Revising PNAs and supplementary statements

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1 OCTOBER 2012 Introduction The White Paper Pharmacy in England: Building on strengths delivering the future was published by the Department of Health in April It highlighted the variation in the structure and data requirements of PCT pharmaceutical needs assessments (PNAs) and confirmed that they required further review and strengthening to ensure they are an effective and robust commissioning tool which supports PCT decisions. The Health Act 2009 amended the National Health Service Act 2006 to include provisions for regulations to set out the minimum standards for PNAs. The NHS (Pharmaceutical Services and Local Pharmaceutical Services) (Amendment) Regulations 2010 come into force on 24 May 2010 and placed a statutory duty on each PCT to develop and publish their first PNA by 1 February The NHS (Pharmaceutical Services) Regulations 2012 (the 2012 Regulations) came into force on 1 September 2012 and require PCTs to publish a revised assessment within three years of its previous one. Although PCTs will cease to exist from 1 April 2013, they are required to keep their PNAs up-to-date and, where they identify changes to the availability of pharmaceutical services, to either revise the assessment and/or issue a supplementary statement. PCT duties The 2012 Regulations set out a number of duties on PCTs with regards their PNA. As noted above the first of these is unlikely to be of relevant to PCTs namely that each PCT must publish a revised assessment within three years of publishing their first PNA ie no later than 1 February 2014 (Regulation 6(1)(b)). Another duty is that if PCTs merge then the newly formed PCT must publish a revised assessment within ten months (Regulation 6(1)(a))). It should be noted that as the clustering of PCTs will not result in the coming into force of any order under section 18 of the NHS Act 2006 varying a PCT s area, then this is also unlikely to be an issue for PCTs in the run-up to 31 March There are however two duties within Regulation 6 that PCTs will need to consider. The first is Regulation 6(2) which requires a PCT to make a revised assessment as soon as is reasonably practicable after identifying changes since the publication of its pharmaceutical needs assessment which are relevant to the granting of applications referred to in section 129(2)(c)(i) or (ii) of the 2006 Act, (regulations as to pharmaceutical services), unless it is satisfied that making a revised assessment would be a disproportionate response to those changes. Primary Care Commissioning 1

2 The second is Regulation 6(3) which provides for supplementary statements (see below for further information on these): Pending the publication of a statement of a revised assessment, a Primary Care Trust may publish a supplementary statement explaining changes to the availability of pharmaceutical services since the publication of its pharmaceutical needs assessment (and any such supplementary statement becomes part of that assessment), where (a) the changes are relevant to the granting of applications referred to in section 129(2)(c)(i) or (ii) of the 2006 Act; and (b) the Primary Care Trust (i) is satisfied that making a revised assessment would be a disproportionate response to those changes, or (i) is in course of making a revised assessment and is satisfied that immediate modification of its pharmaceutical needs assessment is essential in order to prevent significant detriment to the provision of pharmaceutical services in its area. Although PCTs have clustered, PCTs remain the statutory body and therefore each PCT is required to have a PNA. The 2012 Regulations do not allow for one PNA to cover a cluster. This paper looks at these two regulatory requirements in more detail. Delegation of pharmaceutical services functions The PCT board may wish to formally delegate the duties outlined above to a committee, sub-committee or officer of the PCT. For some PCTs this may be the committee that oversaw the development of the first PNA. For others it may be their pharmacy applications decision making committee. In delegating these duties it is essential that PCT boards ensure they comply with the requirements of the National Health Services (Functions of Strategic Health Authorities and Primary Care Trusts and Administration Arrangements) (England) Regulations A separate PCC briefing is available on this issue 2. PCTs are advised to fully document their reasons for all decisions made under Regulation 6. There are no appeal rights to the NHS Litigation Authority s Family Health Service Unit (FHSAU) therefore if a party feels they have been disadvantaged by a PCT decision their only option is to seek recourse via the courts. Supplementary statements Supplementary statements are statements of fact; they are not an assessment of need. For example, the PNA identified the need for a new pharmacy in a particular locality to provide a range of services. An application offering to meet that need in full is duly received and determined by the PCT and the pharmacy subsequently opens. The PCT cannot issue a supplementary statement saying that the identified need has been met; it could only come to that conclusion after revising its PNA and there is evidence to support that conclusion. 1 Statutory Instrument Primary Care Commissioning 2

3 Supplementary statements are a way of updating what the PNA says about which services are provided and where. They are not a way of updating what the PNA says about needs. Template supplementary statements can be found on the PCC website 3. Once issued, a supplementary statement becomes part of the PNA (Regulation 6(3)). Further information on supplementary statements can be found in chapter 2 of the PNA information document issued by DH 4. Decision-making process Regulation 6(2) and (3) is fairly complicated at first reading and it is best to break it down into component parts. A flowchart has been developed to help work through the requirements and can be found in appendix 1. It may be helpful to have it to hand whilst reading the remainder of this paper. a) Identifying changes Firstly the PCT will need to ensure that it regularly reviews the provision of pharmaceutical services in its area in order that it is able to identify changes. This will require a system to be put in place so that changes are identified. Such changes could include: Opening or closing of pharmacy and dispensing appliance contractors premises Commencement or cessation (either in total or to a particular locality) of the provision of pharmaceutical services by doctors Relocations of premises Determinations of areas that are, or are no longer, rural in character (controlled localities) Changes in opening hours Changes in the services that are provided by pharmacies and dispensing appliance contractors. b) Are the changes relevant? If changes are identified the PCT will then need to make a decision as to whether those changes are relevant to the granting of applications referred to in section 129(2)(c)(i) or (ii) of the 2006 Act. Such applications are those submitted under Regulation 12 of the NHS (Pharmaceutical Services) Regulations 2012 ie routine applications. In this document such applications are referred to as market entry applications nce/dh_ Gateway reference Primary Care Commissioning 3

4 For example, if the only pharmacy in a deprived area closed then it is likely that the PCT would view this change as relevant to the granting of an application for a new pharmacy in that locality. Alternatively an exempt pharmacy may open in an area where the PNA didn t identify the need for a new pharmacy or for particular services. In this example as the PNA didn t identify a need the PCT may decide that the change is not relevant to the granting of an application for another pharmacy. The PCT will need to ensure it fully documents: the change in the availability of pharmaceutical services its decision as to whether the change is relevant or not, and its reasons for coming to that decision. Where the PCT is satisfied that a change isn t relevant to the granting of control of entry applications, then the change will still need to be included in the PNA when it is revised. c) Is revising the PNA a proportionate or disproportionate response? Once the PCT has identified that the changes are relevant to the granting of market entry applications, the next step is to check whether the PNA is already being revised. If it is then the PCT will need to decide whether it needs to issue a supplementary statement (see paragraph (e) below). If the PCT is not already revising its PNA then it will need to decide whether revising the PNA is a disproportionate response to identifying a change. PCTs will wish to note that the starting point in Regulation 6(2) is that revising the PNA is the appropriate response, unless the PCT is satisfied this is a disproportionate response. PCTs will therefore need to consider all relevant factors in order to be satisfied that revising the PNA is a disproportionate response rather than starting on the basis that revising the PNA is a disproportionate response unless the evidence says otherwise. As there are no appeal rights against decisions made under Regulation 6, and no court decisions that can be referred to, PCTs will need to consider all the relevant factors before coming to a decision. In some instances it may be relatively easy to decide whether revising the PNA is a proportionate or disproportionate response: A pharmacy in a deprived area to which no other primary care contractor provides services closes. The PCT identifies this change to the availability of pharmaceutical services and decides that based on the facts it is relevant to the granting of control of entry applications. It is not currently revising its PNA. After taking into account all the relevant factors the PCT is satisfied that the PNA needs to be revised in order that it identifies the precise need for pharmaceutical services in that locality. The PCT is also satisfied that it needs to immediately modify its PNA in order to prevent detriment to the provision of pharmaceutical services in its area. A pharmacy notifies the PCT of its intention to reduce its supplementary hours by closing 30 minutes earlier, Monday to Friday. Within the locality there are a number of other pharmacies offering extended core hours and the Primary Care Commissioning 4

5 PNA identifies no gaps in opening hours. The PCT identifies this change to the availability of pharmaceutical services and decides that based on the facts it is not relevant to the granting of control of entry applications due to the number of pharmacies offering extended core hours. A note however is made to incorporate this change when the PNA is revised. Further examples can be found in the PNA information document issued by DH. If the change is likely to lead to a need for pharmaceutical services, or if it may have met a need identified in the PNA, then it is likely that the PCT will decide that it is necessary to revise its PNA. It is important to remember that the document identifies the need for pharmaceutical services, and therefore if a change in the availability of pharmaceutical services is likely to create a need or fill an identified need revising the PNA is likely to be the proportionate response. If the PCT decides that revising the PNA is a proportionate response then it starts the process of doing so. It should be noted that this will include consultation as required by Regulation 8 of the 2012 Regulations. It will also need to consider whether it is satisfied that it needs to issue a supplementary statement to immediately modify the PNA in order to prevent detriment to the provision of pharmaceutical services in its area (see section (d) below). If the PCT decides that revising its PNA would be a disproportionate response then it will need to consider whether it needs to issue a supplementary statement see section (e) below. d) Revising the PNA is a proportionate response and supplementary statements Where the PCT is satisfied that revising the PNA is a proportionate response then it will also need to consider whether it is satisfied that immediate modification of the PNA is essential in order to prevent detriment to the provision of pharmaceutical services in its area. If it is so satisfied then it is required to issue a supplementary statement. If it is not so satisfied then it continues with revising the PNA. For example, the PNA identified the need for a pharmacy providing a range of services in a particular locality. An application is duly received and approved, and in due course the pharmacy opens. The PCT identifies that this change is relevant to the granting of control of entry applications and is satisfied that it needs to revise its PNA to identify whether the need has indeed been met. It is also satisfied that it needs to issue a supplementary statement explaining the change in the provision of pharmaceutical services as the PNA didn t identify the need for two pharmacies and therefore the PCT is satisfied that a second pharmacy may be detrimental as the population is not sufficient to warrant two pharmacies in the locality. It therefore issues a supplementary statement. e) Revising the PNA is a disproportionate response and supplementary statements Where the PCT is satisfied that revising the PNA is a disproportionate response or where it is already revising its PNA, then it will need to consider whether it is necessary to publish a supplementary statement to explain the change to the availability of pharmaceutical services. If the PCT is so satisfied then it may issue a Primary Care Commissioning 5

6 supplementary statement. If the PCT is not satisfied then it will need to incorporate the change into the PNA when it is next revised. Summary and conclusion PCTs are required to keep their PNAs up-to-date and, where they identify changes to the availability of pharmaceutical services, to either revise the assessment and/or issue a supplementary statement. PCTs are advised to ensure: The PCT board has duly delegated these duties, That systems are put in place to identify changes to the availability of pharmaceutical services, Processes are developed and followed to work through the requirements of Regulation 6, and All decisions made are fully reasoned and documented. Due to the risk of legal challenge, PCTs may like to include revising the PNA in their risk register particularly as they are now the basis for the submission of routine applications under the 2012 Regulations. From 1 April 2013 PNAs will transfer to Health and Wellbeing boards (HWBs). It is recommended that if a PCT begins to revise its assessment that it engages with the local HWB at the outset. The DH s Advisory Group is drafting the regulations that will reflect the roles of the Commissioning Board and HWBs from 1 April and further details on the transfer of responsibilities will be made available in due course. Primary Care Commissioning 6

7 Appendix 1 Revising PNAs and supplementary statements flowchart (a) and (b). The PCT regularly reviews the provision of pharmaceutical services in its area and identifies a change since the publication of its PNA. Is it relevant to the granting of control of entry applications? (c) Is the PCT currently revising its PNA? (b) Incorporate change into PNA when next revised. (c) Is revising the PNA a proportionate response? (c) Start the process of developing a revised PNA. This includes full consultation. (e) Does the PCT need to issue a supplementary statement explaining the changes to the availability of pharmaceutical services? (d) Is the PCT satisfied that it needs to immediately modify the PNA in order to prevent detriment to the provision of pharmaceutical services in its area? (e) Issue a supplementary statement explaining the changes to the availability of pharmaceutical services. (e) Incorporate change into PNA when next revised. (d) Continue with revising the PNA. (d) Issue a supplementary statement explaining the changes to the availability of pharmaceutical services. te All decisions should be made by a committee, subcommittee or officer of the PCT to whom this function has been delegated. All decisions made should be documented. Each step is referenced back to the relevant paragraph in the main body of the document. Primary Care Commissioning 7