Health Bill [HL]

PART 3 - MISCELLANEOUS

Tobacco

Clause 20: Prohibition of advertising: exclusion for specialist tobacconists

249.     Clause 20 amends section 6 of the 2002 Act (specialist tobacconists) by inserting a new subsection (A1) at the beginning of that section. This new subsection gives the Secretary of State (in relation to England), the Welsh Ministers (in relation to Wales), and DHSSPSNI (in relation to Northern Ireland) power to provide that specialist tobacconists do not commit an offence under section 2 of the 2002 Act (prohibition of tobacco advertising) if a tobacco advertisement on their premises meets certain requirements (including those to be set out in regulations). This power replaces (except in relation to Scotland) an automatic exclusion for specialist tobacconists currently provided by section 6(1) of the 2002 Act. Accordingly, paragraph 3 of Schedule 4 amends section 6(1) of the 2002 Act to limit its application to Scotland.

Clause 21: Prohibition of tobacco displays etc.

250.     Section 8 of the 2002 Act (displays) currently gives the Secretary of State power to impose requirements on the display in England, Wales and Northern Ireland of tobacco products or their prices in a place or on a website where such products are offered for sale. Clause 21 inserts new sections 7A to 7D into the 2002 Act, which replace section 8 in so far as it relates to England, Wales and Northern Ireland (it will continue to have effect in its existing form for Scotland).

251.     The new section 7A (prohibition of tobacco displays) makes it an offence for a person, in the course of a business, to display tobacco products, or cause tobacco products to be displayed, in a place in England, Wales, or Northern Ireland. It also provides powers for the appropriate Minister to provide by regulations for the meaning of “place” and whether a display, which also amounts to an advertisement, is to be treated as a display, or whether it is to be treated as an advertisement, for the purposes of offences under the 2002 Act. For the purposes of the new sections 7A to 7D, the “appropriate Minister” means the Secretary of State in relation to England, the Welsh Ministers in relation to Wales, and DHSSPSNI in relation to Northern Ireland.

252.     The new section 7B (tobacco displays: exclusions and defence) provides for a number of exclusions from the new section 7A prohibition on tobacco displays. The exclusions cover: displays in the course of a business which is part of the tobacco trade which are for the purposes of that trade and are accessible only to persons engaged in, or employed in, the tobacco trade; and, displays made following a particular request by an individual of at least 18 years of age to purchase, or for information about, a tobacco product (a requested display). The appropriate Minister is also given a general power to provide in regulations that no offence is committed under the new section 7A if the display complies with any requirements which are specified in the regulations. New section 7B(5) provides that for the purposes of the offence of making a display to an individual aged under 18 following a request by that individual, it is a defence that the person making the display believed the individual was 18 or over, and had reasonable grounds for that belief. Section 7B(6) provides that a person has reasonable grounds for so believing only if the individual was asked for evidence of their age and the evidence produced would have convinced a reasonable person; or no person could reasonably have suspected that the person was less than 18 years of age. It is a defence for a person charged with causing a requested display to an individual aged under 18 that they exercised all due diligence to avoid committing the offence (new section 7B(7)).

253.     The new section 7C (displays: prices of tobacco products) gives the appropriate Minister power by regulations to impose requirements in relation to the display, in England, Wales, or Northern Ireland (as the case may be) in the course of a business, of prices of tobacco products (subsection (1)). A person who displays or causes to be displayed, prices of tobacco products in breach of any such requirements is guilty of an offence (subsection (2)).

254.     The new section 7D (displays on a website) replaces section 8(1) of the 2002 Act in relation to England and Wales and Northern Ireland, in so far as it applies to websites. It provides power for the Secretary of State by regulations to impose requirements in relation to the display in England and Wales, or Northern Ireland, in the course of a business of tobacco products or their prices on a website where tobacco products are offered for sale.

255.     New section 7D makes it an offence to display, or cause to be displayed, tobacco products or their prices in breach of any requirements imposed by regulations (subsection (2)), except where this is in the course of providing information society services by a person established outside the United Kingdom (subsection (4)). A person established in England, Wales, or Northern Ireland who, in the course of providing information society services, does anything in another EEA state which would constitute an offence under new section 7D(2) is also guilty of an offence (new section 7D(3)). For these purposes “EEA state” includes member states of the European Union, as well as Norway, Iceland and Liechtenstein.

Clause 22: Power to prohibit or restrict sales from vending machines

256.     Subsection (1) of clause 22 inserts a new section 3A (sales from vending machines in England and Wales) into the 1991 Act. New section 3A provides power for the appropriate national authority (defined as the Secretary of State in relation to England, and the Welsh Ministers in relation to Wales) by regulations to prohibit, or impose requirements on the sale of tobacco from vending machines. Such requirements may, in particular, relate to the location of the vending machine, or the design, construction or operation of the machine. These could include, for example, a requirement that the vending machine is located in sight of the individual managing or running premises where it is used, or that it have age-restricting operational requirements (preventing those who are under 18 years of age from being able to purchase cigarettes from the machine).

257.     The regulations must include provision as to the persons who are liable for a breach of a prohibition or requirement. For example, where the requirement relates to the operation of a vending machine (such as bar staff supplying a special token), the owner or occupier of the premises may be the appropriate persons liable for a breach of the requirement. Alternatively, where the requirement relates to the location of the machine, it may also be appropriate to make the supplier of the machine (who in practice often has a say in where their machine is located) liable for a breach of the requirement. It is an offence for a person liable to breach any prohibition or requirements imposed by the regulations, punishable with a fine not exceeding level 4 on the standard scale (currently £2,500). Subsection (6) of the new section 3A applies sections 13 (enforcement), 14 (powers of entry, etc) and 15 (offences of obstruction, etc of officers) of the 2002 Act for the purposes of the new section. Section 13 of the 2002 Act sets out the authorities who will be responsible for enforcing any prohibition or requirements imposed; section 14 sets out the powers of entry which enforcement officers may exercise; and, section 15 makes obstructing an officer of an enforcement body, or making false statements to an officer, an offence.

258.     Subsection (2) of clause 22 inserts a new paragraph (c) into section 12D(1) of the Children and Young Persons Act 1933 (restricted premises orders and restricted sales orders: interpretation). This extends the definition of “tobacco offence” for the purposes of sections 12A and 12B of that Act to include an offence committed under the new section 3A of the 1991 Act. The effect of this is to enable a magistrates’ court to impose a restricted premises order or a restricted sales order in response to breaches of the new section 3A, where the conditions for imposing such orders are met. Under sections 12A and 12B if three “tobacco offences” are committed (the last of which must have led to a conviction) within a period of two years, then the offender or the relevant premises may be banned from selling tobacco products for up to one year.

Clause 23: Power to prohibit or restrict sales from vending machines: Northern Ireland

259.     Clause 23 inserts a new Article 4A into the 1991 (NI) Order. New Article 4A makes equivalent provision for Northern Ireland to that made for England and Wales by the new section 3A inserted in the 1991 Act by clause 22.

Clause 24 and Schedule 4: Tobacco: minor and consequential amendments

260.     Clause 24 gives effect to Schedule 4. Schedule 4 makes various minor and consequential amendments. These amendments include—

• •      limiting the application of sections 6(1) and 8 of the 2002 Act to Scotland;

• • ?     limiting the power of the Secretary of State under section 13(5) of the 2002 Act to take over the conduct of proceedings to proceedings in relation to offences committed in England and giving power to the Welsh Ministers to take over the conduct of proceedings in relation to offences committed in Wales;

• • ?     amending the definition of “appropriate Minister” for the purposes of the 2002 Act, to confer powers on the Welsh Ministers and DHSSPSNI to make regulations in relation to the new provisions about specialist tobacconists and displays and to transfer to them existing powers under section 4(3) of the 2002 Act (power to provide for exclusions from the section 2 prohibition on tobacco advertising); and

• • ?     provision for the procedure to be adopted in relation to regulations made by the Welsh Ministers and DHSSPSNI under the provisions of the 2002 Act as amended by the Bill.

261.     Schedule 4 also amends section 8 (displays), section 9 (prohibition of free distribution), section 11 (brandsharing) of, and the Schedule (information society providers) to, the 2002 Act to give full effect to Directive 2000/31/EC of the European Parliament and Council of 8th June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (Directive on electronic commerce). It also repeals section 16(1A) of the 2002 Act (limitation of penalties for certain offences relating to information society services) to bring the penalties for offences covered by that provision into line with the penalties which apply generally for offences under the 2002 Act.

Pharmaceutical Services in England

262.     These clauses introduce changes to the way in which PCTs determine applications by contractors to provide NHS pharmaceutical services and also introduce new provisions enabling PCTs to take action against contractors for breaches of the arrangements for providing those services.

263.     In addition, the clauses amend current legislation concerning the provision of local pharmaceutical services (LPS) contracts enabling PCTs to provide services under LPS schemes in prescribed circumstances. Under existing legislation, PCTs can only commission such services.

264.     These measures follow a Department of Health consultation in the autumn of 2008 on a series of proposals to amend the structure and legislation of NHS pharmaceutical services, following publication of the Government’s White Paper Pharmacy in England: Building on strengths - delivering the future published in April 2008. A report of the outcome of that consultation, which concerned the measures contained within this Bill, was published on 16^th January 2009 and is available on the Department of Health website.

Clause 25: Pharmaceutical needs assessments

265.     Clause 25 creates a new duty in the NHS Act for all PCTs in England in respect of their assessments of pharmaceutical needs, commonly known as pharmaceutical needs assessments.

266.     Subsection (1) requires PCTs, in accordance with regulations, to undertake assessments of needs for pharmaceutical services in their respective areas and to publish a statement of their first assessment of those needs and any subsequent revised assessment.

267.     Subsection (2) requires regulations to make provision for certain matters relating to the procedures which PCTs must follow when undertaking their pharmaceutical needs assessments. Regulations must stipulate

• the minimum information requirements which each pharmaceutical needs statement must contain;

• the extent to which the pharmaceutical needs assessment is to take account of likely future needs for pharmaceutical services;

• the date by which each PCT must publish their first assessment; and

• the circumstances in which a PCT must undertake a new assessment.

268.     For example, the regulations might stipulate that a pharmaceutical needs statement must contain information on the demography of the people in its area and any seasonal trends or variations as well as longer-term population projections and age profiles. It might also, for example, stipulate that PCTs must publish their first statement within six months of the regulations coming into force and that they must undertake a new assessment where important new health data, trends in disease or evidence of the effectiveness or ineffectiveness of certain types of service emerge.

269.     Subsection (3) enables regulations to provide for additional matters or relating to pharmaceutical needs assessments. The additional matters may include the kinds of pharmaceutical services which the pharmaceutical needs assessment must relate to, for example, the provision of certain services such as reviews of patient medication, clinical support for patients starting medication to treat a long-term condition, advice and information to patients or other healthcare professionals. The regulations may also impose requirements on PCTs to consult specified persons about specified matters when undertaking their pharmaceutical needs assessment. The PCT may for example, be required by the regulations to consult local authorities, patient and community groups and local professional representative committees. The regulations may also prescribe the manner in which an assessment is to be made. The regulations may require the PCT to show, when publishing its pharmaceutical needs statement, how it has consulted interested parties. The regulations may also include a range of matters which a PCT must have regard to when making an assessment of pharmaceutical needs. Such matters may include for example—

• data on future disease trends;

• population forecasts;

• information on health concerns which may be specific to the PCT (such as asbestosis in mining areas); and

• how the PCT has taken into account the views and comments received as a result of consultation, whether it has accepted or rejected those views and, if rejected, the reasons why.

Clause 26: New arrangements for entry to pharmaceutical list

270.     Section 129 of the NHS Act sets out various requirements under which regulations govern the provision of pharmaceutical services. Clause 26 amends section 129 of the NHS Act.

271.     Section 129(2)(c) sets out the legislative criteria which a PCT must apply when considering applications from pharmaceutical contractors to be included on a PCT’s pharmaceutical list for the provision of NHS pharmaceutical services or for changes to a contractor’s listing following admittance. These criteria are often referred to as the “control of entry” test. The clause inserts new provisions regarding those criteria.

272.     Subsection (2) of clause 26 amends the criteria in section 129(2)(c) to provide for circumstances where an application must be granted by a PCT and circumstances where an application may be granted by a PCT.

273.     Subsection (3) then sets out the circumstances—

• in which a PCT must grant an application; and

• in which a PCT may grant an application.

274.     Under new subsection (2A), a PCT must grant an application where it is satisfied, having first taken account of what is set out in the statement of its assessment of pharmaceutical needs, and any matters which are prescribed in regulations, that the need for the services or some of the services in the application is established and will be met through grant of the application.

275.     Under new subsection (2B), a PCT may grant an application where it is satisfied, having first taken account of what is set out in the statement of its assessment of pharmaceutical needs, and any matters which are prescribed in regulations, that it would secure improvements or better access to pharmaceutical services in its area. The matters prescribed in regulations might include additional criteria such as improvements in access (for example through extended hours), in the choice and diversity of providers or of services in its area (for example, dedicated clinics at evenings or weekends to stop smoking or to review patients’ medications), in innovation in the delivery of services or of services which meet the needs of specific groups of people in the PCT’s area or local health conditions or diseases.

276.     New subsection (2C) makes additional provision in cases where a PCT is satisfied that an application meets the criteria for grant of the application required under subsection (2B). First, new subsection (2C) provides that the regulations may set out the manner in which the PCT is to determine whether to grant the application. For example, a PCT might first seek views from local patient representative bodies and other key interested parties where it is minded to grant an application under new subsection (2B). Second, new subsection (2C) provides that the regulations may stipulate certain matters which a PCT must or must not take into account when deciding whether or not to grant an application under new subsection (2B). For example, the regulations might make provision that a PCT must take account of the views of local patient representative bodies concerning the application in reaching its determination. Conversely, the regulations might make provision that a PCT must not take account of other matters in reaching its determination where such matters lead to the refusal of all applications (for example, on grounds of costs alone or of additional monitoring burdens for the PCT) where the criteria in new subsection (2B) are otherwise met.

277.     Subsections (4) (5) and (6) of clause 26 modify the existing provisions which enable regulations to specify the circumstances in which two or more applications are considered together by the PCT.

278.     Subsection (4) inserts a new subsection (3A) to provide that the regulations may prescribe the circumstances in which two or more such applications may be considered together by a PCT. Subsection (5) amends section 129(4) creating a general power to make provision for the case where two or more applications, taken individually, meet the test under new subsection (2A) or (2B), but taken together, do not.

279.     Subsection (6) of clause 26 inserts a new subsection (4A) which allows regulations under subsection (4) to include, in particular, the provision mentioned in subsection (5), with or without modification. This new subsection ensures the wording in subsection (5) can be tailored to apply to both parts of the two part test under subsection (2A) and (2B).

280.     Subsection (7) introduces a new provision which enables regulations to specify the circumstances in which, and the manner in which, a PCT can invite applications to be included in its pharmaceutical list. For example, this might be appropriate where a PCT has identified, in its first or subsequent statement of needs, areas where there are gaps in provision or where the PCT wishes to secure improvements in access to, or in the choice or quality of, services provided and wishes to invite applications from pharmaceutical contractors.

281.     Subsection (8) inserts a new provision which requires PCTs to give reasons for decisions made in relation to all applications received under section 129 and provides that references to a “needs statement” in the clause are the most recently published statement, which will be the statement in force at the time the application is decided.

Clause 27: Pharmaceutical lists - minor amendment

282.     Clause 27 corrects an apparent anomaly in section 129(6)(d) of the NHS Act. Section 129(6)(c) refers to a particular kind of application for inclusion in a pharmaceutical list and was not intended to affect the meaning of “such an application” in section 129(6)(d). The amendment makes clear that the provision in section 129(6)(d) for the inclusion of an applicant on a PCT’s list for a fixed period of time may apply to any application made under section 129.

Clause 28: Breach of terms of arrangements: notices and penalties

283.     Clause 28 inserts in Part 7 of the NHS Act a new Chapter 5A that concerns the issuing by PCTs of notices to contractors and the withholding of payments to contractors by PCTs.

284.     This clause enables regulations to provide that where a contractor breaches a term of arrangements for providing NHS pharmaceutical services (for example, of a term of service, such as agreed quality standards or of performance in the provision of services) then PCTs will have the power to issue remedial notices, requiring corrective action to be taken or requiring the contractor to refrain from continuing with actions which have led to the breach, within a specified period of time. The regulations may also enable PCTs to withhold all or part of any payments due to the contractor for a prescribed period in view of such a breach. Powers to withhold payments could be used on their own or in conjunction with the issue of remedial notices.

285.     Subsection (2) requires that any regulations under this section must include prescribed rights of appeal for the contractor against decisions made by the PCT under this section.

286.     Subsection (3) provides definitions for this section.

Clause 29: LPS schemes: powers of Primary Care Trusts and Strategic Health Authorities

287.     Clause 29 introduces changes to section 144 of, and Schedule 12 to, the NHS Act that will remove the restrictions in NHS legislation on PCTs providing local pharmaceutical services (LPS) or to other PCTs, in certain circumstances, for example, in the event of any emergency such as a flu pandemic or where there was no alternative provider. Where a PCT is a provider of local pharmaceutical services within its own area it is intended that the (LPS) commissioner must be the Strategic Health Authority.

Pharmaceutical services in Wales

288.     These clauses introduce new provisions enabling Local Health Boards (LHBs) to take action against certain NHS contractors for breaches of the arrangements for providing those services. The clauses that relate to breaches of arrangements between LHBs and contractors relate to the providers of both pharmaceutical and ophthalmic services in Wales.

289.     In addition, the clauses amend current legislation concerning the provision of local pharmaceutical services (LPS) contracts enabling LHBs to provide local pharmaceutical services (LPS) in prescribed circumstances. Under existing legislation, LHBs can only commission such services.

Clause 30: Pharmaceutical lists - minor amendment

290.     Clause 30 corrects an apparent anomaly in section 83(6)(d) of the NHS (Wales) Act 2006. Section 83(6)(c) refers to a particular kind of application for inclusion in a pharmaceutical list and was not intended to affect the meaning of “such an application” in section 83(6)(d). The amendment makes clear that the provision in section 83(6)(d) for the inclusion of an applicant on an LHB list for a fixed period of time may apply to any application made under section 83.