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Earl Howe: I have real difficulties with this amendment. The time to think about the role and functions of regional assemblies is when and if a Bill comes before parliament to set them up. I do not think one can look forward hypothetically in that Bill, as the amendment seeks to do, and imagine a whole structure of government that has not yet come into being.

More substantively, I disagree with the whole premise underlying this idea. It reeks to me of divided responsibilities and confused responsibilities. It also reeks of upheaval. Where does it leave primary care trusts, which will have responsibility for the activities mentioned in the amendment? Where will it leave health authorities, for that matter? I feel that, if you believe in a health service, you should leave the running of it to those whose profession and business it is to do just that.

Baroness Gardner of Parkes: I am very much opposed to the amendment. Having been a member of the Greater London Council, it would have been quite hopeless for us to have had that health responsibility. To find a health responsibility in London, you have to go back as far as the LCC, which existed prior to 1964. It would be a retrograde move and would be very damaging to the health service. I am opposed to the amendment.

Lord Hunt of Kings Heath: It is a nice try, my Lords, and it could best be described as an interesting, speculative amendment.

Since no regional assembly in England is in existence, and there is no legislation on the statute book to enable such an assembly to be established, there could be no question of our enacting a provision to confer any responsibilities on an as yet hypothetical body.

It is important, of course, to ensure close working relationships between the regional offices of the NHS Executive and other regional bodies, not least because of the important contribution that these bodies can make in terms of the wider strategic and economic

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responsibilities within a region, and the links between an economic situation and well-being and improving public health and tackling health inequalities.

I assure Members that the NHS and its regional offices will want to work constructively with the regional development agencies and regional chambers, as they already seek to do with the government offices of the regions. I think that is the appropriate course of action in relation to this issue. On that basis I hope the noble Lord will feel able to withdraw his amendment.

Lord Clement-Jones: I thank the Minister for that reply; at least he did not talk about my amendment reeking. I think it is a fairly odourless amendment. I thank him for his reply, as far as it went. It will be interesting when and if there is a Yorkshire assembly because people in Yorkshire will wonder why they have distinctly fewer powers than, say, a Welsh assembly on matters of health. No doubt we shall have many hours of debate in years to come. I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Lord Clement-Jones moved Amendment No. 155:

After Clause 25, insert the following new clause--

("Specialised services: consultation
Consultation in respect of specialised services

. Before arrangements to provide specialised services between an NHS regional office and the relevant providers are finalised, an NHS regional office shall ensure that the Primary Care Groups and Primary Care Trusts in the area covered by the relevant NHS regional office are fully consulted.").

The noble Lord said: I can be even more brief with this amendment. This is almost a cuckoo at this point in the Committee's proceedings. The Minister took us through the detail of specialised services to show how the pattern varies between different types of treatment and different specialties. However, the mechanics of the way the consultations are expected to take place between NHS regional offices and their primary groups and PCTs are still opaque, and elucidation in this area would be helpful. I beg to move.

11 p.m.

Lord Hunt of Kings Heath: I certainly recognise and support the intention behind this amendment; namely, that we should ensure proper engagement of primary care groups and primary care trusts in the commissioning of specialised services. Indeed, we went a step further, in that we laid down in The New NHS the important principles that all health authorities, primary care groups and primary care trusts should participate in these arrangements, and that those undertaking the commissioning should be accountable back to health authorities, PCGs and PCTS. The reason is clear: the arrangements need not simply to command the confidence of the clinical units concerned but also to be properly dovetailed into the commissioning of local services.

It follows from what I have said that I have some difficulty with the premise upon which the amendment is drafted. The Secretary of State has charged regional

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offices on his behalf with ensuring that there are effective arrangements for commissioning these services in each region, but they do not commission services themselves. The Secretary of State is already holding his regional officers accountable for ensuring that specialised commissioning arrangements more than meet the aims of this amendment. Therefore, on that basis, I hope the noble Lord will feel able to withdraw his amendment.

Lord Clement-Jones: I thank the Minister for that explanation. I shall consider quite carefully what he has said. There may be some elements in respect of which I do not fully understand the pattern, but the Minister's response was very helpful in terms of describing exactly what the regional offices are bound to do. On that basis, I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 26 [Powers relating to voluntary schemes]:

Earl Howe moved Amendment No. 156:

Page 21, line 16, leave out ("The Secretary of State") and insert ("A voluntary scheme").

The noble Earl said: In speaking to this amendment, I shall speak also to Amendments Nos. 157, 158, 159 and 175. There is difficulty with Clause 26(3) as drafted. This part of the clause empowers the Secretary of State to require manufacturers and suppliers who have signed up to the voluntary scheme to "record and keep" any kind of information and to provide that information to him. The difficulty is that these provisions are not limited to those obligations contained in the scheme itself; nor are they subject to any express obligation to consult the industry body on the scope of the information requirements.

I recognise that the wording of the subsection contains the qualifying phrase,

    "which the Secretary of State may require for the purpose of enabling the scheme to operate",
but that is extremely one-sided. It is the Secretary of State who will have the power to decide what information he considers to be relevant. That, effectively, leaves the field completely open. That is a matter of concern, especially as the information powers will now be the subject of statutory penalties under Clause 30.

Therefore, the amendments I propose are quite simple. They seek to define the requirement to supply information by reference to the voluntary scheme itself, so that the provisions are automatically agreed with the industry. Moreover, under Amendment No. 175, I am also suggesting that there should be consultation with the industry about the regulations to impose penalties, so that those penalties can be considered at one and the same time as the voluntary scheme is negotiated. I beg to move.

Lord Walton of Detchant: In giving some support to this group of amendments, I should like to make a number of general comments relating to Clauses 26 to 31 as a whole, because these have given great concern to the Association of the British Pharmaceutical

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Industry. As I did on Second Reading, I must declare an interest as an occasional neuroscience adviser to a particular pharmaceutical company.

The problem is that an effective boundary needs to be established between voluntary and statutory schemes of regulation. The Bill ought to include objectives which reflect the needs of patients, the NHS, the UK pharmaceutical industry and the UK science base. Indeed, we shall be speaking to an amendment later which relates to provision being made for arbitration in disputes.

Similarly, it is important, as the noble Earl said, that there should be clarity as regards consultation and information required by government. The pharmaceutical industry should be regulated in line with best practice in other industries. But the Bill as it stands ignores such best practice, instead potentially threatening the future for the UK-based pharmaceutical industry. One company has pointed out that the UK is a leading country for pharmaceutical investment. Seven of the current top 25 medicines in the world are the result of UK research. One recently discovered medicine, olanzapine, for the treatment of schizophrenia, was discovered in the UK and has revolutionised treatment outcomes for this distressed patient group. It is now one of the best selling medicines in the world. Many companies believe that the current voluntary scheme has served both government and industry well since its inception. It has provided a stable base to maintain investment levels in R&D, and good value for the taxpayer.

There is an ever growing number of demand side controls on pharmaceuticals. The current NHS reforms, including unified budgets, NICE guidelines and national service frameworks, will continue the development of demand side controls. Many companies believe that supply side government imposed price and profit control is not the best way to proceed. They recognise the Government's need to address non-compliance under the voluntary scheme, but that non-compliance has in the past been limited to a small number of companies.

I trust that the Government will be able to assure the pharmaceutical industry that the voluntary scheme will continue and that the clauses in this Bill which potentially might lead to companies at present participating in a voluntary scheme having price controls imposed upon them will be withdrawn as the proceedings continue.

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