Who decides what drugs can be prescribed on the NHS?

Professor David Taylor: There are various bodies which influence whether or not medicines are prescribed in the UK. The European Medicines Agency (EMEA), generally speaking, approves the licensing of drugs in the EU, and our MHRA is part of that system.

MHRA is the Medicines and Health Regulations Authority. So the MHRA via the EMEA, approves medicines for use and that approval is based on assurances that the medicine works and, within limits, is also safe.

Because a medicine is licensed it doesn’t mean it will be prescribed. In the UK, there is another hoop to be jumped through which is NICE, and NICE is the National Institute for (Health and) Clinical Excellence and NICE looks at medicines that are licensed and makes recommendations as to whether they should be used in practice or not, and one of the considerations that they have, which the MHRA and the EMEA don’t, is something called cost-effectiveness – which is how much you get for what you spend on the medication.

NICE look at the treatment of various illnesses in a much broader way. So the EMEA and the MHRA will look at single drugs and decide whether they are effective, whereas NICE will look at a group of drugs and try to give some guidance as to which ones should be given first, second or third, which are better, which are worse, those kind of things. So you generally get much more comprehensive and useful information from NICE.

If something isn’t recommended by NICE, it can still lawfully be prescribed on the NHS, but there are systems in place which make it very difficult for a drug, which isn’t recommended by NICE to be prescribed. So, for example PCTs in the UK will not allow, PCTs – Primary Care Trusts – will not allow GPs in their area to prescribe certain drugs if they are not approved by NICE.

In hospitals, some non-approved NICE drugs are sometimes used, because their drugs budgets are managed in a different way. But it’s rare really, what tends to happen is that if a medicine is recommended by NICE, then the PCTs and the Trusts will also allow its use, but if it’s not recommended, then the PCTs are under no obligation to allow it to be used, and generally doesn’t allow it to be used.