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The basic problem with the creation of PNAs is that they do not address the areas of major concern that were raised during the Government’s consultation exercise. For example, we do not know the extent to which PNAs will in practice be based on robust, high-quality data. Unless they are, they are likely to remain as crude tools that are disproportionately focused on cost-effectiveness as opposed to local health needs. We do not know how effectively PCTs will use PNAs, especially given their record to date of disinvesting in enhanced services such as out-of-hours opening and local delivery, as I pointed out in the last group of amendments, although I will go away and consider the reply that the Minister gave a moment ago. Nor, importantly, can we have confidence that PNAs will create a basis for commissioning pharmacy services that is consistent and rational across the country.

There is much to be said not only for pilot schemes but for a national framework for PNAs that could be adapted at local level to suit local conditions. A national template would include data sets and statistical models from which each PCT should work in order to ensure, first, that the PNA was robust and, secondly, to give clarity for contractors. If there is not to be such a framework, we have to ask how robust the process is likely to be and how precisely assessments will translate into service delivery. Those are the uncertainties here, and I am afraid they are fairly basic ones. I look forward to the Minister’s reply. I beg to move.

Baroness Tonge: I am a fan of pharmacists and pharmacies. There is no question in my mind that they are the first port of call for a huge proportion of the population when seeking advice, healthcare or leaflets. The noble Baroness, Lady Howarth, mentioned people not picking up leaflets, but certainly in our local pharmacist’s there is an enormous amount of advice. They serve the population with important information. As a newly qualified doctor doing GP locums, I found that pharmacists got me out of holes time and again when I got the odd prescription wrong or the decimal point in the wrong place. The pharmacists know it all and they will always gently put you right. I would like that to go on record.

I am also a huge fan of the noble Earl, Lord Howe, who has said everything that needs to be said on these amendments. I support his call for pilot schemes. I think there was one thing, but I am not sure; my mind may have wandered, so I do not know whether he really did mention this. There is a requirement that pharmaceutical needs assessments will,

and,



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I do not think the noble Earl mentioned that. That causes some concern among pharmacists I know. Will it be a conflict of regulatory power with the General Pharmaceutical Council?

Earl Howe: No, I did not mention it because it is coming up in the next amendment.

Baroness Tonge: Is it? Sorry.

Lord Walton of Detchant: Briefly, I support the amendment and the one that follows. It is crucially important that this kind of inquiry, perhaps on a pilot basis, can define more precisely the needs of the pharmaceutical services in a particular area.

The Committee will forgive me for going back to my point about the particular dispensing practice in the village where I live. It has a fascinating and wholly acceptable symbiosis with the local pharmacist, with an agreement which is obviously quite different from that in the village of the noble Baroness, Lady Cumberlege. If you get a prescription from the practice in the morning and you live in the village, you must take it to the pharmacist’s shop; they will not dispense from the individual practice. Dispensing from the practice is for people who live outside the village, a long distance away, or who go the surgery to get a prescription when the local pharmacist is closed. That kind of local agreement, which can be part of a pharmaceutical assessment scheme, is quite invaluable.

Baroness Thornton: The noble Earl, Lord Howe, seeks to amend this clause by requiring piloting and evaluation of pharmaceutical needs assessments. He is joined in this by the noble Baroness, Lady Tonge. I have listened to what the noble Earl has said, am not convinced of the strength of their case for piloting and hope to convince them about this.

In the Bill, primary care trusts will be required to undertake and publish their assessments of pharmaceutical needs in accordance with regulations. These regulations would set out the structure and content of these assessments and how primary care trusts should carry them out. They would also enable the Secretary of State to set out the circumstances under which a primary care trust must make a new assessment. The department expects to work closely with interested parties, including NHS and contractors’ representatives, on drafting these requirements.

When primary care trusts first developed their pharmaceutical needs assessments in 2004-05, they were not piloted. I am not aware that any strategic commissioning tools which PCTs have been tasked with developing, such as joint strategic needs assessments, were first piloted and evaluated. Of course, before this duty went live, there would have been wide discussion and consultation on specific requirements. We do not propose to act differently here.

I well understand the concern that primary care trusts do not yet have sufficient capacity and capability to produce these assessments across the piece, but we have already put in train—with NHS Employers and as promised in the pharmacy White Paper—a

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comprehensive support programme for primary care trusts. The first element of this, Pharmaceutical Needs Assessments (PNAs) as Part of World Class Commissioning: Guidance for Primary Care Trusts, was published by NHS Employers on 7 January this year. Further resources will be available later this spring to include guidance on how to commission pharmaceutical services and more detailed advice on the information that these needs assessments should contain. A formal piloting and evaluation programme would mean a delay of at least two years, and probably longer, in achieving the goal of universally strengthened local assessments of pharmaceutical needs. That is not a delay that we would wish to see.

I will not address the amendments of my noble friend Lady Gibson, as they have not been spoken to. I am sure that she will bring them back at an appropriate time if she so wishes.

The second amendment of the noble Earl, Lord Howe, in which he is joined by the noble Baroness, Lady Cumberlege, proposes a requirement for the Secretary of State to publish guidance on the manner in which commissioning of pharmaceutical services may be informed by the results of an assessment. The virtue of producing guidance to support the regulations is that it can go much wider if it is not tied to the regulations. It can explain what is—and, importantly, what is not—in the legislation. I would not want to fetter this freedom in any way.

I referred earlier to the comprehensive support programme for primary care trusts that we are putting in place. Given the action already under way, we are not convinced of the need to bolster that with a new legislative duty.

The noble Earl referred to new pharmacy contracts awarded as a result of the PNA. No information is currently held on that centrally. Under the current legislation, PCT decisions are not required to be based on PNAs—hence the proposals in the Bill.

I hope that I have been able to reassure noble Lords sufficiently on these matters and that the noble Earl will feel able to withdraw his amendment.

6.30 pm

Earl Howe: I am grateful to the noble Baroness, Lady Tonge, in particular for her support on this amendment and also to the noble Lord, Lord Walton, for his, as ever, very wise and to-the-point intervention.

I am sorry that my amendments have fallen on stony ground with the Minister, although I am not entirely surprised. However, I think that there is an issue here about devolving all decision-making. The noble Baroness said that she did not wish to fetter the freedoms of PCTs. I realise that this is not quite the sense conveyed by my amendment but I spoke about having a national framework so as to arrive at PNAs that are consistent and rational across the country. There can be no better example of what I am thinking about than vascular screening. The Prime Minister announced in January last year the introduction of a uniform and universal vascular risk assessment for everyone in England between the ages of 40 and 74, which will be implemented in full by 2012. The national

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programme can of course be delivered in a variety of settings—not just GP practices but also pharmacies. This is what Pulse magazine had to say about the whole thing about three weeks ago:

“No Government policy illustrates localism gone mad better than the vascular screening programme, which in fact is not a programme at all. A programme implies common aims, an agreed methodology and a consistent set of criteria for evaluating success. Vascular screening has only a vague aspiration, sketched guidance and implementation plans that vary widely from one area to another ... Some areas use pharmacists, others are employing battle-buses outside supermarkets. There is not even any agreement over the methods used to assess risk or consensus over how those at risk should be managed once identified”.

So, by way of example, if there were a national requirement to incorporate an assessment of the needs of a PCT’s population for vascular risk assessment into PNAs, this would be a good first step towards establishing a more systematic and consistent approach to undertaking vascular screening across the country. I am troubled that we are going to leave all this to PCTs. I am afraid that, although many of them are well equipped to do it, many will struggle and will find themselves considerably at sea. There is no more that I wish to say at the moment, unless the Minister wishes to comment.

Baroness Thornton: The note refers to the framework. We agree that the need for consistent and comprehensive assessments is vital, and we intend that the regulations will provide that national framework. I know that I am not going all the way to satisfying the noble Earl but that may help a little.

Earl Howe: It does help a little, and I look forward to reading the draft regulations when they are published. With that, I beg leave to withdraw the amendment.

Amendment 111A withdrawn.

Amendments 111B to 113 not moved.

Clause 23 agreed

Clause 24: New arrangements for entry to pharmaceutical list

Amendment 114

Moved by Earl Howe

114: Clause 24, page 28, line 8, at end insert—

“(2D) Nothing in subsections (2) to (2C) shall be taken to imply that a Primary Care Trust may exercise its powers in a manner which purports to involve an assessment by it of a pharmacist’s professional fitness to practise or the fitness of his premises to deliver pharmacy services.”

Earl Howe: We come to an issue presciently raised by the noble Baroness, Lady Tonge. The amendment is designed to flag the issue up. As I argued earlier, if we rely on localism to determine what pharmacy services there should be in an area and how they should be delivered, they are unlikely—subject to the regulations, which I look forward to reading—to have a recipe for national consistency in the configuration of those services.



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There is another aspect of localism that causes concern, as the noble Baroness said—the power that the Government propose to confer on PCTs to set standards and regulate pharmacy premises. By giving considerable discretion to PCTs to decide the standard of pharmacy services needed in an area and who should and should not provide those services, there is scope for substantial argument, or even litigation. The natural question that arises is who regulates pharmacists. Is it PCTs or is it the Royal Pharmaceutical Society of Great Britain? If it is in effect both, which body takes precedence? I see the potential for confusion here, and I should be glad of the Minister’s comments, which I hope will reassure me in some measure. I beg to move.

Baroness Masham of Ilton: When it is decided by a PCT or whoever decides about pharmacists, will the miles be taken into consideration or the population? If it is the populations, that is very dangerous for rural areas.

Baroness Thornton: The noble Earl, Lord Howe, seeks to amend the clause so that PCTs cannot assess pharmacists’ professional fitness to practise and assess the quality of a pharmacy contractor’s premises when determining an application under the reformed market entry test.

The Government made a commitment in 2002 to provide increased protection to the public by ensuring that all registered primary care practitioners performing NHS services in the community were listed with primary care trusts. They subsequently introduced a framework via the NHS (Pharmaceutical Services) Regulations 2005 within which primary care trusts can take action if a pharmacy contractor’s professional conduct, competence or performance gives cause for concern when an applicant applies to be admitted to a primary care trust’s pharmaceutical list or afterwards. Known as “fitness to practise”, it applies to pharmacies and appliance contractors whether they are sole traders, limited liability partnerships or bodies corporate.

A Vision for Pharmacy for 2003 mapped out the ambition for a contractual framework for community pharmacy to reflect modern service requirements and to help ensure community pharmacy is an integral part of the NHS and not just another shop on the high street. The community pharmacy contractual framework went live from April 2005 with all pharmacies providing essential services from October 2005. Primary care trusts are charged with monitoring performance of the framework in their areas. Under the framework, services are divided into three categories: essential services, advanced services and enhanced services. Service specifications were agreed with pharmacy bodies and published for all essential services, advanced services and a number of enhanced services. These include minimum standards, for example, for premises and accreditation of staff.

In 2007, the Government published their White Paper, Trust, Assurance and Safety—The Regulation of Health Professionals in the 21st Century, which set out a series of proposals to reform professional regulation. The Government are consulting on a draft pharmacy

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order to take forward recommendations to establish a General Pharmaceutical Council—GPhC—in Great Britain. The GPhC will be the new regulator for pharmacists, pharmacy technicians and pharmacy premises, taking over the role currently performed by the Royal Pharmaceutical Society of Great Britain, whose functions are being split. The purpose of this is to modernise and strengthen the regulation of healthcare professionals to ensure patient, public and professional confidence and to make protection of patients and public the first priority. Noble Lords are completely familiar with those issues. As a regulator, the GPhC will have the power both to operate fitness-to-practise procedures to deal with registrants where there are concerns about their fitness to practise and to protect the public from registrants who become unfit to practise and for registration, regulation and inspection of pharmacy premises and enforcement responsibilities.

As noble Lords may be aware, under powers in Sections 151 to 153 of the NHS Act 2006, before including a pharmacy or appliance contractor in its pharmaceutical list, a primary care trust must be satisfied that the practitioner is suitable to be included on that list. The sections outline the grounds on which the trusts can refuse to include that person or, if a person is already on the list, the grounds on which they can be removed. I am concerned that this amendment could potentially undermine the powers that have been in place for over three years.

I assure the noble Earl that the new GPhC will be encouraged to have further discussions with representatives of the NHS and pharmacy contractors on the standards that they set for community pharmacy which will work across Great Britain in both the NHS and the private sector, and avoid any duplication.

The provisions in subsection (2C) of the proposed clause already enable the Secretary of State to stipulate matters that a primary care trust must or must not take into account. I am happy to give every assurance that, in the light of these discussions, we will strive to demarcate in the regulations the respective responsibilities of the new regulator and the responsibilities of primary care trusts. I am not persuaded, however, that it is in the public’s or the NHS’s interest to concede on this particular amendment at this moment.

With regard to the question raised by the noble Baroness, Lady Masham, about miles or population, I will need to write to her with further clarification. I ask the noble Earl to withdraw his amendment.

Earl Howe: That was a helpful reply from the Minister. It told me, if I understood her correctly, that a modus operandi is being framed between PCTs and the Royal Pharmaceutical Society—or the GPhC, as it will be—so that each works in harmony with the other. There is a distinction, albeit a fine one, between deciding that the way a pharmacist is delivering services is unsuited to the needs of an area, for whatever reason, and regulating pharmacy standards and fitness to practise. I have no wish to prevent PCTs taking action where they see that a pharmacist is not up to the mark, but that is rather different from a PCT deciding whether a particular pharmacist is fit to practise. We have to play this one very carefully to

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ensure that the role of the GPhC is not usurped, essentially, and that PCTs are conscious that there is a division of responsibilities that has to be observed. I am happy to go away and consider this further. I thank the Minister again for her helpful reply and beg leave to withdraw the amendment.

Amendment 114 withdrawn.

Clause 24 agreed.

Clause 25 agreed.

Clause 26: Breach of terms of arrangements: notices and penalties

Amendment 114A

Moved by Baroness Thornton

114A: Clause 26, page 29, leave out lines 19 to 21

Baroness Thornton: I shall speak also to Amendments 114B and 115A to 115E. Clause 26 adds a new section after Section 150 of the National Health Service Act 2006. It gives the Secretary of State power through regulations to enable PCTs to issue remedial notices or to withhold payments as part of action to secure quality pharmaceutical services and to manage performance. The effect of the clause will be to give PCTs new powers and discretions in respect of appropriate action to address poor performance and to decommission poor services.

I propose two minor and technical amendments to this clause for England. The first will remove the definition of “pharmaceutical services” from new Section 150A(3). That definition is unnecessary in the clause as the term is already defined in the existing legislation in Section 126(8) of the NHS Act. The second will insert a definition of “practitioner” in Section 150A(3). That will clarify the use of the term “practitioner” in Section 150A(1) and adopts the same language as is used to define the term elsewhere in the NHS Act.

There are five amendments in respect of the provisions regarding the NHS (Wales) Act 2006. These are also minor and technical and, I stress, have been agreed by Welsh Ministers. They concern NHS ophthalmic and pharmaceutical services in Wales. The first four amendments concern the equivalent provisions for Wales regarding notices and penalties, to which I have just referred.

6.45 pm

The first amendment would create a new Chapter 1A of the NHS (Wales) Act 2006 for the provisions concerning notices and penalties. Rather than adding them to an existing chapter, this amendment means that the Welsh provisions are treated in the same way as the English provisions. The actual provisions will be unaltered by this change.

The second amendment clarifies that the provisions in the new Section 106A extend to practitioners who provide pharmaceutical services and general ophthalmic

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services in Wales. This is because Wales has not followed the route in England of direct contracting for ophthalmic services but retains its previous arrangements.

The third and fourth amendments replicate for Wales the amendments for England to which I have already referred and also remove the definition of “ophthalmic services”. Definitions of ophthalmic and pharmaceutical services in the new Section 106A(3) are unnecessary as they are already defined elsewhere in the NHS (Wales) Act 2006. Pharmaceutical services are defined in Section 80(8) and general ophthalmic services in Section 71(10) of that Act. The insertion of a definition of “practitioner” into the new Section 106A(3) ensures that the language used to define “practitioner” is the same as that used elsewhere in Chapter 2 of Part 8 of that Act.

The fifth and final amendment corrects an error made at consolidation in 2006. It adds a reference to ophthalmic contractors in Section 107(9) of the NHS (Wales) Act 2006 to ensure that they must comply with the same fitness-to-practise requirements that pharmaceutical contractors must meet. I hope that Members of the Committee are content with these minor amendments and I beg to move.

Amendment 114A agreed.

Amendment 114B

Moved by Baroness Thornton

114B: Clause 26, page 29, line 21, at end insert—

““practitioner” means a person included in a pharmaceutical list, and”

Amendment 114B agreed.

Clause 26, as amended, agreed.

Clause 27 agreed.

Amendment 115

Moved by Lord Palmer

115: After Clause 27, insert the following new Clause—

“Prescriptions: labelling showing actual cost

(1) The National Health Service (Charges for Drugs and Appliances) Regulations 2000 (S.I. 2000/620) are amended as follows.

(2) After regulation 11 insert—

“11A Prescriptions: labelling showing actual cost

(1) The packaging of any drugs or appliances supplied in accordance with regulations 3 to 6A shall carry a label showing the full retail cost of those drugs or appliances.

(2) Paragraph (1) applies irrespective of whether—

(a) there is an exemption from charging under regulation 7 or 7A, or

(b) a valid exemption certificate under regulation 8 is in force.””


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