Health Committee, 22 Mar 2005

Meeting date: Tuesday, March 22, 2005

Official Report 292KB pdf

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Subordinate Legislation

We have 10 Scottish statutory instruments to consider under the negative procedure. The Subordinate Legislation Committee raised a number of issues on the instruments, several of which are of current interest to the committee, including those that relate to dentistry and the Regulation of Care (Scotland) Act 2001.

I have asked officials from the Scottish Executive and the Food Standards Agency Scotland to come before the committee to explain the purpose of the instruments and to answer questions from members. Although all the officials are sitting round the table, not every one is relevant to each instrument. They are all at the table together because that will save time; we will not have to swap folk to and from the table for each group of instruments.

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Regulation of Care (Excepted Services) (Scotland) Regulations 2002<br />Partial Revocation Regulations 2005<br />(SSI 2005/96)<br />Regulation of Care (Fees) (Scotland) Order 2005 (SSI 2005/97)

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Regulation of Care (Scotland) Act 2001 (Transitional Provisions) Order 2005<br />(SSI 2005/98)

The first group of instruments—SSI 2005/96, SSI 2005/97 and SSI 2005/98—relate to the Regulation of Care (Scotland) Act 2001. I welcome our first two witnesses, who are from the Scottish Executive Health Department; Shaun Eales is from the delivery of care services branch, and Linda Gregson is from the care standards and sponsorship branch.

The purpose of SSI 2005/96 and 2005/98 is to extend the responsibility of the Scottish Commission for the Regulation of Care to include the regulation of independent schools with boarding provision, education authority residential special schools and school hostels. SSI 2005/97 introduces new fees for those schools, including fees for registration with the care commission and cancellation of registration. The instrument also increases existing fees for services that are regulated by the care commission.

Last year, the committee wrote to the Executive to express its concern at the level of increase in fees for registration with the care commission. The Executive's response says that ministers

"will continue to keep a close eye on the impact of fees".

What action has the Executive taken to monitor the impact on schools and hostels of their having to pay fees on services that are regulated by the care commission?

Last year, when the timetable for moving to full cost recovery funding of the care commission was extended to 2006, I think we said that we would work with the care commission over this year and next year to consider what the full cost recovery fees might be for the range of care services that the care commission regulates.

There are two aspects to the setting of fees, the first of which is the overall cost to the care commission. The care commission cannot just do what it likes; it has to work within the requirements of the Regulation of Care (Scotland) Act 2001. Its ability to deliver proportionate risk-assessed regulation is constrained by the requirements of the act. That said, the care commission is doing a number of things to keep its costs down. For example, it has introduced an integrated fee regime for providers who deliver more than one type of care service. That regime applies where services are considered alongside each other at the time that consideration is given to what the level of fee might be. For example, if the fees are determined by the number of staff, the care commission will take the number of staff across the two services and apply a single fee.

The care commission takes a limited risk assessment approach to regulation. It carries out either a concise or a standard inspection. That depends—

Yes, but that is not about the impact of having to pay the fees. You are giving the committee an explanation of how the care commission arrives at the setting of fees, whereas we are concerned about who will monitor the impact on the providers of various services of having to pay the fees. The payment of money in fees will impact on services. Who is monitoring that?

Sorry?

Who monitors the impact that the fees will have?

The fees are subject to a wide-ranging consultation exercise. I think that we issued 14,000 consultation documents on fee levels, and we have had no hard evidence to suggest that a significant number of providers are closing because of the cost of regulation.

That is still not very clear on the issue of monitoring.

When you say that there is no sign of a significant number of providers closing, how many are you talking about?

It is difficult to know how many. I do not have the figures to hand.

Can you get them for us?

We can get the number of cancelled registrations from the care commission. If a care home closes, it has to apply to the care commission for cancellation of registration. The care commission will have information on the number of services that have cancelled their registration, but that may not always be because—

Do you ask why there has been a cancellation of registration?

The care commission needs to know the reasons for a cancellation. So, yes, we can get that information for the committee.

A lot of concern was raised during the initial stages of the Regulation of Care (Scotland) Bill about the impact of fees, especially when they go to full cost. You said that the consultation produced little hard evidence; that suggests that there is quite a lot of soft evidence. What sort of evidence have you received? Have a large number of respondents to the consultation raised concerns about the impact of going to full coverage of costs?

In the recent consultation round, we got 137 responses from 14,000 consultation papers—sorry, it was about 12,000 this year and 14,000 last year. It is fair to say that concerns were raised about the proposed increases in fees, but there was no suggestion that services would close because of the increases—certainly, not in response to the consultation.

The situation is still unclear, though. Your answers do not suggest that you are doing any hard post-increase monitoring. The committee has raised that as a concern in the past, and your answers suggest that the concerns that we have raised are not being addressed.

We do not have any research in place at the moment to monitor that.

I understand that, in some cases, you are reducing the number of mandatory visits from two. Is there a connection between that and the fee? It has been stated that perhaps it is not necessary to visit some establishments twice. Does that have something to do with the number of places that you have to visit, or is it connected with the fee?

That is the point that I was going to make earlier. The care commission is required by the 2001 act to inspect all care services at least once a year, with residential services being inspected at least twice a year. That limits the care commission's scope for manoeuvre in targeting its resources on poor performance and driving up quality. We propose to lodge an amendment—it is one of the three amendments to the Smoking, Health and Social Care (Scotland) Bill to which the minister referred—to give ministers the power to vary the number of inspections that must be done in a year. That could have an impact on the cost to the care commission, which will possibly drive down fees in the long run. That saving will feed through into the fees.

There are two aspects to fees, the first of which is the amount of time that is required to regulate services. The care commission is gathering evidence for us on that aspect across the range of services and regulatory activities that it undertakes, which will feed into the consultation before fees are set at full cost recovery level. Secondly, fees are affected by the cost of running the care commission, which must be efficient and effective. Ministers agree the care commission's budget on an annual basis and we expect them to make efficiencies in 2005-06, in relation to early-years services, by modifying the joint inspection arrangements with Her Majesty's Inspectorate of Education—that approach might feed into other services. Currently, the care commission is part funded through fees and we are still moving towards full cost recovery, so in 2005-06 we do not know what the impact of full cost recovery is likely to be. However, we will receive information that will feed into our understanding later in the year.

I understand that the Deputy Minister for Health and Community Care signed the declaration on the regulatory impact assessment for the Regulation of Care (Fees) (Scotland) Order 2005 (SSI 2005/97), which states:

"I am satisfied that the balance between cost and benefit is the right one".

What work was done in the regulatory impact assessment to enable the minister to reach that conclusion?

The work that was done relates to the original regulatory impact assessment, which was done during the passage of the Regulation of Care (Scotland) Bill. The principles that were set out in that RIA still apply.

Has no new assessment been done in the light of the new situation?

No. We have plans to carry out such an assessment before we set fees at full cost recovery in 2006-07.

Do you know how the minister reached her conclusion about the balance between cost and benefit?

No, sorry.

Was it in response to advice that you gave?

No.

Was it in response to advice that Mr Eales gave?

No.

That is clear, but it is not satisfactory. Do members have further questions in the light of what we have heard? I have concerns about the matter.

According to the schedule to SSI 2005/97, the fee for the "small school care accommodation service", which applies to schools that take fewer than 40 kids, is £4,340. However, for a school that takes 40 kids, the fee jumps to nearly £6,000. What criteria did you use to justify such large jumps in fees? It seems odd that the fee for a school that takes 40 kids is 50 per cent higher than the fee for a school that takes 39 kids.

I do not have the detailed figures in front of me. However, the fees are based on the estimated time that it takes the care commission to regulate services and they were agreed in consultation with the sector. We had a number of meetings with the Scottish Council of Independent Schools, at which we discussed fee levels and the split between small, medium and large schools.

I am glad that there was detailed discussion, but would it have been fairer to have devised a system whereby the more kids who boarded, the more fees the school would pay? Could not the fees have been set out on a per-head basis? The approach that has been taken strikes me as arbitrary.

The fees for school care accommodation services have been changed. The commencement date for the regulation of such services applies to schools that were not already regulated. Fees that were based on a cost per place were already in place for school care accommodation services, but the sector was unhappy with that arrangement. We considered alternatives with the sector.

The sector made the suggestion?

Yes, in consultation with the Scottish Council of Independent Schools. Representatives from the sector were at the meetings that we had.

I am surprised, but thank you.

People who run care homes for older people are seeing the increases come alongside local authorities not paying them the rates that the Convention of Scottish Local Authorities says should be paid. They are concerned about the combination of those two factors. Do you have any comments on that?

Since 2001 and up to 31 March this year, a national agreement has been in place with the voluntary and private sectors. In that time, the Executive and local authorities have put an additional £140 million into care home fees. In May last year, local authorities and Scottish Care commissioned the Scottish local authorities management centre to produce another model for paying care home fees; that model will kick in from 1 April 2005. The Executive has accepted that. In years 2 and 3 of the current spending review, the Executive will provide an additional £94 million specifically for care home fees.

Is that to the satisfaction of the people who run the care homes?

Scottish Care made known its concerns about matters such as the regulation of care, water rates and training costs. However, it is difficult to catch the anticipated fee levels over a period of three years. We can project some costs, and the SLAMC report tried to identify projected costs for training and water rates; it also built in an inflationary increase. Scottish Care and the voluntary sector were happy with that.

I advise the committee that the Subordinate Legislation Committee had no comment to make on the instruments. However, what the committee has heard this afternoon might mean that we should write to the Deputy Minister for Health and Community Care about the concerns that are being expressed. Is the committee agreed on that course of action?

Members indicated agreement.

Otherwise, are we agreed that the committee does not wish to make any recommendation in relation to SSI 2005/96, SSI 2005/97 and SSI 2005/98?

Members indicated agreement.

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National Health Service<br />(General Dental Services) (Scotland) Amendment Regulations 2005<br />(SSI 2005/95)

The next instrument is on general dental services. Dr Hamish Wilson, the head of primary care in the Scottish Executive Health Department is still with us. The instrument, which provides for the introduction of reimbursement of dental practice expenses, including rent and staff costs, has been introduced as a result of the consultation on modernising dental services in Scotland.

The Executive note on the instrument states that provision has been made in the general dental services budget to meet the cost of reimbursement of practice expenses. The instrument has been introduced to amend the National Health Service (Scotland) Act 1978 as a result of the consultation on modernising dental services. Provisions in part 2 of the Smoking, Health and Social Care (Scotland) Bill will also amend the 1978 act. The committee is keen to scrutinise subordinate legislation that results from the consultation, because members have received evidence that the devil is in the detail. We must, therefore, keep our eye on the detail.

Why was an amendment not included under the provisions in part 2 or schedule 3 of the Smoking, Health and Social Care (Scotland) Bill?

To clarify, the amendment will be to the GDS regulations. It is not an amendment to the 1978 act.

Okay, but it relates to what we are doing. Why was it not included in the current bill?

The issue did not need primary legislation through the bill; it simply required an amendment to secondary legislation.

I will explain briefly how the remuneration system operates. We have what is called the statement of dental remuneration, which is a set of directions on how dentists who provide general dental services are paid their fees and allowances. The statement, which has been referred to during our various discussions, contains a number of determinations in relation to fees and allowances but, at present, there is no heading for the reimbursement of practice expenses, which is a new item. Therefore, the regulations need to be amended so that the statement of dental remuneration can go into the details of how practice expenses will be reimbursed under the national contract under which dentists provide general dental services. That is why we are amending secondary, not primary legislation.

Right, but the measure is tied up with the issues of provision.

That is correct—it flows from the modernisation.

Yes, but the amendment is being made by means of an instrument that is dealt with under the negative procedure, which is a different process. Will there be more such instruments, in addition to the regulations that will be introduced under the Smoking, Health and Social Care (Scotland) Bill?

The bill that is before the committee contains the power to make regulations, for example in relation to listing, which was referred to earlier. Therefore, regulations will flow from the bill, which was the subject of earlier discussion. There is no other current matter in relation to modernisation on which we require amendments to existing regulations, although amendments will be required to the regulations that arise from the bill.

So nothing similar to the regulations that we are considering is coming along.

The regulations are a specific item—they are the result of a requirement for an addition to the existing secondary legislation.

There are no further questions. I advise the committee that the Subordinate Legislation Committee had no comment to make on the regulations. Do members agree to make no recommendation in relation to SSI 2005/95?

Members indicated agreement.

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Plastic Materials and Articles in Contact with Food Amendment (Scotland) Regulations 2005 (SSI 2005/92)<br />Colours in Food Amendment (Scotland) Regulations 2005 (SSI 2005/94)

The regulations relate to food safety issues. We have with us Sandy McDougall, from the Food Standards Agency, and Steve Lindsay and Isla McLeod, from the office of the solicitor to the Scottish Executive. The witnesses are not those whose names were on the original agenda.

SSI 2005/92 lays down specific rules to ensure that consumers are protected from chemicals that might migrate into food from plastic food-contact materials and articles. SSI 2005/94 sets out the purity criteria for mixed carotenes and beta-carotene, including a limit on the permitted levels of heavy metals in mixed carotenes. The Subordinate Legislation Committee raised two issues in relation to the regulations, which are intended to transpose into domestic law an amendment to European Community law; the committee's comments are contained in a paper. The Subordinate Legislation Committee does not accept the Executive's argument that existing Scottish regulations remove the requirement under European Community law to consult on the amending regulations. That is a clear conflict of understanding between the Executive and the Subordinate Legislation Committee. I ask the witnesses to explain the logic behind the decision not to consult on the regulations.

I was the lawyer who was engaged with both sets of regulations, particularly and generally. Neither the Food Standards Agency nor the Executive takes the view that there should be no consultation; in fact, we accept unreservedly that consultation is required on both sets of regulations. We had a written exchange with the Subordinate Legislation Committee on what I assume to be a technical drafting matter that is associated with how one refers in the regulations to the fact that consultation has taken place.

The Subordinate Legislation Committee is concerned that, in the part of the regulations that we call the preamble, which contains all our powers—the primary legislation that allows us to make the regulations—we should also refer to the fact that a consultation requirement exists. We have taken the view that, because of the guidance that we follow within the Executive in preparing the instruments, that reference should go in a footnote. I hope that I do not diminish the point by suggesting that that is the difference, but that, in effect, is the substance of it.

But you are confirming to us that there will be consultation.

There will be consultation. I am clear that colleagues from the Food Standards Agency are in no doubt about, and have no difficulty with, the fact that they must consult in advance of making such regulations. They consulted on making both these sets of regulations. Only when there is an acute emergency might they be relieved of the obligation to consult. Of course, that is sometimes the case in relation to what we call FEPA orders—orders that are made under the Food and Environment Protection Act 1985—which are emergency orders to prevent food coming on to the market because of the toxins that are contained in it.

The Subordinate Legislation Committee suggested that an accompanying transposition note should have been prepared to explain how the instruments will implement the European Commission directive. Can you explain why there is no such note?

I am afraid that, in this case, resources did not allow us the time to prepare one.

The background is that my office—the office of the solicitor to the Scottish Executive—has agreed to take a lead in providing guidance to all Scottish Executive departments, and to the Food Standards Agency and other clients that are not part of the Executive but which bring forward legislation, to get them geared up to be able to produce the right sort of information in the transposition notes. Such notes would usually be drafted not by lawyers but by our clients, in the same way that Executive notes are prepared by our clients. I am afraid that progress on that has not been quite as quick as we would have wished, but good progress is being made and we hope to finalise the guidance shortly.

My section of the Executive has been developing pilot programmes on how we would set out the information, with a view to coming forward very shortly to test the committees' reactions and establish whether the notes contain the information that the committees would want. Committees could seek a range of information about what a directive does and how we go about transposing it. We are trying to focus the information so that it is as clear as possible—perhaps it will be in tabular format—and so that we cover as many as possible of the items that the committees want to be covered by such notes.

My expectation is that we will begin to produce specimens of those notes, which will probably arise from the work of the Food Standards Agency and the Scottish Executive Environment and Rural Affairs Department, after the Easter recess.

In this case, however, it was a time issue.

I am afraid that it was. It is as simple as that.

Are we agreed that the committee does not wish to make any recommendation in relation to SSI 2005/92 and SSI 2005/94?

Members indicated agreement.

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National Health Service<br />(Optical Charges and Payments) (Scotland) Amendment Regulations 2005<br />(SSI 2005/119)<br />National Health Service (Dental Charges) (Scotland) Amendment Regulations 2005 (SSI 2005/121)

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Road Traffic (NHS Charges) Amendment (Scotland) Regulations 2005 (SSI 2005/123)<br />National Health Service<br />(Charges for Drugs and Appliances) (Scotland) Amendment Regulations 2005 (SSI 2005/124)

We will now consider four SSIs under the negative procedure: SSI 2005/119, SSI 2005/121, SSI 2005/123 and SSI 2005/124. The Subordinate Legislation Committee commented on SSI 2005/119, in relation to the need to consolidate the regulations that the instrument amends. The committee's comments are reproduced in the paper that has been circulated.

The Subordinate Legislation Committee did not comment on the other three instruments and no comments have been received from members. Are we agreed that the committee does not wish to make any recommendation on the instruments?

Members indicated agreement.

Thank you very much. I thank the officials for attending.

Meeting continued in private until 17:12.