A new drug goes through a long process of testing in a laboratory and then in clinical trials to understand if it is safe and effective. Then the drug must go through a review process to ensure that the benefits of taking the new drug outweigh any potential side-effects. A licence for a drug will outline what health condition it can be used for and the dose which is most appropriate.
The Medicines and Healthcare Products Regulatory Agency (MHRA) is responsible for this process.
What does the MHRA look at?
When deciding if a new drug can be used and granted a licence, the review process will look at:
- the clinical research to check that the drug is effective and safe
- the manufacturing process to ensure quality standards are met
- the safety of the supply chain
- promoting international standards to ensure biological medicines are effective and safe
- educating the public and healthcare professionals about the risks and benefits of the new drug
- supporting research for the benefit of public health
- collaborating with UK and international partners to ensure the earliest access to safe drugs so that they can protect public health
After the MHRA has completed their review process, they will decide if a drug can be authorised. If it is authorised, it is then considered to be 'licenced' or 'approved'.
From the 1st of January 2021, the MHRA has carried out the licensing review process for new drugs in England, Scotland and Wales. In Northern Ireland, new drugs are licensed by the European Commission. This occurs following the recommendations from the European Medicines Agency (EMA).
For more information about the MHRA and the licencing process, please visit the GOV.UK website.
For more information about the EMA and the licencing process, please visit the EMA website.
What happens after the licensing process?
After a new medicine has been licensed and approved for use within a specific health condition, it then needs to go through further review process by the NHS; an appraisal which looks at the cost-effectiveness of the drug and decides whether this is a treatment that can be provided by their services. This process decides if a drug is cost effective as a treatment. Sometimes a drug is approved by the MHRA, but is considered too expensive to actually prescribe to patients.
The NHS is legally obligated to fund the drugs that are recommended to be a cost-effective treatment option.
The appraisal process is completed by the following bodies:
- England - National Institute for Health & Care Excellence (NICE)
- Wales - NICE / All Wales Medicines Strategy Group (AWMSG)
- Scotland - Scottish Medicines Consortium (SMC)
- Northern Ireland - Department of Health (DoH)
Only after this process has taken place will the treatment be able to be prescribed.
How long does this process take?
For a new drug to go through the various stages of research, clinical trials and the licensing process, it can take many years.
When nintedanib was discovered as a new drug for IPF, clinical trial results were published in 2014 and NICE approved the treatment in 2016.
There are occasions where patients can gain access to new drugs that are not yet licenced through the Early Access to Medicines Scheme (EAMS). The scheme applies to England, Scotland, Northern Ireland and Wales.
The EAMS was established in 2014 to ensure that people with a life limiting, or severely debilitating condition have early/priority access to drugs. This scheme can be used when there are no other treatment options available. To find out more about this, please visit the GOV.UK website.
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What is off-label prescribing?
Drugs are licenced with set doses to treat specific conditions and groups of people. There are occasions when a doctor may feel that a patient would benefit from a drug where it has not been approved for that purpose within the drugs licence. This could be:
- using the drug for a different health condition
- in a different group of patients
- changing the dose or how the medicine is received.
When this is the case, the drug can be prescribed for the individual. However, the doctor then takes full responsibility for the individual outcome. This process if known as 'off-label prescribing'.