Primary Medical Services (Scotland) Act 2004<br />(Draft Regulations)
National Health Service<br />(Primary Medical Services Performer's Lists) (Scotland) Regulations 2004 (draft)<br />National Health Service<br />(Section 17C Agreements) (Scotland) Regulations 2004 (draft)
National Health Service<br />(General Medical Services Contracts) (Scotland) Regulations 2004 (draft)
We move on directly to item 3. I refer members to paper HC/S2/04/7/2, which contains three sets of draft regulations—I will not read the titles out—and, again, I thank Tom McCabe, Lorna Clark, bill team leader for the Primary Medical Services (Scotland) Bill, and Jim Patton for attending the meeting. The minister may take us through the regulations as he wishes and I will then open up the meeting to questions from members.
I am pleased to be here to try to make good on the commitment that we made to the committee in November, when we said that we would be happy to continue our dialogue on the regulations that flow from the Primary Medical Services (Scotland) Act 2004.
I have two questions about schedule 2 to the draft National Health Service (General Medical Services Contracts) (Scotland) Regulations 2004. First, paragraph 2(12), on page 32, says:
The panel would comprise three members: a patient representative; a representative of the profession, who would come through the area medical committee; and either the chief executive or an executive director of the health board that was hosting the panel. I stress that the regulations stipulate that the health board that hosted the panel would not be the health board that had the particular issue.
I would like to clarify matters. You mentioned a patient representative and a professional representative, so there would be a professional representative on the assessment panel anyway, irrespective of the status of the director of another health board.
Indeed.
My second question is on paragraph 6 of schedule 2, on page 37. The issue arose when the committee questioned you previously—I think that I asked you about informing patients about opt-outs. I am still concerned that
That there are two sets of obligations is important. There are obligations on practices with regard to notification and specific obligations on health boards, as they have a duty to inform patients of any changes. The two examples that are given in the regulations relate to practices, but there are also specific obligations on boards. I cannot remember the exact wording of the regulation, but I suppose that, on first reading it, a person would be entitled to say that it relates to the obligation on health boards, although it is fairly vague and says merely that health boards shall notify patients. However, a further subset of regulations will be developed to add detail to the methods that the health board must apply with respect to that notification.
So those regulations still have to come to the committee.
If the committee would like us to share them before they are finalised, I would be more than happy to do that. I would probably go a bit further and say that, if members are happy to consider those regulations, they might want to turn their minds to suggestions on how health boards would be required to notify people.
Members may ask questions if they are supplementary questions, as I have a list of members who want to ask questions.
Will you clarify who will be responsible for informing patients about opt-outs? Will the practice or the health board be responsible for letting patients know that contraceptive services, for example, will no longer be provided by the practice?
Both will be responsible. The regulations specify the practice's obligations, but a far more specific obligation on the health board sits beside those obligations. As I said, a further subset of regulations will better define the exact obligations on the health board.
Will those regulations also define the methods that the health board should use to impart information? I would have thought that it would make sense to notify patients in writing that cervical screening services or child immunisation services will no longer be provided by a practice, as people need to know about such things quickly. Will the further subset of regulations specify the process?
The regulations are still being drawn up and might well do so. As I said, I would be happy to share them with the committee before they are finalised and to take on board suggestions that members make. The caveat that I would add is that there should always be a test of reasonableness—members would expect me to say that. Obviously, a request to hand deliver a letter to every patient would be unreasonable, but posting a letter to every patient might be judged to be reasonable.
I think that the draft regulations state that the health board must notify changes in writing, although I cannot find where they say that. I went through them without a pencil—
The reference is to paragraph 80 of schedule 5 to the draft National Health Service (General Medical Services Contracts) (Scotland) Regulations 2004. That is on page 76.
Really? I would not have thought so.
It depends on how "in writing" is interpreted. That is where regulations that are properly scrutinised come into their own.
I had assumed that "in writing" would mean that patients would be notified by a letter.
I may have missed what was said earlier, but I am interested in finding out more about the obligation to inform patients that will be placed on practices that opt out. I feel strongly that, as the practice is the direct link between the patient and the health service, patients should be informed by the practice rather than by a letter from the health board. In my opinion, if a practice has decided that it has a good reason to opt out of the new service, it should be under an obligation to contact patients about that. Perhaps health boards could be involved in informing people over a wider area. Can you give us further information about those obligations, or have they not yet been defined?
The obligations on practices that opt out are defined. Such practices must inform patients both by including the information in the practice leaflet and by posting a notice in the practice's premises.
Do the practice's obligations end there?
Yes, those are the only two obligations on the practice. I understand your argument about the practice's obligations, but I do not entirely agree with you. The contract is between the practice and the health board, so the obligation to make appropriate communications with patients will be placed on the health board that is party to that contract. That is the way that the matter has been thought through.
So the obligations on practices that opt out will be limited to what you have said. Can the issue be revisited so that the obligations on practices that opt out are extended?
The regulations have not yet been laid, so we would obviously take on board any view that the committee expressed. However, let me stress that the further subset of regulations that will deal with health boards will be very important. The committee will have an opportunity to influence the direction of travel of those regulations.
I think that all our questions have laboured the same point. In the end, I doubt that it matters to the committee whether the requirement to inform patients is placed in paragraph 80 of schedule 5, which states that
I say again that I agree with those points. It is important that the information is communicated to patients clearly and in a manner that they can understand. Patients should not be placed under an obligation to seek out the information. For instance, I think that it would be unacceptable to assume that patients purchased a particular local newspaper and hope that they would notice an advert that appeared on a particular page on a particular day. That would not be enough.
We seem to be talking about three circumstances. First, there are proposed opt-outs, for which a letter or other communication would have to be sent to patients. Secondly, there are opt-outs that have been confirmed, for which another letter would have to be sent out. Is that correct? Paragraph 6(2) of schedule 2 goes on about the requirement on contractors to
When I met representatives of the British Medical Association on Friday night and asked them what reaction they thought there would be to the changes, they seemed to think that we would encounter such circumstances rarely. They thought that there would be a low level of opting out of providing additional services—obviously, I am not referring here to out-of-hours services.
Yes, the point is specifically on the additional services. You are saying that opting out will be a rarity.
That is the indication at the moment.
I have a comment on the back of the last discussion. I recently got a letter from the health board informing me that my dentist had given notice to retire. I gather that the letter went to every single one of the NHS patients registered in the practice. The onus was on the health board, not the practice. I throw that in in passing.
Any practice that is providing the additional services at the moment will be able to do so when the new contract comes in on 1 April. Health boards will be able to decide who is going to provide an additional service only if the practice that is providing it at the moment opts out. If the practice wants to continue to provide the additional services, it will be within its rights to do so. The health board will not be able to take additional services from practices that want to continue to provide them.
That is helpful, thank you. That clarifies a couple of points.
Give me a second to find that. Did you say page 7?
Yes. It is about 10 lines up. It is under "enhanced services".
As far as I understand it, that indicates that the practice would have to lay out exactly how it would implement what it intends to do. It has to set out what is almost a business case for what it intends to do.
So it is a matter of negotiation between the practice and the health board.
The practice would lay out its original intentions, which the health board would consider and on particular aspects of which it might wish to comment or negotiate.
On page 11, subparagraph (a) is about the definition of "pharmacist" in the Medicines Act 1968. Subparagraph (c) refers to "a supplier of appliances", but that is a reserved title. There are suppliers of appliances who are not pharmacists, and who do not operate from registered pharmacy premises. Is that a hiccup, or does something somewhere else cover that?
I am not aware of that. The officials may be able to help me out.
That is based on the legal advice that we have received from Scottish Executives solicitors. It mirrors what happens south of the border in England and is included in order to keep the definitions parallel with each other.
I am happy not to have an answer today, if you would prefer to drop us a note about the matter.
I am happy to do that.
Further down that page, there is mention of
I would not mind a wee bit more elaboration on the point.
Very simply, the Robert Gordon University school of pharmacy announced in the press last week that the first fully trained and certified supplementary prescribers who are pharmacists are not actually employed by a contractor in the sense that it is a current GP practice, because they are out there in the community. Are such people covered under the regulation? Unless I have misread the regulation, it appears that they are not covered. I am happy if you want to come back to the committee on that technical point.
We will come back on that point, which is fairly technical.
There is a definition that relates specifically to the regulation. Different definitions may apply to different sets of circumstances. We will write to the committee on that issue.
I am trying to head off a situation in which people out there misread the regulations and seek advice. Those people have spent time and some of their money getting themselves into a situation in which they assumed that they would be entitled to practise.
We will try to clarify that matter.
Fine.
My understanding is that such people will still be covered, as long as they are registered with the relevant professional body.
But they do not actually have to be employed in that capacity.
Do you mean in the interim period?
Yes.
No, but when they take up the employment again, it must be in one of those capacities.
On page 26, in schedule 1, under the heading "Contraceptive services", paragraph 3(2)(d) mentions "emergency hormonal contraception". Strictly speaking, should that not be "emergency hormonal termination"?
No, I do not think so.
That is accepted terminology.
Yes.
Fine. I was just checking.
I am sure that our learned friends have a legal definition of the word "appropriate".
Fine.
It is not about emergency cover or holiday cover; it is about sub-contracting out the services.
Yes.
I understand. I beg your pardon. I misread it.
It is about formal sub-contracting and not holiday cover.
You have covered some of the other points that I wanted to raise, minister. Thank you.
That is a question of drafting. It shows how much the regulations are still works in progress. What the comments in brackets mean is that either we or our lawyers have noticed points that we need to think a bit more about and return to before we finalise the document.
But they will come back to us eventually.
Yes, absolutely. That will be done very soon.
I will keep my question short. I turn to page 87 of the original draft and to paragraph 104(1) of schedule 5 to the draft National Health Service (General Medical Services Contracts) (Scotland) Regulations 2004. I seek a point of clarification. Subparagraph 104(1) begins:
I do not think that we have a wide definition at the moment. It is a general regulation that aims to protect the best interests of patients. If anyone with whom a health board has contracted is engaged in other activities that in any way whatever—and I think that we want to keep it as wide as that—is judged to be detrimental to the level of service that they are supplying to the board's patients, the regulation gives the board a lever in those circumstances.
I am trying to think back to the concerns that were raised during the passage of the bill about the involvement of private companies in the provision of primary medical services. I think that the questions about those concerns were answered adequately at the time. We understood at the time that there would be an element of control over the provision of those services. I am trying to think of examples of how things will work in practice. Are you thinking about a company that is providing those services but is also involved in other activities that might be thought to be dubious?
Take, for instance, an extreme example of a practice with three doctors and four practice nurses in which we discovered that all three of the doctors were spending 50 per cent of their time providing private services and that the nurses were also involved in an activity of that kind, which meant that the practice found it difficult to live up to its obligations under the contract. If that were the case, the board would have the ability to move in and say, "The service that the practice is providing no longer suits our purpose. It is clear that you are not dedicating enough time to properly service your patients."
How would that be monitored? How would it come to the attention of the health board in the first place?
There is a general monitoring scheme that will oversee what happens between the practice and the health board. There will be an obligation on the health board to ensure that it knows what the practice is doing and that it is aware of the standard of service that is being provided.
There is nothing to stop such companies being involved in private work. You are saying that that would become an issue only if it impacted on the company's ability to fulfil the contract. If it was fulfilling the contract, there would be no bar to it being involved in whatever it wanted to be involved in.
They are not allowed to undertake certain activities, particularly those around private practice and treating NHS patients privately. There are lots of rules about what doctors may do privately and what they may do for the NHS—those rules are a separate part of the regulations that we have to sustain. The issue is about making sure that the level of service that a practice provides is not damaged by any other work that it does.
Private practice is a good example, but there may be a raft of other examples.
I would like to ask you about three areas, all of which concern the draft National Health Service (General Medical Services Contracts) (Scotland) Regulations 2004. First, I have a general question on fees and charges, which are dealt with in schedule 4, on page 41. Have there been any changes to the fees and charges that are levied? Have any fees or charges been added to or removed from the list?
My understanding is that the list represents a continuation of the current circumstances.
Secondly, on the removal of patients from lists at the request of the contractor, paragraph 20(2) of schedule 5, on page 48, refers to cases where, in the contractor's reasonable opinion:
Yes, very much so.
Thirdly, I have a general question on the complaints procedure, which is covered in Part 6 of schedule 5 to the regulations, on page 77. I do not want to prolong this, but perhaps you will explain to me briefly what difference the regulations make to the current complaints procedure. I understand that complaints procedures throughout the NHS are under review—how does this fit in?
The document refers to complaints that are specifically on primary medical services. You are right to say that there is a general thrust to achieve a far more transparent and accessible system for patients to lodge a complaint against a range of activities in the national health service, and there is a continuing programme to try to develop that.
I understand that, but I asked you where the regulations fit in. When will the general complaints procedure be in the public domain? The other part of my question asked how the regulations vary from the existing complaints procedure.
As far as I know, they do not vary very greatly at all.
It has been put to me by practitioners that the involvement of the Scottish public services ombudsman is new—is that the case?
No.
It is not.
I could almost certainly say no.
So the procedure is exactly the same as previously—you have just standardised it. That is all that I had to ask.
On the convener's point about the removal of patients from lists at the request of the contractor, paragraph 20 of schedule 5 to the regulations states that
The caveat always applies that the situation depends on the circumstances. In general, that situation would be unreasonable, but some circumstances might invoke that approach. Health boards are obliged to monitor the way in which and the frequency with which a practice removes people from its list. If a practice felt that circumstances occurred regularly in which it could not give a fuller explanation, a health board would be able to express its opinion, as part of its contract with a practice, that the practice was putting an extraneous interpretation on the regulations.
I accept that entirely. A health board could pick up a pattern. However, I am taking the individual patient's point of view. The event happens to them just once. It is hardly any benefit to an individual patient if a health board picks up a pattern. That might help other people later, but it would not help that patient. In the 21st century, should an individual patient know the grounds for their removal from a contractor's list? The regulations refer to the
In a range of circumstances, a practice might believe that an explanation was not in the patient's best interests, for instance.
I cannot believe that a practice should not tell the patient that.
The patient also has recourse to the complaints procedure through the health board. If the patient was unhappy that the practice did not go into detail about the reasons why they were removed from the list, that patient could complain to the health board and the circumstances would then be examined. I understand that no situation exists in which a health board could compel a practice to give those reasons, but if a health board upheld a complaint, a practice would have to think twice before engaging in that activity again. It would have to ensure that it could justify invoking that reason.
I return to the point that that is fine and will sort things out in the long term for everybody, but the individual patient who may feel aggrieved has no redress and receives no benefit.
If a patient complained about a practice's reluctance to specify reasons and the complaint was upheld, the patient would at least know that the practice was wrong to behave in that manner. However, I do not know whether anything could be done to compel a practice to reveal the reasons. I could be wrong about that and I am certainly prepared to examine the matter.
That would be helpful.
What the minister just said conflicts with what he has told me. On page 49, paragraph 20(7) of schedule 5 says:
A health board can do that.
That provision applies without a complaint from a patient.
A health board can ask a practice for the reasons, but it would not be at liberty to disclose that information.
I understand.
That would certainly be true. The only circumstance in which a practice could refuse to treat a patient for a particular condition is if they were being treated through an enhanced service and the health board had contracted with someone other than that practice to provide that service. That would then only be for that particular treatment.
The reason has to be a medical one; that was my point.
Yes.
I did not make the link with paragraph 20(7). If a patient is removed from the list and wants to know why, and the contractor does not tell that person, that person can make a complaint to the health board. Under paragraph 20(7) of schedule 5, the health board can obtain the reasons for the patient's removal and the health board would be able to give the individual the reason for their removal. If that is the case, then I am satisfied.
Are you asking if the health board could tell the individual?
Yes. If that is the case then I am happy.
As far as I know, that is not the case.
So the contractor and the health board will know the reasons for removing an individual patient, but the individual patient will not.
Yes.
That is wrong. That cannot be right.
The health board and the contractor would have to have specific reasons for not imparting that information, and they are defined in paragraph 20(4), where the contractor believes that the information would
With respect, minister, that appears to refer only to subparagraph (3) and not subparagraph (2).
I am reading from subparagraph (4).
Subparagraph (4) says
Yes, it does.
Subparagraph (4) does not relate to subparagraph (2).
I think that you might be right, convener.
Could the minister look at the regulations again?
The problem is that the regulations have to be laid. There are obviously concerns, and clarification is needed about the operation of paragraph 20 of schedule 5. In his evidence, the minister made it plain that there are no third-party rights under the contract, so no third party, or patient, has a right to information. Am I correct in summarising that there are concerns that human rights might be being sidestepped just a little?
The reasons are outlined at the beginning of the procedure. People are warned at that point that they might be removed from the contractor's register and they are given reasons for that.
Unless there are particular grounds for not giving those reasons.
In the majority of cases, the patient will have had prior warning. There might be specific circumstances when that is not appropriate.
It will be the hard cases that test that.
I understand the difficulty. We are trying to be transparent and create a climate within the health service where people have access to as much information as possible. I am happy to take that issue away and perhaps think about a further method of appeal when a patient has been refused the reasons to ensure that there is a second view of the reasons and that a test of reasonableness is applied. That may give people comfort that the decision of the practice is not final and that another look could be taken at the matter.
I think that we are content to move on.
I am very happy with that response.
We are content to move on. Helen Eadie has been waiting patiently to comment.
That is exactly the point that I was going to raise with the minister: we have a flow of dispute resolution that does not end up with an appeal situation. However, the minister has said that he will consider the issue, so I am happy with that.
I have a general question about paragraph 12 of schedule 5 to the draft National Health Service (General Medical Services Contracts) (Scotland) Regulations 2004, on the
In those circumstances we are talking about what is reasonably practicable for the contractor who has opted out to do to provide the records. We would not expect a contractor to get out of his bed at 12 o'clock at night to open up his surgery to access the patient's medical records when he has devolved his responsibility. Therefore, I presume that the records would be available during the normal working day and through the computer system that NHS doctors and GPs use. The key phrase is what it is reasonably practicable for the GP who has to co-operate to provide within core hours.
I will not be the only member who has had several cases of something going wrong because a provider of an out-of-hours service could not access prior medical records. They were trying to deal with a current situation and they did not realise that there was another problem.
It is difficult for us to predict every clause that would be contained within a contract for additional or enhanced services. It would not be unreasonable if a clause were inserted that states that it is very much an exception, because it would be an exception when access was required to the records in the out-of-hours period. It would not be unreasonable for there to be a clause in a contract that coped with such rare exceptions, but I stress that it is difficult for me to make predictions about that. We will certainly issue guidance on the matter and we can bear that point in mind when we draw it up.
Unless there are further questions, the only point that I can add—[Interruption.]
I refer to schedule 2:
That paragraph is designed to provide flexibility in dealing with situations that are thrown up. There might be a range of reasons why a practice decides to opt out temporarily. If a practice is opting out regularly—we have defined regularly as three times within three years—a decision would have to be made one way or the other.
So it would be decision time for the practice.
We are trying to provide continuity of service for the patient. A practice can opt out twice within three years, but we would treat the third opt out as a permanent opt out.
So the practice would need to have a jolly good reason for having changed the way that it worked?
Yes.
That is fine.
I have made sure that Jean Turner does not have any more points.
We certainly want to avoid any delay, because the regulations come into force on 1 April. Depending on the hours that my colleagues Lorna Clark and Jim Patton—and their colleagues—are prepared to work between now and 10 March, we might have a resolution. I can only assure you that we will do our best to achieve a resolution and communicate it to you before the deadline.
Alternatively, you could tell us the reasons for a resolution not being reached, so that the committee would know in advance.
We will certainly strive to do that.
Thank you. As there are no other questions, I close the evidence session and the meeting.
Meeting closed at 14:57.
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