Chamber and committees

Questions and answers

Parliamentary questions can be asked by any MSP to the Scottish Government or the Scottish Parliamentary Corporate Body. The questions provide a means for MSPs to get factual and statistical information.

Written questions must be answered within 10 working days (20 working days during recess)
Other questions such as Topical, Portfolio, General and First Minister's Question Times are taken in the Chamber

Urgent Questions aren't included in the Question and Answers search. There is a SPICe fact sheet listing Urgent and emergency questions.

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Question reference: S4O-01383

Asked by: Dr Richard Simpson, MSP for Mid Scotland and Fife, Scottish Labour
Date lodged: Wednesday, 17 October 2012
Current Status: Taken in the Chamber on 24 October 2012

To ask the Scottish Government what the average cost is of educating a medical school student.

Question reference: S4W-09724

Asked by: Dr Richard Simpson, MSP for Mid Scotland and Fife, Scottish Labour
Date lodged: Thursday, 27 September 2012
Current Status: Answered by Alex Neil on 9 October 2012

To ask the Scottish Government what guidance it has issued to assist individual patient treatment request panels in cases where patients fall into the group for whom the medicine is licensed but are also eligible for medicines licensed under the EU definition of orphan medicines.

The Scottish Government guidance published on 13 February 2012 under cover of SGHD/CMO(2012)1 clarified that in establishing a panel to consider an Individual Patient Treatment Request (IPTR) for any medicine, including an orphan medicine, NHS boards are expected to include a practising medical consultant with (or with access to) the specialist knowledge of the relevant clinical area.

This includes the facility for the panel’s practising medical consultant to seek advice from a specialist outwith NHSScotland if the expertise for a rare condition is to be found elsewhere in the UK.

Question reference: S4W-09725

Asked by: Dr Richard Simpson, MSP for Mid Scotland and Fife, Scottish Labour
Date lodged: Thursday, 27 September 2012
Current Status: Answered by Alex Neil on 9 October 2012

To ask the Scottish Government how it encourages pharmaceutical companies with newly licensed medicines that have not submitted an application to the Scottish Medicines Consortium to do so.

The Scottish Medicines Consortium (SMC) proactively seeks submissions from manufacturers of medicines near to the time that licensing is expected in order that they can appraise the medicine quickly following licensing. The Scottish Medicines Consortium (SMC) undertakes its processes independently of the Scottish Government and there is no role for the Scottish Government in this regard.

The SMC Secretariat engages with the company about the reasons for non-submission and will enter into a dialogue about what might be an acceptable submission timeline before the decision to issue “not recommended” advice as a result of non-submission is taken. In addition, the SMC Secretariat will also direct the company to the Association of the British Pharmaceutical Industry (ABPI) members of the SMC for further discussion on submission requirements where the company has identified challenges in making a submission.

Where a pharmaceutical company is unable to make a submission for a product that is within remit in an acceptable timeframe, the SMC will consider the need to issue advice to NHSScotland indicating that the medicine is not recommended for use. If the company indicates that it does not intend to make a submission to the SMC, the SMC will publish advice to confirm that the medicine is "not recommended due to non-submission".

When "not recommended" advice has been published by the SMC due to a non-submission, this does not prevent the pharmaceutical company from making a submission at any point in the future. SMC advice based on a subsequent submission will supersede the initial "not recommended" advice.

Question reference: S4W-09722

Asked by: Dr Richard Simpson, MSP for Mid Scotland and Fife, Scottish Labour
Date lodged: Thursday, 27 September 2012
Current Status: Answered by Alex Neil on 9 October 2012

To ask the Scottish Government how it ensures that the local processes for individual patient treatment requests are monitored and collated nationally.

Scottish Government guidance published under cover of SGHD/CMO(2011)3 provided consensus-based good practice guidance for NHS board management of Individual Patient Treatment Requests (IPTRs).

IPTRs allow clinicians to put forward a clinical case for an individual patient to receive a medicine within its licensed indication which has not been recommended for routine use by the Scottish Medicines Consortium (SMC). Such considerations are taken on a “case-by-case” basis reflecting the individual patient’s clinical circumstances and, as such, should not be generalised.

As part of the Scottish Government’s commitment to monitoring implementation of CEL 17 (2010) regarding the introduction and availability of newly licensed medicines in the NHS in Scotland, information on IPTR activity was collected from NHS boards for the period 1 April 2011 to 31 March 2012. The information provided by NHS boards indicates that 291 IPTR requests were received during the period, of which 194 (66%) were accepted.

IPTR decisions are of an individualised nature, taking account of individual clinical circumstances. Therefore a central collection of data is of limited value and the Scottish Government has no current plans to instigate a regular IPTR data collection centrally. However, NHS boards are expected to maintain accurate and up to date information on IPTR requests and the outcomes, including the outcome of any appeals.

Question reference: S4W-09716

Asked by: Dr Richard Simpson, MSP for Mid Scotland and Fife, Scottish Labour
Date lodged: Thursday, 27 September 2012
Current Status: Answered by Alex Neil on 9 October 2012

To ask the Scottish Government, based on the number of monthly packs of ticagrelor being reimbursed, how many patients it estimates to be receiving ticagrelor and how this compares with the number of eligible patients estimated by the Scottish Medicines Consortium.

Question reference: S4W-09726

Asked by: Dr Richard Simpson, MSP for Mid Scotland and Fife, Scottish Labour
Date lodged: Thursday, 27 September 2012
Current Status: Answered by Alex Neil on 9 October 2012

To ask the Scottish Government what risk assessment it has undertaken of how the reported decreasing uptake of new medicines relative to the other UK countries will affect Scotland's opportunities for future clinical research.

Each year in the UK, approximately 60 newly licensed medicines, new formulations of existing medicines and major new indications for established products receive a marketing authorisation. There is no accurate or reliable published information on the uptake of these products across the four UK countries. Therefore there is no evidence to suggest that Scotland’s current arrangements for the introduction and availability of newly licensed medicines will impact on its opportunities for future clinical research.

Question reference: S4W-09721

Asked by: Dr Richard Simpson, MSP for Mid Scotland and Fife, Scottish Labour
Date lodged: Thursday, 27 September 2012
Current Status: Answered by Alex Neil on 9 October 2012

To ask the Scottish Government what (a) guidance or (b) consensus there is to help area drug and therapeutics committees ensure that there is equity, fairness and transparency in reaching decisions on equivalence when deciding whether to add Scottish Medicines Consortium-approved medicines to a local formulary.

NHS Board Area Drug and Therapeutic Committees (ADTCs) are the key clinical group who advise on, and ensure there are, safe systems for medicines use and the provision of formularies to support the cost-effective use of new medicines. When the SMC issues advice to accept a new medicine, the ADTC considers it within the context of existing medicines available to treat the condition in question.

It is for the local clinical community to determine which medicines should be available for routine use in the NHS board. Therefore, NHS boards make decisions about which medicines are on their formulary to reflect local clinical opinion regarding patient care.

The Scottish Government guidance published on 13 February 2012 under cover of SGHD/CMO(2012)1 clarified that NHS boards are expected to reach a decision on an SMC “accepted” medicine within 90 days of the issue of SMC advice to the NHS board (which is confidential for the first 30 days) and to publish on their website, the formulary decision within 14 days of the decision being reached.

Question reference: S4W-09718

Asked by: Dr Richard Simpson, MSP for Mid Scotland and Fife, Scottish Labour
Date lodged: Thursday, 27 September 2012
Current Status: Answered by Alex Neil on 9 October 2012

To ask the Scottish Government how many (a) cardiovascular events and (b) myocardial infarctions could have been prevented if NHS board area drug and therapeutics committees had made ticagrelor available within the timescale recommended by the Scottish Medicines Consortium at the time of publication of its advice on the matter.

The guidance published under cover of CEL 17 (2010) clarified that NHS boards were expected to have established local processes for non-formulary requests. This provides the facility for clinicians to access medicines which have been accepted for use by the Scottish Medicines Consortium (SMC) but have not been included on the local formulary through a non-formulary request. As ticagrelor was accepted for use by the SMC in May 2011, there is the facility for clinicians in Scotland to access this medicine via these arrangements.

The timescale for making and publishing formulary decisions was introduced from 1 April 2012 following publication of Scottish Government guidance SGHD/CMO(2012)1.

Question reference: S4W-09715

Asked by: Dr Richard Simpson, MSP for Mid Scotland and Fife, Scottish Labour
Date lodged: Thursday, 27 September 2012
Current Status: Answered by Alex Neil on 9 October 2012

To ask the Scottish Government what advance notice the Scottish Medicines Consortium gave to NHS boards on the possible introduction of ticagrelor and related budgetary implications and whether boards are expected to take account of this advice in resource allocation and budget planning once the product has been licensed.

NHS boards maintain a watching brief on medicines due to be appraised by the SMC but they are not expected to take any action with regard to making preparations for protocol for the medicine until an SMC decision has been made.

The SMC advised NHS boards on 8 April 2011 that ticagrelor had been accepted for use within NHSScotland and it is at that point that NHS boards are expected to consider that medicine within the context of other available medicines to treat the condition in question. The SMC advice to NHS boards remains confidential until it is formally published, which for ticagrelor, was on 9 May 2011.

Question reference: S4W-09723

Asked by: Dr Richard Simpson, MSP for Mid Scotland and Fife, Scottish Labour
Date lodged: Thursday, 27 September 2012
Current Status: Answered by Alex Neil on 9 October 2012

To ask the Scottish Government what steps it has taken or will take to ensure that individual patient treatment requests panels always seek guidance from an expert in the disease in question for (a) rare conditions and (b) conditions other than rare conditions.