of this Act to secure the safe and effective running of the pharmacy business at the premises in question so far as concerns--

(a) the retail sale at those premises of medicinal products (whether they are on a general sale list or not), and

(b) the supply at those premises of such products in circumstances corresponding to retail sale.

(2) A person may not be the responsible pharmacist in respect of more than one set of premises at the same time, except in circumstances specified by the Health Ministers in regulations, and then only if such conditions as may be so specified are complied with.

(3) The responsible pharmacist must establish (if they are not already established), maintain and keep under review procedures designed to secure the safe and effective running of the business as mentioned in subsection (1) of this section.

(4) The responsible pharmacist must make a record (which must be available at the premises) of--

(a) who the responsible pharmacist is in relation to the premises on any day and at any time, and

(b) such other matters as the Health Ministers specify in regulations.

(5) It is the duty of the person carrying on the business to secure that--

(a) the record is properly maintained, and

(b) it is preserved for at least as long as is specified in regulations made by the Health Ministers.

(6) The Health Ministers may make further provision in regulations in relation to the responsible pharmacist.

(7) The regulations may, in particular, make further provision about the matters mentioned in subsections (1) to (4) of this section, and make provision about--

(a) the qualifications and experience which a person must have if he is to be a responsible pharmacist,

(b) the responsible pharmacist's absence from the premises,

(d) circumstances in which the responsible pharmacist may supervise relevant activities at a pharmacy of which he is not the responsible pharmacist,

(e) the form in which the procedures referred to in subsection (3) of this section are to be recorded and matters which must be covered by them,

(f) the form in which the record referred to in subsection (4) of this section is to be kept and particulars which must be included in it.

(8) In subsection (7)(c) and (d), "relevant activities" means things mentioned in section 10 and transactions mentioned in section 52(1)(c) of this Act.

72B Section 72A: supplementary

(1) The failure by a person to comply with any requirements of section 72A of this Act, or of regulations made under that section, may constitute misconduct for the purposes of section 80 of this Act, section 8 of the Pharmacy Act 1954 and Article 20 of the Pharmacy (Northern Ireland) Order 1976; and the Statutory Committee may deal with such a failure accordingly.

(2) A person who does not have the qualifications and experience required by regulations made by virtue of section 72A(7)(a) of this Act is not to be considered as a responsible pharmacist for the purposes of sections 70 to 72 of this Act.

(3) Subsection (4) of this section applies if a person--

(a) fails to comply with the requirements of subsection (2) of section 72A of this Act, or of regulations made under that subsection,

(b) fails to comply with any requirements as to absence from the premises contained in regulations made by virtue of subsection (7)(b) of that section.

(4) If this subsection applies, the person in question is not to be considered while the failure continues as being in charge of the business at the premises in question (or in a subsection (3)(a) case at any of them) for the purposes of sections 70 to 72 of this Act. "

(2) In section 77 of the Medicines Act 1968 (c. 67) (annual return of premises to registrar), omit paragraph (b) and the "and" immediately preceding it.

(3) In section 84 of the Medicines Act 1968 (offences), before subsection (1) insert--

" (A1) A person who fails to comply with either of the following shall be guilty of an offence and liable on summary conviction to a fine not exceeding level 3 on the standard scale--

(a) subsection (4) of section 72A of this Act (which requires the making of entries in a record relating to the responsible pharmacist),

(b) subsection (5) of that section (which requires the keeping and preservation of the record). "

31 Enforcement

(1) In section 108 of the Medicines Act 1968 (c. 67) (enforcement in England and Wales)--

(a) in subsection (1), at the beginning insert "Subject to the provisions of subsection (6C) of this section,",

(b) after subsection (6) insert--

" (6A) The Pharmaceutical Society shall be under a duty, concurrently with the appropriate Minister, to enforce the provisions of subsections (4) and (5) of section 72A of this Act in their application to England and Wales.

(6B) The Pharmaceutical Society shall be under a duty to enforce the other provisions of section 72A of this Act, and any regulations made under them, in their application to England and Wales.

(6C) The appropriate Minister shall be under no duty to enforce those other provisions, or any regulations made under them, in their application to England and Wales.

(6D) Notwithstanding subsection (6C) of this section the appropriate Minister is to be treated for the purposes of sections 111 to 114 of this Act--

(a) as empowered by this section to enforce those other provisions, or any regulations made under them, in their application to England and Wales, and

(b) to that extent as an enforcement authority in relation to those other provisions or those regulations in their application to England and Wales. " ,

(c) in subsection (9)(a), after "hospital" insert "(except in relation to so much of the hospital premises as is a registered pharmacy)",

(d) in subsection (10), for "(4) to (8)" substitute "(4) to (6A), (7) and (8)".

(2) In section 109 of the Medicines Act 1968 (enforcement in Scotland), in subsection (1), at the beginning insert "Subject to the provisions of section 108(6C) of this Act as applied by subsection (2) of this section,".

(3) In section 110 of the Medicines Act 1968 (enforcement in Northern Ireland)--

(a) in subsection (1), for "subsection (4)" substitute "subsections (3C) and (4)",

(b) after subsection (3) insert--

" (3A) The Pharmaceutical Society shall be under a duty, concurrently with the Minister, to enforce the provisions of subsections (4) and (5) of section 72A of this Act in their application to Northern Ireland.

(3B) The Pharmaceutical Society shall be under a duty to enforce the other provisions of section 72A of this Act, and any regulations made under them, in their application to Northern Ireland.

(3C) The Minister shall be under no duty to enforce those other provisions, or any regulations made under them, in their application to Northern Ireland.

(3D) Notwithstanding subsection (3C) of this section the Minister is to be treated for the purposes of sections 111 to 114 of this Act--

(a) as empowered by this section to enforce those other provisions, or any regulations made under them, in their application to Northern Ireland, and

(b) to that extent as an enforcement authority in relation to those other provisions or those regulations in their application to Northern Ireland. " ,

(d) in subsection (5)(b), for "(4) to (8)" substitute "(4) to (6A), (7) and (8)".

32 Order-making powers

In section 129 of the Medicines Act 1968 (c. 67) (orders and regulations), in subsection (5)--

(a) after "power to make" insert "an order or",

(b) after "making the" insert "order or".

33 Orders under s.60 of the Health Act 1999

In Schedule 3 to the Health Act 1999 (c. 8) (which makes further provision about orders under section 60 of that Act regulating health care professions), omit paragraph 2(2) (which imposes a limitation on amendment of the Medicines Act 1968).

Part 4 The National Health Service

Chapter 1 Pharmaceutical services

34 Power to charge

(1) After section 42 of the 1977 Act insert--

" 42A Power to charge: England

(1) The Secretary of State may give directions to a Primary Care Trust requiring it to charge a fee in cases or descriptions of case specified in the directions to persons who make an application referred to in section 42(2)(c)(i) or (ii) to the Primary Care Trust.

(2) The Secretary of State may in the directions--

(a) specify the fee himself, or

(b) require the Primary Care Trust to determine the amount of the fee in accordance with any requirements set out in the directions.

(3) Before determining the amount of the fee–

(a) in a subsection (2)(a) case, the Secretary of State must consult such organisations as he thinks fit that appear to him to represent persons providing pharmaceutical services and such organisations as he thinks fit that appear to him to represent Primary Care Trusts,

(b) in a subsection (2)(b) case, the Primary Care Trust must undertake any consultation required by the directions.

(4) The Secretary of State must publish in such manner as he thinks fit any directions he gives under this section.

(5) In a subsection (2)(b) case, the Primary Care Trust must publish in such manner as it thinks fit the fee which it determines.

42B Power to charge: Wales

(1) The National Assembly for Wales may charge a fee to persons who make an application referred to in section 42(2)(c)(i) or (ii) to the Assembly.

(2) The Assembly may determine the amount of the fee as it thinks fit, and may in particular charge a flat fee or charge different fees in different cases or descriptions of case.

(3) Subsections (4) and (5) apply if the Assembly directs a Local Health Board under section 16BB to exercise its functions of receiving and determining applications referred to in section 42(2)(c)(i) or (ii).

(4) The Assembly may give directions to the Local Health Board requiring it to charge a fee in cases or descriptions of case specified in the directions to persons who make an application referred to in section 42(2)(c)(i) or (ii) to the Local Health Board.

(5) The Assembly may in the directions--

(a) specify the fee itself, or

(b) require the Local Health Board to determine the amount of the fee in accordance with any requirements set out in the directions.

(6) Before determining the amount of the fee--

(a) in a subsection (1) case, the Assembly must consult such organisations as it thinks fit that appear to it to represent persons providing pharmaceutical services,

(b) in a subsection (5)(a) case, the Assembly must consult such organisations as it thinks fit that appear to it to represent persons providing pharmaceutical services and such organisations as it thinks fit that appear to it to represent Local Health Boards,

(7) The Assembly must publish in such manner as it thinks fit any fee it determines and any directions it gives under this section.

(8) In a subsection (5)(b) case, the Local Health Board must publish in such manner as it thinks fit the fee which it determines. "

(2) In section 126 of that Act (orders and regulations, and directions), in subsection (4), before "to give directions" insert "or by section 42A or 42B above,".

35 Applications for provision of pharmaceutical services

In section 42 of the 1977 Act (regulations as to pharmaceutical services), after subsection (2A) insert--

" (2B) The regulations may include the provision mentioned in subsection (2C) for the case where--

(a) two or more applications referred to in subsection (2)(c)(i) or (ii) relate to the same neighbourhood,

(b) they are considered together by the Primary Care Trust or the National Assembly for Wales, and

(c) the Primary Care Trust or the Assembly would be satisfied as mentioned in subsection (2)(c) in relation to each application taken on its own, but are not so satisfied in relation to all of them taken together.

(2C) The provision mentioned in subsection (2B) is provision for the Primary Care Trust or the Assembly, in determining which application (or applications) to grant, to take into account any proposals specified in the applications in relation to the sale or supply at the premises in question, otherwise than by way of pharmaceutical services or in accordance with a private prescription, of--

(a) drugs and medicines, and

(b) other products for, or advice in relation to, the prevention, diagnosis, monitoring or treatment of illness or handicap, or the promotion or protection of health. "

36 Arrangements for dispensing of medicines

(1) In section 43 of the 1977 Act (persons authorised to provide pharmaceutical services), for subsection (2) substitute--

" (2) Except as may be provided for by or under regulations, no arrangements for the dispensing of medicines shall be made under this Part of this Act with persons other than persons who--

(a) are registered pharmacists or persons lawfully conducting a retail pharmacy business in accordance with section 69 of the Medicines Act 1968; and

(b) undertake that all medicines supplied by them under the arrangements will be dispensed either by or under the supervision of a registered pharmacist. "

(2) In section 17S of the National Health Service (Scotland) Act 1978 (c. 29) (eligibility to be contractor under pharmaceutical care services contract), after subsection (1) insert--

" (1A) In such circumstances, and subject to such conditions, as may be prescribed, subsection (1) has effect with the omission of the words from "who undertakes" to the end. "

Chapter 2 Ophthalmic services

37 Provision of primary ophthalmic services

After section 16CC of the 1977 Act insert--

" 16CD Primary ophthalmic services

(1) Each Primary Care Trust must exercise its powers so as to provide or secure the provision, within its area, of the following primary ophthalmic services--

(a) the sight-testing service mentioned in subsection (2);

(b) such other primary ophthalmic services as may be prescribed; and

(c) to the extent that it considers necessary to meet all reasonable requirements, any further primary ophthalmic services.

(2) The sight-testing service mentioned in subsection (1)(a) is a service for testing the sight of all of the following persons (except any such testing which takes place in prescribed circumstances)--

(a) those aged under 16;

(b) those aged 16, 17 or 18 who are receiving qualifying full-time education;

(c) those whose resources are to be treated in accordance with regulations as being less than or equal to their requirements;

(d) those aged 60 or over;

(e) those of such other description as may be prescribed.

(3) Regulations may--

(a) prescribe what "qualifying full-time education" is for the purposes of subsection (2)(b);

(b) make provision for the purposes of subsection (2)(c) about how a person's resources and requirements are to be calculated.

(4) A Primary Care Trust may (in addition to any other power conferred on it)--

(a) provide primary ophthalmic services itself (whether within or outside its area);

(b) make such arrangements for their provision (whether within or outside its area) as it thinks fit, and may in particular make contractual arrangements with any person.

(5) Each Primary Care Trust must publish information about such matters as may be prescribed in relation to the primary ophthalmic services provided under this Part.

(6) A body on which functions are conferred under this section must co-operate with any other such body in the discharge of their respective functions relating to the provision of primary ophthalmic services under this Part.

(7) Regulations may provide that services of a prescribed description are, or are not, to be regarded as primary ophthalmic services for the purposes of this Part (but these regulations may not affect the duty in subsection (1)(a)).

(8) Regulations under subsection (7) may in particular describe services by reference to the manner or circumstances in which they are provided.

(9) Regulations may provide that a person--

(a) whose sight is tested by a person who is a party to a general ophthalmic services contract; and

(b) who is shown during the testing or within a prescribed time after it to fall within any of paragraphs (a) to (d) of subsection (2),

is to be taken for the purposes of the testing to have so fallen immediately before his sight was tested.

(10) In the case mentioned in subsection (9), the testing of his sight is (unless it took place in circumstances prescribed under subsection (2)) to be treated as a testing under the sight-testing service mentioned in subsection (1)(a)--

(a) for the purposes of remuneration in respect of the testing; and

(b) for any such other purpose as may be prescribed.

16CE Regulations under section 16CD: supplementary

(1) Regulations under section 16CD which refer to an Act of Parliament or an instrument made under an Act of Parliament may direct that the reference is to be construed as a reference to that Act or instrument--

(a) as it has effect at the time when the regulations are made; or

(b) both as it has effect at that time and as amended subsequently.

(2) Descriptions of persons may be prescribed under section 16CD(2)(e) by reference to any criterion, including the following--

(a) their age;

(b) the fact that a prescribed person or a prescribed body accepts them as suffering from a prescribed medical condition;

(c) the fact that a prescribed person or a prescribed body accepts that a prescribed medical condition from which they suffer arose in prescribed circumstances;

(d) their receipt of benefit in money or kind under any enactment or their entitlement to receive any such benefit;

(e) the receipt of any such benefit by other persons satisfying prescribed conditions or the entitlement of other persons satisfying prescribed conditions to receive such benefits.

(3) Regulations under section 16CD(3)(b) may direct that a person's resources and requirements be calculated--

(a) by a method set out in the regulations;

(b) by a method described by reference to a method of calculating or estimating income or capital specified in an enactment other than this section or in an instrument made under an Act of Parliament or by reference to such a method but subject to prescribed modifications;

(c) by reference to an amount applicable for the purposes of a payment under an Act of Parliament or an instrument made under an Act of Parliament; or

(d) by reference to the person's being or having been entitled to payment under an Act of Parliament or an instrument made under an Act of Parliament. "

38 General ophthalmic services contracts

After section 28W of the 1977 Act insert--

" General ophthalmic services contracts

28WA General ophthalmic services contracts: introductory

(1) A Primary Care Trust may enter into a contract under which primary ophthalmic services are provided in accordance with the following provisions of this Part.

(2) A contract under this section is called in this Act a "general ophthalmic services contract".

(3) Subject to any provision made by or under this Part, a general ophthalmic services contract may make such provision as may be agreed between the Primary Care Trust and the contractor or contractors in relation to--

(a) the services to be provided under the contract;

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