Health Committee,

Meeting date: Tuesday, May 10, 2005

Official Report 103KB pdf

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Subordinate Legislation

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Mental Health (Medical treatment subject to safeguards) (Section 234) (Scotland) Regulations 2005 (draft)<br />Mental Health (Medical treatment subject to safeguards) (Section 237) (Scotland) Regulations 2005 (draft)

Agenda item 2 is subordinate legislation. The committee is asked to consider two affirmative instruments that deal with medical treatment subject to safeguards. I welcome the Deputy Minister for Health and Community Care, Rhona Brankin, who is accompanied by Moira Milligen from the mental health division of the Scottish Executive Health Department and Shirley Ferguson from OSSE—no doubt she will explain what that stands for.

The office of the solicitor to the Scottish Executive.

Thank you.

The Subordinate Legislation Committee had no comment to make on either instrument. I invite the minister to make an opening statement in which she deals with both instruments.

I ask the committee to consider the two sets of draft regulations, which apply safeguards to certain medical treatments for mental disorder in the Mental Health (Care and Treatment) (Scotland) Act 2003. The regulations allow us to extend existing safeguards to new treatments that are in the near future likely to be available and helpful to patients with a mental disorder.

I will deal first with the regulations that we wish to put in place under section 234 of the 2003 act, which provides for safeguards for treatments that involve surgical operations that destroy brain tissue or the functioning of brain tissue. Those treatments are commonly known as neurosurgery for mental disorder or NMD. The safeguards apply to any patient who is being considered for such treatments, whether or not they are subject to compulsion under the act. The safeguards comprise second opinions from a designated medical practitioner and two lay commissioners who are appointed by the Mental Welfare Commission for Scotland. When the patient is incapable of consenting, an order from the Court of Session is required.

Section 234(2)(b) allows for other types of surgical treatments that require the same safeguards to be specified in regulations. The purpose of the regulations that we propose under section 234(2)(b) is to specify that the treatment known as deep-brain stimulation, which is an invasive procedure that involves the destruction of some brain tissue when it is used as a treatment for mental disorder, will be subject to the same authorisation, conditions and safeguards as NMD.

Section 237 provides for safeguards to apply when a patient is given electroconvulsive therapy and for regulations to specify other treatments that should carry the same level of safeguards. The purpose of the regulations that we propose under section 237 is to specify vagus nerve stimulation and trans-cranial magnetic stimulation, as they are treatments that have effects akin to ECT, as appropriate treatments to attract the same safeguards as ECT when they are given as treatments for mental disorder. The safeguards are that the patient must consent or, when the patient is unable to consent, that a second-opinion certificate must be obtained from a designated medical practitioner. As with ECT, the treatments will not be able to be given when the patient has the capacity to consent and refuses treatment.

I hope that the explanation has been helpful for the committee. As the convener said, I am accompanied by officials and we are happy to answer any questions that the committee might have about the regulations.

Thank you. Does any member want to seek clarification from the deputy minister and her officials with regard to either of the instruments?

Are the treatments established? You said that they were new treatments. Have they been used, recommended and approved by specialists in the field?

Vagus nerve stimulation has been used for mental disorder; it has been used on very few patients—only six to date—at the Dundee neurosurgery for mental disorder service.

The two other treatments—deep-brain stimulation and trans-cranial magnetic stimulation—have not as yet been used for mental disorder. Deep-brain stimulation is used for physical disorders in the involuntary muscle movement of Parkinson's disease, but it has not yet been used in Scotland for mental disorders, although it has been used for that elsewhere. Trans-cranial magnetic stimulation has not yet been used as a treatment for mental disorder or physical disorders in Scotland or elsewhere.

The last one concerns me a little. How has trans-cranial magnetic stimulation been tested?

It is currently being tested, but the evidence base is not yet wide enough for it to be used as a treatment for mental disorder.

Are we at liberty to approve part of the instrument without approving it all? Can we postpone a decision?

You are seeking clarification from the deputy minister. When members have exhausted any questions that they wish to ask, I will ask if any member wants to debate either of the instruments. Subsequent to that, the motion will be moved and members can vote in whatever way they want.

Does any other member of the committee seek clarification or have further questions at this stage?

What results have followed in the few cases in which the surgery has been executed? As a doctor, I sometimes wondered what the outcome would be with ECT. I was amazed on many occasions when someone's mental health improved greatly. There was no doubt that that was the case. What results do you have to prove that the treatment is worth while?

We do not yet have the results. That is why we want to put the safeguards in place. We have been told by the Mental Welfare Commission and the NMD team in Dundee, which is where such operations are done, that further clinical research is necessary before those treatments would be used widely on patients. The likelihood is that they will be used more widely as a treatment for mental disorder in the next two to five years, as the evidence base builds up.

Will they be used once all else has failed?

Yes. Deep-brain stimulation is an invasive surgical operation on the brain, which requires the highest level of safeguards that we can possibly give. The draft regulations try to ensure that patients will be fully safeguarded if, as seems likely, the treatments that I described are to be used for patients suffering from mental disorder.

Do patients give their permission for the treatments to be used?

Yes.

Will you clarify a matter? If the draft regulations are not approved, could the treatments go ahead, without the safeguards that the regulations would put in place? By recommending that the draft regulations be approved, the committee would be safeguarding patients in the event that the procedures were to be used, rather than sanctioning the use of those procedures.

Yes, that is right.

I was going to ask the question about safeguards that the convener asked. For clarification, would a person have to consent to the treatments?

Yes.

We took advice from the Mental Welfare Commission for Scotland, which recommended that the treatments be included in the regulations, to safeguard the rights of patients.

That was useful clarification. If no members want to debate the draft instruments, I ask the minister to move the motion on each instrument in turn, because they deal with different matters.

Motions moved,

That the Health Committee recommends that the draft Mental Health (Medical treatment subject to safeguards) (Section 234) (Scotland) Regulations 2005 be approved.

That the Health Committee recommends that the draft Mental Health (Medical treatment subject to safeguards) (Section 237) (Scotland) Regulations 2005 be approved.—[Rhona Brankin.]

Motions agreed to.

I thank the minister and her officials for attending.

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Miscellaneous Food Additives Amendment (Scotland) Regulations 2005 (SSI 2005/214)<br />Smoke Flavourings (Scotland) Regulations 2005 (SSI 2005/215)

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Food Labelling Amendment (Scotland) Regulations 2005 (SSI 2005/222)

The committee is asked to consider three Scottish statutory instruments that are subject to the negative procedure. The Subordinate Legislation Committee commented on all three instruments and its report was circulated to members. No member of the Health Committee has commented on the instruments. Does the committee agree that it does not wish to make any recommendation in relation to the instruments?

Members indicated agreement.