In the UK, medicines need to have a licence before they can be widely used.
Licensing of medicines
To get a licence, the manufacturer of the medicine has to provide evidence that shows that the medicine works well enough and is safe enough to be used for a specific condition and for a specific group of patients, and that they can manufacture the medicine to the required quality.
At NICE we do not license medicines - you can find out more about the licensing of medicines at NHS Choices.
Unlicensed medicines and 'off-label' use
Medicines can be prescribed if they don't have a licence (unlicensed) or for 'off-label' use. Off-label means that the person prescribing the medicine wants to use it in a different way than that stated in its licence. This could mean using the medicine for a different condition or a different group of patients, or it could mean a change in the dose or that the medicine is taken in a different way.
If a healthcare professional wants to prescribe an unlicensed medicine, or a licensed medicine off-label, they must follow their professional guide, for example for doctors the General Medical Council's good practice guidelines. These include giving information about the treatment and discussing the possible benefits and harms so that the person has enough information to decide whether or not to have the treatment. This is called giving informed consent.
Accessing drugs and medicines recommended by a technology appraisal
Technology appraisals are a special type of guidance about drugs (and occasionally other types of treatment). If NICE recommends the use of a treatment, the NHS Constitution says that it is your legal right to have it if it is right for your particular circumstances.
The first thing to do is to discuss with your healthcare professional whether the treatment is right for you. If they think it is but you are still unable to obtain it, you should speak to the Patient Advice and Liaison Service (PALS) in your local NHS trust if you are being treated by hospital services. Speak to PALS in your local clinical commissioning group (also known as a CCG) if you are being treated by community services. If you are being treated in primary care, for example in a GP or dental surgery, you will need to ask NHS England for advice.
Once you have done this, you should discuss with your healthcare professional how to make a complaint about the organisation not providing you with the treatment (see making a complaint).
Can I still get access to a medicine privately if NICE has not recommended it for use in the NHS?
Yes, our remit is only to decide whether medicines can be made available on the NHS. If we do not recommend a medicine for use on the NHS a private company can still choose whether to provide a medicine or not.
Questions that might be useful to ask about medicines
- Why am I being offered this medicine?
- Why am I being offered a medicine that is unlicensed or is being used off‑label?
- What does the treatment involve?
- What are the benefits I might get?
- How good are my chances of getting those benefits?
- Could having the treatment make me feel worse?
- Are there other treatments I could try?
- What are the risks of the treatment?
- Are the risks minor or serious? How likely are they to happen?
- What could happen if I don't have the treatment?
NICE evidence summaries
Our evidence summaries provide an overview of the best evidence that is available about specific medicines. They also give general information about:
- the condition that the medicine might be prescribed for
- how the medicine is used
- how it works
- what the aim of treatment is.
Evidence summaries explain whether a medicine has a licence and, if it does, what the licence covers.
Evidence summaries aim to help healthcare professionals and patients decide whether medicines are safe to use and if they are likely to work well, especially when there isn't another suitable medicine that has a licence for the condition. They don't contain recommendations from NICE on whether the medicine should be used.