Clause 33: Arrangements for dispensing of medicines

163.      Clause 33 amends section 43 of the National Health Service Act 1977, which concerns the persons who may be authorised to provide NHS pharmaceutical services in England and Wales. The clause makes provision in relation to the supervision of transactions by pharmacists, in addition to those in clause 24 (requirements about supervision in the Medicines Act).

164.      The existing section 43(2) of the 1977 Act provides that, except as may be provided for by or under regulations, arrangements for the dispensing of medicines shall be made only with persons who are registered pharmacists, or are persons lawfully conducting a retail pharmacy business in accordance with section 69 of the Medicines Act, and who undertake that all medicines supplied by them under arrangements for the provision of pharmaceutical services shall be dispensed by or under the direct supervision of a registered pharmacist. Clause 33 substitutes a new subsection (2), to clarify that regulations made by the Secretary of State under section 43(2) may provide for exemptions from the second requirement; i.e. that the registered pharmacist, or the person lawfully conducting a retail pharmacy business, undertakes that medicines will be dispensed by or under the supervision of a pharmacist. The policy intention is that the regulations would allow arrangements under which medicines are to be dispensed by registered and suitably trained pharmacy staff, without the supervision of a pharmacist.

PART 4 CHAPTER 2

OPHTHALMIC SERVICES

165.     General ophthalmic services (GOS) are at present provided by optometrists (previously known as ophthalmic opticians) and ophthalmic medical practitioners (OMPs) under Part 2 of the National Health Service Act 1977 (the 1977 Act).

166.     Part 2 of that Act previously governed the services not only of optometrists and OMPs but also of general medical practitioners, dentists and chemists (the NHS "in the high street").

167.     The Health and Social Care (Community Health and Standards) Act 2003 repealed the provisions in Part 2 of the 1977 Act regarding the provision of services by general medical practitioners and dentists and provided in their place for primary medical services and primary dental services respectively under Part 1 of the 1977 Act. The general effect of these new provisions was to replace the previous arrangements for such services with new general medical services (GMS) or general dental services (GDS) contracts with providers (i.e. those bodies that provided the services contracted for), whilst having a new list system for performers (i.e. the health service professionals who actually perform the services).

168.     The provisions in this Bill will introduce a new "contract system" for the provision of ophthalmic services in place of the present system, very much on the model of what has already been done for primary medical services and primary dental services.

169.     Part 2 of the 1977 Act will remain in force for the delivery of pharmaceutical services.

Clause 34:      Provision of primary ophthalmic services

170.     Clause 34 makes provision for primary ophthalmic services by inserting into the National Health Service Act 1977 new sections 16CD and 16CE.

171.     As regards section 16CD, subsection (1) sets out the duty of a Primary Care Trust to provide or secure the provision of a sight testing service. The testing of sight is carried out in accordance with section 26 of the Opticians Act 1989 and the Sight Testing (Examination and Prescription) (No. 2) Regulations 1989. The Primary Care Trust must also provide or secure the provision of other primary ophthalmic services prescribed in Regulations. Thirdly, a PCT must provide or secure the provision of such further primary ophthalmic services to the extent it considers necessary to meet reasonable requirements.

172.     Subsection (2) sets out the groups for which a Primary Care Trust must provide or secure a sight test pursuant to subsection (1)(a) (except any such testing which takes place in circumstances specified in regulations). Regulations may be made for other groups to become eligible for sight tests. Regulations will be made to cover all groups currently eligible for NHS funded sight tests where they are not expressly mentioned.

Clause 35     General ophthalmic services contracts

173.     Clause 35 makes provision for a general ophthalmic services contract. It inserts new sections 28WA, 28WB, 28WC, 28WD, 28WE and 28WF into the 1977 Act:

Clause 36:     Persons performing primary ophthalmic services

174.     Clause 36 amends section 28X of the 1977 Act, so that, in common with primary medical services and primary dental services, only a person on the performers list of a Primary Care Trust may perform primary ophthalmic services. It also allows the Secretary of State to prescribe the qualifications and experience which a medical practitioner who applies for inclusion in a primary ophthalmic services list must have.

Clause 37:     Assistance and support

175.     Clause 37 amends section 28Y of the 1977 Act to include providers of primary ophthalmic services alongside providers of primary medical and dental services as being eligible for assistance and support under that Act.

Clause 38:     Local Optical Committees

176.     Clause 38 inserts new section 45C in the 1977 Act. The new section relates to Local Optical Committees.

Clause 39:     Payments in respect of optical appliances

177.      Clause 39 amends Schedule 12 to the 1977 by inserting a new paragraph 2B. Paragraph 2B allows for regulations to be made providing for the Secretary of State to give a notice to a provider of optical appliances to the effect that no further payments may be made to that person in respect of optical appliances supplied at a particular location or in a particular area (or replaced or repaired) ("a local disqualification" or "stop notice"). Regulations may also make provision for appeal rights for the person to whom the notice was given. Further, the Secretary of State may following a local disqualification apply to the Family Health Services Appeals Authority (FHSAA) for an order to be given to that person in respect of the supply of optical appliances (or their replacement or repair) wherever it occurred ("a national disqualification" or "stop order").

Clause 40:     General ophthalmic services: transitional

178.     Clause 40 makes transitional provision.

179.     Schedule 8

180.     Schedule 8 makes amendments consequential to the provisions relating to primary ophthalmic services.

PART 4 CHAPTER 3

PROTECTION OF NHS FROM FRAUD AND OTHER UNLAWFUL ACTIVITIES

Clause 41: Compulsory disclosure of documents for purposes of counter fraud or security management functions

181.     Subsection (1) sets out the general purpose of Chapter 3, which is to confer power to require the production of documents in connection with the appropriate national authority's counter fraud functions and the Secretary of State's security management functions. The appropriate national authority is defined in clause 78 as the Secretary of State in relation to England and the National Assembly for Wales in relation to Wales.

182.     Subsection (2) explains that the appropriate national authority's "counter fraud functions", which are derived from section 2(b) of the NHS Act 1977, include the power to take action to prevent, detect or investigate fraud and corruption affecting the NHS in England or Wales.

183.     Subsection (3) explains that the Secretary of State's "security management functions", which are also derived from section 2(b) of the NHS Act 1977, mean his powers to take action to protect and improve the security of the persons, property and information listed in paragraphs (a) to (f).

Clause 42:     Meaning of "NHS body" etc.

184.     Clause 42 provides definitions of those who are subject to the powers in this Chapter.

185.     Subsection (7) explains that the appropriate national authority may make changes to subsections (2) to (6) of this clause, and if they do this they may also make any consequential amendments to this Chapter. Any such order is subject to the affirmative parliamentary procedure under clause 75(4)(c).

Clause 43:      Notice requiring production of documents

186.     Clause 43 sets out when the appropriate national body investigating fraud and security incidents and breaches may serve a notice requesting production of documents relevant to the exercise of their functions defined in clause 41. They may do so where they have reasonable grounds to suspect that such documents are in the possession or under the control of an NHS body; statutory health body or health service provider; or NHS contractor and that a member, officer, director or manager of the body or provider or an employee of that organisation or where a health service provider is an individual that person, is accountable for the documents.

187.     Subsection (4) requires the notice to identify either specifically or by a general description, the documents which are required.

188.     Subsection (5) sets out that the notice may require when, where and how the documents will need to be produced.

189.     Subsections (8) and (9) states that the deadline for producing the documents requested may be altered by the authorised officer by agreement with the person whom the notice was served on. If the notice is varied that variation must be put in writing.

190.     Subsection (10) provides for a person to be regarded as accountable for the documents if he has either day-to-day, or overall, responsibility, for managing the documents required.

Clause 44:     Production of documents

191.     Clause 44 applies once a notice has been given under clause 43 by the appropriate national authority.

192.      Subsection (2) makes it clear that an authorised officer may: take away any documents produced under the notice; take copies of the whole or specific parts of those documents; and ask the person producing those documents to explain them. An authorised officer is defined in clause 52 as an officer authorised by the appropriate national authority or where these functions are to be exercised by a Special Health Authority, an appropriately authorised officer of that body.

193.     Subsection (3) makes it clear that, if a person produces a document for the authorised officer to take away and he makes a request to the officer for a copy of that document, and the officer considers that request reasonable, the officer must as soon as is reasonably practicable give him a copy of the document.

194.     Subsection (4) states that documents may be kept by the appropriate national authority for as long as it considers it necessary to retain them (rather than copies of them).

195.     Subsection (5) allows any of the produced documents that are relevant to any legal proceedings to be kept until the completion of any legal proceedings.

196.     Subsection (6) provides that if a person fails to produce the requested documents, as stated in the notice, they may be required by the authorised officer to state where they are.

197.     Subsection (7) states that a person is only required to produce documents, or state where he believes the documents to be, to those who show appropriate evidence of authority.

198.     Subsection (8) states that a person may not be required to produce documents or disclose any information which is subject to legal professional privilege.

Clause 45:     Delegation of functions

199.     Clause 45 sets out that the appropriate national authority may direct a Special Health Authority to carry out its functions of serving and executing notices for the production of documents.

200.     Subsection (3) provides that any such directions should be given in regulations.

201.     Subsection (4) makes it clear that regulations may make further provision in connection with the Special Health Authority's exercise of this function.

202.     Subsection (5) explains that the regulations may, as well as making general provision about how the Special Health Authority is to exercise the delegated function, require authorised officers investigating fraud and security incidents or breaches to be appropriately trained. The regulations may also make provision for authorised officers investigating fraud and security breaches or incidents to seek specific authorisation before personal information is required.

203.     Subsection (6) sets out that any direction under subsection (1) is to be treated as if it had been made under section 16D of the1977 Act.

Clause 46:     Code of practice relating to delegated functions

204.     Subsection (1) states that the appropriate national authority may publish a code of practice relating to the exercise of these functions by a Special Health Authority. The appropriate national authority must keep the code under review and may amend it as and when appropriate.

205.     Subsections (3) and (4) require the appropriate national authority to consult persons or bodies which the authority considers appropriate before publishing the code of practice or any amended versions where the changes are substantial. Subsection (8) provides that consultation for these purposes will include any consultation undertaken before this section is commenced.

206.     Subsection (6) makes clear that no criminal or civil liability attaches to a failure to follow the code.

207.     Subsection (7) provides that the code may be used in criminal or civil proceedings.

Clause 47:      Disclosure of information

208.     Clause 47 relates to the disclosure of information. It relates to information held by, or on behalf of, the appropriate national authority and which has been acquired under these provisions. The information can only be disclosed in the circumstances set out in subsection (3) unless the person to whom the information relates has given his consent (see subsection (7)).

209.     Subsection (6) makes clear that information may be disclosed under subsection (3) despite any obligation of confidence that would otherwise apply.

210.     Subsection (5) states that where information is disclosed in accordance with subsection (3) the information cannot be used or disclosed to another person unless this is done for purposes connected with the function, proceedings, enactment or order in relation to which it was disclosed.

Clause 48:     Special protection for personal records

211.     Clause 48 provides special protection for information obtained from personal records (as defined in the Police and Criminal Evidence Act 1984) and from which the identity of an individual can be ascertained either from that information alone or that information and other information held by the appropriate national authority and disclosed by or on behalf of the appropriate national authority.

212.     If a person discloses such personal records for the purposes of any court proceedings they must take such measures as are necessary to ensure that information contained in the records is not disclosed to a member of the public without an order from a court (subsection (3). However a party to those proceedings may apply for permission to use the records as evidence (subsection (4)).

213.     Subsection (5) makes it clear that if the party applies for such permission from the court, and the court considers it necessary in the interests of justice, then it can give permission for the information to be adduced as evidence with any conditions it thinks necessary.

214.     Subsection (6) explains that the conditions could require some of the proceedings being held in a closed court.

Clause 49      Offences in connection with production of documents

215.     Clause 49 creates offences of failing to comply with clause 43 or 44.

216.     Subsections (1) to (3) provide that a person commits an offence if they fail to comply with clause 43 or 44 by failing to produce documents that are requested or failing to provide explanations of those documents or to state where they believe they may be found. If found guilty a person could be sentenced to a maximum of 51 weeks imprisonment (3 months until the relevant provisions of the Criminal Justice Act 2003 are commenced - see clause 74) or fined, or both. Further offences are committed if a person fails to produce after conviction and a continuing fine applies.

217.     Subsection (4) and (5) state that it is an offence if a person makes a false or misleading statement in answer to questions put to them under clause 44. If found guilty, a person could be sentenced to a maximum of 2 years' imprisonment or fined, or both. (see section 74 for the transitional modification of the summary penalty).

Clause 50:      Offences relating to disclosure or use of information

218.     Clause 50 relates to the offences in connection with disclosure of information obtained under these clauses.

219.     Subsection (1) states that a person commits an offence if he fails to comply with the provisions of clause 47(2) or (5) relating to the disclosure of information or clause 48(3) which relates to safeguards protecting personal information.

220.     Subsection (3) states that if a person is charged with an offence in respect of the disclosure of information, it is a defence if he can prove (on the balance of probabilities) that he reasonably believed:

221.     Subsection(2) provides that on conviction on indictment the penalty is a maximum of 2 years' imprisonment, a fine or both (see clause 74 for the transitional modification of the summary penalty).

Clause 51:      Manner in which disclosure notice may be served

222.     Clause 51 explains the procedures associated with serving the notice for the production of documents.

223.     Subsection (2) states that a notice may be delivered to a person, left at his proper address or sent to him by post.

PART 4 CHAPTER 4

AUDIT OF SPECIAL HEALTH AUTHORITIES

Clause 53:     Accounts and audit

224.     Clause 53 amends section 98 of the National Health Service Act 1977 to add a new Schedule 12B to the 1977 Act. New Schedule 12B in effect re-enacts section 98 with amendments.

225.     Paragraph 7 of the Schedule makes new provisions to make the Comptroller and Auditor General the auditor of the annual accounts (other than those relating to charitable funds) of English and cross-border Special Health Authorities (SpHAs). This is a new provision in primary legislation, although the same substantive effect is currently in place for all existing SpHAs through orders made under section 25 of the Government Resources and Accounts Act 2000. The effect of paragraph 8 is to remove the legislative requirement for the Secretary of State to prepare summarised accounts for English and cross border SpHAs .

226.     A new provision in paragraph 10 removes the requirement for English and cross border SpHAs to submit accounts to the Secretary of State in relation to funds held on charitable trust - this makes the position consistent with that for other NHS bodies.

227.     The effect of paragraph 11 is that the accounts of any non-charitable trust funds which an NHS body manages are only to be excluded from summarised accounts. There is therefore a new requirement for all NHS bodies to submit accounts of any non-charitable trust funds which they manage to the Secretary of State, and for these to be audited by auditors appointed by the Audit Commission.

PART 5

APPOINTMENTS COMMISSION

Clause 54:     The Appointments Commission

228.     Clause 54 provides for the Appointments Commission to be established as a body corporate in accordance with the further provisions in Schedule 4, and provides for the NHS Appointments Commission ("the NHSAC"), which is a Special Health Authority, to be abolished on such day as the Secretary of State may by order appoint under clause 79.

Clause 55:     Commission to exercise Secretary of State's appointments functions

229.     Clause 55 enables the Secretary of State to direct the Appointments Commission to exercise all or part of his power to appoint the following:

230.     Subsection (5)(a) makes it clear that the functions of the bodies to which subsection (4) refers may relate to matters other than health, social care or the regulation of professions associated with health and social care and may be exercisable more widely than just in England.

231.     This clause reproduces with amendments most of section 187 of the 2003 Act.

Clause 56:     Cases where appointments functions exercisable jointly etc

232.     Clause 56 contains provisions which relate to the appointment functions of the Secretary of State referred to in clause 55 which are exercisable by the Secretary of State jointly or concurrently with a devolved authority or any other person who is not a Minister of the Crown. The Secretary of State may direct the Appointments Commission to exercise his functions in accordance with clause 55, but is required to first consult with the body or person with whom he exercises his functions jointly or concurrently. Clause 56 expressly excludes powers of appointment which are exercised jointly or concurrently with Scottish Ministers. This does not, however, prevent the Secretary of State from giving a direction to the Appointments Commission in relation to functions he alone has in relation to that body, but he cannot give directions in relation to the powers of the Scottish Ministers.

233.     Subsection (3) provides that when the Secretary of State delegates those of his appointment functions that are exercisable by him jointly or concurrently with a devolved authority or any other person who is not a Minister of the Crown to the Appointments Commission, those functions are exercisable by the Appointments Commission acting alone.

234.     This clause replaces the provisions of section 188 of the 2003 Act