- Asked by: Alex Neil, MSP for Central Scotland, Scottish National Party
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Date lodged: Wednesday, 30 November 2005
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Current Status:
Answered by Andy Kerr on 12 December 2005
To ask the Scottish Executive, further to the answer to question S2W-20285 by Mr Andy Kerr on 10 November 2005, why the Scottish Medicines Consortium does not recommend that Memantine (Exiba ®) is used to treat moderately severe to severe Alzheimer’s Disease and whether this indicates that the drug is used to treat milder cases of Alzheimer’s Disease.
Answer
The Scottish Medicines Consortium (SMC) reviewed memantine (Ebixa) in July 2003 and did not recommend it for use within NHS Scotland. Its advice was that, although this is currently the only agent licensed for use in moderately severe to severe Alzheimer's disease, the magnitude of the effect is extremely small. Compared with placebo it is associated with a statistically significant reduction in the rate of deterioration in global, functional and cognitive scales. On the evidence presented, the associated gains appear to be marginal relative to the overall costs.
The company subsequently made a resubmission to SMC for assessment and in December 2003 SMC did not recommend it for use. The economic case submitted by the manufacturer did not suggest that use of this drug would be cost effective relative to standard practice in Scotland.
The licensed indication submitted for review was for the treatment of patients with moderately severe to severe Alzheimer's disease and SMC therefore commented on this indication only.
- Asked by: Alex Neil, MSP for Central Scotland, Scottish National Party
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Date lodged: Wednesday, 30 November 2005
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Current Status:
Answered by Andy Kerr on 12 December 2005
To ask the Scottish Executive, further to the answer to question S2W-20285 by Mr Andy Kerr on 10 November 2005, why NHS Quality Improvement Scotland is awaiting the final recommendation of the National Institute for Clinical Excellence in relation to its consultation document, Alzheimer’s disease – donepezil, rivastigmine, galantamine and memantine, when NHS Quality Improvement Scotland is responsible for making recommendations in respect of the use of these drugs within the NHS in Scotland.
Answer
NHS Quality Improvement Scotland (NHS QIS) has published comments on all NICE appraisals since May 2001. It does not re-assess the evidence used by NICE to avoid duplication of effort and to ensure public resources are used effectively and efficiently. NHS QIS considers possible differences in the application of appraisals for Scotland based on four criteria:
Principles and values of NHSScotland
Epidemiology (frequency, distribution and stage at presentation)
Structure and provision of services in Scotland
Other implications for NHSScotland, including rural issues, predicted uptake or existing advice from the Scottish Medicines Consortium.
NHS QIS involves a small number of experts in this process, and this has allowed it to make decisions about the validity of NICE appraisals for Scotland prior to the publication of the appraisal by NICE. Consequently it issues its comments to NHS board chief executives on the same day as NICE publishes its appraisal (usually on the fourth Wednesday of each month).
- Asked by: Alex Neil, MSP for Central Scotland, Scottish National Party
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Date lodged: Wednesday, 30 November 2005
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Current Status:
Answered by Andy Kerr on 12 December 2005
To ask the Scottish Executive whether it considers that living near a motorway adversely effects the pulmonary function of children living nearby.
Answer
The Scottish Executive recognises traffic as a pollution source and that in certain circumstances, a number of traffic derived air pollutants have the potential to adversely affect human respiratory health. It is also accepted that children constitute a vulnerable group in relation to many environmental exposures.
All local authorities are required by the Environment Act 1995 to regularly review and assess air quality in their areas against objectives for a range of pollutants in the Air Quality Strategy. If this work indicates that any objective is unlikely to be achieved by the required date, the authority concerned must declare an Air Quality Management Area and produce an action plan outlining how it intends to tackle the issues identified.
- Asked by: Alex Neil, MSP for Central Scotland, Scottish National Party
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Date lodged: Wednesday, 30 November 2005
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Current Status:
Answered by Andy Kerr on 12 December 2005
To ask the Scottish Executive, further to the answer to question S2W-20285 by Mr Andy Kerr on 10 November 2005, whether the Medicines and Healthcare products Regulatory Agency is a UK-wide body whose decisions are binding on the Executive and the NHS in Scotland.
Answer
The regulation and safety of medicines is a reserved matter. The Medicines and Healthcare products Regulatory Agency is the government agency which is responsible for ensuring that medicines and medical devices marketed in the UK are acceptably safe.
Information about the agency and its work can be found at www.mhra.gov.uk.
- Asked by: Alex Neil, MSP for Central Scotland, Scottish National Party
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Date lodged: Wednesday, 30 November 2005
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Current Status:
Answered by Andy Kerr on 12 December 2005
To ask the Scottish Executive whether the National Institute for Clinical Excellence advises the NHS in Scotland.
Answer
The conclusions of National Institute for Health and Clinical Excellence (NICE) Multiple Technology Appraisals (MTA) (previously called Technology Appraisal Guidance) are considered by NHS Quality Improvement Scotland (NHS QIS). NHS QIS make recommendations on their validity for Scotland.
NICE are consulting on a new process called Single Technology Appraisal. The Scottish Executive Health Department (SEHD), NHS Quality Improvement Scotland (NHS QIS) and the Scottish Medicines Consortium (SMC) are currently considering the implications of this new process for Scotland.
- Asked by: Alex Neil, MSP for Central Scotland, Scottish National Party
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Date lodged: Wednesday, 30 November 2005
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Current Status:
Answered by Andy Kerr on 12 December 2005
To ask the Scottish Executive, further to the answer to question S2W-20285 by Mr Andy Kerr on 10 November 2005 and if it is the responsibility of the Scottish Medicines Corsortium to advise the NHS on the suitability of medicines, why it is the responsibility of NHS Quality Improvement Scotland to advise NHS Scotland on the implications of the guidance from the National Institute for Clinical Excellence resulting from its consultation document, Alzheimer’s disease – donepezil, rivastigmine, galantamine and memantine.
Answer
The Scottish Medicines Consortium (SMC) advises NHSScotland on the clinical and cost effectiveness of all new medicines, formulations and indications at, or as soon as possible after, the time of launch of a medicine. National Institute for Health and Clinical Excellence (NICE) appraisals (multiple technology appraisals) are conducted over a longer period of time, have access to more evidence beyond that which was available at the time of launch of a medicine, and are able to undertake more detailed appraisal of a medicine. Consequently the SMC process and the NICE multiple technology appraisal process should be seen as complementary processes rather than as alternatives.
NHS Quality Improvement Scotland (NHS QIS) provides the secretariat and other inputs, such as health economics, to the Scottish Medicines Consortium (SMC). SMC, however, is an autonomous body constituted by the Area Drug and Therapeutics Committees (ADTCs) of NHS boards in Scotland.
- Asked by: Alex Neil, MSP for Central Scotland, Scottish National Party
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Date lodged: Wednesday, 30 November 2005
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Current Status:
Answered by Andy Kerr on 12 December 2005
To ask the Scottish Executive, further to the answer to question S2W-20285 by Mr Andy Kerr on 10 November 2005, what the relationship is between the Scottish Medicines Consortium and NHS Quality Improvement Scotland.
Answer
I refer the member to the answer given to S2W-21270, answered on 12 December 2005. All answers to written parliamentary questions are available on the Parliament's website, the search facility for which can be found at:
http://www.scottish.parliament.uk/webapp/wa.search.
- Asked by: Alex Neil, MSP for Central Scotland, Scottish National Party
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Date lodged: Wednesday, 30 November 2005
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Current Status:
Answered by Andy Kerr on 12 December 2005
To ask the Scottish Executive, further to the answer to question S2W-20285 by Mr Andy Kerr on 10 November 2005, whether the decisions of the Medicines and Healthcare products Regulatory Agency or the European Medicines Agency are binding on the Executive and the NHS in Scotland.
Answer
Before a medicine can be placed on the UK market it must have a marketing authorisation either from the Medicines and Healthcare products Regulatory Agency or the European Medicines Agency. Decisions on the marketing authorisations of medicines made by the MHRA or the EMEA are binding on the Executive and the NHS in Scotland.
Information about the MHRA and its work can be found at www.mhra.gov.uk.
- Asked by: Alex Neil, MSP for Central Scotland, Scottish National Party
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Date lodged: Friday, 18 November 2005
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Current Status:
Answered by Cathy Jamieson on 9 December 2005
To ask the Scottish Executive, further to the answers to questions S2W-15435 and S2W-17042 by Cathy Jamieson on 14 April and 17 June 2005, whether it is the Scottish Prison Service Controller based in HM Prison Kilmarnock or Premier Prison Services Ltd which has ultimate responsibility for reporting breaches of contract by the company for its operations at the prison.
Answer
I have asked Tony Cameron, Chief Executive of the Scottish Prison Service (SPS) to respond. His response is as follows:
The contract places the onuson the contractor, requiring them to inform SPS of any failures to meet contractualcommitments.
In addition the SPS Controllerteam based at HM Prison Kilmarnock is responsible for monitoring the performance of thecontractor.
The responsibility for reportingsuch incidents is detailed in the contract which can be viewed at
www.sps.gov.uk.
- Asked by: Alex Neil, MSP for Central Scotland, Scottish National Party
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Date lodged: Wednesday, 30 November 2005
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Current Status:
Answered by Cathy Jamieson on 9 December 2005
To ask the Scottish Executive, further to the answer to question S2W-20864 by Cathy Jamieson on 29 November 2005, why no disciplinary action or penalty was imposed on HM Prison Kilmarnock.
Answer
I have asked Tony Cameron, Chief Executive of the Scottish Prison Service (SPS) to respond. His response is as follows:
Liquidated damages are the remedyspecified in the contract for the late opening of the prison. The contract can beviewed on the SPS website at www.sps.gov.uk.
