Question reference: S6W-26849
- Asked by: Paul Sweeney, MSP for Glasgow, Scottish Labour
- Date lodged: 15 April 2024
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Current status: Answered by Jenni Minto on 29 April 2024
Question
To ask the Scottish Government, further to the answer to question S6W-26199 by Jenni Minto on 26 March 2024, what criteria a medicine would have to meet in order to be considered for "specialist medicine" designation by the Scottish Government.
Answer
Special medicines or ‘specials’ refer to unlicensed medicinal products that should only be supplied to meet the special clinical needs of an individual patient. An unlicensed medicinal product should not be supplied where an equivalent licensed medicinal product is available. Responsibility for deciding whether an individual patient has “special needs” which a licensed product cannot meet is a matter for the prescribing clinician responsible for their care. Examples of “special needs” include an intolerance or allergy to a particular ingredient, or an inability to ingest solid oral dosage forms. These examples are not exhaustive.
The Scottish Government has no role in designating ‘specials’. Regulation for the licensing, quality safety and efficacy of medicines is currently reserved to the UK Government and is the responsibility of the Medicines and Healthcare products Regulatory Agency (MHRA).