SCOTTISH MEDICINES CONSORTIUM
NHS SCOTLAND
Providing advice about the status of all newly licensed medicines
FAQs
- 1. Can a doctor disregard SMC advice?
- 2. Can patients and carers provide information that might influence SMC's recommendations?
- 3. Can the NHSScotland use a medicine before SMC has given its advice?
- 4. Is guidance from the National Institute for Health and Clinical Excellence (NICE) applicable in Scotland?
- 5. Does the SMC license medicines in Scotland?
- 6. Has the role of SMC changed in any way?
- 7. How can patient representative organisations submit information?
- 8. How do I find out more about the SMC?
- 9. How do I know that the SMC’s advice is up to date?
- 10. How does the SMC assess medicines?
- 11. If I know that the SMC have advised the use of a particular medicine and it is not available to me, what do I do?
- 12. Must NHS Boards in Scotland comply with SMC advice?
- 13. What does the Scottish Medicines Consortium (SMC) do?
- 14. What evidence does SMC consider?
- 15. Who are the members of SMC?
- 16. Will there still be differences between what is prescribed in one area compared to another?
- 17. Is SMC Advice Published?
1. Can a doctor disregard SMC advice?
Individual clinicians should take account of SMC’s advice when exercising their clinical judgement, unless there is evidence to justify not doing so in the light of particular circumstances of an individual patient.
2. Can patients and carers provide information that might influence SMC's recommendations?
In order to ensure that the SMC’s recommendations are patient-centred, it is important to hear the experience of those who suffer from those health problems to which a medicine is directed. However because of the timescales involved, contributions from individual patients and carers cannot be made direct to the SMC. Patient representative organisations e.g. National Asthma Campaign, Diabetes UK, High Blood Pressure Foundation, etc. have the opportunity to present their evidence to the SMC. Interested individual patients/carers are encouraged to contact the relevant representative group/organisation so that their contributions can be added to the weight of evidence the organisation may wish to submit.
A list of patient representative organisations together with contact details can be obtained from the SMC Secretariat – Delta House, 50 West Nile Street, Glasgow. Tel: 0141 225 6989.
3. Can the NHSScotland use a medicine before SMC has given its advice?
Any new medicine can legally be prescribed once it has a licence if it is thought to be the most suitable treatment for an individual patient.
However NHSScotland would be expected to await the advice from the SMC before making a new medicine routinely available. The SMC therefore, aims to issue its advice at the time a new medicine becomes available.
4. Is Guidance from the National Institute for Health and Clinical Excellence (NICE) applicable in Scotland?
NICE Multiple Technology Appraisal (MTA): NHS Quality Improvement Scotland (NHS QIS) reviews MTAs and decides whether the recommendations should apply in Scotland Where NHS QIS decides that an MTA should apply in
NICE Single Technology Appraisal (STA): SMC is the source of advice for
HDL (2007) 26
5. Does the SMC license medicines in Scotland?
No. SMC advises NHSScotland on the costs and benefits of new medicines after they have been licensed by the Medicines and Healthcare products Regulatory Agency/European Medicines Evaluation Agency.
6. Has the role of SMC changed in any way?
An Executive letter was issued in November 2003 NHS HDL (2003)60. This letter explains the arrangements being put in place to strengthen the role of the SMC in addition to outlining new processes to ensure the national implementation of innovative new drugs. The HDL can be accessed via
http://www.show.scot.nhs.uk/sehd/mels/hdl2003_60.pdf.
7. How can patient representative organisations submit information?
Guidance on submission of evidence can be accessed online. Copies can also be obtained from the SMC Secretariat – Delta House, 50 West Nile Street, Glasgow. Tel: 0141 225 6989
8. How do I find out more about the SMC?
The SMC is committed to informing the public about its activities. Advice is written so that it can be easily understood and necessary medical terms are explained. The SMC includes representatives of patients and the voluntary sector whose role is to ensure that patient’s interests are fully taken account of in the SMC’s work. All minutes of SMC meetings and advice provided to NHS Scotland are published and are freely available online or by contacting the SMC Secretariat by telephone on 0141 225 6989.
9. How do I know that the SMC’s advice is up to date
The SMC has processes to ensure that as new evidence becomes available its advice can be reviewed.
10. How does the SMC assess medicines?
Following licensing by the Medicines and Healthcare products Regulatory Agency/European Medicines Evaluation Agency, the SMC then considers all new medicines at their time of marketing and issues its advice as soon as possible.
To do this, the SMC has formed a working group of health professionals, called the New Drugs Committee (NDC). The NDC uses the available information to carry out a rapid assessment of the evidence. The SMC then considers the NDC’s recommendations about the costs and benefits of using the medicine in Scotland before issuing its final advice.
11. If I know that the SMC have advised the use of a particular medicine and it is not available to me, what do I do?
The SMC advise that you should address your concerns directly to the clinician responsible for your care. Should you remain dissatisfied with their explanation you may wish to raise the matter with your local NHS Board.
12. Must NHS Boards in Scotland comply with SMC advice?
The Minister for Health and Community Care has publicly stated that "NHSScotland should take account of the advice and evidence from the SMC and ensure that recommended medicines are made available to meet clinical need".
13. What does the Scottish Medicines Consortium (SMC) do?
SMC is part of NHSScotland. It is a central point of advice to NHS Boards and their Area Drug and Therapeutics Committees (ADTCs) about the effectiveness of all newly licensed medicines, all new formulations of existing medicines and any new indications of established medicines. It will benefit patients by providing NHSScotland with advice about the value of each new medicine and the patients for whom it would be of most benefit. SMC advice will help the NHS plan the speedy introduction of beneficial treatments across Scotland and over time will help reduce postcode prescribing.
When a new medicine is produced, SMC assesses it to find out:
- How effective it may be
- Which patients would benefit from it
- Whether it is more effective than treatments being used at present
- What it costs
- Whether it is worth investing NHS money to prescribe it.
14. What evidence does SMC consider?
SMC considers evidence from a variety of sources. One source will be pharmaceutical companies who will supply evidence from their trials of the new medicine. SMC also considers research results from countries where the medicine is already in use.
15. Who are the members of SMC?
The membership of SMC is made up of a wide variety of healthcare professionals from NHS Boards across Scotland who have expertise in assessing medicines. Other members include representatives of patients, health service management and the Association of British Pharmaceutical Industry.
16. Will there still be differences between what is prescribed in one area compared to another?
In attempting to ensure that recommended medicines are made available to meet clinical need, SMC will help to reduce differences in Scottish prescribing by providing the same advice to all NHS Boards. NHS Boards must take account of the different health needs of the people they serve when making decisions about the services that they provide.
17. Is SMC Advice published?
Once the SMC has given its final advice, it is placed on the SMC website, www.scottishmedicines.org.uk
SMC Secretariat Tel: 0141 225 6989.