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How does a drug receive a licence that allows it to be marketed?

A pharmaceutical company will make an application to one of two drug regulatory bodies: either the European Agency for the Evaluation of Medicinal Products (EMEA) or the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA). The application and all the research evidence is then examined by experts, who judge the drug’s safety, quality and effectiveness.

Neither the Department of Health nor the National Institute for Health and Clinical Excellence (NICE) play any part in this process. The application is a confidential matter between the drug company and the regulatory body

Will the NHS fund an unlicensed drug if my doctor wants to prescribe it for me?

It is possible for your doctor to prescribe a drug outside the indications (uses) it is licensed for, if they are willing to take personal responsibility for this ‘off-licence’ use of a treatment. He or she would make this decision after discussing with you the potential risks and taking into account your medical history.

Your local primary care trust (PCT) may also need to be involved, as it would have to decide whether to support your doctor’s decision and pay for the drug from NHS budgets. 

The licensing process is designed to ensure that a drug is both safe and effective. It’s important to balance the possibility of introducing the benefits that new drugs may bring with the need to ensure that they are safe. For example, it is important to ensure that potential side effects from a drug do not outweigh the benefits for which the drug is prescribed. 

What is NICE’s role?

Sometimes when a drug is licensed it is important to give the NHS advice about whether or not it is clinically and cost effective for use in the NHS. This is to ensure that the NHS spends its money on the most efficient treatments.

The National Institute for Health and Clinical Excellence (NICE), an independent body, provides this advice to the NHS in England and Wales. NICE focuses its work on treatments that are of particular significance and where its advice will be of most benefit. 

If NICE recommends that a treatment should be used in the NHS, a PCT must fund its use for eligible patients (i.e. those who meet the criteria specified in the NICE guidance). This ensures that there is national consistency in how the NHS uses these treatments. 

Can I have a drug that is licensed but has not been appraised by NICE?

NICE does not issue guidance until a drug is licensed. The way in which a drug will be used is not always clear until the licensing process is completed. Between a drug being licensed and final NICE guidance being available, primary care trusts (PCTs) will decide whether to fund new treatments if and when they receive a request from a local patient or doctor.

A PCT should not refuse to fund a licensed treatment just because guidance is not available from NICE. They have to base their decision on an assessment of the evidence and the health needs of their local population.

These types of decisions are not new. NICE does not issue guidance on every licensed drug and PCTs already make many decisions locally about the use of their funds for different treatments. PCTs are best placed to make these decisions either until NICE guidance is available or where NICE guidance will not be produced.

Why aren’t I entitled to any treatment I want under patient choice?

The NHS does not have a limitless pot of money. Funding a particular drug/treatment means that these funds cannot then be used to pay for other sorts of healthcare. It is important that the health service uses treatments that are effective enough to justify their cost.

If you have any concerns about the treatment you have been offered, you can discuss this with your doctor or the Patient Advice and Liaison Service (PALS) at your local hospital.

European Agency for the Evaluation of Medicinal Products (EMEA), Medicines and Healthcare Products Regulatory Agency (MHRA), new medicines, new treatments, medicine, treatment


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