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Macmillan and Cancerbackup merged in 2008. Together we provide free, high quality information for people affected by cancer through our publications, website and phone service. Find out more|.
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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 (EMEA|). The organisation that regulates medicines in the UK is The Medicines and Healthcare products Regulatory Agency (MHRA|). A large part of its work is to support the EMEA. 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. So, a drug that is licensed to treat breast cancer, for example, 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.
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 PCT will assess how useful it is. They may then allow it to be prescribed on an individual basis.
Non-drug treatments - for example, new ways of giving radiotherapy| - become available when there’s good evidence from studies that they work well.
NICE |stands for the National Institute for Health and Clinical Excellence. It's an organisation that currently gives advice on which new drugs and treatments should be available on the NHS and how particular illnesses,such as cancer, should be treated.
NICE advises the NHS in England and Wales, but in Scotland and Northern Ireland, there are different bodies involved. 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 makes its decision after looking at NICE guidance.
NICE was set up to help make sure that people have equal access to treatments and drugs wherever they live in the UK. In the past, access to treatments could vary because different areas of the country had different prescribing or funding policies. This is called postcode prescribing.
NICE looks at how a new drug or treatment compares to the treatment we already have and whether it's good value for money. When NICE has reviewed all the information, it makes a decision about the new drug or treatment and then issues guidance.
NICE doesn't decide about all drugs or treatments used in the NHS. If NICE hasn't issued guidance, PCTs can use other information to decide whether to provide a drug or treatment.
A lack of NICE 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 PCT needs to agree to this. However, once NICE has issued guidance this replaces local decisions.
NICE guidance for a drug should get rid of any postcode prescribing. Each PCT must make arrangements to fund the drug within three months. However, NICE guidance for a non-drug treatment is not enforced in the same way, so differences in regions can still happen.
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