NHS SCOTLAND
Providing advice about the status of all newly licensed medicines
The SMC is a consortium of NHSScotland’s 14 Health Boards. It was established in 2001 to benefit patients by providing NHSScotland with a single source of advice about the value of each new medicine and the patients for whom it would be of most benefit.
Its advice also helps NHSScotland plan the speedy uniform introduction of beneficial treatments across Scotland. Its members come from across Scotland and include public partners, doctors, practitioners, economists, pharmacists, nurses, directors of finance, health service managers and representatives from the pharmaceutical industry.
Before SMC was established, Local Area Drug and Therapeutic Committees advised Health Boards which products should be approved for use in the local area. The introduction of SMC provided a single point of advice and reduced the duplication of work across Scotland’s 14 Health Boards and the differences in availability of medicines between local areas.
Now a process is in place where:
Our Assessment Process Diagram illustrates our work further.
Listed below are the main sub committees which work with SMC:
New Drugs Committee (NDC)
The New Drugs Committee is the scientific committee of SMC. It consists of around 20 members, mainly from medical and pharmacy backgrounds as well as 2 representatives from the pharmaceutical industry. Members of the pharmacy and health economic assessment team have observer status on the committee and attend the meetings to present the findings of the critical appraisals to NDC for consideration.
Patient and Public Involvement Group (PAPIG)
This group is responsible for ensuring that the patient/carer perspective is considered during the review process
SMC User Group Forum (SMC UGF)
This group is made up of representatives from the pharmaceutical industry as well as members of SMC and NDC. The aim of the group is to identify, address and resolve process issues relating to the work of the SMC.
SMC expects to receive company submissions before the product is made available for use within NHS Scotland and ideally not later than 3 months after the date of marketing authorisation.
SMC will track the licensing and availability of new products in the UK and contact companies proactively once a product receives a positive opinion from the European Medicines Agency’s Committee for Human Medicinal Products (CHMP) or marketing authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA).
The onus to make a submission to SMC is on the applicant company. SMC advice will not be issued until it has received confirmation that a product has received marketing authorisation for the UK. The SMC assessment process is 18 weeks from receipt and scheduling of submission to publication of advice on the SMC website and the SMC secretariat have set product assessment timelines which provide companies with a guide to relevant dates throughout the assessment process.
However, SMC's work programme is governed by the available resources and expertise in our assessment team at any point in time and the deadline for company submissions can only be regarded as a guide therefore and does not guarantee review at the next meeting of the New Drugs Committee.
Our Assessment Process Diagram shows the assessment process and timelines in detail
In order to assist the Patient and Public Involvement Group with their role, patient interest groups are able to make submissions as part of the review process.
SMC makes 1 of 3 decisions about the use of a medicine within NHS Scotland:
Why aren't all new medicines available in Scotland?
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 via a press statement on this website.