Written Question · S3W-31365 · Session 3
What steps ministers are taking to make the drug, low dose naltrexone (LDN), available to people with multiple sclerosis.
The question
To ask the Scottish Executive what steps ministers are taking to make the drug, low dose naltrexone (LDN), available to people with multiple sclerosis.
The answer
Licensing of medicines is reserved and is the responsibility of the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA has advised that low dose naltrexone (LDN) is not licensed for use in the UK for the treatment of multiple sclerosis.
Before a medicine can receive a marketing authorisation (licence) in the UK, the manufacturer must submit supporting data to the MHRA or the European Medicines Agency (EMEA) demonstrating that the quality, safety and efficacy of the product are satisfactory for its intended use. The decision to seek a marketing authorisation is a commercial decision for the manufacturer.
However, there is provision in both UK and European legislation which allow doctors, on their own direct personal responsibility, to prescribe a medicinal product specially prepared and for administration to a particular patient to meet a special clinical need. It is possible for a pharmaceutical company to produce LDN formulations to supply pharmacists, at the request of a doctor, for use by an individual on a named patient basis. This would be a matter for the individual patient and their doctor to discuss and consider whether the use of LDN is appropriate for their particular clinical need.
Before a medicine can receive a marketing authorisation (licence) in the UK, the manufacturer must submit supporting data to the MHRA or the European Medicines Agency (EMEA) demonstrating that the quality, safety and efficacy of the product are satisfactory for its intended use. The decision to seek a marketing authorisation is a commercial decision for the manufacturer.
However, there is provision in both UK and European legislation which allow doctors, on their own direct personal responsibility, to prescribe a medicinal product specially prepared and for administration to a particular patient to meet a special clinical need. It is possible for a pharmaceutical company to produce LDN formulations to supply pharmacists, at the request of a doctor, for use by an individual on a named patient basis. This would be a matter for the individual patient and their doctor to discuss and consider whether the use of LDN is appropriate for their particular clinical need.
In the Official Report
No contribution in the Official Report cites S3W-31365 by reference.