All medicines in the UK are subject to a system of licensing laid down by European and UK law.
Before a drug is licensed, it will have been through years of research and development. After this, the developer will apply for a licence for the drug. This is when the safety of the drug is looked at, as well as how it compares to drugs currently in use.
Most new cancer drugs must be licensed by the European Medicines Evaluation Agency. The organisation that regulates medicines in the UK is the Medicines and Healthcare Products Regulatory Agency. Until a new drug is licensed, it can't be widely prescribed within the NHS.
When a drug is licensed, it's usually for a specific use. For example, a drug that is licensed to treat breast cancer should not be prescribed to treat any other type of cancer. If new trials show that the drug is also helpful in treating another type of cancer, the makers will have to apply for an additional licence.
Non-drug treatments - for example, new ways of giving radiotherapy - become available when there’s good evidence from studies that they work well.
Organisations that give advice to the NHS
The National Institute for Health and Clinical Excellence (NICE) is an independent organisation. It gives advice on which new and existing drugs and treatments should be available on the NHS, and on how particular illnesses like cancer should be treated. NICE advises the NHS in England and Wales. In Wales, the All Wales Medicines Strategy Group advises on the use of treatments that haven’t yet been evaluated by NICE.
In Scotland, guidance about treatment is developed by the Scottish Intercollegiate Guidelines Network. The Scottish Medicines Consortium (SMC) advises Scottish NHS Boards on the use of new drugs. Sometimes, the NHS in Scotland will choose to adopt NICE guidance on certain treatments.
In Northern Ireland, the Department of Health, Social Services and Public Safety reviews guidance produced by NICE. If it decides the guidance can be applied to Northern Ireland, it will endorse it for use by health and social care trusts.
NICE and the SMC look at how a new drug or treatment compares to the treatment already available and whether it's good value for money. When all the information has been reviewed, a decision is made about the new drug or treatment and guidance is then issued.
NICE and the SMC don't make decisions about all drugs or treatments used in the NHS. If they haven’t issued guidance, local health bodies can use other information to decide whether to provide a drug or treatment.
A lack of NICE or SMC guidance is not a reason for not providing a treatment. Your doctor can prescribe a drug for you before NICE guidance is available, but your local health body needs to agree to this. However, if NICE approves a medicine, this replaces any previous local decisions. If NICE does not approve a particular drug, it may still be accessible through exceptional funding or the Cancer Drugs Fund.
Local health bodies must make arrangements to fund the drug within three months. However, guidance for a non-drug treatment is not enforced in the same way, so differences in regions can happen.
Despite these procedures and any guidance, it's still up to the doctor to decide whether to use a treatment or prescribe a drug. Doctors may wish to treat a patient with an unlicensed drug. In this situation, the local health body will assess how useful it is. They may then allow it to be prescribed on an individual basis.