Licensed vs. Unlicensed Treatments- Do you understand the difference?

In some of our recent blog posts, we have made reference to a medicine being either licensed or unlicensed. We understand that for many people the word ‘unlicensed’ may carry negative connotations, so here is an explanation of how, in a qualified medical context, this should not be the case.

Before a medicine can be widely used in the UK, it must first be granted a licence by the MHRA or Medicines and Healthcare Products Regulatory Agency, or by the European Medicines Agency (EMA). 

While no medicine is completely risk free, the granting of a licence indicates that all the proper checks have been carried out, and that the benefits of a medicine are believed to outweigh the risks. 

The licence for a medicine includes information such as: 

  • what health condition it should be used to treat
  • what dose should be used
  • what form it takes – e.g. tablet or liquid
  • who can use the medicine – e.g. only people above a certain age
  • how long treatment with that medicine should last
  • warnings about known safety issues – e.g. side effects, interactions with other medicines
  • how the medicine should be stored
  • when the medicine expires

You should be able to find this information in a leaflet contained with the medicine.

Unlicensed medicines 
Sometimes a healthcare professional may recommend an unlicensed medication, also known as an “off-label use” for a medicine.

Off-label use means that the manufacturer of the medicine has not applied for a licence for it to be used to treat your condition. In other words, the medicine has not undergone clinical trials to see if it is effective and safe in treating your condition.

However, the medicine will have a licence to treat another condition and will have undergone clinical trials for this.

Many doctors will use an unlicensed medication if they think the medication is likely to be effective and the benefits of treatment outweigh any associated risk.

If your doctor is considering prescribing an unlicensed medication, they should inform you it is unlicensed, and discuss possible risks and benefits with you. 

In summary then, being prescribed an ‘unlicensed’ medication is not a bad thing, provided that the professional prescribing it is suitably qualified to do so. Nevertheless, you should never hesitate to ask for further explanation from your doctor if you have any doubts or concerns. 

Wishing you well,

Winchester GP

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