The Scottish Medicines Consortium (SMC) is part of Healthcare Improvement Scotland
(HIS). Our role is to provide advice to the NHS in Scotland about the clinical and cost-effectiveness of new medicines. This includes:
• How well the medicine works.
• Which patients would benefit from receiving the medicine.
• How safe it is to use compared to currently used treatments.
• How taking the medicine affects the quality of a patient’s life.
• How much the medicine costs compared to the other treatment options.
We review new medicines as well as new formulations of and new ways to use established medicines. Most new medicines have to be approved by the SMC before prescribers are able to use them routinely in the NHS in Scotland.
Each assessment is carried out by our team of pharmacists, health service researchers and health economists, who evaluate the evidence provided by the pharmaceutical company that produces the medicine. This evaluation is then carefully looked at by our New Drugs Committee (NDC), which considers all of the clinical and economic evidence that has been summarised in a draft ‘Detailed Advice Document (DAD)’. The NDC then makes a recommendation on the medicine to SMC. This recommendation, the DAD and the supporting evidence is then carefully considered and discussed further at the SMC meeting.
We also gather information from patient groups and voluntary organisations about how people are affected by the condition and the impact of the new medicine on patients and their carers. This information is also presented and discussed at the SMC meeting.
The final DAD includes a summary of the key points from patient group submissions, and is published on the SMC website.
SMC has around 40 members made up mostly of NHS clinicians and managers. Every health board area in Scotland is represented on either NDC or SMC through doctors, pharmacists and senior managers. There are also three public partner members as well as representatives from the Association of the British Pharmaceutical Industry (ABPI). This wide mixture of backgrounds helps to make sure that decisions are made from a broad perspective. SMC considers all the evidence and decides whether or not to accept the medicine for use in NHS Scotland and any conditions for use.
The process usually takes around 20 weeks to complete.
SMC makes one of three decisions about the use of a medicine within NHS Scotland:
- Accepted for use
- Accepted for restricted use e.g. restricted by patient group or restricted by prescriber
- Not recommended for use
Once the decision is made it is communicated to local NHS Boards and the pharmaceutical company who submitted the product for assessment. Four weeks later the decision is made public on our website.
You can find out more about our work in our guide.