Access to treatment
Medicines go through a review process after they have been through clinical trials. This ensures they're safe and effective, and that the benefits outweigh possible side effects. The licence will confirm what condition a medicine should be used for and what dose is best.
In the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA) are responsible for licensing medicines.
The MHRA reviews all new drugs in the UK. They look at:
the safety and quality standards of medicines, medical equipment and blood products
the safety of the supply chain for medicines, medical equipment and blood products
promoting international standards to ensure biological medicines are effective and safe
educating the public and healthcare professionals about the risks and benefits of medicines, medical equipment and blood products
supporting research and development that benefit public health
influencing UK and international regulations so that they protect public health
At the end of their review, the MHRA will decide whether to authorise the drug. Once a drug has authorisation, it is 'licensed' or 'approved'. All these terms mean the same thing.
Go to more information about the MHRA on the GOV.UK website
The MHRA works with other medicines regulators in certain countries around the world.
If a medicine has been approved by another regulator, the MHRA can consider their review and how they made their decision. This makes the MHRA process faster. They may then approve a drug, or they can reject an application if they don’t think there is enough evidence.
It can take many years for new medicines to go through the research, clinical trials and licensing process. Sometimes, doctors can access new drugs that haven’t been licensed yet through the Early Access to Medicines Scheme (EAMS).
The EAMS aims to give people with life threatening or severely debilitating conditions access to medicines. Doctors can use the scheme when no other treatment is available for these conditions.
After getting a licence, other organisations also need to approve the drugs. Only then can doctors prescribe them.
These organisations decide which drugs work well and are cost effective to use. They are:
The National Institute for Health and Care Excellence (NICE) in England
The Scottish Medicines Consortium (SMC) in Scotland
The All Wales Medicine Strategy Group (AWMSG) in Wales
After licensing, the MHRA continues to collect information. This information is about how well the drug works and about the side effects. So they continue to check the safety and effectiveness of the drug.
A drug is usually licensed to treat a specific:
type of illness or cancer
age group
dose
Sometimes a doctor might want to use a drug in a way that is not included in the drug's licence. This happens when they think it might help a patient for a specific reason.
In this case, they can prescribe that drug for the patient. But the doctor has to take full responsibility for the outcome. This is called 'off label prescribing'.
Last reviewed: 03 Jan 2024
Next review due: 04 Jan 2027
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Once a medicine has a licence, organisations will decide if it should be available as part of free healthcare.
Sometimes there are treatments which aren’t available on the NHS. There are other ways you might be able to access a treatment that isn’t available on the NHS.
Treatments can include surgery, radiotherapy and drug treatments (such as chemotherapy, hormone therapy or targeted cancer drugs). Find out about treatments and how to cope with side effects.
There are several decisions to be made about a cancer treatment before you can have it on the NHS or HSC.
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What to ask your doctor about clinical trials.
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